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Pharmacist-led adherence support in general practice: a qualitative interview study of adults with asthma

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032084 review only Article Type: Research

Date Submitted by the 01-Jun-2019 Author:

Complete List of Authors: Mes, Marissa; UCL School of Pharmacy, Centre for Behavioural Medicine, Practice & Policy Katzer, Caroline; UCL School of Pharmacy, Centre for Behavioural Medicine, Practice & Policy Wileman, Vari; UCL School of Pharmacy, Centre for Behavioural Medicine, Practice & Policy Chan, Amy; UCL School of Pharmacy, Centre for Behavioural Medicine, Practice & Policy Horne, Robert; UCL School of Pharmacy, Centre for Behavioural Medicine, Practice & Policy Taylor, Stephanie; Queen Mary University of London, Centre for Primary Care and Public Health

Medication Adherence, Asthma < THORACIC MEDICINE, Pharmaceutical Keywords: http://bmjopen.bmj.com/ Services, General Practice, Medication Therapy Management

on September 28, 2021 by guest. Protected copyright.

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 15 16 Pharmacist-led adherence support in general practice: a 17 18 For peer review only 19 qualitative interview study of adults with asthma 20 21 22 23 24 25 1 1 1 1 26 Mes, Marissa Ayano ; Katzer, Caroline Brigitte ; Wileman, Vari ; Chan, Amy Hai Yan ; 27 28 Horne, Rob1; & Taylor, Stephanie Jane Caroline2. 29 30 31 32 33 34 1Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Tavistock Square, 35 London WC1H 9JP, London, United Kingdom. 36 2Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University London, 37 http://bmjopen.bmj.com/ 38 Yvonne Carter Building, 58 Turner Street, London E1 2AB, United Kingdom. 39 40 41 Corresponding author: Marissa Ayano Mes ([email protected], +44 7413525215), 42 Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Tavistock 43 Square, London WC1H 9JP, United Kingdom. 44

45 on September 28, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 Word count: 3,902 words 55 56 57 Key words: Medication Adherence, Asthma, Pharmaceutical Services, General Practice, 58 Medication Therapy Management 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 ABSTRACT 5 6 7 Objectives: The National Health Service (NHS) in England recently introduced general 8 9 practice pharmacists (GPPs) to provide medication-focused support to both patients and the 10 11 general practice team. This healthcare model may benefit people with asthma, who currently 12 13 receive sub-optimal care and demonstrate low medication adherence. This study aimed to 14 15 16 explore the perspectives of adults with asthma on pharmacist-led adherence support delivered 17 18 in general practice, Forwith a focus peer on how thesereview perspectives only are formed. 19 20 21 Design and setting: The study was conducted in the United Kingdom (UK) utilising a 22 23 qualitative interview methodology. Participants completed a telephone-based semi-structured 24 25 26 interview, followed by an online questionnaire for demographic details and asthma history. 27 28 Qualitative data were analysed using thematic analysis. 29 30 31 Participants: Participants (n = 17) were adults with asthma in the UK with a prescription for 32 33 an inhaled corticosteroid. Participants did not have previous experience with GPPs and were 34 35 asked to provide their views on a proposed GPP-led service. 36

37 http://bmjopen.bmj.com/ 38 Results: Participant perspectives of GPPs were determined by trust in pharmacists, perceived 39 40 41 gaps in asthma care, and the perceived strain on the NHS. Trust was based on pharmacists’ 42 43 perceived clinical competency, established over time, and gauged through a ‘benchmarking’ 44

45 process. GPP’s fit in current asthma care was assessed based on potential role overlap with on September 28, 2021 by guest. Protected copyright. 46 47 48 other healthcare professionals, continuity of care, and medication-related support needs. 49 50 Participants navigated the NHS based on a perceived hierarchy of healthcare professionals 51 52 (GPs on top, nurses, then pharmacists), and this influenced their perspectives of GPPs. 53 54 55 Conclusions: While the GPP scheme shows promise based on the perspectives of people 56 57 with asthma, the identified barriers to optimal patient engagement and service 58 59 60 implementation will need to be addressed for the service to be effective.

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 ARTICLE SUMMARY 5 6 7 8 strengths and limitations of this study 9 10  The use of qualitative methodology captured the complex processes behind people’s 11 12 13 perceptions of general practice pharmacists (GPPs), including how lived experiences 14 15 shaped perceptions of new pharmacist-led services. 16 17  Telephone-based interviews enabled recruitment across the United Kingdom (UK) 18 For peer review only 19 20 and increased study accessibility for people with severe asthma and travel limitations. 21 22  The study may not have captured the full range of views among adults with asthma in 23 24 the UK because participants were primarily white and female. 25 26 27  Participants had no experience with GPP-led consultations and therefore represented 28 29 the general population with asthma that would initially need to be convinced to 30 31 engage with the service. 32 33 34 35 INTRODUCTION 36

37 http://bmjopen.bmj.com/ 38 The pressure on primary care to deliver core services is increasing rapidly worldwide due to a 39 40 growing and ageing population, the prevalence of long-term conditions, and significant 41 42 resource constraints. Primary care systems are being reshaped and new models of care are 43 44 1

45 emerging to cope with growing demand. on September 28, 2021 by guest. Protected copyright. 46 47 48 One such model is the general practice pharmacist (GPP) model, which was introduced in 49 50 England as part of the NHS General Practice Forward View initiative.2-4 These pharmacists 51 52 support both patients and the general practice team with medication-related issues, with the 53 54 55 aim of expanding the general practice workforce, reducing practice burden, and increasing 56 57 patient access to appointments.4 Initial qualitative feedback from general practitioners (GPs) 58 59 and pharmacists in a pilot study in England suggests that GPPs can have positive impacts on 60

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3 medication safety, medication adherence, healthcare access, and patient satisfaction across a BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 3 6 variety of long-term conditions. 7 8 9 A long-term condition such as asthma may benefit from GPP support. Research shows that 10 11 adherence to inhaled corticosteroids (ICS), an essential medication for asthma, is low.5 6 12 13 Furthermore, only 35% of people with asthma in the United Kingdom (UK) receive basic 14 15 care (i.e. annual reviews, inhaler technique checks, and a written asthma action plan).7 16 17 18 Previous research For suggests peer that pharmacist-led review interventions only can increase medication 19 20 adherence and support asthma self-management among people with asthma.8 However, most 21 22 of the previous research in the UK has been limited to community rather than general practice 23 24 25 pharmacists, and was focused on their impact across a range of long-term conditions rather 26 27 than asthma specifically.9 10 28 29 30 Understanding the specific perspectives of people with asthma regarding GPPs is an 31 32 important first step in establishing the potential benefits of this new service for this specific 33 34 11 35 patient group and identifying any potential issues in its future uptake and effectiveness. The 36

37 aim of this study was to explore the perspectives of adults with asthma on pharmacist-led http://bmjopen.bmj.com/ 38 39 asthma adherence support delivered in general practice, with a focus on how these 40 41 perspectives are formed. 42 43 44

45 METHODS on September 28, 2021 by guest. Protected copyright. 46 47 48 This was a telephone-based semi-structured interview study, using an interpretivist approach 49 50 to understand how adults with asthma construct their perceptions of GPP-led asthma 51 52 53 adherence support. Demographic details and asthma history were collected using a brief 54 55 online questionnaire. 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 participants 5 6 Participants were adults (≥ 18 years old) living in the UK and proficient in English, with a 7 8 self-reported asthma diagnosis, a prescription for ICS, and access to a telephone and e-mail 9 10 11 account. People with respiratory comorbidities (e.g. Chronic Obstructive Pulmonary Disease) 12 13 and/or those in hospital or nursing homes were excluded, as the adherence behaviour and 14 15 support needs of these individuals were hypothesised to be different. 16 17 18 For peer review only 19 recruitment 20 21 Several recruitment channels were used to ensure that participants varied in age, gender, and 22 23 24 self-reported asthma severity. A flyer with study information and researchers’ contact details 25 26 was circulated by researchers, the Asthma UK Centre for Applied Research (AUKCAR), and 27 28 the National Institute for Health Research Collaboration for Leadership in Applied Health 29 30 31 Research and Care (NIHR CLAHRC) North Thames via social media (Facebook and/or 32 33 Twitter). The study was advertised in two electronic newsletters: the Asthma UK volunteer 34 35 bulletin and the University College London student newsletter. Printed flyers were handed 36

37 http://bmjopen.bmj.com/ 38 directly to potential participants by a respiratory consultant at a London hospital, and 39 40 pharmacists at two hospitals in Wales. 41 42 43 People who contacted the researchers were e-mailed an information sheet, consent form, and 44

45 eligibility criteria to review. If they were eligible and willing to participate, they were booked on September 28, 2021 by guest. Protected copyright. 46 47 in for a one-hour telephone interview. In preparation for the call, participants were asked to 48 49 50 read a description of a GPP-led adherence support consultation, sent to them via e-mail (see 51 52 Appendix A). This description was developed based on the work of a clinical respiratory 53 54 pharmacist working in general practice in London. Participants gave verbal consent over the 55 56 57 telephone before the interview began. The consent procedure and interview were audio- 58 59 60

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3 recorded with their permission. All participants were e-mailed a £20 online shopping voucher BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 after the interview to thank them for their time. 7 8 9 data collection and analysis 10 11 12 One researcher (MM) conducted the interviews. Participants were informed that the 13 14 researcher had a background in Health Psychology and an interest in adherence and 15 16 pharmacist-led care for asthma. 17 18 For peer review only 19 The topic guide for the telephone-based interview had two sections (see Appendix B). The 20 21 22 first section focused on participants’ previous experiences of asthma, asthma care, and 23 24 pharmacists. The second section focused on how these lived experiences informed 25 26 participants’ perceptions of GPP-led adherence support. Questions in the second section were 27 28 based on previous research on interpersonal and institutional trust in healthcare 29 30 12 13 14-16 31 professionals, perceptions of the pharmacist role, and pharmacist-led care for 32 33 asthma.10 17-19 34 35 36 Participants also completed an online questionnaire on demographic details and asthma

37 http://bmjopen.bmj.com/ 38 history (self-reported asthma severity, hospitalisations, and GP visits). An online 39 40 41 questionnaire was used because disclosing personal information (e.g. ethnicity or age) 42 43 directly to a researcher during a telephone call can be uncomfortable for some participants. 44

45 The self-report method was chosen because requesting access to people’s medical records can on September 28, 2021 by guest. Protected copyright. 46 47 48 feel invasive for some participants and can therefore hinder recruitment. 49 50 51 All interviews were transcribed and analysed using NVivo (QSR, Version 11). Thematic 52 53 analysis was used to identify themes at the semantic level using a deductive approach, based 54 55 on their relevance to the study aim.20 The flexibility of the thematic analysis method was 56 57 deemed a suitable fit for the study’s exploratory nature. Continuous iterative analyses were 58 59 60 conducted to establish when thematic saturation had been reached. Recruitment was set for

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3 30 participants or thematic saturation, whichever was attained first. All transcripts were BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 analysed by MM, and 25% of the transcripts were independently second-coded by another 7 8 researcher (CK). Discrepancies were resolved through consensus discussion. 9 10 11 patient and public involvement 12 13 14 All study materials (the recruitment flyer, participant information sheet, consent form, 15 16 interview topic guide, GPP consultation example, and online questionnaire) were reviewed 17 18 For peer review only 19 by the AUKCAR Patient Advisory Group (PAG) prior to study commencement. Members of 20 21 the PAG were adults with asthma. Their feedback, often regarding word choice and text 22 23 length, was incorporated into the study materials. 24 25 26 27 RESULTS 28 29 30 Thematic saturation was reached with 17 participants (Table 1). The mean interview length 31 32 was 39 minutes (ranging from 30 to 58 minutes). The participant sample was mostly female 33 34 (59%), aged 30 to 39 years (41%), and White-British (70%). Most participants were recruited 35 36 through the Asthma UK newsletter (41%). The sample included participants with self- 37 http://bmjopen.bmj.com/ 38 39 reported mild (53%), moderate (24%), and severe asthma (17%). Three overarching themes 40 41 (with seven sub-themes) were identified from the data: building trust in pharmacists, filling 42 43 44 gaps in current asthma care, and navigating a strained healthcare system.

45 on September 28, 2021 by guest. Protected copyright. 46 Table 1. Demographic characteristics and asthma history 47 48 Characteristics Frequency 49 (n = 17) n (%) 50 Gender 51 Female 10 (59%) 52 53 Male 7 (41%) 54 Age in years 55 18 – 29 5 (29%) 56 30 – 39 7 (41%) 57 40 – 49 2 (12%) 58 50 - 59 - 59 60 – 69 2 (12%) 60 70 + 1 (6%) 6 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 28

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3 Ethnicity BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Black or Black British 1 (6%) 5 Mixed – White and Black African 1 (6%) 6 7 White – British 12 (70%) 8 White – Irish 1 (6%) 9 White – Any other background 2 (12%) 10 Location of residence 11 England – North 1 (6%) 12 England – Midlands 2 (12%) 13 England – South 7 (41%) 14 Northern Ireland 1 (6%) 15 Scotland 6 (35%) 16 Recruitment channel 17 Asthma UK newsletter 7 (41%) 18 For peer review only 19 Hospital 1 (6%) 20 Social media 3 (17%) 21 University College London newsletter 3 (18%) 22 Word of Mouth 3 (18%) 23 Self-reported asthma severity 24 Mild 9 (53%) 25 Moderate 4 (24%) 26 Severe 3 (17%) 27 Prefer not to disclose 1 (6%) 28 Self-reported hospitalisations for asthma 29 (previous 12 months) 30 31 0 11 (65%) 32 1 – 4 3 (17%) 33 5 – 10 3 (17%) 34 Self-reported GP visits for asthma 35 (previous 12 months) 36 0 2 (12%)

37 1 – 10 13 (76%) http://bmjopen.bmj.com/ 38 10 – 20 2 (12%) 39 40 41 theme 1: building trust in pharmacists 42 43 Trust in healthcare professionals involves the optimistic acceptance of being in a vulnerable 44

45 13 on September 28, 2021 by guest. Protected copyright. 46 situation, knowing that one’s interests will be cared for. For participants, opinions of the 47 48 new service were based on the level of trust they placed in pharmacists. Trust was built over 49 50 time, based on perceived clinical competency, and through a benchmarking process, which 51 52 form the subthemes discussed below. 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Building trust over time 5 6 Participants highlighted that trust in any healthcare professional builds through consistent 7 8 contact over time. Some participants felt hesitant about the new service because it meant 9 10 11 deviating from their usual trusted healthcare professional, suggesting a preference for usual 12 13 care over new initiatives to maintain the quality of their asthma care. 14 15 16 “I don’t really know, I think I’d prefer a doctor [to talk to about my asthma]. It’s the way it’s 17 always been.” 18 – P15, male,For 30 – 39 peeryears, mild asthmareview only 19 20 21 22 Building trust based on perceived clinical competency 23 24 When asked about specific criteria for trust, participants discussed pharmacists’ clinical 25 26 27 competency. One element of competency was pharmacists’ asthma-specific and broad 28 29 clinical knowledge. Support for the new service was high when pharmacists were viewed as 30 31 knowledgeable. 32 33 34 “So I know that in the pharmacy role they’re very knowledgeable. So if [adherence support 35 for asthma] is something they want to do then why not? I have a lot of faith in somebody 36 who’s got a lot of knowledge in something.” 37 http://bmjopen.bmj.com/ 38 – P8, female, 30 – 39 years, severe asthma 39 40 Some participants believed that pharmacists would need extensive additional training to 41 42 develop the knowledge needed for the new service. Their main concern was that pharmacists 43 44 were too medication-focused and therefore lacked broader clinical skills. 45 on September 28, 2021 by guest. Protected copyright. 46 47 48 “…it could be that the [medication] side-effects are something else entirely. So 49 [pharmacists] would be kind of completely thinking down the asthma route, ‘it might just be 50 that you’re taking an inhaler that you feel side-effects’…but what if it turns out you actually 51 have cancer?” 52 – P17, male, 18 – 29 years, mild asthma 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Building trust through a benchmarking process 5 6 None of the participants had previous experiences with GPPs, with some participants 7 8 questioning the differences between GPPs and community pharmacists. Many participants 9 10 11 engaged in a benchmarking process: using their trust and previous experiences of other 12 13 healthcare professionals to gauge how much they could trust a GPP. Common reference 14 15 points included community pharmacists, respiratory consultants, nurses, GPs, and 16 17 18 paramedics. For peer review only 19 20 21 “…I know [pharmacist support] is there but I still don’t understand it with [brittle] asthma 22 because I still get wary. If paramedics have never heard of it and don’t know what they’re 23 doing, how’s a pharmacist going to hear of it?” 24 – P2, female, 30 – 39 years, severe asthma 25 26 “I would much rather go to a pharmacist than to a nurse to discuss the medication issues that 27 I was having… I can see an asthma nurse to discuss medication, and I was like ‘Really?…not 28 29 to be rude, but what do [nurses] know about medication more than my specialist who 30 prescribed it?” 31 – P4, female, 30 – 39 years, mild asthma 32 33 34 theme 2: filling gaps in current asthma care 35 36

37 Participants’ perceptions of GPPs were also informed by perceived gaps in their current http://bmjopen.bmj.com/ 38 39 asthma care. Participants evaluated the new service’s place in their current care based on 40 41 42 potential role overlap between GPPs and other healthcare professionals, continuity of care, 43 44 and medication-specific support.

