Article Text

Original research
Perspectives of mild asthma patients on maintenance versus as-needed preventer treatment regimens: a qualitative study
  1. Juliet Foster1,
  2. Richard Beasley2,
  3. Irene Braithwaite2,
  4. Tim Harrison3,
  5. Mark Holliday2,
  6. Ian Pavord4,
  7. Helen Reddel1
  1. 1The Woolcock Institute of Medical Research and The University of Sydney, Sydney, New South Wales, Australia
  2. 2Medical Research Institute of New Zealand, Wellington, New Zealand
  3. 3Nottingham Respiratory Medicine Unit and NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK
  4. 4Respiratory Medicine Unit and Oxford Respiratory NIHR Biomedical Research Centre, University of Oxford, Oxford, UK
  1. Correspondence to Prof Helen Reddel; helen.reddel{at}sydney.edu.au

Abstract

Objectives As-needed low-dose combination budesonide-formoterol is recommended by asthma guidelines in many countries as an alternative to maintenance inhaled corticosteroids (ICS) for treatment of mild asthma, but there are few data on patient attitudes toward these regimens. This study explored the comparative implementation experiences and future treatment preferences of mild asthma patients who had experienced these two treatment regimens.

Setting A subgroup of adults randomised to maintenance ICS or as-needed ICS-formoterol in a multinational, 52-week open-label randomised controlled trial (NovelSTART) in mild asthma patients were interviewed to explore their motivations for treatment use during the study and their preferences for future treatment.

Participants Semistructured interviews were conducted with 74 participants (Maintenance group: n=39, As-needed group n=35, mean age 38 (range 19–69)) and thematically analysed from transcribed audiorecordings.

Results Emergent themes from analysis comprised: ‘How much my asthma affects me’ (how their asthma’s impact affected their self-management motivation); ‘What I know about asthma’ (limited knowledge impeded appropriate self-management decision making); ‘How much effort this treatment regimen involves for me’ (treatment complexity and/or difficulty establishing a medication routine impeded implementation, particularly in the Maintenance group); and ‘My beliefs about the benefits and risks of this treatment’ (patients who considered their treatment as ineffective, eg, limited difference in symptoms relative to salbutamol (both groups) or slower onset of relief (As-needed group) had poor motivation to use the treatment). Due to the simplicity of the as-needed combination strategy, this was the preferred future regimen, even by patients who had not yet tried it.

Conclusions Key patient perspectives on the implementation of preventer treatments for mild asthma included factors relating to perceived asthma burden, disease knowledge, treatment complexity and treatment usefulness or safety. The as-needed budesonide-formoterol regimen was preferred to maintenance ICS treatment in mild asthma though patient education is urgently needed to address implementation motivation.

Trial registration number ACTRN12615000999538.

  • asthma
  • qualitative research
  • general medicine (see internal medicine)
  • quality in health care
  • primary care

Data availability statement

Data are available on reasonable request. Access to deidentified transcripts from participant interviews will be available on reasonable request from 2 years after article publication, to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to the chief investigator HR (helen.reddel@sydney.edu.au). To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Strengths and limitations of this study

  • Qualitative research was prospectively integrated into the design of the pragmatic clinical trial, in order to obtain patient perspectives about new and existing treatment options for patients with mild asthma.

  • The use of qualitative methods, in a large interview sample size, is a major strength of this study allowing a more patient-centred understanding of inhaled corticosteroid regimen preference than those described from quantitative methodology in the few previous studies.

  • The generalisability of the results to patients in the general community may be limited since interviewees were participants in a 12-month long NovelSTART randomised controlled trial (RCT), most had postschool education, and none had very recently-diagnosed asthma and/or were new to asthma medications.

  • Despite concerted efforts, we were unable to interview patients who had withdrawn from the NovelSTART RCT.

