[The following questions to be asked, verbatim, via phone interview]

Transcription

1 Appendix E1 Interview Script for VAS, TTO, and WTO [The following questions to be asked, verbatim, via phone interview] Visual Analog Scale for Fibroid Symptoms (Before Treatment) [The interviewer will describe the visual analog scale used as a measure of health utility (right) via telephone]: Imagine the degree of discomfort, or lack of it, that you had with fibroid-related symptoms. Imagine a scale that goes from zero to 100. If zero represents death and 100 is optimal health, tell us where you would rate your overall health with the degree of fibroid symptoms. Please take all things into consideration, including both your physical and mental health. Perfect Health Visual Analog Scale for Any Current Baseline Symptoms (After Treatment) [The interviewer will describe the visual analog scale used as a measure of health utility (right) via telephone]: Consider your current degree of discomfort, or lack of it, with fibroid-related symptoms now that you have had treatment. Imagine a scale that goes from zero to 100. If zero represents death and 100 is optimal health, tell us where you would rate your current overall health with the degree of fibroid symptoms. Please take all things into consideration, including both your physical and mental health. Remember, before your fibroid treatment, you rated your health at. TTO (Utility for Uterine Fibroid Health State): Fibroid-related Symptoms before Treatment Please focus again on your state of mind before you underwent treatment for your fibroids. I would like to give you a situation to imagine. Please assume for this exercise that you have a life expectancy of 10 years from now, following which you will have a painless death. Death Page 1 of 5

2 Imagine that you would spend those 10 years living with the same level of fibroid-related symptoms that you had before your treatment. Now, imagine that you could spend the next 10 years completely symptom-free, followed by death. Which offer would you take: 10 years with uterine fibroid symptoms or 10 years without uterine fibroid symptoms? [Patient rationally takes second alternative:] Would you choose 1 month completely symptom-free, followed by death, as opposed to 10 years with the fibroid-related symptoms? [If yes, stop. If no:] Would you choose 5 years completely symptom-free, followed by death, as opposed to 10 years with the fibroid-related symptoms? [Then, bisection to indifference point will be done. We will use a lower boundary of 1 month symptom-free vs 10 years with fibroid-related symptoms before stopping the assessment using bisection to indifference point.] TTO (Current Baseline Utility): Fibroid-related Symptoms after Treatment Please continue to focus on the current fibroid-related symptoms (or lack thereof) that are normal for you on a daily basis, after your treatment for fibroids. For this question, please assume for this exercise that you have a life expectancy of 10 years from now, following which you will have a painless death. Imagine that you would spend those 10 years living with your current level of fibroidrelated symptoms (or lack thereof) that you are having after your treatment. For example, think of your typical level of symptoms during the past few weeks. Now, imagine that you could spend the next 10 years completely symptom-free, followed by death. Which offer would you take: 10 years with current uterine fibroid symptoms after treatment or 10 years without uterine fibroid symptoms? Just to help you compare your answers, remember your stopping point for symptoms prior to treatment was: [We assume patient takes the second alternative, if she does not or is indifferent, then she is scored as having a utility of 1.0 and the assessment stops]. [If second alternative taken]: Would you choose 1 month completely symptom-free, followed by death, as opposed to 10 years with the current fibroid-related symptoms? [If yes, stop. If no:] Would you choose 5 years completely symptom-free, followed by death, as opposed to 10 years with your current level of fibroid-related symptoms? Page 2 of 5

3 WTO [Search pattern to indifference as previously] MR Imaging guided Focused Ultrasound Surgery Version Try to put yourself back in the frame of mind you had as you considered treatment for your keep in mind what you now know about the treatment you actually underwent with MR imaging guided focused ultrasound surgery. You and your doctor decided that it is time to obtain treatment for your uterine fibroid symptoms. Pretend that you are now living with the same pain, discomfort, bleeding, pressure One, you could undergo MR imaging guided focused ultrasound surgery, which, if you remember, involved being placed, belly-down, in an imaging unit that resembled a tunnel. You had an intravenous line placed in your arm for sedation and for injection of dye. You also had a bladder catheter placed. You received multiple short ultrasound treatments that were noisy and sometimes painful. You had to lie in this position for approximately 3 4 hours. Afterward, after some juice and crackers, you were able to leave right away. If you undergo this MR imaging guided focused ultrasound treatment, assume you will get immediate relief of your fibroid symptoms. minutes to complete and is completely pain-free. In addition, there is no known risk associated with it. You can go home immediately after the treatment. The catch is that you have to wait 12 weeks to get equivalent relief of your fibroid symptoms of pain, bleeding, and pressure. So, which option would you choose: MR imaging guided focused ultrasound surgery, which took about 3 4 hours to complete, was noisy and uncomfortable, had some painful ultrasound treatments, required an intravenous catheter for sedation and dye, and required a bladder catheter but gives you immediate pain relief, or option 2, in which you would have a quick, completely pain-free procedure but would require you to wait 12 weeks to get symptom relief. According to your doctor, the treatments would work equally well to provide symptom relief. Which treatment would you prefer? versus immediate relief with MR imaging guided focused ultrasound surgery. Which would you prefer? new treatment? [If yes to new treatment, then bisect between 1 day and 12 weeks to 6 weeks, until indifference point is found]. UAE Version Page 3 of 5

