Key QRI Papers


Elliott, D., Hamdy, F.C., Leslie, T.A., Rosario, D., Dudderidge, T., Hindley, R., Emberton, M., Brewster, S., Sooriakumaran, P., Catto, J.W.F., Emara, A., Ahmed, H., Whybrow, P., le Conte, S., Donovan, J.L., 2018 Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation versus radical prostatectomy for unilateral localised prostate cancer. BJU International(E-Publication ahead of print).

Griffin, DR., Dickenson, EJ., Wall, PDH., Achana, F., Donovan, JL., Griffin, J., Hobson, R., Hutchinson, CE., Jepson, M., Parsons, NR., Petrou, S., Realpe, A., Smith, J., Foster, NE., on behalf of the UK FASHIoN study group, 2018 Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial. The Lancet, 391:10136.

Wilson, C., Rooshenas, L., Paramasivan, S., Elliott, D., Jepson, M., Strong, S., Birtle, A., Beard, D., Halliday, A., Hamdy, FC., Lewis, R., Metcalfe, C., Rogers, CA., Stein, RC., Blazeby, JM., Donovan, JL., 2018 Development of a framework to improve the process of recruitment to Randomised Controlled Trials (RCTs): The SEAR (Screened, Eligible, Approached, Randomised) framework. Trials, 19:50.

Mills, N., Gaunt, D., Blazeby, JM., Elliott, D., Husbands, S., Holding, P., Young, B., Power, P., Tudur Smith, C., Gamble, C., Donovan, JL., 2017 Training key personnel to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT RCT recruitment Training Intervention.  J Clin Epi, (E-Publication ahead of print).

Paramasivan, S., Rogers, C.A., Welbourn, R., Byrne, J.P., Salter, N., Mahon, D., Noble, H., Kelly, J., Mazza, G., Whybrow, P., Andrews, R.C., Wilson, C., Blazeby, J.M., Donovan, J.L., on behalf of the By-Band-Sleeve TMG., 2017 Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.  International Journal of Obesity(E-Publication ahead of print).

Wade, J., Elliott, D., Gaunt, D.M., et al., 2017 Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC). Trials, 18(1):327.

Elliott, D., Husbands, S., Hamdy, F.C., Holmberg, L., Donovan, J.L.,  2017 Understanding and improving recruitment to randomised controlled trials: Qualitative research approaches. European Urology. European Urology (E-Publication ahead of print)

Blackshaw, H.Carding, P.Jepson, M., et al., 2017 Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial. 

Donovan, J.L., Rooshenas, L., Jepson, M., Elliott, D., Wade, J., Avery, K., Mills, N., Wilson, C., Paramasivan, S., & Blazeby, J,M., 2016 Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials 17:283.

Rooshenas, L, Elliott, D, Wade, J, Jepson, M, Paramasivan, S, Strong, S, Wilson, C, Beard, D, Blazeby, J, Birtle, A.J, Halliday, A.W, Rogers, C, Stein, R, Donovan, J.L, et al., 2016 Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials. PloS Medicine, vol 13.

The Bluebelle Study Group, the Severn and Peninsula Audit and Research Collaborative for Surgeons, and the West Midlands Research Collaborative 2016 Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies. BMJ Open 6:9 

Realpe, A., Adams, A., Wall, P., Griffin, D., Donovan, J. L. 2016 A new simple six-step model to promote recruitment to RCTs was developed and successfully implemented. Journal of Clinical Epidemiology 76:166-74.

Stein, R., Dunn, J., Bartlett, J., Campbell, A., Marshall, A., Hall, P., Rooshenas, L., Morgan, A., Poole, C., Pinder, S., Cameron, D., Stallard, N., Donovan, J.L., McCabe, J., Hughes-Davies, L., Makri,s, A., on behalf of the Optima trial management group. 2016 Optima Prelim: a randomised feasibility study of personalised care in the treatment of women with breast cancer.  Health Technology Assessment, vol 20, Issue 10.

Townsend, D., Mills, N., Savovic, J., Donovan, J.L, 2015. A systematic review of training programmes for recruiters to randomised controlled trials. Trials, 16:432 .

Paramasivan, S., Strong, S., Wilson, C. H., Campbell, B., Blazeby, J. M. & Donovan, J.L., 2015  A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. Trials; 16:88.

Donovan, J, L., Salis, IOCd., Toerien, M.G., Paramasivan, S., Hamdy, F.C. & Blazeby, J.M., 2014  The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. Journal of Clinical Epidemiology, vol 67 (8), 912 – 920.

Donovan, J. L., Paramasivan, S., de Salis, I. O. C. & Toerien, M. G., 2014  Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials. Trials, 15:5.

Paramasivan, S., Huddart, R., Hall, E., Lewis, R., Birtle, A. & Donovan, J. L.  2011 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, 12:78.

Mills, N. J., Blazeby, J. M., Hamdy, F. C., Neal, D. E., Campbell, B., Wilson, C. H., Paramasivan, S. & Donovan, J. L.,  2014 Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. Trials, 15:323.

QRI Development Papers

Donovan, J. L., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., Frankel, S., Neal, D., Hamdy, F. for the Protect Study Group, 2002 Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ, 325, 766-770.

Mills, N., Donovan, J. L., Smith, M., Jacoby  A., Neal, D. E., Hamdy. F. C., 2003 Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study. Controlled Clinical Trials; 24 (23), 272-282.

De Salis, I., Tomlin, Z., Toerien, M., Donovan, J., 2008 Qualitative research to improve RCT recruitment: Issues arising in establishing research collaborations.  Contemporary Clinical Trials; 29: 663-670. 

