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• Why clozapine therapy, long acting injectable antipsychotics and community treatment orders may be effective in clinical practice, but not in research trials
  Feras A Mustafa
  Published on: 7 April 2017

• Published on: 7 April 2017

  Why clozapine therapy, long acting injectable antipsychotics and community treatment orders may be effective in clinical practice, but not in research trials

  • Feras A Mustafa, Psychiatrist Northamptonshire Healthcare NHS Foundation Trust

  In their cross sectional examination of a large sample of people with psychosis, Rashmi Patel and colleagues point out that patients who are approached to participate in research have better HoNOS scores and fewer inpatient days, and are less likely to have been compulsorily hospitalised (1). This may produce a potential selection bias towards less unwell patients, resulting in false negative outcomes in studies aimed at evaluating interventions for patients with more severe conditions, such as clozapine therapy (2), long acting injectable antipsychotics (3) and community treatment orders (4,5).
  Clinical research trials that fail to recruit patients with severe psychosis can result in flawed outcomes, potentially misleading clinicians and policy makers and causing harm to patients, not to mention the waste of increasingly scarce research resources. Academics, clinicians, ethics committees and patient groups should work together to resolve this problem.
  References
  1. Patel R, Oduola S, Callard F, et al. What proportion of patients with psychosis is willing to take part in research? A mental health electronic case register analysis. BMJ Open 2017;7(3):e013113.
  2. Taylor DM. Clozapine for treatment-resistant schizophrenia: still the gold standard? CNS Drugs 2017;31(3):177-180.
  3. Kane JM, Kishimoto T, Correll CU. Assessing the comparative effectiveness of long-acting injectable vs oral antipsychotic medications in the prevention of relapse provi...

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  In their cross sectional examination of a large sample of people with psychosis, Rashmi Patel and colleagues point out that patients who are approached to participate in research have better HoNOS scores and fewer inpatient days, and are less likely to have been compulsorily hospitalised (1). This may produce a potential selection bias towards less unwell patients, resulting in false negative outcomes in studies aimed at evaluating interventions for patients with more severe conditions, such as clozapine therapy (2), long acting injectable antipsychotics (3) and community treatment orders (4,5).
  Clinical research trials that fail to recruit patients with severe psychosis can result in flawed outcomes, potentially misleading clinicians and policy makers and causing harm to patients, not to mention the waste of increasingly scarce research resources. Academics, clinicians, ethics committees and patient groups should work together to resolve this problem.
  References
  1. Patel R, Oduola S, Callard F, et al. What proportion of patients with psychosis is willing to take part in research? A mental health electronic case register analysis. BMJ Open 2017;7(3):e013113.
  2. Taylor DM. Clozapine for treatment-resistant schizophrenia: still the gold standard? CNS Drugs 2017;31(3):177-180.
  3. Kane JM, Kishimoto T, Correll CU. Assessing the comparative effectiveness of long-acting injectable vs oral antipsychotic medications in the prevention of relapse provides a case study in comparative effectiveness research in psychiatry. J Clin Epidemiol 2013;66(8):S37–S41.
  4. Mustafa FA. Non-consent bias in OCTET. Lancet Psychiatry 2015;2(12):e33.
  5. Mustafa FA. Notes on the use of randomised controlled trials to evaluate complex interventions: community treatment orders as an illustrative case. J Eval Clin Pract 2017;23(1):185-192.

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  Conflict of Interest:
  None declared.

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