Sleep Breath DOI 10.1007/s11325-015-1151-9
ORIGINAL ARTICLE
Diagnostic pathways for obstructive sleep apnoea in the Australian community: observations from pharmacy-based CPAP providers Carissa A. Hanes & Keith K. H. Wong & Bandana Saini
Received: 7 January 2015 / Revised: 12 February 2015 / Accepted: 25 February 2015 # Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose Models for the diagnosis of obstructive sleep apnoea (OSA) are evolving in many countries to meet public demand. In Australia, the unregulated sleep industry does not provide a framework to govern or review emerging pathways in the community. The objectives of this study were to (1) describe current diagnostic pathways for OSA in Australia as reported by continuous positive airway pressure (CPAP) providers in community pharmacies and (2) obtain stakeholder feedback on pathways and identify potential areas for practice improvement. Methods Semi-structured telephone interviews were conducted with pharmacy-based CPAP practitioners. Participants described diagnostic pathways used in their setting. Subsequently, an expert forum of stakeholders provided feedback on identified pathways during a focus group. Results Twenty-two telephone interviews were conducted, identifying six key diagnostic pathways. Pathways varied in terms of the diagnostic test used, the practitioner who initiated or interpreted the test and who discussed results with the C. A. Hanes (*) : B. Saini Faculty of Pharmacy, The University of Sydney, Pharmacy Building A15, Science Road, Sydney, NSW 2006, Australia e-mail: [email protected] C. A. Hanes : K. K. H. Wong : B. Saini NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, The University of Sydney, Sydney, NSW, Australia K. K. H. Wong Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia K. K. H. Wong Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia
patient and made treatment recommendations. A ninemember stakeholder group raised medical, ethical and organisational concerns over certain pathways. Concerns included diagnostic tests initiated or interpreted in the absence of an appropriately trained medical practitioner and potential conflicts of interest for CPAP providers offering both diagnostic and treatment services. A best practice framework was proposed to guide practice and translate study findings. Preliminary practice recommendations were subsequently developed. Conclusions Diagnostic models have evolved in Australia that raise stakeholder concerns. It is important to address these concerns while still facilitating patient access to services. Development of a practice framework could promote medically appropriate, patient-centred care. Key words Continuous positive airway pressure . Diagnostic techniques and procedures . Obstructive sleep apnoea . Pharmacies . Polysomnography . Primary care
Introduction Advances in the understanding of the epidemiology of obstructive sleep apnoea (OSA) and its health consequences have seen the condition recognised not only as a medical problem but also a significant public health issue [1]. The burden of disease continues to place substantial demands on diagnostic and treatment services within the health-care system. Traditional pathways of care involving diagnosis through in-laboratory polysomnography (PSG) under the management of specialist sleep physicians are insufficient to meet demand [2]. Patients accessing these services frequently face lengthy waiting times and delays in commencing
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treatment [2]. Alternative management pathways are needed to address demand–capacity disparities and improve patient access [3]. In Australia and internationally, models involving ambulatory diagnostic tests, home-based pressure titrations, primary care settings and non-specialist physician personnel have been investigated [4–8]. Against this backdrop, key facets of the sleep industry in many countries are unregulated. For instance, diagnostic tests may be accessed through providers lacking relevant local accreditation, and positive airway pressure equipment may be provided in the absence of appropriate patient education or support [9, 10]. While differences in the health-care systems of individual countries require consideration, internationally, the sleep medicine profession faces concerns arising from a lack of regulation. Notably, the Australian setting presents appreciable regulatory challenges. Australia’s national health insurance system, Medicare, provides reimbursement of PSG, both in-laboratory (level 1 test) and ambulatory (level 2 test), provided a sleep physician determines the test is indicated, and reviews and reports the test [11, 12]. However, for privately funded diagnostic studies, including all limited channel (level 3 or 4) tests and level 2 tests that do not fulfil Medicare eligibility requirements, there is no regulatory requirement for physician involvement [11, 12]. At the same time, ambulatory tests are directly available to the public from a variety of private enterprise providers. Additionally, Australia’s regulatory agency for medical drugs and devices, the Therapeutic Goods Administration (TGA), does not require a prescription prior to the supply of continuous positive airway pressure (CPAP) equipment. CPAP devices are likewise directly available through numerous private providers and, in some instances, from providers that also offer diagnostic tests. Furthermore, there are no regulatory requirements concerning the training or education of practitioners at such outlets. Thus, there is a need to establish whether emerging, simplified pathways of care are medically appropriate and safeguard the best interest of patients, given the absence of quality assurance scrutiny within the industry. Little information has been formally collated regarding diagnostic pathways operating in the Australian community. However, anecdotal reports have raised concerns regarding the appropriateness of certain pathways, particularly with regard to outlets that offer both diagnostic and treatment services [13]. In Australia, one of the private enterprise providers of sleep apnoea services is community (or retail) pharmacy. Of the numerous private providers on the market, pharmacy represents a structured and respected profession subject to stringent regulations governing medicines supply and related health services. They are accessible and widespread in the community, and patients have reported satisfaction with pharmacy-based CPAP services [14]. However, as with other CPAP outlets, there are no regulations specifically pertaining to CPAP provision. In a national survey of pharmacies offering
CPAP services, 54 % of respondents (n=106) reported also providing home diagnostic device hire [15]. However, information was not obtained on the protocols used to initiate these tests, or the onward referral processes after the completion of home-based tests. To date, there are no reports in the literature describing diagnostic pathways operating in any community-based provider setting in Australia, despite the ready accessibility of these outlets to the public. There is a particular need to investigate models utilising level 3 and 4 tests, since there are no formal mechanisms for evaluating these pathways, due to their private funding status. Given the familiarity of the pharmacy profession with practice research and existing sleep-related studies in this area, the pharmacy setting was chosen to explore community models. Thus, the aim of this study was to describe OSA diagnostic pathways operating in the community, as reported by CPAP providers in pharmacies. Further, we sought to obtain feedback on these pathways from an expert forum of key stakeholders to identify potential areas for practice improvement.
