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Deemed consent legislation for deceased organ donation was introduced in England in 2020, and is considered a vital part of the new UK NHS Blood and Transplant's 10-year strategy to increase consent for organ donation. Despite the legislation containing safeguards to protect the public, the introduction of deemed consent creates ethical, psychological and social un/certainties for healthcare professionals in their practice. In this paper, we offer insights into healthcare professionals' perspectives on deemed consent, drawn from interview data with 24 healthcare professionals in an NHS Trust in England, prior to the introduction of the legislation. Whilst participants supported deemed consent in principle, they were concerned that it would present a threat to the nature of donation as a 'gift'; the notion of informed consent (or non-consent); and the autonomy of donors, their relatives, and their own roles as health professionals, posing dilemmas for practice. We argue that healthcare professionals present themselves as guardians of potential (non)donors and thus as having ethics and integrity in their own practice. We draw conclusions around the values and principles that matter to healthcare professionals when contemplating consent in deceased donation which will be useful for organ donation committees and ethics forums. [ABSTRACT FROM AUTHOR]

An increasing vaccine hesitancy among parents, which has resulted in insufficient rates of immunization, provides reason to reconsider childhood vaccination practices. Studies suggest that parents' decision‐making process concerning whether to vaccinate their child is highly influenced by cognitive biases. These biases can be utilized to increase vaccination uptake via changes in the choice context. This article considers childhood vaccination programmes, which involve children being vaccinated in school or daycare unless their parents actively 'opt out'. We suggest that such programmes reconcile parents' decisional authority and vaccination duties. First, opt‐out childhood vaccination based in schools or daycare centres are not disrespectful of parental authority. Second, the programme aligns the default setting with a moral obligation to vaccinate one's child that most parents have. [ABSTRACT FROM AUTHOR]

The creation of the European Health Data Space is a milestone. It establishes something new and makes it possible to have faster and more efficient health treatment, but also to untap the potential of unused data for policy-making and development of new technologies. However, for the EHDS to be functional, it is imperative that a balance it struck between the aim of having useful data to achieve important public objectives on one side and the goal of enabling patients to have control over their health data. The original Draft Report of the European Parliament came closest to achieving these objectives and should have represented the blueprint for the final compromise. Having a harmonised opt-out for secondary use is crucial for striking the right balance between the mentioned objectives. The end result is far from perfect regarding primary use, but represents a good balance in the area of secondary use concerning the opt-out. [ABSTRACT FROM AUTHOR]

Copyright of Revista Brasileira de Políticas Públicas is the property of Revista Brasileira de Politicas Publicas and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England's ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals' decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals. [ABSTRACT FROM AUTHOR]

Objectives: Electronic health records (German: elektronische Patientenakte - ePA) are an important healthcare tool. However, in Germany, current participation remains low for their national ePA. To rectify this, the German government recently adopted an opt-out approach to their national ePA system. The objective of this study is to investigate and provide a brief overview of German public attitudes towards this approach to inform policymakers with evidence-based insights. Methods: Four public focus groups were conducted with 12 German citizens to discuss their opinions on the German governments new opt-out approach to the ePA. Results: Three major thematic categories were identified (Contributors to Opt-Out Implementation, Barriers to Opt-Out Implementation, and Contingent Factors) to describe citizen views on the opt-out approach for the ePA. Conclusion: The public is generally supportive of an opt-out approach to ePAs in Germany, as they see the benefits ePAs can provide to German society; but they are skeptical on how successful this approach might be due to extant issues that policymakers must be aware of in order to successfully implement an opt-out approach for Germany's national ePA system. [ABSTRACT FROM AUTHOR]

