Impact on Diagnostic Accuracy of a Specific Clinical Ultrasound Practical Teaching
Condition: Gallstone
MeSH terms: Gallstones
Study type: Observational

Summary: 
      This research proposal is a pilot double-blind randomized control trial evaluating the impact
      on diagnostic accuracy of a Clinical UltraSound (CUS) teaching for gallbladder assessment
      using exclusively healthy volunteers for practical sessions. Classically, a number of 25 to
      50 CUS of the gallbladder is reported to achieve competency. Many CUS curricula or guidelines
      recommend reporting pathological cases, either a certain amount, either generically, in their
      core-ultrasound competency requirements. Using healthy volunteers is rarely meant to verify
      the hypothesis that practical sessions based on exclusively normal patterns combined with
      presentation of pathological ultrasound loops or images during theoretical sessions, could
      further allow reaching diagnostic accuracy requirements in clinical practice. In the present
      study, participants will be medical students in their 5th year, naïve to CUS use.
      Participants will be randomly be distributed between a control group undergoing a standard
      practical teaching on models presenting uncomplicated gallstones or normal gallbladder (no
      gallstones), and an intervention group undergoing a practical teaching exclusively on models
      presenting a normal gallbladder. Participants will be "blinded" to study endpoints as well as
      to group allocation. After three days of practical teaching on day 0-10-30, students will be
      evaluated on day 60 by 2 external investigators blinded to students group allocation.
      Diagnostic accuracy for gallstones will be measured using sensitivity and specificity.
      Statistical analysis will be performed blinded to students' name using IBM SPSS statistics
      26.0 (SPSS Inc., Chicago, IL, USA). As is classical, the statistical tests will be rejected
      whenever the observed p-value is smaller than 0.05. Corrections for multiple testing will be
      used. A comparable diagnostic accuracy between groups could further support the use of
      healthy volunteers during practical teaching and ease clinical ultrasound curricula. Such a
      finding wouldn't however carry away the need for enhancing competencies during clinical
      practice or the need for continuing medical education, as for any medical procedure.
    

Detailed description: 
      Background Critical care and emergency medicine are both specialties covering all types of
      pathologies concerning multiple etiologies and systems. Clinical UltraSound (CUS) curricula
      concerning those specialties are accordingly covering a wide range of ultrasound improved
      clinical examination. Recently, a questionnaire sent to American medical schools, reporting
      84% response rate, enlightened that 55% of the clinical ultrasound course directors are
      emergency physicians. This supports the great implication of emergency medicine in CUS
      development.

      In 2015, the International Federation for Emergency Medicine (IFEM) Point of Care UltraSound
      (PoCUS) published an evidence-based consensus document for CUS curriculum based on national
      and international guidelines. Previously, the Council of Emergency Medicine Residency
      Director-Academy of Emergency Ultrasound (CORD-AEUS) consensus established guidelines to
      organize CUS training and assess resident competencies. To actual knowledge, although CUS
      training programs around the globe support the use of specific training to achieve CUS
      introduction in the emergency departments endorsing its use, there are still significant
      variations among proposed curricula. The training requirements are mostly described for
      core-ultrasound. Generally, core-ultrasound curricula encompass the skill acquisition of
      extended-Focused Assessment Sonography for Trauma (e-FAST), Aortic Aneurysm Assessment (AAA),
      basic cardiac and lung ultrasound and basic procedural ultrasound. Some include biliary and
      urinary tract assessment whereas others consider biliary and urinary tract assessment part of
      advanced CUS teaching. Most other specialties however focus their ultrasound teaching on the
      field of interest. For instance, urologists learn how to perform an ultrasound assessment of
      the urinary tract or the prostate whereas gastroenterologists focus their ultrasound ability
      on bowel and biliary.

      Currently, based on emergency medicine requirements, the CUS training consist of an initial
      introduction followed by gaining experience throughout image acquisition, image
      interpretation and clinical integration and finally achieving competency. Different
      approaches and methods of teaching are available and often a combination of those is
      recommended in available curricula description. Many recommend reporting pathological CUS
      cases among ultrasound images compeeled in a logbook, either a certain amount (20% to 50%),
      either generically, in their core-ultrasound competency requirements. Although its benefit
      for emergency medicine clinical practice is substantial and evidence based, the introduction
      of CUS in emergency physicians' practice is evidently time consuming possibly due to
      theoretical and practical sessions requirements and assessments as well as bedside
      supervision. Several curricula recently included CUS to emergency medicine requirements
      program and more broadly to medical students' courses. This brings to a large number the need
      for CUS bedside teaching combined with other sources of competence achievement.

      In an emergency clinical setting, the use of CUS for hepatobiliary assessment is mostly
      centered on inflammation and obstruction. Cholecystitis is known to be, from 95% to 99% of
      cases secondary to gallstones. Gallstones are accessible to CUS and, included in the clinical
      context, can strengthen the suspicion of cholecystitis. In a systematic review performed in
      2011, the pooled estimates for sensitivity and specificity were 89.8% (95% confidence
      interval (CI) 86.4% to 92.5%) and 88.0% (95% CI 83.7% to 91.4%), respectively for gallstones
      detection using EUS. This is consistent with this finding being valuable for clinical
      practice. Although some studies supported the number to achieve agreement with expert for
      gallbladder assessment to be 25 to 50, a prospective study including 1837 patients from 1999
      to 2006, reported the learning curve of emergency physicians for the evaluation of
      gallbladder is poorly influenced by the number of bedside examinations. Those considerations
      suggest other sources of competency achievement should be evaluated rather than the number of
      examinations itself.