45 on September 28, 2021 by guest. Protected copyright. 46 47 48 Potential role overlap 49 50 Participants that saw potential role overlap between GPPs and other healthcare professionals 51 52 were more sceptical of the new service. However, other participants clearly delineated the 53 54 55 GPP role, and these participants often recommended ways to integrate pharmacists into their 56 57 care. 58 59 60

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3 “I think if I was having an annual asthma review, I wouldn’t need to use the pharmacist’s BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 service as well, but it might be an alternative to the annual asthma review…” 5 6 – P3, male, 70+ years, mild asthma 7 8 “If you’re asking a GP, you’ve got maybe five, ten minutes… If you know you’ve got another 9 ten or fifteen minutes with this pharmacist… for asking all these questions…with the GP you 10 can concentrate on the problem and get that sorted, and then go see the pharmacist and 11 discuss the medication.” 12 – P5, female, 60 – 69 years, moderate asthma 13 14 15 16 Continuity of care 17 18 For peer review only 19 Participants with self-reported severe asthma often had multiple healthcare professionals 20 21 involved in their care (e.g. respiratory consultants, GPs, and asthma nurses). When asked 22 23 about the new service, some participants felt concerned about involving an additional 24 25 26 healthcare professional in their care. This was unrelated to their views on pharmacist 27 28 competency, and was usually influenced by previous experiences of inadequate continuity of 29 30 care due to a lack of communication between healthcare professionals. 31 32 33 “[Pharmacists] always say speak to your GP but then the GP tells you to speak to the 34 pharmacist because they’re supposed to know more about drugs than what they are…and 35 then you’re somewhere in the middle…” 36 – P2, female, 30 – 39 years, severe asthma 37 http://bmjopen.bmj.com/ 38 39 40 Medication-specific support 41 42 43 Other participants with severe asthma on multiple medications and/or with other health 44

45 concerns welcomed the service. This enthusiasm came from the fact that they identified gaps on September 28, 2021 by guest. Protected copyright. 46 47 in their current care which they believed could be filled by pharmacists as medication 48 49 50 experts. 51 52 53 “…just having contact with someone who actually…knows about the medication, like they 54 know how they work and what the potential side effects are going to be and interactions…it’s 55 that knowledge that a GP wouldn’t necessarily have time to tell you all about…” 56 – P6, female, 30 – 39 years, severe asthma 57 58 59 60

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3 “…I’m trying to conceive at the moment so…and I thought I don’t want to be taking anything BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 that’s unnatural or steroid-y…I did ask the respiratory consultant [about asthma medications 5 6 and In Vitro Fertilisation] but he didn’t know…” 7 –P8, female, 30 – 39 years, severe asthma 8 9 Some participants felt that GPPs should have an independent prescribing qualification to 10 11 fulfil their role as medication experts. They worried that the new service might contribute to 12 13 14 the burden on patients and/or the healthcare system, and that independent pharmacist 15 16 prescribers would minimise the risk of this happening. 17 18 For peer review only 19 “For me, it would just be down to whether or not [pharmacists] are able to prescribe. I 20 don’t imagine that they wouldn’t have the knowledge that was required…It’s just if I had to 21 then see a doctor to be prescribed a different medication, I’d rather just go to see the doctor 22 instead.” 23 24 – P10, female, 40 – 49 years, mild asthma 25 26 27 theme 3: navigating a strained healthcare system 28 29 30 Participants were acutely aware of the limited resources within general practice. They often 31 32 expressed guilt and frustration about booking appointments for asthma. Participants never 33 34 booked appointments just for medication-related questions, and their concerns were 35 36 frequently left unaddressed because other topics took priority in a consultation, particularly if 37 http://bmjopen.bmj.com/ 38 39 the participant had multiple comorbidities. The pharmacist-led service was welcomed by 40 41 these participants because they felt pharmacists would have more time to focus on their 42 43 medication. 44

45 on September 28, 2021 by guest. Protected copyright. 46 “…come Monday morning I wouldn’t want to call the GP because I know on Monday 47 48 morning they’re very, very busy…I’ll just sort of crack on at home, multi-dosing salbutamol 49 and seeing what happens.” 50 – P8, female, 30 – 39 years, severe asthma 51 52 “[GPs] just want you in and out… ‘oh yes, I wanted to ask you something else’ but too late 53 now, you’re away. That’s how you feel.” 54 –P1, female, 30 – 39 years, mild asthma 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 The hierarchy of healthcare professionals 5 6 Many participants constructed a hierarchy of healthcare professionals with GPs at the top, 7 8 followed by nurses and finally pharmacists. This hierarchy determined the importance of 9 10 11 each healthcare professionals’ time. Severe health concerns justified booking a GP 12 13 appointment, while non-urgent concerns were viewed as more suitable for pharmacists. The 14 15 hierarchy of healthcare professionals affected perceptions of GPPs in both directions. Some 16 17 18 participants were enthusiasticFor peer about the newreview service because only they believed it would lessen the 19 20 workload of GPs and nurses. For these participants, seeing a pharmacist (the healthcare 21 22 professional further down the hierarchy) felt less intimidating and formal, slightly easing 23 24 25 concerns about taking up valuable appointment time. 26 27 “…to be honest, GPs have bigger problems to deal with…[they’re] dealing with people with, 28 29 you know, life threatening illnesses, then actually seeing the standard case of asthma or an 30 asthma check-up isn’t the best use of [their] time.” 31 – P16, male, 18 – 29 years, moderate asthma 32 33 “It feels less formal, I think, when you’re with a pharmacist than when you’re in the 34 doctor’s…sometimes when you go to the doctor’s, you’re kind of clock watching…” 35 36 – P10, female, 40 – 49 years, mild asthma

37 http://bmjopen.bmj.com/ 38 Others felt that pharmacists could not extend into a clinical role similar to GPs and nurses, 39 40 with some suggesting a triage-like function to safeguard GP time. 41 42 43 “I never feel as though a pharmacist is a nurse, if you see what I mean. A nurse has practical 44 hands-on experience of trying to make people better. The pharmacist is one who deals with 45 the theory of medication.” on September 28, 2021 by guest. Protected copyright. 46 47 –P9, male, 60 – 69 years, undisclosed asthma severity 48 49 “… the pharmacist has seen you and if there’s communication between the pharmacist and 50 the GP, so that I guess it would help the GPs prioritise who they saw…” 51 –P11, female, 40 – 49 years, moderate asthma 52 53 However, pharmacists themselves were also viewed as a limited resource. Many participants 54 55 56 supported moving pharmacists from community pharmacies to general practice because they 57 58 experienced inadequate care in busy community pharmacies. Others were concerned that 59 60

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3 pharmacist-led adherence support with a wide scope (i.e. for multiple long-term conditions) BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 would limit access for people with asthma. 7 8 9 “If [pharmacists] weren’t running a community pharmacy, if they were linked in, if they 10 worked within the GP surgery with a lot of time, then yes, I don’t see how [a lack of time] 11 would be an issue.” 12 – P12, female, 30 – 39 years, mild asthma 13 14 “…my worry is if a pharmacist has to do [adherence support in general practice] for asthma, 15 what other long-term conditions will they have to do it for?” 16 17 – P6, female, 30 – 39 years, severe asthma 18 For peer review only 19 20 DISCUSSION 21 22 23 This is the first in-depth exploration of the perspectives of adults with asthma on pharmacist- 24 25 led adherence support in general practice. This focused exploration identified potential 26 27 28 barriers to service uptake and has the potential to help further refine and tailor the GPP 29 30 service as it is rolled out. 31 32 33 34 main findings 35 36 Perceptions of GPPs were informed by people’s trust in pharmacists, perceived gaps in

37 http://bmjopen.bmj.com/ 38 current asthma care, and the perceived strain on the NHS. Trust was based on GPPs’ 39 40 41 perceived clinical competency, which was established over time, and gauged through a 42 43 benchmarking process using other healthcare professionals as reference points. Community 44

45 pharmacists were commonly referenced in the benchmarking process, suggesting that on September 28, 2021 by guest. Protected copyright. 46 47 48 participants did not delineate between pharmacy sectors. Participants contemplated how 49 50 GPPs would fit into their current asthma care based on potential role overlap with other 51 52 healthcare professionals, issues with continuity of care, and specific medication-related 53 54 55 support needs. The perceived strain on the NHS led participants to use a hierarchy of 56 57 healthcare professionals to guide their interactions with the healthcare system. For some 58 59 participants, the hierarchy categorised pharmacist consultations as informal and more 60

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3 accessible sources of support. For others, their views acted as barriers that prevented BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 pharmacists from extending into consultation-based roles. 7 8 9 strengths and limitations 10 11 12 The qualitative method in this study captured the complex processes behind people’s 13 14 perceptions of GPPs. The combination of recruitment channels produced variation in the 15 16 sample in terms of age, self-reported asthma severity, healthcare utilisation, and participants’ 17 18 For peer review only 19 place of residence. Telephone-based interviews enabled recruitment across the UK without 20 21 increasing participant burden, thus increasing study accessibility for participants with severe 22 23 asthma and limited travel capacity. In addition, telephone-based interviews can produce data 24 25 26 of higher quality compared to face-to-face interviews when sensitive topics (e.g. long-term 27 28 conditions) are discussed.21 29 30 31 The participant sample may however not have captured the views of all adults with asthma 32 33 because it consisted primarily of White females. Therefore, thematic saturation may have 34 35 been reached due to a lack of variation in the perspectives in the sample. The participants 36

37 http://bmjopen.bmj.com/ 38 recruited through Asthma UK (41%) may have had a strong interest in asthma care or 39 40 pharmacist-led support. However, if scepticism of the new service exists among people who 41 42 are more engaged in their care, then this suggests that the findings may be amplified in the 43 44 general population with asthma who may have less interest in asthma care. 45 on September 28, 2021 by guest. Protected copyright. 46 47 48 A major drawback of the study is that none of the participants had experienced a GPP 49 50 consultation directly, with some participants recruited from Scotland and Northern Ireland 51 52 where the GPP scheme does not exist. However, these participants represent the general 53 54 population with asthma who would initially need to be convinced to engage with the service. 55 56 57 Furthermore, the consultation description that participants were asked to read was based on 58 59 real work by a clinical respiratory pharmacist working in general practice. These study 60

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3 findings therefore reflect patients’ initial views of a GPP service, though these views may BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 change over time, and could potentially be influenced by direct personal experience with a 7 8 GPP. 9 10 11 comparison with existing literature 12 13 14 There is limited research on patient perspectives of GPPs because the care model is relatively 15 16 new. However, findings from this study align with those from community pharmacy-based 17 18 For peer review only 19 research, suggesting that people with asthma may not differentiate between pharmacy sectors. 20 21 12 22 Findings align with work by Gidman, et al. , who found that people were hesitant about 23 24 deviating from their usual trusted care model (often a GP). Both general members of the 25 26 public and people with asthma have been found to use other trusted healthcare professionals 27 28 (e.g. GPs and nurses) as benchmarks for trust when asked about a community pharmacist-led 29 30 12 19 19 31 service. Similarly, Naik Panvelkar, et al. found that previous positive experiences with 32 33 community pharmacists raised expectations for other pharmacist-led services in a population 34 35 of people with asthma. 36

37 http://bmjopen.bmj.com/ 38 Participants’ views of the gaps in their current asthma care shaped their perspectives of GPPs. 39 40 22 41 Similarly, Boyd, et al. found that recipients of the New Medicine Service (NMS) 42 43 welcomed pharmacists’ recommendations if they addressed a concern directly raised by the 44

45 patient. While asthma care guidelines recommend a multidisciplinary approach in treating on September 28, 2021 by guest. Protected copyright. 46 47 48 difficult asthma, the present study suggests that some people with self-reported severe asthma 49 50 were hesitant to include another healthcare professional due to issues with continuity of 51 52 care.23 In line with previous research, the hierarchy of healthcare professionals influenced 53 54 perspectives of pharmacists expanding further into clinical roles.12 14 However, this study also 55 56 57 found that the hierarchy increased support for pharmacist-led care to reduce the burden on 58 59 GPs/nurses. 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 implications for research and practice 5 6 As the GPP model is rolled out, future studies could be conducted using in-depth interviews 7 8 with people with asthma after they have experienced a GPP-led consultation. These 9 10 11 interviews could establish if interpersonal factors (i.e. rapport with the pharmacist) have an 12 13 impact on patient perspectives. Ethnographic observations of pharmacist-led consultations 14 15 and the general practice team will help assess pharmacists’ integration and its effect on 16 17 18 continuity of care forFor asthma peer patients. Future review recruitment onlyshould aim for greater variation in 19 20 participants (e.g. age and ethnicity) through various recruitment channels, with additional 21 22 efforts to look for discordant voices when thematic saturation is reached. 23 24 25 Findings from this study could be implemented in efforts to increase service uptake among 26 27 people with asthma. Given the benchmarking process used to establish trust in pharmacists, 28 29 30 comparisons between GPPs and other healthcare professionals could be used to inform and 31 32 engage the public. For example, public campaigns highlighting the differences and 33 34 similarities between GPs and GPPs may help the public differentiate the pharmacist role and 35 36 understand the added value of the new service within asthma care. 37 http://bmjopen.bmj.com/ 38 39 40 Participants wanted GPPs to have broad clinical skills and a prescribing qualification. The 41 42 Centre for Pharmacy Postgraduate Education has already included these components in their 43 44 GPP training pathways, and these should be made a programme priority.24

45 on September 28, 2021 by guest. Protected copyright. 46 47 Although the hierarchy of healthcare professionals sometimes prevented pharmacists from 48 49 50 being perceived as clinicians, it also made GPP appointments appear less formal and 51 52 intimidating to access. Participants felt more comfortable making an appointment with a 53 54 pharmacist for medication-related questions. This is encouraging because the new service 55 56 may encourage people with asthma to address medication-related concerns that may be 57 58 25 59 barriers to medication adherence. 60

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3 While the perspectives of people with asthma explored in this study show that the GPP model BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 has promise, they identified several barriers to optimal patient engagement and service 7 8 implementation that will need to be addressed for the service to be effective. Meeting patient 9 10 expectations will be the first crucial step in ensuring the programme’s long-term benefit and 11 12 reducing the pressure on general practice in England. 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 ACKNOWLEDGMENTS 5 6 7 We would like to thank the Asthma UK Centre for Applied Research (AUKCAR) Patient 8 9 Advisory Group for their feedback and support for this study. 10 11 12 13 AUTHOR CONTRIBUTIONS 14 15 The study was designed by MM, RH, and SJCT. All interviews were conducted by MM. Data 16 17 18 was analysed by MMFor and CK.peer The manuscript review was written only by MM, AHYC, and VW, with 19 20 input from RH and SJCT. 21 22 23 24 FUNDING 25 26 The research was funded by the National Institute for Health Research (NIHR) Collaboration 27 28 29 for Leadership in Applied Health Research and Care North Thames at Barts Health NHS 30 31 Trust. The views expressed are those of the authors and not necessarily those of the NHS, the 32 33 NIHR, or the Department of Health and Social Care. 34 35 36

37 COMPETING INTERESTS http://bmjopen.bmj.com/ 38 39 40 None declared. 41 42 43 44 PATIENT CONSENT FOR PUBLICATION

45 on September 28, 2021 by guest. Protected copyright. 46 Not required. 47 48 49 50 ETHICS APPROVAL 51 52 53 The research was approved by the NHS London-Harrow Research Ethics Committee (12th 54 55 October 2017, Ref: 17/LO/1565) and Cwm Taf University Health Board (17th November 56 57 58 2017, Ref: CT/831/205928/17). 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 DATA SHARING STATEMENT 5 6 7 No additional data are available. 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 REFERENCES 5 6 1. World Health Organization. Primary Health Care - Now More Than Ever. 7 8 The World Health Report. Geneva: World Health Organization, 2008. 9 2. NHS England. General Practice Forward View: NHS England, 2016:1-58. 10 3. Boyd MJ, Mann C, Waring J, et al. Clinical pharmacists in general practice: 11 12 pilot scheme. Independent Evaluation Report. University of Nottingham, 13 UK: NHS England, 2018. 14 4. NHS England. Clinical pharmacists in general practice pilot. England, UK: 15 NHS England, 2015. 16 17 5. Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: 18 current statusFor and peer future perspectives. review Respir only Care 2015;60(3):455-68. 19 doi: 10.4187/respcare.03200 [published Online First: 2014/08/15] 20 21 6. Murphy AC, Proeschal A, Brightling CE, et al. The relationship between 22 clinical outcomes and medication adherence in difficult-to-control 23 asthma. Thorax 2012;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096 24 25 [published Online First: 2012/03/23] 26 7. Cumella A. Falling through the gaps: Why more people need basic asthma 27 care. Annual Asthma Survey. United Kingdom: Asthma UK, 2017. 28 29 8. Mes MA, Katzer CB, Chan AHY, et al. Pharmacists and medication 30 adherence in asthma: a systematic review and meta-analysis. Eur 31 Respir J 2018;52(2) doi: 10.1183/13993003.00485-2018 [published 32 Online First: 2018/07/07] 33 34 9. Elliott R, Boyd MJ, Salema NE, et al. Supporting adherence for people 35 starting a new medication for a long-term condition through community 36 pharmacies: A pragmatic randomised controlled trial of the New

37 http://bmjopen.bmj.com/ 38 Medicine Service. BMJ quality & safety 2016;25(10):747-58. 39 10. Latif A, Pollock K, Boardman HF. The contribution of the Medicines Use 40 Review (MUR) consultation to counseling practice in community 41 42 pharmacies. Patient Educ Couns 2011;83(3):336-44. 43 11. Gann B. Understanding and using health experiences: the policy 44 landscape. In: Ziebland S, Coulter A, Calabrese JD, et al., eds. 45 Understanding and using health experiences: improving patient care. on September 28, 2021 by guest. Protected copyright. 46 47 Oxford, United Kingdom: Oxford University Press 2013. 48 12. Gidman W, Ward P, McGregor L. Understanding public trust in services 49 provided by community pharmacists relative to those provided by 50 51 general practitioners: a qualitative study. BMJ Open 2012;2(3) 52 13. Hall MA, Dugan E, Zheng B, et al. Trust in physicians and medical 53 institutions: what is it, can it be measured, and does it matter? Milbank 54 55 Q 2001;79(4):613-39, v. [published Online First: 2002/01/16] 56 14. Latif A, Boardman HF, Pollock K. Understanding the patient perspective of 57 the English community pharmacy Medicines Use Review (MUR). Res 58 59 Social Adm Pharm 2013;9(6):949-57. 60