Methods Approval to conduct this study was obtained from the University of Sydney Human Research Ethics Committee (protocol 2012/2830). Two distinct phases were employed in this study. Study design: phase 1 (telephone interviews) The first phase involved telephone interviews, using a semistructured interview guide, with pharmacy-based CPAP practitioners. Detailed methods for this phase have been reported previously [16]. To summarise, purposive sampling from a compiled database of pharmacies providing CPAP services was used for recruitment. Pharmacies from a variety of states and geographic locations were sought to provide diversity in participant demographics and capture potential regional variations in diagnostic pathways. Participants were asked to reflect on their current practices, including how patients they interacted with were diagnosed with OSA, and conventions for initiating CPAP therapy. Recruitment continued until no further insight was obtained (‘data saturation’) [17]. All interviews were audio-recorded and transcribed verbatim prior to analysis. Study design: phase 2 (focus group) A joint stakeholder focus group was conducted to obtain feedback on the diagnostic pathways identified in phase 1. To comprise an expert forum, individuals were nominated by the research team and directly invited to participate.
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Additionally, key organisations were contacted and asked to nominate an appropriate representative to attend. The focus group was held in Sydney in August 2013. Signed consent and confidentiality forms were obtained from all participants before the session commenced. Prior to the group discussion, a presentation of the identified diagnostic models was provided. An experienced, senior member of the research team (BS) facilitated the group discussion component. The focus group was audio-recorded and transcribed verbatim. Two members of the research team also took detailed field notes. Immediately after the focus group proceedings concluded, the research team discussed key findings and overall impressions. The session duration was 3 h, with the audio-recording component lasting 2 h. The transcript was de-identified (names and places were removed) and provided to all participants prior to analysis for their review and final feedback. Participants were reimbursed for their travel expenses.
Results Participant characteristics Twenty-two telephone interviews, averaging 35 min in length, were conducted with pharmacy-based CPAP practitioners. These participants represented metropolitan (n=10), regional (n=6) and rural or remote (n=6) pharmacies across five Australian states and territories; the majority of participants were pharmacist proprietors (n=14) [16]. Nine stakeholders attended the focus group; the represented stakeholder groups are described in Table 1. Table 1
Diagnostic pathways identified Six key diagnostic pathways were identified during the phase 1 interviews (Fig. 1a–f). Pathways varied with respect to the type of diagnostic test used, the personnel who initiated and interpreted the test, and who discussed results with the patient and made treatment recommendations. Participants primarily reported on their own practices; however, some described additional practices they had observed in the community. Inlaboratory PSG was utilised in one pathway (Fig. 1a), while all other pathways involved home-based sleep studies. The most commonly reported pathway involved the interpretation of results by a ‘remote’ sleep physician (Fig. 1b); in some scenarios, the physician was located interstate. Patient information, including anthropometric data and clinical parameters, was generally provided to the remote physician, but a face-to-face consultation between the sleep physician and patient did not occur. Many pharmacies reported more than one pathway operating in their practice. Some regional variations were also observed, with traditional pathways (Fig. 1a) tending to be more common in metropolitan areas. Participants conveyed that patient consultations regarding sleep concerns in the pharmacy were often the primary presentation, leading pharmacists to provide initial screening, regardless of the subsequent diagnostic pathway followed. Reported screening strategies included identifying the presence of known risk factors and common comorbidities, or medications for these comorbidities, exploring suggestive symptoms and utilising screening questionnaires (there were no particular questionnaires in widespread use; however, some participants reported using the Berlin questionnaire or the Epworth Sleepiness Scale).
Stakeholder groups represented by focus group participants
Stakeholder group
Peak professional bodies Australasian Sleep Association Australasian Sleep Technologists Association Pharmacy Guild of Australia Pharmaceutical Society of Australia Practicing professionalsa Pharmacist Sleep physician CPAP manufacturers Patients Sleep Disorders Australia Total
Description of organisation/peak body
Number of representatives
Represents sleep clinicians, scientists and researchers Represents technologists, scientists, nurses and clinical physiologists working in sleep medicine and/or research Represents community pharmacy proprietors Represents pharmacists
1 1 1 2
–
1
– –
1 1
Provides support services to patients with sleep disorders and their families
1 9
CPAP continuous positive airway pressure a
A general practitioner scheduled to participate was unable to attend. Certain peak body representatives were also practicing professionals in their field
Sleep Breath Fig. 1 a Traditional pathway. a Variation: level 2 study (unattended PSG). Patient is eligible for Medicare reimbursement. b Home sleep test and remote sleep physician pathway. a Predominantly level 2 studies (patient eligible for Medicare reimbursement); some variations with level 3 or 4 studies (no Medicare reimbursement). c Home sleep test and remote sleep physician (with Teleconsult) pathway. a Level 2 study (patient eligible for Medicare reimbursement). b Variation: HST facilitated through hospital clinic. d Home sleep test and remote sleep physician: pharmacy initiated pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). e Home sleep test: general practitioner managed pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). b A report from a remote sleep technician may accompany study results. f Home sleep test: pharmacy managed pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). b A report from a remote sleep technician or remote GP may accompany study results. CPAP continuous positive airway pressure, GP general practitioner, HST home sleep test, PSG polysomnography. Key: light grey box general practitioner, blue box sleep physician, white box pharmacy
a Patient sees GP
GP refers patient to sleep physician
SCREENING
Attended a PSG
Sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient referred to CPAP provider to start trial
TREATMENT
b Patient sees GP
GP writes referral for HST
SCREENING
HSTa through pharmacy, results to remote sleep physician
Remote sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient starts CPAP trial in pharmacy
TREATMENT
Teleconsult to discuss diagnosis and treatment options
c
Patient sees GP
GP writes referral ffor HST
SCREENING
HSTa through b pharmacy , results to remote sleep physician
Remote sleep physician makes diagnosis
Patient starts CPAP trial in pharmacy
TREATMENT
DIAGNOSIS
d Patient screened in pharmacy
Pharmacy initiates HSTa
SCREENING
Results sent to remote sleep physician
Remote sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient referred back to pharmacy to start CPAP trial
TREATMENT
e Patient sees GP
GP writes referral for HST
SCREENING
HSTa through pharmacy, results to GP
