End-of-life research presents a range of specific challenges. Deteriorating health for patients and strain on carers limit the desire and the ability to participate in research at the end-of-life. The resulting high rates of attrition and low levels of participation in studies have been widely discussed in the literature
[1, 2]. Whilst researchers are sensitive and accepting of these limitations on study accrual, the barriers presented by ethical and organisational reviews are more controversial.
The requirement for research to be approved by a Research Ethics Committee and the organisation where the research will be carried out (National Health Service (NHS) research governance in the United Kingdom (UK)) provides important safeguards for patients. These safeguards are in place to protect potentially vulnerable people from being exploited or distressed by research that is intrusive or inappropriate. In common with many other countries, the UK does not allow direct approaches by researchers to patients
. Data protection legislation prevents UK NHS organisations from sharing patients’ contact details with researchers without the patients’ permission. Death registration data may be used to identify informants for studies into end-of-life care but all contact must be made through the Office for National Statistics (ONS). A national survey recommended by the End-of-life Strategy in England and Wales was run by ONS, for the first time in 2011/12, for example. But for most projects, initial contact between end-of-life researcher and potential participant must be indirect, via clinicians responsible for a patient’s care or advertisements placed strategically in locations considered visible to the target population
As with all safeguards, it is important that protection should be commensurate with the level of risk
. In the past, researchers have felt that research ethics committees were too restrictive in denying access to patients
. In end-of-life care research, the approach preferred by governance and ethical reviews is generally one where the invited participant must opt-in and contact the researcher to signal their interest in taking part. Opt-in approaches compared with opt-out can easily lead to a reduction in the size and representativeness of a sample
[9, 10]. Referrals by health professionals into a study may be selective, and judgement on who is a suitable candidate can vary from one doctor or nurse to another
[5, 6, 9, 11]. Greater participation in research amongst higher socioeconomic groups is also well recognised
If end-of-life care research is to be methodologically sound and useful to clinicians
[13–15], it needs to be conducted in relevant, rather than atypical, settings. Extending studies beyond specialist palliative care is crucial for groups such as older adults who are more likely to be cared for by their general practitioner (GP)
[9, 13]. The majority of people who receive specialist palliative care have a cancer diagnosis, though they comprise only one in four of all deaths
. Almost every person in the UK is registered with a GP, thus there exists the potential for primary care to offer an ideal sampling frame for end-of-life care studies. Ensuring that a study population is representative of different subgroups of the population allows research to contribute to the development of equitable services. Subgroups of race, ethnicity, culture, gender, age, and disease states within the population are known to experience end-of-life care differently, and these differences remain poorly understood
Participant accrual is one of the most important issues in end-of-life care research
. There is much discussion of the difficulties in the literature, but few data to guide researchers who are planning end-of-life research in primary care. The practicalities of study planning have tended to be informed by personal experience and advice from colleagues. Estimating how many people a research project may need to approach to attain a certain sample, for example, can be very difficult. Ewing and colleagues sent 1871 letters to yield 36 participants in their primary care study of patients in their last year of life
. They felt that gatekeeping by health professionals and ethics committees contributed to their smaller than anticipated sample.
There have been a number of changes since much of the published work on the research process was completed. The processes of applying for NHS Research governance in the UK have recently been centralised. UK data protection law has been strengthened and applications for research ethics committee approval streamlined. In the UK, there has been substantial investment in research infrastructure, with the establishment of research networks in every English region, with staff funded to assist recruitment to approved studies
The aim of this paper is to report on the processes of recruitment to end-of-life studies with carers and patients in three different health regions of England, and identify any common challenges. We compare recruitment in areas where researchers are in direct contact with GPs with those in which research network staff intervene between researchers and GPs.