De Salis, I., Tomlin, Z., Toerien, M., Donovan, J., 2008 Using qualitative research methods to improve recruitment to randomized controlled trials: the Quartet study.  Journal of Health Services Research & Policy; 13 (Suppl 3), 92-96.

Howard, L., de Salis, I., Tomlin, Z., Thornicroft, G., Donovan, J. L., 2009. Why is recruitment to trials difficult?  An investigation into recruitment difficulties in an RCT of supported employment for people with severe mental illness.  Contemporary Clinical Trials 30, 40-46.

Donovan, J. L., Lane. A. J., Peters, T. J., Brindle, L., Salter, E., Gillatt, D., Powell, P., Bollina, P., Neal, D. E., Hamdy, F. C. for the ProtecT Study Group., 2009 Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. Journal of Clinical Epidemiology, 62, (1), 29-36.

Toerien, M., Brookes, S. T., Metcalfe, C., de Salis, I., Tomlin, Z., Peters, T. J., Sterne, J., Donovan, J. L.,  2009 A review of reporting of participant and retention in RCTs in six major journals.  Trials, 10: 52.

Wade, J., Donovan, J. L., Lane, J. A., Neal, D. E., Hamdy, F, C.,   2009  It’s not just what you say, it’s also how you say it: Opening the ‘black box’ of informed consent appointments in randomized controlled trials.  Social Science and Medicine; 68, (11),  2018-2028.

Mills, N., Donovan, J. L., Wade, J., Hamdy, F. C., Neal, D.E., Lane, J. A., 2011 Exploring treatment preferences facilitated recruitment to randomized controlled trials. Journal Clinical Epidemiology; 64: 1127-1136.

Hamilton, D. W., de Salis  I., Donovan, J. L., Birchall, M.,  2013 The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.   European Archives of Oto-Rhino-Laryngology and Head & Neck; 270, (80), 2333-2337. 

Outcomes from RCTs with developmental and full QRIs  

Beard, DJ., Rees, JL., Rombach, I., Cooper, C., Merritt, N., Shirkey, BA., Donovan, JL., Gwilym, S., Savulescu, J., Moser,J., Gray, A., Jepson, M., Tracey, I., Judge, A., Wartolowska, K., Carr, AJ on behalf of the CSAW Study Group, 2017 Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. The Lancet(E-Publication ahead of print).

Donovan, J., Hamdy, FC., Lane, A., Mason, M., Metcalfe, C., Walsh, E., Blazeby, J., Peters, T., Davis, M., Turner, E & Martin, R, 2016 Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. New England Journal of Medicine, vol 375., pp. 1425-1437

Hamdy,FC.,  Donovan, J, L., Lane, A,L., Mason, M., Metcalfe, C., Holding, P., Davis, M., Peters, T., Turner, E., Martin, R., Oxley,J., Robinson, M., Staffurth, J., Walsh, E., Bollina, P., Catto,J., Doble, A., Doherty, A., Gillatt, D., Kockelbergh, R. Kynaston, H., Paul, A., Powell, P., Prescott, S., Rosario, D., Rowe, E., Neal, D. for the ProtecT Study Group., 2016 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer New England Journal of Medicine, vol 375., pp. 1415-1424

Mulvenna, P., Nankivell, M., Barton, R., Faivre-Finn, C., Wilson, P., McColl, E., Moore, B., Brisbane, I., Ardron, D., Holt, t., Morgan, S., Lee, C., Waite, K., Bayman, N., Pugh, C., Sydes, B., Stephens, R., Parmar, M., Langley, R., 2016 Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial The Lancet, vol 388 no. 10055, pp.2004-2014

Other QuinteT Papers

Reeves, B. C., Scott, L. J., Taylor, J., Hogg, R., Rogers, C. A., Wordsworth, A., Townsend, D., Muldrew, A., Peto, T., Violato, M., Dakin, H., Cappel-Porter, H., Mills, N., O’Reilly, D., Harding, S. P., Chakravarthy, U., 2016 The Effectiveness, cost-effectiveness and acceptability of Community versus Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease: a virtual randomised balanced incomplete block trial (ECHoES). Health Technology Assessment.

 Isaacs T, Hunt D, Ward D, Rooshenas L, Edwards L., 2016 The Inclusion of Ethnic Minority Patients and the Role of Language in Telehealth Trials for Type 2 Diabetes: A Systematic Review. J Med Internet Res 2016;18(9):e256

Townsend, D., Reeves, B. C., Taylor, J., Chakravarthy, U., O'Reilly, D., Hogg, R. E., Mills, N., 2015 Health professionals’ and service users’ perspectives of shared care for monitoring wet age-related macular degeneration: a qualitative study alongside the ECHoES trial. BMJ Open 5.

Potter, S., Mills, N., Cawthorn, S. J., Donovan, J. & Blazeby, J. M., 2014 Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials,15: 80.

Crawley, E., Mills, N., Hollingworth, W., Dean,s Z., Sterne, J. A., Donovan, J. L., Beasant L, Montgomery A., 2013 Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Trials. ; 14: 444.

Crawley, E., Mills, N., Beasant. L., Johnson, D., Collin, S.M., Deans, Z., White, K., Montgomery, A., 2013 The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). Trials, 14: 415.

Tomlin, Z., de Salis, I., Toerien, M., Donovan, J. L., 2012 Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent.  Health Expectations, 17, (5), 670-82.

Moore, L., Campbell, R., Whelan, A., Mills, N., Lupton, P., Misselbrook, E., Frohlich, J., 2002 Self-help smoking cessation in pregnancy: a cluster randomised controlled trial. BMJ; 325: 1383-1386.

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