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3 15. Tinelli M, Ryan M, Bond C. Patients' preferences for an increased BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 pharmacist role in the management of drug therapy. Int J Pharm Pract 6 2009;17(5):275-82. 7 16. Latif A, Waring J, Watmough D, et al. Examination of England's New 8 9 Medicine Service (NMS) of complex health care interventions in 10 community pharmacy. Res Social Adm Pharm 2016;12(6):966-89. 11 17. Bereznicki B, Peterson G, Jackson S, et al. Perceived feasibility of a 12 13 community pharmacy-based asthma intervention: a qualitative follow- 14 up study. J Clin Pharm Ther 2011;36(3):348-55. 15 18. Bradley F, Wagner AC, Elvey R, et al. Determinants of the uptake of 16 17 medicines use reviews (MURs) by community pharmacies in England: a 18 multi-methodFor study. peer Health reviewPolicy 2008;88(2):258-68. only 19 19. Naik Panvelkar P, Armour C, Saini B. Community pharmacy-based asthma 20 services-what do patients prefer? J Asthma 2010;47(10):1085-93. 21 22 20. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative 23 Research in Psychology 2006;3(2):77-101. 24 21. Sturges JE, Hanrahan KJ. Comparing Telephone and Face-to-Face 25 26 Qualitative Interviewing: a Research Note. Qualitative Research 27 2004;4(1):107-18. 28 22. Boyd MJ, Elliott R, Barber N, et al. The impact of the New Medicines 29 30 Service (NMS) in England on patients adherence to their medicines. Int 31 J Pharm Pract 2014;22:66. 32 23. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British 33 34 guideline on the management of asthma: a national clinical guideline. 35 Edinburgh: British Thoracic Society/Scottish Intercollegiate Guidelines 36 Network, 2016:1-172. 37 24. Centre for Pharmacy Postgraduate Education. Clinical pharmacists in http://bmjopen.bmj.com/ 38 39 general practice education. Manchester, United Kingdom: University of 40 Manchester, 2018. 41 25. Horne R, Weinman J. Self-regulation and self-management in asthma: 42 43 exploring the role of illness perceptions and treatment beliefs in 44 explaining non-adherence to preventer medication. Psychol Health

45 2002;17(1):17-32. on September 28, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 APPENDIX A: DESCRIPTION OF A PHARMACIST-LED ADHERENCE 6 7 8 CONSULTATION DELIVERED IN GENERAL PRACTICE 9 10 11 We will describe this service as if you were receiving it. 12 13 The service 14 The service is delivered by a clinical pharmacist based at your local GP practice. The aim is 15 16 to help people with asthma get on better with their inhalers. This means answering all of 17 your questions and discussing all of your concerns about your inhalers in detail. 18 For peer review only 19 Pre-consultation 20 You are booked in for a consultation with the clinical pharmacist by the GP receptionist (just 21 22 like you would with a GP appointment). 23 The main consultation 24 25 You have a one-to-one consultation with the pharmacist in a consultation room. They will 26 begin with a standard asthma review. You will talk about your asthma control, recent 27 symptoms, smoking history, and your asthma action plan. They will check your inhaler 28 29 technique and lung function. 30 You will then have an in-depth discussion about your inhalers. You can ask any questions 31 32 or mention any concerns you have about your inhalers. This could be anything from concerns 33 about side effects or questions about how the medication works. The pharmacist will give 34 you useful information and feedback that is specifically suited to you. They may use a short 35 video or print-outs to guide their discussion with you. 36

37 At the end of the consultation, you will set an asthma-related goal with the pharmacist. This http://bmjopen.bmj.com/ 38 could be something like “less night time asthma symptoms”. The pharmacist will advise you 39 on how to achieve your personal goal using your inhalers. 40 41 The follow-up consultation 42 43 1 month later, you will see the pharmacist again for a short consultation (no more than 10 44 minutes). The pharmacist will briefly ask how your asthma has been and check your inhaler

45 technique/lung function. You will then discuss how you are getting on with your medicines on September 28, 2021 by guest. Protected copyright. 46 and your personal asthma goal. Based on this discussion, the pharmacist will give further 47 recommendations regarding your medication. 48 49 50 51 52 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 APPENDIX B: INTERVIEW TOPIC GUIDE 5 6 7 Background and Previous Experience 8 9 10 1. To start the interview, could you tell me when you were diagnosed with asthma? 11 12 2. What type of medications are you currently prescribed for your asthma? 13 14 a. How has your experience been with these medications? (Prompting to see if 15 there are concerns, side effects etc.) 16 17 18 3. A lot of peopleFor with asthmapeer have reviewquestions or concerns only about their inhalers or tablets. 19 What do you do when you have any questions or concerns specifically about your 20 asthma medication? 21 22 a. Prompts: do you do research online? Do you talk to friends and family? Do 23 24 you go talk to a healthcare professional? 25 b. Could you tell me a bit about why you prefer (insert route, e.g. researching 26 online, talking to the GP, talking to family etc.) when it comes to your 27 medication? 28 29 4. Have you ever talked to a pharmacist about your asthma medication? 30 31 32 a. If YES: Could you walk me through what happened during that interaction? 33 i. Where did it take place? (community pharmacist, hospital pharmacist 34 etc.) 35 ii. Prompts: what type of information did they give you? Were they able 36 to answer your questions? Did you feel comfortable talking to them 37 about your asthma medication? Did you feel like it was helpful for http://bmjopen.bmj.com/ 38 39 you? 40 iii. Would you consider the pharmacist as a regular part of your asthma 41 care team? Why or why not? 42 43 b. If NO: Could you imagine a pharmacist as part of your regular asthma care 44 team?

45 on September 28, 2021 by guest. Protected copyright. 46 47 5. I’d now like to talk specifically about your preventer inhaler (brown inhaler, steroid 48 inhaler). They’re normally prescribed for daily or twice daily use. A lot of asthma 49 patients we’ve talked to often don’t take the inhaler as regularly as prescribed, is this 50 something you’ve experienced as well? 51 a. Could you tell me a little bit about why? 52 53 54 Pharmacist in general practice 55 56 Great, that’s the first part of our interview. Now we’re going to continue on to the part where 57 I’d like to get your thoughts on pharmacist-led consultations in general practice. I’ve e- 58 mailed you a description of the service already, but would you like to review it to refresh 59 your memory? 60

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3 Do you have any questions or anything you would like me to clarify before we move on BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 to the questions? 5 6 7 6. What are your initial thoughts on this pharmacist medication support service? 8 a. Explore which aspects of the service are most salient to the participant, use 9 prompts below when needed. 10 11 - In your opinion, would this type of service be a useful addition to the care you get 12 from your GP/nurse/asthma specialist? 13 14 o Is this a type of service you could see yourself using? Why or why not? 15 o Do you think this service is any different from the asthma care you already 16 receive? 17 - Do you think this type of service would help you take your preventer inhaler more 18 regularly? For peer review only 19 - How do you feel about a pharmacist taking on this type of clinical role? 20 21 o Do you think pharmacists have enough training for this type of work? 22 . What type of knowledge would you expect the pharmacist to have? 23 o How do pharmacists compare to your other healthcare professionals (e.g. GP 24 or nurse)? 25 o Do you think this service is any different from seeing a community 26 pharmacist? (Are they familiar with the NMS and MUR?) 27 Would you feel comfortable talking to a pharmacist about your asthma and 28 o 29 your medication? 30 o Do you feel like you can trust a pharmacist in this type of role? 31 - How do you feel about having a pharmacist based in a GP surgery? 32 o How would you feel about this pharmacist having access to your medical 33 records? 34 - What do you think about seeing a pharmacist on an appointment basis? 35 - When you think about (concerns/side effects discussed for question 2a), do you think 36 those types of questions or concerns could be addressed by a pharmacist? 37 http://bmjopen.bmj.com/ 38 o What would be the ideal way to support you with those questions or concerns? 39 - Do you think this type of service is convenient for people with asthma? 40 41 42 43 44

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1 2 3 Reporting checklist for qualitative study. 4 5 6 Based on the SRQR guidelines. 7 8 9 Instructions to authors 10 11 Complete this checklist by entering the page numbers from your manuscript where readers will find each of the 12 items listed below. 13 14 15 Your article may not currently address all the items on the checklist. Please modify your text to include the 16 missing information. If youFor are certain peer that an item review does not apply, pleaseonly write "n/a" and provide a short 17 18 explanation. 19 20 Upload your completed checklist as an extra file when you submit to a journal. 21 22 In your methods section, say that you used the SRQRreporting guidelines, and cite them as: 23 24 25 O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a 26 synthesis of recommendations. Acad Med. 2014;89(9):1245-1251. 27 28 Page 29 30 Reporting Item Number 31 32 Title

33 http://bmjopen.bmj.com/ 34 #1 Concise description of the nature and topic of the study 0 35 36 identifying the study as qualitative or indicating the approach 37 (e.g. ethnography, grounded theory) or data collection methods 38 39 (e.g. interview, focus group) is recommended 40 41 Abstract on September 28, 2021 by guest. Protected copyright. 42 43 44 #2 Summary of the key elements of the study using the abstract 1 45 format of the intended publication; typically includes 46 47 background, purpose, methods, results and conclusions 48 49 Introduction 50 51 Problem formulation #3 Description and signifcance of the problem / phenomenon 2-3 52 53 studied: review of relevant theory and empirical work; problem 54 statement 55 56 57 Purpose or research #4 Purpose of the study and specific objectives or questions 3 58 question 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 27 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

1 Methods 2 3 Qualitative approach and #5 Qualitative approach (e.g. ethnography, grounded theory, case 3 4 5 research paradigm study, phenomenolgy, narrative research) and guiding theory if 6 appropriate; identifying the research paradigm (e.g. 7 8 postpositivist, constructivist / interpretivist) is also 9 recommended; rationale. The rationale should briefly discuss 10 11 the justification for choosing that theory, approach, method or 12 technique rather than other options available; the assumptions 13 14 and limitations implicit in those choices and how those choices 15 influence study conclusions and transferability. As appropriate 16 For peer review only 17 the rationale for several items might be discussed together. 18 19 Researcher characteristics #6 Researchers' characteristics that may influence the research, 5 20 21 and reflexivity including personal attributes, qualifications / experience, 22 relationship with participants, assumptions and / or 23 24 presuppositions; potential or actual interaction between 25 researchers' characteristics and the research questions, approach, 26 27 methods, results and / or transferability 28 29 Context #7 Setting / site and salient contextual factors; rationale 5 30 31 Sampling strategy #8 How and why research participants, documents, or events were 3-5 32

33 selected; criteria for deciding when no further sampling was http://bmjopen.bmj.com/ 34 necessary (e.g. sampling saturation); rationale 35 36 37 Ethical issues pertaining to #9 Documentation of approval by an appropriate ethics review 17 38 human subjects board and participant consent, or explanation for lack thereof; 39 40 other confidentiality and data security issues

41 on September 28, 2021 by guest. Protected copyright. 42 Data collection methods #10 Types of data collected; details of data collection procedures 5 43 44 including (as appropriate) start and stop dates of data collection 45 and analysis, iterative process, triangulation of sources / 46 methods, and modification of procedures in response to 47 48 evolving study findings; rationale 49 50 Data collection instruments #11 Description of instruments (e.g. interview guides, 5 51 52 and technologies questionnaires) and devices (e.g. audio recorders) used for data 53 collection; if / how the instruments(s) changed over the course 54 55 of the study 56 57 Units of study #12 Number and relevant characteristics of participants, documents, 6 58 59 or events included in the study; level of participation (could be 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 28 of 28 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from reported in results) 1 2 3 Data processing #13 Methods for processing data prior to and during analysis, 5 4 including transcription, data entry, data management and 5 6 security, verification of data integrity, data coding, and 7 anonymisation / deidentification of excerpts 8 9 Data analysis #14 Process by which inferences, themes, etc. were identified and 5-6 10 11 developed, including the researchers involved in data analysis; 12 usually references a specific paradigm or approach; rationale 13 14 15 Techniques to enhance #15 Techniques to enhance trustworthiness and credibility of data 6 16 trustworthiness For analysispeer (e.g. reviewmember checking, onlyaudit trail, triangulation); 17 18 rationale 19 20 Results/findings 21 22 Syntheses and #16 Main findings (e.g. interpretations, inferences, and themes); 7-13 23 24 interpretation might include development of a theory or model, or integration 25 with prior research or theory 26 27 28 Links to empirical data #17 Evidence (e.g. quotes, field notes, text excerpts, photographs) to 7-13 29 substantiate analytic findings 30 31 32 Discussion

33 http://bmjopen.bmj.com/ 34 Intergration with prior #18 Short summary of main findings; explanation of how findings 13-16 35 work, implications, and conclusions connect to, support, elaborate on, or challenge 36 37 transferability and conclusions of earlier scholarship; discussion of scope of 38 contribution(s) to the field application / generalizability; identification of unique 39 40 contributions(s) to scholarship in a discipline or field

41 on September 28, 2021 by guest. Protected copyright. 42 Limitations #19 Trustworthiness and limitations of findings 13-14 43 44 45 Other 46 47 Conflicts of interest #20 Potential sources of influence of perceived influence on study 17 48 conduct and conclusions; how these were managed 49 50 51 Funding #21 Sources of funding and other support; role of funders in data 17 52 collection, interpretation and reporting 53 54 The SRQR checklist is distributed with permission of Wolters Kluwer © 2014 by the Association of American 55 56 Medical Colleges. This checklist was completed on 01. June 2019 using https://www.goodreports.org/, a tool 57 made by the EQUATOR Network in collaboration with Penelope.ai 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

Pharmacist-led adherence support in general practice: a qualitative interview study of adults with asthma

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032084.R1 review only Article Type: Original research

Date Submitted by the 30-Aug-2019 Author:

Primary Subject General practice / Family practice http://bmjopen.bmj.com/ Heading:

Secondary Subject Heading: Respiratory medicine, Health services research

Medication Adherence, Asthma < THORACIC MEDICINE, Pharmaceutical Keywords: Services, General Practice, Medication Therapy Management

on September 28, 2021 by guest. Protected copyright.

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45 on September 28, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 Word count: 3,936 words 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Abstract 5 6 7 8 Objectives: The National Health Service (NHS) in England recently introduced general 9 10 practice pharmacists (GPPs) to provide medication-focused support to both patients and the 11 12 general practice team. This healthcare model may benefit people with asthma, who currently 13 14 15 receive sub-optimal care and demonstrate low medication adherence. This study aimed to 16 17 explore the perspectives of adults with asthma on the potential for pharmacist-led adherence 18 For peer review only 19 support delivered in general practice, with a focus on how these perspectives are formed. 20 21 22 Design and setting: The study was conducted in the United Kingdom (UK) utilising a 23 24 qualitative interview methodology. Participants were invited to partake in a telephone-based 25 26 27 semi-structured interview, followed by an online questionnaire for demographic details and 28 29 asthma history. Qualitative data was analysed using thematic analysis. 30 31 32 Participants: Participants (n = 17) were adults with asthma in the UK with a prescription for 33 34 an inhaled corticosteroid. Participants did not have previous experience with GPPs and were 35 36 asked to provide their views on a proposed GPP-led service. 37 http://bmjopen.bmj.com/ 38 39 40 Results: Participant perspectives of GPPs were determined by trust in pharmacists, perceived 41 42 gaps in asthma care, and the perceived strain on the NHS. Trust was based on pharmacists’ 43 44 perceived clinical competency, established over time, and gauged through a ‘benchmarking’

45 on September 28, 2021 by guest. Protected copyright. 46 process. GPP’s fit in current asthma care was assessed based on potential role overlap with 47 48 49 other healthcare professionals, continuity of care, and medication-related support needs. 50 51 Participants navigated the NHS based on a perceived hierarchy of healthcare professionals 52 53 (GPs on top, nurses, then pharmacists), and this influenced their perspectives of GPPs. 54 55 56 57 58 59 60

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3 Conclusions: While the GPP scheme shows promise based on the perspectives of people BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 with asthma, the identified barriers to optimal patient engagement and service 7 8 implementation will need to be addressed for the service to be effective. 9 10 11 12 Strengths and limitations of this study 13 14 15 16  The use of qualitative methodology captured the complex processes behind people’s 17 18 perceptions Forof general peer practice pharmacists review (GPPs), only including how lived experiences 19 20 21 shaped perceptions of new pharmacist-led services. 22 23  Telephone-based interviews enabled recruitment across the United Kingdom (UK) 24 25 and increased study accessibility for people with severe asthma and travel limitations. 26 27 28  The study may not have captured the full variation in views among adults with asthma 29 30 in the UK because participants primarily had self-reported mild asthma and were 31 32 recruited through an asthma charity. 33 34 35  Participants had no experience with GPP-led consultations and therefore represented 36

37 the general population with asthma that would initially need to be convinced to http://bmjopen.bmj.com/ 38 39 engage with the service. 40 41 42 43 Background 44

45 on September 28, 2021 by guest. Protected copyright. 46 47 The pressure on primary care to deliver core services is increasing rapidly worldwide due to a 48 49 growing and ageing population, the prevalence of long-term conditions, and significant 50 51 52 resource constraints. Primary care systems are being reshaped and new models of care are 53 54 emerging to cope with growing demand.1 55 56 57 One such model is the general practice pharmacist (GPP) model, which was introduced in 58 59 England as part of the NHS General Practice Forward View initiative.2-4 These pharmacists 60

