Table 6 Different identified barriers and lessons learned on technical, patient selection, patient counseling, medical specialist and organizational level

Technique

1. Malfunction of device

2. Treatment failures resulting in low NPV%

- Bowel/ovaries in sonication beam pathway

- Abdominal scar in sonication beam pathway

- Abortion of sonication as a result of experienced pain

- Motion artifacts in case of small fibroids

1. Ensure well-trained technical medical staff

2. Facilitate site visitation by proctor before start

3. Train team after every update of device

4. Ensure the possibility of remote consultation of device manufacturer

5. Optimize manipulation protocol

6. Ensure continuous feedback from patient during treatment

7. Be able to perform alterations in treatment strategy: longer intermissions between sonications, wider distribution of sonication, altered wattage of sonication

8. Use a light or moderate sedation protocol with the possibility to perform patient specific alterations

9. Use breath holding instructions in case of small (< 3 cm diameter) fibroids

Patient selection

1. Low eligibility number

2. Heating failures resulting in no or low NPV%

3. High number of adverse events

4. Misinterpretation of retention bladder

5. Low NPV% resulting in high reintervention rate

6. No uniformity in collected MRI data leading to difficulties in assessing eligibility

7. No uniformity in collected MRI data of treatment effect in follow-up

1. Expend inclusion criteria based on recent literature and gained experience

2. Keep in mind that multiple inclusion criteria combined can lead to unsuitable patients

3. Use the latest equipment version including an integrated cooling system

4. Keep in mind that a uterine fibroid on a bladder ultrasound, performed after removal of a catheter, can be mistaken for urinary retention and therefore lead to unnecessary interventions

5. Manipulation and sedation protocol optimization can contribute to a high NPV%

6. Development of MRI scan review templates, either for screening, treatment or follow-up, leads to uniform data collection

Patient counseling

1. Inadequate counseling

2. To high expectations of treatment effect

1. Facilitate additional counseling performed by a direct involved member of the treatment team

2. Emphasize on realistic expectations of MR-HIFU treatment and timespan of treatment effect

Medical specialists

1. Fear for loss of income at gynecology department

2. Responsibility for patient on treatment day

1. Collect referral data

2. Perform substitution analysis

3. Appoint a medical specialist who is responsible during screening, on the treatment day and during follow-up

Organization

1. Unfamiliar with implementation of new treatment option

2. Lack of research department in non-academic hospital

3. Lack of nursing ward in radiology department and unfamiliarity with MR-HIFU treatment on nursing ward

4. Sparse MRI scanner time and time-consuming preparations

1. Invest in infrastructure (e.g., a research unit) to smoothen the implementation process

2. Involve all responsible parties (e.g., medical specialists) from the start to feel jointly responsible for success of implementation

3. Train nurses and develop a standardized nursing protocol

4. Develop a Standardized Operating Procedure (SOP) besides a nursing protocol to save sparse MRI scanner time and improve both efficiency and safety

5. Add administration of a uterus stimulant during treatment to improve sonication efficiency