Lung cancer patients’ perceptions of informed consent documents

Sand, Kari; Loge, Jon Håvard; Berger, Ola; Grønberg, Bjørn Henning; Kaasa, Stein

doi:10.1016/j.pec.2008.06.011

Cited by 20 publications

(24 citation statements)

References 16 publications

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“…Concerning specific aspects of a clinical trial, such as the understanding of side effects and randomisation, our survey found that 40% of patients were able to report some potential side effects, whereas only 16% and 21% of patients, respectively, were able to recall study examinations and additional procedures such as blood sampling, which are more specific but less relevant aspects of the clinical trial 13. Moreover, in line with other studies, we observed that very few patients understood the randomisation procedure 10.…”

Section: Resultsmentioning

confidence: 93%

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Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

et al. 2013

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We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

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Section: Resultsmentioning

confidence: 93%

“…It was also observed that both age and educational level were associated with a higher level of comprehension 13. This may suggest a need for greater care in explaining clinical trials to the elderly.…”

Section: Discussionmentioning

confidence: 92%

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

et al. 2013

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“…An influential strain in the bioethics literature on clinical trials is devoted to revealing research participants' failure to appreciate that research and health care serve fundamentally different goals (Featherstone and Donovan, 2002;Brown et al, 2004;Bergenmar et al, 2008;Sand et al, 2008;Hereu et al, 2010;McCann et al, 2010;Behrendt et al, 2011;Sanchini et al, 2013). To explain this phenomenon, Appelbaum et al's concept of "therapeutic misconception" (Appelbaum et al, 1987;Lidz et al, 2004) is often evoked (Miller, 2000;Featherstone and Donovan, 2002;Miller and Rosenstein, 2003;Canvin and Jacoby, 2006).…”

Section: From Principles To Practice: Moral Friction In Clinical Resementioning

confidence: 99%

Beyond the ‘therapeutic misconception’: Research, care and moral friction

Wadmann

Hoeyer

2014

BioSocieties

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In research ethics regulation, health care and research are depicted as serving distinct goals, and policies are in place to prevent what is seen as patients' misconceived understanding of research as health care. On the basis of ethnographic research in four Danish hospitals in conjunction with a cardiovascular drug trial in patients with chronic disease, we argue that the objectives of health care and research often merge in mutually constitutive practices. We build on observations of trial activities, interviews with physician-investigators, research nurses, patient-participants and trial sponsors and a survey of the patient-participants. We found an organization of clinical drug trials allowing extraordinary care relationships to form, which makes trial participation attractive for patients and allows information to flow more freely. However, the research-care intermingling generates moral concerns for those involved. We conceptualize these concerns as a productive moral friction resulting from research staff caring too much for patients. We identify four situations in which friction arises: when care-giving comes to replace specialist contact, when caring for individuals appears unfair for the collective, when care motives may be doubted and when patients invent their own ways of helping staff in order to reciprocate their care. We conclude that the presentation of the research-care tension as an ethical dilemma is misleading and even part of the problem that must be dealt with by those involved.

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“…For the author of an ICD, initiating a document with background information might be familiar, since it typically comprises the first part of other genres in the research community, such as research articles and protocols. However, it might not necessarily be an appropriate introduction in ICDs, which have a patient audience, since it might indicate that the ICD first and foremost is oriented towards the reader's disease and treatment instead of a document concerning research, including a request for the reader to participate in that research (even if information about diagnosis and treatment is probably considered as very relevant and important for most patients [Sand et al, 2008]). …”

Section: Research-oriented New Icdsmentioning

confidence: 99%

“…Some of the details given in the ICDs appear to be addressed to the ethics review board, rather than the patient, for example the details concerning who is involved in data processing, the acts that regulate processing and storage of the data, sources of finance, and all approving authorities. In a previous study of subjects' evaluation of ICDs, we found that lung cancer patients eligible for a clinical trial were most interested in practical information concerning which hospital they would go to for treatment, who was going to perform the blood tests, and who they might contact if they had questions (Sand et al, 2008). The readability of an ICD can be improved if the information is more clearly directed towards the main reader: the eligible trial participant.…”

Section: Complex Cast Of Characters In Icdsmentioning

confidence: 99%

Readability of Informed Consent Documents (1987–2007) for Clinical Trials: A Linguistic Analysis

Sand

Eik-Nes

Loge

2012

Journal of Empirical Research on Human Research Ethics

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We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987-1992 and ten from 2006-2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: main themes, order of themes, rhetorical functions, the relationship between reader and writer, metadiscourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.

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Lung cancer patients’ perceptions of informed consent documents

Cited by 20 publications

References 16 publications

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension

Beyond the ‘therapeutic misconception’: Research, care and moral friction

Readability of Informed Consent Documents (1987–2007) for Clinical Trials: A Linguistic Analysis

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