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Informed consent for ankle fracture surgery: patient comprehension of verbal and videotaped information.

BACKGROUND: The purpose of our study was to evaluate the effectiveness of using a videotape to give patients information about the risks, benefits, alternatives, and treatment of a common orthopaedic procedure before they sign consent forms. METHODS: During a 9-month period, 48 patients with isolated closed ankle fractures requiring surgical intervention were randomized into two groups that received either videotaped or conventional verbal information regarding consent for surgery. The study group watched a videotape containing information about the risks, benefits, and treatment alternatives, while the control group obtained this information verbally. To determine comprehension and retention, all patients completed a multiple-choice questionnaire immediately after receiving the information, and 37 patients (77%) were available to complete a questionnaire at an average of 10 weeks later. RESULTS: The videotape group outperformed the verbal consent group by 40.1% on the initial questionnaire (p = .0002) and by 27.2% on the followup questionnaire (p = 0.0139). Patients with educational levels of less than or equal to the 12th grade performed 67.8% better on the initial questionnaire after watching the video than after receiving the information verbally. (p = .0001). CONCLUSION: Patients who received information about their surgery on a videotape before giving their consent demonstrated a significant increase in comprehension compared to patients who received this information verbally. The benefit was even greater for patients with lower education levels.

Adult↗

Variability in institutional review board assessment of minimal-risk research.

OBJECTIVES: To examine variability in responses from institutional review boards (IRBs) to submission of a proposed minimal-risk survey. METHODS: Identical research proposals to obtain information concerning beliefs about the needs of victims of intimate partner violence via surveys were submitted for IRB approval to three institutions in the Baltimore metropolitan area. One institution is an academic center, one is an inner-city hospital affiliated with the academic center, and the third is a suburban community hospital. The study population consisted of emergency department health care providers and individuals in emergency department waiting areas. RESULTS: Inconsistencies emerged among the three IRBs in the review process itself, the need for participant consent, and the need for revision of the consent form and study protocol. One institution approved the proposal in 15 business days after expedited review. The second institution approved the proposal in 12 business days and waived the requirement for informed consent. The third institution approved the research in 77 business days after three revisions. Questions raised included: methodology for selecting participants; appropriateness of surveying individuals in emergency department waiting areas; a request for background literature to assure that the research questions had not already been answered; and concerns about study methodology and sample size justification. CONCLUSIONS: In this sample, there is considerable variability in IRB processes even for minimal-risk studies.

Baltimore↗

Informed consent, parental awareness, and reasons for participating in a randomised controlled study.

BACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures. RESULTS: 181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%). CONCLUSIONS: Parents' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.

Adult↗

What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK.

BACKGROUND: Medical decision making is based on patient autonomy and informed consent, which is an integral part of medical ethics, risk management and clinical governance. Consent to treatment has been extensively discussed, but the viewpoint of patients is not well represented. A new consent form was introduced by the Department of Health in 2001. AIMS: To determine the information most important to patients, to facilitate evidence-based guidelines and to provide a valid and reliable consent-procedure-satisfaction questionnaire. METHODS: An anonymous quantitative survey was carried out, asking 100 patients 15 questions regarding procedures they may need to undergo, using a Visual Analogue Scale to test the importance of each question. RESULTS AND DISCUSSION: In total there were 77 respondents and the mean age was 48.8 (SD 17.63, range 20-82) years. There were 52% women and 48% men. Major complications, such as not undergoing the procedure, future management and long-term effect on work, all scored a median of 95%. Least concerns were related to technical details of the procedure and minor complications (median 64% and 63%, respectively). All other questions were still considered important (median 79-93%). No significant differences were observed between sex, age and professional groups, but a significant difference was observed between the education groups. Qualifications of the doctor did not correlate to any other question. CONCLUSIONS: This questionnaire is proposed as a basis for informed consent guidelines to health workers and for measures of satisfaction with the consent procedure.

Adult↗

Trends in malpractice litigation.

Physicians who make mistakes are not necessarily negligent, contrary to prevailing opinion in the medical community. The article discusses the legal concepts of "standard of care" and "proximate cause." The incidence of favorable jury verdicts in those cases in which malpractice suits are litigated is quite high. The effects of insurance company policies in decisions about settlements on the incidence of claims is discussed and alternatives are suggested. The prevailing belief that a consent form with a patient's signature on it is sufficient to prevent a malpractice suit is also discussed.

Informed Consent↗

The right to participate in research studies.

