JBI database of systematic reviews and implementation reports
-
JBI Database System Rev Implement Rep · Oct 2015
ReviewExploring conceptual and theoretical frameworks for nurse practitioner education: a scoping review protocol.
The objective of this review is to examine conceptual and/or theoretical frameworks that are relevant to nurse practitioner education.The specific review question is: What conceptual and/or theoretical frameworks are available that are relevant to the structuring of nurse practitioner education? ⋯ The use of conceptual and theoretical frameworks to organize the educational curriculum of nursing programs is essential to protect and preserve the focus and clarity of nursing's distinct contribution to health care. Conceptual frameworks of nursing provide a means to look at nursing in relationship to external factors, thereby assigning meaning to the practice. Graduate level nursing education in the preparation of Nurse Practitioners (NPs) specifically and Advanced Practice Nurses (APNs) in general, is significantly compromised by the tendency to conceptualize the learning in these complex programs as being primarily related to skills-based tasks and competencies alone. According to Baumann, advanced nursing education must focus on the uniqueness of the NP position, in contrast to other health care professions. To do this, Baumann suggests using a conceptual nursing model and nursing theory as opposed to a strictly biomedical model. This allows NPs to interpret information in a way that differs from the strict biomedical model, providing opportunities for the NPs to be truly present in the lives of their patients.Canadian Nurse Practitioner (NP) practice competency documents are based primarily on the Canadian Nurses Association (CNA) Nurse Practitioner (NP) Core Competency Framework. This document defines the core set of entry-level competencies required for all NPs to practice in all Canadian jurisdictions, settings and client populations. The Core Competencies in the CNA NP Framework are organized within four main categories: professional role, responsibility and accountability; health assessment and diagnosis; therapeutic management; and health promotion and prevention of illness and injury. Although vital to the organization of provincial entry-level registration standards, this framework provides little direction to educational providers for curricula organization and philosophical perspectives.The Canadian Association of Schools of Nursing developed a national framework for NP education following a multi-phase consultation and literature and curriculum synthesis project. While the task force addressed the guiding principles and essential components of NP education along with contextual factors that impact on the delivery of curricula in Canadian jurisdictions, the philosophical approaches guiding and organizing the education were not addressed.A similar set of documents has been created in the United States by the National Organization of Nurse Practitioner Faculties (NONPF). These documents are organized by six population level foci (including the specialty of family/individual across the lifespan) and outline core competencies for entry to practice and registration and educational standards. The Core Competency documents provided by the NONPF are presented in the same manner as the CNA NP Framework and likewise, do not provide a guiding or organizing framework or philosophy for NP education.A full curriculum overhaul based on the NONPF competency requirements was performed at a university center in Oregon. The new curriculum was based on competencies that students must acquire, rather than learning objectives. While the NONPF Framework does provide an extensive list of entry-level requirements for NPs, the challenges faced by the institution as it aimed to incorporate the framework into the curriculum clearly provide evidence that these overarching frameworks need to include both a philosophical and organizational component to help guide educators.Conceptual frameworks are useful for establishing a congruent relationship between program curricula, objectives and content. Walker and Avant advance the utility of conceptual frameworks as providing the logic behind the interrelationships of terms and variables, and improving explanation and understanding. Gold, Haas & King assert that conceptual frameworks facilitate grounding of a nursing lens in the curricula of advanced practice nursing programs. It has been noted that newly practicing NPs have demonstrated an allegiance withmedical model thinking, second only in importance to wellness/health promotion considerations. Blasdell and colleagues surveyed 188 practicing NPs to investigate the relationship between education and the use of theory in clinical practice. Educated graduate NPs rated the importance of nursing theory to the NP practice role significantly higher than did diploma and baccalaureate degree NPs (4.05±2.06 versus 2.65±1.69, p<.001) but both groups rated the nursing models as less important for practice than a medical model approach.Huckabay highlighted the need for the