Showing papers on "Informed consent published in 2011"

Clinical practice: The approach to the deaf or hard-of-hearing paediatric patient.

Abstract: Approximately 1 child in 1,000 is deaf or severely hard of hearing from birth, and the prevalence rises to about 1.6 per 1,000 in adolescents. Providing medical care for this group of children poses special challenges for professionals. To allow a medical consultation to proceed successfully and to the satisfaction of the patient, it is essential that physicians are aware of the different linguistic and cultural background of these patients. Healthcare workers should be aware of the possible higher incidence of comorbidities, sexual abuse and (psycho)social problems, of the possible pitfalls in obtaining informed consent and higher frequency of medical mistakes. This review describes the communication challenges and medical, ethical and legal issues a physician can experience when faced with these patients.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

Abstract: Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

The Ethics of Research with Children and Young People: A Practical Handbook

Abstract: Introduction Defining Some Terms Research Ethics The Purpose of This Book: Starting from Uncertainty and the Question Format Researchers as Insiders or Outsiders The Contents of This Book PART ONE: THE PLANNING STAGES Planning the Research: Purpose and Methods Two Basic Questions Questions about Purpose and Methods Is the Research Worth Doing? Do Theories Matter? Do Viewpoints Matter? Do Methods Matter? Three Phases in Growing Awareness of Research Ethics Three Ethics Frameworks for Assessing Research Uncertainty - The Basis of Ethical Research Summary of Questions Assessing Harms and Benefits Harms Benefits Risk, Cost, Harm and Benefit Assessments Confusion in Risk-Benefit Assessments Risk of Distress or Humiliation Summary of Questions Respect for Rights: Privacy and Confidentiality Legal Rights to Confidentiality Opt-in or Opt-out Access Practical Respect Privacy Rights Data Protection Act 1998 Confidentiality or Acknowledgement? Intimacy between Strangers: Research Interviews Ethics and the Internet Respecting Local Values Privacy and Encouraging Freely Given Responses in Face-to-Face Contact Does Traditional Ethics Cover Modern Research Experiences and Relationships? Summary of Questions Designing Research: Selection and Participation Framing the Topics and Extent of the Research Combining Respect, Inclusion and Protection Does Traditional Ethics Cover Social Exclusion? Images and Symbols Beyond Inclusion to Participation: Children and Young People as Researchers UN-Related Work With Young People Respecting Young Researchers' Own Qualities Summary Of Questions Money Matters: Contracts, Funding Research and Paying Participants Planning, Budgeting and Research Agendas Ethics and Funding Sources Carbon Costs Ethics and Contracts Freedom to Publish Paying Young Researchers and Participants Payments in Context Summary of Questions Reviewing Aims and Methods: Ethics Guidance and Committees Review and Revision of Research Aims and Methods Does Social Research Need Research Ethics Committees? Recent Experiences with Research Ethics Committees International Standards A National Social Research Ethics Forum? Summary of Questions PART TWO: THE DATA COLLECTING STAGE Information Spoken and Written Information Research Information Leaflets Leaflet Layout Examples of Research Information Leaflets Leaflets in Other Languages Information in Semi-Literate Societies Relevant Research? Two-Way Information Exchanged Throughout the Research Study Summary of Questions Consent Consent and Rights The Meaning of Consent Consent to Open-Ended Research Assent Consent and the Law Consent by and for Children and Young People Double Standards Complications in Parental Consent Defining and Assessing Competence to Consent Levels of Involvement in Decision Making Respecting Consent and Refusal Consent to Longitudinal Research Consent and Secondary Data Analysis International Standards of Consent Research and International Contexts Why Respect Children's Consent? General Questions about Children's Consent Summary of Questions PART THREE: THE WRITING, REPORTING AND FOLLOW-UP STAGES Disseminating and Implementing the Findings Involving Children in Data Analysis Dissemination: Getting to the Heart of Debate and Change Dissemination and Implementation: Children, Young People and Adults Working Together for Change Problems with Dissemination Creative Ways Round the Problems Dissemination and the News Media Critical Readers and Viewers Underlying Attitudes to Children and The 3 Ps Summary of Questions The Impact on Children What Collective Impact Can Research Have on Children and Young People? Reviewing the Impact of Research on Children Positive Images Summary of Questions Conclusion Ways Forward for Individuals and Teams Questions that Cannot be Solved by Individuals Alone The Need for Social Research Ethics Authorities Summary of National Policy Is the Research Worth Doing? And Finally References And Index

What are the major ethical issues in conducting research? is there a conflict between the research ethics and the nature of nursing?

