There are few studies describing the use of POCUS in general medicine. Most of them are
descriptive studies made more than ten years ago while recent technological development has
resulted in better quality images. There is no study with high level of evidence, and the
majority of the literature is made of descriptive reports based on the activity of a small
number of physicians.
Unlike other countries, France has currently no recommendations on the modalities of use for
POCUS. There are no guidelines on the GP curriculum nor on the appropriate equipment for
general practitioners, nor on the certification process.
In the current state of knowledge, it seems relevant to establish an overview of the practice
of POCUS in general medicine in France. This work is part of an international European
reflection on the use of POCUS in general practice and its role in the diagnostic process,
therapeutic process and the patients' care pathway in Denmark, in Norway and in France.
The current protocol was written in collaboration with the GP Research Unit of Aalborg. The
Danish protocol was completed between January 2018 and July 2019 in Denmark, registered at
clinicaltrials.gov NCT03375333. This part of the protocol constitutes the French study.
The aim of this study is to describe the use of POCUS and its role in the diagnostic and
therapeutic process in general medicine.
Description of the use of POCUS through indication, organs scanned, findings, frequency, time
consumption.
Analysis of the role of POCUS in the diagnostic process: change of diagnostic hypotheses and
change of certainty in the main diagnostic hypothesis.
Analysis of the role of POCUS in the therapeutic process: change in the care pathway and the
therapeutic initial plan.
The study is a prospective observational cohort study. It will take place in France among 30
GPs that use POCUS during consults in their office or during home visits.
Any patient having a POCUS scan during a consultation by a participant GP may be included in
the study. Patients will be informed and asked to sign a consent form before inclusion in the
study. Patients will be informed of the study terms by their GP and through an information
note in the waiting room. Patients will be excluded if they refuse to participate in the
study or are unable to give informed consent. Refusal to participate in the study will not
change patient management.
There will be no intervention in this study. The GPs already use ultrasound during their
physical examination. The data recorded for this study will reflect the daily practice of
general practitioners using POCUS. There will be no additional exams or other ways to change
the patient management. If a second POCUS is performed later for the same patient, this data
will not be collected. Only data from the patient's first examination will be collected.
Each investigator will collect data about every POCUS examination performed during the
inclusion period of 22 consecutive working days.
The data collection tool is based on the questionnaire originally developed by the Center for
General Practice at Aalborg University in Denmark from literature data, a dialogue with the
"Ultrasound group of the Danish College of General Medicine" and an interview study. The
registration tool was developed as a questionnaire to be used before and after the GP uses
POCUS in the consultation. A time log is included to ensure that the questionnaire has been
completed before and after the exam.
For this study, the questionnaire will first be translated into French and then
back-translated (reverse French-English translation) by two bilingual translators separately.
The result of the back-translation will be analyzed and a second French version will be
submitted to French general practitioners practicing POCUS and members of the "Ultrasounds
group of the College of General Medicine" in France. For each theme of the questionnaire,
there will be a common part of questions, to ensure the comparability of the results between
the different European countries. An additional set of questions relevant to general practice
in France will be discussed and validated by the French College of General Medicine. The
acceptability and validity of the questionnaire will be tested during focus groups and a
pilot study.
The GPs will be asked to fill a questionnaire in the online database SurveyXact each time
they use POCUS during their daily work. The data will be registered electronically in
SurveyXact with a time log to ensure a before and after registration.
The GPs can access the questionnaire on their mobile phone, iPad or computer, using a unique
link (respondent link) allocated to each participant. A key file, connecting each GP
participant with the respondent link in SurveyXact (link), will be safely stored at Center
for General Practice at Aalborg University, Denmark.
The GPs will give each patient a unique ID-number. A key file connecting this ID-number and
the patient's identity will be safely stored at the GP's clinic.
There will be a registration of the date and time, when the GP starts filling the
questionnaire and finishes the final question. Furthermore, a variable with the exact time
between "before" and "after" questions will be created. If GPs use less than one minute on
this page and the GP registers a duration of the POC-US > 1 minute, there will be no "before
and after" registration, but only an "after" registration. In that case, the "before" answers
will be excluded.
Participants retention In order to calculate the participant retention rate, defined by the
proportion of eligible patients included in the study, GPs will be asked to record age and
gender for each patient eligible but not included in the study (time constraints, patient
refusal or other reasons).
Data management Data will be saved electronically on the SurveyXact server and on a server at
Aalborg University and will only be accessed by the research group using personal passwords.
The patient key file and consent forms will be safely stored at the GPs' office and the
research group will not have access to this information during the study.
