Opt-out Systems Research Articles

Trends in organ donation in England, Scotland and Wales in the context of the COVID-19 pandemic and 'opt-out' legislation.

In May 2020, England implemented soft 'opt-out' or 'deemed consent' for deceased donation with the intention of raising consent rates. However, this coincided with the COVID-19 pandemic, making it difficult to assess the early impact of the law change. Wales and Scotland changed their organ donation legislation to implement soft opt-out systems in 2015 and 2021 respectively. This study provides a descriptive analysis of changes in consent and transplant rates for deceased organ donation in England, Scotland and Wales. Logistic regression and descriptive trend analysis were employed to assess the probability of a patient who died in critical care becoming a donor, and to report consent rates using data, respectively, from the Intensive Care National Audit and Research Centre (ICNARC) in England from 1 April 2014 to 30 September 2021, and from the Potential Donor Audit for England, Scotland and Wales from April 2010 to June 2023. The number of eligible donors in April-June 2020 were 56.5%, 59.3% and 57.6% lower in England, Scotland and Wales relative to April-June 2019 (pre-pandemic). By April-June 2023, the number of eligible donors had recovered to 87.4%, 64.2% and 110.3%, respectively, of their levels in 2019. The consent rate in England, Scotland and Wales reduced from 68.3%, 63.0% and 63.6% in April-June 2019 to 63.2%, 60.5% and 56.3% in April-June 2023. While the UK organ donation system shows signs of recovery from the COVID-19 pandemic, the number of eligible potential donors and consent rates remain below their pre-pandemic levels.

How do opt-in versus opt-out settings nudge patients toward electronic health record adoption? An exploratory study of facilitators and barriers in Austria and France.

Electronic health records (EHR)are becoming an integral part of the health system in many developed countries, though implementations and settings vary across countries. Some countries have adopted an opt-out policy, in which patients are enrolled in the EHR system following a default nudge, while others have applied an opt-in policy, where patients have to take action to opt into the system. While opt-in systems may exhibit lower levels of active user requests for access, this contrasts with opt-out systems where a notable percentage of users may passively retain access. Thus, our research endeavor aims to explore facilitators and barriers that contribute to explaining EHR usage (i.e., actively accessing the EHR system) in two countries with either an opt-in or opt-out setting, exemplified by France and Austria. A qualitative exploratory approach using a semi-structured interview guideline was undertaken in both countries: 1) In Austria, with four homogenously composed group discussions, and 2) in France, with 19 single patient interviews. The data were collected from October 2020 to January 2021. Influencing factors were categorized into twelve subcategories. Patients have similar experiences in both countries with regard to all facilitating categories, for instance, the role of health providers, awareness of EHR and social norms. However, we highlighted important differences between the two systems regarding hurdles impeding EHR usage, namely, a lack of communication as well as transparency or information security about EHR. Implementing additional safeguards to enhance privacy protection and supporting patients to improve their digital ability may help to diminish the perception of EHR-induced barriers and improve patients' health and commitment in the long term. Understanding the differences and similarities will help to develop practical implications to tackle the problem of low EHR usage rates in the long run. This problem is prevalent in countries with both types of EHR default settings.

Public Opinions on Removing Disincentives and Introducing Incentives for Organ Donation: Proposing a European Research Agenda.

The shortage of organs for transplantations is increasing in Europe as well as globally. Many initiatives to the organ shortage, such as opt-out systems for deceased donation and expanding living donation, have been insufficient to meet the rising demand for organs. In recurrent discussions on how to reduce organ shortage, financial incentives and removal of disincentives, have been proposed to stimulate living organ donation and increase the pool of available donor organs. It is important to understand not only the ethical acceptability of (dis)incentives for organ donation, but also its societal acceptance. In this review, we propose a research agenda to help guide future empirical studies on public preferences in Europe towards the removal of disincentives and introduction of incentives for organ donation. We first present a systematic literature review on public opinions concerning (financial) (dis)incentives for organ donation in European countries. Next, we describe the results of a randomized survey experiment conducted in the United States. This experiment is crucial because it suggests that societal support for incentivizing organ donation depends on the specific features and institutional design of the proposed incentive scheme. We conclude by proposing this experiment's framework as a blueprint for European research on this topic.

How can we promote vaccination of the mass population?-Lessons from the COVID-19 vaccination defaults.

