Patient characteristics and refusal to participate in a head and neck cancer intervention trial: experience of two tertiary UK head and neck cancer centres

Ann R Coll Surg Engl. 2022 Feb;104(2):121-124. doi: 10.1308/rcsann.2021.0166. Epub 2021 Dec 20.


Introduction: Randomised clinical trials are an essential component for robust clinical evaluation. They are expensive to deliver but can fail to achieve the required outcomes. This paper reports details of trial recruitment in a head and neck Patient Concerns Inventory intervention trial from two UK head and neck tertiary centres.

Materials and methods: Data were collected for a pragmatic cluster preference randomised control trial with 15 consultants recruiting patients treated with curative intent after a diagnosis of head and neck cancer (all sites, disease stages, treatments). Ethical approval was given to report on those not recruited by the following characteristics: trial site, trial arm, age, sex, tumour site, overall stage, index of multiple deprivation quintile, timeframe.

Results: There were 368 patients approached who remained eligible and 80 (22%) declined to participate. Logistic regression suggested that age group (p = 0.008) and index of multiple deprivation quintile group (p = 0.003) were independent predictors of refusal.

Conclusions: Although recruitment to the trial was very good, it raised the issue of lower recruitment in the more deprived older group and lower social economic strata. Innovative ways need to be explored to facilitate the 'hard to reach' group contributing to, and benefiting from, clinical trials.

Keywords: Head and neck cancer recruitment; Health-related quality of life; Intervention; Patient concerns inventory; Prompt list; Randomised clinical trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Head and Neck Neoplasms* / therapy
  • Humans
  • Quality of Life
  • Refusal to Participate*
  • United Kingdom