Any paper editions of the registration tool or questionnaire (in case of server breakdown)
will be safely stored at the GPs office until the end of the data collection. Afterwards,
they will be safely stored at the General Practice Department of Sorbonne University, 27 rue
de Chaligny, PARIS 75012, FRANCE.
The use of ultrasound will be described in terms of ultrasound indications, organs explored,
findings, frequency of use and duration of the examination.
The indications of POCUS will be described through the GP's intention regarding ultrasound:
to answer a specific clinical question (yes / no / maybe) and document the answer in the
medical file
to conduct therapeutic education
to monitor or control an ultrasound finding
to screen an asymptomatic patient
to scan to improve technical ultrasound skills without any clinical profit
to perform a diagnostic scan with a detailed description of anatomical regions and
provide a complete diagnostic report.
The frequency of the different POCUS examinations will be summarized in relation to the
organs scanned. The performed POCUS examinations are defined as organs scanned and not as
standardized procedures such as FAST, FATE or LUS since there might be differences in the
definition and interpretation of these examinations. The organs scanned are registered on a
list of organs in the questionnaire. The possibilities in this list originate from interviews
with GPs using POCUS and from Danish pilot testing. This list will be discussed during a
focus group of French GPs using POCUS. The GPs will be allowed to write in free text if
organs are missing from the list.
The frequency of POCUS use will be described as the number of GP consultations where POCUS is
used over the total number of GP consultations per day during 22 consecutive working days.
Each participant will provide information on the total number of face-to-face consultations
she or he has had during the study period. If the GP uses a portable or ultraportable
ultrasound device during home visits, they will be included in the total number of
consultations.
The GPs will measure the time used for the POCUS examination. The time registration starts
when the scanning begins and ends when the scanning has been finished. Hence, it will only
include the duration of the POC-US examination, not information about the scanning or other
elements of the consultation. This time registration will be described in minutes for each
type of POC-US examination.
The study will describe the main diagnostic hypothesis recorded before and after POCUS, the
total number of diagnostic hypotheses recorded before and after POCUS, the change in the
total number of diagnoses hypotheses, the change in the GP's confidence in the diagnostic
hypotheses (5-point Likert scale). To test the reliability of the GP confidence in the
diagnoses, we will describe the correlation between the GP's confidence and the type of organ
scanned, the change from a symptom diagnosis to a disease diagnosis and the decrease in the
number of diagnostic hypotheses. A scatter plot will be used to describe the relationship
between "confidence in the main diagnostic hypothesis" and "the number of diagnostic
hypotheses". Frequency of incidental findings will be described separately related to the
organs explored.
After the use of POCUS, the GPs will be shown their "Before-POCUS" diagnostic hypothesis and
asked if these diagnoses have changed. If the diagnoses have changed, they will be asked to
specify them.
The diagnostic hypotheses are registered as detailed free text in the questionnaire. The
corresponding ICPC-2 (International Classification of Primary Care-2) codes will be coded
from the free text by the research team.
The observed change in the diagnostic hypotheses will be described by the frequency of
declared diagnostic hypotheses changes and the overall registered change in the ICPC-2 codes.
The patient's plan before and after POCUS and the planned treatment before and after POCUS
will be described. The analysis will describe the relationship between the ultrasound
findings and the change in the patient management (diagnostic process, treatment, care
pathway). The diagnostic and therapeutic modifications will be described by the frequency of
responses or by the change in the total number of responses.
The statistical analysis will be descriptive. Data collection will mainly be done using
nominal variables. However, the variable "GP's confidence in the diagnostic hypotheses" will
be measured by an ordinal variable, "the duration of the examination" and "the patient's age"
by a continuous variable.
The categorical variables will be described using contingency tables and Chi-2 test and
Fisher's exact test will be used to test the relationship between the variables. If the
continuous variables follow the normal distribution, they will be described with means and
either a standard deviation or a 95% confidence interval of the mean. If they are not
normally distributed, they will be described with a median and interquartile range.
After using POC-US the GP is shown the "before POC-US plan for the patient" and asked if this
plan has changed. If the plan has changed, the GP is asked to specify.
Change in the plan for the patient is defined as the frequency of declared change after
registration from one possible answer to another or change in the total number of possible
answers.
After using POCUS, the GP is shown the "before POC-US planned treatment for the patient" and
asked if this planned treatment has changed. If the planned treatment has changed, the GP is
asked to specify.
Change in the planned treatment of patients is defined as the frequency of declared change
described before and after registration from one possible answer to another, or in the total
number of possible answers.