Abstract: Background: Research ethics involve requirements on daily work, the protection of dignity of subjects and the publication of the information in the research. However, when nurses participate in research they have to cope with three value systems; society; nursing and science which may be in conflict with the values of subjects, communities, and societies and create tensions and dilemmas in nursing. Method and material: Using the Medline and the Nursing Cinahl data base, the most important ethical issues which appear in bibliography, will be addressed. After a short description of the nature of nursing, and the advocacy role of nurses, the writer will attempt to highlight the possible conflicts that nurses have to deal with, when undertaking or participating in research. Results: The major ethical issues in conducting research are: a) Informed consent, b) Beneficence- Do not harm c) Respect for anonymity and confidentiality d) Respect for privacy. However, both the nature of nursing which focuses on caring, preventing harm and protecting dignity and the advocates role of nurses which calls for defending the rights of subjects, are sometimes incongruent with the ethics in research. Conclusions: Ethical issues, conflicting values, and ambiguity in decision making, are recurrently emerging from literature review on nursing research. Because of lack of clarity in ethical standards, nurses must develop an awareness of these issues and an effective framework to deal with problems involving human rights.

Substance Use in Pregnancy

Abstract: Objective To improve awareness and knowledge of problematic substance use in pregnancy and to provide evidence-based recommendations for the management of this challenging clinical issue for all health care providers Options This guideline reviews the use of screening tools, general approach to care, and recommendations for clinical management of problematic substance use in pregnancy. Outcomes Evidence-based recommendations for screening and management of problematic substance use during pregnancy and lactation. Evidence Medline, PubMed, CINAHL, and The Cochrane Library were searched for articles published from 1950 using the following key words: substance-related disorders, mass screening, pregnancy complications, pregnancy, prenatal care, cocaine, cannabis, methadone, opioid, tobacco, nicotine, solvents, hallucinogens, and amphetamines. Results were initially restricted to systematic reviews and randomized control trials/controlled clinical trials. A subsequent search for observational studies was also conducted because there are few RCTs in this field of study. Articles were restricted to human studies published in English Additional articles were located by hand searching through article reference lists. Searches were updated on a regular basis and incorporated in the guideline up to December 2009. Grey (unpublished) literature was also identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on the Preventive Health Care Recommendations for practice were ranked according to the method described in that report (Table 1) Benefits, harms, and costs This guideline is intended to increase the knowledge and comfort level of health care providers caring for pregnant women who have substance use disorders Improved access to health care and assistance with appropriate addiction care leads to reduced health care costs and decreased maternal and neonatal morbidity and mortality. Recommendations 1. All pregnant women and women of childbearing age should be screened periodically for alcohol, tobacco, and prescription and illicit drug use. (III-A) 2. When testing for substance use is clinically indicated, urine drug screening is the preferred method. (II-2A) Informed consent should be obtained from the woman before maternal drug toxicology testing is ordered. (III-B) 3. Policies and legal requirements with respect to drug testing of newborns may vary by jurisdiction, and caregivers should be familiar with the regulations in their region. (III-A) 4. Health care providers should employ a flexible approach to the care of women who have substance use problems, and they should encourage the use of all available community resources. (II-2B) 5. Women should be counselled about the risks of periconception, antepartum, and postpartum drug use. (III-B) 6. Smoking cessation counselling should be considered as a first-line intervention for pregnant smokers. (I-A) Nicotine replacement therapy and/or pharmacotherapy can be considered if counselling is not successful. (I-A) 7. Methadone maintenance treatment should be standard of care for opioid-dependent women during pregnancy. (II-IA) Other slow-release opioid preparations may be considered if methadone is not available. (II-2B) 8. Opioid detoxification should be reserved for selected women because of the high risk of relapse to opioids. (II-2B) 9. Opiate-dependent women should be informed that neonates exposed to heroin, prescription opioids, methadone, or buprenorphine during pregnancy are monitored closely for symptoms and signs of neonatal withdrawal (neonatal abstinence syndrome). (II-2B) Hospitals providing obstetric care should develop a protocol for assessment and management of neonates exposed to opiates during pregnancy. (III-B) 10. Antenatal planning for intrapartum and postpartum analgesia may be offered for all women in consultation with appropriate health care providers. (III-B) 11. The risks and benefits of breastfeeding should be weighed on an individual basis because methadone maintenance therapy is not a contraindication to breastfeeding. (II-3B)

Primary care of adults with developmental disabilities: Canadian consensus guidelines.

