This paper provides an overview of the societal impact of a rising dementia population and examines the legal and ethical implications posed by voluntary registries as a community-oriented solution to improve interactions between law enforcement and individuals with dementia. It provides a survey of active voluntary registries across the United States, with a focus on Arizona, which has the highest projected growth for individuals living with dementia in the country.

Much biomedical research cannot be performed without recruiting human subjects. Increasingly, volunteer registries are being developed to assist researchers with this challenging task. Yet, volunteer registries raise confidentiality issues. Having recently developed a registry of volunteers, the authors searched for normative guidance on how to implement the principle of confidentiality. The authors found that the protection of confidentiality in registries are based on the 10 key elements which are elaborated in detail in the Canadian Standards Association Model (...) Code. This paper describes how these 10 detailed key principles can be used during the developmental stages of volunteer registries. (shrink)

In 2017 Ploug and Holm argued that anonymizing individuals in the Danish circumcision registry was insufficient to protect these individuals from what they regard as the potential harms of being in the registry. We argue that Ploug and Holm’s fears in each of the areas are misguided, not supported by the evidence, and could interfere with the gathering of accurate data. The extent of the risks and harms associated with ritual circumcision is not well known. The anonymized personal health data (...) supplemented with the circumcision registry will enable more precise research into the medical consequences of ritual circumcision, and allow parents to make more fully informed decisions about circumcision with minimal, if any, adverse consequences. (shrink)

We argue that voluntary mental health registries integrated into the 9-1-1 system, where patients and caregivers can establish a repository of this information, will help fill this information gap by enabling first responders to quickly understand the context of a call for service with a mental health component, and to make better informed decisions. Despite valid concerns about privacy, stigma, and the potential misuse of protected health information, such registries, if carefully designed and administered, can improve the health (...) outcomes of 9-1-1 calls for service involving mental health-related crises. (shrink)

In recent years it has been demonstrated that the use of the traditional property registry models involves the risk of corruption along with long waiting times. This paper points out the main problems associated with conventional models and makes a survey of the new ones that are based on blockchain technology. This type of model is already being developed as a proof of concept by different countries. With the use of this technology in land registry systems, it is possible to (...) improve the transparency of the processes as well as optimize costs and execution time. To show the theoretical results of this study, the Spanish land registry has been taken as an example of a use case scenario. (shrink)

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The (...) main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

In 1971, President Richard Nixon declared a “war against cancer,” stating that “the same kind of concentrated effort that split the atom and took man to the moon should be turned toward conquering this dread disease.” Nixon signed the National Cancer Act, and shortly thereafter the first national registry listing all ongoing clinical trials for cancer therapies was published by the National Cancer Institute. The registry was proposed by Mary Lasker (“a patroness and advocate of clinical research”) to help doctors (...) find open trials in which to enroll their patients and to help researchers maintain a steady supply of research participants. The registry appeared to be a win for doctors, patients, researchers, and pharmaceutical companies alike. However, it ended up exposing corrupt practices and tensions between ethics, the corporate need for profits, and public health goals. How did this happen? (shrink)

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, (...) a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries (...) and biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

Several high-profile episodes have recently thrust drug safety and the pharmaceutical industry's practices into the spotlight. Merck's recall of the drug Vioxx, for instance, was a major news event. GlaxoSmithKline's suppression of data linking suicidal behavior among children to Paxil also galvanized tremendous public attention. What differentiates these events from the usual evolving process of scientific knowledge, and marks them with an aura of “scandal,” are questions about the propriety of corporate behavior. Who knew what, and when did they know (...) it? Concerns are growing about the potential for industry sponsors to suppress negative results from clinical trials research. Scientists, medical journal editors, legislators, and the public have called for greater transparency in the conduct of clinical trials and the drug approval process. (shrink)

