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162 Recruitment for clinical trials for elderly patients – insights from the XIMA and RINCAL trials
  1. Rebecca Godfrey,
  2. Adam De Belder
  1. Brighton & Sussex University Hospitals NHS Trust

Abstract

Introduction The XIMA trial was a randomised comparison of BMS or DES in patients undergoing stenting for CAD in patients aged 80 and over. Recruitment of 800 patients across 20 centres proved straightforward and timely with a high uptake rate in suitable patients.

The RINCAL trial randomised patients to a conservative or an invasive approach for the management of NSTEMI in patients aged 80 and above. Recruitment of 250 patients across 10 sites was laboured and recruitment challenging with participation reluctance.

We determined to understand the causes of this enrolment discrepancy.

Methods Review of the RINCAL study screening log over an 18-month period at a single high recruiting site, and reasons tabulated for lack of enrolment.

Results During an 18-month period within the RINCAL study at a single site, 102 out of 136 octogenarians with NSTEMI were eligible for inclusion. Of the 34 excluded patients, 14 were due to cognitive impairment [including dementia, lacking capacity to consent to participation, not understanding the patient information sheet], and 20 had concomitant medical comorbidities restricting invasive management.

Of the 102 eligible patients, 24 [24%] patients participated. 37 [36%] eligible elderly patients declined to participate. The reasons for declining were: 1) patient declined invasive management, 2) patient wanted invasive management. In 41 [40%] eligible patients, the managing cardiologist decided that randomisation was not appropriate in one or other of the treatment arms.

Conclusion Evidence is needed to guide management of acute anginal syndromes in older patients. Studies asking simple binary questions have been able to recruit reasonably well [as in the XIMA trial]. Trials asking more complex questions, including RINCAL, have observed high numbers of octogenarians declining to participate. This needs to be borne in mind when designing studies in the elderly, with a greater focus on supporting patients through the consent process.

Conflict of Interest None

  • NSTEMI
  • elderly
  • recruitment

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