Evaluation of the instruments
The PFDI-20 instrument
In general, women with POP thought that the PFDI-20 was easy to complete, had a good choice of items with a satisfactory layout. However, some clinicians did not think that the PFDI-20 may be as relevant as it did not capture all patient experiences: “I get a lot of people who've got urinary systems, overactive bladder, for example, which this doesn't include and probably should. Because one of the treatable causes of overactive bladder is POP, so in that sense it's a little bit deficient” (C010).
In addition, some clinicians thought that some important topics were not covered: “you need more on their pain, you need more on their sexual function” (C004).
Women shared similar views, they also thought that this instrument would better suit if it was administered pre-surgery: “Well, I think, it didn’t cover specifics. I would think a lot of it’s before you have surgery, a lot of this, this is all pre-surgical with regards to bulges, with regards to toileting, with regards to urinary leakage or incontinence. I think a lot of this is presurgical questionnaire” (P014).
The PFIQ-7 instrument
Despite varying opinions most clinicians referred to the PFIQ-7 questions as straightforward and capturing patient experiences: “I thought these questions were quite good” (C003). Many women with POP expressed similar impressions: “it seems to cover […] the ability to do physical activities, entertainment activities” (P003). However, some other female participants believed that this instrument required improvement as it did not cover all the aspects of their health: “I guess under the emotional health and the feeling frustrated. I think there, there could’ve been room to actually be able to voice why” (P001). Women also felt that the PFIQ-7 did not cover all the aspects of work and social life: “They don’t ask me how it impacted my work” (P010).
A few clinicians said that a few questions lacked clarity or overlapped: “I don’t think the questions are as clear as they should be” (C006). Women agreed with this: “I just thought the ‘entertainment’ one, like maybe the concert, and social activities outside the home, were sort of the same” (P006).
The P-QOL instrument
Almost all study participants agreed that this instrument was easy and quick to complete as it covered all relevant aspects: “It hits the bulk of the categories, in terms of they are good questions, they’re good bladder questions, good bowel questions” (C002). Response options were acceptable for both groups of participants; however, the scoring system was not preferred by some clinicians: “I think four is not a great scoring system. You’re better of having five. But it forces them not to tick the middle one” (C005).
However, this instrument appeared too lengthy: “When I printed out all the pages I thought, “Oh no, I'm not going to print all this stuff” (P010). This reflection was supported by the clinicians: “I think it’s very long. And if it was to be incorporated and used in other questionnaires, I think that would make the whole thing too long” (C004).
The PISQ-IR instrument
Most clinicians believed that this instrument was relevant, however, it missed an important aspect of pain: “What I find is that pain with intercourse is the thing that most people – if surgery affects them, it will be to cause pain with intercourse” (C005). Clinicians also said that this instrument did not capture prolapse-specific symptoms: “It doesn’t just ask that specific symptoms of the prolapse like urine and bowel symptoms that are given a standalone” (C006).
Women also thought that this instrument was relevant, but noted that, it did not specify a timeframe nor reason for those not sexually active due to the procedure: “Because I wasn’t sure […] ‘why are you not sexually active?’ ‘No interest’, ‘no partner’. It doesn’t say about a timeframe, but basically, the breakdown of my marriage was because my husband wanted a physical relationship, which I just couldn’t.” (P006).
Overall, the study participants thought that this instrument would be hard to complete and some found it invasive.
The International Consultation on Incontinence Questionnaire Vaginal Symptoms Module (ICIQ-VS)
Both women and clinician participants felt that the ICIQ-VS captured most of patient experiences, however, it was not very comprehensive: “It does cover the emotional side, the impact on sex and relationships and then everyday life, but it’s not as comprehensive” (C006). Some clinicians thought that questions were ambiguous, especially those relating to sex life: “Probably the harder ones for people to interpret are the sexual matters one. Not the, do you have a sex life, but do you worry about it and does it affect your relationship, or do you feel like your sex life’s been spoilt by vaginal symptoms? They’re the probably slightly more ambiguous ones” (C001). Women also felt that some of the questions were hard to answer: “[…] How much does it bother you,” those questions were a bit harder to answer” (P004).
In addition, some clinicians were concerned with the scale: “It’s about them, and it is useful in terms of before and after” (C002).
Clinicians also thought that this instrument was too long and would make respondents frustrated: “I feel this one would take me […] so it’s going to take a little bit longer. Whereas this one, you get asked the question, you have to answer it, and then you have to think some more about it. And then you go through – it’s like surveys like this – I virtually find frustrating” (C006).