Defaults are powerful nudges to shape individuals' behavior: In three experiments, including a large experiment using representative samples from five European countries (n = 4207), we show that they can significantly affect risk‐taking by medium to large effect sizes. We also show that implementing a default nudge leads to a lower rating of the advice delivered by the wealth manager compared to no default, an effect that has a medium to large effect size. In addition, defaults the targeted individuals refuse result in lower advice ratings. These side effects call for caution before applying nudges and individualized defaults rather than a one‐size‐fits‐all approach. Additionally, we find evidence pointing to two small effects of framing in default presentation. First, asking how much individuals want to invest in the risky asset emphasizes risk. It reduces investment in the risky asset compared to asking them how much they want to leave on the safe account, particularly for more risk‐averse individuals. Second, asking individuals if they want to change a default allocation of 100% in the risky asset leads to more investment in the risky asset than asking them whether they accept such an allocation. Perceived wealth manager honesty appears to mediate the relationship between the default nudge and the rating of the advice. [ABSTRACT FROM AUTHOR]

On the one hand, default nudges are proven to strongly influence behavior. On the other hand, a number of consumer autonomy and welfare concerns have been raised that hinder public policy applications. Both nudge success and ethical concerns depend heavily on the design of defaults. We identify six taxonomic characteristics that matter to the ethical and the nudge success dimension. We review the default nudge literature (N = 61) and review ethical studies to assess both dimensions concerning the taxonomy. When designing a default, a choice architect inevitably makes a decision concerning the characteristics. Among others, the results show three main findings. (1) The initial choice architecture regularly imposes welfare losses and impedes consumer autonomy. Forced active choosing can mitigate both issues. (2) Empirical evidence suggests that transparent defaults are similarly effective as the non-transparent counterparts. (3) The framing of the choice in combination with a choice structuring default leads to greater nudge success and tends to involve the reflective decision-making patterns. Choice architects can trade-off nudge success for legitimacy but a design change may also benefit one without harming the other. We discuss further options of choice architects to legitimize a default. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ObjectivesElectronic health records (German: elektronische Patientenakte - ePA) are an important healthcare tool. However, in Germany, current participation remains low for their national ePA. To rectify this, the German government recently adopted an opt-out approach to their national ePA system. The objective of this study is to investigate and provide a brief overview of German public attitudes towards this approach to inform policymakers with evidence-based insights.MethodsFour public focus groups were conducted with 12 German citizens to discuss their opinions on the German governments new opt-out approach to the ePA.ResultsThree major thematic categories were identified (Contributors to Opt-Out Implementation, Barriers to Opt-Out Implementation, and Contingent Factors) to describe citizen views on the opt-out approach for the ePA.ConclusionThe public is generally supportive of an opt-out approach to ePAs in Germany, as they see the benefits ePAs can provide to German society; but they are skeptical on how successful this approach might be due to extant issues that policymakers must be aware of in order to successfully implement an opt-out approach for Germany’s national ePA system.

Abstract Background Continued 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. Methods Semi-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. Results A 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. Conclusions While 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.

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. [ABSTRACT FROM AUTHOR]

Limited published data suggest rates of HIV may be high among trauma patients. This study compares rates of HIV screening and diagnosis among trauma and medical patients at a Level 1 trauma center emergency department (ED) with a universal HIV screening program. This is a retrospective cross-sectional study of all ED encounters from May 1, 2018, through May 1, 2021. Duplicate encounters, encounters with repeat testing within one year, and patients younger than 18 or older than 65 were excluded. Chi-squared analysis was used to compare demographics, rates of HIV testing, new and known HIV infections, and linkage to care between trauma and medical patients. After exclusion criteria were applied, 147,430 encounters from 91,468 unique patients were analyzed. Trauma comprised 7,497 (5.4%) encounters. Trauma patients were less likely to be screened for HIV than medical patients (18.1% vs 25.6%; OR 0.64; 95%CI, 0.61–0.68, p <.01). Trauma patients had higher rates of HIV (2.2% vs 1.3%; OR 1.78; 95% CI, 1.22–2.58, p <.01). Both trauma and medical patients would benefit from strategies to increase screening. Including trauma patients in routine ED HIV screening should be a priority to increase diagnosis rate and linkage to care in key populations. [ABSTRACT FROM AUTHOR]

