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      Perceived Patient Comprehension in Acute and Chronic Cardiovascular Clinical Trials


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          An anonymous patient perception comprehension and satisfaction questionnaire was sent to 438 patients 1–3 months after they had participated in a clinical cardiovascular trial to examine the level of patient comprehension as perceived by the patient. We compared perceived comprehension in acute (acute myocardial infarction) and chronic (outpatient heart failure) clinical trials. Partially or fully completed questionnaires were received from 220 patients (70 chronic, 150 acute). The findings were similar in the 2 patient groups. Perceived full comprehension (understood most or all) of the trial was reported by 18 (27%) of chronic and 40 (31%) of 129 acute patients, while almost 20% of both groups reported little or no understanding of the trial. The level of comprehension was related to the recollected duration of explanation (p = 0.003 chronic, p < 0.001 acute). Perceived comprehension was not related to the personnel explaining the study (physician or nurse) or to whether the explanation as recollected was oral or written. However, in both acute and chronic patients, the majority (51% chronic; 63% acute) preferentially recalled the oral rather than written explanation of the trial. The very similar findings in the acute and chronic situation suggest that perceived understanding reflects human nature and willingness to be involved in medical issues. Considerable effort should be directed to improve the duration of explanation (particularly oral), if we are to achieve our goal of true informed consent in clinical cardiovascular trials.

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          Quality of informed consent in cancer clinical trials: a cross-sectional survey.

          Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.
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            ISIS-4: A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction

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              Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction.

              Although randomized clinical trials are currently the standard for the evaluation of new therapeutic strategies, little attention has been paid to the viewpoint of the patients recruited to these trials. To examine the perspective of the Israeli patient cohort who participated in the Fourth International Study of Infarct Survival, a randomized trial in acute myocardial infarction. A patient questionnaire was mailed to 360 Israeli patients who participated in the Fourth International Study of Infarct Survival and was returned by 150 of them. Main outcome measures included patient perception of consent procedures, comprehension of the study, subjective reaction to participating in the trial, and interest in present and future trials. Forty (31%) of 129 patients perceived that they had full comprehension of the trial, while 64 (50%) claimed partial understanding and 25 (19%), no understanding at all. Comprehension was related to a recollected explanation of 5 minutes or more (P<.001) and to an opportunity for discussion at the time of consent (P<.001). Most patients recollected the oral explanation; fewer, the written material. Patient consent was given by 64 (43%) of 150 patients in the hope of better treatment. In 36 cases (25%), the patients felt they received better treatment because of participation in the trial. Despite proper attention to accepted ethical and legal standards, perceived patient comprehension in this trial in acute myocardial infarction was incomplete or lacking in a considerable number of subjects. Much progress must be made toward the goal of true informed consent in clinical trials.

                Author and article information

                S. Karger AG
                April 2003
                25 April 2003
                : 99
                : 2
                : 68-71
                Cardiovascular Clinical Trials Unit, Department of Cardiovascular Medicine, Lady Davis Carmel Medical Center and the Bruce Rappaport School of Medicine, Technion-IIT, Haifa, Israel
                69729 Cardiology 2003;99:68–71
                © 2003 S. Karger AG, Basel

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                Page count
                Tables: 1, References: 11, Pages: 4
                General Cardiology – Basic Science


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