use of a harmonized nursing model at the undergraduate level to ensure that students have a thorough understanding of what nursing is and what nursing care entails. At the graduate level, Huckabay suggested the use of multiple nursing models, depending on specialty. Regardless of the educational level, a conceptual framework used for education must enable nurse educators to have sufficient guidelines to construct a curriculum and determine what knowledge and skills are needed by the nursing students. Further, Furlong identified the need for Advanced Practice Nursing (APN) curriculae to be innovative and critically reflective, preparing students to be readily adaptable to challenges in the work place. Furlong suggests that to do this, the curriculum must rely upon an interdisciplinary framework to deliver content. Gold, Haas & King suggest that core curricula based on a medical model or a skill-related task list do not reflect the critical thinking of nurses, nor the uniqueness of the profession. Thus, conceptual models used for curricula development must: encompass the distinct nursing worldview, promote learning, and be efficient and comprehensive.Frameworks have been proposed and tested to guide the development and implementation of inter-professional education (IPE) and collaborative practice curricula for NP and medical students. A qualitative assessment of a framework guided IPE module illustrated the benefit of improving the focus on role awareness in participating students. However, this particular curriculum was limited to a two-week period and not presented as a pervasive approach to the educational programs of each discipline.In education, an overarching philosophy can provide a road map for goal identification, teaching material development and the formulation of evaluation methods. For instance, when creating a curriculum that was a result of the collaboration of three different post-secondary institutions, the SHARE (students, humor, administrative support, resources, and educational technology) model was used. This model brings together resources, students and faculty, surrounding them with humor, which was viewed as a fundamental part of the process while the program was still in its early stages. According to the authors, the program has been widely successful and the reliance on humor as an underlying philosophy has enabled the students and faculty to deal with problems arising in the new program.Focusing on evaluation, Kapborg & Fischbein promoted the use of the Education Interaction Model. The model identifies how educational influences can interact with abilities of students and how the consequences of this interaction can be evaluated by observing changes in both students and programs. The authors argue that, while the educational interaction model is effective, it is not the only model that can be used to carry out evaluations. The authors stress that the model chosen to perform an evaluation should be based upon what or who is going to be evaluated.The standards outlined in the CNA NP framework are an essential part of organizing the education process for NPs and ensuring that NPs have acquired the necessary skills to practice in Canada as an NP. However, the framework is lacking philosophy and organization regarding NP education programs to ensure that the curriculum is preparing the NPs for the ever-changing work environment.An Australian survey of NP education documents from relevant universities as well as interviews with NPs and academic conveners from Australia and New Zealand found that, while NP educational programs need to have strong clinical and science based learning components, student directed and flexible learning models act to ensure the capability of NPs as they strive to adapt to practice situations. Capability, as an approach to the learning process, includes the flexibility to respond to the specific, self-identified learning needs of students. Knowing how to learn, having high self-efficacy, applying competencies to new tasks, collaborating with others, and being creative are all signs of a capable practitioner. Gardner et al. emphasized the need for a program that fosters both competent and capable NPs. In a follow-up study, using the same data, Gardner et al. confirmed that NPs viewed the attributes of a capable NP as imperative to practice. Thus, a framework for NP education must include both competency building elements, such as those currently found in the CNA NP framework and capability building elements which can be fostered through self-directed learning.Similarly, Schaefer investigated the role of caring in nursing practice through a class for APN students in which the students reflected on their narratives of caring for patients. This qualitative study revealed that when APN students provide care by meeting the complex needs of suffering patients, the art and science of nursing combine. (ABSTRACT TRUNCATED)
-
JBI Database System Rev Implement Rep · Oct 2015
ReviewThe experiences of persons living with HIV who participate in mind-body and energy therapies: a systematic review protocol of qualitative evidence.
