Questionnaire.
Supplementary data to: Physicians’ experiences and attitudes regarding imiquimod
treatment of vaginal and cervical intraepithelial neoplasia: survey among Dutch gynecologists.
1. What is your professional function?
Gynecologic oncologist or fellow gynecologic oncology
Gynecologist with semi-specialization in gynecologic oncology
Gynecologist with other (semi-) specialization
2. In what hospital type are you currently employed?
University hospital or specialized oncological center
Semi-specialized teaching hospitals
Non-teaching hospital
3. How many colposcopies do you conduct or supervise yearly?
Less than 30
30-100
More than 100
4. Which method do you usually apply for suspected high-grade dysplasia during colposcopy?
See-and-treat, regardless of age or future pregnancy wish
See-and-treat in older patients without future pregnancy wish and diagnostic biopsies in younger patients with potential pregnancy wish
Diagnostic biopsies, regardless of age or future pregnancy wish
Other: …
5. How large do you consider the additional risk of future premature birth following LLETZ, compared to the general population?
Not increased or marginally increased
Increased with a factor: … (whole number)
6. Do you discuss the additional risk of premature birth in pregnancies following LLETZ, with patients who have an indication for LLETZ?
Yes
No
Other: …
7. Are you aware of the application of imiquimod (Aldara®) for genital warts, in literature or clinical practice? Have you ever applied imiquimod for this indication?
I am aware of this, I have not applied it myself.
I am aware of this, I have applied it myself.
I am not aware of this.
8. Are you aware of the application of imiquimod (Aldara®) for vulvar intraepithelial neoplasia (VIN), in literature or clinical practice? Have you ever applied imiquimod for this indication?
I am aware of this, I have not applied it myself.
I am aware of this, I have applied it myself.
I am not aware of this.
9. Are you aware of the application of imiquimod (Aldara®) for vaginal intraepithelial neoplasia (VAIN), in literature or clinical practice? Have you ever applied imiquimod for this indication?
I am aware of this, I have not applied it myself. (to question 22)
I am aware of this, I have applied it myself. (to question 10)
I am not aware of this. (to question 22)
10. You have applied imiquimod in VAIN. How often have you applied it for this indication?
1-5 times
6-10 times
More than 10 times
11. What was(/were) the lesion grade(s)?
Low grade lesion(s) (VAIN 1)
High grade lesion(s) (VAIN 2-3)
Both
12. Was it a primary or recurrent lesion?
Primary lesion(s)
Recurrent lesion(s)
Both
13. What was your rationale for using imiquimod in the treatment of this lesion? (open question)
14. How did you apply the imiquimod? (multiple options possible)
Vaginal capsule
Vaginal suppository
Vaginal tampon
Vaginal applicator
Other: …
15. What was the dosing scheme and treatment period? (open question)
16. How did you evaluate treatment efficacy (multiple options possible)
Cytology only
Colposcopy without biopsies
Colposcopy with biopsies
Other: …
17. Was treatment of the VAIN lesion(s) with imiquimod successful? (multiple options possible)
Yes: lesions regression, invasive treatment no longer necessary
Yes: complete remission, invasive treatment no longer necessary
No: persistent lesion
No: progressive lesion
18. Which side effects did you notice in the patients who were treated with imiquimod for VAIN?
(multiple options possible)
Vaginal/vulvar pain
Vulvar erythema
Vulvar erosion/ulceration
Vaginal discharge
Flu-like symptoms
Other: …
19. How serious were the side effects mentioned in the last questions, in general?
No side effects noticed
Mild side effects
Moderate side effects
Severe side effects
Comment: …
20. Did any of your patients stop imiquimod treatment due to side effects?
Yes
No
Comment: …
21. Would you recommend treatment of VAIN with imiquimod and would you apply it again?
Yes
No
Comment: ….
22. Are you aware of the application of imiquimod (Aldara®) for cervical intraepithelial neoplasia (CIN), in literature or clinical practice? Have you ever applied imiquimod for this indication?
I am aware of this, I have not applied it myself. (to question 36)
I am aware of this, I have applied it myself. (to question 23)
I am not aware of this. (to question 36)
23. You have applied imiquimod in CIN. How often have you applied it for this indication?
1-5 times
6-10 times
More than 10 times
24. What was(/were) the lesion grade(s)?
Low grade lesion(s) (CIN 1)
High grade lesion(s) (CIN 2-3)
Both
25. Was it a primary or recurrent lesion?
Primary lesion(s)
Recurrent lesion(s)
Both
26. What was your rationale for using imiquimod in the treatment of this lesion? (open question)
27. How did you apply the imiquimod? (multiple options possible)
Vaginal capsule
Vaginal suppository
Vaginal tampon
Vaginal applicator
Other: …
28. What was the dosing scheme and treatment period? (open question)
29. How did you evaluate treatment efficacy (multiple options possible)
Cytology only
Colposcopy without biopsies
Colposcopy with biopsies
Other: …
30. Was treatment of the CIN lesion(s) with imiquimod successful? (multiple options possible)
Yes: lesions regression, invasive treatment no longer necessary
Yes: complete remission, invasive treatment no longer necessary
No: persistent lesion
No: progressive lesion
31. Which side effects did you notice in the patients who were treated with imiquimod for CIN?
(multiple options possible)
Vaginal/vulvar pain
Vulvar erythema
Vulvar erosion/ulceration
Vaginal discharge
Flu-like symptoms
Other: …
32. How serious were the side effects mentioned in the last questions, in general?
No side effects noticed
Mild side effects
Moderate side effects
Severe side effects
Comment: …
33. Did any of your patients stop imiquimod treatment due to side effects?
Yes
No
Comment: …
34. Would you recommend treatment of CIN with imiquimod and would you apply it again?
Yes
No
Comment: ….
35. We wish to conduct a retrospective analysis of treatment of (recurrent) CIN lesions with
imiquimod. Are you willing to share more detailed data with us? If you agree, you can leave your contact details here. We will not use you contact details for the analysis of this questionnaire.
36. Recently, an RCT was published on the treatment efficacy of imiquimod in high-grade CIN (Grimm, Obstet Gynecol, 2012). 59 patients with high-grade CIN (CIN2-3) were randomized to receive imiquimod or placebo during 16 weeks. Disease regression and remission was
significantly more common in patients who were treated with imiquimod than in patients treated with placebo (73% vs 39% and 47% vs 14% respectively). There was no disease progression in the imiquimod group. Side effects were acceptable for all patients.
If these results were to be confirmed in a larger trial, would you then consider using imiquimod in the treatment of high-grade CIN (CIN 2-3), for example in younger patients with a future
pregnancy wish?
Yes
No
Comment: …
37. Would you consider participating in a randomized controlled trial, evaluating treatment efficacy of imiquimod in treatment of high-grade CIN?
Yes
Maybe
No
Comment in case of ‘maybe’ or ‘no’: …