Introduction

In many countries, as-needed low-dose combination budesonide-formoterol is now recommended as an alternative to maintenance low-dose inhaled corticosteroids (ICS) for treatment of mild asthma. These guidelines, following on from 2019 Global Initiative for Asthma recommendations,1 2 are based on randomised controlled trial (RCT) evidence in almost 10 000 patients showing that as-needed ICS-formoterol outperforms as-needed short-acting beta2-agonist (SABA) alone3 4 and performs similarly or better than twice daily maintenance ICS plus as-needed SABA,3–6 for exacerbation prevention in mild asthma. It achieves this without clinically important differences in symptom control or lung function,3–6 and at a lower ICS dose3–6 relative to ICS maintenance.7

Knowledge of patient attitudes is crucial for optimising their treatment implementation, particularly when new treatments are introduced. Despite growing data about patient perspectives in moderate to severe asthma, there is still limited information on attitudes toward using ICS-containing treatment in mild asthma, although it is known that patients using a SABA-alone regimen may find it difficult to justify, or may have concerns about, adding a corticosteroid medication if they consider their disease insignificant or unproblematic.8 9

A qualitative substudy (‘NovelQ’) was incorporated into the 12-month NovelSTART RCT3 to understand mild asthma patients’ attitudes toward two different ICS-containing regimens: maintenance twice daily budesonide (200 µg) plus as-needed salbutamol, or as-needed combination budesonide-formoterol (200/6 µg). We have previously reported that patients randomised to as-needed combination therapy found it to be an acceptable reliever therapy compatible with established reliever-taking habits, but they identified the importance of health professional support with transition to this treatment.10

The present paper explores the comparative implementation experiences and future treatment preferences of mild asthma patients randomised to either maintenance twice daily budesonide plus as-needed salbutamol or as-needed budesonide-formoterol, who had used SABA-only treatment for ≥3 months before study enrolment.

Material and methods

We reported our results following the Consolidated Criteria for Reporting Qualitative Research guidelines.11 See online supplemental material for detailed methods.

Patient and public involvement

There was no patient or public involvement in the study development or design.

Participants

Adults enrolled in a multinational, 52-week open-label RCT had doctor-diagnosed mild asthma with no recent asthma hospitalisations and used SABA as their sole asthma therapy in the previous 3 months. Full details are reported elsewhere.3 12

Of NovelSTART RCT patients randomised to maintenance twice-daily budesonide 200 µg by Turbuhaler plus as-needed salbutamol by pMDI (‘Maintenance’ regimen), or as-needed budesonide-formoterol 200/6 µg by Turbuhaler (‘As-needed combination’ regimen), a subsample was selected for the NOVELQ qualitative study by purposive sampling to provide diversity by age and sex. Each patient in the sub-sample was provided with NOVELQ study information and invited, by letter, for one telephone interview occurring after 10 months participation in the RCT. Any invited participant who indicated their interest by contacting the study coordinator was scheduled for interview after providing written informed consent.

Study design and interviews

This qualitative study involved a single semistructured, in-depth interview ≥10 months into the study with each NovelQ patient randomised to receive either the ‘Maintenance’ (twice daily low dose ICS), or ‘As-needed combination’ (as-needed low dose budesonide-formoterol) regimen. The interviews aimed to investigate patients’ motivations for implementing these regimen options (both before and during the study) and their preferences regarding future mild asthma treatment. All interviews were conducted by telephone and audiorecorded. Each participant was informed that their interview data would be kept confidential and that the interviewer (JF) had no involvement in the NovelSTART RCT.

Our interview guide (online supplemental material) incorporated semistructured questions on mild asthma patients’: (1) experiences with their allocated RCT treatment (eg, implementation or treatment concerns and/or changes in asthma symptoms); (2) preferences regarding future reliever and preventer treatment options for mild asthma and (3) life with mild asthma, if this arose during the interview, to provide context to the experiences and preferences described. Using an iterative process, any new theme emerging from a prior interview was followed up in subsequent patients’ interviews.

Analysis

Interviews were transcribed verbatim then anonymised. Interviews and analysis were conducted by coauthor JF, using thematic content analysis,13 followed by descriptive then inductive pattern coding and finally synthesis into the themes which emerged from the data.14 An audit trail was created to optimise analysis rigour.15 Full details are reported in online supplemental material and elsewhere.10

Results

Of 108 participants invited, 39 of 50 (78%) in the ‘Maintenance’ group and 35 of 58 (60%) ‘As-needed combination’ group participated in an interview (online supplemental material). The 74 participants (‘Maintenance’ group: mean age 38 (range 19–69), Asthma Control Questionnaire (ACQ) 5-item score mean±SD 1.12±0.71; ‘As-needed combination’ group: mean age 44 (18-74), ACQ-5 1.09±0.55; table 1) were interviewed for an average of 40 (range 18–62) min. Sixty-four per cent of the ‘Maintenance’ group, and 71% of the ‘As-needed combination’ group, reported ever having used an ICS-containing controller prior to participation in, but not within 3 months of enrolling in NovelSTART.

