Advertisement

European Archives of Oto-Rhino-Laryngology

, Volume 270, Issue 8, pp 2333–2337 | Cite as

The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer

  • D. W. Hamilton
  • I. de Salis
  • J. L. Donovan
  • M. Birchall
Head and Neck

Abstract

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.

Keywords

Laser surgery Radiotherapy Laryngeal neoplasm Laryngeal carcinoma Randomised control trial 

Notes

Acknowledgments

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.

References

  1. 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
  2. 2.
    Cohen SM, Garrett CG, Dupont WD, Ossoff RH, Courey MS (2006) Voice-related quality of life in T1 glottic cancer: irradiation versus endoscopic excision. Ann Otol Rhinol Laryngol 115(8):581–586PubMedGoogle Scholar
  3. 3.
    Hirano M, Hirade Y, Kawasaki H (1985) Vocal function following carbon dioxide laser surgery for glottic carcinoma. Ann Otol Rhinol Laryngol 94(3):232–235PubMedGoogle Scholar
  4. 4.
    Keilmann A, Bergler W, Artzt M, Hormann K (1996) Vocal function following laser and conventional surgery of small malignant vocal fold tumours. J Laryngol Otol 110(12):1138–1141PubMedCrossRefGoogle Scholar
  5. 5.
    McGuirt WF, Blalock D, Koufman JA, Feehs RS, Hilliard AJ, Greven K, Randall M (1994) Comparative voice results after laser resection or irradiation of T1 vocal cord carcinoma. Arch Otolaryngol Head Neck Surg 120(9):951–955PubMedCrossRefGoogle Scholar
  6. 6.
    Sagar SM, McKenna G, Nolan MC (1994) A clinical audit of glottic cancer in Nova Scotia: a paradigm for effectiveness research. Clin Oncol (R Coll Radiol) 6(1):14–23CrossRefGoogle Scholar
  7. 7.
    Ton-Van J, Lefebvre JL, Stern JC, Buisset E, Coche-Dequeant B, Vankemmel B (1991) Comparison of surgery and radiotherapy in T1 and T2 glottic carcinomas. Am J Surg 162(4):337–340PubMedCrossRefGoogle Scholar
  8. 8.
    de Salis I, Tomlin Z, Toerien M, Donovan J (2008) Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations. Contemp Clin Trials 29(5):663–670PubMedCrossRefGoogle Scholar
  9. 9.
    Miles MB, Huberman AM (eds) (1994) Qualitative data analysis, 2nd edn. Sage, LondonGoogle Scholar
  10. 10.
    Glaser BG, Strauss AL (1967) The discovery of grounded theory; strategies for qualitative research. Aldine Publications Co., ChicagoGoogle Scholar
  11. 11.
    Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC (2009) It’s not just what you say, it’s also how you say it: opening the ‘black box’ of informed consent appointments in randomised controlled trials. Soc Sci Med 68(11):2018–2028PubMedCrossRefGoogle Scholar
  12. 12.
    Benson AB 3rd, Pregler JP, Bean JA, Rademaker AW, Eshler B, Anderson K (1991) Oncologists’ reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J Clin Oncol 9(11):2067–2075PubMedGoogle Scholar
  13. 13.
    Cook JA, Ramsay CR, Norrie J (2008) Recruitment to publicly funded trials–are surgical trials really different? Contemp Clin Trials 29(5):631–634PubMedCrossRefGoogle Scholar
  14. 14.
    McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D (2002) Randomised trials in surgery: problems and possible solutions. BMJ 324(7351):1448–1451PubMedCrossRefGoogle Scholar
  15. 15.
    Higgins KM, Wang JR (2008) State of head and neck surgical oncology research–a review and critical appraisal of landmark studies. Head Neck 30(12):1636–1642PubMedCrossRefGoogle Scholar
  16. 16.
    Stadhouder A, Buskens E, Vergroesen DA, Fidler MW, de Nies F, Oner FC (2009) Nonoperative treatment of thoracic and lumbar spine fractures: a prospective randomized study of different treatment options. J Orthop Trauma 23(8):588–594PubMedCrossRefGoogle Scholar
  17. 17.
    Berger RL, Celli BR, Meneghetti AL, Bagley PH, Wright CD, Ingenito EP, Gray A, Snider GL (2001) Limitations of randomized clinical trials for evaluating emerging operations: the case of lung volume reduction surgery. Ann Thorac Surg 72(2):649–657PubMedCrossRefGoogle Scholar
  18. 18.
    Thomas L, Wilson JA (2006) Systematic reviews—triumph of form over substance? Clin Otolaryngol 31(6):492–5Google Scholar
  19. 19.
    Abraham NS, Young JM, Solomon MJ (2006) A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery 139(4):469–483PubMedCrossRefGoogle Scholar
  20. 20.
    Bentsianov BL, Boruk M, Rosenfeld RM (2002) Evidence-based medicine in otolaryngology journals. Otolaryngol Head Neck Surg 126(4):371–376PubMedCrossRefGoogle Scholar
  21. 21.
    Donovan JL, Lane JA, Peters TJ, Brindle L, Salter E, Gillatt D, Powell P, Bollina P, Neal DE, Hamdy FC (2009) Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 62(1):29–36PubMedCrossRefGoogle Scholar
  22. 22.
    Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan J (2009) Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness. Contemp Clin Trials 30(1):40–46PubMedCrossRefGoogle Scholar
  23. 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. 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. 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. 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

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • D. W. Hamilton
    • 1
  • I. de Salis
    • 2
  • J. L. Donovan
    • 2
  • M. Birchall
    • 3
  1. 1.Institute of Health and SocietyNewcastle UniversityNewcastle upon TyneUK
  2. 2.University of BristolBristolUK
  3. 3.University College LondonLondonUK

Personalised recommendations