Institutional review boards for the use of human subjects in scientific studies were initially established to focus on protection of human subjects from the risks of research. It has become evident in recent years, however, that it is also important to protect the rights of individuals to have access to the benefits of research participation. These include, but are not limited to, certain experimental drugs or treatments, closer monitoring, free care or direct remuneration, and societal benefits of results of studies on specific populations. Researchers, so long sensitized by their respective institutional review boards to the need for protection of the subjects, now must also focus on the added burden of efforts to include individuals and the increased efforts it may take to protect the safety and rights of certain populations, including patients with AIDS, women, minorities, children, and the elderly. Additional care must be taken to design appropriate studies, recruit an appropriate spectrum of the population, craft a complete yet understandable and nondeterent informed consent form, and make efforts to assure that participants are informed.

Beneficence↗

Informed consent and blood transfusions: what does Krever's interim report mean to doctors?

What implications does the interim report of the Krever inquiry that is studying Canada's blood-supply system hold for doctors? The report notes that "until recently, few physicians talked about the risks of a blood transfusion with their patients" and few hospitals "considered asking patients to sign a consent form before receiving blood or blood products." Lawyer Karen Capen says this situation is changing. Krever's first report says physicians must be aware that part of the decision-making process involves patients' specific consent to the possible use of blood or blood products during medical treatment and care.

Blood Transfusion↗

Informed consent for molecular-based diagnostic and prognostic studies in the cancer patient.

The consent of the subject who is donating cells, tissues, organs or body fluid for research purposes is a precondition for biomedical research on human samples. Before such consent can be obtained, comprehensive information should be provided to the subject by the investigators. This information includes the scope of research, the intended use of subject's body parts and associated data, the risks and benefits associated with the research project, and the right to withdraw their consent at any time without prejudice. Consent is free and must not be obtained under any kind of pressure. The traditional practice of obtaining consent for unspecified future use of biological samples and data generated from clinical trials is no longer adequate for genetic research. However, the investigator has still interest to keep the definition of the field of research as broad as possible. Privacy is an issue of importance for the patient, who is the primary supplier of human samples, and for his relatives. Benefit sharing is another field of contradictory discussion. Normal volunteers are a special case among gene expression studies. An example of informed consent form is provided.

Confidentiality↗

Informed consent for treatment of childhood cancer: factors affecting parents' decision making.

Both the treatment for childhood cancer and the legal requirements for gaining parents' consent to treatment have become increasingly complex. The purpose of the exploratory investigation reported here was to identify influential circumstances surrounding the consent process in the pediatric setting, to describe the relationship of parental anxiety to these factors, and to delineate related practice and research implications. Twenty-eight parents of children entered on one of four protocols for the treatment of newly diagnosed acute lymphoblastic leukemia at the Childrens Hospital Los Angeles and the University of California San Francisco were asked to complete two questionnaires within 48 hours after consenting to treatment: the State-Trait Anxiety Index and the Parent Informed Consent Questionnaire. Results of the study confirmed clinical experience that parents are given complex information and asked to make decisions about their child's life in a highly anxious state. Although participants were generally satisfied with the informed consent process 48 hours after signing a consent form, further research is needed to document how well parents understand and remember key information, as well as the influence of time, experience, and changes in state anxiety on their perceptions of the adequacy of the consent process. In current clinical practice, simple strategies can be applied to improve the informed consent process for families of children with cancer.

Adult↗

An audit to assess the quality of necropsies performed on stillborn infants.

AIMS: To determine the quality of stillbirth postmortem reports and their contribution to a final diagnosis following the introduction of explicit consent forms after the Alder Hey inquiry. METHODS: Necropsy reports from 100 consecutive stillbirths were reviewed from 2001 onwards. A spreadsheet compiled data items that were considered essential in the Royal College of Pathologists guidelines. The type of consent (with permission for organs/tissue retention) was recorded to assess the impact on establishing a cause of death. RESULTS: Consent for tissue retention was obtained in 95 cases, whereas consent for organ retention was significantly lower (52 cases). In two cases, permission was refused for tissue retention and three requested external examinations only. Of these five, four had an undetermined cause of death, compared with 35 of 95 cases where permission for tissue retention was granted. All data items considered essential were recorded in every report. In 65 cases, the necropsy provided useful information, helped clinical care, and addressed parental concerns. CONCLUSIONS: There was no major impact of the type of necropsy consent on establishing a cause of death, apart from the case of limited necropsies without histological examination of tissue samples.

Autopsy↗

Evaluation of an information booklet for patients considering participation in phase I clinical trials in cancer.

