Patient interviews
Table 1
Patient
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
Gender
|
Female
|
Male
|
Male
|
Female
|
Female
|
Male
|
Male
|
Vascular Medical
Notes
|
Previous arterial ulcerations.
PAD.
|
Intermittent Claudication (IC).
PAD.
|
IC.
PAD.
|
Current venous ulceration
|
Previous arterial ulceration.
Amputee.
PAD.
|
IC.
Previous arterial ulceration.
PAD.
|
Current venous ulceration.
|
Place of intervew
|
Own home
Oslo
|
Own home Oslo
|
Meeting room
Oslo
|
Meeting room Trondheim
|
Meeting room Trondheim
|
Meeting room Trondheim
|
Meeting room Trondheim
|
Theme 1. Impact of the disease process
Experiences of using FlowOx™ revealed recurrent dialogue from patients that focused on symptomatic changes to lower limb health. Personal accounts highlighted significant functional daily living changes from diagnosis and through disease progression. Pain levels and ulceration changes dictated physical activity limits:
“I could walk for some distance, and then I had to stop because it hurt so much.” [p3]
The experience of pain also affected the quality of sleep:
“It was like I put my toes in hot water. So, I had to go get up once every hour each night to walk around, slow it down…” [p6]
Most described treatment for ulceration and were within various stages ranging from static healing to complete resolution. Dialogue revealed how vascular compromise led to clinician discussion of the risks of amputation:
“There is the danger that I may lose a leg…” [p1]
The risk of limb loss ultimately led to experiencing feelings of fear and worry:
“So, I was afraid that I was going to lose both of them.” [p5]
“To go from being physically fit to talking about an amputation in a course of six months did things with me. It did do things with me mentally.” [p6]
Theme 2. Practicalities of using the “boot”
Description and demonstrations of how practical the device was to use emerged as a prominent theme. Most found the device comfortable and easy to use:
“Nothing difficult, ‘cause everything was easy.” [p4]
All were able to use the device independently:
“It’s an easy device to use. Just put it on and press the button and forget about it.” [p2]
Some practical usage issues were revealed with the seal component. Pulling on the seal proved difficult for some. It was postulated that the elderly may have difficulties with the design.:
“So there is some difficulty getting hold of it to get it over there...” [p3]
“I think that elderly people will not manage to use this without having home care or something similar…” [p7]
Differences in the seal material lead to an increase in size, corrosion and problems achieving maximum pressure:
“It started failing because it just got a little bigger and bigger.” [p1]
“The machine shows leakage.” [p2]
Views on whether personal health insurance would cover costs for this novel device were mixed and with one who was unsure:
“I don't know. I haven't asked. But I really hope they will do it, because I think many people can have another life with it.” [p2]
During device use, patients’ experienced various sensations within the leg and foot described as tingling and pain relief:
“And if I did feel discomfort, a lot of discomfort, it was the device that I actually used. So, if I really was having a lot pain, I used to put my foot into the boot and it did have an effect. Because it wasn't painful… When it was bad it was what I used to ease and comfort.” [p5]
The time taken to use the device, its inability to be a mobile device, the space taken to accommodate it and its sound became a burden for some:
“Three hours a day is three hours a day. And it's three hours missed to do something else.” [p4]
All described accommodating the device in their homes and around routines. One patient described using the device for longer than the prescribed daily two hours:
“…I was a little bit desperate at that time, so I was willing to push the boundaries probably. Okay, you know and I did use, I have probably overused it…I took control of it. I did. And being able to decide for myself that I was going to overuse the boot really was a decision that I'm quite happy that I did as well. Without actually knowing the technical or the medical information behind it. It was a chance I took.” [p6]
Theme 3. Positive experiences
Positive experiences from device use emerged throughout most interviews:
“I am a 100% happy up to now…I have nothing negative.” [p6]
Two patients gave lengthy detail to the changes to their lower limb health during device use and that had resulted in a complete symptomatic reversal, varying degrees of wound healing and complete wound resolution:
“…I understand that it was this block in the vein that was coming out. That was amazing…my usual doctor she couldn’t understand what’s happening. She was just wow… And the feeling was fantastic, too, because then I realised that my toes was safe.” [p6]
“I'm warm and good in my leg and my foot which was dead.” [p1]
Some described fond feelings for the device and relief in avoiding amputation. Continued use was described as necessary to prevent symptom deterioration:
“So now it's not repairing but keeping it as it shall be.” [p4]
“A little week without and my foot is going to be bigger.” [p7]
These positive health improvements were described as having a significant impact on the ability to carry out daily tasks:
“I couldn't walk…I had to use the wheelchair all the time, but now I can walk, I can do different things. “I am more like a normal person." [p2]
“I do everything which I could do before, so, my life quality has been very improved through this project.” [p5]
Theme 4. Perceived outcomes
Outcomes included improved healing, circulation, pain reduction and mobility:
“I think the healing may have come quicker because of it. I cannot say why, but, why I think so, but that's what I feel. I feel that everything…all the wounds were healed, eventually. And I think that healing process was a little bit quicker because of that.” [p6]
However, dialogue emerged from one patient with chronic venous ulceration experiencing minimal improvement:
“Maybe in the start in the first 14 days, my head thinks… It was a little tiny better, but then it all stopped.” [p4]
One patient remained unsure as to whether observed improvements were due to device use alone:
“I wish I had the information to say it was the boot that did that. I don't have that, and I don't know if anybody does, to be honest. If you take it in terms of where I was…and what was then introduced in my treatment from that period and after. There was only one change in my treatment, and that was the usage of the boot. It wouldn't be wrong to insinuate that the boot has had a very positive effect, if all, to my situation.” [p6]
For those with some or minimally perceived benefit, there remained a level of optimism for further use:
“I want it to work.” [p5]
Theme 5. Reflecting on use
The participants recommendations were a reflection on the potential value of device for others:
“ Well, as time goes by one is willing to try almost anything. I could not guarantee they would benefit from it, but I would be recommending it because of what experience that I've had.” [p1]
With current recommendation being implemented through social media, chat forums and casual discussion:
“There is a lot of people out there that have big problems. Big, big problems. I have spoken to them, and I have posted up my treatment. The thing that has always pushed forward which is the difference, which they don't have out there, is this treatment boot. There is interest for it. And people will, when it comes to your life, it is about being functional. If you're not functional it just ‘disabilitates’ everything else that's in your life.”[p4]
Views on how much they were willing to pay along with marketing suggestions for the device were mixed:
“So monetary wise it's certainly is worth a lot in terms of improving people’s functionality in their everyday life…it is a foot saver, you could say.” [p5]
"I call it the wonder machine."[p4]
“I can't set a price on it because it saved my life. It gave me my life back, in a way, so for me it's… priceless…one suck and you're hooked.”[p1]
Theme 1. Ideal clinical outcomes and how to measure them
Clinician experiences from prescribed use revealed a range of desired clinical outcomes, specifically saving limbs, relieving pain and wound stabilisation:
“I think it’s limb salvage… to save limbs.” [p5]
“I think the pain scale of the patient is an important aspect of this, if this improves the pain from the ulcer in any way, simply for the QoL for the patient.” [p2]
“…stop the progression of the ischaemic wound.” [p1]
Clinicians described clinical methods used for measuring device efficacy and effectiveness from wound size, pain scales and blood flow. Some gave detailed accounts as to how traditional clinical methods used to measure blood flow may not provide efficacious results:
“There is a study where they have done training on claudicants, where they have done an exercise program and where they have clinically a longer walking distance, which with no benefit at the ankle-brachial index for example. So, it’s an indication that maybe these measurements are not done necessarily reflect the clinical reality.” [p2]
“If you have wound healing and all the other parameters will tell you that there is no change, I would still continue using the boot.” [p4]
Clinicians suggested that assessing small vessel blood flow may be more indicative of device effects:
“If you’re looking for a minimal effect it could maybe be to measure skin blood flow with laser doppler.” [p3]
“The boot has not necessarily an effect on the big vessels, it's more on micro level.” [p5]
Theme 2. Ways to potentially use "the boot"
Opinions revealed a need to find the best patient group for the device:
“I think hopefully over time we'll be able to select the patient group that will have a benefit from this rather than all of them, because I don't think everybody will have a benefit of the boot.” [p2]
The potential need to discover when in the disease process to use the device was also suggested. One comment highlighted that perhaps the trials happening now were too late:
“Also, since this is a new equipment, there is a chance that some of the patients have come too far in the process. It's important to be aware that they’re maybe too late. In my opinion, many of the patients we have tested it on so far, it's actually too late, so then it would end in amputation anyway.” [p3]
In contrast, the device was also implicated as having the potential to provide a last option for patients:
“I think that the FlowOx™ boots could be a promising supplement to patients who basically have reached the end of the line.” [p2]
Clinicians postulated that the device has potential to be used with other patient groups, such as those with vasospastic disorders and pressure ulceration. It was also suggested that device effect on infection and safe use during sleep could be further investigated:
“The treatment of antibiotics could also in theory have been more effective using this system, if you, in that way, can get the antibiotics closer to the bacteria in the wound by using the system…” [p3]
Theme 3. Using research in healthcare
Research in Norwegian healthcare was described as requiring rigorous testing of new medical interventions to provide the evidence to secure funding:
“What we need to work on is developing new methods maybe in a high-volume centre and then when this is proven, try and get it out to the more peripheral areas.” [p2]
Research was highlighted as essential to improve outcomes for patients:
“We have to try out new equipment and new devices and be in the research to see if we can improve the outcome for our patients where there is no other hope for them.” [p1]
The practicalities of facilitating new research in hospitals and with novel interventions was reported by clinicians as more receptive in those hospitals with academic links:
“It depends on the hospital region because some are research facilitated or has connection to the University, such as this hospital, who are more inclined to break barriers, try out new things, do more research.” [p3]
Theme 4. Device positives
Positive opinions of device implementation and uptake revealed its ease of use, simple instructions and low adverse effects:
“I just want to add that it's fairly easy for patients to understand how this works in theory and it's easy for us, as clinicians, to convince patients to try it because of the adverse effects are very small. It's easy for them to administer at home. It's easy for them to be positive in terms of wanting to try this. I think that's a huge positive in terms of getting more experience in using the boot.” [p5]
The device was suggested as a good potential supplementary option for patients unable to engage in alternative therapies:
“We know that supervised exercise training is the best, but the problem is that it's not easy to get the patients do it. It's not always even our option around, so I think this maybe something that could be added early on. If that's possible, that would be great.” [p2]
“I like the theoretical background on this device and also seen some good clinical results. As a summary, I'm going to say that it could be a good supplementary device for treating patients with ischemia.” [p1]
Theme 5. Observed effects and next steps
Clinicians described seeing varied effectiveness from patient use, yet remained hopeful:
“We have had two patients who had very good effect of the device. Then we have two patients with intermittent effect of the device and two patients without any effect of the device.” [p4]
“I hope that the study will be able to show that it has some limited benefit.” [p5]
It was stated throughout the focus group that there was a need for more research as numbers were limited:
“We really need more data to say if there is a proved effect or not.” [p2]
When discussing price points, a high price was said to be unrealistic. There were suggestions that Government subsidies should shoulder medical device costs along with low contributions from patients, as this was considered an affordable solution that could benefit more people:
“Our patients, they don't have that much money, so the price could not be very high.” [p3]
“I think as well, you need to put this in health benefits frame and maybe it would be better to have a lower price so that it could be used over a larger area rather than it be limited by a high price range.” [p4]
The high cost of amputation was highlighted and how limb salvage should be a priority when considering research into new medical devices:
“Now, we're back to the limb salvage thing because that's very important because if you are saving a limb, it's much less cost than if you have to amputate.” [p5]
Theme 6. Potential improvements
The final theme reveals opinions on design improvements. Problems arose with the seal which resulted in a loss of controlled pressure:
“The problem has been this silicone, as you call it, that has been porous and patients get leak in use…” [p4]
Suggested improvements included adding a device to measure skin blood, making it mobile and creating an adaption for use on other body parts:
“You have to sit still in a way for a long time. If you can move around, it would be more easy to use it.” [p3]