Qualitative interview study on the experiences and acceptability of different bisphosphonate regimens

Some text, tables and figures in this chapter have been reproduced from Paskins Z, et al. BMJ Open 2020;10:e040634. https://doi.org/10.1136/bmjopen-2020-040634. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) licence, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See https://creativecommons.org/licenses/by/4.0/. The text, tables and figures below include minor additions and formatting changes to the original text.

Some text, tables and figures in this chapter have been reproduced from Narayanasamy M, Bishop S, Sahota O, Paskins Z, Gittoes N, Langley T. Acceptability and engagement amongst patients on oral and intravenous bisphosphonates for the treatment of osteoporosis in older adults. Age Ageing 2022;51(11):afac255. https://doi.org/10.1093/ageing/afac255.

Permission for reuse is in place as per: © The Author(s) 2022. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. The text, tables and figures below include minor additions and formatting changes to the original text.

Introduction

Our findings from Chapter 2 identified the need for a theoretically informed, whole-system approach to enable clinicians and patients to get the best from BP treatment. Patients need comprehensive support that takes account of the perceptions (e.g. treatment necessity beliefs and concerns) and practicalities (e.g. capability and resources) that influence their motivation and ability to start and continue with treatment. Clinicians need to moderate patient expectations and clarify what constitutes BP treatment success. Further research is needed to explore perspectives of managers, patients receiving IV BP, men receiving BP and the use of BP in the context of multimorbidity.

Therefore, the aim of this qualitative study was to elicit patients’ and clinicians’ experiences of using different BP regimens and understand patients’, clinicians’ and service and research leads’ preferences for alternative BP regimens compared to first-line oral ALN treatment.

Methods

Sampling

The inclusion criteria for patients participating were adults who had taken or received BP for the prevention of fragility fractures within the previous 24 months, and they needed to have the capacity to provide informed consent. The purpose of the interviews was to explore patients’ experiences of BP treatment regimens for the prevention of fragility fractures, focusing on which BP were most acceptable to patients. Originally, we planned to recruit participants via regional primary and secondary care clinicians and the regional Clinical Research Network. Due to COVID-19, recruitment methods were adapted.

With ethical approval, in January 2020 [North West-Preston Research Ethics Committee (REF: 19/NW/0714)], semistructured interviews were conducted between June 2020 and August 2020 and March 2021. A study advertisement in the Spring 2020 edition of the Royal Osteoporosis Society (ROS) newsletter invited individuals to take part in one telephone semistructured interview. Replies were used as part of purposive sampling, thus ensuring that the sample included enough participants who had experience of oral BP, IV BP and those who had experience of both types of treatment. Once major COVID-19 restrictions had been lifted, the research team were able to engage with clinicians across the region, via professional networks, to support the recruitment of patients who were receiving IV BP in the community. Such experiences were sought since community provision of IV BP is not usual practice across the UK.

A total of 78 participants with a mean age of 69.9 years were recruited through the advertisement in the ROS newsletter and through engagement with clinicians via professional networks. Forty-three patients had most recently taken oral BP (for the majority of these participants, the current or most recent oral BP that they had taken was ALN tablets). Thirty-seven participants had most recently received IV ZOL BP infusions in hospital or community settings. Interviews ranged in duration from 20 to 60 + minutes. Table 4 provides an overview of participants’ demographics.

Clinicians, specialist experts and service lead sampling

In order to understand the wider contexts of BP treatments and the service systems surrounding them, general practitioners (GPs), secondary care clinicians, specialist experts (including those involved in research), as well as those providing and leading novel treatments were recruited for qualitative interviews. These groups were purposefully sampled to include those with a good knowledge of the BP regimens in use and involved the following approaches.

First, GPs were contacted through a snowball approach, beginning with the existing professional networks of the study team. Although it was originally planned to focus GP recruitment on the practices in which patient samples were drawn from, due to the COVID-19 changes identified in patient recruitment, existing networks allowed the identification of GPs both with and without specialist/research involvement and commissioning/service leadership for osteoporosis and BP treatment. Study team members identified potential participants, and a research advertisement was also placed in the West Midlands Comprehensive Local Research Network (CLRN) newsletter for research-active GPs. GPs who were interested in taking part were invited to contact the study team and were then sent a formal invitation e-mail/letter and Participant Information Sheet.

Second, we contacted specialist clinicians, including those involved in research and service leadership. These respondents were identified through snowball sampling, beginning with the study team. Eligible participants identified by the study team were sent a Study Information pack, which included an informal invitation e-mail/letter and participant information sheet.

Third, we sampled from two specific areas where different or novel first-line BP regimens are used. This included participants from around the country (Table 5), where first-line ALN is recommended with a programme of blood test monitoring which is not usual practice elsewhere in the UK. Potential participants were sent a formal invitation e-mail/letter and participant information sheet.