Phase I trials in cancer patients, although essential, are a difficult field of clinical research. A particularly challenging area for all members of the clinical research team is that concerned with information-giving and informed consent leading to patient participation in the trial. An information booklet for patients was written in an attempt to address some of those issues, with the overall aim of improving the informed consent process and influencing patient decision-making. Questions covered in the booklet include: What is a phase I trial? Who can take part? Are there any side-effects or risks involved? What if I say no? The booklet was given to patients prior to consent. On the first day of receiving treatment they were given a questionnaire to evaluate the usefulness and acceptability of the booklet. The results showed the booklet to be generally well accepted by patients and the majority of them perceived the content and volume of information to be appropriate. The booklet did support patient decision-making and the evaluation showed that the optimal time for patients to receive it was prior to the signing of a consent form. Minor amendments have been made to the booklet, which is now given routinely to all patients at the cancer centre who are considering participation in a phase I trial, and is a valuable addition to the informed consent process.

Clinical Trials, Phase I as Topic↗

Enhancing informed consent for research and treatment.

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Clinical Trials as Topic↗

[Surgical management of incidental Meckel's diverticulum: the necessity to obtain the informed consent].

Surgical approach to the incidentally found Meckel's diverticulum (MD) is still source of debate: some support the systematic search and the surgical resection, others suggest to leave in situ the asymptomatic diverticulum. A wide literature review and some claims for malpractice referred to resection of diverticular formations (2 cases are described herein) allow us to deem that the removal of an asymptomatic MD may be an excess of surgical indication regarding an entity that cannot be defined as pathological for itself; anyway, the informed consent must be obtained before the incidental resection. The consent to the removal of MD must always be requested for laparotomies in which the surgeon forecasts the possibility to remove a diverticulum eventually found. Finally, an easy informed consent form about an incidentally found MD to be submitted to the patient is proposed.

Child↗

Overcoming Depression on the Internet (ODIN) (2): a randomized trial of a self-help depression skills program with reminders.

BACKGROUND: Guided self-help programs for depression (with associated therapist contact) have been successfully delivered over the Internet. However, previous trials of pure self-help Internet programs for depression (without therapist contact), including an earlier trial conducted by us, have failed to yield positive results. We hypothesized that methods to increase participant usage of the intervention, such as postcard or telephone reminders, might result in significant effects on depression. OBJECTIVES: This paper presents a second randomized trial of a pure self-help Internet site, ODIN (Overcoming Depression on the InterNet), for adults with self-reported depression. We hypothesized that frequently reminded participants receiving the Internet program would report greater reduction in depression symptoms and greater improvements in mental and physical health functioning than a comparison group with usual treatment and no access to ODIN. METHODS: This was a three-arm randomized control trial with a usual treatment control group and two ODIN intervention groups receiving reminders through postcards or brief telephone calls. The setting was a nonprofit health maintenance organization (HMO). We mailed recruitment brochures by US post to two groups: adults (n = 6030) who received depression medication or psychotherapy in the previous 30 days, and an age- and gender-matched group of adults (n = 6021) who did not receive such services. At enrollment and at 5-, 10- and 16-weeks follow-up, participants were reminded by email (and telephone, if nonresponsive) to complete online versions of the Center for Epidemiological Studies Depression Scale (CES-D) and the Short Form 12 (SF-12). We also recorded participant HMO health care services utilization in the 12 months following study enrollment. RESULTS: Out of a recruitment pool of 12051 approached subjects, 255 persons accessed the Internet enrollment site, completed the online consent form, and were randomized to one of the three groups: (1) treatment as usual control group without access to the ODIN website (n = 100), (2) ODIN program group with postcard reminders (n = 75), and (3) ODIN program group with telephone reminders (n = 80). Across all groups, follow-up completion rates were 64% (n = 164) at 5 weeks, 68% (n = 173) at 10 weeks, and 66% (n = 169) at 16 weeks. In an intention-to-treat analysis, intervention participants reported greater reductions in depression compared to the control group (P = .03; effect size = 0.277 standard deviation units). A more pronounced effect was detected among participants who were more severely depressed at baseline (P = .02; effect size = 0.537 standard deviation units). By the end of the study, 20% more intervention participants moved from the disordered to normal range on the CES-D. We found no difference between the two intervention groups with different reminders in outcomes measures or in frequency of log-ons. We also found no significant intervention effects on the SF-12 or health care services. CONCLUSIONS: In contrast to our earlier trial, in which participants were not reminded to use ODIN, in this trial we found a positive effect of the ODIN intervention compared to the control group. Future studies should address limitations of this trial, including relatively low enrollment and follow-up completion rates, and a restricted number of outcome measures. However, the low incremental costs of delivering this Internet program makes it feasible to offer this type of program to large populations with widespread Internet access.