Metacognitive abilities, the capacity to think about one's own thinking processes, offer a range of advantages that may drive their evolution in non-primate animals (NPAs). These advantages include enhancing adaptive decision-making in uncertain situations, efficient resource management, error detection and correction, and facilitating complex social interactions and problem-solving. In this comprehensive study, we have chosen two key paradigms -- namely, uncertainty monitoring and information-seeking tasks -- to study metacognitive phenomena in NPAs. The first paradigm involves an extensive meta-analysis of existing research, shedding light on how NPAs monitor and respond to uncertainty. We then transition to the second paradigm, which focuses on information-seeking behaviors, employing a different analytical approach. Our study aims to provide a holistic understanding of these cognitive processes in NPAs, contributing valuable insights into their cognitive complexity and ecological contexts. Through a coverage of 30 articles spanning 13 different NPA species, we bridge gaps in our understanding of metacognition beyond primates and explore potential divergent evolutionary paths, challenging assumptions about cognitive capability in NPAs. [ABSTRACT FROM AUTHOR]

This paper focuses on the important topic of collective actions, namely the participation of class members in the collective proceedings. The article essentially asks whether class members should express their consent to take part in the collective action, whether such consent shall be explicit and when should it be given. In the first part, the article analyses the different aspects of class members' status, setting out the different options and elaborating on their advantages and disadvantages. The paper focuses primarily on the methods of opt-in and opt-out. This is followed by an analysis of EU law, the law of selected European jurisdictions and also Model European Rules on Civil Procedure. In the following chapter, the article describes the development of this issue in the Czech legislation, focusing on the current proposal for the collective proceedings act. The last chapter contains the final recommendation as to what the author believes the optimal method should look like. The author suggests there should be a differentiated approach to injunctive and redress measures since each of these measures requires different optimal solution. [ABSTRACT FROM AUTHOR]

Background: Continued 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. Methods: Semi-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. Results: A 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. Conclusions: While 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. [ABSTRACT FROM AUTHOR]

(Series Information) European Papers - A Journal on Law and Integration, 2022 7(3), 1211-1227 | Article | (Table of Contents) I. Introduction. - II. Conceptual confusion. - III. Learning the lessons on differentiated integration. - III.1. The advent of Brexit. - III.2. The challenge for the future. - IV. Conclusion. | (Abstract) Historically, the use of differentiated integration mechanisms has been based on the idea of the widening and deepening of the European Union, necessitated by the enlargement of the bloc through the addition of Member State countries. The advent of Brexit means that we are in a rather different situation today, where the monodirectional march towards deeper, uniform integration between an ever increasing number of States is neither inevitable nor assured. The differences between all of the then 28 individual Member States in the pre-Brexit Union were multifarious. These differences have not disappeared along with the UK upon its exit from the Union. They still exist between the remain-ing 27 Member States and will likely increase in prominence as the European Union pursues its future path. Addressing those differences will require an alternative approach to uniform integration from the EU, it will require differentiated integration. This Article suggests that there are lessons to be learnt on differentiated integration from applying Brexit as a framework. The confusion surrounding differentiated integration as a concept, and the prominent role of the UK in availing itself of opportunities to utilise differentiated integration mechanisms, has led differentiated integration to be attributed to the UK as a form of British exceptionalism. Brexit is not just an opt-out but the ultimate opt-out, a form of flexibility sought from outside the European Union, consequent on a lack of wider acceptance of differentiated integration in terms of both legal permissiveness and extent as well as attitude within the Union. The maintenance of differences between the remaining Member States means that there needs to be increased open acceptance of the likely need for greater differentiated integration in the future.

