Lung cancer diagnosed following emergency admission: a mixed methods study protocol to improve understanding of patients’ characteristics, needs, experiences and outcomes

This is a single centre, prospective mixed methods study. The research setting is a large University Hospital National Health Service Trust in England and the project comprises of three work packages, two using quantitative methods of data collection and one employing qualitative methods. Mixed methods research is that in which ‘the investigator collects and analyses data, integrates the findings, and draws inferences using both qualitative and quantitative approaches or methods in a single study or a program of inquiry’ [5]. Such research takes a pragmatic philosophical and methodological stance in order to address to real world problems.

This involves the identification of all patients with lung cancer through the hospital's lung cancer multidisciplinary team meeting (LC-MDT), and collecting information from their hospital records. Over one year, all patients assigned a histological or clinical diagnosis of lung cancer at the two lung cancer multidisciplinary team (LC-MDT) meetings held weekly at the study centre, will be identified by the research team in conjunction with collaborators and the lung cancer nurse specialists and categorised as DFEA or not-DFEA. As quasi-anonymised data, similar to that collected as part of the National Lung Cancer Audit, there is no need to obtain informed consent for this work package [6].

The following data will be collected for all patients: age, gender, ethnicity, performance status (Eastern Co-operative Oncology Group Scale) [7], postcode (recorded as a lower super-output area code to produce a deprivation score), whether seen by a lung cancer nurse specialist at diagnosis or not, diagnostic investigations undertaken (type and timing from referral to secondary care), histological type and stage of lung cancer, time from referral to secondary care to discussion at LC-MDT, treatment recommendation of LC-MDT, treatment received and time from LC-MDT, hospital days utilised, discharge destination, outcome (survival or place of death).

This work package will provide information on the demographics, navigation through the diagnostic and treatment pathway, and outcomes for patients DFEA, and permit comparison with patients who are not-DFEA.

All adult patients with lung cancer DFEA are potentially eligible to participate in the questionnaires and the in-depth interview. When a patient is unable to participate, e.g. because of being too unwell, an adult carer will be approached and invited instead. Exclusion criteria are patients and carers who are: experiencing severe distress; who lack capacity to consent or awareness of the diagnosis of lung cancer or are who are unable to communicate in English.

All adult patients with lung cancer DFEA identified in work package 1 will be potentially eligible. When the patient is unable to take part, e.g. because of being too unwell, their main carer will be approached instead. After providing an information sheet for a minimum of 24 hours, if they agree to take part, written informed consent will be obtained by a member of the research team. The Charlson co-morbidities index is completed and the patient (or carer) will be asked to complete the Sheffield Profile for Assessment and Referral to Care (SPARC^©) questionnaire [8‐10] and selected items from the 2012 National Cancer Patient Experiences Survey (NCPES) [11]. Questions in the NCPES which relate to information already collected or are irrelevant to this group have been removed. Patients or their carers will only need to complete the questionnaires once.

These data will provide detailed information about the performance status, co-morbidity, holistic needs and experiences of patients who are DFEA. The potential interest of the patient or carer in taking part in the in-depth interview several weeks later (work package 3) is gauged and consent obtained to contact them subsequently.

Until recruitment is complete, all patients DFEA and carers who take part in work package 2 will be offered the opportunity to take part in an exploratory qualitative interview, and those indicating a willingness to be involved will receive an information sheet. Subsequently they will be contacted by the Research Assistant and if they agree to take part, written informed consent will be obtained. The qualitative interviews are designed to obtain an understanding of their experiences prior to emergency admission, especially with regards to symptoms and problems experienced. The interview also explores their narratives of the overall care experienced since emergency admission. The interviews will take place several weeks after discharge from hospital. Some patients are likely to die in hospital or shortly after discharge; if so, their informal carers will be approached for interviews at least 6 weeks after bereavement.

We will seek to undertake interviews [12] with patients and carers separately, although some may prefer to be interviewed together. Each interview will be person centred, with questioning taking a flexible format guided by an aide memoire [13]. Participants will be encouraged to recount their experiences in their own terms [14]. Arrangements will be made to follow up issues raised in the interviews, such as unrelieved symptoms or problems in bereavement, with participants’ permission and in collaboration with the responsible clinical teams.

The research team will analyse these data using parametric and non-parametric descriptive and comparative statistics as appropriate. Kaplan and Meier survival curves will be compared using the log-rank test. All calculations will be performed using Statistical Package for the Social Sciences (version 18) with a P value of <0.05 considered statistically significant.

The research team will analyse these data using appropriate descriptive statistics. All calculations will be performed using Statistical Package for the Social Sciences (version 18).

Data collected from the interviews will be analysed by a grounded theory perspective [17], so that attention is focused on the systematic comparison between issues in interviews with patients who are likely to be typical of those DFEA and their carers. Interviews will be recorded, transcribed and entered into a qualitative data analysis package. Coding and thematic analysis will be undertaken by two researchers to check validity. Standard procedures for evaluating rigour in qualitative research will be employed [18].