Hostname: page-component-78c5997874-t5tsf Total loading time: 0 Render date: 2024-11-10T06:22:39.820Z Has data issue: false hasContentIssue false
  • English
  • Français

The Importance of Non-biological Factors in Influencing the Outcome of Clinical Trials

Published online by Cambridge University Press:  06 August 2018

W. Gaebel
W. Gaebel*
Affiliation:
Psychiatrische Klinik der Heinrich-Heine-Universität, Rheinische Landes- und Hochschulklinik Düsseldorf, Bergische Landstrasse 2, D-40629 Düsseldorf Germany
Get access Rights & Permissions [Opens in a new window]

Abstract

The outcome of clinical drug trials is influenced both by biological and by non-biological factors. Non-biological factors can be subdivided into methodological factors and non-drug factors. The former are related to the definition and measurement of treatment course, response, and outcome itself; the latter cover characteristics of the patient, the treatment milieu, the patient's milieu apart from treatment, and (planned) psychosocial interventions. Although their mechanism of interaction with treatment outcome is not yet fully understood, these non-drug factors should be routinely monitored in clinical trials for three practical reasons: (a) to control for the heterogeneity of outcome; (b) to develop individualised outcome predictors; and (c) to promote the development of individualised guidelines for treatment indication.

Type
Research Article
Information
The British Journal of Psychiatry , Volume 163 , Issue S22: The Psychopharmacology of Schizophrenia , December 1993 , pp. 45 - 50
Copyright
Copyright © 1993 The Royal College of Psychiatrists 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Alpert, M. (1985) The signs and symptoms of schizophrenia. Comprehensive Psychiatry, 26, 103–112.Google Scholar
Awad, A. (1992) Quality of life of schizophrenic patients on medications and implications for new drug trials. Hospital and Community Psychiatry, 43, 262–265.Google Scholar
Barrowclough, C. & Tarrier, N. (1992) Interventions with families. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 79–101. Chichester: Wiley.Google Scholar
Birchwood, M., Macmillan, R. & Smith, J. (1992) Early intervention. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 115–145. Chichester: Wiley.Google Scholar
Carpenter, W. T., McGlashan, T. & Strauss, J. S. (1977) The treatment of acute schizophrenia without drugs: an investigation of some current assumptions. American Journal of Psychiatry, 134, 14–20.Google ScholarPubMed
Carpenter, W. T., Heinrichs, D. W. & Hanlon, T. E. (1981) Methodologic standards for treatment outcome research in schizophrenia. American Journal of Psychiatry, 138, 465–471.Google Scholar
Clarkin, J. F., Glick, I. D., Haas, G., et al (1991) The effects of inpatient family intervention on treatment outcome. In Psychiatric Treatment. Advances in Outcome Research (eds Mirin, S., Gossett, J. T. & Grob, M. C.), pp. 47–59. Washington: American Psychiatric Press.Google Scholar
Clements, K. & Turpin, G. (1992) Vulnerability models and schizophrenia: the assessment and prediction of relapse. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 21–47. Chichester: Wiley.Google Scholar
Engel, G. L. (1980) The clinical application of the biopsychosocial model. American Journal of Psychiatry, 137, 535–544.Google Scholar
Friis, S. (1986) Characteristics of a good ward atmosphere. Acta Psychiatrica Scandinavica, 74, 469–473.Google Scholar
Gaebel, W. & Linden, M. (1984) Kombination von Pharmakotherapie und Psychotherapie in der Behandlung depressiver Störungen. In Klinische Psychologic Trends in Forschung und Praxis (eds Baumann, U., Berbalk, H. & Seidenstücker, G.), Vol. 6, pp. 186–210. Bern: Huber.Google Scholar
Gaebel, W., Pietzcker, A. & Baumgartner, A. (1986) 3 year follow-up of schizophrenic patients – outcome dimensions and neuroleptic treatment. Pharmacopsychiatry, 19, 208–209.Google Scholar
Gaebel, W., Pietzcker, A. & Baumgartner, A. (1987) A prospective study of the course of illness in schizophrenic patients. Part III: Catamnestic treatment and outcome one year after clinic discharge. Schizophrenia Bulletin, 13, 307–316.Google Scholar
Gaebel, W., Pietzcker, A., Ulrich, G., et al (1988) Predictors of neuroleptic treatment response in acute schizophrenia. Pharmacopsychiatry, 21, 384–386.Google Scholar
Gaebel, W. & Renfordt, E. (1989) Objective methods for behavioral analysis in psychiatry and psychopharmacology – examples and concepts. Pharmacopsychiatry, 22 (suppl.), 1–50.Google Scholar
Goldberg, S. C., Schooler, N. R., Hogarty, G. E., et al (1977) Prediction of relapse in schizophrenic outpatients treated by drug and sociotherapy. Archives of General Psychiatry, 34, 171–184.Google Scholar
