A multicenter two by two factorial trial of cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: design of a veterans affairs cooperative study (CSP #470)

The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) Study #470 is a 2 x 2 factorial trial designed to evaluate the hypothesis that both cognitive behavioral therapy (CBT) and aerobic exercise will significantly improve physical function in participants with Gulf War veterans' illnesses (GWVI), and that adding CBT to aerobic exercise will provide further incremental benefit. One thousand three hundred fifty-six veterans will be randomized to one of four treatment arms: CBT plus aerobic exercise plus usual and customary care, aerobic exercise plus usual and customary care, CBT plus usual and customary care, or usual and customary care alone. The study duration is 2.5 years with 1.5 years of intake and 1 year of follow-up. The primary outcome measure is the proportion of veterans improved more than seven units on the physical component summary (PCS) scale of the Short Form Health Survey for Veterans (SF-36V) measured 12 months after randomization. This generic quality-of-life measure was chosen because there is no disease-specific measure for GWVI and the symptoms of GWVI span a wide range of physical manifestations that are related to the domains covered by the PCS scale. Sample size was determined to detect all six pairwise comparisons between the four treatment arms with 90% power and a Bonferroni adjustment for an overall type I error of 0.05 or 0.05/6 = 0.0083. CSP #470 was initiated in May 1999 in 18 VA and two Department of Defense medical centers. To date this represents the largest randomized trial designed to evaluate treatments for individuals with unexplained physical symptoms. This paper will focus on the rationale and unique features of the study design. Control Clin Trials 2001;22:310-332     

National efforts to improve the informed consent process

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.     

The role of the consent document in informed consent for pediatric leukemia trials

PURPOSE: To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent. METHODS: Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences. RESULTS: Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy. CONCLUSIONS: Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.     

Informed consent in medical research

That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.     

Informed consent: An Israeli bone marrow transplant unit's perspective

Israeli bone marrow transplant (BMT) patients are drawn from a heterogenous population of Israeli Jews, Israeli Arabs and patients from outside Israel. This presents difficulties in communicating the ethical dilemmas that surround the BMT procedure to the patients and their families. Among these dilemmas is the issue of informed consent. A pilot study was conducted to assess the current informed consent practices in an Israeli BMT Unit. The sample consisted of 13 Hebrew speaking patients. The purpose of the study was to evaluate BMT patients: (i) information seeking behaviour; (ii) preferences for participation in treatment decisions; and (iii) attitudes and behaviours towards the current informed consent document. The study found that patients did not read the informed consent form. Of the nine patients who read it, three considered it superfluous and seven signed it almost immediately after reading it. Surprisingly, the results also showed that, despite the greater degree of risk associated with BMT treatment, the information seeking behaviour scores of BMT patients were similar to those of cancer patients receiving oncology treatment on an ambulatory basis.     

Teaching the informed consent process to residents

We believe the focus and emphasis of this committee on informed consent is unique, and that the development of an informed consent teaching process for residents will focus on the moral and ethical issues regarding informed consent. Even more important, we believe we will emphasize the patient care aspects of informed consent and also teach residents their responsibilities for long-term patient care with regard to patients' satisfaction and understanding of their disease process.     

Using principles of health literacy to enhance the informed consent process

THE LANGUAGE COMMONLY used in procedural/surgical consent forms often exceeds the average reading level of US patients, and many do not read the document before signing it.INCORPORATING READER-FRIENDLY language and formatting makes it more likely that patients will read the document, understand it, and therefore give informed consent. Adding “teach back” into the document provides a means of evaluating patient understanding.USING READER-FRIENDLY procedural/surgical consent documents merges the objectives of both health literacy and informed consent. AORN J 88 (July 2008) 23-29. © AORN, Inc, 2008.     

Improving understanding of the informed consent process and document

OBJECTIVES: To review theoretical perspectives relating to the communication of informed consent and to describe research efforts and strategies to enhance the informed consent process and document. DATA SOURCES: Research studies review articles, education and communication models, and NCI National Working Group on Informed Consent Recommendations. CONCLUSIONS: Information communicated during the informed consent process is difficult to understand, raising ethical concerns about whether informed decision-making has taken place. Empirical research focuses on the nature of patient-provider interactions and the effectiveness of various delivery systems, a need exists to overcome conceptual and methodologic limitations. IMPLICATIONS FOR NURSING PRACTICE: Nurses must ensure that patients understand informed consent information. Several communication strategies are posited.     

