Aims and objectives
This study aims to explore the views of patients and their GPs of administering denosumab injection to breast cancer patients, away from the specialist cancer centre, for example in GP practices and via self-administration.
The objectives of this study are to:
- To determine the acceptability of different models of denosumab administration away from the specialist cancer centre
- To understand the enablers and barriers from the point of view of patients who will be receiving denosumab injection
- To understand the enablers and barriers from the point of view of general practitioners
Benefits of the research
This research will be used to inform the commissioning decision for denosumab administration in an area of London serving a population of 1.5 million. It will support the local health economy to achieve compliance with NICE Technology Appraisal 265, and to implement a pathway that is responsive to the needs of the patient population.
The findings of this research will be used to inform pharmacists involved in the delivery and commissioning of supportive therapy in breast cancer, to ensure they understand the views of two important stakeholders. By carrying out this work as a formal research project, it will ensure that a more robust methodology is followed to reach a conclusion about the most appropriate commissioning pathway.
Denosumab 120 mg subcutaneous injection (Xgeva®) is part of supportive care given to patients with or who have suffered from solid tumours, to prevent them from developing skeletal related events associated with bone metastases.  This treatment has been recommended as a cost-effective intervention for this patient cohort by the National Institute for Health and Care Excellence (NICE TA 265), therefore should be an option for treatment. 
Current practice in North Central London (NCL) is to administer the injection in the specialist chemotherapy centre unit. For two groups of patients (those whose chemotherapy cycle falls outside the denosumab cycle and those no longer receiving chemotherapy) this is inconvenient as they attend the chemotherapy centre just for this injection. It is also expensive to the Clinical Commissioning Group (CCG) that pays for the treatment (up to £513 + MFF per administration). By moving away from hospital administration of denosumab, CCGs in NCL could free-up approximately £1.5 million per annum which could be used to reinvest in alternative models of care.
The NHS Constitution seeks to ensure that the experience of the patient is at the heart of everything that is done.  This project seeks to support achievement of this goal by robustly investigating patients’ views and opinions on a particular medicine commissioning pathway. A well-established
evidence base exists demonstrating the positive association between clinical outcomes and patients’ experience of health care (both self-reported and objectively measured),  thus it is hoped that by conducting this research it will be possible to advise on the commissioning pathway most likely to result in optimised outcomes.
In addition, from the chemotherapy units’ perspective, the change in pathway has the potential to increase capacity to allow administration of chemotherapy to more patients.
In London, there is support for developing alternative delivery models for denosumab (e.g. GP administration, use of community health centres), including from London Cancer, the NCL Joint Formulary Committee and the NCL Cancer Board. However, individual stakeholders have highlighted a wish that any change in practice provides adequate support and protection for both the GP and the patient. [4,5] A specialist prescriber asking a GP to take part in the prescribing and monitoring of an aspect of a specialist condition is known as shared care, which must be carried out in accordance with the General Medical Council recommendations on shared care.  However, even where attempts are made to comply fully with this guidance, GPs may not feel fully supported to share care for these patients and may refuse to prescribe. [7,8]
This research asks two questions:
- What are the enablers and barriers to GPs in providing denosumab administration for breast cancer patients?
- What are the views and opinions of patients about receiving denosumab injections from their GP?
This research links in with the objectives of both BOPA and PRUK. It aims to promote a high standard of pharmaceutical care in oncology by exploring ways to deliver a service that is more responsive to patient needs and meets the requirements of NICE TA 265. This research aims to establish a standard of care whereby redesign of services base their interpretation of stakeholder views and beliefs about medicines on empirical research. The research also attempts to establish an alliance between GPs, pharmacists and oncologists.
This research is timely as increasingly health policy aims to move services out of hospital and into the community, better integrating them with the needs of patients.  It is hoped that moving treatment from hospitals to the community will contribute to NHS efficiency savings that need to be found as community care is generally less expensive than secondary care.  Previous research to understand the barriers GPs face when attempting to share care identified that GPs were worried that colleagues didn’t always comply with monitoring arrangements and that they were dependent on the specialist for advice on treatment.  However, this research was conducted ten years ago, in which time GPs have taken on an increased responsibility for patient care.