Together with large biobanks of human samples, medical registries with aggregated data from many clinical centers are vital parts of an infrastructure for maintaining high standards of quality with regard to medical diagnosis and treatment. The rapid development in personalized medicine and pharmaco-genomics only underscores the future need for these infrastructures. However, registries and biobanks have been criticized as constituting great risks to individual privacy. In this article, I suggest that quality with regard to diagnosis and treatment is (...) an inherent, morally normative requirement of health care, and argue that quality concerns in this sense may be balanced with privacy concerns. (shrink)

Healthy Volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation (...) of HVs in clinical trials are properly obtained informed consent, and a minimization of exposure to risk, in particular by avoiding concealed participation in multiple trials. To minimize the risk of exploitation of HVs and their exposure to risk, we propose ways to ensure genuine informed consent, and advocate setting up national Healthy Volunteer volunteer registries as established in France and the U.K. (shrink)

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain (...) informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA. (shrink)

ArgumentSince the 1970s, Danish population registries were increasingly used for research purposes, in particular in the health sciences. Linked with a large number of disease registries, these data infrastructures became laboratories for the development of both information technology and epidemiological studies. Denmark's system of population registries had been centralized in 1924 and was further automated in the 1960s, with individual identification numbers (CPR-numbers) introduced in 1968. The ubiquitous presence of CPR-numbers in administrative routines and everyday lives created (...) a continually growing data archive of the entire population. The resulting national-level database made possible unprecedented record linkage, a feature epidemiologists and biomedical scientists used as a resource for population health research. The specific assemblages that emerged with their practices of data mining were constitutive of registry-based epidemiology as a style of thought and of a distinct relationship between science, citizens, and the state that emerged as “Scandinavian.”. (shrink)

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether (...) alternative arrangements are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent—in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements—from an ethical standpoint—of the recently reformed Swiss policy on cancer registration. (shrink)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for (...) waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries. (shrink)

The artist and analytic Kant scholar Adrian Piper has been aptly described as “one of the most important and influential cultural figures of our time. The award-winning work of installation and participatory performance art, Probable Trust Registry: Rules of the Game #1-3, implicitly poses philosophical questions of interest to contractarian philosophy and its critique, including whether through an art installation one can execute a genuine, morally binding commitment to be honest, authentic, and respectful of oneself. Especially for audiences who closely (...) identify with her experiences, Piper’s artwork, like that of other important artists, has powerfully catalytic ethical potential. Motivated by admiration for the artist and a perceived conflictual relationship between women of color and conventional discourses of moral solidarity, I offer three different ways to understand Piper’s Probable Trust Registry. I suggest that Piper’s thought-provoking artwork, which implicitly nods at John Rawls and Charles Mills, can be interpreted as asking its audiences to agree to selections from a menu of rules that, in the alternative, embrace universal moral imperatives, predict future moral integrity, or vow moral integrity. (shrink)

Despite exponential growth in the past decades, most aspects of the assisted reproductive technology industry remain largely unregulated; recently, pressure has been mounting for coordinated study and regulation of this developing industry. On March 28, 2008, lawyers, health care professionals, representatives from sperm banks, consumers of ART services, and other stakeholders in ART industry gathered at DePaul University College of Law for its Health Law Institute’s symposium titled “Tracking Change: The Feasibility of a Voluntary Gamete Donor Registry in the United (...) States.” The implementation of a registry would mark the first effort in the United States to centralize, maintain, and disseminate information about gamete donors by collecting and storing genetic and identifying information about egg and sperm donors. Establishing a registry requires balancing the interests of donor-conceived individuals, their parents, gamete donors, health care professionals, and society as a whole, as well as ensuring the privacy and safety of all involved. (shrink)

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain underreported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of interest can be mitigated and (...) trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly accessible registries for researcher conflicts of interest and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest; and the ability to automatically generate conflicts of interest statements for use in published articles. (shrink)

Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, (...) the percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation. (shrink)