While vaccines are pivotal in combating COVID-19, concerns about side effects and complex procedures have hindered complete vaccination. Prior studies suggest that individuals defaulted to opt-out exhibit higher COVID-19 vaccination rates compared to those in opt-in systems. However, these studies were conducted in countries with a tolerant attitude towards vaccination and default changes, targeting specific age groups, and did not address potential deterrents like the increase in cancellation rates on the day, discomfort towards changing defaults, or the possibility of the opt-out effect being a one-time occurrence. Under the hypothesis that the default nature of the COVID-19 vaccination system influences attitudes towards vaccination even in countries conservative about vaccination and default changes like in Japan, we aimed to examine the differences in the first and second dose vaccination rates, cancellation rates, and the number of complaints between the opt-in and opt-out systems for COVID-19 vaccination. An email survey was conducted in 10 cities in A Prefecture, Japan. The results showed not only higher COVID-19 vaccination rates across all comparable age groups in the opt-out group but also a notably smaller decrease in the second-dose vaccination rate compared to the opt-in group, all achieved without any complaints about the system's introduction. Consequently, it can be inferred that the potential inhibiting factors were largely overcome. Despite some limitations, such as regional specificity, the study suggests that opt-out systems might increase COVID-19 vaccination coverage without leading to significant cancellations or complaints, presenting a promising strategy to facilitate vaccination efforts.

The right to know from the opt-out effectiveness system perspective in organ transplantation cases.

Aim: This article examines the legal challenges associated with opt-out and opt-in systems in transplantation cases. It focuses on the low public knowledge and awareness of the national transplantation system, assessing its compliance with international prerequisites for an opt-out system. The analysis centres on the "right to know" perspective and the effectiveness of opt-out in organ transplantation. . Materials and Methods: The research methodology includes scientific principles, public surveys, relevant regulations from the Republic of Latvia and EU, and grey literature on the health system and organ donation in the EU. Scientific articles from databases such as Scopus and WOS were selected based on criteria such as language (English and Latvian) and focus on living wills and comparisons of organ donation systems. Previous EU and national studies, reports, and court judgments were used to analyse data on opt-in and opt-out transplantation systems and policy efficiency in organ transplantation. Conclusions: Individuals' right to autonomy over their bodies extends even after death, encompassing the right to integrity. Organ donation, being a deeply personal choice reflecting one's values and beliefs, plays a crucial role in saving lives through transplantation. To enhance cooperation and donation rates, international regulations stress the significance of public awareness regarding organ and tissue transplantation. Unfortunately, inadequate compliance by authorities and low awareness pose ethical and legal dilemmas, potentially violating constitutional rights. Reports highlight limited public understanding of transplantation systems, raising concerns, particularly in opt-out systems. National governments bear the responsibility of safeguarding these rights and addressing challenges beyond legal means, thus establishing a more ethical organ donation system that upholds voluntariness, generosity, and individual autonomy.

Assessing the influence of affective attitudes, demography and blood donor status on organ donor registration active decisions in opt-out systems.

In contrast to opt-in systems, relatively little is known about what influences whether or not people register a decision about organ donation in opt-out systems. We address this gap in the literature. Participants (N = 756) living in a country with opt-out consent (Wales, UK) provided information on demographics and blood donor status. Participants indicated whether they had opted-in or opted-out (i.e. active decision), or not registered a decision under the assumption of deemed consent. Subsequently, their negative emotional beliefs (or affective attitudes) towards organ donation were measured. Opting-in was associated with being younger, having donated blood and holding superstitious beliefs about donation (jinx). Disgust (ick factor) deterred opting-in, and bodily integrity concerns increased opting-out. Positive affective attitudes increased opting-in and deterred opting-out. Actively opting-in increases the likelihood of organs being transplanted, thus, modifying affective attitudes and targeting blood donors should enhance the number of donors available under opt-out systems.