      Classically, initial CUS introduction uses short lectures combined with demonstration,
      "hands-on" skill teaching, simulation sessions, discussions, web-based learning and practical
      scanning on volunteers, models and patients. Occasionally, pathological models are difficult
      to find and bedside teaching, apart from clinical shift, is exclusively possible on
      volunteers presenting a normal pattern. This enlightens the need for studies evaluating the
      CUS training pathway using exclusively healthy volunteers compared to the use of pathological
      findings during practical sessions. This is strengthen by the introduction of CUS courses
      among medical schools. Indeed, unlike residents or physicians, medical students don't have as
      much possibility to access practical CUS training on patients presenting pathological
      patterns.

      The following study is meant to give insights about the CUS skills acquisition to accurately
      diagnose gallstones using exclusively training on healthy volunteers after a standardized web
      based theoretical teaching about pathological and non-pathological gallbladder CUS. This
      could support the use of only healthy volunteers during practical sessions. The teaching of
      pathological images recognition could exclusively be done throughout theoretical sessions.
      Although this would neither avoid the need for enhancing competencies bedside, neither avoid
      continuous logging activity and regular CUS continuing medical education, this could
      secondary help CUS teaching by reducing the need for bedside supervision during clinical
      shifts. Indeed, to knowledge, bedside supervision is difficult to achieve in some emergency
      departments and CUS fellows have trouble to properly fill out a " logbook ". Organizing CUS
      teaching around normal pattern recognition associated to a theoretical course presenting
      pathological findings could lead to change CUS fellows' assessment. Those could be evaluated
      theoretically using pathological ultrasound images or loops and could be evaluated
      practically on healthy volunteers. This would avoid compelling a " logbook " which can arise
      some ethical discussion about patient consent and use of images even if the latter are
      classically anonymized.

      According to scope literature review, no randomized control study has been published
      establishing the skills acquisition for gallstones findings. This study being a pilot one, it
      will allow to precise the feasibility of a proper randomized control trial and to evaluate
      sample size. This study could also be the starting point of randomized control trials
      concerning the teaching of other pathological findings such as free fluid, aortic aneurism,
      cardiac assessment, hydronephrosis.

      The Main objectives to evaluate if CUS skills to diagnose gallstones can be acquired by 5th
      year medical students naïve to CUS use exclusively throughout practical sessions on healthy
      volunteers after a standardized theoretical teaching using a web-based passive video
      learning.

      The Trial design is a pilot double-blind randomized control trial. 20 participants are
      randomly assigned to CG or IG using pre-defined blocks of 10 participants per group.
      Consolidation of knowledge and skills' acquisition for gallbladder evaluation using CUS take
      place during 3 teaching sessions (day 0-10-30) given by CUS instructors on volunteers.
      Evaluation of diagnostic accuracy (day 60) is performed at the end of the 2 months teaching
      period by two blinded examiners. The teaching is performed according to an expanding time
      interval as supported by a recent review.

      Study members

      --> Instructors Instructors are selected from the population of experts in CUS of the
      gallbladder in Belgium ; they are invited to participate via e-mail.

      Each instructor receives a financial compensation for participating to the study.

      Instructors are not blinded to participants' allocation. Instructors sign a "non-disclosure
      agreement" meaning they cannot give information to a third party during the entire duration
      of the study.

      --> Volunteers Healthy volunteers are invited to participate by e-mail. Volunteers are
      selected using a web-based questionnaire asking for characteristics (age, sex, BMI).

      Volunteers presenting a pathological gallbladder status (gallstones, sludge), are invited to
      participate throughout the consultation of surgery of the "Cliniques Universitaires
      Saint-Luc", before an elective surgery is planned.

      Volunteers are paired for age (+/- 5 years) and BMI (+/- 1) between groups to avoid selection
      bias.

      Volunteers are eligible if:

        -  Between 18 and 70 years old

        -  Signed consent for participation and "non-disclosure agreement" 1 obtained

        -  Underwent a formal ultrasound previous to the study day in order to confirm gallbladder
           status (gallstones or sludge yes/no), performed by a CUS expert independent from the
           study

        -  Do not have persistent abdominal pain or cholecystitis symptoms Volunteers are committed
           to "non-disclosure agreement" about their gallbladder status during their participation
           to the study, except in case of medical consultation for personal matter.

             -  Examiners Two examiners, blinded to participant allocation, evaluate practical
                skills of participants for gallbladder assessment using CUS on day 60.

      Examiners are international experts in CUS coming from United Kingdom.
    

Intervention name(s): Practical sessions to learn CUS exclusively on volunteers presenting a healthy gallbladder
Intervention type(s): Other
Intervention description(s): The study days are 1 day apart for CG and IG but follow the exact same organization. Studytake place on day 0-10-30 (+/-2days). Practical sessions to learn CUS are organized either on volunteers presenting a healthy gallbladder or a pathological gallbladder (sludge, gallstones) (CG), either exclusively on volunteers presenting a healthy gallbladder (IG).
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical students →Participants An e-mail invitation is send three times over a two weeks
        period for participants enrollment. Participants are selected among medical students in
        their 5th year (Master 2). If e-mail is not sufficient, participants are invited during a
        medical course given in Université Catholique de Louvain. Medical students are invited to
        answer to a questionnaire defining their CUS use status (naïve or not) to assess for
        eligibility.