Abstract: Objective To update the 2006 Canadian guidelines for primary care of adults with developmental disabilities (DD) and to make practical recommendations based on current knowledge to address the particular health issues of adults with DD. Quality of evidence Knowledgeable health care providers participating in a colloquium and a subsequent working group discussed and agreed on revisions to the 2006 guidelines based on a comprehensive review of publications, feedback gained from users of the guidelines, and personal clinical experiences. Most of the available evidence in this area of care is from expert opinion or published consensus statements (level III). Main message Adults with DD have complex health issues, many of them differing from those of the general population. Good primary care identifies the particular health issues faced by adults with DD to improve their quality of life, to improve their access to health care, and to prevent suffering, morbidity, and premature death. These guidelines synthesize general, physical, behavioural, and mental health issues of adults with DD that primary care providers should be aware of, and they present recommendations for screening and management based on current knowledge that practitioners can apply. Because of interacting biologic, psychoaffective, and social factors that contribute to the health and well-being of adults with DD, these guidelines emphasize involving caregivers, adapting procedures when appropriate, and seeking input from a range of health professionals when available. Ethical care is also emphasized. The guidelines are formulated within an ethical framework that pays attention to issues such as informed consent and the assessment of health benefits in relation to risks of harm. Conclusion Implementation of the guidelines proposed here would improve the health of adults with DD and would minimize disparities in health and health care between adults with DD and those in the general population.

Informed consent: its history, meaning, and present challenges.

Abstract: The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Ethical issues in deep brain stimulation

Abstract: Deep brain stimulation (DBS) is currently used to treat neurological disorders like Parkinson’s disease (PD), essential tremor and dystonia, and is explored as an experimental treatment for psychiatric disorders like Major Depression (MD) and Obsessive Compulsive Disorder (OCD). This mini review discusses ethical issues in DBS treatment and research, as they have been discussed in the medical and ethical literature. With regard to DBS treatment, the most important issues are balancing risks and benefits and ensuring respect for the autonomous wish of the patient. This implies special attention to patient selection, psycho-social impact of treatment, effects on personal identity, and treatment of children. Moreover, it implies a careful informed consent process in which unrealistic expectations of patients and their families are addressed and in which special attention is given to competence. In the context of research, the fundamental ethical challenge is to promote high-quality scientific research in the interest of future patients, while at the same time safeguarding the rights and interests of vulnerable research subjects. Several guidelines have been proposed to ensure this. One of the preconditions to further development of responsible and transparent research practices is the establishment of a comprehensive registry.

Can Broad Consent be Informed Consent

Abstract: In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making.

What Oncologists Believe They Said and What Patients Believe They Heard: An Analysis of Phase I Trial Discussions

Abstract: Purpose Evaluation of the communication and informed consent process in phase I clinical trial interviews to provide authentic, practice-based content for inclusion in a communication skills training intervention for health care professionals. Patients and Methods Seventeen oncologists and 52 patients from five United Kingdom cancer centers consented to recording of phase I trial discussions. Following each consultation, clinicians completed questionnaires indicating areas they felt they had discussed, and researchers conducted semistructured interviews with patients examining their recall and understanding. Patients and oncologists also completed the Life Orientation Test-Revised questionnaire, measuring predisposition toward optimism. Independent researchers coded the consultations identifying discussion of key information areas and how well this was done. Observed levels of agreement were analyzed for each consultation between oncologist-coder, oncologist-patient, and patient-coder pairs. Results In several key areas, information was either missing or had been explained but was interpreted incorrectly by patients. Discussion of prognosis was a frequent omission, with patients and coders significantly more likely to agree that oncologists had not discussed it (odds, 4.8; P < .001). In contrast, coders and oncologists were more likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .023). Conclusion These data indicate that fundamental components of communication and information sharing about phase I trial participation are often missing from interviews. Important omissions included discussion of prognosis and ensuring patient understanding about supportive care. These findings will inform educational initiatives to assist communication about phase I trials.