Interlinking Organ Scarcity to Human Rights

Organ failure is a medical emergency that causes immense suffering and a life-threatening situation. Organ transplant is the only treatment for organ failures other than renal failure. Even in cases of kidney failure, transplant is the most cost effective treatment for organ failure to prolong the lives of sufferers. The advancement of medical science in the field of transplants has improved human longevity and on an average life could be prolonged by ten- eleven years. Organ procurement from a donor is the first stage in a transplant. As in the case of blood, the organ is required to be healthy and must match. However, there is an inadequacy of organs across the world and patients who could be given a new life, die during the wait. The connection with human rights has been least explicit in the context of organ scarcity. Globally, two consent systems for organ donation can be found. The opt- in system also known as the explicit consent system requisites an express consent of either the person when alive for organ donation or their relatives after death. By contrast, opt-out systems presume everyone to be a donor and people are required to express their objection. It is generally seen that countries with presumed consent system have higher rates of organ donation in comparison to countries with opt- in system. India has opted- in system and despite having the highest population is donor rate is among the lowest in the world. This essay has two distinct objectives: First, it seeks to interlink organ scarcity to human rights. For this purpose it draws upon International Human Rights Framework. Second, it looks into the Indian law and analyses the lessons India needs to learn to improve its organ donation rate. Technological developments in the field have opened up the possibility of transplanting an increasing number of human organs, including the non vital ones like uterus, to those in need. However, the focus of the present research is limited to vital organs and does not extend to tissues and non- vital organs. Though there are human rights issues involved with allocation of organs and organ trafficking, those fall beyond the scope of the Article.

Opt-out, mandated choice and informed consent.

A number of authors criticise opt-out (or 'deemed consent') systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed.

Stakeholder perceptions of using “opt-out” for tobacco use treatment in a cancer care setting: a qualitative evaluation of patients, providers, and desk staff

BackgroundContinued tobacco use in cancer patients increases the risk of cancer treatment failure and decreases survival. However, currently, most cancer patients do not receive evidence-based tobacco treatment. A recently proposed “opt-out” approach would automatically refer all cancer patients who use tobacco to tobacco treatment, but its acceptability to cancer patients and providers is unknown. We aimed to understand stakeholder beliefs, concerns, and receptivity to using the “opt-out” approach for tobacco treatment referrals in a cancer care setting.MethodsSemi-structured interviews were conducted with oncology patients, providers, and desk staff. The sample size was determined when theoretical saturation was reached. Given the differences among participant roles, separate interview guides were developed. Transcripts were analyzed using standard coding techniques for qualitative data using the Consolidated Framework for Implementation Research (CFIR) codebook. Emergent codes were added to the codebook to account for themes not represented by a CFIR domain. Coded transcripts were then entered into the qualitative analysis software NVivo to generate code reports for CFIR domains and emergent codes for each stakeholder group. Data were presented by stakeholder group and subcategorized by CFIR domains and emergent codes when appropriate.ResultsA total of 21 providers, 19 patients, and 6 desk staff were interviewed. Overall acceptance of the “opt out” approach was high among all groups. Providers overwhelmingly approved of the approach as it requires little effort from them to operate and saves clinical time. Desk staff supported the opt-out system and believed there are clinical benefits to patients receiving information about tobacco treatment. Many patients expressed support for using an opt-out approach as many smokers need assistance but may not directly ask for it. Patients also thought that providers emphasizing the benefits of stopping tobacco use to cancer treatment and survival would be an important factor motivating them to attend treatment.ConclusionsWhile providers appreciated that the system required little effort on their part, patients clearly indicated that promotion of tobacco cessation treatment by their provider would be vital to enhance willingness to engage with treatment. Future implementation efforts of opt-out systems will require implementation strategies that promote provider engagement with their patients around smoking cessation while continuing to limit burden on providers.

'Take my kidneys but not my corneas'-Selective preferences as a hidden problem for 'opt-out' organ donation policy.

With aims to both increase organ supply and better reflect individual donation preferences, many nations worldwide have shifted from 'opt-in' to 'opt-out' systems for post-mortem organ donation (PMOD). In such countries, while a prospective donor's willingness to donate their organs/tissues for PMOD was previously ascertained-at least partially-by their having recorded positive donation preferences on an official register prior to death, this willingness is now presumed or inferred-at least partially-from their not having recorded an objection to PMOD-on an official organ donation register. Using evidence regarding the presence and prevalence of selective donation preferences, and via exploration of how appeals to donation preferences are used to both motivate and legitimate shifts to opt-out frameworks, this paper draws attention to a set of previously unexplored problems for opt-out organ donation arising in contexts where: (a) individuals demonstrate selective post-mortem organ/tissue donation preferences, (b) legislation provides prospective donors with the opportunity to selectively permit/refuse the donation of certain organs/tissues in line with these preferences. While selective preferences pose few problems for opt-in systems where a selective occasion is built into the process of signing the donor register, this is not the case for opt-out systems. The loss of this selective occasion can cause significant problems where appeals to preferences motivate/legitimate shifts to opt-out but evidence regarding variable preferences does not feed into determinations regarding organ/tissue exclusions. The nature of these problems depends on how the authorization aspect of 'opt-out' systems is framed (e.g. as presumed consent, deemed consent or, given the role of familial consent in many jurisdictions as consent in name only).