Supporters of opt‐in organ procurement policies typically claim that the absence of consent to postmortem transplantable organ retrieval is a normative barrier to such retrieval. On this ground, justification of opt‐out policies is demanded. The paper shows that postmortem organ retrieval is normatively different from live organ removal, and so the doctrine of informed consent does not apply to it in the way it does in other types of cases. First, seen as the instrument of protection of autonomy or the right to self‐determination, informed consent cannot be relied on in the case of dead persons; secondly, viewed as an instrument of annulment of harm or wrong to the dead (volenti non fit injuria), informed consent relies on indefensible accounts of posthumous harm or wrong. Postmortem organ retrieval in cases of absence of the decedent's consent and refusal is governed by other norms than those related to consent. Such norms include, among others, respectful treatment of human remains (such as those found in regulations of medicine, law enforcement, and research) and avoidance of inherently wrong contexts and purposes (such as killing for the purpose of organ retrieval or trade in the human body or its parts). It is concluded that the onus probandi is on the supporters of opt‐in, rather than opt‐out, policies of posthumous organ retrieval. [ABSTRACT FROM AUTHOR]

Abstract Background With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts. Methods The current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers. Discussion This study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings. Trial Registration ClinicalTrials.gov: NCT05019495 (August 24, 2021).

Objective: To study the information, supposition and impression of the general population concerning organ donation and transplantation in Pakistan. Study Design: Cross-sectional analytical survey. Place and Duration of Study: Study was conducted at Tertiary Care Hospital, from Jan to Aug 2020. Methodology: We used the web-based questionnaire, devised from relevant studies and National Health Service (NHS) protocols. The questionnaire comprised of 20 multiple-choice questions (MCQs) in addition to demographic profile,distributed among the general population (n=1000) which assessed basic knowledge regarding organ transplantation and willingness for donation. Results: One thousand participants were enrolled in the study. The age range was 24–61, with a mean age of 36.66±9.00 years.933(93.3%) participants believed organ donation should be mandatory, and 600(60%) expressed willingness to donate or accept organ donation. In addition, 933(93.3%) participants believed in arranging awareness campaigns, and 1000(100%) had an opinion of establishing a convenient donor registration system. Conclusion: There are momentous awareness and willingness for organ donation; therefore, befitting tactics can enhance organ donation in Pakistan, and this issue will no longer be considered a haunted one.

Abstract Background The aim of the present survey was to investigate newly discharged hospital patients’ opinions on secondary use of their hospital data and biospecimens within the context of health research in general and, more specifically, on genetic research, data sharing across borders and cooperation with the health industry. Methods A paper questionnaire was sent to 1049 consecutive newly discharged hospital patients. Results The vast majority of the respondents preferred to be informed (passive consent) or to receive no notification at all for secondary research on their health data and biospecimens (88% and 91% for data and biospecimens respectively). The rest wanted to be asked for active consent. The same trend applied for the other aspects also. 81% of respondents were positive towards genetic research without active consent. 95% were positive towards cooperating with the health industry, and 90% were positive towards data sharing. Conclusions These results suggest that hospital patients generally are very positive to secondary research and support the concept of opting out rather than opting in.

Differentiated integration (DI) in the European Union (EU) has mainly been understood as variation in participation in common policies. But DI also has implications for the nature and functioning of the EU as a polity. While temporary DI may facilitate deeper integration, permanent DI is liable to increase transaction costs and fragmentation. However, little is known about how such alternatives are assessed by decision-makers in the member states. This article uses novel quantitative and qualitative data to shed light on this question. It looks at the explanatory role of various types of opt-outs and at member states' dependence, capacity, and identity. We find that temporary and permanent differentiation are assessed differently in the member states but neither alternative is clearly preferred. Long-term involuntary opt-outs are related to negative assessments of both forms of DI. Surprisingly, voluntary opt-outs do not seem to lead to more positive assessments of DI. We also find that the temporary DI is preferred in smaller member states, while support for permanent DI is higher in larger member states. Finally, we find differences in the effects of dependency, capacity, and identity between older and newer member states. [ABSTRACT FROM AUTHOR]