Goodman, A. (1991) Organic unity theory: the mind–body problem revisited. American Journal of Psychiatry, 148, 553–563.Google Scholar
Helmchen & Gaebel, W. (1987) Strategies of clinical research on neurobiological determinants of psychosis. Psychiatric Developments, 5, 51–62.Google Scholar
Hirsch, S. R., Bowen, J. T., Emami, J., et al (1993) The effect of life events and medication in the aetiology of schizophrenic relapse. Schizophrenia Research, 9, 266.Google Scholar
Hogan, T. & Awad, G. (1983) A self-report scale predictive of drug compliance in schizophrenics: reliability and discriminative ability. Psychological Medicine, 13, 177–183.CrossRefGoogle Scholar
Hogarty, G. E., Goldberg, S. C., Schooler, N. R., et al (1974) Drug and sociotherapy in the aftercare of schizophrenic patients: two year relapse rates. Archives of General Psychiatry, 31, 603–608.Google Scholar
Hogarty, G. E., McEvoy, J. P., Munetz, M., et al (1988) Dose of fluphenazine, familial expressed emotion, and outcome in schizophrenia. Archives of General Psychiatry, 45, 797–805.CrossRefGoogle ScholarPubMed
Hsiao, J. K., Bartko, J. J. & Potter, W. Z. (1989) Diagnosing diagnoses: receiver operating characteristic methods and psychiatry. Archives of General Psychiatry, 46, 664–667.Google Scholar
Johnson, D. A. W. (1984) Observations on the use of long-acting depot neuroleptic injections in the maintenance therapy of schizophrenia. Journal of Clinical Psychiatry, 45, 13–21.Google Scholar
Koenigsberg, H. W. & Handley, R. (1986) Expressed emotion: from predictive index to clinical construct. American Journal of Psychiatry, 143, 1361–1373.Google Scholar
Leff, J. P. (1985) Social factors and maintenance neuroleptics in schizophrenic relapse: an integrative model. Integrative Psychiatry, 3, 72–88.Google Scholar
Leff, J. P. & Vaughn, C. (1981) The role of maintenance therapy and relatives’ expressed emotion in relapse of schizophrenia: a two-year follow-up. British Journal of Psychiatry, 139, 102–104.CrossRefGoogle ScholarPubMed
MacMillan, J. F., Gold, T. J., Crow, T. J., et al (1986) IV. Expressed emotion and relapse. British Journal of Psychiatry, 148, 133–143.CrossRefGoogle Scholar
May, P. R. A. & Goldberg, S. C. (1978) Prediction of schizophrenic patients’ response to pharmacotherapy. In Psychopharmacology: a Generation of Progress (eds Lipton, M. A., Dimascio, A. & Killam, K. F.). New York: Raven Press.Google Scholar
Moos, R. & Schwartz, J. (1972) Treatment environment and treatment outcome. Journal of Nervous and Mental Disease, 154, 264–275.Google Scholar
Moos, R., Shelton, R. & Petty, C. H. (1973) Perceived ward climate and treatment outcome. Journal of Abnormal Psychology, 82, 291–298.Google Scholar
Pietzcker, A. & Gaebel, W. (1983) Prediction of ‘natural’ course, relapse, and prophylactic response in schizophrenic patients. Pharmacopsychiatry, 16, 206–211.Google Scholar
Shapiro, A. K. (1969) Iatroplacebogenics. International Pharmacopsychiatry, 2, 215–248.Google Scholar
Spadoni, A. J. & Smith, J. A. (1969) Milieu therapy in schizophrenia. Archives of General Psychiatry, 20, 547–551.Google Scholar
Strauss, J. S. & Carpenter, W. T. (1974) The prediction of outcome in schizophrenia – II. Relationships between predictor and outcome variables. Archives of General Psychiatry, 31, 37–42.CrossRefGoogle ScholarPubMed
Tuma, H., May, P. R. A., Yale, C., et al (1978) Therapist characteristics and the outcome of treatment in schizophrenia. Archives of General Psychiatry, 35, 81–985.Google Scholar
Vaccaro, J. V. & Roberts, L. (1992) Teaching social and coping skills. In Innovations in the Psychological Management of Schizophrenia (eds Birchwood, M. & Tarrier, N.), pp. 103–114. Chichester: Wiley.Google Scholar
Van Praag, H. M., Kahn, R. S., Asnis, G. M., et al (1987) Denosologization of biological psychiatry or the specificity of 5-HT disturbances in psychiatric disorders. Journal of Affective Disorders, 13, 1–8.Google Scholar
Van Putten, T. & May, P. R. A. (1978) Subjective response as a predictor of outcome in pharmacotherapy. Archives of General Psychiatry, 35, 477–480.CrossRefGoogle ScholarPubMed
Vaughn, C. E. & Leff, J. P. (1976) The influence of family and social factors on the course of psychiatric illness. British Journal of Psychiatry, 129, 125–137.CrossRefGoogle ScholarPubMed
Vaughn, C. E., Snyder, K. S., Freeman, W., et al (1982) Family factors in schizophrenic relapse: a replication. Schizophrenia Bulletin, 8, 425–426.Google Scholar
Wing, J. K. (1978) The social context of schizophrenia. American Journal of Psychiatry, 135, 1333–1339.Google Scholar
World Health Organization (1979) Schizophrenia: an International Follow-up Study. WHO/Geneva: Wiley & Sons.Google Scholar
Submit a response

eLetters

No eLetters have been published for this article.