Based on the experiences of two high profile voluntary data collection programs for engineered nanomaterials, this article considers the merit of an international online registry for scientific data on engineered nanomaterials and environmental, health and safety (EHS) data. Drawing on the earlier experiences from the pharmaceutical industry, the article considers whether a registry of nanomaterials at the international level is practical or indeed desirable, and if so, whether such an initiative—based on the current state of play—should be voluntary or mandatory. (...) The article commences with an examination of the success and failures of voluntary reporting schemes in the UK and the US, as well as the International Council of Nanotechnology’s EHS Database and the OECD’s Working Party on Manufactured Nanomaterials. The article then examines the history of clinical trials registries, including the key motivations behind their creation, the role of self-regulation, and the perceived benefits thereof. Key lessons of the rise of clinical trials registration are highlighted, as are crucial considerations that must be addressed by policy makers should a multi-lateral public registry for data on nanoscale materials and EHS research be perceived to be a desirable option. The article concludes by arguing that while the creation of a registry to record information generated on nanomaterials is not straightforward, this reason alone should not deter industry from taking a proactive approach to the dissemination of fundamental data and research findings. (shrink)

Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues.

Rationale Treatment guidelines recommend a more conservative surgical approach than mastectomy for early stage breast cancer and a stronger emphasis on adjuvant therapy. Registry data at South Australian teaching hospitals have been used to monitor survivals and treatment in relation to these guidelines.Aims and objectives To use registry data to: (1) investigate trends in survival and treatment; and (2) compare treatment with guidelines.Methods Registry data from three teaching hospitals were used to analyse trends in primary courses of treatment of breast (...) cancers during 1977–2003 (n = 4671), using univariate analyses and multiple logistic regression. Disease-specific survivals were analysed using Kaplan–Meier product limit estimates and multivariable Cox proportional hazards regression.Results The 5-year survival was 79.9%, but with a secular increase, reaching 83.6% in 1997–2003. The relative risk of death (95% confidence limits) was 0.74 (0.62, 0.88) for 1997–2003, compared with previous diagnoses, after adjusting for tumour node metastasis stage, grade, age and place of residence. Treatment changes included an increase in conservative surgery (as opposed to mastectomy) from 51.7% in 1977–1990 to 76.8% in 1997–2003 for stage I (P < 0.001) and from 31.1% to 52.2% across these periods for stage II (P < 0.001). Adjuvant radiotherapy also became more common (P < 0.001), with 20.6% of patients receiving this treatment in 1977–1990 compared with 60.7% in 1997–2003. Radiotherapy generally was more prevalent when conservative surgery was provided, although also relatively common in mastectomy patients when tumour diameters exceeded 50 mm or when there were four or more involved nodes. The proportion of patients receiving chemotherapy increased (P < 0.001), from 19.6% in 1977–1990 to 36.9% in 1997–2003, and the proportion having hormone therapy also increased (P < 0.001), from 34.3% to 59.4% between these periods.Conclusions Survivals appear to be increasing and treatment trends are broadly consistent with guideline directions, and the earlier research on which these recommendations were based. (shrink)

_The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ Uniform Requirements (...) for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research proposal are (...) reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)

We respond to Morgan and Feeley’s critique on our article “Mass Media in Organ Donation: Managing Conflicting Messages and Interests.” We noted that Morgan and Feeley agree with the position that the primary aims of media campaigns are: “to educate the general public about organ donation process” and “help individuals make informed decisions” about organ donation. For those reasons, the educational messages in media campaigns should not be restricted to “information from pilot work or focus groups” but should include evidence-based (...) facts resulting from a comprehensive literature research. We consider the controversial aspects about organ donation to be relevant, if not necessary, educational materials that must be disclosed in media campaigns to comply with the legal and moral requirements of informed consent. With that perspective in mind, we address the validity of Morgan and Feeley’s claim that media campaigns have no need for informing the public about the controversial nature of death determination in organ donation. Scientific evidence has proven that the criteria for death determination are inconsistent with the Uniform Determination of Death Act and therefore potentially harmful to donors. The decision by campaign designers to use the statutory definition of death without disclosing the current controversies surrounding that definition does not contribute to improved informed decision making. We argue that if Morgan and Feeley accept the important role of media campaigns to enhance informed decision making, then critical controversies should be disclosed. In support of that premise, we will outline: (1) the wide-spread scientific challenges to brain death as a concept of death; (2) the influence of the donor registry and team-huddling on the medical care of potential donors; (3) the use of authorization rather than informed consent for donor registration; (4) the contemporary religious controversy; and (5) the effects of training desk clerks as organ requestors at the Department of Motor Vehicles offices. We conclude that organ donation is a medical procedure subject to all the ethical obligations that the medical profession must uphold including that of transparency and truthfulness. (shrink)