Presumed Dissent? Opt-out Organ Donation and the Exclusion of Organs and Tissues.

It is often claimed that a legitimate approach to organ donation is an opt-out system, also known as ‘presumed consent’, ‘deemed consent’, or ‘deemed authorisation’, whereby individuals are presumed or deemed willing to donate at least some of their organs and tissues after death unless they have explicitly refused permission. While sharing a default in favour of donation, such systems differ in several key respects, such as the role and importance assigned to the family members of prospective donors and their preferences, and exclusions and safeguards which often specify the demographic groups, purposes, or organs and tissues that will remain outside the scope of the opt-out system. Using the recent shift to opt-out in England, Scotland, and Northern Ireland as case studies, and by reference to the key goals motivating this shift across the UK, this article asks whether and, if so, why, and how, opt-out systems for post-mortem organ donation should restrict the types of organs and tissues for which consent is deemed. In other words, ought opt-out systems for PMOD presume dissent regarding the donation of certain organs and tissues?

Are Opt-Out Systems Regressive? Evidence from the Church Tax

Are Opt-Out Systems Regressive? Evidence from the Church Tax

Australian Perspectives on Opt-In and Opt-Out Consent Systems for Deceased Organ Donation.

Introduction: As many countries change to opt-out systems to address organ shortages, calls for similar reform in Australia persist. Community perspectives on consent systems for donation remain under-researched, therefore Australian perspectives on consent systems and their effectiveness in increasing donation rates were explored. Design: In this descriptive cross-sectional study, participants completed a survey presenting opt-in, soft opt-out, and hard opt-out systems, with corresponding descriptions. Participants chose the system they perceived as most effective and described their reasoning. Results: Participants (N = 509) designated soft opt-out as the most effective system (52.3%; hard opt-out 33.7%; opt-in 13.7%). Those who identified with an ethnic/cultural group or were not registered had greater odds of choosing opt-out. Six themes identified in thematic analysis reflected their reasoning: (1) who decides (individual, shared decision with family); (2) right to choose; (3) acceptability (ethics, fairness); and utility in overcoming barriers for (4) individuals (apathy, awareness, ease of donating, fear/avoidance of death); (5) family (easier family experience, family veto); (6) society (normalizing donation, donation as default, expanding donor pool). Choice and overcoming individual barriers were more frequently endorsed themes for opt-in and opt-out, respectively. Discussion: Results suggested the following insights regarding system effectiveness: uphold/prioritize individual's recorded donation decision above family wishes; involve family in decision making if no donation preference is recorded; retain a register enabling opt-in and opt-out for unequivocal decisions and promoting individual control; and maximize ease of registering. Future research should establish whether systems considered effective are also acceptable to the community to address organ shortages.

The devil is in the details: an analysis of patient rights in Swiss cancer registries

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...

Opt-out paradigms for deceased organ donation are ethically incoherent

The Organ Donation Act 2019 has introduced an opt-out organ donor register in England, meaning that consent to the donation of organs upon death is presumed unless an objection during...

Healthcare students support opt-out organ donation for practical and moral reasons

Background and purposeChanges to deceased organ donation policy in the USA, including opt-out and priority systems, have been proposed to increase registration and donation rates. To study attitudes towards such...

Assessing Global Organ Donation Policies: Opt-In vs Opt-Out.

This paper argues that there is little difference between opt-in and opt-out organ donation systems for increasing donor numbers when used in isolation. Independently diverting to an opt-out system confers no obvious advantage and can harm efforts to bolster donations. Rather, it is essential to address barriers to organ donation on several levels along with a switch in system. Moreover, for many countries, it may be more beneficial to adequately capacitate the donation system already in place, rather than entertain a significant change with its attendant resource requirements. For decades, the international transplant community has been involved in vigorous debate as to the merits of moving from default opt-in systems to opt-out policies to grow organ donor numbers and better meet the ever-increasing demand for lifesaving transplants. Opt-out is certainly en vogue, with Wales, England and Nova Scotia recently switching over, Scotland due to become opt-out in March 2021 and Northern Ireland and Canada seriously considering a similar move. Thanks to several countries making the switch from opt-in to opt-out over the last 20–30 years, there are sets of robust longitudinal data that aid in analysing the efficacy of donation systems. However, these data are often contradictory and largely inconclusive, suggesting other factors may be in play. This paper reviews some emerging trends in opt-in versus opt-out organ donation policies and considers recent data that elucidates some of the main contentions across each. Ethical frameworks underpinning donation systems, such as informed consent, trust and transparency, are discussed in detail. Substantial time is also devoted to opt-in vs opt-out systems in developing countries, which tend to be excluded from many analyses, and where the challenges faced are magnified by socio-economic constraints. This constitutes a major gap in recently published literature, as developing countries often lag far behind their developed counterparts in donor and transplant numbers.