GP reviews resultsb, advises treatment
DIAGNOSIS
Patient referred back to pharmacy to start CPAP trial
TREATMENT
Patient visits GP to discuss results and treatment
f
Patient screened in pharmacy
SCREENING
Pharmacy initiates HSTa
HST results to pharmacy
DIAGNOSIS
Pharmacy reviews resultsb, advises treatment
Patient starts CPAP trial in pharmacy
TREATMENT
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Several pharmacies issued formal referral forms for patients to take to their general practitioner (GP), or faxed referrals to the GP on the patient’s behalf. Written materials were often provided to patients. Much of the screening conducted was opportunistic, while in-store promotion or community advertisement of OSA prompted some patients to directly seek help. Stakeholder feedback There was general consensus amongst stakeholders that traditional pathways alone (Fig. 1a) were insufficient to meet public demand, and alternative pathways needed to evolve. There was also common recognition of the potential role the pharmacy profession could play in providing OSA patient care. Table 2
However, numerous concerns were raised with certain pathways identified. Stakeholder concerns fell under three broad categories: medical, ethical and organisational concerns. Table 2 summarises these concerns and presents selected stakeholder quotations. Regarding ethical concerns, the group presented differing opinions. Some believed that the potential conflict of interest for pharmacies providing both diagnostic (home-based sleep tests) and treatment (CPAP) services was insurmountable. Others expressed that the scenario was manageable, so long as the decision to initiate testing and treatment was removed from pharmacies, clear arrangements were in place for physician referral, and patients were made aware of potential conflicts of interest. Others felt that in rural settings, this scenario could be appropriate. It was acknowledged
Summary of stakeholder concerns with identified diagnostic pathways and selected stakeholder quotations
Area of concern
Summary of concerns
Selected stakeholder quotations
1. Medical
• Diagnostic tests initiated in absence of medical practitioner (1d, f)a • Diagnostic tests interpreted in absence of appropriately trained medical practitioner (potentially 1e, f) • Decision to initiate treatment and choice of treatment modality made by non-trained personnel (potentially 1e, f) • Absence of trained professional to oversee patient care and assume responsibility for ongoing management (potentially 1b–f) • Lack of clinical exam and/or personal review of patient by trained medical practitioner (potentially 1b, d–f) • Initiation of CPAP without a prescription or specifications (potentially 1b, d–f) • Absence of clear pathway for referral (trained medical practitioner available for feedback) (potentially 1b, d–f)
2. Ethical
• Potential conflicts of interest for CPAP providers offering both diagnostic and treatment services (1b–f) • Lack of opportunity for patient to receive Medicare subsidised test (where level 3 or 4 test used) (1d–f) • Lack of opportunity for patient to consider treatment options other than CPAP (potentially 1b, d–f)
3. Organisational
• Training and upskilling of GPs needed • Access to sleep physician support needed for GP-managed pathways (1e) • Lack of OSA-specific practice guidelines within pharmacy profession to define best practice • Lack of industry regulation (training and practice standards cannot be enforced)
• “…And many of these comorbid conditions have sleep disordered breathing associated with them, which may not be straightforward obstructive sleep apnoea anymore, and therefore may require different forms of, um…might require more sophisticated diagnosis and more sophisticated management…” (S5)b • “I don’t consider this report from somebody in another state that just gives a raft of treatment recommendations, generically, to be overseeing the patient’s care… without seeing them.” (S8) • “I think the key point is this sort of eye-to-eye, whether that’s by teleconference or directly across a desk, or in a consulting room…adds a lot more, a sort of… indefinable quality which informs clinical judgement, which…I think is key to good outcomes for the majority of patients.” (S3) • “..For some people that works [pharmacy managed pathways], but for other people… it’s an overly simplistic model. It does require some skilled input from a physician or a GP at some stage in the process.” (S5) • “I’m pretty keen…that there be GP referral to start with… I don’t have…any time for pharmacy initiating the service. I think that’s wrong. I think it has to be initiated by the medical profession.” (S6) • “I remain uncomfortable with the conflict between diagnosis and treatment provision…at a pharmacy level… a sleep physician level…I think it’s unmanageable…in all but the most compelling geographical services.” (S8) • I think the reality is… is that the GPs don’t know a lot about sleep apnoea at the moment… One of the challenges we’ve got as a field is to… develop education programs… for general practitioners to upskill them…” (S8) • “…We’ve probably got to try and set the standards for best practice… I guess we have to accept at the moment that there’re going to be people doing things that are not best practice and…that’s the way it is…” (S8) • “I think we’re at the point now where pharmacy… needs to… take the initiative, involve the appropriate stakeholders, and drive this [training and education programs for pharmacists].” (S5)
CPAP continuous positive airway pressure, GP general practitioner a
Figure numbers in italics refer to the relevant diagnostic pathways from Fig. 1a–f
b
Numbers in parentheses represent the code assigned to each stakeholder during the de-identification of the focus group transcript
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that conflict of interest issues were not exclusive to pharmacy-based providers but applied to the sleep industry at large and presented a challenge for many stakeholders. Patients’ lack of access to Medicare-funded diagnostic tests was also raised as a potential ethical issue for pharmacies solely offering privately funded studies. It was, however, recognised that some patients preferred to pay privately for tests for reasons of convenience and to bypass public-system waiting periods. Pathways that entirely circumvented the involvement of any medical practitioner in the diagnostic pathway were unanimously opposed. Stakeholders expressed mixed views regarding pathways that involved diagnosis by a ‘remote’ physician (Fig. 1b–d). Some conveyed that a personal review of the patient was important to allow holistic evaluation and identification of comorbidities and considered these ‘remote’ pathways inappropriate. Others proffered that, as long as there were sleep physicians willing and permitted to diagnose patients in this manner, it would be difficult to stipulate the exclusion of these pathways in any proposed best practice framework. Pathways involving teleconferencing (Fig. 1c) were seen to overcome the lack of personal review apparent in other ‘remote’ models (Fig. 1b, d). This pathway was considered by the majority of stakeholders to be potentially adequate; however, it was acknowledged that this practice was not yet widely adopted in Australia. Some expressed that telehealth options should only be considered in non-metropolitan areas. A key area of concern for GP-managed pathways (Fig. 1e) was the belief that not all GPs possessed the level of training necessary to diagnose and manage OSA, given the lack of sleep-specific training provided in current medical degree curricula. Training and upskilling of GPs was seen as a priority area for the sleep profession.