Ethical issues posed by cluster randomized trials in health research

Abstract: The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

Researching with Young Children: Seeking Assent

Abstract: Changing views of children and childhood have resulted in an increased focus on the nature of children’s participation in research. Rather than conducting research on children, many researchers now seek to engage with children in research. Such a change recognises children’s agency as well as their rights to have a say in matters that affect them. Research that reflects a participatory rights perspective and respects children’s agency must be based on children making informed decisions about their participation. However, prevailing views of children’s competence to make these decisions often preclude their involvement. While recognising the importance of informed consent from parents/guardians, we argue the importance of assent as a means of recognising the wishes of young children in relation to research participation. In this context, assent is defined as a relational process whereby children’s actions and adult responses taken together, reflect children’s participation decisions.

Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

Abstract: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns.

Multimedia patient education to assist the informed consent process for knee arthroscopy.

Abstract: Background: In contemporary clinical practice, the ability for orthopaedic surgeons to obtain true ‘informed consent’ is becoming increasingly difficult. This problem has been driven by factors including increased expectations of surgical outcome by patients and increasing complexity of surgical procedures. Surgical pamphlets and computer presentations have been advocated as ways of improving patient education, but evidence of their efficacy is limited. The aim of this study was to compare the efficacy of a computer-based multimedia (MM) presentation against standardized verbal consent and information pamphlets for patients considering knee arthroscopy surgery. Methods: A randomized, controlled prospective trial was conducted, comparing the efficacy of three methods of providing preoperative informed consent information to patients. Sixty-one patients were randomly allocated into MM, verbal consent or pamphlet groups 3–6 weeks prior to knee arthroscopy surgery. Information recall after the initial consent process was assessed by questionnaire. Retention of this information was again assessed by questionnaire at the time of surgery and 6 weeks after surgery. Results: The MM group demonstrated a significantly greater proportion of correct responses, 98%, in the questionnaire at the time of consent, in comparison with 88% for verbal and 76% for pamphlet groups, with no difference in anxiety levels. Information was also better retained by the MM group up to 6 weeks after surgery. Patient satisfaction with information delivery was higher in the MM group. Conclusion: MM is an effective tool for aiding in the provision and retention of information during the informed consent process.

Ethical aspects of human biobanks: a systematic review.

Abstract: Aim To systematically assess the existing literature on ethical aspects of human biobanks.

The rise, fall and subsequent triumph of thalidomide: lessons learned in drug development.

Abstract: Perhaps no other drug in modern medicine rivals the dramatic revitalization of thalidomide. Originally marketed as a sedative, thalidomide gained immense popularity worldwide among pregnant women because of its effective anti-emetic properties in morning sickness. Mounting evidence of human teratogenicity marked a dramatic fall from grace and led to widespread social, legal and economic ramifications. Despite its tragic past thalidomide emerged several decades later as a novel and highly effective agent in the treatment of various inflammatory and malignant diseases. In 2006 thalidomide completed its remarkable renaissance becoming the first new agent in over a decade to gain approval for the treatment of plasma cell myeloma. The catastrophic collapse yet subsequent revival of thalidomide provides important lessons in drug development. Never entirely abandoned by the medical community, thalidomide resurfaced as an important drug once the mechanisms of action were further studied and better understood. Ongoing research and development of related drugs such as lenalidomide now represent a class of irreplaceable drugs in hematological malignancies. Further, the tragedies associated with this agent stimulated the legislation which revamped the FDA regulatory process, expanded patient informed consent procedures and mandated more transparency from drug manufacturers. Finally, we review recent clinical trials summarizing selected medical indications for thalidomide with an emphasis on hematologic malignancies. Herein, we provide a historic perspective regarding the up-and-down development of thalidomide. Using PubMed databases we conducted searches using thalidomide and associated keywords highlighting pharmacology, mechanisms of action, and clinical uses.

Engaging with children in research Theoretical and practical implications of negotiating informed consent/assent

Abstract: At the outset of an ethnographic inquiry, we navigated national and international resources to search for theoretical and practical guidance on obtaining parents and children's informed consent/assent. While much theoretical guidance debating ethical issues to children's participation in research was found, a paucity of published papers offering practical guidance on assent processes and/or visual representations of child assent forms and information sheets was discovered. The purpose of this article is to describe our experiences, both theoretically and practically, of negotiating the process of obtaining informed consent and assent with parents and children for a non-therapeutic qualitative research study. We hope this article instigates a platform for others to explicate their experience and contributes to the construction of a coherent body of knowledge which will clearly delineate important elements that must be considered when negotiating children's agreement to participate in research.