In total, we recruited 23 clinicians and clinical specialists, including those active in research and service leadership. Interviews ranged in duration from 20 to 60 + minutes, and the background of participants is provided in Table 5.

Data collection

Interview schedules for participants were developed in collaboration with the study team and steering group, which included patient and public involvement and engagement (PPI) representatives and comprised questions about patients’ experiences of the osteoporosis diagnosis, perceptions about their BP treatment regimen(s) and clinician and service factors. The interview schedule was piloted with two PPI representatives and refined as appropriate. All participants provided informed consent. All interviews were conducted over the telephone.

Data analysis

Interviews were digitally recorded, transcribed verbatim and anonymised. The interview transcripts were uploaded to NVivo (version 12) (QSR International, Warrington, UK) and were subjected to intense open coding to identify early ideas and issues (referred to in NVivo as ‘nodes’). Two researchers independently coded the first five transcripts and then compared analyses, allowing interpretations of the data to be critically assessed, refined and agreed. Once first-level nodes had been agreed, the remaining transcripts were coded according to these by two researchers. Newer subnodes were added over time to enable specific and relevant issues to be categorised effectively. These subnodes were developed and agreed by two researchers. Once all the transcripts had been coded, the process of iterative categorisation86 was used to provide a clear and rigorous written trail reflecting the development of themes from initial nodes. This involved identifying key NVivo nodes as particularly pertinent to the research question and exporting the content to Word. Table 6 describes these nodes and what aspects of the data they captured.

Once exported into Word, the data that had been coded to each node were examined and systematically reread. Summary and interpretive notes were added, reflecting on the content of the theme in relation to other themes, research questions and prior literature. The results below first cover the degree to which different forms of treatment were acceptable to patients, with data interpretation considered in relation to our definition of ‘acceptability’ based on Sekhon et al.’s (2017) framework,87 which proposes that it is a multifaceted construct underpinned by seven key domains. These domains are collectively known as the TFA and their descriptive definitions are conveyed in Table 7. The codes were then formally mapped to the TFA as a framework, providing appropriate constructs to capture key dimensions of treatment acceptability and engagement.

Results

Acceptability of treatment regimes

Patients’ acceptability and engagement behaviours were captured through the TFA domains. Participant identifiers at the end of each quote indicate their role as patient, clinician, specialist, research expert or service lead. For patient participants, it also indicates the BP treatment they reported experience of. O = oral BP treatment only; IV = intravenous BP treatment only; Dif = experience of different types of BP treatment.

Intervention coherence and perceived effectiveness

Participants' views on ‘intervention coherence’ and ‘perceived effectiveness’ were often closely related, with both requiring participants to make sense of how, and to what extent, the medication could be said to be ‘working’. For the BP medicine, this commonly involved developing both a conception of the future risk posed by reducing bone density and the potential reduction of such risk. Many patients described the treatment as a way of avoiding a negative consequence of ongoing bone deterioration. This is sometimes derived from the personal experience of seeing a family member suffer:

The state of my father really, because mentally he was one hundred percent, and physically he was an absolute wreck. His spine had bent completely.

The desire to avoid fractures was identified as a key motivation for engaging in treatment, particularly for patients who had already experienced one:

Oh, just because I’d had, I’d fallen and broken my hip and I didn’t want to fall and break something else again.

This motivation had also been observed by secondary care clinicians:

In more, let’s say 70- or 80-year-olds who have had a hip fracture, then they tend not to question it at all, they just go for whichever you tell the best we will take it, that sort of thing.

Moreover, one specialist nurse suggested that certain types of fractures prompted patients to take osteoporosis and the prospect of treatment seriously:

I mean a lot of patients are really scared of like the Dowager’s Hump. The spinal fractures tend to, if you tell somebody they’ve got a fracture in their spine they’re more likely to buy into treatment and understanding because they desperately don’t want to curve over. So that’s a huge thing, but when patients have just like fractured a wrist or a humerus or a hip, yeah, then you do struggle to get them to buy into actually it is quite serious.

As BP do not necessarily address any felt symptoms, the coherence of the medication involved envisioning it as providing a level of protection from either such acute or chronic health problems.

And when they said I would be having it I felt good because it’s protecting me, that’s what I thought you know.

In some instances, patients felt they had sufficient support to understand this protection and were reassured by a good relationship with HCPs.

I felt that everything had been explained and I just thought [treatment] was a way of preventing it getting worse really.

This was particularly the case where participants felt they had perceived tangible evidence of the treatment working, which drove them to continue taking the medication. This was often prompted by receiving positive results from Dual Energy X-ray Absorptiometry (DEXA) scans denoting improved T-scores. (A T-score is an indication of how close the person’s bone density is to the average peak bone density.)

