Informed consent during the clinical emergency of acute myocardial infarction (HER0-2 consent substudy): a prospective observational study

Williams, Barbara F.; French, John K.; White, Harvey D.

doi:10.1016/s0140-6736(03)12773-0

Cited by 111 publications

(89 citation statements)

References 14 publications

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“…In the HERO-2 consent sub-study, only a small minority of patients (6%) were unable to remember the consent process. This difference of rate of recall may be due to the different times elapsed between the consent process and the second interview of the studies [15]. In other studies including patients with acute myocardial infarction, the rates of lack of recall were similar to our rate.…”

Section: Discussionsupporting

confidence: 82%

Informed consent for research in ICU obtained before ICU admission

2006

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in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. Conclusions: Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.

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Section: Discussionsupporting

confidence: 82%

Informed consent for research in ICU obtained before ICU admission

2006

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“…The following is a sample of readability studies that used formulas: political literature (Zingman 1977), corporate annual reports (Courtis 1987), customer service manuals (Squires and Ross 1990) drivers' manuals (Stahl and Henk 1995), dental health information (Alexander 2000), palliative-care information (Payne et al 2000), research consent forms (Hochhauser 2002;Mathew 2002;Paasche-Orlow et al 2003), informed consent forms (Williams et al 2003) online health information (Oermann and Wilson 2000), lead-poison brochures (Endres et al 2002) online privacy notices (Graber et al 2002) medical journals (Weeks and Wallace 2002), environmental health information (Harvey and Fleming 2003) and mental-health information (King et al 2003). Fry (1989a) points out that the validity of the formulas has been challenged in court and found suitable for legal purposes.…”

Section: Formula Applicationsmentioning

confidence: 99%

Measuring translation difficulty

Sun

Shreve

2014

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The Principles of Readability gives a brief introduction to the literacy studies in the U.S. and the research on readability and the readability formulas. Readers' CommentsPlease send all comments and suggestions regarding this document to:William RESEARCH SummaryOver 80 years of research and testing have contributed to the worldwide use in many languages of the readability formulas.They help us improve the text on the level of words and sentences, the first causes of reading difficulty.The principles of readability are in every style manual. Readability formulas are in every word processor. What is missing is the research and theory on which they stand. The Principles of ReadabilityWilliam H. DuBay IntroductionIn 1998, traffic accidents caused 46 percent of all accidental deaths of infants and children aged 1 to 14 (National Center for Health Statistics, 2000). One study (Johnston et al. 1994) showed that the single strongest risk factor for injury in a traffic accident is the improper use of child-safety seats. Another study (Kahane 1986) showed that, when correctly used, child safety seats reduce the risk of fatal injury by 71 percent and hospitalization by 67 percent.To be effective, however, the seats must be installed correctly. Other studies, showed that 79 to 94 percent of car seats are used improperly (National Highway Traffic Safety Administration 1996, Decina and Knoebel 1997, Lane et al. 2000.Public-health specialists Dr. Mark Wegner and Deborah Girasek (2003) suspected that poor comprehension of the installation instructions might contribute to this problem. They looked into the readability of the instructions and published their findings in the medical journal Pediatrics. The story was covered widely in the media.The authors referred to the National Adult Literacy Study (National Center for Educational Statistics, 1993), which states the average adult in the U.S. reads at the 7 th grade level. They also cited experts in health literacy who recommend that materials for the public be written at the fifth or sixth-grade reading level (Doak et al., 1996;Weiss and Coyne, 1997).Their study found that the average reading level of the 107 instructions they examined was the 10 th grade, too difficult for 80 percent adult readers in the U.S. When texts exceed the reading ability of readers, they usually stop reading. The authors did not address the design, completeness, or the organization of the instructions. They did not say that the instructions were badly written. Armed with the SMOG readability formula, they found the instructions were written at the wrong grade level. You can be sure the manufacturers of the car safety seats are scrambling to re-write their instructions. Many experts, through much research, have compiled golden rules of documentation writing. These rules apply regardless of medium:• Use short, simple, familiar words• Avoid jargon.• Use culture-and-gender-neutral language.• Use correct grammar, punctuation, and spelling.• Use simple sentences, active voice, and present tens...

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“…Indeed, consent forms vary in length between trials and centres, and may range from 2 to 10 pages even within a same trial (13). One study of informed consent procedures in the context of clinical emergency (i.e., myocardial infarction) indicated that there was a mismatch between the level of education of the study participants and the level of education required to comprehend the informed consent form (14). Similarly, there may be a mismatch between the provider of the information (i.e., the physician) and the patient, such that the communication fails to achieve its objective of relaying important factual information to the patient about the study so that they may make a decision about participation.…”

Section: Decisional Incapacitymentioning

confidence: 99%

Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit

Ecarnot¹,

Quenot²,

Besch³

et al. 2017

Ann. Transl. Med.

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Clinical research remains a vital contributor to medical knowledge, and is an established and integral part of the practice of medicine worldwide. Respect for patient autonomy and ethical principles dictate that informed consent must be obtained from subjects before they can be enrolled into clinical research, yet these conditions may be difficult to apply in real practice in the intensive care unit (ICU).A number of factors serve to complexify the consent process in critically ill patients, notably decisional incapacity of the patient due to illness or sedation. Obtaining consent for research from a designated proxy or family member, commonly termed a "surrogate decision maker" (SDM) may be difficult, since SDMs dealing with the emotional, psychological and logistic impact of a sudden hospitalisation of their lovedone are not always receptive to the idea of research or emotionally equipped to reflect rationally on the opportunities being proposed to them. In addition, time constraints and workload pressures on the attending physician may render consent opportunities unfeasible, and the resulting loss of eligible patients could represent a bias in clinical trials, or limit the generalizability of their results. Alternative procedures such as deferred or waived consent have been used in the past and may be suitable alternatives in certain conditions, provided appropriate approval from institutional review boards (IRBs) can be obtained, in accordance with existing legislation. Some of the main questions inherent to the conduct of clinical research in critically ill patients are discussed in this review.

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Informed consent during the clinical emergency of acute myocardial infarction (HER0-2 consent substudy): a prospective observational study

Cited by 111 publications

References 14 publications

Informed consent for research in ICU obtained before ICU admission

Informed consent for research in ICU obtained before ICU admission

Measuring translation difficulty

Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit

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