DESCRIPTION OF THE STUDY POPULATION AND THE RESEARCH ENVIRONMENT

2.1.1 STUDY POPULATION

The study population for this project involved adults affected by advanced cancer receiving care in the Marie Curie Hospice Liverpool (MCHL). Advanced cancer was defined as a histological or radiological diagnosis of cancer which was incurable. Participants were recruited according to the following eligibility criteria.

2.1.2 ELIGIBILITY CRITERIA

The eligibility criteria for entry into the study are listed below:

2.1.2.1 INCLUSION CRITERIA

- Admitted to the Marie Curie Hospice Liverpool (MCHL) from December 2013 onwards.

- Aged 18 years or above.

- Known diagnosis of cancer (proven by histology or radiological imaging).

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- Able to understand and communicate in English (this may be through the use of communication aides and/or interpreter).

- Serum urea and creatinine recorded by the clinical team in the previous 72 hours.

2.1.2.2 EXCLUSION CRITERIA

- Patients with implantable defibrillator devices.

- Patients unable to provide fully informed consent.

- Active transmissible infections (including, Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium Difficile Toxin (CDT) and Norovirus infections).

- Receiving clinically assisted hydration (CAH) at time of assessment.

- Currently receiving antineoplastic treatment.

Participants were enrolled to the study providing they met the above eligibility criteria and were able to provide informed consent. BIA is safe, non-invasive with no history of adverse events. The use of BIA is not recommended in patients with implantable pacemakers as these devices are untested with the BIA technology. Only subjects who were able to provide full consent (with understanding of the reason for participation in the study and the potential risks and benefits) were included. Every effort was made to accommodate patients unable to communicate orally in English within the study, through individual assessment of the need for communication support for each participant. Patients with active transmissible infections were excluded, due to the risk of contamination of the research equipment resulting in subsequent transmission to other participants. These individuals would be eligible to participation once they were free of infection and deemed suitable (and able) to participate by the clinical team.

All study participants were receiving specialised palliative care but were not necessarily at the end of their lives. All participants were free from antineoplastic

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treatment and were not receiving clinically assisted nutrition or hydration at the time of assessment.

2.1.3 DESCRIPTION OF THE RESEARCH SETTING

The MCHL is a 30 bedded specialist palliative care unit situated in North West England and provides inpatient, outpatient and day care services. Specialist palliative care is provided for a broad range of palliative problems for a

predominantly Caucasian population of approximately 890,971.265 Patients are admitted directly from community and/or hospital settings. Inpatients are reviewed daily by the medical team, which is led by a consultant in palliative medicine. All patients receive individualised supportive therapies and, if necessary, medical interventions. The hospice mainly cares for metastatic cancer patients (of various subtypes) but also cares for non-cancer patients (prevalence approximately 66% vs. 34% respectively).266 Approximately, the length of stay for patients is two weeks; 60% of patients are discharged, either to their own home or an alternative care facility. In the calendar year of 2012, the MCHL received 853 unique referrals for either inpatient, outpatient or day therapy care services.267 This included 740 inpatient admissions (comprising of 387 patients) and 259 (67%) deaths.267 The MCHL is integrated with the Marie Curie Palliative Care Institute Liverpool (MCPCIL), a partnership comprising of the MCHL, the University of Liverpool and the Royal Liverpool University and Broadgreen NHS Hospitals Trust.268 This

relationship helped facilitate the development of the research infrastructure, which was necessary to conduct the study.

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2.1.4 DEVELOPMENT OF A RESEARCH INFRASTRUCTURE IN THE

HOSPICE SETTING

Several factors create difficulties when attempting to conduct a research project with a hospice. This includes a lack of a research infrastructure within the

institution, limited research personnel and, importantly, the absence of an over- seeing research governance structure. Consequently, a formal plan to develop a research structure in the hospice was undertaken as part of this study, in order to facilitate the conduct of this research (and proposed future work) within the hospice setting. The research infrastructure involved the development of the following:

Staff involvement

A series of meetings were held with members of the multi-disciplinary teams providing care for patients in the hospice. These meetings provided the researcher with an opportunity to meet with staff members to introduce himself and the project, whilst providing explanations of the methodology, protocol and practical demonstrations of the equipment.

Research in the Hospice

Prior to commencement of the study, posters advertising the study (appendix 3) were placed on notice boards throughout the hospice. A factsheet was developed to provide healthcare professionals with a summary of the proposed study

(appendix 4); this was distributed during multidisciplinary research seminars. Additionally, research support folders (containing the healthcare professional factsheet, participant information sheets, examples of data collection sheets, and the published systematic review by Nwosu et al105) were created and placed in the clinical ward areas, nurses’ offices, and the MCPCIL office.

Meetings with the clinical consultants and a senior nurse matron were conducted to raise awareness of the study protocol and establish the roles and responsibilities of clinical and research staff.

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