Plan of investigation
GP enablers and barriers
GPs working in practices within North Central London (Barnet, Camden, Enfield, Haringey and Islington) will be invited to take part in one of two focus group. From those who respond to the invitation, purposeful sampling will be used to ensure there is a range of genders and experiences in each focus group. [1a] The researcher will facilitate focus groups run with up to 7 participants each, achieving a mix of experience at each group. Written consent will be obtained from the participants. The facilitator will use a focus group guide to ensure the same key topics are covered during each focus group (see below). Focus group has been chosen as the preferred method to elicit responses from GPs as it allows the group dynamic to generate discussion.
The focus group will be audio recorded and a verbatim transcription will be carried out by the researcher. A framework analysis approach will be used to analyse the focus group discussion. A summary of the focus group analysis will be sent to all members for content check and consent. The results of these focus groups will be used to generate the recommendations to the CCGs.
Patient enablers and barriers
Patients attending the Macmillan Cancer Centre, University College London Hospital for denosumab injections will be identified, provided with an information sheet about the study and invited to participate. They will be provided with a stamped addressed envelope and an email address to respond to the invitation. Those who respond positively will be invited to a semi-structured, face-to-face interview on the day of their next denosumab injection. The interviews will take place in a private, quiet room at the Macmillan Cancer Centre, to preserve the patient’s anonymity. We anticipate each interview will last for approximately 30 minutes. Participants will be recruited by purposeful sampling, ensuring there is a range of genders and ages as far as possible. Patients will continue to be sampled until there is “content saturation”, with a maximum of ten participants recruited.
Written consent will be obtained from all participants. The interviews will be conducted and audio recorded by the researcher. A verbatim transcription will be taken of the interviews, with the researcher conducting initial transcriptions, with further transcriptions commissioned from a transcription service. Analysis of the interviews will be carried out by the researcher according to the devised framework. The findings of these interviews will be used to inform the recommendations to the CCGs.
The interviews and focus groups have been planned to be conducted and analysed according to a framework analysis. A coding framework will be developed based on the work conducted by Michie et al (2005) that aims to understand professional’s barriers to implementing evidence based medicine. [3a] The framework will be used in its original form for the GP focus group analysis, and in a modified form when analysing the patient interviews. The coding framework will then be applied to all of the transcripts. Further themes may arise during analysis of transcripts; these will be incorporated into the framework and applied to all transcripts. The thematic analysis will allow the researcher to draw conclusions based on both the themes that occur and the relationship between themes in individual interviews.
Development of semi-structured interview guide
The researcher will create a semi-structured interview guide to ensure consistent and relevant information is generated in and the patient interviews. A guide will also be developed for the GP focus groups to ensure they are all run in the same way. The domains recommended by Michie et al (2005), for example memory, beliefs about consequences, role & identity, skills, etc. will be used as a framework when developing the semi-structured interview guide.[3a] This framework offers a validated tool that is useful to understand the barriers to implementation of evidence based medicine. This framework also offers useful domains when developing the patient interview guide, such as beliefs about consequences and social influences.
References Summary of Product Characteristics. Xgeva® denosumab 120mg/1.7 mL solution for injection. Last updated: April 2016  NICE TA 265: Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours. October 2012  Data source: HES Data. Health Episode Statistics, HSCIC  NCL Joint Formulary Committee Minutes November 2015  NCL Cancer Board Minutes January 2016  Prescribing Guidance: Shared Care. 2013. London: General Medical Council  Nicholls JA, et al. Legal and professional implications of shared care: a case study in oral anticoagulation stroke prevention therapy. BMC Health Services Research 2015; 15: 93  Carrington IM, et al. Why shared-care arrangements for prescribing in attention deficit hyperactivity disorder may not be accepted. Eur J Hosp Pharm 2015; 0: 1-3. doi:10.1136/ejhpharm-2015-000743  NHS England. Five Year Forward View. October 2014. London: NHS. https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf  Crowe S, et al. Shared care arrangements for specialist drugs in the UK: the challenges facing GP adherence. Qual Saf Health Care 2010; 19(6): e54  Department of Health. 2015. The NHS Constitution for England. https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhs-constitution-for-england  Doyle C et al. A systematic review of evidence on the links between patient experience and clinical safety and effectiveness. BMJ Open 2013; 3: e001570 doi:10.1136/bmjopen-2012-001570 [1a] Coyne IT. Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries. J Adv Nursing 1997; 26: 623 – 630 [2a] Starks H and Trinidad SB. Choose your method: a comparison of phenomenology, discourse analysis and grounded theory. Qualitative Health Research 2007; 17(10): 1372 – 1380 [3a] Michie et al Making psychological theory useful for implementing evidence-based practice: a consensus approach. Quality and Safety in Health Care 2005; 14(1): 26-33