My hip then improved over three years to -1.1, so OK, it was a slight improvement but as the consultant said, ‘it is an improvement, and it hasn’t got worse’. And I think well, something is working somewhere along the line … That encouraged me then just to keep going with it.

Others disclosed feeling motivated by the fact that they had not sustained fractures since beginning treatment:

I haven’t had any more vertebral fractures and just to take the positives from that, but yeah, and I’m able to walk and do all sorts of things.

In these cases, patients developed hope that treatment would maintain or improve their bone density. Therefore, working to attain these goals also encouraged patients to engage in treatment:

And if it adds another five years or longer, ten years of me having a more stable life, I want that, I’ll go for it, thank you.

However, uncertainties about the effectiveness of BP treatment were also very common, and several questioned the degree to which their efforts to adhere were working. Underpinning this, participants described a wide variability in the level of information, support and/or feedback. This included perceived limitations or contradictions in the way in which the medication was explained.

I was waking up in the middle of the night, thinking I’m not doing it, I’m not going to take it. The side effects aren’t explained to you, well not to me when they were discussing this was the medication that you’re going to get.

And my first initial reaction was ‘you’re taking something for osteoporosis that causes a fracture!’ And it didn’t make sense. It was almost too much to take on-board at the time. And from that to say, ‘will you just pop in and collect your prescription and start taking it’- ‘mm-mm, no way’!

Further, patients often perceived wide gaps in their ongoing care. For example, a patient spoke about requesting a scan, as opposed to waiting for this to be initiated by her GP, in order to ascertain whether her bone health had improved, which was important for her:

…That’s why I asked for the scan, because I thought, I’m doing all this, I’m doing all this running, I’m doing these weights, I’m doing this diet, I’m taking all the tablets, I’m doing everything that I can do, I needed to know if it was actually making a difference ... I can’t say what was making the difference but all together it was making a difference and that made me feel better sticking with everything.

Similarly, others on oral BP described disappointment at the poor follow-up and lack of opportunities to discuss effectiveness, which left them uncertain as to whether the treatment was still appropriate:

I do think that somebody should have carried out a proper, as I said before, a proper review after five years ... and said you know ‘I think you need another DEXA scan to see if that’s the right drug.’

The only time I was made aware of the reading from the DEXA scan was when it was the first one in 2010. And so, the subsequent ones, I’ve never had a patient’s copy, or I don’t really know whether there’s been an improvement.

Moreover, even when follow-up was planned, the timescale for accessing another DEXA scan after oral BP had been prescribed was sometimes perceived to be too long:

I found that the DEXA scan that I was eventually referred to was quite informative. But I feel the gap between, well 5 years before you can have another one. I feel as if I’m a little bit in the dark about what’s going on and I’ve got an enquiring mind, so I like to know more.

The variation in treatment plans and follow-up in primary care was reflected in GPs’ responses. While some had a specialist interest in osteoporosis and had set up systems for periodic checks on patients (e.g. 3 months following treatment initiation), others commented on the lack of scope to check patient adherence or review medication. One GP also mentioned the lack of incentives in the form of quality outcome payments.

Well if we had infinite resources then I would have a sort of annual review in general practice but that’s never going to happen because GPs are just too busy at the moment.

I think we’re as I’ve already discussed, not good at picking up when compliance drops off. Because actually we haven’t got a formal strategy for auditing or reviewing, non-requesting of medication and that’s actually a quite tricky to identify, but perhaps not impossible.

Patients receiving IV treatment generally had fewer concerns over effectiveness and coherence of the medication. This could be seen as due to the fact that this group had more regular scheduled appointments, as well as the way that the administration of the treatment required the presence of a HCP. This enabled more opportunities for patients to interact with clinicians to discuss the reasons for taking the medication and also how to deal with any side effects:

So, she took me through absolutely everything to make sure I didn’t suffer once I’d had the Zoledronate [intravenous treatment]. And I think it was so much easier for her to tell me face to face. I mean she could have done it on the phone, but as opposed to just sending the instructions, which they did too, they did send instructions in the mail as well.

The care particularly centred on the second infusion was so reassuring … I felt so well looked after. And having it explained to me I think several times in several different ways because people realised that I just wasn’t taking stuff in.

This was further enhanced when IV treatment was provided at home, with the nursing team taking on larger responsibility for organising the appointment, and then being able to focus exclusively on one patient for the duration of the treatment. This included opportunity to discuss effectiveness and the findings or previous scans:

Well, I think they give reassurance, and they give you their time, because I was very impressed with the chap, who came last week, because when I asked about my DEXA scan results he had to go out to the car to get his laptop and he, you know he wasn’t rushing me. He got his laptop, and he sorted out exactly what the data was from the DEXA scan and told me all the data.