Deceased by default: Consent systems and organ-patient mortality.

Previous research shows that countries with opt-out consent systems for organ donation conduct significantly more deceased-donor organ transplantations than those with opt-in systems. This paper investigates whether the higher transplantation rates in opt-out systems translate into equally lower death rates among organ patients registered on a waiting list (i.e., organ-patient mortality rates). We show that the difference between consent systems regarding kidney- and liver-patient mortality rates is significantly smaller than the difference in deceased-donor transplantation rates. This is likely due to different incentives between the consent systems. We find empirical evidence that opt-out systems reduce incentives for living donations, which explains our findings for kidneys. The results imply that focusing on deceased-donor transplantation rates alone paints an incomplete picture of opt-out systems’ benefits, and that there are important differences between organs in this respect.

Categories of systematic influences applied to increase cancer screening participation: a literature review and analysis.

Health authorities can influence citizens in subtle ways that render them more likely to participate in cancer screening programmes, and thereby possibly increase the beneficial effects. If the influences become too severe, the citizens' ability to make a personal choice may be lost on the way. The purpose of this analysis was to identify and categorize the influences while questioning whether they still permit the citizens to make their own choices regarding participation. A two-stringed approach was used to obtain empirical examples of systematic influences that aim to raise participation rates in cancer screening programmes: First, a systematic literature search was conducted on three databases. Second, relevant experts were contacted via internationally based e-mail lists and asked for examples of systematic influences in cancer screening. The present analysis was based on direct, conventional content analysis to address different categories of systematic influences. The literature search yielded 19 included articles and the expert inquiry yielded 11 empirical examples of which content analysis of the empirical examples generated six major categories of systematic influence: (i) misleading presentation of statistics, (ii) misrepresentation of harms vs. benefits, (iii) opt-out systems, (iv) recommendation of participation, (v) fear appeals and (vi) influencing the general practitioners and other healthcare professionals. The six categories of identified influences work through psychological biases and personal costs and are still in widely use. The use of these types of influence remains ethically questionable in cancer screening programmes since they might compromise informed decision making.

A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol

BackgroundPeople with a psychiatric diagnosis smoke at high rates, yet are rarely treated for tobacco use. Health care systems often use a “no treatment” default for tobacco, such that providers must actively choose (opt-in) to treat their patients who express interest in quitting. Default bias theory suggests that opt-in systems may reinforce the status quo to not treat tobacco use in psychiatry. We aim to conduct a pilot study testing an opt-out system for implementing a 3As (ask, advise, assist) tobacco treatment model in outpatient psychiatry.MethodsWe will use a mixed-methods, cluster-randomized study design. We will implement a tobacco use clinical reminder for outpatient psychiatrists at the VA New York Harbor Healthcare System. Psychiatrists (N = 20) will be randomized 1:1 to one of the two groups: (1) opt-in treatment approach—psychiatrists will receive a reminder that encourages them to offer cessation medications and referral to cessation counseling; (2) opt-out treatment approach—psychiatrists will receive a clinical reminder that includes a standing cessation medication order and a referral to cessation counseling that will automatically generate unless the provider cancels. Prior to implementation of the reminders, we will hold a 1-h training on tobacco treatment for psychiatrists in both arms. We will use VA administrative data to calculate the study’s primary outcomes: (1) the percent of smokers prescribed a cessation medication and (2) the percent of smokers referred to counseling. During the intervention period, we will also conduct post-visit surveys with a cluster sample of 400 patients (20 per psychiatrist) to assess psychiatrist fidelity to the 3As approach and patient perceptions of the opt-out system. At 6 months, we will survey the clustered patient sample again to evaluate the study’s secondary outcomes: (1) patient use of cessation treatment in the prior 6 months and (2) self-reported 7-day abstinence at 6 months. At the end of the intervention period, we will conduct semi-structured interviews with 12–14 psychiatrists asking about their perceptions of the opt-out approach.DiscussionThis study will produce important data on the potential of opt-out systems to overcome the barriers in implementing tobacco use treatment in outpatient psychiatry.Trial registrationClinicaltrials.gov NCT04071795 (registered on August 28, 2019)