Practice framework recommendations Stakeholders suggested that a collaborative best practice framework be developed to guide care and delineate roles. Some expressed that it would not be possible to eliminate inappropriate practices in the community, but there was a need to define best practice and provide a benchmark as a pragmatic ‘first step’ forward. It was proposed that general recommendations applicable to all pathways in the community be developed, rather than accepting or rejecting specific pathways. At the conclusion of the study, the focus group transcript was examined and the views of participating stakeholders discussed. After an in-depth review, four recommendations were developed that aim to provide a preliminary practice framework for OSA diagnostic processes in pharmacies. Table 3 presents the developed recommendations.
Table 3 Recommendations developed from stakeholder feedback for pharmacies involved in the diagnosis and/or treatment of obstructive sleep apnoea Recommendation 1. A referral from a physiciana is received before a home sleep test is initiated 2. The diagnosis of OSA is made by an appropriately trained physiciana 3. The treatment recommendation (for either CPAP or other treatment options) is made by an appropriately trained physiciana 4. The diagnostic and treatment pathway allows for physiciana involvement in the patient’s ongoing treatment review and management OSA obstructive sleep apnoea, CPAP continuous positive airway pressure a
Medical practitioner (general practitioner or specialist physician)
Discussion This is the first study to describe the array of communitybased OSA diagnostic pathways in Australia, as observed by CPAP providers in the pharmacy setting. The study also provides valuable insight on the unregulated nature of the sleep industry in Australia and the challenges this poses to the sleep medicine profession. The feedback obtained from expert stakeholders highlights key concerns with current practices and areas for improvement. The findings bring to light the need to review emerging, simplified diagnostic pathways and set best practice standards. Recommendations arising from the study findings have translational implications; these recommendations may serve as a preliminary practice framework to promote medically and ethically appropriate, patientcentred care. The training and upskilling of GPs was emphasised by stakeholders as a priority area for the profession. GPs are key players in the OSA diagnostic pathway in Australia, either as primary referrers to specialists, or in initiating diagnostic investigations themselves. They are also becoming involved in treating and managing OSA patients, both in Australia and Europe [18, 19]. Mansfield and colleagues [19] have proposed that the future of sleep medicine in Australia may lay in a trained primary care workforce managing uncomplicated cases of OSA with access to specialist physician support. Upskilling of GPs and the primary care workforce may be an important strategy for addressing the burden of disease, particularly in rural settings where access to health care services is especially problematic [20]. Effective screening measures are critical to address the estimated 80–90 % of middle-aged adults with OSA that remain undiagnosed [21]. Initiatives in primary care are especially important, and pharmacies in particular offer ready access to a tertiary-educated health workforce. The role of pharmacies in sleep disorders screening has been described both nationally and internationally [22–28]. Pharmacy-based
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programmes have been shown to be feasible and costeffective approaches to screening for sleep disorders [24, 27]. Pharmacists in this study reported active involvement in OSA screening activities; training of the broader pharmacy workforce could be an efficient strategy to enhance the detection of sleep disorders in primary care. This is consistent with other Australian health initiatives, such as those by the National Stroke Foundation and Lung Foundation Australia, which have actively engaged the pharmacy profession in national screening activities [29, 30]. The potential for real or perceived conflicts of interest for pharmacies providing both diagnostic and treatment services was a central topic of discussion. Stakeholder views varied appreciably. Similarly, pharmacists themselves have expressed contrasting opinions on this matter, with some viewing the arrangement as a method to facilitate patient access, and others regarding the practice as inappropriate [16]. The issues surrounding this topic are multifaceted and complex. Both inter- and intra-professional collaboration is required to define appropriate practice. A framework to govern the conditions for recommending tests that could lead to diagnoses and initiating treatment services is an important and pragmatic starting point. Beyond the diagnosis of OSA and commencement of treatment, patient follow-up and ongoing management are also important aspects of OSA care. The pathways described in this study conclude at the ‘treatment’ stage of care (Fig. 1a–f), which is appropriate for the study aim, but these aspects require consideration in a comprehensive practice framework. Study limitations The identified pathways do not necessarily represent all diagnostic pathways operating in pharmacies or the wider community. Pathways reported as common amongst this sample may not reflect the frequency with which pathways are utilised in the broader community. While we did not seek generalisability of the study findings, the recruitment approach may have introduced sampling and selection bias. The views and experiences of participants in this study may not be representative of wider professional opinions. An additional source of potential bias is interviewer bias; however, adherence to a semi-structured interview template sought to minimise this. It is difficult to formally evaluate pathways utilising level 3 and 4 tests, given their private funding status and the unregulated nature of the industry. Identification of these pathways is reliant on self-report study methods, which introduces potential response bias. In an effort to minimise this, the interview guide questions were pre-piloted to limit potential social desirability bias, and anonymity of all participants was ensured [16]. Inherent to the CPAP provider setting, all pathways assumed that CPAP was the prescribed treatment for patients. Thus, we
were unable to investigate pathways for non-CPAP treatment alternatives. Future directions Further stakeholder discussion is needed to determine the appropriateness of pathways arising from this study. The preliminary recommendations developed also require broader stakeholder input and review before being implemented in a formal best practice framework. Clinical outcome data for the different pathways identified would allow comparison of models and inform evidence-based practice. Research to investigate diagnostic pathways existing in other provider settings and whether there is a need for practice improvement initiatives in these locales is also required. A significant challenge exists for the sleep health profession to meet community demands and facilitate access to care, while still ensuring high standards of practice in a largely unregulated environment. Collaborative approaches between stakeholders and clearly defined practice frameworks are key to meeting this challenge. Acknowledgments We would like to thank all participants and stakeholders who took part in this study and contributed their time and opinions. This research received funding support from the National Health and Medical Research Council (NHMRC) Centre for Integrated Research and Understanding of Sleep (CIRUS). CH is the recipient of scholarships from the Australian Postgraduate Award (APA) and the NHMRC Centre of Research Excellence, NeuroSleep, and gratefully acknowledges this support. Conflict of interest and compliance with ethical standards The authors declare that they have no conflict of interest. Approval to conduct this study was obtained from the University of Sydney Human Research Ethics Committee (protocol 2012/2830). All participants gave informed consent prior to their inclusion in the study.