Further, patients on IV BP also tended to have well-established time points for follow-up:

Oh, I’m just sent a letter with an appointment date and time. And I can sort of change it, if it’s not convenient … it’s always been alright.

Secondary care consultants confirmed that appointments and follow-up plans were well established for patients on IV BP, underpinned by clear rationales, including scheduling a point at which such treatment could be reviewed:

The nurses follow them up regularly to do the infusion. After three infusions, we will see them, look at the DEXA to see whether they need to remain a bit longer on the bisphosphonates.

This was reflected in the views of the community team delivering IV treatment in community settings who valued the opportunity to provide direct and individual care.

So from, just comparing to when I worked in the hospital and obviously being in their home address, there is only one patient, so your attention is a hundred percent on that person or the people that are in the room with you.

Having clarity around when DEXA scans were going to be scheduled was important for enabling patients to see a potential end point for treatment. One patient pointed out that this is what made IV BP treatment particularly favourable:

And it’s time limited as well, knowing that it’s just for three years and then I will have a bone scan and hopefully it’s better, it’s quite nice as well because you see light at the end of the tunnel with yet one more health condition.

Moreover, a few patients seemed to have higher expectations of IV treatment itself, even before scan results were attained. They associated the format of this type of treatment as facilitating a direct, and seemingly stronger, intervention for the actual problem of osteoporosis. This was reflected in patients’ comparisons with previous oral BP treatment:

I had no sort of medical expertise at all, but to have an infusion would seem to me to get to the heart of the matter more than a pill!

While this might not have been an explicit message from health professionals, the IV treatment was often seen as a ‘step up’ in the intensity of care for patients who had previously been on oral BP. In this context, a greater efficacy of IV treatment was seen to make sense. Some clinicians providing IV treatments did indeed suggest these would be more effective than oral BP, as captured by a specialist nurse below:

So if we give IV we know there’s no absorption problems, it’s getting straight in, so it will be effective basically, if it’s not going to be effective IV then it’s never going to be effective sort of thing.

In most instances, however, clinicians described IV treatments as recommended due to side effects, non-adherence and/or intolerance to ‘first-line’ oral treatments.

Opportunity costs and burden

When the BP treatments required patients to make sacrifices (i.e. ‘opportunity costs’) and/or the regimens were regarded as burdensome, this contributed to overall negative views, which balanced against whether the treatment was seen as effective and coherent. Although a small portion of patients who were on or who had been on oral BP found the regimen relatively straightforward when weighed against the benefits, a larger portion identified wide-ranging costs and burdens. Most commonly, patients described struggling with the general treatment routine, which was regarded as complex, and the disruption this caused to their morning habits.

I find it a total burden to be honest … I’m an early riser, and I do like to wake up early and have a cup of tea, I know this is all trivial, but just have to swallow a huge amount of water with this tablet, and then sit around for half an hour, trying to occupy myself – it just, it’s just alien.

This could be seen to be exacerbated when the patients had other commitments, priorities or health issues:

To take the pill and to sort out the timing of it and everything, I just couldn’t be dealing with that, because I had quite a lot of stresses in other areas of my life, emotional stresses and stuff like that.

As a point of contrast, others highlighted that their personal circumstances facilitated dealing with the burdens.

It’s a bit of a pain I have to admit, if you want to get on and you’re going out to take it. But it wasn’t – that had nothing to do with the reason why I stopped taking it. I was able to fit that into my daily life quite easily. I can imagine had I been working it might have been a little harder.

The common problems for patients on oral BP were the restrictions around not being able to eat straight away and also needing to remain upright. The latter was particularly challenging for patients who had previously suffered from particular fractures or other conditions which affected their posture:

I mean, in fact you can sort of sit bolt upright but I’m not very good at that, so I always seem to hunch a bit and since I had the fractures that’s really not possible.

Other patients highlighted the practical difficulties of the oral BP treatment regimen which prevented them from taking them properly, such as not being able to swallow the tablets:

I really couldn’t get them down my throat, because I knew that I would start gagging and a good chance of vomiting and I can’t live like this, you know.

The requirement to follow strict instructions caused high levels of burden for some patients, to the extent that they felt that their mental well-being was compromised:

I try to keep active for an hour – because I’m frightened, you’re frightened taking that particular Alendronic Acid. I don’t like taking it, I find it a real inconvenience.

General practitioners in the study also recognised the challenges their patients faced in terms of medication burden.

You’re not meant to take particular drugs at the same time, isn’t it, either, I don’t think, that then messes up timing for other medications, so yes, if it was a pill that you just take at the same time as your anti-hypertensives and your aspirin and your lansoprazole then I think compliance would be much better.