Table 1

Demographics and baseline characteristics

Emergent themes from the analysis of interviews described the motivations for patients’ regimen implementation decisions or behaviours. The themes comprised: ‘How much my asthma affects me’, ‘What I know about asthma’, ‘How much effort this treatment regimen involves for me’ and ‘My beliefs about the benefits and risks of this treatment’. In the results reported below, themes emerged from both randomisation groups unless otherwise specified; some data from the ‘As-needed combination’ group have been reported elsewhere.10 Brief interview quotations are presented below with a unique patient ID and randomisation group; see expanded quotes in the following tables.

Motivations for treatment implementation in mild asthma

The motivations common to patients who had received either RCT regimen were represented by the themes ‘How much my asthma affects me’ and ‘What I know about asthma’.

How much my asthma affects me (theme 1)

Most individuals described predominantly unproblematic asthma which they felt required only minimal active treatment:

I don't manage my asthma very actively. 'Cause like I don't need to… (ID98-Maint)

Indeed some did not consider their asthma in any way life-threatening:

I know [if] I want to go climbing a hill…I'm going to get some symptoms but that’s really about it. I'm not disabled by it, and there’s nothing life-threatening about it (ID97-As-needed)

One interviewee described their own, and their healthcare professionals’, complacency around mild asthma:

Everyone is complacent. I mean me, my GP, the pharmacist and even my husband…Medical professionals don't treat mild asthma seriously. They think “You'll be right. Just take Ventolin”. There’s no follow up (ID96-Maint)

Interestingly, interviewees also described habituating to their asthma symptoms and/or having difficulty differentiating symptoms from other potential causes; this perhaps impacted their perceptions of the risks of mild asthma:

Yeah it’s hard for me to decipher. I would also feel chest tightness anyways in amongst [anxiety] so I would definitely be confused whether it was asthma or if it was just something else… (ID50-Maint)

In contrast, some individuals described periods of uncontrolled asthma symptoms, or progressively worsening asthma control (prior to the study), that required closer and/or intermittent, management, for example,

I’d noticed now I’m in my 40s, [my asthma] seemed to be getting worse. I just seemed to be needing [my reliever] more… (ID87-As-needed)

Despite the diversity of asthma experiences, interviewees rarely mentioned significant hindrances on their life due to mild asthma. The life limitations reported were predominantly associated with physical exertion, sometimes only during a respiratory illness. However, asthma did limit some interviewees’ lifestyle choices in both regimen groups, though it was unclear the extent to which this influenced the patient’s use of their RCT treatment.

Expanded quotes relating to theme 1 are found in table 2.

Table 2

How much my asthma affects me (theme 1)

What I know about asthma (theme 2)

Interviewees described limited knowledge about asthma and limited learning opportunities in primary care settings:

It depends on which GP you go to. Some of them you see for 5, 10 minutes max, and which is only just enough for them to look at you and go ‘Yes this is what your problem is. Here’s some drugs. Off you go’… (ID79-Maint)

Doubt about the credibility of their asthma diagnosis was also communicated by interviewees, often due to comparisons they made with sicker peers who had asthma:

I never really thought about [having] asthma um, because even in those moments it wasn't like really struggling for breath. And I had a friend who died … from asthma, so I know what his struggles were like and obviously mine were nothing even remotely close to what he had. (ID63-Maint).

Further, limited asthma knowledge affected appropriate management, such as knowing when to seek healthcare:

There was that one night where I was coughing and coughing and I actually started getting concerned. I thought ‘Well where is the point where I need to actually, you know, get help?’. (ID64-As-needed).

Expanded quotes relating to theme 2 are found in table 3.

Table 3

What I know about asthma (theme 2)

The motivations for treatment implementation that were more diverse between the two RCT treatment groups were represented by the themes: ‘How much effort this treatment regimen involves for me‘ (theme 3) and ‘My beliefs about the benefits and risks of this treatment’ (theme 4).