The purpose of this systematic review is to explore the experiences and perceptions of persons living with HIV who participate in mind-body and energy therapies. The review will focus on the use of mind-body medicine and energy therapies that include meditation, prayer, mental healing, Tai Chi, yoga, art therapy, music therapy, dance therapy, Qigong, reiki, therapeutic touch, healing touch and electromagnetic therapy. These mind-body and energy therapies are selected categories because they do not involve options that might be contraindicated to an individual's current treatment regime. More specifically, the review questions are: ⋯ Complementary and alternative medicine (CAM) is a popular adjunct to conventional medicine across global populations. Complementary generally refers to a non-mainstream approach together with conventional medicine whereas alternative refers to a non-mainstream approach in place of conventional medicine. Most people use non-mainstream approaches along with conventional treatments. The World Health Organization [WHO] defines CAM as distinct health-care practices that have not been assimilated into a country's mainstream health care system.The USA's National Center for Complementary and Integrative Health (NCCIH), formerly National Center for Complementary and Alternative Medicine (NCCAM), organizes CAM into five medical system categories: whole medical systems, mind-body medicine, biologically based practices, manipulative and body-based practices, and energy therapies. Whole medical systems include homeopathy, naturopathy, traditional Chinese medicine and Ayurveda. Mind-body medicine includes meditation, prayer, mental healing, Tai Chi, yoga, art therapy, music therapy and dance therapy. Biologically based practices include dietary supplements, herbal supplements and a few scientifically unproven therapies. Manipulative and body-based practices include massage and spinal manipulation such as chiropractic and osteopathic. Energy therapies include Qigong, reiki, therapeutic touch, healing touch and electromagnetic therapy.The NCCAM, the Alternative Medicine's Strategic Plan for 2011-2015 and the Healthy People 2020 envision a society in which all people have the opportunity to live long, healthy lives. In most countries, life expectancy has increased, but unfortunately, the incidence of chronic illnesses such as cardiovascular disease, cancer, hypertension, diabetes and depression continues to increase. Research findings indicate that the use of CAM is often greater among people living with a chronic or life threatening illness compared with the general population,Until the development of highly active antiretroviral medications (ARVs) in 1996, a diagnosis of human immunodeficiency virus (HIV) was considered to be a death sentence. The human immunodeficiency virus attacks the immune system and weakens a person's ability to combat infections and some types of cancer. Currently, there is no cure for HIV but because of lifesaving medications, the mortality rate has declined significantly. The disease is now considered a chronic illness and highly manageable. Effective treatment has resulted in approximately 35 million people worldwide still living with HIV at the end of 2012.Because HIV is no longer a death sentence but a chronic illness, there is a need to evaluate the experiences and perceptions of people using CAM, considering the prevalence of CAM use within this population. In the United States and Canada, the rate of CAM use among HIV positive persons is approximately 50% to 70%, whereas in Africa, rates of CAM use range from 36% to 68%. Popular forms of CAM among persons living with HIV include herbal or nutritional supplements, mind and body practices, and spiritual or religious healing. Worldwide, only a small percentage of persons who have access to ARVs refuse to take them and utilize CAM exclusively to treat their HIV infection.People living with HIV often report using CAM because they believe that these therapies will improve their overall health and well-being and provides them an opportunity to take some responsibility in managing their personal health, which includes medication side effects. However, the effect of CAM on an individual's physical health often cannot be measured physiologically, but may be felt or experienced.Understanding CAM use is essential so that health professionals will have the most accurate information about which integrative therapies may or may not be helpful for people living with HIV. As recommended by the Institute of Medicine report entitled, 'Integrative Medicine and Patient Centered Care', health professionals have a moral commitment to find innovative ways of obtaining evidence and expanding knowledge about diverse interpretations of health and healing. Research aimed at exploring patients' experiences and perceptions of mind-body and energy therapies is imperative so asto offer comprehensive care and promote shared decision making regarding complementary therapeutic options.
-
JBI Database System Rev Implement Rep · Oct 2015
ReviewThe impact of knowledge on attitudes of emergency department staff towards patients with substance related presentations: a quantitative systematic review protocol.