The Australian Pelvic Floor Questionnaire (APFQ)
Most of the study participants found this instrument easy and simple: “I mean the questions that are being asked here are really the questions that pretty much I ask in my language as well. I like that it’s Australian. And the questions are simple” (C005). Women thought that it was relevant to their procedure and covered their experiences: “Very relevant to the experience that I’ve been having because I’ve been having a lot of bladder problems” (P004). They also felt that it was the most comprehensive compared to the other surveys: “I thought it was a summary of quite a few of the other questionnaires. And I actually thought it was quite good, because it gave you a chance to write what you thought or the reason why you sort of answered like this” (P006). This was seconded by the clinicians: “It’s probably the best overall in terms of not missing things” (C002).
When asked whether additional questions were required, a few participants thought that the instrument lacked details regarding urinary tract infections and bowel issues: “The only thing it misses, and so do a lot of others, are urinary tract infections” (C002); or “The bowel function.” (P009)
Despite that the APFQ appeared to be lengthy, the clinicians found it comprehensive, as it covered most of the aspects of health: “I like they were short, sharp questions, it is a little bit longer but it’s quite comprehensive because it covered a lot of systems. And it’s clearly going through sexual function as well” (C006). Women with POP did not mind the length:” It wasn’t a problem. There were questions there that always have to be answered and so that you can see how things are all going together.” (P012). However, one clinician thought that scoring was complex: “In fact, this would have to be one of my favourite questionnaires, but the two weaknesses are that it is quite long − 43 questions - and the other thing is the scoring. This one is quite complex to score” (C008).
The Pelvic Floor Bother Questionnaire (PFBQ)
Many participants believed that this instrument was useful. However, according to some clinicians the questions and response options were “just not comprehensive enough” (C006). They also believed that the instrument did not capture “the emotional aspect” or “mental health and [women’s] daily lives” (C007).
Women thought that this instrument was very general: “it didn’t cover it to enough depth for me” (P006). They suggested including additional questions regarding pain and relationship: “Does pain or discomfort curtail your ability –’ and […] ‘Has this impacted your relationship? Because the amount of divorces within the surgically mesh injured is phenomenal” (P007). Some women also found it hard to complete: “There were a few questions I couldn’t answer a yes or a no to and there was only a yes or a no answer” (P001).
In general, this instrument appeared to be the least preferred amongst the study participants.
Modes, methods, location and frequency for PROMs data collection
In general, most women preferred online administration of PROMs, however, they also suggested other options, such as postal mail-out or phone interviews: “Well, I did print it out because I wear bifocals and doing a survey like this online without being able to sit down and consider the questions, I find it difficult” (P011).
Clinicians thought that to ensure higher response rates PROMs should be collected at clinic: “I’d probably do them in the clinic, as I said, you know, feasibility-wise, doing them at the time of consenting for the surgery is probably best. Perhaps doing it around the time of seeing the doctor because then they can ask any questions. Doing it at home, you know, I think there’s less likelihood that they’ll complete it. And so they don’t have the opportunity for that support” (C011).
For the pre-operative questionnaire, some clinicians felt it would be best if patients filled them out at home: “I feel it's got to be filled in before they see the doctor and I think it would be best to send it out for them to fill out at home. […] I think that if you leave it to the clinic appointment, then some people might just be running late” (C008). Women did not have preference but also thought that home location would be better: “Either or, either or – probably I would be good doing it at home. I’d be good if they gave it at the clinic as well” (P005).
Most women participants believed that collecting PROMs every three to six months would suit them best. In general, women agreed that frequent data collection was useful: “I would go the six weeks, which is basically looking for any surgical related complications, and then three months – or maybe, you could flag the three months, and do six months – annual – depending on the responses” (P006).
Potential barriers to completing PROMs
Some women participants were not certain how long it would take to complete the questionnaires: “[…] I don’t know whether it would take anybody else long.” (P003).
Some other women noted that some questionnaires were repetitive and that only one instrument should be used instead: “So that, maybe, you could have the same questionnaire, but one – or had straight prolapse, you know.” (P006).
Other barriers to completing PROMs included health literacy and physical issues: “Health literacy. English not as their first language. Eyesight issues. You might have to have people like sometimes we’ve had to read the questions out to people and do it by telephone when we’ve had to complete data […]” (P009).