Informed Consent in the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial: A Survey of Collaborating Physicians

Fukui, Tsuguya; Rahman, Mahbubur; Morita, Satoshi; Sakamoto, Junichi

doi:10.1291/hypres.29.471

Cited by 4 publications

(4 citation statements)

References 7 publications

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“…It seems appropriate for physicians to utilize various methods in order to improve their relationship with patients, especially in terms of availability for answering their questions. One way of addressing this concern is to educate physicians about the best ways to communicate with their patients and obtain informed consent (Daugherty 1999;Fukui et al 2006). Although patients' reluctance to participate in decision making has been blamed as a factor for providing insufficient information (Lo 2000;Yousef et al 2007), studies have not shown that the patients are unwilling to receive more information (Howlader et al 2004;McKeague and Windsor 2003;San et al 2000).…”

Section: Discussionmentioning

confidence: 99%

“…Braddock (2000, 247-251) introduced five characteristics of informed consent: decision-making capacity, absence of manipulation or coercion, adequate information, adequate understanding, and opportunity to express preferences. Furthermore, communication skills and the doctor-patient relationship are cited as important elements of informed consent (Fukui et al 2006;Simon 2004). We consider six components for an ideal informed consent process: information disclosure, comprehensibility of information, voluntariness, decision-making capacity (including legal competency), consenting to the treatment, and an established physician-patient relationship.…”

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confidence: 99%

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Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study

Sheikhtaheri

Farzandipour

2010

AJOB Primary Research

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Informed consent is regarded as a pillar of medical ethics. The purpose of this study was to evaluate perceptions of the informed consent process prior to surgery. Three hundred elective surgery patients were randomly selected from three teaching hospitals in Kashan, Iran, and asked to complete a questionnaire about four key aspects of the informed consent process: information disclosure, voluntariness, comprehension, and their relationship with physicians. Data were scored and analyzed using univariate and multivariate methods. Based on the responses, the perceived quality of information disclosure (7.96 ± 4.9 out of 18 points), comprehension of the consent form (0.55 ± 1.1 out of 4 points), and voluntariness (1.73 ± 2.1 out of 8 points) were considered to be unacceptable and the perceived quality of the physician-patient relationships (10.6 ± 4.1 out of 14 points) acceptable. Most of the participants (88.7%) reported that they had requested to be informed about the complications of the surgical procedures, including severe complications such as death, but most of them did not receive this information. The most important factors associated with the perceived quality of informed consent were the patient's level of education and type of surgery. In conclusion, practices consistent with the principles of informed consent have not been adequately implemented in the surgical departments of these hospitals in Kashan. To improve current practices, patients should receive more information about the risks and benefits of surgery as well as any available alternatives. Information about the expected length of hospital stay, post-discharge follow-up, and the cost of surgery should also be provided to patients. To improve the perceived quality of the informed consent process, more emphasis should be placed on ensuring that patients receive the requested information in a manner they can comprehend. Redesigning consent forms may be an important step in improving the patients' experience of the informed consent process.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study

Sheikhtaheri

Farzandipour

2010

AJOB Primary Research

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“…) Extraction and investigation of observational studies on IC in Japan Thirty-two of 89 Japanese studies had abstracts. Among the 32 articles, 17 that reported observational studies on IC for participation in clinical trials using a questionnaire or an interview of patients, doctors or co-medicals were extracted [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] . Most of them dealt with IC for trials for new drug application(NDA) .…”

Section: Forummentioning

confidence: 99%

“…Six , and the others studied aspects of IC for clinical trials, such as preference of physicians to recruit participants 5,17) , perception of pediatric nurses with regard to competency 8) , use of videotape instruction for clinical trials 18) and communication training for CRC 19) . Articles onthe contribution of a CRC in clinical trials revealed the factors that participants and physicians recognized as merits in the clinical trials and their impressions of a CRC 4,6,[11][12][13]16) .…”

Section: Forummentioning

confidence: 99%