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PubMed2005

Comparing participants and nonparticipants recruited for an effectiveness study of nicotine replacement therapy.

BACKGROUND: Interventions for smoking cessation have been typically evaluated on reactively recruited samples in clinical trials (efficacy trials). However, to have an impact on smoking rates in a general population, the intervention should also be evaluated with proactively recruited representative samples (effectiveness trials). PURPOSE: The characteristics of participants and two groups of nonparticipants recruited for a population-based nicotine replacement therapy study were compared. METHODS: All members of a large New England Veterans' Administration Medical Center were contacted, and interviews were completed with 3,239 identified smokers (at least 10 cigarettes per day). At the end of the interview, all smokers were offered participation in a multiple intervention study. Of the interviewed smokers, 2,915 verbally agreed to participate in the study (90%). Of those who gave initial verbal consent, 2,054 returned the written informed consent form and became participants (70%). RESULTS: The participants (full consent group) differed significantly from both nonparticipant groups-that is, the smokers who were interviewed but declined participation by active refusal (survey only group) and those who gave verbal consent but passively refused participation by failing to return the written consent form (verbal consent only group). Participants were more likely to be married, younger, and female; to live with others; and to have previously used or considered using nicotine replacement therapy. The survey only group was also more likely to be in the precontemplation stage (54%), whereas the participants were more likely to be in the contemplation (46%) or preparation stage (35%). The verbal consent only group was intermediate of the other two groups in stage-of-change characteristics. CONCLUSIONS: An important finding was that it is possible to recruit a large proportion of a sample of identified smokers to an nicotine replacement therapy study. However, the participants are likely to differ in significant ways from those who either actively or passively decline participation.

Female↗

PubMed2004

Informed consent for elective and emergency surgery: questionnaire study.

OBJECTIVES: To evaluate women's experience of giving consent to obstetric and gynaecological surgery and to examine differences between those undergoing elective and emergency procedures. DESIGN: A prospective questionnaire study. SETTING: A large teaching hospital. POPULATION: 1006 consecutive patients undergoing elective or emergency surgery in obstetrics and gynaecology. METHODS: Questionnaires were administered to women who had given consent to surgery following the introduction of national guidelines and consent form. Differences in responses between elective and emergency patients were assessed using frequencies, single and multivariable analyses. MAIN OUTCOME MEASURES: Patients' experience and recall of the consent process, their overall satisfaction and their views on what is important for adequate consent. RESULTS: There were significant differences between patients undergoing elective or emergency surgery. Patients undergoing emergency surgery were less likely to have read (OR 0.22) or understood (OR 0.40) the consent form, and were more likely to report feeling frightened by signing it (OR 2.52). They were more likely to report they felt they had no choice about signing the consent form (OR 2.11), and that they would have signed regardless of its content (OR 3.14). Overall, significantly more patients undergoing elective (80%) or emergency (63%) surgery reported satisfaction with the consent process. Patients were more likely to report satisfaction if they read (OR 1.80) and agreed with (OR 3.49) the consent form, and if someone checked that they understood (OR 3.09). CONCLUSION: Patients' needs may not be adequately addressed by current guidelines for consent to treatment, particularly in emergency circumstances. The introduction of more complex forms and procedures appears to conflict with patients' need for personal communication and advocacy. The implications on the ethical and legal standing of consent are considerable.

Elective Surgical Procedures↗

PubMed1997

[Effects of a written consent for liver biopsy on information and anxiety of patients].

INTRODUCTION: The present study gathers information on the influence of a consent form for liver biopsy on the information and anxiety of patients. METHODS: The study had two phases, which included 30 patients each: before the consent form was started and the second once it was started. Two questionnaires were administered to every patient: one to evaluate the degree of patient's information, and the other to evaluate the patient's anxiety. RESULTS: Patients who received the consent form were more informed on the obtention (p < 0.001) and complications (p < 0.0001) of the biopsy, more satisfied with the information (p < 0.0001) and showed no increased anxiety. CONCLUSIONS: While apparently changes observed are not exclusively accounted for by consent form, this seems to be helpful and encouraging to improve patient's information.

Anxiety↗

PubMed1992

Effects of readability on the impact and recall of written informed consent material.

