Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis-staff insights from an embedded qualitative study

Hayley Prout, Angela Tod, Richard Neal, Annmarie Nelson, Hayley Prout, Angela Tod, Richard Neal, Annmarie Nelson

Abstract

Background: The ELCID Trial was a feasibility randomised controlled trial examining the effect on lung cancer diagnosis of lowering the threshold for referral for urgent chest X-ray for smokers and recent ex-smokers, aged over 60 with new chest symptoms. The qualitative component aimed to explore the feasibility of individually randomising patients to an urgent chest X-ray or not and to investigate any barriers to patient recruitment and participation. This would inform the design of any future definitive trial. This paper explores general practice staff insights into participating in and recruiting to diagnostic trials for possible/suspected lung cancer.

Methods: Qualitative interviews were conducted with 11 general practice staff which included general practitioners, a nurse practitioner, research nurses and practice managers. Interviews were analysed using a framework approach.

Results: Findings highlight general practice staff motivators to participate in the trial as recruiters, practice staff interactions with patients recruited onto the study, methods of organisation staff used to undertake the trial, the general impact of the trial on practice staff, how the trial research team supported the practices and lastly practice staff suggestions for trial delivery improvement.

Conclusions: The integration of a qualitative component focused on staff experiences participating in a lung diagnostic trial has demonstrated the feasibility to recruit for similar future studies within general practice. Although recruitment into trials can be difficult, results from our study offer suggestions on maximising patient recruitment not just to trials in general but also specifically for a lung diagnosis study.

Trial registration: ClinicalTrials.gov, NCT01344005. Registered on 27 April 2011.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
ELCID trial format
Fig. 2
Fig. 2
Recruitment of GP practices for ELCID trial
Fig. 3
Fig. 3
Staff roles and responsibilities

