Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team

M W Ho; A S Pick; D N Sutton; K Dyker; K Cardale; K Gilbert; J Johnson; J Quantrill; J A McCaul

doi:10.1016/j.bjoms.2018.02.005

Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team

Br J Oral Maxillofac Surg. 2018 May;56(4):278-282. doi: 10.1016/j.bjoms.2018.02.005. Epub 2018 Mar 6.

Authors

M W Ho¹, A S Pick², D N Sutton², K Dyker³, K Cardale³, K Gilbert⁴, J Johnson², J Quantrill², J A McCaul⁵

Affiliations

¹ Head and Neck Research, Bradford Institute of Health Research, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK; Oral and Maxillofacial Surgery, Leeds Dental Institute, University of Leeds, West Yorkshire LS2 9LU, UK. Electronic address: [email protected].
² Head and Neck Research, Bradford Institute of Health Research, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK.
³ Head and Neck Research, Bradford Institute of Health Research, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK; Clinical Oncology, Leeds Teaching Hospitals NHS Trust, West Yorkshire, UK.
⁴ Clinical Trials, Northwick Park Hospital, North-West London, UK.
⁵ Clinical Trials, Northwick Park Hospital, North-West London, UK; Oral and Maxillofacial/Head and Neck Surgery, NHS Greater Glasgow and Clyde, Scotland.

PMID: 29523362
DOI: 10.1016/j.bjoms.2018.02.005

Abstract

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials.

Keywords: Acceptability clinical trials; Clinical trials; Head and Neck research; Trial design; Trial recruitment.

MeSH terms

Head and Neck Neoplasms / therapy*
Humans
Observational Studies as Topic / methods
Observational Studies as Topic / standards
Observational Studies as Topic / statistics & numerical data
Patient Acceptance of Health Care* / statistics & numerical data
Patient Preference
Patient Selection*
Randomized Controlled Trials as Topic / methods*
Randomized Controlled Trials as Topic / standards
Randomized Controlled Trials as Topic / statistics & numerical data
Research Personnel / statistics & numerical data