Informed consent for invasive procedures in the emergency department

BackgroundInformed consent for procedures in the emergency department (ED) challenges practitioners to navigate complex ethical and medical ambiguities. A patient's altered mental status or emergent medical problem does not negate the importance of his or her participation in the decision-making process but, rather, necessitates a nuanced assessment of the situation to determine the appropriate level of participation. Given the complexities involved with informed consent for procedures in the ED, it is important to understand the experience of key stakeholders involved.MethodsFor this review, we searched Medline, the Cochrane database, and Clinicaltrials.gov for studies involving informed consent in the ED. Inclusion and exclusion criteria were designed to select for studies that included issues related to informed consent as primary outcomes. The following data was extracted from included studies: Title, authors, date of publication, study type, participant type (i.e. adult patient, pediatric patient, parent of pediatric patient, patient's family, or healthcare provider), number of participants, and primary outcomes measured.ResultsFifteen articles were included for final review. Commonly addressed themes included medical education (7 of 15 studies), surrogate decision-making (5 of 15 studies), and patient understanding (4 of 15 studies). The least common theme addressed in the literature was community notification (1 of 15 studies).ConclusionsStudies of informed consent for procedures in the ED span many aspects of informed consent. The aim of the present narrative review is to summarize the work that has been done on informed consent for procedures in the ED.     

Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?

BACKGROUND: Requiring written informed consent for a minimal-risk survey may result in limited participation rates. METHODS: Data from a cross-sectional survey of 177 older patients (87 blacks and 90 whites) with hypertension enrolled in the managed care Medicare risk product were used to assess participation rates pre- and postwaiver of written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. Prior to the waivers being granted, patients were contacted two times via mail with an introductory letter and an informed consent document. Those who completed and returned the informed consent document were administered the questionnaire. After 6 weeks, a waiver of written informed consent and HIPAA authorization was obtained from the Institutional Review Board. Nonparticipants were reapproached and asked to complete the questionnaire. Participation rates were recorded before and after receiving the waivers. RESULTS: Participation rates increased from 21.5% in the prewaiver period to 57.4% in the postwaiver period (p < .001). Prewaiver participation differed by demographic subgroup and was higher among whites (26.7%) versus blacks (16.1%; p = .087), men (31.6%) versus women (16.7%; p = .024), and participants > or = 75 years old (28.4%) versus < 75 years old (14.6%; p = .025). In contrast, the postwaiver participation rate did not differ significantly across race, gender, or age subgroupings. Significant increases in participation rates from the pre- to the postwaiver time period were noted within each demographic subgroup (all p < .01). CONCLUSIONS: We identified a substantial increase in participation rates postwaiver of written informed consent and HIPAA authorization in a minimal-risk survey. The need for written documentation for minimal-risk surveys may negatively impact recruitment of blacks, women, and patients < 75 years old.     

Informed consent in opioid therapy: a potential obligation and opportunity

Most patients receiving opioids for the spectrum of pain disorders tolerate opioids well without major complications. However, a subset of this population encounters significant difficulties with opioid therapy (OT). These problems include protracted adverse effects, as well as misuse, abuse, and addiction, which can result in significant morbidity and mortality and make informed consent an important consideration. Opioid treatment agreements (OTAs), which may include documentation of informed consent, have been used to promote the safe use of opioids for pain. There is a debate regarding the effectiveness of OTAs in reducing the risk of opioid misuse; however, most practitioners recognize that OTAs provide an opportunity to discuss the potential risks and benefits of OT and establish mutually agreed-on treatment goals, a clear plan of treatment, and circumstances for continuation and discontinuation of opioids. Informed consent is an important component of an OTA but not often the focus of consideration in discussions of OTAs. This article examines the principles, process, and content of informed consent for OT of pain in the context of OTAs.     

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals.The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process.Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study.Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.     

Informed consent practices of physiotherapists in the treatment of low back pain

Our purpose was to explore and describe physiotherapists' informed consent practices in the treatment of clients with low back pain. Forty-four physiotherapists were assigned to six focus group interviews. Focus group interaction elicits insights that are less accessible in individual interviews and which can be corroborated immediately through inbuilt checks and balances. Participating physiotherapists described not only fulfilling but also exceeding their regulatory and ethical duty to obtain explicit and implicit informed consent from clients according to professional guidelines. Client autonomy could not always take precedence in the fast-paced and seamless therapy session. A shared decision-making process of embodied, implicit consent or refusal was embedded in a reciprocal client–therapist care relationship of trust and rapport. A typology of modes of consent is provided. A process for obtaining a more explicit consent alongside implicit consent that does not interrupt the continuity of physiotherapy treatment is outlined.     