A framework for risk-benefit evaluations in biomedical research.

Abstract: Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.

Fears, Feelings, and Facts: Interactively Communicating Benefits and Risks of Medical Radiation With Patients

Abstract: OBJECTIVE. As public awareness of medical radiation exposure increases, there has been heightened awareness among patients and physicians of the importance of holistic benefit-and-risk discussions in shared medical decision making.CONCLUSION. We examine the rationale for informed consent and risk communication, draw on the literature on the psychology of radiation risk communication to increase understanding, examine methods commonly used to communicate radiation risk, and suggest strategies for improving communication about medical radiation benefits and risk.

Polypharmacy and nutritional status in older adults: a cross-sectional study.

Abstract: Background: Older adults have more chronic medical conditions, and the level of polypharmacy increases with advancing age. Malnutrition and drug nutrient interactions are of concern in this population. Objectives: The aims of this cross-sectional study were to examine nutritional status, the use of medications, and drug-nutrient interactions in older adults. Methods: Interviewer-administered surveys were conducted in 1100 community-dwelling older (age >65 years) adults. Information regarding demographics, nutritional status, medical history and medication usage was obtained. Self-reported data were verified by third parties when feasible. Informed consent and Human Subjects Committee approval were obtained. A pilot conducted prior to the onset of the study revealed high rates of inter-rater reliability. Data were recorded and entered into Excel spreadsheets for coding and cleaning and transferred to SPSS v. 17.0 for analyses. Results: The respondents’ mean age was 75.5 years. The top six most frequently used classes of medications were gastrointestinal agents, antihypertensives, diuretics, analgesics, β-adrenoceptor antagonists and antihyperlipidaemics. The prevalence of polypharmacy among the participants was 43.4%, with 51.1% of those participants using five or more medications. Most notable was the statistically significant inverse correlation between increasing number of medications and intake of fibre. Intake of cholesterol, glucose and sodium were positively associated with increasing medication use. A trend was also observed for increased phosphorus intake and increased number of medications used. Intake of fat-soluble vitamins, B vitamins, carotenoids and minerals was lower in those with increasing number of medications. Decrements in physical health were associated with decreasing intake of many fat-soluble and water-soluble vitamins, major minerals, trace minerals and electrolytes. Excessive macronutriture, specifically relating to the intake of saturated fats, refined carbohydrates and cholesterol, along with decreased intake of fibre and bioavailable protein sources, was also associated with poor physical health. Conclusions: The number of medications used by older adults in this convenience sample was associated with poorer nutritional status. Decrements in physical health have a statistically significant effect on nutrient intake. Further research into these issues is required.

Assessing the Privacy Risks of Data Sharing in Genomics

Abstract: The protection of identity of participants in medical research has traditionally been guaranteed by the maintenance of the confidentiality of health information through mechanisms such as only releasing data in an aggregated form or after identifying variables have been removed. This protection of privacy is regarded as a fundamental principle of research ethics, through which the support of research participants and the public is maintained. Whilst this traditional model was adopted for genetics and genomics research, and was generally considered broadly fit for purpose, we argue that this approach is increasingly untenable in genomics. Privacy risk assessments need to have regard to the whole data environment, not merely the quality of the dataset to be released in isolation. As sources of data proliferate, issues of privacy protection are increasingly problematic in relation to the release of genomic data. However, we conclude that, by paying careful attention to potential pitfalls, scientific funders and researchers can take an important part in attempts to safeguard the public and ensure the continuation of potentially important scientific research.

Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1.

Abstract: Pain exposure'' physical therapy (PEPT) is a new treatment for patients with complex regional pain syn- drome type 1 (CRPS-1) that consists of a progressive-loading exercise program and management of pain- avoidance behavior without the use of specific CRPS-1 medication or analgesics. The aim of this study was to investigate primarily whether PEPT could be applied safely in patients with CRPS-1. Twenty patients with CRPS-1 were consecutively enrolled in the study after giving informed consent. The diag- nosis of CRPS-1 was defined using the Bruehl and Harden/IASP diagnostic criteria. CRPS-1 was diagnosed between 3 and 18 months after the inciting event (trauma). According to a multiple single-case design (baseline (A1), treatment (B), follow-up (A2)), multiple baseline and follow-up measurements were per- formed to evaluate changes in CRPS signs and symptoms and to assess functional parameters. When com- paring the baseline with the follow-up phase, patients improved significantly with respect to pain on the visual analogue scale (57%), pain intensity (48%), muscle strength (52%), arm/shoulder/hand disability (36%), 10-meter walking speed (29%), pain disability index (60%), kinesiophobia (18%), and the domains of perceived health change in the SF-36 survey (269%). Three patients initially showed increased vegeta- tive signs but improved in all other CRPS parameters and showed good functional recovery at follow-up. We conclude that PEPT is a safe and effective treatment for patients with CRPS-1.