University of Manitoba and Queens Joanna Briggs Collaboration for Patient Safety: a Collaborating Center of the Joanna Briggs Institute ⋯ Substance-related emergency department (ED) visits are common worldwide. Estimates of cases with alcohol involvement presenting to the ED range from 6% to 45%. Research conducted in the UK and Australia suggests that presentations related to illicit drug use are common and have increased in recent years.In 2012, an estimated six million Canadians met the criteria for substance use disorder; alcohol was the most common substance of abuse followed by cannabis and other drugs. The relationship between substance use and physical injury is well documented. The risk of mortality is increased by the side effects of substances on users involved in accidents and trauma. Not surprisingly, substance-related ED visits have been on the rise. Although only 3 to 10% of overall visits are typically related to a primary entrance complaint of drug or alcohol use or abuse, studies estimate that up to 35% of ED visits may be directly or indirectly substance related. These reasons may range from injury resulting from accidents or violence to substance-related illnesses.Health care providers (i.e., typically medical and nursing staff) have often perceived substance using patients as a challenging group to manage and as adding to the workload of already busy staff. The challenges of providing care to this patient population may be attributed to: (1) the chaotic ED environment, (2) health care providers' lack of knowledge, experience or skill in identifying and addressing substance misuse, (3) health care providers' lack of support structures such as sufficient time, staff and resources in working with this population, (4) health care providers' negative attitudes towards this patient population, (5) unpleasant tasks (i.e. intoxicated patients who urinate on themselves) associated with care delivery to this patient population, (6) patients' aggressive or violent behavior, and (7) patients' lack of motivation to change.Health care providers' attitudes towards patients with substance use problems have been found to affect health care delivery. This is of concern given the research findings that suggest they generally hold negative attitudes towards this patient population. For instance, in their study of nurses' attitudes towards patients who use illicit drugs, Ford, Bammer and Becker found that only 15% of nurses gained satisfaction from caring for these patients and only 30% were motivated to care for this patient group. Researchers who have examined substance using patients' experiences accessing health care also point to the suboptimal attitudes of health care providers towards this patient population. In the Neale, Tompkins and Sheard study of the barriers encountered by injecting drug users when accessing health and social care services, injecting drug users reported that they were often treated poorly or differently from other patients (i.e. sent home prematurely, not given appropriate aftercare or discharge), and made them feel not worthy of receiving help. Although the evidence relating to health care providers' attitudes toward substance using patients comes primarily from studies conducted in mental health or primary care settings, researchers who have examined ED staff attitudes towards this patient population paint a similar picture. For instance, Camilli & Martin's review of ED nurses' attitudes toward intoxicated and psychiatric patients suggests that nurses are often frustrated when it comes to these patients as they are time consuming and offer repeat business to the ED. An ethnographic study of care delivery in an ED also points to the negative attitudes of ED staff towards this patient group. Henderson, Stacey and Dohan found that ED providers had interactions with substance using patients that may be considered excluding, rejecting or de-valuing, that is, in observations and interviews, providers often spoke of this patient population as abusing the system, overusing system resources, and not caring about their own health care. Other negative attitudes of ED staff towards substance using patients found in the literature pertain to: (1) being reluctant to ask patients about substance use, (2) believing little can be done in EDs to help these patients, (2) feeling angry or professionally dissatisfied when treating this patient group, (4) lacking a sense of responsibility for referring to specialist treatment, and (5) believing patients lack motivation to change following interaction with medical staff.Although there is considerable evidence that indicates health care providers hold negative attitudes towards substance using patients, there are also some studies that have found positive attitudes towards this patient population. For instance, in their study of physician attitudes toward injecting drug users, Ding et al. found that seeing more injecting drug users was associated with more positive attitudes towards this patient population. Similarly, Kelleher & Cotter's descriptive study of ED doctors' and nurses' knowledge and attitudes concerning substance use found that the ED doctors and nurses who participated in the study had positive attitudes with regards to working with substance using patients. In the majority of these studies, however, positive attitudes were reported when health care providers were professionals working in addiction services, had more experience caring for this patient population, or had more personal contact with substance using patients. But does knowledge about substance use impact attitudes towards patients with substance-related presentations?Providing education or experience-based exercises may impact positively on attitudes towards substance using patients. Brief educational interventions, typically, informational sessions, either didactic or online, about alcohol and other drugs and how to assess and work with individuals using them, have been shown to have a positive impact on students' attitudes, knowledge and confidence relating to substance use and substance users. Whether ED staff attitudes towards patients with substance-related presentations are similarly impacted by the knowledge acquired through educational interventions remains unknown. A full systematic review of the literature will answer this question. A systematic review that examines the impact of knowledge on attitudes of ED staff will inform the design of educational strategies with emergency department staff to improve attitudes towards this patient population.To confirm that no other systematic review has been published on this topic, a preliminary literature search was conducted. The following databases were searched and no current or planned review was found related to this topic: JBI Database of Systematic Reviews and Implementation Reports, Cochrane Database of Systematic Reviews, PROSPERO, CINAHL, PubMed, and Scopus. Grey literature was also searched; however, no systematic review addressing the impact of knowledge on attitudes of ED staff towards patients with substance-related presentations was located.