Some patients on oral BP discussed developing strategies to cope with the more challenging aspects of the regimen, thus reducing costs and burdens. This included planning ahead, thinking positively, engaging with the ROS and setting reminders:

I’ve got an alarm on my phone to remind me that it’s Wednesday and I’ve got to take my Alendronic Acid.

In some cases, this also included adapting instructions to make the oral BP regimen more bearable:

So, I was really suffering and in the end I just thought I’m going to make my own rules up here. So, I was doing an hour, I was doing a pint [of water], sometimes more than a pint, I was not moving, because if I moved I suffered all day.

In comparison with the costs and burdens of oral treatment, patients generally identified practical challenges and inconveniences relating to accessing IV BP treatment, as opposed to the treatment per se. This included travelling to hospital appointments, issues around parking and navigating one’s way around the hospital:

I think I had to go to something like atrium three which didn’t happen to be marked and it was all a bit, it was a bit confusing and a bit open, but I found it. I blundered my way towards it. It wasn’t ideal.

Such issues were removed for patients receiving IV treatment at home. Having home-based IV treatment also enabled some patients to cope better with the regimen since they would have faced difficulties with travelling due to the physical restrictions caused by osteoporosis and/or comorbidities:

I would prefer it at home, because it is a bit of a struggle for me to get to places, you know with the multiple sclerosis.

Moreover, having IV BP treatment at home was valued since it enabled patients to receive such treatment even more comfortably:

That’s great, because you see, I went to have scans in the hospitals, and I knew what a scan was like and a drip and all that kind of thing. And I was just, well I was amazed to be able to sit in my favourite chair.

In addition, the fact that the IV treatment regimen required a nurse to administer, it took much of the work out for the patients and did not seem to cause much inconvenience for patients having it at home:

They just come into the dining room, the chair is pulled out, they set their gear up on the table and we’re away, no problem … I mean how could it be better? You just sit down, she puts a needle in, pops it in and then Bob’s your Uncle! No problem!

Thus, IV treatment seemed to offer patients a regimen that was lower burden, with fewer opportunity costs. Some patients who had direct experience of both oral and IV BP even suggested that side effects from the latter treatment regimen were more favourable:

Basically, it’s a morning and a day of feeling woozy and that’s it for in my case eighteen months, you know, compared with wrestling yet another lot of pills to take every week.

This was similarly reflected in the experience of those delivering IV treatments for patients at home.

They’re in their own home at the end of the day. If they can’t be comfortable there where can they be comfortable? So we have even done a few infusions in the garden sometimes because the weather is nice.

A small number of patients did comment on difficulties with the administration of IV treatment, for example, having the needle inserted into the vein, and clinicians reported that a number of patients were concerned about needles. There were also some patients who felt happy with the oral BP regimen, and a small number drew on points of comparison with the IV treatment to justify their preference:

I just [worry] about side effects and if you put intravenously, you know, how you counter them. And I thought I’m not going down this road at the moment.

Generally, though, there were more positive accounts relating to IV treatment regimens, with patients enthusing about the overall ‘experience’. They recounted the staff approaches that contributed to little burden and opportunity costs on the part of the patients:

It’s wonderful, they even come round and offer you a cup of tea and a sandwich or whatever. Oh, they’re just really friendly, really welcoming and getting you sat down, ask you which arm you want in, making sure you’re comfortable, you’ve got something to put your feet on, you’ve got something to read. No, I couldn’t fault them at all.

Regardless of treatment type, a regimen which led to no side effects or manageable side effects enabled patients to cope with their treatment regimens, supporting acceptability and engagement. But for patients where side effects were particularly severe, this was enough to cause them to stop engaging in the treatment:

And I just thought the side effects from the Alendronate just weren’t worth it, they were impacting my life.

For some patients who did not experience severe side effects, this did not preclude the worry that these could occur. Such concern served to be a burden for some, while living with the risk of such side effects was one of the costs required for engaging in the treatment:

You know, it does worry me that if I have to have a tooth out there could be complications … it’s adding to my decision to stop when I’ve been on it for five years.

Mostly, those on IV treatments were less concerned with side effects. While one patient on oral BP did worry more about the potential side effects from the IV treatment, the comparison between the two could also be seen in light of higher levels of support for patients receiving IV treatment, as noted above. Professional support and care may have helped to both reduce side effects as well as reduce the concern of these occurring.

Ethicality

In the context of BP treatment acceptability and engagement, the TFA domain of ‘ethicality’ was linked to the extent to which patients regarded the treatment regimens as aligning with their individual values and whether they perceived the treatment to be fair and suitable for their needs. This often related to the way in which they had come to be prescribed the treatment and the manner in which the treatment had been offered to them.