How much effort this treatment regimen involves for me (theme 3)

Patients taking the ‘Maintenance’ regimen reported difficulty comprehending two different treatment approaches in the same regimen:

I have to consciously think ‘Right this inhaler needs to be used that way' [taken twice a day], as opposed to just having one [treatment approach] and thinking of one way of using it [take it as-needed]. (ID102-Maint)

The requirement for two different inhalers in the ‘Maintenance’ regimen prompted comparison of the inhalers; if the preventer inhaler was perceived to have comparatively little physical benefit this sometimes resulted in poor motivation for adherence:

…I feel like [the ICS inhaler’s] the main one that I should be taking but I just don't feel as motivated because I don't feel the symptom relief from it. (ID50-Maint)

Barriers to taking the separate ICS inhaler were obviously reported only by those randomised to the ‘Maintenance’ regimen; these barriers included the burden or difficulty of establishing an effective ICS-taking routine (which could be worse at night, weekends, when travelling), or forgetting their preventer treatment when they did not perceive any symptoms:

When I've been feeling really well, and not really thinking about my inhalers that makes me forget to use them. (ID102-Maint).

Expanded quotes relating to theme 3 are found in table 4.

Table 4

How much effort this treatment regimen involves (theme 3)

My beliefs about the benefits and risks of this treatment (theme 4)

Though many interviewees found their randomised treatment regimen effective (eg, perceiving longer relief, that is, feeling less wheezy, needing to use their reliever less), for others, in both RCT regimens, a lack of perceived benefit from adding a preventer medication to their previous SABA-only regimen, either via a second inhaler, or inside a single combined inhaler, limited its perceived effectiveness:

I didn't really see much of an improvement in my triggers like hiking, cold air, flu when I was taking it really regularly when I started the study.…I don't do stuff just because I'm told it’s good for me.…[so my use] just kind of dropped off … (ID66-Maint).

Notably, some interviewees in the ‘As-needed combination’ group felt their study inhaler had less overall relief action or less speed of action compared with their previous SABA inhaler (as reported elsewhere10).

While a small number of interviewees in both groups had general concerns about the potential for treatment side effects prior to and/or when beginning the study regimen, some interviewees in the ‘Maintenance’ regimen group described a specific concern about corticosteroid-related weight gain;

I was a bit concerned because I believe [steroids], can make you put on weight…but because I take it in [nasal spray for hay fever] as well I was slightly concerned about that. (ID84-Maint)

This concern was only raised by females, and they did not report it to have affected their study medication use.

The side effects patients described actually experiencing were largely similar between regimens, most commonly unpleasant taste, and these also generally did not impact on RCT treatment implementation:

I just observe after I use [the study inhaler], like, numbing, my hands, like, shaking or sweating, something like that, a few minutes after taking…[but] it doesn’t bother me. (ID15-As-needed)

Oral thrush, only reported by one ‘Maintenance’ regimen patient who had past and RCT experiences of this side effect, significantly impacted on the likelihood of future use of maintenance ICS:

Sometimes [oral thrush] gets too much and I'll just stop doing [my preventer] and I'm not gonna lie and say that that’s never, ever going to happen again (ID96-Maint)

Expanded quotes relating to theme 4 are found in table 5.

Table 5

The benefits and risks of this treatment (theme 4)

Personal preferences regarding future treatments for mild asthma

Rationales for preferring a single combined inhaler

Interviewees reported their treatment preferences, and the associated rationales, for either a single combined preventer/reliever inhaler (taken as-needed) or separate preventer (taken twice daily) and reliever (taken as-needed) inhalers at the end of the interview. Most interviewees, within both RCT groups, preferred a single combined inhaler over separate reliever and preventer inhalers for their future treatment (77% in ‘As-needed’; 64% in ‘Maintenance’ group). Interviewees, within both RCT groups, considered a combined inhaler easier to manage (eg, one thing to remember to carry); as requiring less prescriptions and lower costs; and as providing a physical feeling of relief after use to motivate ongoing use that is missing with a separate ICS-only medication:

[What motivates me to take it is] to, to feel the effects, that relief and not only in that short-term but also in the long-term knowing that it’ll be that much easier to walk up that hill…. (ID50-Maint).