Adult↗

Outcome at 6 months after admission for pediatric intensive care: a report of a national study of pediatric intensive care units in the United kingdom.

OBJECTIVE: The goal was to measure, by using the Health Utilities Index, the health status of children 6 months after admission to PICUs in the United Kingdom. METHODS: All PICUs in the United Kingdom were invited to participate. Children who were > or = 6 months of age at admission and were discharged alive from participating units during a 1-year period were eligible for this study. Children with completed consent forms who had survived to 6 months after admission received the Health Utilities Index questionnaire. RESULTS: Admission data on 7214 admissions to 22 units were collected between March 2001 and February 2002. Of those patients, 6786 survived to unit discharge, and consent for follow-up contact was obtained for 2642. At 6 months after admission, the mortality rate was estimated at 11.1% and 2034 children were still alive and contactable. Of those children, Health Utilities Index questionnaires were returned by 1455. No impairment was indicated for 767, 951, 940, 919, 962, and 939 children with respect to the Health Utilities Index sensation, cognition, emotion, pain, mobility, and self-care attributes, respectively. The mean +/- SE Health Utilities Index utility score was 0.73 +/- 0.01, with 397 children (27.3%) in full health. CONCLUSIONS: Death after pediatric intensive care in the United Kingdom is uncommon, making assessment of health status important. At 6 months after admission, there is significant morbidity. To assess the impact of strategies to improve or to optimize care on longer-term outcomes, standardized collection of data on preexisting comorbidities and illness severity is required.

Child↗

Informed consent for screening sigmoidoscopy in a Veterans Administration population.

PURPOSE: This study was performed to test the hypotheses that current consent methods may not convey the data that we imagine that they do, and that many patients may not want the data that we believe that we ought to provide. We also argue that excessive and unthinking emphasis on informed consent documentation may ignore real and important issues. METHODS: Fifty-nine male patients consecutively scheduled for screening sigmoidoscopy were interviewed before and after the procedure in a tertiary care academic health center. Chi-squared analysis was used to determine if the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience were able to discriminate various components of the informed consent process. RESULTS: Thirty-nine percent of patients could describe no indication other than doctor recommendation for the procedure. Although 86 percent of patients had heard of the word "polyp," 16 percent could not define it. Fifteen percent of patients could not pick out from a list subsequent steps to be taken in case of an abnormal examination. Although most patients could describe discomforts associated with the procedure, only 19 percent of patients mentioned bleeding and perforation as possible complications. Only 5 percent of patients knew any alternatives to sigmoidoscopy. No patient could explain risks and benefits of alternatives. Eighty-eight percent of patients could not identify their endoscopist, but this only bothered 13 percent. Ninety-three percent of patients were given an opportunity to ask questions, but only 22 percent actually did so. All patients signed the consent form, but only 14 percent of patients actually read all of it. Most patients, 97 percent, thought that they had enough information to proceed with the endoscopy. CONCLUSIONS: By traditional and classic standards, the patients in this study did not give informed consent. Yet, surprisingly, despite this lack of informed consent, most of the patients failed to ask further questions of their physicians and claimed that they had sufficient information to proceed with the procedure. This was the case across the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience.

Aged↗

Barriers to obtaining a desired postpartum tubal sterilization.

OBJECTIVE: To determine why women do not undergo postpartum sterilization despite expressing desire during antepartum care. METHODS: In a retrospective chart review, we identified all women between March 2002 and November 2003 who requested postpartum sterilization during antepartum care but did not undergo the procedure. We report the reasons why sterilizations were not performed. RESULTS: We reviewed 6,589 prenatal care and delivery records identifying 324 women meeting inclusion criteria. One hundred and four women changed their mind. Of women still desiring sterilization at discharge, the most common reasons for not undergoing the procedure were lack of valid Medicaid sterilization consent forms [n=121; 37.3%, 95% confidence interval (CI) 32.0-42.6%]; a medical condition precluding the procedure (n=47; 14.5%, 95% CI 10.7-18.3%); lack of availability of an operating room (n=2; 6.5%, 95% CI 3.8-9.2%). CONCLUSION: We found that the Medicaid consent process, medical conditions and insufficient operating room space prevented women from having the desired surgery.

Adult↗

Are research subjects really informed?

To determine how adequately patients who participate as subjects for clinical investigation understand their commitment, 50 patients admitted to the Clinical Research Center of the University of Washington were interviewed. Their responses were compared with the detailed statements in the consent forms for the 23 specific protocols under which they were being studied. In spite of careful controls in accord with guidelines of a review committee, only half the patients were able to describe accurately their expectations of the studies to which they had given signed consent.

Adolescent↗