Epidemiology and Psychiatric Sciences http://journals.cambridge.org/EPS Additional services for Epidemiology
and Psychiatric Sciences:
Email alerts: Click here Subscriptions: Click here Commercial reprints: Click here Terms of use : Click here
Many more reasons behind difculties in recruiting patients to randomized controlled trials in psychiatry C.E. Adams Epidemiology and Psychiatric Sciences / Volume 22 / Issue 04 / December 2013, pp 321 - 323 DOI: 10.1017/S2045796013000267, Published online: 12 June 2013
Link to this article: http://journals.cambridge.org/abstract_S2045796013000267 How to cite this article: C.E. Adams (2013). Many more reasons behind difculties in recruiting patients to randomized controlled trials in psychiatry. Epidemiology and Psychiatric Sciences, 22, pp 321-323 doi:10.1017/S2045796013000267 Request Permissions : Click here
Downloaded from http://journals.cambridge.org/EPS, IP address: 128.243.253.104 on 30 Oct 2013
Epidemiology and Psychiatric Sciences (2013), 22, 321–323. doi:10.1017/S2045796013000267
© Cambridge University Press 2013
C O M M E N TA R Y
Many more reasons behind difficulties in recruiting patients to randomized controlled trials in psychiatry
Received 18 March 2013; Revised 4 April 2013; Accepted 5 April 2013; First published online 12 June 2013 Key words: Evidence-based psychiatry, mental health, randomized controlled trials, research governance.
Commentary on: Leeson V.C. and Tyrer P. The advance of research governance in psychiatry: one step forward, two steps back. Epidemiology and Psychiatric Sciences 2013; in press. Leeson and Tyrer aim to investigate ‘the reasons behind difficulties in recruiting patients to randomised controlled trials in psychiatry’ (Leeson & Tyrer, 2013). Their paper fails to do this and is methodologically not suited for this purpose. What it does is illustrate that there are difficulties in both instigation and recruitment; that, at least for England, these issues do not seem to be getting better; and lists some problems for consideration. Other important difficulties that apply everywhere are omitted and these have been thoroughly documented elsewhere (Duley et al. 2008) (see Table 1). Setting research priorities is made problematic by being far from the clinical coal-face and those undertaking this task have to balance political expediency and time scales with research and clinical need. This can delay instigation of studies. Initiatives such as the James Lind Alliance, helping set answerable priorities for research, should begin to help erode this difficulty across specialities (Lloyd & White, 2011; Lloyd et al. 2012). Little needs to be said about acquisition of funding. Delay of instigation of research can occur in spite of every effort to structure and govern funding panels broadly and fairly. It is difficult for them, in turn, not to prioritize one subspecialty against another, one district over another, and easy to remain blinkered and culture-bound. The collectivism of the funding board guards against ill-advised radical impulsive decision making and can also mitigate against innovative, imaginative and, perhaps, risky [but important] work. Difficulties with research regulation and governance are discussed by Leeson & Tyrer (2013), as are issues Address for correspondence: C.E. Adams, Institute of Mental Health, University of Nottingham Innovation Park, Jubilee Campus, Triumph Road, Nottingham NG7 2TU, UK. (Email:
[email protected])
around health care partnerships and data acquisition. There is, however, no mention of how Research Ethics Committees may be acting unethically and in this way delaying either instigation (Savulescu et al. 1996) or undertaking of the work (Roberts et al. 2011). A randomized trial is a collaborative effort. Leeson & Tyrer (2013) list issues with the professional carers that may hinder progression but notably omits other issues specific to lay carers, trial participants and, most importantly, researchers themselves. These protagonists are interconnected. Why should clinical staff not be anything but apathetic about study recruitment if they feel no study ownership? This too applies to the lay carers or trial participants. When entry criteria are seen as irrelevant to everyday care, interventions are unlikely to be accessible once recruitment closes, and outcomes are time-consuming to collect and not the routine data that could change care, recruitment is likely to drag. Many specialities have not learnt the value of truly pragmatic, collaborative, design (Thorpe et al. 2009), but perhaps ours more than most. Tools, however, are now available to help considering these at design and funding stages (Tosh et al. 2011). Beyond the day to day running are issues with the design of the analysis. Why would a person with schizophrenia sign informed consent to enter a trial that collects data that may be redundant [especially is not statistically significant] and that will be analysed in a less than transparent manner (Goldacre, 2012)? If more informed consents involved stipulation that the full analysis plan along with ‘dummy tables’ for the results was in the public domain perhaps informed consent would be less of a broken contract (Hayden, 2012). Hopefully the All Trials initiative will help (Creative Commons, 2013). Staff intimately involved in running the trial may inhibit process for a large variety of reasons. The wrong person may end up in the role. Running a trial is an enormous demand on a person’s academic, logistic and social reserve. Even for the right person, the training or support may be inadequate. Many studies are now designed and run in conjunction