Indeed, for one participant receiving the ‘Maintenance’ regimen, there was a firm caveat that any single combined inhaler must be as effective as two separate inhalers.

A rationale, which emerged only in relation to future treatment, was that a single combined inhaler could support preventer medicine use (through taking reliever doses of the combination inhaler), with the interviewee likening this to an adherence prompt:

You’d remember to take it because obviously if it was relieving the symptoms as well, that would help you to remember to take it… (ID84-Maint)

This echoes a treatment implementation challenge during the RCT described by patients in the ‘Maintenance’ group (see Theme 3, above) of difficulty establishing an effective medication-taking routine with their separate ICS inhaler.

Rationales for preferring separate reliever and preventer inhalers

In contrast some interviewees in both RCT groups preferred separate reliever and preventer inhalers over a single combined inhaler for their future management. This preference was considerably more common among those allocated to the ‘Maintenance’ than the ‘As-needed combination’ regimen, and there were also clear differences in rationale by RCT group.

Only ‘Maintenance’ regimen interviewees felt that a combination inhaler may cause unnecessary use or overuse of preventer medication:

How would you know that you definitely need both [medications], if you're not taking them separately [first]?…I think I'm happy with the two separate ones, as it’s what I am used to now…I like the option of possibly just needing one [reliever] inhaler and being able to separate that out. (ID102-Maint).

and/or that there could be increased side effects when taking a combination preventer-reliever as-needed, due to what they assumed would be greater corticosteroid exposure:

I think I would be concerned that if the only puffer I could take had that preventer medication in it, that it would worsen those side effects, if I needed to take it more often. (ID96-Maint)

Others felt that a combination inhaler may be insufficiently effective compared with the familiar SABA inhaler.

A rationale for separate inhalers, which emerged only in relation to future treatment preferences in both groups, was the familiarity/security of previously experienced treatment:

I’m not in an immediate rush to change. The course of medication I’ve been doing for my asthma for this past while I’ve been on the study I am happy with, so why risk that? (ID74-Maint)

Some ‘Maintenance’ group patients reasoned it was counterintuitive and detrimental to sustained use of their ICS to take a combination preventer medication as-needed in the future:

I don’t think [an as-needed preventer] would work ‘cause …you’d be back into that ebb and flow thing, of you’d take it lots, lots, lots, feel good, stop taking it… (ID96-Maint)

In the ‘As-needed combination’ group, some interviewees cited effectiveness of salbutamol itself as a rationale for preferring separate reliever and preventer inhalers (or SABA therapy alone), reporting that they felt salbutamol worked faster for symptom relief or thought a salbutamol reliever may be a less strong medication than the combination medication (as reported elsewhere10).

Expanded quotes relating to rationales given by interviewees for preferring a single combined inhaler or separate preventer and reliever inhalers for future treatment are found in table 6.

Table 6

Patient rationales* for their preferences regarding future treatment implementation

Discussion

Our study reveals key patient perspectives on the factors motivating use of two different preventer treatments for mild asthma; these include: perceived asthma burden, disease knowledge, treatment complexity and treatment usefulness or safety. Such factors emerged in patients who had used either a maintenance or as-needed combination ICS-containing regimen for ≥10 months prior to interview, but had previously used SABA-only treatment for the 3 months before study enrolment.3 Most interviewees tended to perceive their asthma as requiring little active care, and not inhibiting to their daily life, though it is uncertain if these perceptions were reliable given that asthma symptom habituation and difficulty distinguishing asthma symptoms from other causes (eg, anxiety) were also reported. The findings emphasise the importance of understanding patient perspectives in decision-making and education about new asthma treatments.