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3 support both patients and the general practice team with medication-related issues, with the BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 aim of expanding the general practice workforce, reducing practice burden, and increasing 7 8 patient access to appointments.4 Initial qualitative feedback from general practitioners (GPs) 9 10 and pharmacists in a pilot study in England suggests that GPPs can have positive impacts on 11 12 medication safety, medication adherence, healthcare access, and patient satisfaction across a 13 14 15 variety of long-term conditions.3 16 17 18 People with asthmaFor may benefit peer from GPP review support. Research only shows that adherence to inhaled 19 20 corticosteroids (ICS), an essential medication for asthma, is low.5 6 Furthermore, only 35% of 21 22 people with asthma in the United Kingdom (UK) receive basic care (i.e. annual reviews, 23 24 7 25 inhaler technique checks, and a written asthma action plan). Previous research suggests that 26 27 pharmacist-led interventions can increase medication adherence and support asthma self- 28 29 management among people with asthma.8 However, most of the previous research in the UK 30 31 32 has been limited to community rather than general practice pharmacists, and focused on their 33 34 impact across a range of long-term conditions rather than asthma specifically.9 10 35 36

37 Understanding the specific perspectives of people with asthma regarding GPPs is an http://bmjopen.bmj.com/ 38 39 important first step in establishing the potential benefits of this new service for this specific 40 41 patient group, as well as identifying any potential issues in its future uptake and 42 43 11 44 effectiveness. The aim of this study was to explore the perspectives of adults with asthma

45 on September 28, 2021 by guest. Protected copyright. 46 on the potential of pharmacist-led asthma adherence support delivered in general practice, 47 48 with a focus on how these perspectives are formed. 49 50 51 52 53 Methods 54 55 56 This study is reported according to the Standards for Reporting Qualitative Research.12 It was 57 58 59 a telephone-based semi-structured interview study, using an interpretivist approach to 60

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3 understand how adults with asthma construct their initial opinions of GPP-led asthma BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 adherence support. Demographic details and asthma history were collected using a brief 7 8 online questionnaire. 9 10 11 12 Participants 13 14 15 Participants were adults (≥ 18 years old) living in the UK and proficient in English, with a 16 17 18 self-reported asthmaFor diagnosis, peer a prescription review for ICS, and only access to a telephone and e-mail 19 20 account. People with respiratory comorbidities (e.g. Chronic Obstructive Pulmonary Disease) 21 22 and/or those in hospital or nursing homes were excluded, as the adherence behaviour and 23 24 support needs of these individuals were hypothesised to be different. 25 26 27 28 Recruitment 29 30 31 32 Several recruitment channels were used to ensure that participants varied in age, gender, and 33 34 self-reported asthma severity. A flyer with study information and researchers’ contact details 35 36 was circulated by researchers, the Asthma UK Centre for Applied Research (AUKCAR), and

37 http://bmjopen.bmj.com/ 38 39 the National Institute for Health Research Collaboration for Leadership in Applied Health 40 41 Research and Care North Thames via social media. The study was advertised in two 42 43 electronic newsletters: the Asthma UK volunteer bulletin and the University College London 44

45 on September 28, 2021 by guest. Protected copyright. 46 student newsletter. Printed flyers were handed directly to potential participants by a 47 48 respiratory consultant at a London hospital, and pharmacists at two hospitals in Wales. 49 50 51 People who contacted the researchers were e-mailed an information sheet, consent form, and 52 53 eligibility criteria to review. If they were eligible and willing to participate, they were booked 54 55 in for a one-hour telephone interview. In preparation for the call, participants were asked to 56 57 58 read a description of a GPP-led adherence support consultation, sent to them via e-mail (see 59 60 Appendix A). This description was based on the work of a clinical respiratory pharmacist

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3 working in general practice in London. Participants gave verbal consent over the telephone BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 before the interview began. The consent procedure and interview were audio-recorded with 7 8 their permission. All participants received a £20 online shopping voucher to thank them for 9 10 their time. 11 12 13 14 Data collection and analysis 15 16 17 18 One researcher (MM)For conducted peer the review interviews. Participants only were informed that the 19 20 researcher had a background in Health Psychology and an interest in adherence and 21 22 pharmacist-led care for asthma. 23 24 25 The interview topic guide had two sections (see Appendix B). The first section focused on 26 27 participants’ previous experiences of asthma, asthma care, and pharmacists. The second 28 29 30 section focused on how these lived experiences informed participants’ opinions of GPP-led 31 32 adherence support, with questions based on previous research on interpersonal/institutional 33 34 trust in healthcare professionals,13 14 perceptions of the pharmacist role,15-17 and pharmacist- 35 36 led care for asthma.10 18-20 37 http://bmjopen.bmj.com/ 38 39 40 Participants also completed an online questionnaire on demographic details (gender and age) 41 42 and asthma history (self-reported asthma severity, hospitalisations, and GP visits). An online 43 44 questionnaire was used because participants may have felt uncomfortable disclosing personal

45 on September 28, 2021 by guest. Protected copyright. 46 information (e.g. age) directly to a researcher during the telephone call. The self-report 47 48 49 method was chosen because recruitment to the study may have been difficult if access to 50 51 participants’ medical records was required. 52 53 54 All interviews were professionally transcribed, with transcripts checked for accuracy by MM. 55 56 Data were analysed using NVivo (QSR, Version 11). Thematic analysis was used to identify 57 58 59 themes at the semantic level using a deductive approach, based on their relevance to the study 60

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3 aim.21 Continuous iterative analyses were conducted to establish when thematic saturation BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 had been reached. Recruitment was set for 30 participants or thematic saturation, whichever 7 8 was attained first. The study ran from October 2017 to February 2018. All transcripts were 9 10 analysed by MM, and four transcripts (representing 25% of the total transcripts) were 11 12 independently second-coded by another researcher (CK), as recommended by MacPhail, et al. 13 14 15 22. Discrepancies were resolved through consensus discussion. 16 17 18 For peer review only 19 Patient and public involvement 20 21 22 All study materials (recruitment flyer, participant information sheet, consent form, interview 23 24 topic guide, GPP consultation example, and online questionnaire) were reviewed by the 25 26 27 AUKCAR Patient Advisory Group (PAG) prior to study commencement. Members of the 28 29 PAG were adults with asthma. Their feedback, often regarding word choice and text length, 30 31 was incorporated into the study materials. 32 33 34 35 36 Results

37 http://bmjopen.bmj.com/ 38 39 Thematic saturation was reached with 17 participants (Table 1). The mean interview length 40 41 42 was 39 minutes (ranging from 30 to 58 minutes). The participant sample was 59% female, 43 44 with most participants (41%) aged 30 to 39 years and recruited through the Asthma UK

45 on September 28, 2021 by guest. Protected copyright. 46 newsletter (41%). The sample included participants with self-reported mild (53%), moderate 47 48 49 (24%), and severe asthma (17%). Three overarching themes (with seven sub-themes) were 50 51 identified from the data: building trust in pharmacists, filling gaps in current asthma care, and 52 53 navigating a strained healthcare system. 54 55 56 Table 1. Demographic characteristics and asthma history 57 58 Characteristics Frequency 59 (n = 17) n (%) 60 Gender

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3 Female 10 (59%) BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Male 7 (41%) 5 Age in years 6 7 18 – 29 5 (29%) 8 30 – 39 7 (41%) 9 40 – 49 2 (12%) 10 50 - 59 - 11 60 – 69 2 (12%) 12 70 + 1 (6%) 13 Recruitment channel 14 Asthma UK newsletter 7 (41%) 15 Hospital 1 (6%) 16 Social media 3 (17%) 17 University College London newsletter 3 (18%) 18 For peer review only 19 Word of Mouth 3 (18%) 20 Self-reported asthma severity 21 Mild 9 (53%) 22 Moderate 4 (24%) 23 Severe 3 (17%) 24 Prefer not to disclose 1 (6%) 25 Self-reported hospitalisations for asthma 26 (previous 12 months) 27 0 11 (65%) 28 1 – 4 3 (17%) 29 5 – 10 3 (17%) 30 31 Self-reported GP visits for asthma 32 (previous 12 months) 33 0 2 (12%) 34 1 – 10 13 (76%) 35 10 – 20 2 (12%) 36

37 http://bmjopen.bmj.com/ 38 Theme 1: building trust in pharmacists 39 40 41 Trust in healthcare professionals involves the optimistic acceptance of being in a vulnerable 42 43 situation, knowing that one’s interests will be cared for.14 For participants, opinions of the 44

45 on September 28, 2021 by guest. Protected copyright. 46 new service were based on the level of trust they placed in pharmacists. Trust was built over 47 48 time, based on perceived clinical competency, and through a benchmarking process, which 49 50 form the sub-themes discussed below. 51 52 53 54 Building trust over time 55 56 57 58 Participants highlighted that trust in any healthcare professional builds through consistent 59 60 contact over time. Some participants felt hesitant about the new service because it meant

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3 deviating from their usual trusted healthcare professional, suggesting a preference for usual BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 care over new initiatives to maintain the quality of their asthma care. 7 8 9 “I don’t really know, I think I’d prefer a doctor [to talk to about my asthma]. It’s the way it’s 10 always been.” 11 – P15, male, 30 – 39 years, mild asthma 12 13 14 15 Building trust based on perceived clinical competency 16 17 18 When asked aboutFor specific peer criteria for review trust, participants only discussed pharmacists’ clinical 19 20 21 competency. This included pharmacists’ asthma-specific and broad clinical knowledge. 22 23 Support for the new service was high when pharmacists were viewed as knowledgeable. 24 25 26 “So I know that in the pharmacy role they’re very knowledgeable. So if [adherence support 27 for asthma] is something they want to do then why not? I have a lot of faith in somebody 28 who’s got a lot of knowledge in something.” 29 – P8, female, 30 – 39 years, severe asthma 30 31 32 Some participants believed that pharmacists would need extensive additional training to 33 34 develop the knowledge needed for the new service. Their main concern was that pharmacists 35 36 were too medication-focused and therefore lacked broader clinical skills.

37 http://bmjopen.bmj.com/ 38 39 “…it could be that the [medication] side-effects are something else entirely. So 40 [pharmacists] would be kind of completely thinking down the asthma route, ‘it might just be 41 that you’re taking an inhaler that you feel side-effects’…but what if it turns out you actually 42 43 have cancer?” 44 – P17, male, 18 – 29 years, mild asthma

45 on September 28, 2021 by guest. Protected copyright. 46 47 48 Building trust through a benchmarking process 49 50 51 None of the participants had previous experiences with GPPs, with some participants 52 53 questioning the differences between GPPs and community pharmacists. Many participants 54 55 56 engaged in a benchmarking process: using their trust and previous experiences of other 57 58 healthcare professionals to gauge how much they could trust a GPP. Common reference 59 60

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3 points included community pharmacists, respiratory consultants, nurses, GPs, and BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 paramedics. 7 8 9 “…I know [pharmacist support] is there but I still don’t understand it with [brittle] asthma 10 because I still get wary. If paramedics have never heard of it and don’t know what they’re 11 doing, how’s a pharmacist going to hear of it?” 12 – P2, female, 30 – 39 years, severe asthma 13 14 “I would much rather go to a pharmacist than to a nurse to discuss the medication issues that 15 I was having… I can see an asthma nurse to discuss medication, and I was like ‘Really? What 16 17 do nurses know about…not to be rude, but what do they know about medication more than 18 my specialist who prescribedFor peer it?” review only 19 – P4, female, 30 – 39 years, mild asthma 20 21 22 23 Theme 2: filling gaps in current asthma care 24 25 26 Participants’ opinions of GPPs were also informed by perceived gaps in their current asthma 27 28 29 care. Participants evaluated the new service’s place in their current care based on potential 30 31 role overlap between GPPs and other healthcare professionals, continuity of care, and 32 33 medication-specific support. 34 35 36

37 Potential role overlap http://bmjopen.bmj.com/ 38 39 40 41 Participants that saw potential role overlap between GPPs and other healthcare professionals 42 43 were more sceptical of the new service. 44

45 on September 28, 2021 by guest. Protected copyright. 46 “I think if I was having an annual asthma review I wouldn’t need to use the pharmacist’s 47 service as well, but it might be an alternative to the annual asthma review…” 48 – P3, male, 70+ years, mild asthma 49 50 However, other participants clearly delineated the GPP role, and these participants often 51 52 53 recommended ways to integrate pharmacists into their care. 54 55 56 “If you’re asking a GP, you’ve got maybe five, ten minutes… If you know you’ve got another 57 ten or fifteen minutes with this pharmacist… for asking all these questions…with the GP you 58 can concentrate on the problem and get that sorted, and then go see the pharmacist and 59 discuss the medication.” 60 – P5, female, 60 – 69 years, moderate asthma 8 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 30 BMJ Open

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Continuity of care 5 6 7 Participants with self-reported severe asthma often had multiple healthcare professionals 8 9 10 involved in their care (e.g. respiratory consultants, GPs, and asthma nurses). When asked 11 12 about the new service, some participants felt concerned about involving an additional 13 14 healthcare professional in their care. This was unrelated to their views on pharmacist 15 16 17 competency, and was usually influenced by previous experiences of inadequate continuity of 18 For peer review only 19 care due to a lack of communication between healthcare professionals. 20 21 22 “[Pharmacists] always say speak to your GP but then the GP tells you to speak to the 23 pharmacist because they’re supposed to know more about drugs than what they are…and 24 then you’re somewhere in the middle…” 25 – P2, female, 30 – 39 years, severe asthma 26 27 28 29 Medication-specific support 30 31 32 33 Other participants with severe asthma on multiple medications and/or with other health 34 35 concerns welcomed the service. This enthusiasm came from the fact that they identified gaps 36

37 in their current care that they believed could be filled by pharmacists as medication experts. http://bmjopen.bmj.com/ 38 39 40 “…just having contact with someone who actually…knows about the medication, like they 41 know how they work and what the potential side effects are going to be and interactions…it’s 42 43 that knowledge that a GP wouldn’t necessarily have time to tell you all about…” 44 – P6, female, 30 – 39 years, severe asthma

45 on September 28, 2021 by guest. Protected copyright. 46 “…I’m trying to conceive at the moment so…and I thought I don’t want to be taking anything 47 that’s unnatural or steroid-y…I did ask the respiratory consultant [about asthma medications 48 and In Vitro Fertilisation] but he didn’t know…” 49 –P8, female, 30 – 39 years, severe asthma 50 51 52 Some participants felt that GPPs should have an independent prescribing qualification to 53 54 fulfil their role as medication experts. They worried that the new service might contribute to 55 56 the burden on patients and/or the healthcare system, and that independent pharmacist 57 58 59 prescribers would minimise the risk of this happening. 60

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3 “For me, it would just be down to whether or not [pharmacists] are able to prescribe. I BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 don’t imagine that they wouldn’t have the knowledge that was required…It’s just if I had to 5 6 then see a doctor to be prescribed a different medication, I’d rather just go to see the doctor 7 instead.” 8 – P10, female, 40 – 49 years, mild asthma 9 10 11 12 Theme 3: navigating a strained healthcare system 13 14 15 Participants were acutely aware of the limited resources within general practice. They often 16 17 18 expressed guilt andFor frustration peer about booking review appointments only for asthma. Participants never 19 20 booked appointments just for medication-related questions, and their medication-related 21 22 concerns were frequently left unaddressed because other topics took priority in a 23 24 consultation, particularly if the participant had multiple comorbidities. The pharmacist-led 25 26 27 service was welcomed by these participants because they felt pharmacists would have more 28 29 time to focus on their medication. 30 31 32 “…come Monday morning I wouldn’t want to call the GP because I know on Monday 33 morning they’re very, very busy…I’ll just sort of crack on at home, multi-dosing salbutamol 34 and seeing what happens.” 35 – P8, female, 30 – 39 years, severe asthma 36

37 http://bmjopen.bmj.com/ 38 “[GPs] just want you in and out… ‘oh yes, I wanted to ask you something else’ but too late 39 now, you’re away. That’s how you feel.” 40 –P1, female, 30 – 39 years, mild asthma 41 42 43 44 The hierarchy of healthcare professionals

45 on September 28, 2021 by guest. Protected copyright. 46 47 Many participants constructed a hierarchy of healthcare professionals with GPs at the top, 48 49 50 followed by nurses and finally pharmacists. This hierarchy determined the importance of 51 52 each healthcare professional’s time. Severe health concerns justified booking a GP 53 54 appointment, while non-urgent concerns were viewed as more suitable for pharmacists. 55 56 57 The hierarchy of healthcare professionals affected perceptions of GPPs in both directions. 58 59 60 Some participants were enthusiastic about the new service because they believed it would

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3 lessen the workload of GPs and nurses. For these participants, seeing a pharmacist (the BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 healthcare professional further down the hierarchy) felt less intimidating and formal, slightly 7 8 easing concerns about taking up valuable appointment time. 9 10 11 “…to be honest, GPs have bigger problems to deal with…[they’re] dealing with people with, 12 you know, life threatening illnesses, then actually seeing the standard case of asthma or an 13 asthma check-up isn’t the best use of [their] time.” 14 – P16, male, 18 – 29 years, moderate asthma 15 16 17 “It feels less formal, I think, when you’re with a pharmacist than when you’re in the 18 doctor’s…sometimesFor when youpeer go to the reviewdoctor’s, you’re kindonly of clock watching…” 19 – P10, female, 40 – 49 years, mild asthma 20 21 Others felt that pharmacists could not extend into a clinical role similar to GPs and nurses, 22 23 24 with some suggesting a triage-like function to safeguard GP time. 25 26 “I never feel as though a pharmacist is a nurse, if you see what I mean. A nurse has practical 27 28 hands-on experience of trying to make people better. The pharmacist is one who deals with 29 the theory of medication.” 30 –P9, male, 60 – 69 years, undisclosed asthma severity 31 32 “… the pharmacist has seen you and if there’s communication between the pharmacist and 33 the GP, so that I guess it would help the GPs prioritise who they saw…” 34 35 –P11, female, 40 – 49 years, moderate asthma 36