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ORIGINAL ARTICLE
Diagnostic pathways for obstructive sleep apnoea in the Australian community: observations from pharmacy-based CPAP providers Carissa A. Hanes & Keith K. H. Wong & Bandana Saini
Received: 7 January 2015 / Revised: 12 February 2015 / Accepted: 25 February 2015 # Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose Models for the diagnosis of obstructive sleep apnoea (OSA) are evolving in many countries to meet public demand. In Australia, the unregulated sleep industry does not provide a framework to govern or review emerging pathways in the community. The objectives of this study were to (1) describe current diagnostic pathways for OSA in Australia as reported by continuous positive airway pressure (CPAP) providers in community pharmacies and (2) obtain stakeholder feedback on pathways and identify potential areas for practice improvement. Methods Semi-structured telephone interviews were conducted with pharmacy-based CPAP practitioners. Participants described diagnostic pathways used in their setting. Subsequently, an expert forum of stakeholders provided feedback on identified pathways during a focus group. Results Twenty-two telephone interviews were conducted, identifying six key diagnostic pathways. Pathways varied in terms of the diagnostic test used, the practitioner who initiated or interpreted the test and who discussed results with the C. A. Hanes (*) : B. Saini Faculty of Pharmacy, The University of Sydney, Pharmacy Building A15, Science Road, Sydney, NSW 2006, Australia e-mail: [email protected] C. A. Hanes : K. K. H. Wong : B. Saini NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, The University of Sydney, Sydney, NSW, Australia K. K. H. Wong Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia K. K. H. Wong Faculty of Medicine, The University of Sydney, Sydney, NSW, Australia
patient and made treatment recommendations. A ninemember stakeholder group raised medical, ethical and organisational concerns over certain pathways. Concerns included diagnostic tests initiated or interpreted in the absence of an appropriately trained medical practitioner and potential conflicts of interest for CPAP providers offering both diagnostic and treatment services. A best practice framework was proposed to guide practice and translate study findings. Preliminary practice recommendations were subsequently developed. Conclusions Diagnostic models have evolved in Australia that raise stakeholder concerns. It is important to address these concerns while still facilitating patient access to services. Development of a practice framework could promote medically appropriate, patient-centred care. Key words Continuous positive airway pressure . Diagnostic techniques and procedures . Obstructive sleep apnoea . Pharmacies . Polysomnography . Primary care
Introduction Advances in the understanding of the epidemiology of obstructive sleep apnoea (OSA) and its health consequences have seen the condition recognised not only as a medical problem but also a significant public health issue [1]. The burden of disease continues to place substantial demands on diagnostic and treatment services within the health-care system. Traditional pathways of care involving diagnosis through in-laboratory polysomnography (PSG) under the management of specialist sleep physicians are insufficient to meet demand [2]. Patients accessing these services frequently face lengthy waiting times and delays in commencing
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treatment [2]. Alternative management pathways are needed to address demand–capacity disparities and improve patient access [3]. In Australia and internationally, models involving ambulatory diagnostic tests, home-based pressure titrations, primary care settings and non-specialist physician personnel have been investigated [4–8]. Against this backdrop, key facets of the sleep industry in many countries are unregulated. For instance, diagnostic tests may be accessed through providers lacking relevant local accreditation, and positive airway pressure equipment may be provided in the absence of appropriate patient education or support [9, 10]. While differences in the health-care systems of individual countries require consideration, internationally, the sleep medicine profession faces concerns arising from a lack of regulation. Notably, the Australian setting presents appreciable regulatory challenges. Australia’s national health insurance system, Medicare, provides reimbursement of PSG, both in-laboratory (level 1 test) and ambulatory (level 2 test), provided a sleep physician determines the test is indicated, and reviews and reports the test [11, 12]. However, for privately funded diagnostic studies, including all limited channel (level 3 or 4) tests and level 2 tests that do not fulfil Medicare eligibility requirements, there is no regulatory requirement for physician involvement [11, 12]. At the same time, ambulatory tests are directly available to the public from a variety of private enterprise providers. Additionally, Australia’s regulatory agency for medical drugs and devices, the Therapeutic Goods Administration (TGA), does not require a prescription prior to the supply of continuous positive airway pressure (CPAP) equipment. CPAP devices are likewise directly available through numerous private providers and, in some instances, from providers that also offer diagnostic tests. Furthermore, there are no regulatory requirements concerning the training or education of practitioners at such outlets. Thus, there is a need to establish whether emerging, simplified pathways of care are medically appropriate and safeguard the best interest of patients, given the absence of quality assurance scrutiny within the industry. Little information has been formally collated regarding diagnostic pathways operating in the Australian community. However, anecdotal reports have raised concerns regarding the appropriateness of certain pathways, particularly with regard to outlets that offer both diagnostic and treatment services [13]. In Australia, one of the private enterprise providers of sleep apnoea services is community (or retail) pharmacy. Of the numerous private providers on the market, pharmacy represents a structured and respected profession subject to stringent regulations governing medicines supply and related health services. They are accessible and widespread in the community, and patients have reported satisfaction with pharmacy-based CPAP services [14]. However, as with other CPAP outlets, there are no regulations specifically pertaining to CPAP provision. In a national survey of pharmacies offering
CPAP services, 54 % of respondents (n=106) reported also providing home diagnostic device hire [15]. However, information was not obtained on the protocols used to initiate these tests, or the onward referral processes after the completion of home-based tests. To date, there are no reports in the literature describing diagnostic pathways operating in any community-based provider setting in Australia, despite the ready accessibility of these outlets to the public. There is a particular need to investigate models utilising level 3 and 4 tests, since there are no formal mechanisms for evaluating these pathways, due to their private funding status. Given the familiarity of the pharmacy profession with practice research and existing sleep-related studies in this area, the pharmacy setting was chosen to explore community models. Thus, the aim of this study was to describe OSA diagnostic pathways operating in the community, as reported by CPAP providers in pharmacies. Further, we sought to obtain feedback on these pathways from an expert forum of key stakeholders to identify potential areas for practice improvement.