In our interviewees, there was generally limited knowledge about asthma, and a tendency to believe that their personal asthma risk was low. These patient perspectives are of obvious concern because, as in other research,16 they appeared to influence attitudes toward, and implementation of, prescribed preventer treatment. For example, the perception of low health risk from asthma combined with limited asthma knowledge meant that the necessity for an additional (ie, preventer) treatment was unclear especially when no direct physical benefit could be observed after using the ICS-containing inhaler. A recent qualitative study among patients predominantly prescribed maintenance ICS/long-acting beta2-agonist reported a lack of understanding about asthma as a barrier to self-management, and doubts about the necessity of ICS.16 The poor patient disease education in our interviewees with mild asthma may explain misconceptions about the (low) risk of their disease, a finding observed in studies of patients with more severe asthma.17 Education in mild asthma patients is urgently needed to increase understanding of the potential for severe exacerbations even in mild asthma,18 19 and the ability of ICS-containing treatment to reduce these risks even if symptoms are periodic and/or appear mild and inconsequential.20 21 Patient-centred education can be provided not only by general practitioners and nurses, but also by pharmacists22; it should come not only from an academic medical/pharmacologic perspective, but also from an understanding of patients’ lived experience of asthma.23

There were important differences in implementation behaviours between RCT regimen groups. Those randomised to the ‘Maintenance’ group reported greater difficulty implementing their regimen due to its greater complexity (adding a preventer inhaler to their previous SABA-only regimen), its higher cognitive demand (understanding the difference between two inhaled medications) and/or greater behavioural effort (taking one inhaler as-needed and another twice daily) compared with SABA alone. Obviously, this issue did not arise in the ‘As-needed combination’ group. A desire for convenient, simple treatments (easy to know when or how to take) has been reported in other asthma research.16 Indeed, those receiving the ‘Maintenance’ regimen reported a range of implementation problems with their daily preventer that that did not interfere with the ‘As-needed combination’ regimen, such as difficulty establishing an effective preventer-taking routine or forgetting preventer treatment when symptoms were not present. Similarly, in the INSPIRE study, the proportion of patients underusing their maintenance medication was significantly higher when they felt well (34%) compared with periods of worsening asthma (18%).9

With respect to future treatment preferences, most patients randomised to either ICS-containing regimen in the NovelSTART RCT preferred the concept of a single combined inhaler (containing both a preventer and a reliever medication inside it) and taken as-needed, over separate reliever and preventer inhalers. In a quantitative survey at the end of the PRACTICAL study,6 90% of those who had been randomised to as-needed budesonide-formoterol and 40% of those randomised to maintenance ICS said they would prefer an as-needed combination inhaler for their future treatment.24 In the present interviews, patients receiving maintenance treatment who favoured as-needed combination treatment for the future (though they had not yet tried it) gave similar reasons for their preference as those who had used as-needed budesonide-formoterol in the RCT. These included: easy management (eg, one thing to remember); potential for lower prescription costs; and support for preventer adherence (eg, a single combined inhaler could provide a physical feeling of relief to motivate ongoing use). A recent study in asthma patients prescribed ICS reported a critical physiological/psychological motivation from feeling a tangible relief plus emotional reassurance from their reliever inhaler that was not felt with ICS-only inhalers.17

However, certain concerns about the single combined inhaler were reported. Some receiving the ‘As-needed combination’ regimen in the RCT felt that a single combined inhaler must always have an equivalent effectiveness for symptom relief as a SABA, and some preferred the familiarity/security of their past maintenance treatment. Those receiving the ‘Maintenance’ regimen in the RCT had additional issues such as difficulty grasping, or trusting in, the feasibility of a preventer medication taken as-needed and concerns around insufficient treatment benefit or unnecessary or overuse of preventer medication with the single combination inhaler. Attachment to previously used treatments, perceived lack of need for ICS when not experiencing symptoms, and concerns about ICS overuse have been reported in recent research with asthma patients prescribed maintenance ICS.16 17 25 Similarly, in a recent discrete choice experiment (DCE) study26 of mild asthma patients at the end of the 12-month PRACTICAL RCT comparing as-needed combination treatment over maintenance therapy,6 the most important attributes for choosing an ICS regimen were prevention of shortness of breath and reduced risk for future flare ups. This mirrors our present findings regarding the importance of perceived effectiveness for treatment implementation. Regimen type was also important in the DCE study but only in those who preferred an as-needed regimen, though, as in this study, most patients overall (64%) preferred as-needed combination over the maintenance regimen.26 While the present data suggest that the most easily implementable treatment for patients appears to be a single combined inhaler, patient concerns about this treatment approach must be addressed in order to ensure optimal implementation if this treatment is prescribed. Further, future research investigating the extent to which components of behavioural models (eg, the necessity-concerns framework)27 influence treatment preferences and impact patient care in mild asthma would be a very useful next step to enhance the literature on patient choices and acceptance of regimen options for mild asthma.