For some patients who were prescribed ALN oral BP, they felt that their personal wishes had been dismissed, which led to negative attitudes towards the treatment:

I wrote to my doctor and said I’d read all the information, so when she started prescribing, ‘pretty please prescribe the soluble tablet’, which to my way of thinking was the least harmful or least – the one I could tolerate most, of the options. And that got ignored, and I got sent the prescription for the Alendronic tablet, and I refused to take it. I took it once, and I just found it so difficult I felt I’m not taking it – I’d rather not have it.

Even for patients who had come to accept any inconveniences of the oral BP treatment regimen and were engaging in the treatment, many still expressed dissatisfaction with the fact that they had not been presented with other treatment options:

I shouldn’t complain really because so many people have so many things, and their lives are really dictated by their meds. But what annoys me is the reluctance to actually discuss any options.

One patient described the ramifications of her GP discounting the advice of the osteoporosis nurse to offer the patient a soluble form of ALN to minimise the risk of GI side effects:

So basically, I’ve always had a dodgy tummy. And so, if they give me medication, they give me the stomach liner thing as well. And so [the osteoporosis nurse] said to me ‘Well you might be advised to take the bisphosphonate in a soluble solution form’. So, when I told the GP this, he said ‘No, you can’t have that, you’ve got to have the Alendronate tablet’. And I assume it’s because it was cheaper. So, I started off on the Alendronate. Well, it got to about four months in, or three to four months in and I was, it had made my tummy bad.

On the other hand, other patients did not find it a problem that they had not been presented with alternative options, and in fact, this encouraged them to engage in the treatment because of the implications of osteoporosis:

I was, you know I never enjoyed the fact that I had to have my glass of water and potter around the house but well, there was sort of no option, so I was perfectly happy. I knew what, I know what osteoporosis can do.

Moreover, some patients felt that oral BP were right for them, particularly when they could identify improvements in health which they attributed to the treatment. As such, they did not wish to pursue other options:

I mean when I look back to what it was like when I first had the spinal fractures, you know it was unbelievably painful, and then now as I say, I can mow the grass, pick up weeds, do all these sort of things – clean windows. And so I mean I’m very happy on it really. I can’t see any reason to change it.

For some patients on IV BP treatment, they had previously been on oral BP and could make direct comparisons between both regimens. IV BP treatment was generally viewed as easier to engage in with optimal frequency due to being just once a year. This suggested that the IV treatment regimen was a better fit with their lifestyle and therefore more suitable:

I know it’s only little things really but the convenience of having something once a year compared to 52 times a year is amazing.

While this could be seen as pointing to the generally lower burden of IV treatment, it could also be identified that such comparisons played into overall perceptions of equity; namely, it was more common for those on IV treatment to see themselves as being treated fairly.

Self-efficacy and affective attitude

In the context of accepting and engaging in BP treatments, the balancing of the aforementioned TFA domains could be seen to shape patients’ overall feelings of self-efficacy and affective attitudes towards their regimens. As per Table 1, self-efficacy reflected patients’ confidence in their abilities to undertake the necessary behaviours to engage in the treatment. Affective attitude is related to patients’ feelings towards their treatment.

Positive affective attitudes of patients, including gratitude and hope for the future were apparent when they understood the reasons for the treatment, felt they had made sense of its potential effects and felt that they were well supported by clinicians and the wider service. This often appeared to be facilitated by regular contact with professionals and access to diagnostic tests to track the progress of bone health.

The consultant that diagnosed it, because he looked back at this x-ray and saw it and he just put everything into action and was very clear … so professional … And yes, so that was very positive for me. And the actual treatments, because I’ve always felt quite secure and quite happy with them.

No, but I do appreciate, that you know the trouble, I do appreciate having the treatment that I’ve had. Because, if it helps my bone density then that’s really good.

Many of the patients on IV treatment had previously had difficulties in adhering to regimen for oral BP and were therefore pleased to have ‘arrived at’ a more acceptable form of treatment. Having experience of both types of regimens led to some patients enthusing about IV treatment. Being able to reflect on negative experiences of oral BP led to them conveying positive affective attitudes and feelings about IV treatment.

No, when considering the tablets, I was rather pleased that I was getting this one … I thought I would come off the better actually.

And then of course I hit the jackpot with the infusion and that’s marvellous.

[Intravenous treatment is] just wonderful … I’ve never been up nor down or anything, and compared to what I was suffering with, fabulous. For me it’s been great.

Others on IV treatment who had not previously been on oral treatments made speculative comparisons, weighing up the negatives against the positives. The IV treatment was often regarded as the better option, leading to feelings of satisfaction:

I’ve talked to people afterwards who just have the tablet, and they’re surprised that I had the infusion, but I was quite happy to have the infusion.