Tenosynovitis of the extensor carpi ulnaris tendon predicts erosive progression in early rheumatoid arthritis

Abstract: Studies have shown ultrasonographic findings to be associated with radiographic progression and relapse from clinical remission in rheumatoid arthritis (RA).1,–,5 Our group has reported a predictive value of an overall ultrasonography score6 and a cross-sectional association between ultrasonographic erosions and erosions assessed by MRI and conventional radiographs.7 However, most previous studies did not include multivariate analyses, and we wanted to further examine the predictive value of inflammatory ultrasonographic findings of the wrist, including tenosynovitis, in early RA patients. Patients were recruited from a cohort of early RA patients (disease duration ≤ 1 year) examined by joint counts, serology, conventional hand radiographs, MRI and ultrasonography at 0, 12 and 36 months.8 The regional ethics committee approved the study and all patients gave their informed consent. Sixty patients had complete 1-year data and were included in …

Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Goals

Abstract: INFORMED CONSENT IS A FUNDAMENTAL TENET OF THE US health care system, rooted in the ethical principles of respect for patient autonomy and enhanced patient wellbeing. As famously stated in a pivotal court case, “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” Over the past century, that has come to mean that patients should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values. Although practice varies widely, the current reality of informed consent for medical and surgical interventions often falls far short of stated goals. In many settings clinical informed consent involves a laundry list of potential risks recited to a patient who has already committed to a procedure, followed by the requisite signatures on a form. It is not surprising that patient comprehension is often poor. In a recent study of patients who had just provided informed consent for elective diagnostic cardiac catheterization with possible percutaneous coronary intervention, 88% had mistaken beliefs about the benefits of the procedure. Without a basic understanding of risks, benefits, and alternatives, patients cannot meaningfully participate in decision making (although providing such information does not guarantee that patients will understand the information, use it, and use it wisely). Although failures of informed consent can have disastrous consequences, more commonly the process simply takes up valuable time and does little to promote patient autonomy or well-being, leading to cynicism of some physicians and patients who view informed consent as a legal nuisance without true meaning, and the conclusion of some scholars that expectations for patient understanding and involvement in medical care are unreasonable. Accumulating evidence suggests that the informed consent process can be improved. A recent systematic review identified 44 controlled trials of a wide range of interventions designed to improve patient comprehension in informed consent for medical and surgical procedures. While standardized measures of understanding in informed consent are lacking, the majority of these studies showed some benefit. The challenge lies in how to implement these research findings to achieve an agreed-on minimum standard of comprehension, with the overall goal of elevating the process of informed consent in clinical care to fulfill the ethical principles on which the process was founded. In this pursuit, 3 practical issues bear special consideration.

A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen

Abstract: Background Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care. Purpose We describe a novel randomized clinical trial that uses the informatics and statistics infrastructure of the Veterans Affairs Healthcare System (VA) to illustrate one key component (called the point-of-care clinical trial – POC-CT) of a ‘learning healthcare system,’ and settles a clinical question of interest to the VA. Methods This study is an open-label, randomized trial comparing sliding scale regular insulin to a weight-based regimen for control of hyperglycemia, using the primary outcome length of stay, in non-ICU inpatients within the northeast region of the VA. All non-ICU patients who require in-hospital insulin therapy are eligible for the trial, and the VA’s automated systems will be used to assess eligibility and present the possibility of randomization to the clinician at the point of care. Clinicians will indicate their approval for informed consent to be obtained by study staff. Adaptive randomization will assign up to 3000 patients, preferentially to the currently ‘winning’ strategy, and all care will proceed according to usual practices. Based on a Bayesian stopping rule, the study has acceptable frequentist operating characteristics (Type I error 6%, power 86%) against a 12% reduction of median length of stay from 5 to 4.4 days. The adaptive stopping rule promotes implementation of a successful treatment strategy.