Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Introduction:
Despite consistently high discontinuation rates due to the withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and drop-out is limited. A better understanding of these factors could help to improve trial design and completion rates.
Methods:
Using data from 1136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) drop-out due to WOC and ITE, and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses.
Results:
ITE was associated with poor clinical improvement, investigator’s satisfaction with treatment, and patient’s insight into their own disease, whereas WOC only showed a meaningful association with a poor patient’s satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with PANSS positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association with satisfaction with treatment among investigators and patients, neither did a patient’s experienced psychopathology, or self-rating of functional impairment.
Conclusion:
Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient’s decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with treatment.
Original languageEnglish
Number of pages10
JournalCNS Spectrums
DOIs
Publication statusE-pub ahead of print - 2019

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@article{c5d704164c8f4569a07cb51ce28024eb,
title = "Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia",
abstract = "Introduction: Despite consistently high discontinuation rates due to the withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and drop-out is limited. A better understanding of these factors could help to improve trial design and completion rates. Methods: Using data from 1136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) drop-out due to WOC and ITE, and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. Results: ITE was associated with poor clinical improvement, investigator’s satisfaction with treatment, and patient’s insight into their own disease, whereas WOC only showed a meaningful association with a poor patient’s satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with PANSS positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association with satisfaction with treatment among investigators and patients, neither did a patient’s experienced psychopathology, or self-rating of functional impairment. Conclusion: Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient’s decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with treatment.",
author = "J.H. Schoemaker and A.J.J.M. Vingerhoets and Robin Emsley",
year = "2019",
doi = "10.1017/S109285291700044X",
language = "English",
journal = "CNS Spectrums",
issn = "1092-8529",
publisher = "Cambridge University Press",

}

Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia. / Schoemaker, J.H.; Vingerhoets, A.J.J.M.; Emsley, Robin.

In: CNS Spectrums, 2019.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

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AU - Vingerhoets, A.J.J.M.

AU - Emsley, Robin

PY - 2019

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N2 - Introduction: Despite consistently high discontinuation rates due to the withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and drop-out is limited. A better understanding of these factors could help to improve trial design and completion rates. Methods: Using data from 1136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) drop-out due to WOC and ITE, and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. Results: ITE was associated with poor clinical improvement, investigator’s satisfaction with treatment, and patient’s insight into their own disease, whereas WOC only showed a meaningful association with a poor patient’s satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with PANSS positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association with satisfaction with treatment among investigators and patients, neither did a patient’s experienced psychopathology, or self-rating of functional impairment. Conclusion: Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient’s decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with treatment.

AB - Introduction: Despite consistently high discontinuation rates due to the withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and drop-out is limited. A better understanding of these factors could help to improve trial design and completion rates. Methods: Using data from 1136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) drop-out due to WOC and ITE, and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. Results: ITE was associated with poor clinical improvement, investigator’s satisfaction with treatment, and patient’s insight into their own disease, whereas WOC only showed a meaningful association with a poor patient’s satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with PANSS positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association with satisfaction with treatment among investigators and patients, neither did a patient’s experienced psychopathology, or self-rating of functional impairment. Conclusion: Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient’s decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with treatment.

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