Ethical Standards of Patient Education In Health Care and Nursing Education

Health Care and Nursing Education and Ethical Standards of Patient Education

Patient Education and Ethical Standards,Consent for Research In Health Care and Nursing Education,Misunderstanding and Misconceptions About Consent and Health Research.

Patient Education and Ethical Standards

    Ethical standards, both for patient care and particularly for research, continue to evolve. The legal standard of care has focused on disclosure of information but not on ensuring that patients possess sufficient understanding to make an autonomous and informed decision such as to enroll in a clinical trial or develop an advanced directive. 

    The ethical (as opposed to the legal) view, that patients or research subjects should fully understand that to which they are agreeing, is gradually gaining ground. Not surprisingly, a patient education function will be required to accomplish this.

    Very beginning work is addressing the ethics of patient education itself, that is, what moral precepts should guide decisions about whether education is available to patients and how it should be designed and delivered. 

Consent for Research In Health Care and Nursing Education

    Most potential research subjects have limited knowledge about randomized clinical trials (RCCTs)-their aims as well as use of randomization, blinding, and placebo. Table 3.1 describes the type of information needed for ethically informed consent to be given. It is easy to see why potential subjects could be confused about these unfamiliar concepts.

    In one study (Criscione, Sugarman, Sanders, Pisetsky, & St. Clair, 2003), 13% of subjects thought their symptoms would help determine the treatment assigned in the trial. Despite having received detailed information about risks prior to starting the trial, 37% believed study drugs were completely safe. 

    Some also didn't understand the likelihood they would receive a placebo. Not only is it necessary to understand the basics of study design, being persuaded of clinical equipoise is also important for true informed consent and for subject willingness to be recruited and to accept randomization. 

    In a study of men with localized prostate cancer, from a variety of educational backgrounds, all were able to understand and recall concepts of chance, comparison, and equipoise. Although they understood randomization, it was a struggle for them to accept it as a method of choosing a treatment (Mills, Donovan, Smith, Jacoby, Neal, & Hamdy, 2003).

    In a study of patients with advanced cancer, who had given informed consent to participate in Phase I trials, 44% said the worst thing that could happen to them would be that the investigational agent would not work, and only 25% mentioned death as a possibility. Sixtynine percent of those who had graduated from college understood the real purpose of Phase I trials was to determine dose, toxicity, or drug interactions. 

    Only 26% of non college graduates understood this. A large portion clearly had therapeutic goals or expectations that simply was not achievable (Daugherty, Banik, Janish, & Ratain, 2000), although subjects in Phase I trials should be told that a chance or response is quite small and a cure should not be expected. Patients also often don't understand that some will get a sub therapeutic dose and others will suffer severe toxicities

    Additional deficiencies in patients understanding include lack of awareness of being a subject in a research study, inadequate recall of important risks of procedures or treatment, lack of awareness of the ability to withdraw from a research study at any time, and confusion about dual roles of doctors/researchers. 

    Twenty five of 34 studies found that patients' understanding or recall showed improvement with a wide variety of interventions including providing corrected feedback, multiple learning trials, and well organized and simplified consent forms with illustrated formats (Dunn & Jeste, 2001).

Misunderstanding and Misconceptions About Consent and Health Research

  The term “therapeutic misconception” is used to refer to these various misunderstandings when they are part of a belief that patients will receive the same individually focused treatment that they would receive in a non research clinical context. Many research practices support this misconception or at least do little to explicitly refute the natural assumption, there is reason to believe that its prevalence is substantial (Lidz & Appelbaum, 2002).

    There is a general sense in the field that these misunderstandings cannot be corrected and must be tolerated. Yet, in these situations, subjects have not given valid information con sent. It is a health professional's responsibility to probe for and ensure understanding and voluntarism. 

    Describing how and why treatment and research differ should be as much a part of the consent disclosure in a research project as the nature, purpose, overall risks and benefits, alternatives, and other disclosures required. 

    The distinctive features to be called to potential attention subjects are the nature and purpose of the research, the risks and benefits of being a subject, and the available options for obtaining the same or different therapeutic interventions outside of the research setting (Lidz & Appel baum, 2002).

    A neutral discloser, trained to teach participants how research participation would differ from clinical care and having no involvement with the research projects, has been successful in helping participants better understand randomization, placebos, double-blinding, and other research methods (Dresser, 2002). 

    The understanding of potential subjects should be assessed continually and additional information provided to correct misperceptions or misunderstandings as they occur. Currently, no research shows that this will work or what impact it would have on subject recruitment and dropout rates from clinical trials (Lidz & Appelbaum, 2002). 

    Clinical trial data managers not infrequently find themselves in the middle of these misunderstandings but without authority to correct them (Loh, Butow, Brown, & Boyle, 2002).

    In the absence of a robust effort to teach potential participants accurate and meaningful information (regarding regulations that require it), it is disingenuous to blame the misconception of patients' psychological needs to find a cure (Dresser, 2002).

    Other potentially correctable misassumptions and misunderstandings have been documented particularly in informed consent for clinical treatment. There has been an assumption that individuals with illnesses such as schizophrenia could not provide fully informed consent, such a diagnosis does not pre-determine whether a person can understand key information. 

    Several studies have found that consent-related capacity of persons with schizophrenia was enhanced with straightforward educational interventions (Carpenter et al., 2000; Dunn, Lindamer, Palmer, Golshan, Schneiderman, & Jeste, 2002; Styles, Poythress, Hall, Falkenbach, & Williams, 2001). 

    In each of these studies, with the help of education, patients with psychotic disorders were able to significantly improve their understanding of the research involved, in one instance reaching a level not significantly different from normal comparison subjects who received a routine consent procedure. Educational approaches included corrected feedback, multiple learning trials, and summaries of information.

    In fact, persons with medical or surgical conditions as well as those with psychiatric illnesses show variable ability to achieve sufficient understanding to provide informed consent. Assuming they cannot consent, or withholding the repeated educational interventions necessary to prepare them to decide whether to consent, stigmatizes and deprives these individuals of the opportunity to participate in clinical trials. 

    At the same time, such an attitude significantly retards development of a research base from which to better treat their disease. Without these additional educational assists, some subjects might agree to participate in protocols they might have otherwise refused (Dunn et al., 2002).

    In general, there has not been a commitment to invest whatever it takes to provide whatever education is needed to ensure truly informed consent. The legal standard of disclosure, which does not require patient understanding, is dominant, and it should be noted that while federal research regulations ac- knowledge vulnerability of persons who are educationally dis advantaged, no guidance regarding appropriate protections is given.

    With the exception of articles pertaining to the read ability of consent documents there is a depth of literature ad dressing how institutional review boards (IRBs) should approach the review of research involving educationally disadvantaged persons (Stone, 2003). While ethics requires a higher standard than does the law, the ethics literature also does not address this issue.