Definition of the problem: In 1997, Percutaneous Transluminal Coronary Angioplasty (PTCA) was performed in 138.001 cases in Germany. The standard indications, single vessel disease and badly controlled angina, are more and more extended to multivessel disease with and without severe angina, unstable or preinfarction angina, and acute myocardial infarction (AMI) itself. Dilating asymptomatic stenoses of more than 70–80% is a widely used indication, intending prophylaxis of complete occlusion and AMI. Actually there is no generally accepted guideline for the different new (...) indications, conservative versus invasive treatment schedule. It is difficult for the patient to get appropriate information before his decision between mechanical procedures and conservative methods; authentic informed consent actually seems to be in a very bad position. In 1992 the working group called ”Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte (ALKK)” decided to start a registry of all PTCA procedures, in order to gain knowledge about the present status of PTCA in Germany. Up to March 1999, 198.608 PTCA are logged.Arguments: Each PTCA was included on an intention-to-treat basis. The registry succeeded in a nearly complete recording with 98,6% of all PTCA procedures complete on March 17th, 1999. 93,5% of stenosed and 72,2% of the total occluded vessels were successfully dilated. In 4.729 cases (2,63%) the PTCA caused severe complications. The overall in-hospital mortality was only 0,5%, if the procedures done for AMI were excluded (including AMI it was 1,1%). The calculation of complications should be an essential part of the patients informed consent.Conclusion: Complete recording of all PTCA procedures is feasible even on a nationwide basis. Some results of the registry, as the indication control and the complication rate may help to realize a better doctor-patient-conversation on risks and benefits of either concept. The trend of many CHD patients is ”modern”: It should be done what can be done (mechanically), with results at once. Although said somehow paternalistic, this point of view cannot be tolerated: Proper informed consent today includes the realistic alternative of modern medicaments, especially those with an aggressive cholesterol lowering potency. (shrink)

Mass media campaigns are widely and successfully used to change health decisions and behaviors for better or for worse in society. In the United States, media campaigns have been launched at local offices of the states’ department of motor vehicles to promote citizens’ willingness to organ donation and donor registration. We analyze interventional studies of multimedia communication campaigns to encourage organ-donor registration at local offices of states’ department of motor vehicles. The media campaigns include the use of multifaceted communication tools (...) and provide training to desk clerks in the use of scripted messages for the purpose of optimizing enrollment in organ-donor registries. Scripted messages are communicated to customers through mass audiovisual entertainment media, print materials and interpersonal interaction at the offices of departments of motor vehicles. These campaigns give rise to three serious concerns: (1) bias in communicating information with scripted messages without verification of the scientific accuracy of information, (2) the provision of misinformation to future donors that may result in them suffering unintended consequences from consenting to medical procedures before death (e.g, organ preservation and suitability for transplantation), and (3) the unmanaged conflict of interests for organizations charged with implementing these campaigns, (i.e, dual advocacy for transplant recipients and donors). We conclude the following: (1) media campaigns about healthcare should communicate accurate information to the general public and disclose factual materials with the least amount of bias; (2) conflicting interests in media campaigns should be managed with full public transparency; (3) media campaigns should disclose the practical implications of procurement as well as acknowledge the medical, legal, and religious controversies of determining death in organ donation; (4) organ-donor registration must satisfy the criteria of informed consent; (5) media campaigns should serve as a means of public education about organ donation and should not be a form of propaganda. (shrink)