Methods Approval to conduct this study was obtained from the University of Sydney Human Research Ethics Committee (protocol 2012/2830). Two distinct phases were employed in this study. Study design: phase 1 (telephone interviews) The first phase involved telephone interviews, using a semistructured interview guide, with pharmacy-based CPAP practitioners. Detailed methods for this phase have been reported previously [16]. To summarise, purposive sampling from a compiled database of pharmacies providing CPAP services was used for recruitment. Pharmacies from a variety of states and geographic locations were sought to provide diversity in participant demographics and capture potential regional variations in diagnostic pathways. Participants were asked to reflect on their current practices, including how patients they interacted with were diagnosed with OSA, and conventions for initiating CPAP therapy. Recruitment continued until no further insight was obtained (‘data saturation’) [17]. All interviews were audio-recorded and transcribed verbatim prior to analysis. Study design: phase 2 (focus group) A joint stakeholder focus group was conducted to obtain feedback on the diagnostic pathways identified in phase 1. To comprise an expert forum, individuals were nominated by the research team and directly invited to participate.
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Additionally, key organisations were contacted and asked to nominate an appropriate representative to attend. The focus group was held in Sydney in August 2013. Signed consent and confidentiality forms were obtained from all participants before the session commenced. Prior to the group discussion, a presentation of the identified diagnostic models was provided. An experienced, senior member of the research team (BS) facilitated the group discussion component. The focus group was audio-recorded and transcribed verbatim. Two members of the research team also took detailed field notes. Immediately after the focus group proceedings concluded, the research team discussed key findings and overall impressions. The session duration was 3 h, with the audio-recording component lasting 2 h. The transcript was de-identified (names and places were removed) and provided to all participants prior to analysis for their review and final feedback. Participants were reimbursed for their travel expenses.
Results Participant characteristics Twenty-two telephone interviews, averaging 35 min in length, were conducted with pharmacy-based CPAP practitioners. These participants represented metropolitan (n=10), regional (n=6) and rural or remote (n=6) pharmacies across five Australian states and territories; the majority of participants were pharmacist proprietors (n=14) [16]. Nine stakeholders attended the focus group; the represented stakeholder groups are described in Table 1. Table 1
Diagnostic pathways identified Six key diagnostic pathways were identified during the phase 1 interviews (Fig. 1a–f). Pathways varied with respect to the type of diagnostic test used, the personnel who initiated and interpreted the test, and who discussed results with the patient and made treatment recommendations. Participants primarily reported on their own practices; however, some described additional practices they had observed in the community. Inlaboratory PSG was utilised in one pathway (Fig. 1a), while all other pathways involved home-based sleep studies. The most commonly reported pathway involved the interpretation of results by a ‘remote’ sleep physician (Fig. 1b); in some scenarios, the physician was located interstate. Patient information, including anthropometric data and clinical parameters, was generally provided to the remote physician, but a face-to-face consultation between the sleep physician and patient did not occur. Many pharmacies reported more than one pathway operating in their practice. Some regional variations were also observed, with traditional pathways (Fig. 1a) tending to be more common in metropolitan areas. Participants conveyed that patient consultations regarding sleep concerns in the pharmacy were often the primary presentation, leading pharmacists to provide initial screening, regardless of the subsequent diagnostic pathway followed. Reported screening strategies included identifying the presence of known risk factors and common comorbidities, or medications for these comorbidities, exploring suggestive symptoms and utilising screening questionnaires (there were no particular questionnaires in widespread use; however, some participants reported using the Berlin questionnaire or the Epworth Sleepiness Scale).
Stakeholder groups represented by focus group participants
Stakeholder group
Peak professional bodies Australasian Sleep Association Australasian Sleep Technologists Association Pharmacy Guild of Australia Pharmaceutical Society of Australia Practicing professionalsa Pharmacist Sleep physician CPAP manufacturers Patients Sleep Disorders Australia Total
Description of organisation/peak body
Number of representatives
Represents sleep clinicians, scientists and researchers Represents technologists, scientists, nurses and clinical physiologists working in sleep medicine and/or research Represents community pharmacy proprietors Represents pharmacists
1 1 1 2
–
1
– –
1 1
Provides support services to patients with sleep disorders and their families
1 9
CPAP continuous positive airway pressure a
A general practitioner scheduled to participate was unable to attend. Certain peak body representatives were also practicing professionals in their field
Sleep Breath Fig. 1 a Traditional pathway. a Variation: level 2 study (unattended PSG). Patient is eligible for Medicare reimbursement. b Home sleep test and remote sleep physician pathway. a Predominantly level 2 studies (patient eligible for Medicare reimbursement); some variations with level 3 or 4 studies (no Medicare reimbursement). c Home sleep test and remote sleep physician (with Teleconsult) pathway. a Level 2 study (patient eligible for Medicare reimbursement). b Variation: HST facilitated through hospital clinic. d Home sleep test and remote sleep physician: pharmacy initiated pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). e Home sleep test: general practitioner managed pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). b A report from a remote sleep technician may accompany study results. f Home sleep test: pharmacy managed pathway. a Level 2, 3 or 4 study (patient not eligible for Medicare reimbursement). b A report from a remote sleep technician or remote GP may accompany study results. CPAP continuous positive airway pressure, GP general practitioner, HST home sleep test, PSG polysomnography. Key: light grey box general practitioner, blue box sleep physician, white box pharmacy
a Patient sees GP
GP refers patient to sleep physician
SCREENING
Attended a PSG
Sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient referred to CPAP provider to start trial
TREATMENT
b Patient sees GP
GP writes referral for HST
SCREENING
HSTa through pharmacy, results to remote sleep physician
Remote sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient starts CPAP trial in pharmacy
TREATMENT
Teleconsult to discuss diagnosis and treatment options
c
Patient sees GP
GP writes referral ffor HST
SCREENING
HSTa through b pharmacy , results to remote sleep physician
Remote sleep physician makes diagnosis
Patient starts CPAP trial in pharmacy
TREATMENT
DIAGNOSIS
d Patient screened in pharmacy
Pharmacy initiates HSTa
SCREENING
Results sent to remote sleep physician
Remote sleep physician makes diagnosis, advises treatment
DIAGNOSIS
Patient referred back to pharmacy to start CPAP trial
TREATMENT
e Patient sees GP
GP writes referral for HST
SCREENING