4 Try to put yourself back in the frame of mind you had as you considered treatment for your keep in mind what you now know about the treatment you actually underwent with UAE. You and your doctor decided that it is time to obtain treatment for your uterine fibroid symptoms. Pretend that you are now living with the same pain, discomfort, bleeding, pressure, One, you could undergo UAE, which, if you remember, involved lying on your back in the angiography suite in radiology. You had an intravenous line placed in your arm for sedation. You also had a bladder catheter placed. You received local anesthesia in the groin before having a small nick made in your skin. Through this little incision, and under x-ray guidance, a needle was placed, which was then substituted for a catheter, though which you received dye. Particles were then injected through the catheter to block the blood supply to your fibroid (s). You had to lie in this position for approximately 1 2 hours. Afterward, you were possibly admitted to the hospital overnight, or were monitored for some time afterward, before being discharged. You possibly had some pain and cramping for a few days afterward. If you undergo this UAE treatment, assume you will get immediate relief of your fibroid symptoms. minutes to complete, is completely pain-free, and there is no known risk associated with it. You can go home immediately after the treatment. The catch is that you have to wait 12 weeks to get equivalent relief of your fibroid symptoms of pain, bleeding, and pressure. So, which option would you choose: UAE, which took about 1 2 hours to complete, required you to remain in hospital for observation for some time afterward or overnight, required an intravenous line for sedation and a bladder catheter, required a small nick in the skin for catheter placement, and also may have resulted in some pain and cramping for a few days, but gives you immediate fibroid pain relief, or option 2, in which you would have a quick, completely pain-free procedure, but would require you to wait 12 weeks to get symptom relief. According to your doctor, the treatments would work equally well to provide symptom relief. Which treatment would you prefer? versus immediate relief with UAE? Which would you prefer? new treatment? [If yes to new treatment, 6 weeks is offered and then bisect until indifference point is found.] Abdominal Hysterectomy Version Try to put yourself back in the frame of mind you had as you considered treatment for your keep in mind what you now know about the treatment you actually had with abdominal hysterectomy. Page 4 of 5

5 You and your doctor decided that it is time to obtain treatment for your uterine fibroid symptoms. Pretend that you are now living with the same pain, discomfort, bleeding, pressure, One, you could undergo abdominal hysterectomy, which, if you remember, involved being in the operating room. You had an intravenous line placed in your arm and you also had a bladder catheter placed. You received general anesthesia, and when you were woken up you had monitors attached to you, you were receiving pain medication, and you had an abdominal wall wound. You remained in the hospital for some days, and after discharge you may have been tired and weak and had abdominal pain and perhaps some bleeding for some time. You could not return to your normal daily activities for some time. If you undergo an abdominal hysterectomy, assume you will get immediate relief of your fibroid symptoms. minutes to complete and is completely pain-free; in addition, there is no known risk associated with it. You can go home immediately after the treatment. The catch is that you have to wait 12 weeks to get equivalent relief of your fibroid symptoms of pain, bleeding, and pressure. So, which option would you choose: abdominal hysterectomy, which involved general anesthesia, noisy monitors, a bladder catheter, an abdominal incision, nausea, substantial abdominal pain for some time afterward, and inability to get back to normal daily activities for some weeks but which gives you immediate pain relief from fibroids, or option 2, in which you would have a quick, completely pain-free procedure but would require you to wait 12 weeks to get symptom relief. According to your doctor, the treatments would work equally well to provide symptom relief. Which treatment would you prefer? versus immediate relief with hysterectomy. Which would you prefer? new treatment? [If yes to new treatment, 6 weeks is offered and then bisect until indifference point is found.] Page 5 of 5