The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer
- 443 Downloads
We aimed to investigate the factors contributing to poor recruitment to the EaStER trial “Early Stage glottic cancer: Endoscopic excision or Radiotherapy” feasibility study. We performed a prospective qualitative assessment of the EaStER trial at three centres to investigate barriers to recruitment and implement changes. Methods used included semi-structured interviews, focus groups and audio-recordings of recruitment encounters. First, surgeons and recruiters did not all accept the primary outcome as the rationale for the trial. Surgeons did not always adhere to the trial eligibility criteria leading to variations between centres in the numbers of “eligible” patients. Second, as both treatments were considered equally successful, recruiters and patients focused on the pragmatics of the different trial arms, favouring surgery over radiotherapy. The lack of equipoise was reflected in the way recruiters presented trial information. Third, patient views, beliefs and preferences were not fully elicited or addressed by recruiters. Fourth, in some centres, logistical issues made trial participation difficult. This qualitative research identified several major issues that explained recruitment difficulties. While there was insufficient time to address these in the EaStER trial, several factors would need to be addressed to launch further RCTs in head and neck cancer. These include the need for clear ongoing agreement among recruiting clinicians regarding details in the study protocol; an understanding of the logistical issues hindering recruitment at individual centres; and training recruiters to enable them to explain the need for randomisation and the rationale for the RCT to patients.
KeywordsLaser surgery Radiotherapy Laryngeal neoplasm Laryngeal carcinoma Randomised control trial
The Quartet study was funded by the Medical Research Council. The authors would like to acknowledge the data collection carried out by Merran Toerien and Zelda Tomlin and their intellectual input to the Quartet study.
Conflict of interest
The authors declare that they have no conflict of interest.
- 1.Dey P, Arnold D, Wight R, MacKenzie K, Kelly C, Wilson J (2002) Radiotherapy versus open surgery versus endolaryngeal surgery (with or without laser) for early laryngeal squamous cell cancer. Cochrane Database Syst Rev (2):CD002027Google Scholar
- 9.Miles MB, Huberman AM (eds) (1994) Qualitative data analysis, 2nd edn. Sage, LondonGoogle Scholar
- 10.Glaser BG, Strauss AL (1967) The discovery of grounded theory; strategies for qualitative research. Aldine Publications Co., ChicagoGoogle Scholar
- 18.Thomas L, Wilson JA (2006) Systematic reviews—triumph of form over substance? Clin Otolaryngol 31(6):492–5Google Scholar
- 23.Boncheck L (1982) The role of the randomized clinical trial in the evaluation of new operations. Surg Clin North Am 62(4):761–769Google Scholar
- 24.Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E et al (1985) Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 312(11):665–673PubMedCrossRefGoogle Scholar
- 25.Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan J (2011) Key issues in recruitment to randomized controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial. Trials 12:78Google Scholar
- 26.Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F (2002) Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 325(7367):766–770PubMedCrossRefGoogle Scholar