HSTa through pharmacy, results to GP
GP reviews resultsb, advises treatment
DIAGNOSIS
Patient referred back to pharmacy to start CPAP trial
TREATMENT
Patient visits GP to discuss results and treatment
f
Patient screened in pharmacy
SCREENING
Pharmacy initiates HSTa
HST results to pharmacy
DIAGNOSIS
Pharmacy reviews resultsb, advises treatment
Patient starts CPAP trial in pharmacy
TREATMENT
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Several pharmacies issued formal referral forms for patients to take to their general practitioner (GP), or faxed referrals to the GP on the patient’s behalf. Written materials were often provided to patients. Much of the screening conducted was opportunistic, while in-store promotion or community advertisement of OSA prompted some patients to directly seek help. Stakeholder feedback There was general consensus amongst stakeholders that traditional pathways alone (Fig. 1a) were insufficient to meet public demand, and alternative pathways needed to evolve. There was also common recognition of the potential role the pharmacy profession could play in providing OSA patient care. Table 2
However, numerous concerns were raised with certain pathways identified. Stakeholder concerns fell under three broad categories: medical, ethical and organisational concerns. Table 2 summarises these concerns and presents selected stakeholder quotations. Regarding ethical concerns, the group presented differing opinions. Some believed that the potential conflict of interest for pharmacies providing both diagnostic (home-based sleep tests) and treatment (CPAP) services was insurmountable. Others expressed that the scenario was manageable, so long as the decision to initiate testing and treatment was removed from pharmacies, clear arrangements were in place for physician referral, and patients were made aware of potential conflicts of interest. Others felt that in rural settings, this scenario could be appropriate. It was acknowledged
Summary of stakeholder concerns with identified diagnostic pathways and selected stakeholder quotations
Area of concern
Summary of concerns
Selected stakeholder quotations
1. Medical
• Diagnostic tests initiated in absence of medical practitioner (1d, f)a • Diagnostic tests interpreted in absence of appropriately trained medical practitioner (potentially 1e, f) • Decision to initiate treatment and choice of treatment modality made by non-trained personnel (potentially 1e, f) • Absence of trained professional to oversee patient care and assume responsibility for ongoing management (potentially 1b–f) • Lack of clinical exam and/or personal review of patient by trained medical practitioner (potentially 1b, d–f) • Initiation of CPAP without a prescription or specifications (potentially 1b, d–f) • Absence of clear pathway for referral (trained medical practitioner available for feedback) (potentially 1b, d–f)
2. Ethical
• Potential conflicts of interest for CPAP providers offering both diagnostic and treatment services (1b–f) • Lack of opportunity for patient to receive Medicare subsidised test (where level 3 or 4 test used) (1d–f) • Lack of opportunity for patient to consider treatment options other than CPAP (potentially 1b, d–f)
3. Organisational
• Training and upskilling of GPs needed • Access to sleep physician support needed for GP-managed pathways (1e) • Lack of OSA-specific practice guidelines within pharmacy profession to define best practice • Lack of industry regulation (training and practice standards cannot be enforced)
• “…And many of these comorbid conditions have sleep disordered breathing associated with them, which may not be straightforward obstructive sleep apnoea anymore, and therefore may require different forms of, um…might require more sophisticated diagnosis and more sophisticated management…” (S5)b • “I don’t consider this report from somebody in another state that just gives a raft of treatment recommendations, generically, to be overseeing the patient’s care… without seeing them.” (S8) • “I think the key point is this sort of eye-to-eye, whether that’s by teleconference or directly across a desk, or in a consulting room…adds a lot more, a sort of… indefinable quality which informs clinical judgement, which…I think is key to good outcomes for the majority of patients.” (S3) • “..For some people that works [pharmacy managed pathways], but for other people… it’s an overly simplistic model. It does require some skilled input from a physician or a GP at some stage in the process.” (S5) • “I’m pretty keen…that there be GP referral to start with… I don’t have…any time for pharmacy initiating the service. I think that’s wrong. I think it has to be initiated by the medical profession.” (S6) • “I remain uncomfortable with the conflict between diagnosis and treatment provision…at a pharmacy level… a sleep physician level…I think it’s unmanageable…in all but the most compelling geographical services.” (S8) • I think the reality is… is that the GPs don’t know a lot about sleep apnoea at the moment… One of the challenges we’ve got as a field is to… develop education programs… for general practitioners to upskill them…” (S8) • “…We’ve probably got to try and set the standards for best practice… I guess we have to accept at the moment that there’re going to be people doing things that are not best practice and…that’s the way it is…” (S8) • “I think we’re at the point now where pharmacy… needs to… take the initiative, involve the appropriate stakeholders, and drive this [training and education programs for pharmacists].” (S5)
CPAP continuous positive airway pressure, GP general practitioner a
Figure numbers in italics refer to the relevant diagnostic pathways from Fig. 1a–f
b
Numbers in parentheses represent the code assigned to each stakeholder during the de-identification of the focus group transcript
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that conflict of interest issues were not exclusive to pharmacy-based providers but applied to the sleep industry at large and presented a challenge for many stakeholders. Patients’ lack of access to Medicare-funded diagnostic tests was also raised as a potential ethical issue for pharmacies solely offering privately funded studies. It was, however, recognised that some patients preferred to pay privately for tests for reasons of convenience and to bypass public-system waiting periods. Pathways that entirely circumvented the involvement of any medical practitioner in the diagnostic pathway were unanimously opposed. Stakeholders expressed mixed views regarding pathways that involved diagnosis by a ‘remote’ physician (Fig. 1b–d). Some conveyed that a personal review of the patient was important to allow holistic evaluation and identification of comorbidities and considered these ‘remote’ pathways inappropriate. Others proffered that, as long as there were sleep physicians willing and permitted to diagnose patients in this manner, it would be difficult to stipulate the exclusion of these pathways in any proposed best practice framework. Pathways involving teleconferencing (Fig. 1c) were seen to overcome the lack of personal review apparent in other ‘remote’ models (Fig. 1b, d). This pathway was considered by the majority of stakeholders to be potentially adequate; however, it was acknowledged that this practice was not yet widely adopted in Australia. Some expressed that telehealth options should only be considered in non-metropolitan areas. A key area of concern for GP-managed pathways (Fig. 1e) was the belief that not all GPs possessed the level of training necessary to diagnose and manage OSA, given the lack of sleep-specific training provided in current medical degree curricula. Training and upskilling of GPs was seen as a priority area for the sleep profession.