37 However, pharmacists themselves were also viewed as a limited resource. Many participants http://bmjopen.bmj.com/ 38 39 supported moving pharmacists from community pharmacies to general practice because they 40 41 experienced inadequate care in busy community pharmacies. Others were concerned that 42 43 44 pharmacist-led adherence support with a wide scope (i.e. for multiple long-term conditions)

45 on September 28, 2021 by guest. Protected copyright. 46 would limit access for people with asthma. 47 48 49 “If [pharmacists] weren’t running a community pharmacy, if they were linked in, if they 50 worked within the GP surgery with a lot of time, then yes, I don’t see how [a lack of time] 51 would be an issue.” 52 – P12, female, 30 – 39 years, mild asthma 53 54 55 “…my worry is if a pharmacist has to do [adherence support in general practice] for asthma, 56 what other long-term conditions will they have to do it for?” 57 – P6, female, 30 – 39 years, severe asthma 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Discussion 5 6 7 8 This is the first in-depth exploration of the perspectives of adults with asthma on pharmacist- 9 10 led adherence support in general practice. This focused exploration identified potential 11 12 13 barriers to service uptake, and has the potential to help further refine and tailor the GPP 14 15 service as it is rolled out. 16 17 18 For peer review only 19 Interpretation of findings 20 21 22 Trust played an important role in participants’ initial perspectives of GPP-led care – it was an 23 24 25 essential component of the patient-pharmacist relationship and it informed participants’ views 26 27 of pharmacists’ role in asthma care. These findings suggest that general awareness of the 28 29 existence of pharmacist-led services is insufficient to encourage service uptake. 30 31 32 Participants based their trust in pharmacists on perceived clinical competency and 33 34 comparisons with other trusted healthcare professionals (e.g. GPs and nurses), guided by 35 36 perceptions of pharmacists’ position in the hierarchy of healthcare professionals. These 37 http://bmjopen.bmj.com/ 38 39 findings may suggest that explicit endorsement of GPP-led care by other trusted healthcare 40 41 professionals might improve service uptake among adults with asthma. Reassurance and 42 43 44 support from GPs and nurses may address some of the concerns raised by study participants,

45 on September 28, 2021 by guest. Protected copyright. 46 including those about fragmented care, pharmacists’ clinical competency, and potential role 47 48 overlap. 49 50 51 Support for GPP-led care did not seem to differ based on participants’ age, gender, or self- 52 53 reported asthma severity – there was a variety of views in each group of participants. 54 55 56 However, participants on multiple medications or those with additional health concerns 57 58 seemed to be more open to pharmacist input, perhaps because they felt current asthma care 59 60

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3 was unable to meet these additional needs. Targeting this group of adults with asthma may BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 improve service uptake in the future. 7 8 9 10 Strengths and limitations 11 12 13 The qualitative method in this study captured the complex processes behind people’s initial 14 15 opinions of GPPs. The combination of recruitment channels produced variation in the sample 16 17 18 in terms of age, self-reportedFor peer asthma severity,review and healthcare only utilisation. Telephone-based 19 20 interviews enabled recruitment across the UK without increasing participant burden, thus 21 22 increasing study accessibility for participants with severe asthma and limited travel capacity. 23 24 In addition, telephone-based interviews can produce data of higher quality compared to face- 25 26 23 27 to-face interviews when sensitive topics (e.g. long-term conditions) are discussed. 28 29 30 The participant sample may however not have captured the views of all adults with asthma 31 32 because it consisted primarily of people with self-reported mild asthma (53%) and people 33 34 recruited through Asthma UK (41%). Thematic saturation may have been reached due to the 35 36 relative homogeneity of the participant sample. The participants recruited through Asthma 37 http://bmjopen.bmj.com/ 38 39 UK may have had a stronger interest in asthma care or pharmacist-led support, and may 40 41 therefore have been more supportive of the new service compared to the general population 42 43 44 with asthma. However, if scepticism of the new service exists among people who are more

45 on September 28, 2021 by guest. Protected copyright. 46 engaged in their care, then the findings may be amplified in the general population with 47 48 asthma who may have less interest in asthma care. 49 50 51 A major drawback of the study is that none of the participants had experienced a GPP 52 53 consultation directly, with some participants recruited from Scotland and Northern Ireland 54 55 56 where the GPP scheme does not exist. While the consultation description that participants 57 58 were asked to read was based on real work by a clinical respiratory pharmacist working in 59 60 general practice, study findings can only be used to understand patients’ initial views of a 13 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 30

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3 GPP-led service. These participants represent the general population with asthma who would BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 initially need to be convinced to engage with the service. Addressing some of the concerns 7 8 identified by participants may help improve the uptake of existing GPP-led care among adults 9 10 with asthma. However, participants’ views may change over time, and could potentially be 11 12 influenced by direct personal experience with a GPP consultation. 13 14 15 16 Comparison with existing literature 17 18 For peer review only 19 20 There is limited research on patient perspectives of GPPs because the care model is relatively 21 22 new. However, findings from this study align with those from community pharmacy-based 23 24 research, suggesting that people with asthma may not differentiate between pharmacy sectors. 25 26 27 Findings align with work by Gidman, et al. 13, who found that people were hesitant about 28 29 30 deviating from their usual trusted care model (often a GP). However, a few of the older 31 32 participants in this study were open to GPP-led care, in contrast to previous research that 33 34 suggests that older patients may be less likely to accept an expanded pharmacist role.24 35 36

37 Both general members of the public and people with asthma have been found to use other http://bmjopen.bmj.com/ 38 39 40 trusted healthcare professionals (e.g. GPs and nurses) as benchmarks for trust when asked 41 42 about a community pharmacist-led service.13 20 Similarly, Naik Panvelkar, et al. 20 found that 43 44 previous positive experiences with community pharmacists raised expectations for other

45 on September 28, 2021 by guest. Protected copyright. 46 pharmacist-led services in a population of people with asthma. 47 48 49 Participants’ views of the gaps in their current asthma care shaped their perspectives of GPPs. 50 51 25 52 Similarly, Boyd, et al. found that recipients of the New Medicine Service (NMS) 53 54 welcomed pharmacists’ recommendations if they addressed a concern directly raised by the 55 56 patient. While asthma care guidelines recommend a multidisciplinary approach in treating 57 58 59 difficult asthma, the present study suggests that some people with self-reported severe asthma 60

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3 were hesitant to include another healthcare professional due to issues with continuity of BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 26 6 care. In line with previous research, the hierarchy of healthcare professionals influenced 7 8 perspectives of pharmacists expanding further into clinical roles.13 15 However, this study also 9 10 found that the hierarchy increased support for pharmacist-led care to reduce the burden on 11 12 GPs/nurses. 13 14 15 16 Implications for research and practice 17 18 For peer review only 19 20 As the GPP model is rolled out, future studies could be conducted using in-depth interviews 21 22 with people with asthma after they have experienced a GPP-led consultation. These 23 24 interviews could establish if interpersonal factors (i.e. rapport with the pharmacist) have an 25 26 27 impact on patient perspectives. Ethnographic observations of pharmacist-led consultations 28 29 and the general practice team will help assess pharmacists’ integration and its effect on 30 31 continuity of care for asthma patients. Future recruitment should aim for greater variation in 32 33 34 participants (e.g. self-reported asthma severity) through various recruitment channels, with 35 36 additional efforts to look for discordant voices when thematic saturation is reached.

37 http://bmjopen.bmj.com/ 38 39 Findings from this study could be implemented in efforts to increase service uptake among 40 41 people with asthma. Given the benchmarking process used to establish trust in pharmacists, 42 43 44 comparisons between GPPs and other healthcare professionals could be used to inform and

45 on September 28, 2021 by guest. Protected copyright. 46 engage the public. For example, public campaigns highlighting the differences and 47 48 similarities between GPs and GPPs may help the public differentiate the pharmacist role and 49 50 understand the added value of the new service within asthma care. 51 52 53 Participants wanted GPPs to have broad clinical skills and a prescribing qualification. 54 55 56 Encouragingly, the Centre for Pharmacy Postgraduate Education has already included these 57 58 components in their GPP training pathways.27 59 60

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3 Although the hierarchy of healthcare professionals sometimes prevented pharmacists from BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 being perceived as clinicians, it also made GPP appointments appear less formal and 7 8 intimidating to access. Participants felt more comfortable making an appointment with a 9 10 pharmacist for medication-related questions. This is encouraging because the new service 11 12 may encourage people with asthma to address medication-related concerns that may be 13 14 15 barriers to medication adherence.28 16 17 18 While the perspectivesFor of people peer with asthma review explored in thisonly study show that the GPP model 19 20 has promise, they identified several barriers to optimal patient engagement and service 21 22 implementation that will need to be addressed for the service to be effective. Meeting patient 23 24 25 expectations will be the first crucial step in ensuring the programme’s long-term benefit and 26 27 reducing the pressure on general practice in England. 28 29 30 31 Acknowledgements 32 33 34 35 We would like to thank the Asthma UK Centre for Applied Research (AUKCAR) Patient 36

37 Advisory Group for their feedback and support for this study. http://bmjopen.bmj.com/ 38 39 40 41 Contributors 42 43 44

45 The study was designed by MM, RH, and SJCT. All interviews were conducted by MM. Data on September 28, 2021 by guest. Protected copyright. 46 47 was analysed by MM and CK. The manuscript was written by MM, AHYC, and VW, with 48 49 50 input from RH and SJCT. 51 52 53 54 Funding 55 56 57 58 The research was funded by the National Institute for Health Research (NIHR) Collaboration 59 60 for Leadership in Applied Health Research and Care North Thames at Barts Health NHS

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3 Trust. The views expressed are those of the authors and not necessarily those of the NHS, the BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 NIHR, or the Department of Health and Social Care. 7 8 9 10 Competing interests 11 12 13 14 None declared. 15 16 17 18 Patient consentFor for peerpublication review only 19 20 21 Not required. 22 23 24 25 26 Ethics approval 27 28 29 The research was approved by the NHS London-Harrow Research Ethics Committee (12th 30 31 th 32 October 2017, Ref: 17/LO/1565) and Cwm Taf University Health Board (17 November 33 34 2017, Ref: CT/831/205928/17). 35 36

37 http://bmjopen.bmj.com/ 38 Data sharing statement 39 40 41 42 No additional data are available. 43 44

45 on September 28, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 References 5 6 7 8 1. World Health Organization. Primary Health Care - Now More Than Ever. 9 10 Geneva: World Health Organization, 2008. 11 12 2. NHS England. General Practice Forward View. NHS England, 2016. 13 14 https://www.england.nhs.uk/gp/gpfv/. 15 16 3. Mann C, Anderson C, Avery AJ, et al. Clinical pharmacists in general 17 18 practice: pilotFor scheme. peer University review of Nottingham, only UK: NHS England, 19 20 2018. 21 22 https://www.nottingham.ac.uk/pharmacy/documents/generalpracticeyea 23 24 rfwdrev/clinical-pharmacists-in-general-practice-pilot-scheme-full- 25 report.pdf. 26 27 4. NHS England. Clinical pharmacists in general practice pilot. England, UK: 28 29 NHS England, 2015. 30 31 https://www.england.nhs.uk/gp/gpfv/workforce/building-the-general- 32 33 practice-workforce/cp-gp/. 34 35 5. Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: 36

37 current status and future perspectives. Respir Care 2015;60(3):455-68. http://bmjopen.bmj.com/ 38 39 doi: 10.4187/respcare.03200 [published Online First: 2014/08/15] 40 41 6. Murphy AC, Proeschal A, Brightling CE, et al. The relationship between 42 clinical outcomes and medication adherence in difficult-to-control 43 44 asthma. Thorax 2012;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096

45 on September 28, 2021 by guest. Protected copyright. 46 [published Online First: 2012/03/23] 47 48 7. Cumella A. Falling through the gaps: Why more people need basic asthma 49 50 care. United Kingdom: Asthma UK, 2017. 51 52 https://www.asthma.org.uk/about/media/news/press-release-around- 53 54 800000-brits-with-asthma-getting-poor-care/. 55 56 8. Mes MA, Katzer CB, Chan AHY, et al. Pharmacists and medication 57 58 adherence in asthma: a systematic review and meta-analysis. Eur 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Respir J 2018;52(2) doi: 10.1183/13993003.00485-2018 [published 5 6 Online First: 2018/07/07] 7 8 9. Elliott R, Boyd MJ, Salema NE, et al. Supporting adherence for people 9 10 starting a new medication for a long-term condition through community 11 pharmacies: A pragmatic randomised controlled trial of the New 12 13 Medicine Service. BMJ quality & safety 2016;25(10):747-58. 14 15 10. Latif A, Pollock K, Boardman HF. The contribution of the Medicines Use 16 17 Review (MUR) consultation to counseling practice in community 18 For peer review only 19 pharmacies. Patient Educ Couns 2011;83(3):336-44. doi: 20 21 http://dx.doi.org/10.1016/j.pec.2011.05.007 22 23 11. Gann B. Understanding and using health experiences: the policy 24 25 landscape. In: Ziebland S, Coulter A, Calabrese JD, et al., eds. 26 Understanding and using health experiences: improving patient care. 27 28 Oxford, United Kingdom: Oxford University Press 2013. 29 30 12. O'Brien BC, Harris IB, Beckman TJ, et al. Standards for reporting 31 32 qualitative research: a synthesis of recommendations. Acad Med 33 34 2014;89(9):1245-51. doi: 10.1097/acm.0000000000000388 [published 35 36 Online First: 2014/07/01]

37 http://bmjopen.bmj.com/ 38 13. Gidman W, Ward P, McGregor L. Understanding public trust in services 39 40 provided by community pharmacists relative to those provided by 41 42 general practitioners: a qualitative study. BMJ Open 2012;2(3) 43 14. Hall MA, Dugan E, Zheng B, et al. Trust in physicians and medical 44

45 institutions: what is it, can it be measured, and does it matter? Milbank on September 28, 2021 by guest. Protected copyright. 46 47 Q 2001;79(4):613-39. [published Online First: 2002/01/16] 48 49 15. Latif A, Boardman HF, Pollock K. Understanding the patient perspective of 50 51 the English community pharmacy Medicines Use Review (MUR). Res 52 53 Social Adm Pharm 2013;9(6):949-57. doi: 54 55 http://dx.doi.org/10.1016/j.sapharm.2013.01.005 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 16. Tinelli M, Ryan M, Bond C. Patients' preferences for an increased 5 6 pharmacist role in the management of drug therapy. Int J Pharm Pract 7 8 2009;17(5):275-82. 9 10 17. Latif A, Waring J, Watmough D, et al. Examination of England's New 11 Medicine Service (NMS) of complex health care interventions in 12 13 community pharmacy. Res Social Adm Pharm 2016;12(6):966-89. doi: 14 15 http://dx.doi.org/10.1016/j.sapharm.2015.12.007 16 17 18. Bereznicki B, Peterson G, Jackson S, et al. Perceived feasibility of a 18 For peer review only 19 community pharmacy-based asthma intervention: a qualitative follow-up 20 21 study. J Clin Pharm Ther 2011;36(3):348-55. 22 23 19. Bradley F, Wagner AC, Elvey R, et al. Determinants of the uptake of 24 25 medicines use reviews (MURs) by community pharmacies in England: a 26 multi-method study. Health Policy 2008;88(2):258-68. 27 28 20. Naik Panvelkar P, Armour C, Saini B. Community pharmacy-based 29 30 asthma services-what do patients prefer? J Asthma 2010;47(10):1085- 31 32 93. doi: https://dx.doi.org/10.3109/02770903.2010.514638 33 34 21. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative 35 36 Research in Psychology 2006;3(2):77-101. doi:

37 http://bmjopen.bmj.com/ 38 10.1191/1478088706qp063oa 39 40 22. MacPhail C, Khoza N, Abler L, et al. Process guidelines for establishing 41 42 Intercoder Reliability in qualitative studies. 2016;16(2):198-212. doi: 43 10.1177/1468794115577012 44

45 23. Sturges JE, Hanrahan KJ. Comparing Telephone and Face-to-Face on September 28, 2021 by guest. Protected copyright. 46 47 Qualitative Interviewing: a Research Note. Qualitative Research 48 49 2004;4(1):107-18. doi: 10.1177/1468794104041110 50 51 24. Perepelkin J. Public Opinion of Pharmacists and Pharmacist Prescribing. 52 53 2011;144(2):86-93. doi: 10.3821/1913-701x-144.2.86 54 55 25. Boyd MJ, Elliott R, Barber N, et al. The impact of the New Medicines 56 57 Service (NMS) in England on patients adherence to their medicines. Int 58 59 J Pharm Pract 2014;22:66. doi: 10.1111/ijpp.12146 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 26. British Thoracic Society/Scottish Intercollegiate Guidelines Network. 5 6 British guideline on the management of asthma: a national clinical 7 8 guideline. Edinburgh: British Thoracic Society/Scottish Intercollegiate 9 10 Guidelines Network, 2016. https://www.brit-thoracic.org.uk/quality- 11 improvement/guidelines/asthma. 12 13 27. Centre for Pharmacy Postgraduate Education. Clinical pharmacists in 14 15 general practice education. Manchester, United Kingdom: University of 16 17 Manchester, 2018. https://www.cppe.ac.uk/career/cpgpe/clinical- 18 For peer review only 19 pharmacists-in-general-practice-education. 20 21 28. Horne R, Weinman J. Self-regulation and self-management in asthma: 22 23 exploring the role of illness perceptions and treatment beliefs in 24 25 explaining non-adherence to preventer medication. Psychol Health 26 2002;17(1):17-32. 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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3 Do you have any questions or anything you would like me to clarify before we move on BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 to the questions? 5 6 7 6. What are your initial thoughts on this pharmacist medication support service? 8 a. Explore which aspects of the service are most salient to the participant, use 9 prompts below when needed. 10 11 - In your opinion, would this type of service be a useful addition to the care you get 12 from your GP/nurse/asthma specialist? 13 14 o Is this a type of service you could see yourself using? Why or why not? 15 o Do you think this service is any different from the asthma care you already 16 receive? 17 - Do you think this type of service would help you take your preventer inhaler more 18 regularly? For peer review only 19 - How do you feel about a pharmacist taking on this type of clinical role? 20 21 o Do you think pharmacists have enough training for this type of work? 22 ▪ What type of knowledge would you expect the pharmacist to have? 23 o How do pharmacists compare to your other healthcare professionals (e.g. GP 24 or nurse)? 25 o Do you think this service is any different from seeing a community 26 pharmacist? (Are they familiar with the NMS and MUR?) 27 o Would you feel comfortable talking to a pharmacist about your asthma and 28 29 your medication? 30 o Do you feel like you can trust a pharmacist in this type of role? 31 - How do you feel about having a pharmacist based in a GP surgery? 32 o How would you feel about this pharmacist having access to your medical 33 records? 34 - What do you think about seeing a pharmacist on an appointment basis? 35 - When you think about (concerns/side effects discussed for question 2a), do you think 36 those types of questions or concerns could be addressed by a pharmacist? 37 http://bmjopen.bmj.com/ 38 o What would be the ideal way to support you with those questions or concerns? 39 - Do you think this type of service is convenient for people with asthma? 40 41 42 43 44

