Time, tenacity and trials: improving the quality of research
Medical research studies are increasing in number but evaluating efficacy, effectiveness, and public health impact of new interventions remains difficult because of inconsistent reporting in scientific journals. The CONSORT guidelines for reporting randomised trials were recommended over 15 years ago,1 and were adopted by many journals across disciplinary boundaries and specialties.2-5 The guidelines have clear implications for trial design and execution.6 Further guidelines have emerged for the reporting of systematic reviews and observational studies.7 These guidelines aim to improve transparency in research to inform decisions about clinical effectiveness and treatment recommendations. Have these guidelines had sufficient impact on the reporting and the accessibility of research to the wider public, as well as clinicians and researchers? It appears that the answer to this is no, at least not in psychiatry8,9 nor for pharmacological10 and nonpharmacological trials in general,11 for trials of treatments for cancer12 nor for some trials in anaesthetics.13 Psychiatric studies are especially challenging as the trials can include pharmacological and non-pharmacological interventions, devices, surgery, psychological treatments, complex multi-component interventions in hospital or community settings, public health and policy interventions in single or cluster randomised designs, and more. Are these multiple study designs a reason why the guidelines are not more widely used in mental health research? The CONSORT group have been busy generating evidence for effective ways of improving uptake of the guidelines, not least creating guidelines for parallel group designs,14 social and psychological interventions,15 addictions research,16 trials in child and adolescent mental health services,17 cluster randomised trials of those with cognitive impairment,18 and pragmatic trials in general.19
The number of trials in psychiatric and mental health research is increasing, as seen in the trends in the BJPsych; for example, Chien & Thompson (pp. 52-59) in this month’s Journal show that mindfulness-based group psychoeducation for patients with schizophrenia leads to improvement in symptoms, function, insight and readmissions profile at 2-year follow-up. Other designs are still needed in psychiatric and mental health research; for example, in this issue there are studies that seek to identify biomarkers to improve diagnosis (see Howes & Kapur, pp. 1-3; Pearlman et al, pp. 8-16; and Li et al, pp. 29-35), and to understand aetiology and developmental pathways to mental disorders in order to identify new interventions (Stringaris et al, pp. 17-23; Hung et al, pp. 24-28; Gumley et al, pp. 60-67; Muralidharan et al, pp. 36-43). Two important issues are raised by observational studies that show a higher mortality risk associated with antipsychotic use in people with cognitive impairment (see Gerhard et al, pp. 44-51 and the linked editorial by Ballard et al, pp. 4-5) and in behavioural management in people with intellectual disabilities (see editorial by Glover et al, pp. 6-7). Prescribing without any scientific rationale is still common, so better evidence is needed about mechanisms by which psychiatric illness emerges and can be prevented and treated.
The skills, tenacity, temperament and time required to progress research along the pathway towards new and effective interventions always seem more than patients, researchers, clinicians, commissioners and policy makers would like. As a refreshing counterpoint to this proliferation of best evidence, Patterson et al (pp. 68-75) argue that including service users in research can lead to realisation of benefits. Indeed, the way research is assessed for impact is rapidly evolving, and patient involvement in both the design and execution of clinical research may well be the way we can be assured of more meaningful progress20 while ensuring that the evidence-based agenda remains relevant to everyday experiences of patients and clinicians.21
- Royal College of Psychiatrists