Recruiting patients into a primary care based study of palliative care: why is it so difficult?

Abstract

In the UK, researchers' access to study populations and control over selection of participants is becoming increasingly constrained by data protection and research governance legislation. Intervening stages placed between researchers and the population they wish to study can have serious effects on recruitment and ultimately on the validity of studies. In this paper we describe our experiences of gaining access to patients for a study of palliative care in primary care. Despite considerable time and resources dedicated to recruitment, a smaller than anticipated study sample was achieved. We found that gatekeeping by ethics committees and practitioner control over sample selection were significant hurdles in accessing patients for the study. Gatekeeping responsibilities represent considerable challenges for researchers seeking to obtain a representative study sample, not just in palliative care, but for research in general in health care.

Place of death for the ‘oldest old’: ≥85-year-olds in the CC75C population-based cohort

“…The authors' prospective cohort study provided data from the year before death for a section of the population -predominantly frail individuals in advanced old age -which is now difficult to access due to current research ethics and governance regulatory procedures that are intended to protect vulnerable people. 18 Individually linking anonymised study and death certificate data offered a unique additional perspective to public records, meriting examination as there is scant information on which to base urgently needed planning for the rising numbers of deaths in very old age.…”

Mixed Methods Research in the Development and Evaluation of Complex Interventions in Palliative and End-of-Life Care: Report on the MORECare Consensus Exercise

“…12 There can also be an inability to provide informed consent. 12,14-17 Gatekeeping can occur when well-intentioned clinicians 12,14,17,[18][19][20] or family members 15 seek to protect patients from research participation at the end of life, despite research suggesting that some even very ill patients [21][22] and bereaved relatives 23 find it helpful and would like the opportunity to participate. This gatekeeping can impact on the efficiency of research, as well as its validity and reliability due to potentially biased samples.…”

“…This gatekeeping can impact on the efficiency of research, as well as its validity and reliability due to potentially biased samples. 18,20 Gatekeeping can also occur by ethics committees. 18,24 Attrition Attrition (including drop-out, nonresponse, withdrawal, and protocol deviation) is a major issue in studies with a follow-up element.…”

“…18,20 Gatekeeping can also occur by ethics committees. 18,24 Attrition Attrition (including drop-out, nonresponse, withdrawal, and protocol deviation) is a major issue in studies with a follow-up element. [11][12][13][25][26][27][28] Some attrition is inevitable in end-of-life care research due to deterioration in a patient's condition or death, but might also result from respondent burden and changes, such as in respondents' circumstances (e.g., relocation) or contextual changes (e.g., changes in local services or treatments).…”

Place of death — how much does it matter?

“…One alternative approach is to obtain the views of patients close to the end of life by means of interviews or questionnaires, but such studies encounter difficulties of identification, recruitment and attrition 15 and are probably not practical outside academic research studies. A more fruitful approach for routine NHS use may be to seek the views of informal carers after death by interview or questionnaire.…”