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1 2 3 Reporting checklist for qualitative study. 4 5 6 Based on the SRQR guidelines. 7 8 9 Instructions to authors 10 11 Complete this checklist by entering the page numbers from your manuscript where readers will find 12 each of the items listed below. 13 14 15 Your article may not currently address all the items on the checklist. Please modify your text to 16 include the missing information.For Ifpeer you are certain review that an item doesonly not apply, please write "n/a" and 17 18 provide a short explanation. 19 20 Upload your completed checklist as an extra file when you submit to a journal. 21 22 In your methods section, say that you used the SRQRreporting guidelines, and cite them as: 23 24 25 O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: 26 a synthesis of recommendations. Acad Med. 2014;89(9):1245-1251. 27 28 Page 29 30 Reporting Item Number 31 32 Title

33 http://bmjopen.bmj.com/ 34 #1 Concise description of the nature and topic of the study 0 35 36 identifying the study as qualitative or indicating the 37 approach (e.g. ethnography, grounded theory) or data 38 39 collection methods (e.g. interview, focus group) is 40 recommended 41 on September 28, 2021 by guest. Protected copyright. 42 43 Abstract 44 45 #2 Summary of the key elements of the study using the 1 46 47 abstract format of the intended publication; typically 48 includes background, purpose, methods, results and 49 50 conclusions 51 52 Introduction 53 54 Problem formulation #3 Description and signifcance of the problem / 2-3 55 56 phenomenon studied: review of relevant theory and 57 empirical work; problem statement 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 28 of 30 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

1 Purpose or research #4 Purpose of the study and specific objectives or 3 2 3 question questions 4 5 Methods 6 7 Qualitative approach and #5 Qualitative approach (e.g. ethnography, grounded 3 8 9 research paradigm theory, case study, phenomenolgy, narrative research) 10 and guiding theory if appropriate; identifying the 11 12 research paradigm (e.g. postpositivist, constructivist / 13 interpretivist) is also recommended; rationale. The 14 15 rationale should briefly discuss the justification for 16 For peerchoosing thatreview theory, approach, only method or technique 17 18 rather than other options available; the assumptions 19 and limitations implicit in those choices and how those 20 21 choices influence study conclusions and transferability. 22 As appropriate the rationale for several items might be 23 24 discussed together. 25 26 Researcher characteristics #6 Researchers' characteristics that may influence the 5 27 28 and reflexivity research, including personal attributes, qualifications / 29 experience, relationship with participants, assumptions 30 31 and / or presuppositions; potential or actual interaction 32 between researchers' characteristics and the research

33 http://bmjopen.bmj.com/ 34 questions, approach, methods, results and / or 35 transferability 36 37 Context #7 Setting / site and salient contextual factors; rationale 5 38 39 40 Sampling strategy #8 How and why research participants, documents, or 3-5

41 events were selected; criteria for deciding when no on September 28, 2021 by guest. Protected copyright. 42 43 further sampling was necessary (e.g. sampling 44 saturation); rationale 45 46 Ethical issues pertaining to #9 Documentation of approval by an appropriate ethics 17 47 48 human subjects review board and participant consent, or explanation for 49 lack thereof; other confidentiality and data security 50 51 issues 52 53 Data collection methods #10 Types of data collected; details of data collection 5 54 55 procedures including (as appropriate) start and stop 56 dates of data collection and analysis, iterative process, 57 58 triangulation of sources / methods, and modification of 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 29 of 30 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from procedures in response to evolving study findings; 1 2 rationale 3 4 Data collection #11 Description of instruments (e.g. interview guides, 5 5 6 instruments and questionnaires) and devices (e.g. audio recorders) 7 technologies used for data collection; if / how the instruments(s) 8 9 changed over the course of the study 10 11 Units of study #12 Number and relevant characteristics of participants, 6 12 documents, or events included in the study; level of 13 14 participation (could be reported in results) 15 16 Data processing For#13 peerMethods forreview processing data only prior to and during 5 17 18 analysis, including transcription, data entry, data 19 management and security, verification of data integrity, 20 21 data coding, and anonymisation / deidentification of 22 excerpts 23 24 25 Data analysis #14 Process by which inferences, themes, etc. were 5-6 26 identified and developed, including the researchers 27 28 involved in data analysis; usually references a specific 29 paradigm or approach; rationale 30 31 Techniques to enhance #15 Techniques to enhance trustworthiness and credibility 6 32

33 trustworthiness of data analysis (e.g. member checking, audit trail, http://bmjopen.bmj.com/ 34 triangulation); rationale 35 36 37 Results/findings 38 39 Syntheses and #16 Main findings (e.g. interpretations, inferences, and 7-13 40 interpretation themes); might include development of a theory or 41 on September 28, 2021 by guest. Protected copyright. 42 model, or integration with prior research or theory 43 44 Links to empirical data #17 Evidence (e.g. quotes, field notes, text excerpts, 7-13 45 46 photographs) to substantiate analytic findings 47 48 Discussion 49 50 Intergration with prior #18 Short summary of main findings; explanation of how 13-16 51 52 work, implications, findings and conclusions connect to, support, elaborate 53 transferability and on, or challenge conclusions of earlier scholarship; 54 55 contribution(s) to the field discussion of scope of application / generalizability; 56 identification of unique contributions(s) to scholarship in 57 58 a discipline or field 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 30 of 30 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

1 Limitations #19 Trustworthiness and limitations of findings 13-14 2 3 Other 4 5 6 Conflicts of interest #20 Potential sources of influence of perceived influence on 17 7 study conduct and conclusions; how these were 8 9 managed 10 11 Funding #21 Sources of funding and other support; role of funders in 17 12 13 data collection, interpretation and reporting 14 15 The SRQR checklist is distributed with permission of Wolters Kluwer © 2014 by the Association of 16 American Medical Colleges.For This peerchecklist was review completed on 01.only June 2019 using 17 18 https://www.goodreports.org/, a tool made by the EQUATOR Network in collaboration with 19 Penelope.ai 20 21 22 23 24 25 26 27 28 29 30 31 32

33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40

41 on September 28, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

Pharmacist-led adherence support in general practice: a qualitative interview study of adults with asthma

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032084.R2 review only Article Type: Original research

Date Submitted by the 22-Sep-2019 Author:

Primary Subject General practice / Family practice http://bmjopen.bmj.com/ Heading:

Secondary Subject Heading: Respiratory medicine, Health services research

Medication Adherence, Asthma < THORACIC MEDICINE, Pharmaceutical Keywords: Services, General Practice, Medication Therapy Management

on September 28, 2021 by guest. Protected copyright.

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45 on September 28, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 Word count: 3,944 words 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Abstract 5 6 7 Objectives: The National Health Service (NHS) in England recently introduced general 8 9 practice pharmacists (GPPs) to provide medication-focused support to both patients and the 10 11 general practice team. This healthcare model may benefit people with asthma, who currently 12 13 14 receive sub-optimal care and demonstrate low medication adherence. This study aimed to 15 16 explore the perspectives of adults with asthma on the potential for pharmacist-led adherence 17 18 support delivered inFor general practice,peer with review a focus on how onlythese perspectives are formed. 19 20 21 Design and setting: The study was conducted in the United Kingdom (UK) utilising a 22 23 24 qualitative interview methodology. Participants were invited to partake in a telephone-based 25 26 semi-structured interview, followed by an online questionnaire for demographic details and 27 28 asthma history. Qualitative data was analysed using thematic analysis. 29 30 31 Participants: Participants (n = 17) were adults with asthma in the UK with a prescription for 32 33 an inhaled corticosteroid. Participants did not have previous experience with GPPs and were 34 35 36 asked to provide their views on a proposed GPP-led service.

37 http://bmjopen.bmj.com/ 38 39 Results: Participant perspectives of GPPs were determined by trust in pharmacists, perceived 40 41 gaps in asthma care, and the perceived strain on the NHS. Trust was based on pharmacists’ 42 43 perceived clinical competency, established over time, and gauged through a ‘benchmarking’ 44

45 on September 28, 2021 by guest. Protected copyright. 46 process. GPP’s fit in current asthma care was assessed based on potential role overlap with 47 48 other healthcare professionals, continuity of care, and medication-related support needs. 49 50 Participants navigated the NHS based on a perceived hierarchy of healthcare professionals 51 52 53 (GPs on top, nurses, then pharmacists), and this influenced their perspectives of GPPs. 54 55 56 Conclusions: While the GPP scheme shows promise based on the perspectives of people 57 58 with asthma, the identified barriers to optimal patient engagement and service 59 60 implementation will need to be addressed for the service to be effective.

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Strengths and limitations of this study 5 6 7  The use of qualitative methodology captured the complex processes behind people’s 8 9 perspectives of general practice pharmacists (GPPs), including how lived experiences 10 11 shaped opinions of new pharmacist-led services. 12 13 14  Telephone-based interviews enabled recruitment across the United Kingdom (UK) 15 16 and increased study accessibility for people with severe asthma and travel limitations. 17 18  The study mayFor not have peer captured reviewthe full variation onlyin views among adults with asthma 19 20 21 in the UK because participants primarily had self-reported mild asthma and were 22 23 recruited through an asthma charity. 24 25  Participants had no experience with GPP-led consultations and therefore represented 26 27 28 the general population with asthma that would initially need to be convinced to 29 30 engage with the service. 31 32 33 34 Background 35 36 The pressure on primary care to deliver core services is increasing rapidly worldwide due to a

37 http://bmjopen.bmj.com/ 38 39 growing and ageing population, the prevalence of long-term conditions, and significant 40 41 resource constraints. Primary care systems are being reshaped and new models of care are 42 43 emerging to cope with growing demand.1 44

45 on September 28, 2021 by guest. Protected copyright. 46 One such model is the general practice pharmacist (GPP) model, which was introduced in 47 48 England as part of the NHS General Practice Forward View initiative.2-4 These pharmacists 49 50 51 support both patients and the general practice team with medication-related issues, with the 52 53 aim of expanding the general practice workforce, reducing practice burden, and increasing 54 55 patient access to appointments.4 Initial qualitative feedback from general practitioners (GPs) 56 57 58 and pharmacists in a pilot study in England suggests that GPPs can have positive impacts on 59 60

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3 medication safety, medication adherence, healthcare access, and patient satisfaction across a BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 3 6 variety of long-term conditions. 7 8 9 People with asthma may benefit from GPP support. Research shows that adherence to inhaled 10 11 corticosteroids (ICS), an essential medication for asthma, is low.5 6 Furthermore, only 35% of 12 13 people with asthma in the United Kingdom (UK) receive basic care (i.e. annual reviews, 14 15 inhaler technique checks, and a written asthma action plan).7 Previous research suggests that 16 17 18 pharmacist-led interventionsFor peer can increase review medication adherence only and support asthma self- 19 20 management among people with asthma.8 However, most of the previous research in the UK 21 22 has been limited to community rather than general practice pharmacists, and focused on their 23 24 9 10 25 impact across a range of long-term conditions rather than asthma specifically. 26 27 28 Understanding the specific perspectives of people with asthma regarding GPPs is an 29 30 important first step in establishing the potential benefits of this new service for this specific 31 32 patient group, as well as identifying any potential issues in its future uptake and 33 34 11 35 effectiveness. The aim of this study was to explore the perspectives of adults with asthma 36

37 on the potential of pharmacist-led asthma adherence support delivered in general practice, http://bmjopen.bmj.com/ 38 39 with a focus on how these perspectives are formed. 40 41 42 43 Methods 44

45 on September 28, 2021 by guest. Protected copyright. 12 46 This study is reported according to the Standards for Reporting Qualitative Research. It was 47 48 a telephone-based semi-structured interview study, using an interpretivist approach to 49 50 understand how adults with asthma construct their initial opinions of GPP-led asthma 51 52 53 adherence support. Demographic details and asthma history were collected using a brief 54 55 online questionnaire. 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Participants 5 6 Participants were adults (≥ 18 years old) living in the UK and proficient in English, with a 7 8 self-reported asthma diagnosis, a prescription for ICS, and access to a telephone and e-mail 9 10 11 account. People with respiratory comorbidities (e.g. Chronic Obstructive Pulmonary Disease) 12 13 and/or those in hospital or nursing homes were excluded, as the adherence behaviour and 14 15 support needs of these individuals were hypothesised to be different. 16 17 18 For peer review only 19 Recruitment 20 21 Several recruitment channels were used to ensure that participants varied in age, gender, and 22 23 24 self-reported asthma severity. A flyer with study information and researchers’ contact details 25 26 was circulated by researchers, the Asthma UK Centre for Applied Research (AUKCAR), and 27 28 the National Institute for Health Research Collaboration for Leadership in Applied Health 29 30 31 Research and Care North Thames via social media. The study was advertised in two 32 33 electronic newsletters: the Asthma UK volunteer bulletin and the University College London 34 35 student newsletter. Printed flyers were handed directly to potential participants by a 36

37 http://bmjopen.bmj.com/ 38 respiratory consultant at a London hospital, and pharmacists at two hospitals in Wales. 39 40 People who contacted the researchers were e-mailed an information sheet, consent form, and 41 42 43 eligibility criteria to review. If they were eligible and willing to participate, they were booked 44

45 in for a one-hour telephone interview. In preparation for the call, participants were asked to on September 28, 2021 by guest. Protected copyright. 46 47 read a description of a GPP-led adherence support consultation, sent to them via e-mail (see 48 49 50 Appendix A). This description was based on the work of a clinical respiratory pharmacist 51 52 working in general practice in London. Participants gave verbal consent over the telephone 53 54 before the interview began. The consent procedure and interview were audio-recorded with 55 56 57 their permission. All participants received a £20 online shopping voucher to thank them for 58 59 their time. 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Data collection and analysis 5 6 One researcher (MM) conducted the interviews. Participants were informed that the 7 8 researcher had a background in Health Psychology and an interest in adherence and 9 10 11 pharmacist-led care for asthma. 12 13 14 The interview topic guide had two sections (see Appendix B). The first section focused on 15 16 participants’ previous experiences of asthma, asthma care, and pharmacists. The second 17 18 section focused on Forhow these peer lived experiences review informed only participants’ opinions of GPP-led 19 20 21 adherence support, with questions based on previous research on interpersonal/institutional 22 23 trust in healthcare professionals,13 14 perceptions of the pharmacist role,15-17 and pharmacist- 24 25 led care for asthma.10 18-20 26 27 28 Participants also completed an online questionnaire on demographic details (gender and age) 29 30 and asthma history (self-reported asthma severity, hospitalisations, and GP visits). An online 31 32 33 questionnaire was used because participants may have felt uncomfortable disclosing personal 34 35 information (e.g. age) directly to a researcher during the telephone call. The self-report 36

37 method was chosen because recruitment to the study may have been difficult if access to http://bmjopen.bmj.com/ 38 39 40 participants’ medical records was required. 41 42 43 All interviews were professionally transcribed, with transcripts checked for accuracy by MM. 44

45 Data were analysed using NVivo (QSR, Version 11). Thematic analysis was used to identify on September 28, 2021 by guest. Protected copyright. 46 47 themes at the semantic level using a deductive approach, based on their relevance to the study 48 49 21 50 aim. Continuous iterative analyses were conducted to establish when thematic saturation 51 52 had been reached. Recruitment was set for 30 participants or thematic saturation, whichever 53 54 was attained first. The study ran from October 2017 to February 2018. All transcripts were 55 56 analysed by MM, and four transcripts (representing 25% of the total transcripts) were 57 58 59 60

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3 independently second-coded by another researcher (CK), as recommended by MacPhail, et al. BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 22 6 . Discrepancies were resolved through consensus discussion. 7 8 9 Patient and public involvement 10 11 12 All study materials (recruitment flyer, participant information sheet, consent form, interview 13 14 topic guide, GPP consultation example, and online questionnaire) were reviewed by the 15 16 AUKCAR Patient Advisory Group (PAG) prior to study commencement. Members of the 17 18 For peer review only 19 PAG were adults with asthma. Their feedback, often regarding word choice and text length, 20 21 was incorporated into the study materials. 22 23 24 25 Results 26 27 Thematic saturation was reached with 17 participants (Table 1). The median interview length 28 29 30 was 42 minutes (ranging from 30 to 58 minutes). The participant sample was 59% female, 31 32 with most participants (41%) aged 30 to 39 years and recruited through the Asthma UK 33 34 newsletter (41%). The sample included participants with self-reported mild (53%), moderate 35 36 (24%), and severe asthma (17%). Three overarching themes (with seven sub-themes) were 37 http://bmjopen.bmj.com/ 38 39 identified from the data: building trust in pharmacists, filling gaps in current asthma care, and 40 41 navigating a strained healthcare system. 42 43 44 Table 1. Demographic characteristics and asthma history