-
JBI Database System Rev Implement Rep · Oct 2015
Adherence to a standardized protocol for measuring grip strength and appropriate cut-off values in adults over 65 years with sarcopenia: a systematic review protocol.
The objective of this review is to examine the use of grip strength analysis in well and unwell populations in adults 65 years and over as a tool to establish muscle strength in sarcopenia.More specifically, the main review question is:1. What protocol, if any, is most commonly used among older adults with sarcopenia and does this match the standardized protocol suggested in 2011 by Roberts et al.1?Secondary review questions are:2. What are the reported cut-off values being used to determine sarcopenia in older adults, with consideration for ethnic and gender variability?3. Is grip strength, as a tool to measure muscle strength, suitable for people with common comorbidities and geriatric syndromes, such as osteoarthritis, often associated with sarcopenia? ⋯ Sarcopenia, a commonly used concept in geriatrics and gerontology, is characterized by a loss of muscle mass, muscle strength and/or physical functioning. Prevalence rates vary between 1-39% in community dwelling older populations and 14-33% in long-term care populations. Several epidemiological studies have shown the association of sarcopenia with adverse health outcomes such as falls, disability, hospitalization and mortality. Originally, sarcopenia refers to the loss of muscle mass with aging, which was later complemented with loss of muscle strength and physical functioning.In 2010, the European Working Group on Sarcopenia in Older People (EWGSOP) reported a consensus definition of sarcopenia, which included measurement of low muscle mass and low muscle function (strength or physical performance). This consensus definition can be used to identify sarcopenia patients in clinical practice and to select individuals for clinical trials. Well-designed clinical trials could ultimately lead to effective treatment and prevention strategies for sarcopenia. Since the publication of the consensus report, many studies have adopted this definition, which could potentially lead to better comparison of results between studies. On the other hand, within this definition there still is wide variability in measurement tools and use of cut-off values, which could actually hamper comparability between studies.To assess muscle strength, the EWGSOP has recommended grip strength measurement which is easy and inexpensive. A recent systematic review on the measurement properties of tools to assess sarcopenia concluded that grip strength measurement is a valid and reliable method. In a comprehensive review of the measurement of grip strength in clinical and epidemiological studies by Roberts et al., it was shown that there is wide variability in the choice of equipment and protocols for measuring grip strength. To enable comparison between studies, a standardized approach, incorporating more consistent measurement of grip strength is warranted. Based on the results of the review, a standardized approach was described including the utilization of the widely used Jamar hydraulic hand dynamometer, as was a clear assessment protocol. So far, it is unknown whether this approach has been adopted in studies investigating grip strength for sarcopenia. The primary aim of this current review is to identify whether studies are adhering to the suggested protocol, or whether a more common method is prevalent. The EWGSOP has suggested multiple cut-off values to define sarcopenia regarding muscle strength: an absolute cut-off score of 20 kilograms (kg) for women and 30 kg for men, and Body Mass Index (BMI) specific cut-off values for men and women. Alternatively, the Foundation for the National Institutes of Health (FNIH) Sarcopenia Study suggested cut-off points of 26kg for males and 16kg for females, based on the likelihood of mobility impairment. Similar values have also been suggested by Dodds et al., who generated grip strength reference values and calculated cut-off points 2.5 standard deviations below the mean from 12 United Kingdom (U.K)based epidemiology studies.Recently, Beaudart et al. showed that large differences in sarcopenia prevalence occur when both cut-off values are compared, especially in women. Additionally, prevalence has also shown to be dependent upon the tool used to assess muscle strength. Evidently, cut-off values are highly varied and may be selected for statistical, theoretical or practical reasons, and/or are based on the type and magnitude of association with clinical endpoints such as hospitalization, falls or mobility. Difficulties arise in promoting a clear-cut definition of sarcopenia with no consistent recommendation for cut-off values of grip strength available. It is therefore important to identify which grip strength cut-off values should be used for the identification of sarcopenia patients and how comorbidities such as osteoarthritis may affect such values. This review will aim to report on the cut-off values used, the justification for and the considerations of comorbidities within the identified articles. Furthermore, a study has suggested that cut-off values may be different within Asian populations. Therefore, ethnicity will also be taken into account for