FACTORS INFLUENCING RECRUITMENT TO A UK RANDOMISED CONTROLLED TREATMENT TRIAL; THE ROLE OF PATIENT-PREFERENCE

Autor: Sonia Shahper, Srinivas Gopi, Sukhwinder Kaur, Karen Irvine, Sally Otto, Ricky A. Sachdev, Naomi A. Fineberg, David Wellsted, Jemma Reid, Jasmine Hanson, Yana Varlakova, Virender Marwah, Solange Wyatt, Thanusha Balakumar, Davis Mpavenda, Tim M. Gale
Rok vydání: 2018
Předmět:
Zdroj: European Neuropsychopharmacology. 28:764-765
ISSN: 0924-977X
DOI: 10.1016/j.euroneuro.2017.10.006
Popis: Background Recruitment to target is a major challenge for randomised controlled treatment trials (RCTs) in psychiatry. Strong patient preference may hamper recruitment of protocol-eligible participants, thereby compromising statistical power and limiting the external validity and generalisability of study findings to target populations. The Optimal Treatment in OCD (OTO) is a UK non-placebo feasibility trial of CBT and sertraline (two standard treatments) and their combination, randomly allocated, designed to ascertain the optimal community-based treatment for OCD. OTO aims to provide information about relevant design issues, to optimise feasibility of the definitive trial. Aim To identify the factors influencing recruitment to the RCT. Methods The study was approved by the relevant NHS ethics committee. Adult OCD outpatients were recruited at three UK centres. They were identified from routine referrals, primary healthcare services, community mental health clinics, other clinics attracting high levels of OCD, trust databases of patients likely to be suffering with OCD and the use of promotional materials. Patients subjected to screening were given detailed information about the treatments. Flexible and responsive clinical support was offered for the trial duration. Those eligible candidates declining to consent to participate were asked for their reasons. We report the data from one centre. Results 86 individuals satisfied the trial eligibility criteria. Of these, only 24 (27.9%) agreed to participate in the study. Of the remaining 62 (72.1%) who refused to participate, 35 (56.5%) gave treatment-related reasons. The commonest treatment-related reason was refusal to take pharmacological treatment (N=17; 27.4% all refusers). 12 of these individuals refused medication in general, while 5 refused sertraline. Another 8 (12.9% all refusers), showed a clear preference for CBT. However, 10 (16.1% all refusers) declined because they were reluctant to discontinue ongoing medication prior to randomisation. Conclusions and Future Directions Treatment–related preferences constituted a major obstacle to the recruitment of UK OCD patients to a non-placebo RCT of standard pharmacotherapy and CBT, to the extent that only 27.9% eligible patients were actually randomised. Over 40% (40.3%) of those refusing to enter the study gave as the reason a reluctance to receive pharmacotherapy or a bias toward receiving CBT, while 16.1% refused washout. These choices occurred despite patients being informed of the current evidence suggesting equivalent clinical effectiveness for CBT and SSRI and being offered clinical support during the washout phase. Trial designs that account for patient preference e.g. ‘patient-preference RCT’ ‘or ‘comprehensive cohort’ designs (Brewin & Bradley, 1989) or omit washout may increase recruitment but have methodological limitations. RCTs should gather information on the effect of pre-randomisation preference on outcomes to inform better trial design (Torgerson, Klaber-Moffett & Russell, 1996). New approaches to overcome public prejudice toward psychopharmacology are also needed to support robust trial design in psychiatry.
Databáze: OpenAIRE
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