45 on September 28, 2021 by guest. Protected copyright. 46 Characteristics Frequency 47 (n = 17) n (%) 48 Gender 49 Female 10 (59%) 50 Male 7 (41%) 51 Age in years 52 18 – 29 5 (29%) 53 54 30 – 39 7 (41%) 55 40 – 49 2 (12%) 56 50 - 59 - 57 60 – 69 2 (12%) 58 70 + 1 (6%) 59 Recruitment channel 60 Asthma UK newsletter 7 (41%)

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3 Hospital 1 (6%) BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Social media 3 (17%) 5 University College London newsletter 3 (18%) 6 7 Word of Mouth 3 (18%) 8 Self-reported asthma severity 9 Mild 9 (53%) 10 Moderate 4 (24%) 11 Severe 3 (17%) 12 Prefer not to disclose 1 (6%) 13 Self-reported hospitalisations for asthma 14 (previous 12 months) 15 0 11 (65%) 16 1 – 4 3 (17%) 17 5 – 10 3 (17%) 18 For peer review only 19 Self-reported GP visits for asthma 20 (previous 12 months) 21 0 2 (12%) 22 1 – 10 13 (76%) 23 10 – 20 2 (12%) 24 25 Theme 1: building trust in pharmacists 26 27 28 Trust in healthcare professionals involves the optimistic acceptance of being in a vulnerable 29 30 situation, knowing that one’s interests will be cared for.14 For participants, opinions of the 31 32 new service were based on the level of trust they placed in pharmacists. Trust was built over 33 34 35 time, based on perceived clinical competency, and through a benchmarking process, which 36

37 form the sub-themes discussed below. http://bmjopen.bmj.com/ 38 39 40 41 Building trust over time 42 43 Participants highlighted that trust in any healthcare professional builds through consistent 44

45 on September 28, 2021 by guest. Protected copyright. 46 contact over time. Some participants felt hesitant about the new service because it meant 47 48 deviating from their usual trusted healthcare professional, suggesting a preference for usual 49 50 care over new initiatives to maintain the quality of their asthma care. 51 52 53 “I don’t really know, I think I’d prefer a doctor [to talk to about my asthma]. It’s the way it’s 54 always been.” 55 – P15, male, 30 – 39 years, mild asthma 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Building trust based on perceived clinical competency 5 6 When asked about specific criteria for trust, participants discussed pharmacists’ clinical 7 8 competency. This included pharmacists’ asthma-specific and broad clinical knowledge. 9 10 11 Support for the new service was high when pharmacists were viewed as knowledgeable. 12 13 14 “So I know that in the pharmacy role they’re very knowledgeable. So if [adherence support 15 for asthma] is something they want to do then why not? I have a lot of faith in somebody 16 who’s got a lot of knowledge in something.” 17 – P8, female, 30 – 39 years, severe asthma 18 For peer review only 19 Some participants believed that pharmacists would need extensive additional training to 20 21 22 develop the knowledge needed for the new service. Their main concern was that pharmacists 23 24 were too medication-focused and therefore lacked broader clinical skills. 25 26 27 “…it could be that the [medication] side-effects are something else entirely. So 28 [pharmacists] would be kind of completely thinking down the asthma route, ‘it might just be 29 that you’re taking an inhaler that you feel side-effects’…but what if it turns out you actually 30 have cancer?” 31 32 – P17, male, 18 – 29 years, mild asthma 33 34 35 Building trust through a benchmarking process 36

37 http://bmjopen.bmj.com/ 38 None of the participants had previous experiences with GPPs, with some participants 39 40 questioning the differences between GPPs and community pharmacists. Many participants 41 42 engaged in a benchmarking process: using their trust and previous experiences of other 43 44 healthcare professionals to gauge how much they could trust a GPP. Common reference 45 on September 28, 2021 by guest. Protected copyright. 46 47 points included community pharmacists, respiratory consultants, nurses, GPs, and 48 49 paramedics. 50 51 52 “…I know [pharmacist support] is there but I still don’t understand it with [brittle] asthma 53 because I still get wary. If paramedics have never heard of it and don’t know what they’re 54 doing, how’s a pharmacist going to hear of it?” 55 56 – P2, female, 30 – 39 years, severe asthma 57 58 “I would much rather go to a pharmacist than to a nurse to discuss the medication issues that 59 I was having… I can see an asthma nurse to discuss medication, and I was like ‘Really? What 60

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3 do nurses know about…not to be rude, but what do they know about medication more than BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 my specialist who prescribed it?” 5 6 – P4, female, 30 – 39 years, mild asthma 7 8 9 Theme 2: filling gaps in current asthma care 10 11 12 Participants’ opinions of GPPs were also informed by perceived gaps in their current asthma 13 14 care. Participants evaluated the new service’s place in their current care based on potential 15 16 role overlap between GPPs and other healthcare professionals, continuity of care, and 17 18 For peer review only 19 medication-specific support. 20 21 22 Potential role overlap 23 24 25 Participants that saw potential role overlap between GPPs and other healthcare professionals 26 27 were more sceptical of the new service. 28 29 30 “I think if I was having an annual asthma review I wouldn’t need to use the pharmacist’s 31 service as well, but it might be an alternative to the annual asthma review…” 32 – P3, male, 70+ years, mild asthma 33 34 35 However, other participants clearly delineated the GPP role, and these participants often 36

37 recommended ways to integrate pharmacists into their care. http://bmjopen.bmj.com/ 38 39 40 “If you’re asking a GP, you’ve got maybe five, ten minutes… If you know you’ve got another 41 ten or fifteen minutes with this pharmacist… for asking all these questions…with the GP you 42 can concentrate on the problem and get that sorted, and then go see the pharmacist and 43 discuss the medication.” 44 – P5, female, 60 – 69 years, moderate asthma

45 on September 28, 2021 by guest. Protected copyright. 46 47 48 Continuity of care 49 50 51 Participants with self-reported severe asthma often had multiple healthcare professionals 52 53 involved in their care (e.g. respiratory consultants, GPs, and asthma nurses). When asked 54 55 about the new service, some participants felt concerned about involving an additional 56 57 healthcare professional in their care. This was unrelated to their views on pharmacist 58 59 60

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3 competency, and was usually influenced by previous experiences of inadequate continuity of BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 care due to a lack of communication between healthcare professionals. 7 8 9 “[Pharmacists] always say speak to your GP but then the GP tells you to speak to the 10 pharmacist because they’re supposed to know more about drugs than what they are…and 11 then you’re somewhere in the middle…” 12 – P2, female, 30 – 39 years, severe asthma 13 14 15 16 Medication-specific support 17 18 Other participants withFor severe peer asthma who review spoke about being only on multiple medications and/or 19 20 having other health concerns welcomed the service. This enthusiasm came from the fact that 21 22 23 they identified gaps in their current care that they believed could be filled by pharmacists as 24 25 medication experts. 26 27 28 “…just having contact with someone who actually…knows about the medication, like they 29 know how they work and what the potential side effects are going to be and interactions…it’s 30 that knowledge that a GP wouldn’t necessarily have time to tell you all about…” 31 – P6, female, 30 – 39 years, severe asthma 32 33 34 “…I’m trying to conceive at the moment so…and I thought I don’t want to be taking anything 35 that’s unnatural or steroid-y…I did ask the respiratory consultant [about asthma medications 36 and In Vitro Fertilisation] but he didn’t know…”

37 –P8, female, 30 – 39 years, severe asthma http://bmjopen.bmj.com/ 38 39 Some participants felt that GPPs should have an independent prescribing qualification to 40 41 42 fulfil their role as medication experts. They worried that the new service might contribute to 43 44 the burden on patients and/or the healthcare system, and that independent pharmacist

45 on September 28, 2021 by guest. Protected copyright. 46 prescribers would minimise the risk of this happening. 47 48 49 “For me, it would just be down to whether or not [pharmacists] are able to prescribe. I 50 51 don’t imagine that they wouldn’t have the knowledge that was required…It’s just if I had to 52 then see a doctor to be prescribed a different medication, I’d rather just go to see the doctor 53 instead.” 54 – P10, female, 40 – 49 years, mild asthma 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Theme 3: navigating a strained healthcare system 5 6 Participants were acutely aware of the limited resources within general practice. They often 7 8 expressed guilt and frustration about booking appointments for asthma. Participants never 9 10 11 booked appointments just for medication-related questions, and their medication-related 12 13 concerns were frequently left unaddressed because other topics took priority in a 14 15 consultation, particularly if the participant had multiple comorbidities. The pharmacist-led 16 17 18 service was welcomedFor by these peer participants review because they onlyfelt pharmacists would have more 19 20 time to focus on their medication. 21 22 23 “…come Monday morning I wouldn’t want to call the GP because I know on Monday 24 morning they’re very, very busy…I’ll just sort of crack on at home, multi-dosing salbutamol 25 and seeing what happens.” 26 – P8, female, 30 – 39 years, severe asthma 27 28 29 “[GPs] just want you in and out… ‘oh yes, I wanted to ask you something else’ but too late 30 now, you’re away. That’s how you feel.” 31 –P1, female, 30 – 39 years, mild asthma 32 33 34 The hierarchy of healthcare professionals 35 36

37 Many participants constructed a hierarchy of healthcare professionals with GPs at the top, http://bmjopen.bmj.com/ 38 39 followed by nurses and finally pharmacists. This hierarchy determined the importance of 40 41 42 each healthcare professional’s time. Severe health concerns justified booking a GP 43 44 appointment, while non-urgent concerns were viewed as more suitable for pharmacists.

45 on September 28, 2021 by guest. Protected copyright. 46 47 The hierarchy of healthcare professionals affected opinions of GPPs in both directions. Some 48 49 participants were enthusiastic about the new service because they believed it would lessen the 50 51 52 workload of GPs and nurses. For these participants, seeing a pharmacist (the healthcare 53 54 professional further down the hierarchy) felt less intimidating and formal, slightly easing 55 56 concerns about taking up valuable appointment time. 57 58 59 60

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3 “…to be honest, GPs have bigger problems to deal with…[they’re] dealing with people with, BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 you know, life threatening illnesses, then actually seeing the standard case of asthma or an 5 6 asthma check-up isn’t the best use of [their] time.” 7 – P16, male, 18 – 29 years, moderate asthma 8 9 “It feels less formal, I think, when you’re with a pharmacist than when you’re in the 10 doctor’s…sometimes when you go to the doctor’s, you’re kind of clock watching…” 11 – P10, female, 40 – 49 years, mild asthma 12 13 14 Others felt that pharmacists could not extend into a clinical role similar to GPs and nurses, 15 16 with some suggesting a triage-like function to safeguard GP time. 17 18 For peer review only 19 “I never feel as though a pharmacist is a nurse, if you see what I mean. A nurse has practical 20 hands-on experience of trying to make people better. The pharmacist is one who deals with 21 the theory of medication.” 22 –P9, male, 60 – 69 years, undisclosed asthma severity 23 24 25 “… the pharmacist has seen you and if there’s communication between the pharmacist and 26 the GP, so that I guess it would help the GPs prioritise who they saw…” 27 –P11, female, 40 – 49 years, moderate asthma 28 29 However, pharmacists themselves were also viewed as a limited resource. Many participants 30 31 32 supported moving pharmacists from community pharmacies to general practice because they 33 34 experienced inadequate care in busy community pharmacies. Others were concerned that 35 36 pharmacist-led adherence support with a wide scope (i.e. for multiple long-term conditions)

37 http://bmjopen.bmj.com/ 38 would limit access for people with asthma. 39 40 41 “If [pharmacists] weren’t running a community pharmacy, if they were linked in, if they 42 43 worked within the GP surgery with a lot of time, then yes, I don’t see how [a lack of time] 44 would be an issue.”

45 – P12, female, 30 – 39 years, mild asthma on September 28, 2021 by guest. Protected copyright. 46 47 “…my worry is if a pharmacist has to do [adherence support in general practice] for asthma, 48 what other long-term conditions will they have to do it for?” 49 – P6, female, 30 – 39 years, severe asthma 50 51 52 53 Discussion 54 55 56 This is the first in-depth exploration of the perspectives of adults with asthma on pharmacist- 57 58 led adherence support in general practice. This focused exploration identified potential 59 60

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3 barriers to service uptake, and has the potential to help further refine and tailor the GPP BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 service as it is rolled out. 7 8 9 Interpretation of findings 10 11 12 Trust played an important role in participants’ initial perspectives of GPP-led care – it was an 13 14 essential component of the patient-pharmacist relationship and it informed participants’ views 15 16 of pharmacists’ role in asthma care. These findings suggest that general awareness of the 17 18 For peer review only 19 existence of pharmacist-led services is insufficient to encourage service uptake. 20 21 22 Participants based their trust in pharmacists on perceived clinical competency and 23 24 comparisons with other trusted healthcare professionals (e.g. GPs and nurses), guided by 25 26 perceptions of pharmacists’ position in the hierarchy of healthcare professionals. These 27 28 findings may suggest that explicit endorsement of GPP-led care by other trusted healthcare 29 30 31 professionals might improve service uptake among adults with asthma. Reassurance and 32 33 support from GPs and nurses may address some of the concerns raised by study participants, 34 35 including those about fragmented care, pharmacists’ clinical competency, and potential role 36

37 http://bmjopen.bmj.com/ 38 overlap. 39 40 41 Support for GPP-led care did not seem to differ based on participants’ age, gender, or self- 42 43 reported asthma severity – there was a variety of views in each group of participants. 44

45 However, participants who spoke about being on multiple medications and/or having on September 28, 2021 by guest. Protected copyright. 46 47 48 additional health concerns seemed to be more open to pharmacist input, perhaps because they 49 50 felt current asthma care was unable to meet these additional needs. Targeting this group of 51 52 adults with asthma may improve service uptake in the future. 53 54 55 56 57 58 59 60

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Strengths and limitations 5 6 The qualitative method in this study captured the complex processes behind people’s initial 7 8 opinions of GPPs. The combination of recruitment channels produced variation in the sample 9 10 11 in terms of age, self-reported asthma severity, and healthcare utilisation. Telephone-based 12 13 interviews enabled recruitment across the UK without increasing participant burden, thus 14 15 increasing study accessibility for participants with severe asthma and limited travel capacity. 16 17 18 In addition, telephone-basedFor peerinterviews canreview produce data ofonly higher quality compared to face- 19 20 to-face interviews when sensitive topics (e.g. long-term conditions) are discussed.23 21 22 23 The participant sample may however not have captured the views of all adults with asthma 24 25 because it consisted primarily of people with self-reported mild asthma (53%) and people 26 27 recruited through Asthma UK (41%). Thematic saturation may have been reached due to the 28 29 30 relative homogeneity of the participant sample. The participants recruited through Asthma 31 32 UK may have had a stronger interest in asthma care or pharmacist-led support, and may 33 34 therefore have been more supportive of the new service compared to the general population 35 36 with asthma. However, if scepticism of the new service exists among people who are more 37 http://bmjopen.bmj.com/ 38 39 engaged in their care, then the findings may be amplified in the general population with 40 41 asthma who may have less interest in asthma care. 42 43 44 A major drawback of the study is that none of the participants had experienced a GPP

45 on September 28, 2021 by guest. Protected copyright. 46 47 consultation directly, with some participants recruited from Scotland and Northern Ireland 48 49 where the GPP scheme does not exist. While the consultation description that participants 50 51 were asked to read was based on real work by a clinical respiratory pharmacist working in 52 53 general practice, study findings can only be used to understand patients’ initial views of a 54 55 56 GPP-led service. These participants represent the general population with asthma who would 57 58 initially need to be convinced to engage with the service. Addressing some of the concerns 59 60

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3 identified by participants may help improve the uptake of existing GPP-led care among adults BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 with asthma. However, participants’ views may change over time, and could potentially be 7 8 influenced by direct personal experience with a GPP consultation. 9 10 11 Comparison with existing literature 12 13 14 There is limited research on patient perspectives of GPPs because the care model is relatively 15 16 new. However, findings from this study align with those from community pharmacy-based 17 18 For peer review only 19 research, suggesting that people with asthma may not differentiate between pharmacy sectors. 20 21 13 22 Findings align with work by Gidman, et al. , who found that people were hesitant about 23 24 deviating from their usual trusted care model (often a GP). However, two of the older 25 26 participants in this study were open to GPP-led care, in contrast to previous research that 27 28 suggests that older patients may be less likely to accept an expanded pharmacist role.24 29 30 31 In line with the present study’s findings, previous research with general members of the 32 33 34 public and people with asthma found that other trusted healthcare professionals (e.g. GPs and 35 36 nurses) were used as benchmarks to inform opinions of community pharmacist-led services.13

37 http://bmjopen.bmj.com/ 38 20 Similarly, Naik Panvelkar, et al. 20 found that previous positive experiences with 39 40 41 community pharmacists raised expectations for other pharmacist-led services in a population 42 43 of people with asthma. 44

45 on September 28, 2021 by guest. Protected copyright. 46 Participants’ views of the gaps in their current asthma care shaped their perspectives of GPPs. 47 48 Similarly, Boyd, et al. 25 found that recipients of the New Medicine Service (NMS) 49 50 51 welcomed pharmacists’ recommendations if they addressed a concern directly raised by the 52 53 patient. While asthma care guidelines recommend a multidisciplinary approach in treating 54 55 difficult asthma, the present study suggests that some people with self-reported severe asthma 56 57 were hesitant to include another healthcare professional due to issues with continuity of 58 59 26 60 care. In line with previous research, the hierarchy of healthcare professionals influenced