Participants (49 women, 23 men) rated a hypothetical psychologist after (a) receiving either no informed consent information, a highly readable consent form, or a less readable form; and (b) reading a transcript of a therapy session containing either positive or negative self-involving statements. Informed consent forms had no effect on ratings; there was a trend for participants to recall less of the less readable form. Participants rated the therapist more favorably when he used positive self-involving statements. In a second study, participants (62 women, 28 men) received 1 of the 3 levels of informed consent information and a transcript with either no mention of informed consent or a brief mention at the end. Men who received the less readable consent form had poorer first impressions of the therapist and recalled less of the form. The mention of informed consent in the transcript had no effect.

Comprehension↗

PubMed2004

A comparison of methods to obtain active parental consent for an international student survey.

Many school-based research efforts require active parental consent for student participation. Maximizing rates of consent form return and agreement is an important issue, because sample representativeness may be compromised when these rates are low. This article compares two methods for obtaining active parental consent: return of consent forms in the mail versus return by students to their classrooms. The methods were tested in a pilot study of 46 schools (1,058 students), with half of the schools randomly allocated to each of the alternative methods. A hierarchical nonlinear model of consent form return and agreement rates suggests that the student-delivered method is more successful at producing higher rates of consent form return and agreement to participate in the study, after controlling for school-level characteristics. The authors discuss the findings and their implications for other researchers engaged in school-based research with adolescents.

Adolescent↗

PubMed1993

Informed consent: using a structured interview changes patients' attitudes towards informed consent.

Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

Adult↗

PubMed1982

[The physician's obligation to educate patients - legal aspects - patients' expectations].

There is some uncertainty among doctors and lawyers about the form and content of presurgical medical enlightenment of the patient. Presurgical enlightenment is of increasing significance with respect to malpractice suits. Current jurisdiction has developed principles of enlightenment that are often difficult for the doctor to handle. For routine procedures in major hospitals a standardized, pragmatically designed consent form is therefore necessary. At Würzburg University Eye Hospital the results of glaucoma and cataract surgery have been documented for years by using computer-readable forms. On the basis of these large-scale results from many thousands of procedures a written consent form was developed and tested for its suitability. Two hundred and twenty-two patients were questioned on their expectations as to proper enlightenment. The results of these broadly scattered interviews are summed up and presented. Especially with glaucoma patients, the best method of enlightenment, satisfying both medical and legal requirements, is an information booklet designed for lay people together with verbal information furnished by the doctor. Nearly all of the patients interviewed found the preoperative enlightenment complete and sufficiently clear. The majority ot them could repeat the contents of the enlightenment form four to six days after the operation. This speaks well for the adequacy of the enlightenment. As a rule, the written consent form was supplemented by verbal enlightenment from the operating physician immediately before hospitalization of the patient. A psychological investigation of preoperative anxiety with enlightened and non-enlightened patients revealed that the enlightenment form did not increase preoperative anxiety. Surgical ophthalmology lends itself to a written consent form more readily then other surgical disciplines, because diseases with poor prognoses for life are fortunately rare.

Aged↗

PubMedDate not supplied

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices.

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.

Biomedical Research↗

PubMed2005

Effect of informed consent for intravascular contrast material on the level of anxiety: how much information should be given?

PURPOSE: To compare the effect of two different informed consent forms on patients' anxiety level prior to intravenous contrast material (IVCM) injection. MATERIAL AND METHODS: Two different informed consent forms were randomly given to 265 consecutive patients referred for either intravenous pyelography or computed tomography requiring IVCM injections. Form 1 had brief information, including only the common risks and risk factors associated with IVCM, while Form 2 had more comprehensive information. Before being presented with the two different informed consent forms, 191 of the 265 patients filled out two other forms evaluating: 1: How they felt in that particular situation/moment (STAI-T); and 2: How they felt independently of the situation or condition at that moment (STAI-S). After the patients were informed, the STAI-T (measuring how they felt in that particular situation) was filled out once more to see if the anxiety level had changed. RESULTS: The anxiety level for 88 patients receiving Form 1 decreased after they were given the informed consent (P=0.033). However, among the 103 patients receiving Form 2, the anxiety level showed a significant increase (P=0.001) compared to the values obtained before Form 2 was given. CONCLUSION: These results indicate that informed consent, including brief information about the risk factors and potential adverse reactions of IVCM, reduces anxiety level, while detailed information before the procedure increases the anxiety level.

