Reflections on study settings

A number of settings for the study were considered, including being based within secondary care at the difficult asthma clinic at the hospital, or within primary care in community pharmacies or designated GP practices.

A study based in primary care may be more convenient for patients to attend, particularly if multiple study sites are identified in community pharmacies.

However, as the study was designed to investigate the management of patients with difficult asthma, which usually takes place within secondary care, it was considered essential that the location of the pharmacist intervention should take place within this same setting. This would ensure that patients were treated equally apart from the intervention, because locating the pharmacist

intervention in primary care may result in a design bias (Bowling, 2002).

An intervention solely delivered by pharmacists working within community pharmacies or GP practices could possibly result in an unintentional negative bias, if patients with difficult asthma think that these pharmacists may not have the expertise to manage their condition, which could have adversely affected recruitment rates, or affect patients’ adherence to the intervention. One patient preference study reported that the majority of patients rated asthma services in community pharmacies as good to excellent (Naik-Panvelkar et al., 2012), but the opinions of patients with difficult asthma on pharmacist-led services is unknown. Alternatively patients could be more likely to report improvements in

asthma control and symptoms, especially if they know their pharmacist who is performing the intervention. This is an example of acquiescence bias (Bowling, 2002), and may be managed by using validated measures of asthma control and quality of life.

A final risk of setting the study in GP practices or community pharmacies is that it would be difficult for all GP practices and community pharmacies to be

recruited as study sites for economical and logistical reasons, despite this approach potentially maximising patient recruitment. Consequently this

approach would require a cluster sample of practices or pharmacies to be used as study sites, but this could incorporate risk associated with the location of the practices or pharmacies, as different socio-economic factors might affect asthma control, and could result in the sample population being

unrepresentative of the overall population. However evidence about a link between socio-economic status and difficult asthma is limited and is variable across the UK (Heaney et al., 2010).

Setting the study in hospital would overcome problems associated with potential sampling biases as patients are referred from all GP practices in the local area and thus patients from all socio-economic backgrounds may be encountered.

Patients with uncontrolled asthma in Leeds are referred to the local difficult asthma clinic, which allows easy identification of suitable participants for the study.

Therefore it was decided to conduct this study in the Leeds Difficult Asthma Clinic at Leeds General Infirmary, Leeds, West Yorkshire. The Leeds Teaching Hospitals NHS Trust serves a population of approximately 757,655 people (Office for National Statistics, 2013). This site was selected, as it has a difficult asthma clinic that reviews patients appropriate for this study, and is the

employing organisation of the researcher and the clinical supervisor. The difficult asthma clinic operates on one day each week and has capacity for two consultants, one or two specialist registrars, one asthma nurse specialist and one pharmacist to review patients.

Setting the study in the difficult asthma clinic would allow interventions in two study groups to be performed in the same clinic setting, ensuring that both study groups would be treated equally. This would also allow for follow-up interventions in the pharmacist intervention group to be performed in the same clinic, ensuring a consistent approach to asthma management in the study.

Similar pharmacist intervention studies, set in community pharmacies utilised regular follow-up interventions, such as at months 1, 3 and 6 to reinforce the baseline intervention (See Chapter 3.3.1) (Armour et al., 2007, Basheti et al., 2008, Charrois et al., 2004, Mangiapane et al., 2005, Mehuys et al., 2008).

However, due to insufficient capacity within the clinic, it was not possible to perform additional routine follow-up visits in addition to baseline and end of study visits in the difficult asthma clinic. Therefore it was decided that follow-up reinforcement of baseline interventions could be performed by community pharmacists who provide the nationally commissioned t-MUR service

(Department of Health, 2013) (see Chapter 4.6). The involvement of community pharmacists providing t-MUR follow-up of participants in this study was

supported by the Chief Executive for Leeds, Bradford & Airedale, Calderdale &

Kirklees Local Pharmaceutical Committees (now known as Community Pharmacy West Yorkshire) (see Appendix 4).

In order to ensure that community pharmacists had the knowledge and skills to undertake effective targeted asthma MURs, two evening educational sessions on asthma, the medical condition, its treatment and management were

arranged with the Leeds, Bradford and Airedale Local Pharmaceutical Committee. Bradford and Airedale were encouraged to attend, particularly those working in areas with high admission rates due to asthma. Funding for these sessions were not available for community pharmacists outside this region, and so patients attending the difficult asthma clinic as a tertiary referral from outside this region were not recruited to the study.

The format to these educational sessions were broadly similar to sessions arranged in other interventional studies (Charrois et al., 2004, Basheti et al., 2008, Armour et al., 2007, Mehuys et al., 2008), comprising education of the pathophysiology, trigger factors and the pharmacological and

non-pharmacological treatment of asthma, followed by education on the importance

of and method of teaching inhaler technique. In addition community

pharmacists working in areas of Leeds and Bradford with high admission rates due to asthma were also encouraged to attend follow-up intensive educational sessions on inhaler education.

Inhaler technique training for community pharmacists at these educational sessions was provided by the lead investigator for this study, who has expertise on theoretical and practical aspects of inhaler technique (Capstick and Clifton, 2012). Education on asthma pathophysiology, trigger factors and the

pharmacological and non-pharmacological treatment of asthma was provided by one of the local consultant respiratory physicians.