The global COVID-19 pandemic has created significant financial and operational challenges for some businesses. As a result, temporary welfare benefit reduction may be a tough but future-oriented choice for both employers and employees. The present study examined whether default nudges can be used to promote employees' approval of welfare-cutting policy while avoiding negative attitudes. Two online surveys were conducted during the first pandemic wave in China (February 2020). In the first study (N = 310), the participants were presented with a hypothetical welfare-cutting policy that used either an opt-in approach or an opt-out approach. We aimed to investigate how their approval and attitudes were different between two conditions. The results showed that the employees in the opt-out condition were more likely to accept the welfare-cutting policy than those in the optin condition, while participants' attitudes toward the policy employing optout approach were as negative as that employing opt-in approach. Study 2 (N = 1,519) involved a replication of Study 1 with two additional improved optout approaches (opt-out education and opt-out transparency). Compared with the opt-in approach and standard opt-out approach, the opt-out education approach both increased policy support and improved attitudes toward the welfare-cutting policy. The theoretical and practical implications of these findings are discussed. [ABSTRACT FROM AUTHOR]

Background: Scientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known. Objective: This review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes. Methods: A systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided. Results: A total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status. Conclusions: Consent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias. [ABSTRACT FROM AUTHOR]

This paper looks at the ethics of opt-in vs. opt-out of organ donation as Scotland has transitioned its systems to promote greater organ availability. We first analyse studies that compare the donation rates in other regions due to such a system switch and find that organ increase is inconclusive and modest at best. This is due to a lack of explicit opt-out choices resulting in greater resistance and family override unless there are infrastructures and greater awareness to support such change. The paper then looks at the difference between informed consent of the opt-in vs. presumed consent in the opt-out approaches. Patient autonomy and dignity are better reflected with informed consent. Eighteen months have passed since the new organ donation policy has come into effect, this paper recommends more research into organ donors' psychological motivations to help governments and the healthcare profession obtain more organs for transplantation. [ABSTRACT FROM AUTHOR]

Background: With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts. Methods: The current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers. Discussion: This study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings. Trial Registration: ClinicalTrials.gov: NCT05019495 (August 24, 2021). [ABSTRACT FROM AUTHOR]

Online firms frequently increase profit by selling optional extras. However, opt-in rates tend to be low. In response, questionable design practices have emerged to nudge consumers into inadvertent choices. Many of these design constructs are presented using an opt-out design. Using eye tracking and think-aloud data techniques, this research investigates the impact of the framing and optionality of micro-decisions on user perceptions and error rates. Focusing on opt-out decisions, the study found: up to one in three users make errors in decision-making; there is a higher error rate for rejection-framed opt-out decisions; users widely misinterpret decision framing; and failure to read decision text results in rushed and unsighted decisions, even leading users to automatically construe un-ticked checkboxes as opt-in decisions. In talking afterwards about their experiences, users expressed strong negative emotions, feeling confused, manipulated and resentful. Many suggested they would, in practice, steer away from similar encounters toward more unambiguous and honest sites. These findings might alert managers and developers, tempted to use dark patterns, that such a strategy might backfire over time. [ABSTRACT FROM AUTHOR]

Incarcerated populations experience higher rates of sexually transmitted infections (STIs) than the general population, alongside inconsistent testing strategies. In response, universal opt-out STIs (chlamydia, gonorrhea, syphilis, and HIV) screening was implemented at admission in a short-term correctional facility in Alberta, Canada, for individuals £35 years. A cross-sectional, retrospective evaluation of testing outcomes between March 2018 and February 2020 was completed. Descriptive statistics were used to stratify STIs by gender, age group, and date for univariate analysis. Despite low uptake (31.2%), opt-out screening resulted in high positivity rates (14.9%, 10.8%, 29.5%, and 0.3%, respectively) and treatment completion (93.7%) while capturing a high proportion (52.6%) of asymptomatic cases. Opt-out screening at admission is feasible and can improve STI testing in high-risk individuals experiencing incarceration in Canada. [ABSTRACT FROM AUTHOR]