Informed consent to treatment in clinical trials

Special characteristics of clinical trials place unique demands on the concept and practice of informed consent to treatment. We focus on the practical problem that consent to treatment forms are not typically able to be understood by patients in clinical trials research. Informed consent forms are significantly less comprehensible than popular press written material and may be as difficult to read as medical journals. Several guidelines for improving informed consent to treatment documents such as the use of non-professionals and patients to critique drafts of consent to treatment forms are proposed and discussed. The use of these guidelines can insure that patients have the opportunity to understand more clearly what their treatment will involve within a clinical trial before they give an informed consent.     

Informed consent for blood transfusion: a regional hospital survey

Ninety-two hospitals in a three-state mid-Atlantic region were surveyed to determine their policy toward obtaining written informed consent for transfusion and to examine the content of written consent documents and the process by which consent is obtained. Of 81 hospitals responding, 50 (62%) required written informed consent. Hospitals with fewer than 200 beds were more likely to require written informed consent. The attending physicians had responsibility for obtaining consent in 28 (57%) of 49 institutions, most often on the day or evening before surgery. Twenty-seven of 48 forms mentioned complications: hepatitis in 80 percent, human immunodeficiency virus infection in 46 percent, nonhemolytic reactions in 32 percent, and hemolysis in 25 percent. Alternatives to allogeneic transfusion were mentioned infrequently; eight hospital forms listed autologous transfusion options and only two mentioned designated donation. The reading level required to comprehend 34 consent forms submitted was grade 14.6, which has been attained by only 23 percent of the adult United States population. Although the majority of respondent institutions require written informed consent, those forms, per se, do not document that the fundamental tenets of informed choice have been applied to the decision to transfuse blood.     

Medical informed consent: general considerations for physicians

Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.     

The quality of parental consent for research with children: a prospective repeated measure self-report survey

BACKGROUND: Researchers have ethical and legal responsibilities to ensure that individuals give informed consent to participate in research. The few studies of parental consent for paediatric research suggest there may be inadequate competence, information, understanding, or voluntariness for valid consent to occur. OBJECTIVES: To determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process. PARTICIPANTS: English literate parents of children actively involved in research studies. METHODS: A repeated measures self-report survey was conducted to measure parent understanding (actual and perceived) of the study consented for and satisfaction with the informed consent process. Relationships between parents understanding of the research and their satisfaction with the consent process were explored and changes in parent understanding or satisfaction over time were described. RESULTS: Questionnaires from 109 parents were returned, representing 25 different studies. Parents demonstrated a high level of knowledge of information essential for informed consent, such as the purpose, benefits, and participant rights. Nervousness or inability to concentrate, and reading ease of the information sheet were found to relate to parents' knowledge and their perceptions of the adequacy of the consent. Parents overall reported high satisfaction with the consent process. CONCLUSIONS: These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.     

Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process

Objective

The purpose of this study was to develop an integrated care pathway for doctors of chiropractic, primary care providers, and mental health professionals who manage veterans with low back pain, with or without mental health comorbidity, within Department of Veterans Affairs health care facilities.

Informed consent for blood transfusion as a transfusion medicine educational intervention

SUMMARY. The aim here was to determine the effectiveness of a transfusion medicine educational intervention in a medicine core clerkship program.
Third-year medical students enrolled in their medicine core clerkship rotations at tertiary care hospitals affiliated with our institution underwent a two-part educational intervention that incorporated a transfusion medicine curriculum within the context of the medicolegal, ethical and educational elements of informed consent. Part one was a 1-h didactic session on standards of practice for red blood cell transfusion. Part two was a 90-min multidisciplinary workshop on informed consent. The effectiveness of the educational intervention was analysed by an objective structured clinical evaluation.
The student group receiving the educational intervention scored significantly higher than in the comparison group (65.8 ± 9.2 vs. 54.1 ± 10.56, P <0.001). When student scores were used to determine changes in student response patterns over time, the largest change occurred in identifying possible other options to allogeneic blood transfusion.
These results suggest that a transfusion medicine curriculum using an informed consent model can be used effectively as an educational intervention in a medicine core clerkship programme.