322
C.E. Adams
Table 1. Some [but probably not all] difficulties instigating and recruiting people to randomized trials Difficulties in central priority setting Can be driven by political ethos and time scales Limited skill prioritizing answerable questions of importance to everyone concerned Difficulties presented by the funding decision-making process May be made without knowledge of innovations in methodology in other specialties Unimaginative Risk-averse Self-serving Biased Difficulties at the level of research regulation and governance Integrated Research Application System*(IRAS) Research Ethics Committee* Local Scientific Committees Difficulties to do with health care organization partnerships e.g. NHS support costs* Difficulties to do with data acquisition Quality* Access* Difficulties to do with carers Clinical staff* Attitudes* Time constraints* Families/other lay carers Difficulties to do with patients Illness-specific Attitude Difficulties to do with research design Explanatory v. pragmatic Participants Interventions Outcomes Consent practices disempowering participants Less than transparent research practice Difficulties in trial management Staff issues Trail unit ethos *Mentioned in Leeson & Tyrer (2013).
with a clinical trial unit (CTU). These can be enormously helpful but their ethos or understanding can also hinder progress of smooth instigation or recruitment. If a unit works primarily with cardiologists it may be problematic for them to enter the world of mental health trials. If the CTU works primarily for industry that dynamic may effect design and subsequent recruitment in other types of trials when past priorities have been focused on shareholder and regulatory authority need (Goldacre, 2012) rather than those of patients or carers. Part of the difficulty for anyone in this area is lack of knowledge of what is effective in helping instigate trials and make recruitment successful. Just as for the interventions being tested in trials, a trial-conduct evidence-base is needed. It is increasing (Treweek et al. 2013) but remains limited. We have little
knowledge about best techniques for trial-specific training of researchers, managers, clinicians, economists, statisticians, CTUs, funders, ethicists, consumers, policy-makers and commissioners. Here is where psychiatry and psychology along with colleagues in sociology and anthropology, with our expertise in understanding behaviour – and its change – may be able to lend an especially constructive hand. Acknowledgements None.
Financial Support This work received no specific grant from any funding agency, commercial or not-for-profit sectors.
Many more reasons behind difficulties in recruiting patients to randomized controlled trials in psychiatry Conflict of Interest None. Ethical Standards Not applicable. C.E. Adams Chair of Mental Health Services Research, Co-ordinating Editor Cochrane Schizophrenia Group, University of Nottingham, UK References Creative Commons (2013). All Trials Registered/All Results Reported. Retrieved 17 April 2013 from http://www.alltrials.net/ Duley L, Antman K, Arena J, Avezum A, Blumenthal M, Bosch J, Chrolavicius S, Li T, Ounpuu S, Perez AC, Sleight P, Svard R, Temple R, Tsouderous Y, Yunis C, Yusuf S (2008). Specific barriers to the conduct of randomized trials. Clinical Trials 5, 40–48. Goldacre B (2012). Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. Fourth Estate: London. Hayden EC (2012). Informed consent: a broken contract. Nature 486, 312–314. Leeson VC, Tyrer P (2013) The advance of research governance in psychiatry: one step forward, two steps back. Epidemiology and Psychiatric Sciences, in press.
323
Lloyd K, White J (2011). Democratizing clinical research. Nature 474, 277–278. Lloyd K, White J, Chalmers I (2012). Schizophrenia: patients’ research priorities get funded. Nature 487, 432. Roberts I, Prieto-Merino D, Shakur H, Chalmers I, Nicholl J (2011). Effect of consent rituals on mortality in emergency care research. Lancet 377, 1071–1072. Savulescu J, Chalmers I, Blunt J (1996). Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. British Medical Journal 313, 1390–1393. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology 62, 464– 475. Tosh G, Soares-Weiser K, Adams CE (2011). Pragmatic vs explanatory trials: the Pragmascope tool to help measure differences in protocols of mental health randomized controlled trials. Dialogues in Clinical Neuroscience 13, 209– 215. Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED (2013). Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. British Medical Journal Open 3, 2 DOI: i10.1136/ bmjopen-2012-002360.