Equally, some patients on oral BP felt positively towards the tablets and that they were in control of managing them themselves:

I managed the five years without missing them, I think. It was convenient having the tablets because once or twice we were on holiday, to just take them with you and do the same thing.

Moreover, this patient also highlighted that the COVID-19 pandemic had made the prospect of going to hospital to receive IV treatment more burdensome, thus leading to a more negative affective attitude:

I’m not looking forward to going to the hospital with all these COVID problems.

Further, despite curiosity about alternative treatments, when the experience of oral BP had been unproblematic, patients described being happy to remain on their current regimen:

Not that I would want to change over, but it was only just something that I read. So no, I wouldn’t want that anyway. I’m quite happy with my tablets.

It might be nice to know that they were aware that there are alternatives, but I don’t take a massive amount of notice of what they are because, at the moment, I’m quite happy on the Risedronate.

This was also the case for patients who had had a treatment break and needed to resume the oral BP regimen:

I was very happy to go back on Alendronic Acid having had no trouble previously.

Regardless of treatment type, in circumstances where opportunity costs and burdens were low, patients expressed high levels of self-efficacy, sharing their confidence in being able to execute the necessary actions to partake in the treatment regimen:

…so I think all in all [the tablet] definitely agrees with me, and it’s so easy to take. You just get into a routine you know, like Friday morning, I know exactly what I’m doing and what times I’m doing it at you know.

…they were a good, shaped tablet, you know, they were oblongs – not big round ones. I’ve had all sorts of trouble with big round tablets. But they’re a good shape. I had no trouble in swallowing it with a full glass of water.

Sometimes, patients discussed the steps that were taken to reduce the burden of undergoing treatment and how such measures made them feel more positive and able to cope with the regimens, thus increasing their self-efficacy. By nature of the oral BP regimen, such strategies had to be instigated by the patients themselves. For example, one patient discussed keeping herself occupied during the period when she needed to remain upright after taking the tablet:

Interviewer: Did you manage to fit it into your weekly routine?

Oh yes, because I got loads of jobs done while I was upright and swallowing loads of water.

In contrast, for patients receiving IV treatment, it was often the healthcare staff who could facilitate a smooth and comfortable experience for them:

I know what [the staff are] there for and yeah, I just, put your arm out and keep it in a safe place. So, they just, put you in a comfortable position. And then they just do it, so … I don’t really feel anything to be honest.

Also, when the treatment aligned with one’s personal beliefs, this also led to positive affective attitudes and higher levels of self-efficacy. Patients openly expressed their satisfaction when they believed that they were on the most appropriate treatment for osteoporosis:

I need to be on a treatment. I think [intravenous is] the best one for me at the moment but I’m fully aware I am at high fracture risk anyway.

Some patients described positivity at being on what they perceived to be the right treatment, particularly if their experience of previous treatments had been negative:

I was really sort of rather pleased that I’d finally achieved, you know, some other treatment and I didn’t have to keep taking the wretched [oral] bisphosphonates.

Therefore, perceived fairness of treatment allocation, including the timing of this allocation, also appeared to be related to the patients’ affective attitudes.

Discussion

We have demonstrated how patients’ acceptability and engagement in BP treatment can be described and explained through the seven TFA domains. Specifically, we have described how the balancing of specific TFA domains impacted on the extent to which patients with osteoporosis accepted and engaged in their treatment, manifesting as self-efficacy and affective attitude. By nature of treatment format, lower regularity of treatment, more established contact points and follow-up with HCPs, IV BP treatment was generally perceived to offer lower opportunity costs, be less burdensome and was often regarded as appropriate treatment by patients. This latter point was the case for some patients who had previous negative experiences with oral BP. Moreover, there were often more opportunities to build up coherence around IV treatment and develop confidence around its effectiveness since such patients were more likely to have frequent contact with HCPs, who could address patients’ queries and explain details around the treatment on more than one occasion. In addition, dual-energy X-ray absorptiometry (DXA) scans (bone density scans used to measure how much bone tissue an individual has undertaken to help assess fracture risk) tended to be implemented at earlier points compared with patients taking oral BP, thus providing a means to measure the success of treatment.

Crucially, TFA domains were found to be interconnected, with patients balancing treatment burden, opportunity costs and ethicality issues against treatment coherence and perceived effectiveness. The outcome of this balancing act ultimately determined patients’ attitudes towards, and engagement in, their treatment regimens, thus informing their affective attitudes and self-efficacy.

This is conveyed in Figure 3.

FIGURE 3 Relationship between TFA domains. Reproduced from Narayanasamy M, et al. Age Ageing 2022. https://doi.org/10.1093/ageing/afac255. (Figure not reproduced here; see the original article.)