Practice framework recommendations Stakeholders suggested that a collaborative best practice framework be developed to guide care and delineate roles. Some expressed that it would not be possible to eliminate inappropriate practices in the community, but there was a need to define best practice and provide a benchmark as a pragmatic ‘first step’ forward. It was proposed that general recommendations applicable to all pathways in the community be developed, rather than accepting or rejecting specific pathways. At the conclusion of the study, the focus group transcript was examined and the views of participating stakeholders discussed. After an in-depth review, four recommendations were developed that aim to provide a preliminary practice framework for OSA diagnostic processes in pharmacies. Table 3 presents the developed recommendations.
Table 3 Recommendations developed from stakeholder feedback for pharmacies involved in the diagnosis and/or treatment of obstructive sleep apnoea Recommendation 1. A referral from a physiciana is received before a home sleep test is initiated 2. The diagnosis of OSA is made by an appropriately trained physiciana 3. The treatment recommendation (for either CPAP or other treatment options) is made by an appropriately trained physiciana 4. The diagnostic and treatment pathway allows for physiciana involvement in the patient’s ongoing treatment review and management OSA obstructive sleep apnoea, CPAP continuous positive airway pressure a
Medical practitioner (general practitioner or specialist physician)
Discussion This is the first study to describe the array of communitybased OSA diagnostic pathways in Australia, as observed by CPAP providers in the pharmacy setting. The study also provides valuable insight on the unregulated nature of the sleep industry in Australia and the challenges this poses to the sleep medicine profession. The feedback obtained from expert stakeholders highlights key concerns with current practices and areas for improvement. The findings bring to light the need to review emerging, simplified diagnostic pathways and set best practice standards. Recommendations arising from the study findings have translational implications; these recommendations may serve as a preliminary practice framework to promote medically and ethically appropriate, patientcentred care. The training and upskilling of GPs was emphasised by stakeholders as a priority area for the profession. GPs are key players in the OSA diagnostic pathway in Australia, either as primary referrers to specialists, or in initiating diagnostic investigations themselves. They are also becoming involved in treating and managing OSA patients, both in Australia and Europe [18, 19]. Mansfield and colleagues [19] have proposed that the future of sleep medicine in Australia may lay in a trained primary care workforce managing uncomplicated cases of OSA with access to specialist physician support. Upskilling of GPs and the primary care workforce may be an important strategy for addressing the burden of disease, particularly in rural settings where access to health care services is especially problematic [20]. Effective screening measures are critical to address the estimated 80–90 % of middle-aged adults with OSA that remain undiagnosed [21]. Initiatives in primary care are especially important, and pharmacies in particular offer ready access to a tertiary-educated health workforce. The role of pharmacies in sleep disorders screening has been described both nationally and internationally [22–28]. Pharmacy-based
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programmes have been shown to be feasible and costeffective approaches to screening for sleep disorders [24, 27]. Pharmacists in this study reported active involvement in OSA screening activities; training of the broader pharmacy workforce could be an efficient strategy to enhance the detection of sleep disorders in primary care. This is consistent with other Australian health initiatives, such as those by the National Stroke Foundation and Lung Foundation Australia, which have actively engaged the pharmacy profession in national screening activities [29, 30]. The potential for real or perceived conflicts of interest for pharmacies providing both diagnostic and treatment services was a central topic of discussion. Stakeholder views varied appreciably. Similarly, pharmacists themselves have expressed contrasting opinions on this matter, with some viewing the arrangement as a method to facilitate patient access, and others regarding the practice as inappropriate [16]. The issues surrounding this topic are multifaceted and complex. Both inter- and intra-professional collaboration is required to define appropriate practice. A framework to govern the conditions for recommending tests that could lead to diagnoses and initiating treatment services is an important and pragmatic starting point. Beyond the diagnosis of OSA and commencement of treatment, patient follow-up and ongoing management are also important aspects of OSA care. The pathways described in this study conclude at the ‘treatment’ stage of care (Fig. 1a–f), which is appropriate for the study aim, but these aspects require consideration in a comprehensive practice framework. Study limitations The identified pathways do not necessarily represent all diagnostic pathways operating in pharmacies or the wider community. Pathways reported as common amongst this sample may not reflect the frequency with which pathways are utilised in the broader community. While we did not seek generalisability of the study findings, the recruitment approach may have introduced sampling and selection bias. The views and experiences of participants in this study may not be representative of wider professional opinions. An additional source of potential bias is interviewer bias; however, adherence to a semi-structured interview template sought to minimise this. It is difficult to formally evaluate pathways utilising level 3 and 4 tests, given their private funding status and the unregulated nature of the industry. Identification of these pathways is reliant on self-report study methods, which introduces potential response bias. In an effort to minimise this, the interview guide questions were pre-piloted to limit potential social desirability bias, and anonymity of all participants was ensured [16]. Inherent to the CPAP provider setting, all pathways assumed that CPAP was the prescribed treatment for patients. Thus, we
were unable to investigate pathways for non-CPAP treatment alternatives. Future directions Further stakeholder discussion is needed to determine the appropriateness of pathways arising from this study. The preliminary recommendations developed also require broader stakeholder input and review before being implemented in a formal best practice framework. Clinical outcome data for the different pathways identified would allow comparison of models and inform evidence-based practice. Research to investigate diagnostic pathways existing in other provider settings and whether there is a need for practice improvement initiatives in these locales is also required. A significant challenge exists for the sleep health profession to meet community demands and facilitate access to care, while still ensuring high standards of practice in a largely unregulated environment. Collaborative approaches between stakeholders and clearly defined practice frameworks are key to meeting this challenge. Acknowledgments We would like to thank all participants and stakeholders who took part in this study and contributed their time and opinions. This research received funding support from the National Health and Medical Research Council (NHMRC) Centre for Integrated Research and Understanding of Sleep (CIRUS). CH is the recipient of scholarships from the Australian Postgraduate Award (APA) and the NHMRC Centre of Research Excellence, NeuroSleep, and gratefully acknowledges this support. Conflict of interest and compliance with ethical standards The authors declare that they have no conflict of interest. Approval to conduct this study was obtained from the University of Sydney Human Research Ethics Committee (protocol 2012/2830). All participants gave informed consent prior to their inclusion in the study.
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