variations in appropriate cut-off values.The overarching objective of this review is to provide insight into the current use of grip strength within the literature among older adults aged 65 and over and, subsequently, to provide commentary on the consistency of protocol and cut-off values reported for grip strength measures. This insight into current research practice will lead to well-considered recommendations concerning the measurement of grip strength in research and clinical practice. A preliminary search for sarcopenia revealed five systematic reviews in the Cochrane Library and two within the JBI Database of Systematic Reviews and Implementation Reports, but none that examine the protocol of grip strength measures. A single study was identified through a search of Medline [Via EBSCOhost] which examines the psychometric properties of common measures of muscle mass, strength and physical performance in sarcopenia, but it was not specific to grip strength measures, nor did it examine the used protocol within studies. A lack of research into this area warrants further research and the need for the conduct of this proposed review.
-
JBI Database System Rev Implement Rep · Oct 2015
ReviewThe effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.
The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? ⋯ Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers both to the health professional's obligation of information disclosure to the patient and to the quality of the patient's understanding and decision making. In other words, it does not refer to the single moment of the agreement, but to the whole complex process of gaining information, deciding and consenting. Several factors may restrict informed consent, including the patient's competence, provision of limited information, ineffective communication between patients and professionals, the hospital environment itself and privacy problems.According to the World Health Organization (WHO), people are increasingly urged to make choices for themselves or for their family members in regards to health care use. However, at the same time, inadequate or problematic health literacy skills have been reported in approximately half of the adult population in eight European countries. "Health literacy is linked to literacy and entails people's knowledge, motivation and competences to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course". There are many instruments measuring either health literacy in general or some dimensions of health literacy (e.g. numeracy), health literacy related to specific issues (e.g. nutrition, diabetes) or health literacy of specific populations (e.g. adolescents). The diversity of existing instruments, which includes diversity in terms of scoring and ranges, makes the comparison of the results of different studies difficult. Index thresholds and ranges for different levels of health literacy for most tools were set based either on that of other well established health literacy instruments used in the same study, or on experts' assessments of the required health literacy scores. Adequate health literacy could be considered as the capacity of successfully completing most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions designed to reduce the effects of limited health literacy in general. Some of the outcomes of the included studies were comprehension and behavioral intent, outcomes which could be strongly related to the informed consent process. Without making any distinction of the studies referring to the informed consent process, they conclude that several health literacy interventions, for example, adding video to narrative, could improve an individual's comprehension. Schenker et al. conducted a systematic review on the interventions to improve patient comprehension of medical and surgical procedures, including articles published until 2008. One of their conclusions was that, in most studies, while particular attention is needed for interventions provided to patients with limited literacy, the literacy of the patients was not addressed or assessed.Since then, many articles on health literacy and informed consent have been published. According to a recent review on best practices and new models of health literacy for informed consent, which includes papers published from 2004 to 2014, over half of the collected articles were published since 2010. This review, which is limited to literature within the US and its territories, and does not focus on the evaluation of the recommended practices in the literature, concludes that different tactics for simplifying written documents and clarifying verbal exchanges, and the use of multimedia formats and computerized exchanges might ameliorate constraints to health literate communications required for informed consent.Studies have evaluated the effectiveness of health literacy interventions which aim to improve the informed consent process. Improvement of the informed consent process may refer not only to the patients' comprehension but also, for example, to the recall of the information provided, to their intention to ask for clarifications, or to their satisfaction with the procedure. Interventions described and tested in the literature focus on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)