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3 perspectives of pharmacists expanding further into clinical roles.13 15 However, this study also BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 found that the hierarchy increased support for pharmacist-led care to reduce the burden on 7 8 GPs/nurses. 9 10 11 Implications for research and practice 12 13 14 As the GPP model is rolled out, future studies could be conducted using in-depth interviews 15 16 with people with asthma after they have experienced a GPP-led consultation. These 17 18 For peer review only 19 interviews could establish if interpersonal factors (i.e. rapport with the pharmacist) have an 20 21 impact on patient perspectives. Ethnographic observations of pharmacist-led consultations 22 23 and the general practice team will help assess pharmacists’ integration and its effect on 24 25 26 continuity of care for asthma patients. Future recruitment should aim for greater variation in 27 28 participants (e.g. self-reported asthma severity) through various recruitment channels, with 29 30 additional efforts to look for discordant voices when thematic saturation is reached. 31 32 33 Findings from this study could be implemented in efforts to increase service uptake among 34 35 people with asthma. Given the benchmarking process used to establish trust in pharmacists, 36

37 http://bmjopen.bmj.com/ 38 comparisons between GPPs and other healthcare professionals could be used to inform and 39 40 engage the public. For example, public campaigns highlighting the differences and 41 42 similarities between GPs and GPPs may help the public differentiate the pharmacist role and 43 44 understand the added value of the new service within asthma care. 45 on September 28, 2021 by guest. Protected copyright. 46 47 48 Participants wanted GPPs to have broad clinical skills and a prescribing qualification. 49 50 Encouragingly, the Centre for Pharmacy Postgraduate Education has already included these 51 52 components in their GPP training pathways.27 53 54 55 Although the hierarchy of healthcare professionals sometimes prevented pharmacists from 56 57 being perceived as clinicians, it also made GPP appointments appear less formal and 58 59 60 intimidating to access. Participants felt more comfortable making an appointment with a

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3 pharmacist for medication-related questions. This is encouraging because the new service BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 6 may encourage people with asthma to address medication-related concerns that may be 7 8 barriers to medication adherence.28 9 10 11 While the perspectives of people with asthma explored in this study show that the GPP model 12 13 has promise, they identified several barriers to optimal patient engagement and service 14 15 implementation that will need to be addressed for the service to be effective. Meeting patient 16 17 18 expectations will beFor the first peer crucial step review in ensuring the programme’sonly long-term benefit and 19 20 reducing the pressure on general practice in England. 21 22 23 24 Acknowledgements 25 26 27 We would like to thank the Asthma UK Centre for Applied Research (AUKCAR) Patient 28 29 Advisory Group for their feedback and support for this study. 30 31 32 33 Contributors 34 35 The study was designed by MM, RH, and SJCT. All interviews were conducted by MM. Data 36

37 http://bmjopen.bmj.com/ 38 was analysed by MM and CK. The manuscript was written by MM, AHYC, and VW, with 39 40 input from RH and SJCT. 41 42 43 44 Funding

45 on September 28, 2021 by guest. Protected copyright. 46 47 The research was funded by the National Institute for Health Research (NIHR) Collaboration 48 49 for Leadership in Applied Health Research and Care North Thames at Barts Health NHS 50 51 Trust. The views expressed are those of the authors and not necessarily those of the NHS, the 52 53 NIHR, or the Department of Health and Social Care. 54 55 56 57 Competing interests 58 59 60 None declared.

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 Patient consent for publication 5 6 7 Not required. 8 9 10 Ethics approval 11 12 13 The research was approved by the NHS London-Harrow Research Ethics Committee (12th 14 15 October 2017, Ref: 17/LO/1565) and Cwm Taf University Health Board (17th November 16 17 18 2017, Ref: CT/831/205928/17).For peer review only 19 20 21 Data sharing statement 22 23 24 No additional data are available. 25 26 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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3 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 References 5 6 7 1. World Health Organization. Primary Health Care - Now More Than Ever. 8 Geneva: World Health Organization, 2008. 9 2. NHS England. General Practice Forward View. NHS England, 2016. 10 11 https://www.england.nhs.uk/gp/gpfv/. 12 3. Mann C, Anderson C, Avery AJ, et al. Clinical pharmacists in general 13 practice: pilot scheme. University of Nottingham, UK: NHS England, 14 15 2018. 16 https://www.nottingham.ac.uk/pharmacy/documents/generalpracticeye 17 arfwdrev/clinical-pharmacists-in-general-practice-pilot-scheme-full- 18 report.pdfFor. peer review only 19 20 4. NHS England. Clinical pharmacists in general practice pilot. England, UK: 21 NHS England, 2015. 22 https://www.england.nhs.uk/gp/gpfv/workforce/building-the-general- 23 24 practice-workforce/cp-gp/. 25 5. Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: 26 current status and future perspectives. Respir Care 2015;60(3):455-68. 27 28 doi: 10.4187/respcare.03200 29 6. Murphy AC, Proeschal A, Brightling CE, et al. The relationship between 30 clinical outcomes and medication adherence in difficult-to-control 31 32 asthma. Thorax 2012;67(8):751-3. doi: 10.1136/thoraxjnl-2011-201096 33 7. Cumella A. Falling through the gaps: Why more people need basic asthma 34 care. United Kingdom: Asthma UK, 2017. 35 https://www.asthma.org.uk/about/media/news/press-release-around- 36

37 800000-brits-with-asthma-getting-poor-care/. http://bmjopen.bmj.com/ 38 8. Mes MA, Katzer CB, Chan AHY, et al. Pharmacists and medication 39 adherence in asthma: a systematic review and meta-analysis. Eur 40 41 Respir J 2018;52(2) doi: 10.1183/13993003.00485-2018 42 9. Elliott R, Boyd MJ, Salema NE, et al. Supporting adherence for people 43 starting a new medication for a long-term condition through community 44 pharmacies: A pragmatic randomised controlled trial of the New 45 on September 28, 2021 by guest. Protected copyright. 46 Medicine Service. BMJ quality & safety 2016;25(10):747-58. doi: 47 10.1136/bmjqs-2015-004400 48 49 10. Latif A, Pollock K, Boardman HF. The contribution of the Medicines Use 50 Review (MUR) consultation to counseling practice in community 51 pharmacies. Patient Educ Couns 2011;83(3):336-44. doi: 52 10.1016/j.pec.2011.05.007 53 54 11. Gann B. Understanding and using health experiences: the policy 55 landscape. In: Ziebland S, Coulter A, Calabrese JD, et al., eds. 56 Understanding and using health experiences: improving patient care. 57 58 Oxford, United Kingdom: Oxford University Press 2013. 59 60

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3 12. O'Brien BC, Harris IB, Beckman TJ, et al. Standards for reporting BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 qualitative research: a synthesis of recommendations. Acad Med 6 2014;89(9):1245-51. doi: 10.1097/acm.0000000000000388 7 13. Gidman W, Ward P, McGregor L. Understanding public trust in services 8 9 provided by community pharmacists relative to those provided by 10 general practitioners: a qualitative study. BMJ Open 2012;2(3) doi: 11 10.1136/bmjopen-2012-000939 12 13 14. Hall MA, Dugan E, Zheng B, et al. Trust in physicians and medical 14 institutions: what is it, can it be measured, and does it matter? Milbank 15 Q 2001;79(4):613-39. doi: 10.1111/1468-0009.00223 16 17 15. Latif A, Boardman HF, Pollock K. Understanding the patient perspective of 18 the EnglishFor community peer pharmacy review Medicines only Use Review (MUR). Res 19 Social Adm Pharm 2013;9(6):949-57. doi: 20 10.1016/j.sapharm.2013.01.005 21 22 16. Tinelli M, Ryan M, Bond C. Patients' preferences for an increased 23 pharmacist role in the management of drug therapy. Int J Pharm Pract 24 2009;17(5):275-82. doi: 10.1211/ijpp.17.05.0004 25 26 17. Latif A, Waring J, Watmough D, et al. Examination of England's New 27 Medicine Service (NMS) of complex health care interventions in 28 community pharmacy. Res Social Adm Pharm 2016;12(6):966-89. doi: 29 30 10.1016/j.sapharm.2015.12.007 31 18. Bereznicki B, Peterson G, Jackson S, et al. Perceived feasibility of a 32 community pharmacy-based asthma intervention: a qualitative follow- 33 34 up study. J Clin Pharm Ther 2011;36(3):348-55. doi: 10.1111/j.1365- 35 2710.2010.01187.x 36 19. Bradley F, Wagner AC, Elvey R, et al. Determinants of the uptake of 37 medicines use reviews (MURs) by community pharmacies in England: a http://bmjopen.bmj.com/ 38 39 multi-method study. Health Policy 2008;88(2):258-68. doi: 40 10.1016/j.healthpol.2008.03.013 41 20. Naik Panvelkar P, Armour C, Saini B. Community pharmacy-based asthma 42 43 services-what do patients prefer? J Asthma 2010;47(10):1085-93. doi: 44 10.3109/02770903.2010.514638

45 21. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative on September 28, 2021 by guest. Protected copyright. 46 47 Research in Psychology 2006;3(2):77-101. doi: 48 10.1191/1478088706qp063oa 49 22. MacPhail C, Khoza N, Abler L, et al. Process guidelines for establishing 50 51 Intercoder Reliability in qualitative studies. Qualitative Research 52 2016;16(2):198-212. doi: 10.1177/1468794115577012 53 23. Sturges JE, Hanrahan KJ. Comparing Telephone and Face-to-Face 54 Qualitative Interviewing: a Research Note. Qualitative Research 55 56 2004;4(1):107-18. doi: 10.1177/1468794104041110 57 24. Perepelkin J. Public Opinion of Pharmacists and Pharmacist Prescribing. 58 Canadian Pharmacists Journal 2011;144(2):86-93. doi: 10.3821/1913- 59 60 701x-144.2.86

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3 25. Boyd MJ, Elliott R, Barber N, et al. The impact of the New Medicines BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 5 Service (NMS) in England on patients adherence to their medicines. Int 6 J Pharm Pract 2014;22:66. doi: 10.1111/ijpp.12146 7 26. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British 8 9 guideline on the management of asthma: a national clinical guideline. 10 Edinburgh: British Thoracic Society/Scottish Intercollegiate Guidelines 11 Network, 2016. https://www.brit-thoracic.org.uk/quality- 12 13 improvement/guidelines/asthma. 14 27. Centre for Pharmacy Postgraduate Education. Clinical pharmacists in 15 general practice education. Manchester, United Kingdom: University of 16 17 Manchester, 2018. https://www.cppe.ac.uk/career/cpgpe/clinical- 18 pharmacists-in-general-practice-educationFor peer review .only 19 28. Horne R, Weinman J. Self-regulation and self-management in asthma: 20 exploring the role of illness perceptions and treatment beliefs in 21 22 explaining non-adherence to preventer medication. Psychol Health 23 2002;17(1):17-32. doi: 10.1080/08870440290001502 24 25 26 27 28 29 30 31 32 33 34 35 36

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3 Do you have any questions or anything you would like me to clarify before we move on BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from 4 to the questions? 5 6 7 6. What are your initial thoughts on this pharmacist medication support service? 8 a. Explore which aspects of the service are most salient to the participant, use 9 prompts below when needed. 10 11 - In your opinion, would this type of service be a useful addition to the care you get 12 from your GP/nurse/asthma specialist? 13 14 o Is this a type of service you could see yourself using? Why or why not? 15 o Do you think this service is any different from the asthma care you already 16 receive? 17 - Do you think this type of service would help you take your preventer inhaler more 18 regularly? For peer review only 19 - How do you feel about a pharmacist taking on this type of clinical role? 20 21 o Do you think pharmacists have enough training for this type of work? 22 ▪ What type of knowledge would you expect the pharmacist to have? 23 o How do pharmacists compare to your other healthcare professionals (e.g. GP 24 or nurse)? 25 o Do you think this service is any different from seeing a community 26 pharmacist? (Are they familiar with the NMS and MUR?) 27 o Would you feel comfortable talking to a pharmacist about your asthma and 28 29 your medication? 30 o Do you feel like you can trust a pharmacist in this type of role? 31 - How do you feel about having a pharmacist based in a GP surgery? 32 o How would you feel about this pharmacist having access to your medical 33 records? 34 - What do you think about seeing a pharmacist on an appointment basis? 35 - When you think about (concerns/side effects discussed for question 2a), do you think 36 those types of questions or concerns could be addressed by a pharmacist? 37 http://bmjopen.bmj.com/ 38 o What would be the ideal way to support you with those questions or concerns? 39 - Do you think this type of service is convenient for people with asthma? 40 41 42 43 44

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1 Standards for Reporting Qualitative Research (SRQR)* 2 http://www.equator-network.org/reporting-guidelines/srqr/ 3 4 Page no. 5 Title and abstract 6 7 8 Title - Concise description of the nature and topic of the study Identifying the 9 study as qualitative or indicating the approach (e.g., ethnography, grounded 10 theory) or data collection methods (e.g., interview, focus group) is recommended 0 11 Abstract - Summary of key elements of the study using the abstract format of the 12 intended publication; typically includes background, purpose, methods, results, 13 14 and conclusions 1 15 16 Introduction For peer review only 17 18 19 Problem formulation - Description and significance of the problem/phenomenon 20 studied; review of relevant theory and empirical work; problem statement 2 - 3 21 Purpose or research question - Purpose of the study and specific objectives or 22 questions 3 23 24 25 Methods 26 27 28 Qualitative approach and research paradigm - Qualitative approach (e.g., 29 ethnography, grounded theory, case study, phenomenology, narrative research) 30 and guiding theory if appropriate; identifying the research paradigm (e.g., 31 postpositivist, constructivist/ interpretivist) is also recommended; rationale** 3 32

33 http://bmjopen.bmj.com/ 34 Researcher characteristics and reflexivity - Researchers’ characteristics that may 35 influence the research, including personal attributes, qualifications/experience, 36 37 relationship with participants, assumptions, and/or presuppositions; potential or 38 actual interaction between researchers’ characteristics and the research 39 questions, approach, methods, results, and/or transferability 4 40 Context - Setting/site and salient contextual factors; rationale** 4

41 on September 28, 2021 by guest. Protected copyright. 42 Sampling strategy - How and why research participants, documents, or events 43 were selected; criteria for deciding when no further sampling was necessary (e.g., 44 sampling saturation); rationale** 4-5 45 Ethical issues pertaining to human subjects - Documentation of approval by an 46 47 appropriate ethics review board and participant consent, or explanation for lack 48 thereof; other confidentiality and data security issues 17 49 Data collection methods - Types of data collected; details of data collection 50 51 procedures including (as appropriate) start and stop dates of data collection and 52 analysis, iterative process, triangulation of sources/methods, and modification of 53 procedures in response to evolving study findings; rationale** 5 54 55 56 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 27 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

1 2 Data collection instruments and technologies - Description of instruments (e.g., 3 interview guides, questionnaires) and devices (e.g., audio recorders) used for data 4 collection; if/how the instrument(s) changed over the course of the study 5 5 6 7 Units of study - Number and relevant characteristics of participants, documents, 8 or events included in the study; level of participation (could be reported in results) 6-7 9 Data processing - Methods for processing data prior to and during analysis, 10 11 including transcription, data entry, data management and security, verification of 12 data integrity, data coding, and anonymization/de-identification of excerpts 5 13 Data analysis - Process by which inferences, themes, etc., were identified and 14 developed, including the researchers involved in data analysis; usually references a 15 specific paradigm or approach; rationale** 5-6 16 For peer review only 17 Techniques to enhance trustworthiness - Techniques to enhance trustworthiness 18 and credibility of data analysis (e.g., member checking, audit trail, triangulation); 19 rationale** 5-6 20 21 22 Results/findings 23 Synthesis and interpretation - Main findings (e.g., interpretations, inferences, and 24 25 themes); might include development of a theory or model, or integration with 26 prior research or theory 7-12 27 Links to empirical data - Evidence (e.g., quotes, field notes, text excerpts, 28 photographs) to substantiate analytic findings 7-12 29 30 31 Discussion 32

33 Integration with prior work, implications, transferability, and contribution(s) to http://bmjopen.bmj.com/ 34 the field - Short summary of main findings; explanation of how findings and 35 conclusions connect to, support, elaborate on, or challenge conclusions of earlier 36 scholarship; discussion of scope of application/generalizability; identification of 37 unique contribution(s) to scholarship in a discipline or field 12 - 17 38 Limitations - Trustworthiness and limitations of findings 14 - 15 39 40

41 Other on September 28, 2021 by guest. Protected copyright. 42 Conflicts of interest - Potential sources of influence or perceived influence on 43 study conduct and conclusions; how these were managed 17 44 45 Funding - Sources of funding and other support; role of funders in data collection, 46 interpretation, and reporting 17 47 48 49 *The authors created the SRQR by searching the literature to identify guidelines, reporting 50 standards, and critical appraisal criteria for qualitative research; reviewing the reference 51 lists of retrieved sources; and contacting experts to gain feedback. The SRQR aims to 52 improve the transparency of all aspects of qualitative research by providing clear standards 53 for reporting qualitative research. 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 28 of 28 BMJ Open: first published as 10.1136/bmjopen-2019-032084 on 6 November 2019. Downloaded from

1 **The rationale should briefly discuss the justification for choosing that theory, approach, 2 method, or technique rather than other options available, the assumptions and limitations 3 4 implicit in those choices, and how those choices influence study conclusions and 5 transferability. As appropriate, the rationale for several items might be discussed together. 6 7 Reference: 8 O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative 9 research: a synthesis of recommendations. Academic Medicine, Vol. 89, No. 9 / Sept 2014 10 DOI: 10.1097/ACM.0000000000000388 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

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