Adolescent↗

PubMed2003

Informed consent in gerontology.

The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which in gerontology research, should be reviewed at each encounter with study participants.

Aged↗

PubMed1982

Informed consent to biomedical research in Veterans Administration Hospitals.

To illuminate the process of obtaining informed consent to research in a medically dependent population, we interviewed 156 patients and 37 physicians involved in research projects at four Veterans Administration hospitals. Most patients knew they were research subjects, had voluntarily consented, and knew the details of their medical treatment, but few understood the research well. Readability analysis indicated that consent forms required college-level education. Twenty-eight percent of patients were not aware of their participation in research although they had signed consent forms. No single act, omission, or personal attribute completely explains this unawareness, but it is associated with incomplete consent forms, the identity of the person explaining the research, the manner of the explanation, and, in some cases, grave illness.

Awareness↗

PubMed1993

Factors affecting quality of informed consent.

OBJECTIVE: To examine the factors influencing quality of informed consent. DESIGN: Prospective study comprising interviews with patients and patients' completing standard questionnaires. SETTING: Academic surgical unit of large teaching hospital. PATIENTS: 265 patients undergoing intrathoracic, intraperitoneal, and vascular surgical procedures. Of these patients, 192 have been followed up for six months. MAIN OUTCOME MEASURES: Patients' recall of information at various points in the study; this score was compared by age, provision of written information, cognitive function, intelligence quotient (IQ), mood state and personality traits, and health locus of control. RESULTS: The patients were best informed immediately after signing the consent form and from then on recall of information deteriorated. A total of 172/250 (69%) patients admitted to not reading the consent form before signing it. Old age adversely affected recall of information at all assessment points. Impaired cognitive function reduced information recall only during the stay in hospital. Patients with above average IQs handled information better than those with a lower IQ except immediately after the signing of consent forms. Patients with an internal locus of health control (that is, those who believed their health to be in their own control) were better informed than those with an external locus of health control. Operation information cards improved recall only on the day of discharge. CONCLUSION: Elderly patients and patients with below average IQ, impaired cognitive functions, and an external locus of control have poor information recall. Written information may be more useful if given before admission to hospital.

Adult↗

PubMed2002

Dissatisfaction with consent for diagnostic gastrointestinal endoscopy.

INTRODUCTION: Little is known about patients' perspectives on the amount of information they receive prior to diagnostic gastrointestinal endoscopies. Our unit's policy for obtaining consent consists of initially posting an information leaflet to the patient followed by subsequent explanation of the procedure on arrival for the test. The consent form is signed by the patient immediately prior to the test. METHODS: A questionnaire survey was conducted to assess patient perception and satisfaction with the amount of information received before diagnostic endoscopy. RESULTS: The information was obtained from 127 of the 175 questionnaires that were distributed. Whereas 97% had read the information leaflet, only 52% had read the consent form before signing it. 64/127(51%) felt dissatisfied because they would have wanted more information while 3% were dissatisfied because they would have liked less information relating to one or more aspects of the test. Dissatisfaction was higher in patients who had not read the consent form (p < 0.001) and those with some formal education (p = 0.01). CONCLUSIONS: Patients who did not read the consent form were more dissatisfied. Strategies to improve the rate of reading this document may increase patient satisfaction.

Endoscopy, Gastrointestinal↗

PubMed2004

Orthognathic surgery: an informed consent model.

In this study, the authors propose an informed consent form for orthognathic surgery. A careful review of the international literature and clinical practice suggested the feasibility of dividing the informed consent form into two parts. In first part, the diagnostic procedures and the therapeutic and surgical times are described. The patient must sign it as soon he or she accepts the orthodontic/surgical therapy proposed. The second part describes the possible problems and difficulties of the procedure, and it must be read by the patient before starting the therapy. In the opinion of the authors, this informed consent form allows the patient to know the risks related to the orthodontic/surgical therapy, thus preserving the surgeons from the civil risk and penalties of omission.

