What proportion of patients with psychosis is willing to take part in research? A mental health electronic case register analysis

Abstract

Objective: The proportion of people with mental health disorders who participate in clinical research studies is much smaller than for those with physical health disorders. It is sometimes assumed that this reflects an unwillingness to volunteer for mental health research studies. We examined this issue in a large sample of patients with psychosis.

Design: Cross-sectional study.

Setting: Anonymised electronic mental health record data from the South London and Maudsley NHS Foundation Trust (SLaM).

Participants: 5787 adults diagnosed with a psychotic disorder.

Exposure: Whether approached prior to 1 September 2014 for consent to be approached about research participation.

Main outcome measures: Number of days spent in a psychiatric hospital, whether admitted to hospital compulsorily, and total score on the Health of the Nation Outcome Scale (HoNOS) between 1 September 2014 and 28 February 2015 with patient factors (age, gender, ethnicity, marital status and diagnosis) and treating clinical service as covariates.

Results: 1187 patients (20.5% of the total sample) had been approached about research participation. Of those who were approached, 773 (65.1%) agreed to be contacted in future by researchers. Patients who had been approached had 2.3 fewer inpatient days (95% CI -4.4 to -0.3, p=0.03), were less likely to have had a compulsory admission (OR 0.65, 95% CI 0.50 to 0.84, p=0.001) and had a better HoNOS score (β coefficient -0.9, 95% CI -1.5 to -0.4, p=0.001) than those who had not. Among patients who were approached, there was no significant difference in clinical outcomes between those agreed to research contact and those who did not.

Conclusions: About two-thirds of patients with psychotic disorders were willing to be contacted about participation in research. The patients who were approached had better clinical outcomes than those who were not, suggesting that clinicians were more likely to approach patients who were less unwell.

Keywords: C4C; CRIS; bipolar disorder; clinical research; consent.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: the CRIS team MB and RS have received research funding from Roche, Pfizer, Johnson & Johnson and Lundbeck. PM has received research funding from Janssen, Sunovion, GW and Roche.

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