References

    1. The Academy of Medical Sciences. Research in general practice: bringing innovation into patient care. Workshop Report. 2009.
    1. Research Ready. []. Accessed Oct 2020.
    1. Primary Care Speciality Profile: why you should deliver primary care research in the UK. []. Accessed Oct 2020.
    1. Foster JM, Sawyer SM, Smith L, Reddel HK, Usherwood T. Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials. BMC Med Res Methodol. 2015;15(1):1–9. doi: 10.1186/s12874-015-0012-3.
    1. Pearl A, Wright S, Gamble G, Doughty R, Sharpe N. Randomised trials in general practice-a New Zealand experience in recruitment. N Z Med J. 2003;116(1186):U681.
    1. van der Gaag WH, van den Berg R, Koes BW, Bohnen AM, Hazen LMG, Peul WC, et al. Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment. BJGP Open. 2017;1(3) 10.3399/bjgpopen17X101085.
    1. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2(1):e000496. doi: 10.1136/bmjopen-2011-000496.
    1. Donovan J, Little P, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F. Quality improvement reportImproving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) studyCommentary: presenting unbiased information to patients can be difficult. Bmj. 2002;325(7367):766–770. doi: 10.1136/bmj.325.7367.766.
    1. Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan J. 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. 2009;30(1):40–46. doi: 10.1016/j.cct.2008.07.007.
    1. Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011) Trials. 2011;12(1):78. doi: 10.1186/1745-6215-12-78.
    1. Noble SI, Nelson A, Fitzmaurice D, Bekkers M-J, Baillie J, Sivell S, Canham J, Smith JD, Casbard A, Cohen A. A feasibility study to inform the design of a randomised controlled trial to identify the most clinically effective and cost-effective length of Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT) Health Technol Assess (Winchester, England) 2015;19(83):vii.
    1. Neal RD, Barham A, Bongard E, Edwards RT, Fitzgibbon J, Griffiths G, Hamilton W, Hood K, Nelson A, Parker D. Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial. Br J Cancer. 2017;116(3):293–302. doi: 10.1038/bjc.2016.414.
    1. Hurt CN, Roberts K, Rogers T, Griffiths GO, Hood K, Prout H, Nelson A, Fitzgibbon J, Barham A, Thomas-Jones E. Protocol for a feasibility clinical trial examining the effect on lung cancer diagnosis of offering a chest X-ray to higher risk patients with chest symptoms. Trials. 2013;14(1):405. doi: 10.1186/1745-6215-14-405.
    1. Prout HC, Barham A, Bongard E, Tudor-Edwards R, Griffiths G, Hamilton W, Harrop E, Hood K, Hurt CN, Nelson R. Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study. Trials. 2018;19(1):419. doi: 10.1186/s13063-018-2803-4.
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–357. doi: 10.1093/intqhc/mzm042.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Costing psychiatric interventions. Discussion Paper 1536. PSSRU, University of Kent at Canterbury. []. Accessed Oct 2020.
    1. Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program. Value Health. 2010;13(8):867–872. doi: 10.1111/j.1524-4733.2010.00788.x.
    1. Ridyard CH, Hughes DA, Team D Development of a database of instruments for resource-use measurement: purpose, feasibility, and design. Value Health. 2012;15(5):650–655. doi: 10.1016/j.jval.2012.03.004.
    1. Coast J, Peters TJ, Natarajan L, Sproston K, Flynn T. An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people. Qual Life Res. 2008;17(7):967–976. doi: 10.1007/s11136-008-9372-z.
    1. Group TE EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. EQ-5D-3 L user guide. [Available at L_UserGuide_2015.pdf]. Accessed Oct 2020.
    1. Qualitative data analysis software. []. Accessed Oct 2020.
    1. Ritchie J. SL, Bryman A, Burgess RG: Analysing qualitative data. London: Routledge; 1994.
    1. Ngune I, Jiwa M, Dadich A, Lotriet J, Sriram D. Effective recruitment strategies in primary care research: a systematic review. Qual Prim Care. 2012;20(2):115–123.
    1. Hange D, Björkelund C, Svenningsson I, Kivi M, Eriksson MC, Petersson E-L. Experiences of staff members participating in primary care research activities: a qualitative study. Int J Gen Med. 2015;8:143. doi: 10.2147/IJGM.S78847.
    1. Adult smoking habits in the UK: 2018. []. Accessed Oct 2020.
    1. Ward E, King M, Lloyd M, Bower P, Friedli K. Conducting randomized trials in general practice: methodological and practical issues. Br J Gen Pract. 1999;49(448):919–922.
    1. Van der Windt D, Koes BW, Van Aarst M, Heemskerk M, Bouter LM. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment. Br J Gen Pract. 2000;50(454):371–374.
    1. Brodaty H, Gibson LH, Waine ML, Shell AM, Lilian R, Pond CD. Research in general practice: a survey of incentives and disincentives for research participation. Mental Health Fam Med. 2013;10(3):163–173.
    1. Potter R, Dale J, Caramlau I. A qualitative study exploring practice nurses’ experience of participating in a primary care–based randomised controlled trial. J Res Nurs. 2009;14(5):439–447. doi: 10.1177/1744987108098228.
    1. Tognoni G, Alli C, Avanzini F, Bettelli G, Colombo F, Corso R, Marchioli R, Zussino A. Randomised clinical trials in general practice: lessons from a failure. BMJ Br Med J. 1991;303(6808):969–971. doi: 10.1136/bmj.303.6808.969.
    1. Peto V, Coulter A, Bond A. Factors affecting general practitioners’ recruitment of patients into a prospective study. Fam Pract. 1993;10(2):207–211. doi: 10.1093/fampra/10.2.207.
    1. Schreijenberg M, Luijsterburg P, Van Trier Y, Rizopoulos D, Koopmanschap M, Voogt L, Maher C, Koes B. Discontinuation of the PACE Plus trial: problems in patient recruitment in general practice. BMC Musculoskelet Disord. 2018;19(1):146. doi: 10.1186/s12891-018-2063-1.
    1. Bower P, Wilson S, Mathers N. How often do UK primary care trials face recruitment delays? Fam Pract. 2007;24(6):601–603. doi: 10.1093/fampra/cmm051.
    1. Foy R, Parry J, Duggan A, Delaney B, Wilson S. Lewin-van den Broek N, Lassen A, Vickers L, Myres P: How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Fam Pract. 2003;20(1):83–92. doi: 10.1093/fampra/20.1.83.
    1. Bell-Syer SE, Moffett JAK. Recruiting patients to randomized trials in primary care: principles and case study. Fam Pract. 2000;17(2):187–191. doi: 10.1093/fampra/17.2.187.
    1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143–1156. doi: 10.1016/S0895-4356(99)00141-9.
    1. McMullen H, Griffiths C, Leber W, Greenhalgh T. Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory. Trials. 2015;16(1):242. doi: 10.1186/s13063-015-0755-5.
    1. Dormandy E, Kavalier F, Logan J, Harris H, Ishmael N, Marteau TM, Team SR Maximising recruitment and retention of general practices in clinical trials: a case study. Br J Gen Pract. 2008;58(556):759–766. doi: 10.3399/bjgp08X319666.
    1. Primary Care Research Incentive Scheme (PiCRIS) applications now being accepted. []. Accessed Oct 2020.
    1. Williamson MK, Pirkis J, Pfaff JJ, Tyson O, Sim M, Kerse N, Lautenschlager NT, Stocks NP, Almeida OP. Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Med Res Methodol. 2007;7(1):42. doi: 10.1186/1471-2288-7-42.
    1. Liu H, Massi L, Eades A-M, Howard K, Peiris D, Redfern J, Usherwood T, Cass A, Patel A, Jan S. Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study. Trials. 2015;16(1):425. doi: 10.1186/s13063-015-0956-y.
    1. Ellis SD, Bertoni AG, Bonds DE, Clinch CR, Balasubramanyam A, Blackwell C, Chen H, Lischke M, Goff DC., Jr Value of recruitment strategies used in a primary care practice-based trial. Contemp Clin Trials. 2007;28(3):258–267. doi: 10.1016/j.cct.2006.08.009.
    1. Gaglio B, Nelson CC, King D. The role of rapport: Lessons learned from conducting research in a primary care setting. Qual Health Res. 2006;16(5):723–734. doi: 10.1177/1049732306286695.
    1. Csipke E, Serfaty M, Buszewicz M. Optimizing recruitment from primary care: methods of recruiting older people with depression. Prim Health Care Res Dev. 2006;7(2):116–123. doi: 10.1191/1463423606pc283oa.
    1. Fransen GA, Van Marrewijk CJ, Mujakovic S, Muris JW, Laheij RJ, Numans ME, De Wit NJ, Samsom M, Jansen JB, Knottnerus JA. Pragmatic trials in primary care. Methodological challenges and solutions demonstrated by the DIAMOND-study. BMC Med Res Methodol. 2007;7(1):16. doi: 10.1186/1471-2288-7-16.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다