Consent Forms↗

PubMed1994

Informed consent in optometric institutions.

BACKGROUND: Modern bioethics has been traced to the interaction of advanced medical technology and the patient's rights movement. A fundamental principle of bioethics is the autonomy which allows patients to exercise personal judgment in their health decisions. The process used to exercise this choice is informed consent and its documentation is the consent form. METHODS: A survey was undertaken of the schools and colleges of optometry in order to learn more about patient autonomy in teaching institutions. RESULTS: Some institutions feel uncomfortable with the process of informed consent and use of the consent form. Research areas were most compliant. Contact lens and ocular disease clinics were compliant. CONCLUSIONS: Review of consent forms had little value in evaluating the ethics process and education taking place in clinics.

Consent Forms↗

PubMed2005

The consent and counselling of patients for cataract surgery: a prospective audit.

PURPOSE: The aims of ideal preoperative informed consent include educating the patient adequately to enable an autonomous decision to be made without causing undue anxiety. We study how the paternalistic and nonpaternalistic approaches meet this ideal. The influence of the new patient consent forms is also assessed. METHODS: Two cycles of a prospective clinical audit are presented. An assessment of relevant patient knowledge was performed by patient interview. Visual analogue scales were used to quantify patient anxiety. RESULTS: The first cycle, examining a paternalistic approach, demonstrated: 37% of patients understood what a cataract was and 48% understood what surgery involved. 48% misunderstood that cataract surgery was completely risk free. In total, 80% of patients undergoing second eye surgery believed that it was completely risk-free. Average anxiety visual analogue scores (VAS) for cataract surgery were low (2.89). The second cycle, examining the nonpaternalistic approach combined with the implementation of new consent forms showed that, despite more explicit repeated preoperative consent: 39% of patients understood correctly what a cataract was, 28% understood what surgery involved and 43% misunderstood that surgery was completely risk-free. All patients undergoing second eye surgery thought that it was risk-free. The average anxiety VAS for cataract surgery were moderate (5.00). CONCLUSIONS: Both paternalistic and non-paternalistic approaches to informed consent are inadequate in meeting the demands of the ideal informed consent. The new patient consent forms appear to have little effect in influencing patient knowledge about their surgery. Patients undergoing second eye surgery often have an overoptimistic view of cataract surgery.

Aged↗

PubMed1999

Understanding informed consent.

Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to document the informed consent discussion. The place of informed consent in leading international codes of research ethics is reviewed. Some prominent examples of past violations of informed consent are discussed. Even when properly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information must be given to research subjects, and how much is too much; and how to ensure the full voluntariness of subjects' consent, especially when the researcher is also the patient's physician. An ongoing problem is the 'therapeutic misconception'--the belief that proposed research is a promising treatment intended to benefit the subjects. The complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied.

Communication↗

PubMed2005

Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury.

PURPOSE: Although the Institute of Medicine (IOM) calls for research organizations to compensate subjects for research-related injury, administrators may fear that candid presentation of such policies would create financial risk. We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship. METHODS: Medical school websites (N = 123) were surveyed for informed consent language for research-related injury. Text was extracted from 113 sites (92%) and evaluated for details regarding financial liability for research-related injury. When sufficient template text was available (n = 106), the readability of liability policies was compared with the readability of other standardized passages using Flesch-Kincaid analysis. RESULTS: Coverage for medical bills is offered at 61% (23/38) of schools when there is an industry sponsor as compared with 22% (22/102) when there is none (P <0.001). When coverage is offered in studies with no industry sponsor, it is limited to emergency bills in half (11/22) of these policies. Seventy-two percent (81/113) of medical school consent forms specifically rule out the possibility of monetary compensation. The mean (+/- SD) reading grade level of liability text in consent forms is higher than that in other template paragraphs (11.5 +/- 1.4 vs. 10.6 +/- 1.4; P = 0.0001). CONCLUSION: Federally funded research at most U.S. medical schools is conducted with consent form language that is particularly complex and that fails to protect subjects from the financial burden of research-related injury. Few schools meet IOM standards.

Biomedical Research↗