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Delirium Research Sections
Author Bio
Introduction
Definition And Clinical Features
Patient Population
Consent For Participation
Assessment for Delirium
Clinical Characteristics And Etiology
Management of Delirium
Currently selected section: Other Study Implications
Conclusion
Chapter 5: Delirium Research Questions: Implications For Study of Other Symptoms
        

The prevalence of delirium in cancer patients near the end of life has implications for studies of other symptomatic interventions; in addition, it interferes with the assessment of symptoms.

Question 8.1

You wish to do a study on the effects of fish oil on cachexia in cancer patients. Which patients would you include in the study?

Selection AAll patients who can read and sign the consent form
Selection BOnly patients with normal cognitive function on formal assessment
Selection CPatients who do not appear confused to a physician and research nurse and who can read and sign a consent form

71 patients approached, 67 consented. Of the 67 consented, 13 (or 19%) had MMSE values less than 24/30. 8 of the 13 (or 62%) dropped out before the study completed. Of the 67 consented, 54 (or 81%) had MMSE values greater than or equal to 24/30 (p of .01, chi squared test). 6 of the 54 (or 11%) dropped out before the study completed (p of .01, chi squared test).

In another study, mini-mental state examination (MMSE) (Folstein et al., 1975) was used to assess cognitive function after patients were entered in the trial. Values of 24/30 are regarded as normal. All patients fulfilled requirements for adequate interpretation of the results of the MMSE (had good knowledge of English and at least grade 8 education). 13 of 67 patients (19%) who agreed to participate in a clinical trial had cognitive failure as measured by the MMSE. The principal investigator or a research nurse had not detected cognitive impairment in these patients. The fact that a patient is not able to complete the MMSE does not necessarily imply that he is unable to adequately judge participation in a clinical trial. However, cognitive deficits raise significant concern about some patients’ ability to completely understand the study, and the high dropout rate observed due to complications or noncompliance gives cause for concern and raises ethical issues.

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