Importance: Optimal data availability for secondary use is crucial for continuous improvement in healthcare. At the same time, it is imperative to uphold patients' rights to be informed, to control the use of their health data and to protect their privacy. To balance these two needs, we investigated which consent procedure (opt-in or opt-out) would be most supportive of data availability., Objective: This study explores an opt-in procedure versus an opt-out procedure as a consent procurement method for secondary use of routinely recorded health data, images and tissues for scientific research purposes., Design/setting: A randomized controlled trial was performed in Erasmus Medical Center, a large tertiary hospital in the Netherlands. New, first time patients were recruited from 16 outpatient clinics and randomily assigned to either the opt-in (intervention group) or the opt-out procedure (control group), until the equally balanced sample size of 2228 was reached., Results: Patient inclusion spanned from December 2022 to September 2023. The opt-out procedure resulted in higher consent rates compared to the opt-in procedure. Differences were found for gender, socioeconomic status and country of birth., Conclusions: An opt-out procedure appears to be more effective in ensuring optimal data availability with less bias for the secondary use of health data compared to opt-in. To uphold patient control over data, it is pivotal that patients are well-informed about the consent procedure., (Copyright © 2025 The Author(s). Published by Elsevier B.V. All rights reserved.)

The potential utilization of a cold-contact approach to research recruitment, where members of the research team are unknown to the patient, has grown with the expanded use of electronic health records (EHRs) and affiliated patient portals. Institutions that permit this strategy vary in their implementation and management of it but tend to lean towards more conservative approaches. This process paper describes the Medical University of South Carolina’s transition to an opt-out model of “cold-contact” recruitment (known as patient outreach recruitment or POR), wherein patients can be contacted so long as they do not express an unwillingness to receive such communication. The work highlights the benefits of this model by explaining how it, in many ways, supports and protects autonomy, beneficence, and justice for patients. The paper then describes the process of standing up the recruitment strategy, communicating the change to patients and the community, and documenting study team contact and patient research preference. Data supporting increased access to potentially eligible patients of greater diversity as well as initial researcher feedback on perceived success of POR is also shared. The paper ends with a discussion of next steps to enhance the POR process via more detailed data collection and reengagement with community stakeholders.

Background: Chlamydia trachomatis and Neisseria gonorrhea are the most reported sexually transmitted infections in the United States. Testing rates remain suboptimal and may be subject to implicit bias. We evaluated the effectiveness of an opt-out chlamydia and gonorrhea testing program for adolescents and young adults in improving testing rates and promoting equity. Methods: An opt-out testing program that standardized testing to once annually for 14 to 24-year-old patients was implemented across 28 federally qualified health centers spanning 4 specialties. A quasi-experimental design using interrupted time series analyses evaluated testing and infection rates between baseline, intervention, and pandemic-associated test shortage periods. Reduction in testing inequities based on sex, race, ethnicity, insurance, and language preference were also examined. Results: A total of 57 452 encounters during the baseline, 17 320 during the intervention, and 26 993 during the test supply shortage periods were included. Testing increased from 66.8% to 81.0% (14.2% absolute increase) between baseline and intervention periods. Pediatric clinics demonstrated the largest improvement compared to other settings (absolute increase 30.9%). We found significant reductions in testing inequities for language preference (P <.001), and un-insured and public insured individuals (P <.001). More cases of chlamydia and gonorrhea were detected in the intervention period (chlamydia-29.7; gonorrhea-7.4 per 1000 patients) than in the baseline period (chlamydia-20.7; gonorrhea-4.4 per 1000 patients; P <.001). Conclusions: An opt-out approach increased testing, reduced inequities between some groups and detected more infections than a risk-based approach. Opt-out testing should be considered as an approach to increase detection of chlamydia and gonorrhea and promote equity. [ABSTRACT FROM AUTHOR]

Background: The aim of the present survey was to investigate newly discharged hospital patients' opinions on secondary use of their hospital data and biospecimens within the context of health research in general and, more specifically, on genetic research, data sharing across borders and cooperation with the health industry. Methods: A paper questionnaire was sent to 1049 consecutive newly discharged hospital patients. Results: The vast majority of the respondents preferred to be informed (passive consent) or to receive no notification at all for secondary research on their health data and biospecimens (88% and 91% for data and biospecimens respectively). The rest wanted to be asked for active consent. The same trend applied for the other aspects also. 81% of respondents were positive towards genetic research without active consent. 95% were positive towards cooperating with the health industry, and 90% were positive towards data sharing. Conclusions: These results suggest that hospital patients generally are very positive to secondary research and support the concept of opting out rather than opting in. [ABSTRACT FROM AUTHOR]

