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Article

A tolerability burden index in schizophrenia: incorporating patient perspective in clinical trial adverse event reporting

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Article: 1372026 | Received 27 Mar 2017, Accepted 21 Aug 2017, Published online: 13 Sep 2017

References

  • Voruganti L, Cortese L, Oyewumi L, et al. Comparative evaluation of conventional and novel antipsychotic drugs with reference to their subjective tolerability, side-effect profile and impact on quality of life. Schizophr Res. 2000;43:1–10.
  • Ashoorian D, Davidson R, Rock D, et al. A review of self-report medication side effect questionnaires for mental health patients. Psychiatry Res. 2014;219:664–673.
  • Hamer S, Haddad PM. Adverse effects of antipsychotics as outcome measures. Br J Psychiatry Suppl. 2007;50:s64–s70.
  • Weiden PJ. Discontinuing and switching antipsychotic medications: understanding the CATIE schizophrenia trial. J Clin Psychiatry. 2007;68(Suppl 1):12–19.
  • Pritchett YL, Tamura R. Global benefit-risk assessment in designing clinical trials and some statistical considerations of the method. Pharm Stat. 2008;7:170–178.
  • Cha DS, McIntyre RS. Treatment-emergent adverse events associated with atypical antipsychotics. Expert Opin Pharmacother. 2012;13:1587–1598.
  • Rapaport M, Barbato LM, Heisterberg J, et al. Efficacy and safety of bifeprunox versus placebo in the treatment of patients with acute exacerbations of schizophrenia. Presented at: American College of Neuropsychopharmacology, 2006 Dec 3–7; Hollywood, FL, USA.
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382:951–962.
  • Young SL, Taylor M, Lawrie SM. “First do no harm.” A systematic review of the prevalence and management of antipsychotic adverse effects. J Psychopharmacol. 2015;29:353–362.
  • Leucht S, Corves C, Arbter D, et al. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009;373:31–41.
  • Dunayevich E, Ascher-Svanum H, Zhao F, et al. Longer time to antipsychotic treatment discontinuation for any cause is associated with better functional outcomes for patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder. J Clin Psychiatry. 2007;68:1163–1171.
  • Thomas P. The stable patient with schizophrenia – from antipsychotic effectiveness to adherence. Eur Neuropsychopharmacol. 2007;17(Suppl 2):S115–22.
  • Bech P. Quality of life measurements in chronic disorders. Psychother Psychosom. 1993;59:1–10.
  • Bech P. Quality of life measurement in the medical setting. Eur Psychiatry. 1995;10(Suppl 3):83s–5s.
  • Gerlach J, Korsgaard S, Clemmesen P, et al. The St. Hans Rating Scale for extrapyramidal syndromes: reliability and validity. Acta Psychiatr Scand. 1993;87:244–252.
  • Wolters HA, Knegtering H, Van Den Bosch RJ, et al. Effects and side effects of antipsychotic treatment in schizophrenia: pros and cons of available self-rating scales. Schizophr Res. 2009;112:114–118.
  • Waddell L, Taylor M. A new self-rating scale for detecting atypical or second-generation antipsychotic side effects. J Psychopharmacol. 2008;22:238–243.
  • Lingjaerde O, Ahlfors UG, Bech P, et al. The UKU side effect rating scale: a new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987;334:1–100.
  • Day JC, Wood G, Dewey M, et al. A self-rating scale for measuring neuroleptic side-effects. Validation in a group of schizophrenic patients. Br J Psychiatry. 1995;166:650–653.
  • Weiden PJ, Miller AL. Which side effects really matter? Screening for common and distressing side effects of antipsychotic medications. J Psychiatr Pract. 2001;7:41–47.
  • Bebbington PE, Angermeyer M, Azorin JM, et al. Side-effects of antipsychotic medication and health-related quality of life in schizophrenia. Acta Psychiatr Scand Suppl. 2009;22–28.
  • McTaggart-Cowan HM, Shi P, Fitzgerald JM, et al. An evaluation of patients’ willingness to trade symptom-free days for asthma-related treatment risks: a discrete choice experiment. J Asthma. 2008;45:630–638.
  • Seston EM, Ashcroft DM, Griffiths CE. Balancing the benefits and risks of drug treatment: a stated-preference, discrete choice experiment with patients with psoriasis. Arch Dermatol. 2007;143:1175–1179.
  • Harris G. Wife’s cancer prods F.D.A. on new drugs. New York Times. January 3, 2016;A: 1.
  • Xiao C, Polomano R, Bruner DW. Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nurs. 2013;36:E1–E16.
  • Laugsand EA, Sprangers MA, Bjordal K, et al. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010;8:104.