Few studies have previously investigated patient acceptability and engagement for different BP treatment regimens. Roh et al.88 investigated adherence to BP amongst patients with limited health literacy. The study found that adherence rates were significantly higher amongst patients who were receiving quarterly IV BP compared with those taking weekly oral BP. Moreover, another study found that 65% of newly diagnosed patients with osteoporosis preferred an annual infusion compared with weekly oral BP treatment, and this preference was particularly apparent in patients with a higher perceived risk of future fractures.89 This may suggest that patients have more confidence that IV BP treatment will be more effective in reducing fracture risk. This certainly reflects the findings of the current study, which highlighted that perceived effectiveness was a key factor in influencing self-efficacy and affective attitude, ultimately impacting treatment acceptability and engagement.

Regarding specific patient groups, two studies90,91 identified that postmenopausal women with osteoporosis preferred treatments that occurred less frequently, citing such regimens as more comfortable, simpler and enabling them to take fewer tablets. This suggests that weekly oral BP regimens are harder to adhere to for certain patient groups due to the frequency and perceived complexity. Furthermore, domiciliary treatment, such as IV drugs at home, may be more beneficial for older patients living with long-term conditions due to the challenges associated with travelling to hospital appointments, including distance, reduced mobility and pain, as highlighted by participants in the study and also in other studies.92,93 This could be seen as consistent with wider calls to shift aspects of services for chronic conditions away from acute facilities, although this shift remains an ongoing policy and funding challenge.94

Despite the recognised challenges with taking oral BP, there were clear examples in the current study where participants accepted and engaged with oral BP when opportunity costs and burden levels were low. Similarly, a study investigating BP treatments in women with breast cancer95 confirmed that most participants had been able to accommodate oral BP treatment into their lifestyle and were completely satisfied with the treatment. This suggests that such regimens are not always burdensome for patients and that opportunity costs can be met. However, in the current study, there were patients who continued to engage amid difficult circumstances, such as side effects which were burdensome, and where treatment had a significant impact on lifestyle. In these cases, the TFA cannot account as strongly for such patients’ experiences. Such patients may have prioritised the outcome of treatment (i.e. the hope of improved bone health and fewer fractures) more highly than the treatment experience, thus withstanding the negative aspects of treatment. The complexities of using the TFA in the context of examining treatment acceptability found that there were overlaps between TFA domains, and that it is not always a comprehensive framework for offering understanding into patient acceptability and engagement with medicines. Other frameworks such as the NCF96 may be helpful in understanding and transforming adherence-related beliefs and behaviours. This framework understands patients’ adherence to be the outcome of a cost–benefit analysis whereby adherence is likely to be higher when the perceived need for treatment is prioritised over the risk of negative consequences such as side effects. This lens may be relevant to understanding some patients in our sample who pursued treatment amid high burden levels and significant opportunity costs.

Strengths and limitations

A key strength of this study is the fact that a large sample of participants were recruited to provide in-depth insight into different experiences of BP treatment regimens. The main limitation is that findings were largely drawn from a sample of participants who had membership with the ROS, with a smaller number recruited through NHS services. This may have caused the sample to be biased, for example, it may have largely comprised individuals who had the financial means to fund membership and who were possibly taking a more proactive approach to their health by investing in resources. This may restrict applicability to other patient groups, such as those who are financially disadvantaged and those who are less proactive in their care and treatment. Moreover, our sample of patients receiving IV BP comprised those receiving ZOL only and not 3-monthly IV IBN treatment. However, the paper has been able to effectively demonstrate to some extent the relevance of TFA domains in explaining attitudes and behaviours around acceptability and engagement in BP treatment regimens. Moreover, utilising the TFA domains to explain acceptability and engagement of IV BP treatments is particularly novel. It will be useful to explore whether such findings apply to other patient groups.

The study has identified several questions for further research, including whether it would be feasible and appropriate to offer specific patients first-line IV ZOL treatment for osteoporosis and how acceptability and engagement can be optimised. In addition, it has also highlighted the possibility of treating long-term conditions in alternative ways, such as in the community, which may be favourable for an ageing population, where hospital travel may be challenging due to comorbidities and the COVID-19 pandemic. These uncertainties will feed into a research priority-setting exercise alongside other questions which have arisen from the wider research study programme.

Conclusion

Intravenous BP, ZOL treatment was generally more acceptable to patients. Such regimens were perceived to be more straightforward to engage in, although a portion of patients taking oral BP were satisfied with their current treatment. The TFA was a useful model in accounting for how patients accept and engage in BP treatments but was limited as a comprehensive framework that could explain all patient experiences. Further research is needed to identify whether findings apply across other patient groups, how acceptability and engagement can be optimised and to identify other frameworks for investigating patient acceptability of, and engagement in, BP treatment regimens.