Harriet Rosanne Etheredge1,2 1Wits Donald Gordon Medical Centre, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa; 2Steve Biko Centre for Bioethics, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South AfricaCorrespondence: Harriet Rosanne EtheredgeWits Donald Gordon Medical Centre, 1st Floor, Max Price Building, 27 Eton Road, Parktown, Johannesburg, 2193, South AfricaTel +27 113566395Email harriet.etheredge@mediclinic.co.zaAbstract: 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.Keywords: organ donation, opt-in, opt-out, consent, transparency, developing countries

« La fin du SIDA » prévue en 2030 par le plan 90-90-90 de l’ONUSIDA est-elle possible au Québec? L’offre universelle proportionnée et systématique de dépistage avec consentement opt-out (consentement présumé) apparait comme la politique sanitaire la plus pertinente et équitable à mettre en place en vue d’identifier les personnes vivant avec le VIH ignorant leur statut sérologique. Cette démarche à première vue contraignante vis-à-vis des libertés individuelles peut être largement compensée par des bénéfices sanitaires, sociaux, économiques et structurels à l’échelle individuelle et populationnelle. Dans la mesure où le VIH/SIDA reste un révélateur puissant des inégalités sociales, cette approche ne sera prolifique qu’en présence d’une ambition politique d’amélioration de l’accès aux soins et de couverture sanitaire universelle et inclusive à l’égard des individus échappant au dépistage. L’approche opt-out au sein des groupes à forte prévalence est une stratégie éthiquement pertinente pour augmenter les taux de dépistage. Bien que le consentement n’y soit pas explicite, la présomption tiendrait compte de « l’injustice structurelle » auxquels les groupes clés – présentant de forts taux de prévalence – sont soumis initialement. Cette dernière est responsable de leurs difficultés d’accès aux soins et aux dépistages. Cet article propose d’uniformiser l’offre de dépistage. La Comité des Infections Transmissibles Sexuellement et par le Sang du Québec recommande actuellement l’approche opt-in pour les groupes-clés et le consentement opt-out en population générale. Nous pensons que cette différenciation constitue une barrière dans l’accès au dépistage et produit un effet d’éviction des groupes-clés craignant la stigmatisation.

Background: The prevalence of mental health conditions is higher in cigarette smokers than nonsmokers. However, those with diagnosed mental health disorders are understudied within general inpatient hospital settings. This study seeks to evaluate how having a mental health diagnosis influences response to a brief opt-out inpatient tobacco treatment intervention. Methods: Data included 4,153 admitted patients who completed a tobacco treatment visit. Post-discharge self-reported abstinence was obtained via response to an automated call 1-month after discharge. Mental health co-morbidities were assessed by reviewing electronic medical records. Logistic regression was used to assess associations between having a mental health diagnosis and patients' smoking history, interest in quitting smoking, and post-discharge abstinence. Results: Overall 34.1% of patients were diagnosed with mental health disorders, most commonly depression or substance use disorders. Patients with a diagnosed mental health disorder were more likely to report a history of long-term heavy smoking and were less likely to express an interesting in remaining abstinent from smoking after hospitalization. An intent-to-treat analysis using logistic regression analysis found lower rates of self-reported smoking abstinence in those with a mental health disorder compared to those without (9 vs. 13.2%, p < 0.001). Conclusions: Patients with a history of mental health diagnoses, such as depression or substance use disorders, was associated with lower rates of smoking abstinence in patients after hospitalization. Hospital based opt-out smoking cessation programs have shown to be generally effective and efficient. However, certain subpopulations may require tailored intervention in order to improve treatment outcomes. Future research is needed to develop brief, effective tobacco treatment for hospital patients with comorbid mental health diagnoses. [ABSTRACT FROM AUTHOR]