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PWE-086 What Motivates Patients to Enter Clinical Trials Involving Endoscopic or Surgical Treatment? Qualitative Interviews of Patients Approached for The Bride Study (NCT01733719)
  1. S Budihal1,
  2. C Jackson2,
  3. JS deCaestecker1
  1. 1University Hospitals Leicester, Leicester
  2. 2Department of Health Sciences, University of Leicester,

Abstract

Introduction Poor recruitment is an issue for randomised trials. We aimed to explore patient attitudes towards recruitment in an RCT comparing ablative therapies in Barrett’s early neoplasia (BRIDE) & to a proposed trial comparing surgery to endotherapy.

Methods Patients sampled from among 100 entering/declining BRIDE in each of 6 UK centres, had telephone interviews by an experienced qualitative researcher using a topic guide developed with patients, audio-recorded, anonymised & transcribed verbatim. Transcript analysis used the constant comparative approach, managed by NVivo software. Scrutiny of initial transcripts during 3–4 intensive readings generated open codes (short descriptors summarising points), grouped into themes. Data from other transcripts contradicting the codes/themes were explored & the coding frame revised, resulting in a set of issues important to patients that can help/hinder recruitment and retention.

Results 18 (16 men, age 47–85) were interviewed. Main findings: 1) Gaining informed consent is time-consuming, but necessary as there is potential for misunderstanding. 2) Some patients received information about BRIDE before results of investigations. Recruitment process should be designed to prevent this. 3) Recruiters need a pleasant attitude, honesty, respect for potential participants, & good interpersonal skills. If not their own doctor, the approach should be from someone suitably qualified & introduced by the doctor/their team. 4) Presence of others during recruitment (eg Macmillan nurse or multiple professionals) may frighten patients into interpreting their diagnosis as serious/terminal. 5) Some believed that treatment had been chosen based on individual need, & others that trial participation was the only route to a particular treatment & better follow up, misunderstanding randomisation. 6) The expectation that taking part could benefit people like themselves or their descendants facilitated successful recruitment. 7) Inconvenience/additional costs to patients and their families should be minimised (e.g. many more visits to hospital). 8) Recruitment was facilitated by awareness that outcomes & side effects of the 2 treatments were roughly equivalent. Surgery was not seen as equivalent, but for most was riskier, involving additional suffering & longer recovery. It was seen as less preferable & would need to offer some probability of advantage over endoscopy.

Conclusion Communication, openness & trust are key; patients need to understand randomisation does not ensure a particular treatment. Reducing expense/inconvenience assists recruitment. Randomisation to surgery requires clear potential benefits to be acceptable. (NIHR RfPB Grant No PB-PG-0711-25066)

Disclosure of Interest None Declared

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