Evaluation of competence in ultrasound-guided procedures-a generic assessment tool developed through the Delphi method.

OBJECTIVES: To develop a generic and objective tool for assessing competence in percutaneous ultrasound-guided procedures. METHODS: Interventional ultrasound experts from the Nordic countries were invited to participate in a three-round Delphi process. A steering committee was formed to manage the process. In round 1, the experts were asked to suggest all aspects to consider when assessing competence in US-guided procedures. Suggestions were analyzed and condensed into assessment items. In round 2, the expert panel rated these items on a 1-5 scale and suggested new items. Items with a mean rating of ≤ 3.5 were excluded. In round 3, the expert panel rated the list items and suggested changes to the items. RESULTS: Twenty-five experts were invited, and response rates in the three rounds were 68% (17 out of 25), 100% (17 out of 17), and 100% (17 out of 17). The three-round Delphi process resulted in a 12-item assessment tool, using a five-point rating scale. The final assessment tool evaluates pre-procedural planning, US technique, procedural technique, patient safety, communication, and teamwork. CONCLUSIONS: Expert consensus was achieved on a generic tool for assessment of competence in percutaneous ultrasound-guided procedures-the Interventional Ultrasound Skills Evaluation (IUSE). This is the initial step in ensuring a valid and reliable method for assessment of interventional US skill. KEY POINTS: • Through a Delphi process, expert consensus was achieved on the content of an assessment tool for percutaneous ultrasound-guided procedures-the Interventional Ultrasound Skills Evaluation (IUSE) tool. • The IUSE tool is comprehensive and covers pre-procedural planning, US technique, procedural technique, patient safety, communication, and teamwork. • This is an important step in ensuring valid and reliable assessment of interventional US skills.

Simulation-Based Training of Ultrasound-Guided Procedures in Radiology - A Systematic Review.

PURPOSE: To perform a systematic review of the effect of simulation-based training (SBT) of percutaneous abdominal and thoracic ultrasound-guided procedures and to assess the transfer of procedural competence to a clinical context. MATERIALS AND METHODS: This systematic review was conducted in accordance with the PRISMA statement. Pubmed, Embase, Web of Science, and the Cochrane Library were searched for studies assessing procedural competence after SBT. Two authors independently reviewed all studies and extracted data. Risk of bias was assessed using the Cochrane tool for randomized studies (RoB) and non-randomized studies (ROBINS-I). Quality of evidence was assessed using the GRADE approach. RESULTS: 42 studies were included. 6 were randomized controlled, 3 non-randomized controlled, and 33 non-randomized non-controlled. 26 studies examined US-guided abdominal procedures, 13 examined thoracic procedures, and 3 examined both. The results favored SBT compared to other educational interventions and found that training was superior to no training. Only two studies examined the transfer of procedural skills to a clinical context. All studies had a high or critical risk of bias. Thus, the quality of evidence for the effect of SBT on procedural competence was low, and evidence for its transfer to a clinical context was very low. CONCLUSION: The evidence supporting SBT of percutaneous abdominal and thoracic US-guided procedures remains insufficient due to methodological problems and a high risk of bias. Future studies should be randomized and single-blinded, use assessment tools supported by validity evidence, compare different educational strategies, and examine the transfer of skills to a clinical setting.

The Concizumab Pen-Injector is Easy to Use and Preferred by Hemophilia Patients and Caregivers: A Usability Study Assessing Pen-Injector Handling and Preference.

Introduction: Concizumab is a once-daily prophylactic treatment developed for patients with hemophilia A or B (HA/HB) with or without inhibitors. It is the first treatment for hemophilia patients to be delivered subcutaneously using a pre-filled, multi-dose pen-injector with a 4 mm, 32 G needle. Aim: To investigate patient and caregiver handling and preference for the concizumab pen-injector compared with current injection systems used to treat hemophilia. Methods: This preference and handling study was conducted in accordance with authority guidelines for approval of new devices and included adults and adolescents with HA/HB with or without inhibitors and caregivers currently administering factor replacement therapy or factor VIII mimetic (emicizumab) therapy. All participants underwent a training session, followed by a test session during which participants independently administered a single pen-injection into an injection pad or manikin. Time to train, time to prepare and inject, and number of complete independent injections handling the pen were assessed. Participants evaluated handling and preference via the Hemophilia Device Handling and Preference Assessment Questionnaire. Results: 80 participants (44 adults, 21 adolescents, 15 caregivers) currently using factor replacement therapy (n=41, 51%) or emicizumab (n=39, 49%) participated. Average training time and time to complete an injection were 7 min 49s and 1 min 21s. In total, 98% of independent complete injections were achieved at first attempt. 98% (n=78; 95% confidence interval [CI] 91-100%) of participants assessed the pen-injector as either "easy" or "very easy" to use. 88% of participants preferred the pen-injector (n=70; 95% CI 78-94%) over their current injection system, and 9% (n=7) reported "no preference". Conclusion: Participants found the concizumab pen-injector easy to learn and easy to use and preferred it over their current injection systems.

People with hemophilia lack clotting factors that help stop bleeding after an injury. If left untreated, it can lead to life-threatening bleeding episodes. Treatment such as replacement therapy with clotting factors needs to be administered at regular intervals to prevent bleeding. The administration of intravenous (inside the vein) medication can be challenging due to the required skills, injection pain and availability of a good vein to inject into. Factor VIII mimetic therapy now allows people to inject medication under the skin (subcutaneously). However, using vials and syringes still poses challenges with the time to prepare and inject medication. Pen-injectors have been developed to address these challenges and provide additional benefits, including increased dose accuracy, portability, reduced discomfort, and less administration time. Concizumab is a medication developed for once-daily subcutaneous injection for people with hemophilia A or hemophilia B, with or without inhibitors, using a pen-injector. The objective of this preference and handling study was to understand patient and caregiver pen-injector handling experiences, and device preferences compared to their existing devices. In this study, most participants found it easy to learn to use the pen-injector. 98% of participants reported that the pen-injector was easy or very easy to use compared with their current device. 88% of participants reported a preference for the concizumab pen-injector over their current device. This shows that the pen-injector can easily and effectively be used to inject concizumab, providing more control and independence in patients' treatment while reducing the burden caused by intravenous modes of administration.