The use of qualitative methods, prospectively integrated into the design of the pragmatic clinical trial, is a major strength of this study allowing a less clinical and more patient-centred understanding on perspectives about new treatment options for patients with mild asthma. The fact that the rationales for ICS regimen preference provided by our interviewees were wider ranging than those described in previous mild asthma studies using survey-based or DCE methods24 26 supports the need for this patient-centred qualitative study. Limitations include that interviewees were participants in a 12-month long RCT (which for those prescribed maintenance ICS may have increased their treatment adherence during the study) and had been receiving SABA-only treatment for at least 3 months prior to enrolment, and most had postschool education, thus limiting the generalisability of the results to patients in the general community, including those with very recently diagnosed asthma and/or new to asthma medications. A smaller proportion of RCT participants invited from the ‘As-needed combination’ group agreed to be interviewed, so those who consented to interview may have had a more positive view towards this treatment. Despite concerted efforts, we were unable to interview patients who had withdrawn from the RCT.

Conclusions

Our interviewees provided some of the first patient-centred guidance on factors to consider when introducing ICS-containing treatments now recommended by guidelines for patients with mild asthma. Common self-management challenges were described as factors affecting mild asthma treatment implementation. The concept of a single combined inhaler was the preferred future treatment option even among patients who had not yet tried it, due to its simplicity and similar usage patterns as those already acquired with SABA. However, other issues reported by interviewees make it clear that patient education is urgently needed to increase disease knowledge and to address implementation barriers when adding either type of preventer treatment in mild asthma.

Data availability statement

Data are available on reasonable request. Access to deidentified transcripts from participant interviews will be available on reasonable request from 2 years after article publication, to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to the chief investigator HR (helen.reddel@sydney.edu.au). To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.

Ethics statements

Patient consent for publication

Ethics approval

The study protocol was approved in Australia by the South Western Sydney Local Health District Human Research Ethics Committee (ref. HREC/15/LPOOL/554); in New Zealand by The Northern B Health and Disability Ethics Committee (ref: 15/NTB/96); and in the UK by the Health Research Authority (IRAS Project ID: 188191).

Acknowledgments

We warmly thank the participants in the study; NovelSTART clinical site staff for inviting their patients for NovelQ interviews, and Woolcock Institute staff Marilyn Yee, Khanh Huynh and Jesse Xu for assisting with recruiting patients, scheduling interviews and/or transcribing interviews.

References

Supplementary materials

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Footnotes

  • Contributors JF: conceptualisation, methodology, formal analysis, investigation, writing-original draft. RB, IB, TH, MH and IP: contributed to conceptualisation, methodology, writing-review and editing. HR: conceptualisation, methodology, contributed to formal analysis, writing-review and editing, and is responsible for the overall content as guarantor for the work.

  • Funding This work was supported by an investigator-sponsored research grant from Astra Zeneca (ESR14/10452) and by Independent Research Organisation funding from Health Research Council of New Zealand (18/002). AstraZeneca was provided with a draft copy of the manuscript but had no involvement in the collection or analysis of the data, in the preparation of the manuscript, or in the decision to submit the manuscript for publication.

  • Competing interests JF reports independent research funding from AstraZeneca (AZ) and honoraria from AZ and Boehringer Ingelheim (BI) for independent medical educational presentations unrelated to this work. RB reports research funding from AZ, GlaxoSmithKline (GSK) and Genentech, and honoraria for consulting and/or advisory boards from AstraZeneca, Cipla, Avillion and Theravance. TH reports research grants from AZ and honoraria for advisory boards and speaker meetings from AZ and GSK. IP reports honoraria from AZ, BI, Aerocrine, Almirall, Novartis (Nov), GSK, Genentech, Regeneron, Teva, Chiesi, Sanofi,Circassia, Knopp. HKR reports advisory boards for AZ, BI, GSK, Nov, and Sanofi-Genzyme; consulting for AZ, GSK and Nov; honoraria from AZ, BI, GSK, Nov and Teva for independent medical educational presentations; and independent research funding from AZ, GSK and Nov. MH and IB have no conflicts of interest to declare in relation to this work.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.