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"Opt-in"
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Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review
2023
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.
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.
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.
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.
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.
Journal Article
An international comparison of deceased and living organ donation/transplant rates in opt-in and opt-out systems: a panel study
by
Ferguson, Eamonn
,
Shepherd, Lee
,
O’Carroll, Ronan E
in
Biomedicine
,
Comparative analysis
,
Consent Forms
2014
Background
Policy decisions about opt-in and opt-out consent for organ donation are based on limited evidence. To fill this gap we investigated the difference between deceased and living organ donation rates in opt-in and opt-out consent systems across a 13 year period. We controlled for extensive covariates and estimated the causal effect of consent with instrumental variables analysis.
Method
This panel study used secondary data analysis to compare organ donor and transplant rates in 48 countries that had either opt-in or opt-out consent. Organ donation data were obtained over a 13-year period between 2000 and 2012. The main outcome measures were the number of donors, number of transplants per organ and total number (deceased plus living) of kidneys and livers transplanted. The role of consent on donor and transplant rates was assessed using multilevel modeling and the causal effect estimated with instrumental variables analysis.
Results
Deceased donor rates (per-million population) were higher in opt-out (
M
= 14.24) than opt-in consent countries (
M
= 9.98;
χ
= -4.27, 95% confidence interval (CI) = -8.08, -0.45,
P
= .029). However, the number of living donors was higher in opt-in (
M
= 9.36) than opt-out countries (
M
= 5.49;
B
= 3.86, 95% CI = 1.16, 6.56,
P
= .006). Importantly, the total number of kidneys transplanted (deceased plus living) was higher in opt-out (
M
= 28.32) than opt-in countries (
M
= 22.43;
B
= -5.89, 95% CI = -11.60, -0.17,
P
= .044). Similarly, the total number of livers transplanted was higher in opt-out (
M
= 11.26) than opt-in countries (
M
= 7.53;
B
= -3.73, 95% CI = -7.47, 0.01,
P
= .051). Instrumental variables analysis suggested that the effect of opt-in versus opt-out consent on the difference between deceased and living donor rates is causal.
Conclusions
While the number of deceased donors is higher than the number of living donors, opt-out consent leads to a relative increase in the total number of livers and kidneys transplanted.
Journal Article
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.
Journal Article
Changing to an Opt Out System for Organ Donation—Reflections From England and Netherlands
by
Jansen, N. E.
,
Williment, C.
,
Gardiner, D.
in
Blood & organ donations
,
Consent
,
Health Archive
2022
Recently England and Netherlands have changed their consent system from Opt In to Opt Out. The reflections shared in this paper give insight and may be helpful for other nation considering likewise. Strong support in England for the change in legislation led to Opt Out being introduced without requiring a vote in parliament in 2019. In Netherlands the bill passed by the smallest possible majority in 2018. Both countries implemented a public campaign to raise awareness. In England registration on the Donor Register is voluntary. Registration was required in Netherlands for all residents 18 years and older. For those not already on the register, letters were sent by the Dutch Government to ask individuals to register. If people did not respond they would be legally registered as having “no objection.” After implementation of Opt Out in England 42.3% is registered Opt In, 3.6% Opt Out, and 54.1% has no registration. In contrast in Netherlands the whole population is registered with 45% Opt In, 31% Opt Out and 24% “No Objection.” It is too soon to draw conclusions about the impact on the consent rate and number of resulting organ donors. However, the first signs are positive.
Journal Article
Advancing Hepatitis C Elimination through Opt-Out Universal Screening and Treatment in Carceral Settings, United States
by
Furukawa, Nathan
,
McNamara, Maeve
,
Cartwright, Emily J.
in
Advancing Hepatitis C Elimination through Opt-Out Universal Screening and Treatment in Carceral Settings, United States
,
Antiviral Agents - therapeutic use
,
Black people
2024
Incarcerated persons are infected with hepatitis C virus (HCV) at rates ≈10 times higher than that of the general population in the United States. To achieve national hepatitis C elimination goals, the diagnosis and treatment of hepatitis C in incarcerated persons must be prioritized. In 2022, the Centers for Disease Control and Prevention recommended that all persons receive opt-out HCV screening upon entry into a carceral setting. We review recommendations, treatments, and policy strategies used to promote HCV opt-out universal HCV screening and treatment in incarcerated populations in the United States. Treatment of hepatitis C in carceral settings has increased but varies by jurisdiction and is not sufficient to achieve HCV elimination. Strengthening universal HCV screening and treatment of HCV-infected incarcerated persons is necessary for HCV elimination nationwide.
Journal Article
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
2024
Background
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.
Methods
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.
Results
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.
Conclusion
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.
Practical implications
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.
Journal Article
“To Be Honest, You Probably Would Have to Read It 50 Times”: Stakeholders Views on Using the Opt-Out Approach for Vaccination in Jails
by
Beckwith, Curt G
,
Pickard, Bridget
,
Wurcel, Alysse
in
Editor's Choice
,
Immunization
,
Imprisonment
2023
Abstract
Background
Despite national guidelines on infectious disease testing and vaccination in prisons, there is heterogeneity on the implementation of these practices in jails. We sought to better understand perspectives on the implementation of opt-out vaccination for infectious diseases in jails by interviewing a broad group of stakeholders involved in infectious diseases vaccination, testing, and treatment in Massachusetts jails.
Methods
The research team conducted semistructured interviews with people incarcerated in Hampden County Jail (Ludlow, Massachusetts), clinicians working in jail and community settings, corrections administrators, and representatives from public health, government, and industry between July 2021 and March 2022.
Results
Forty-eight people were interviewed, including 13 people incarcerated at the time of interview. Themes that emerged included the following: misunderstandings of what opt-out means, indifference to the way vaccines are offered, belief that using the opt-out approach will increase the number of individuals who receive vaccination, and that opt-out provides an easy way for vaccine rejection and reluctance to accept vaccination.
Conclusions
There was a clear divide in stakeholders’ support of the opt-out approach, which was more universally supported by those who work outside of jails compared to those who work within or are incarcerated in jails. Compiling the perspectives of stakeholders inside and outside of jail settings on the opt-out approach to vaccination is the first step to develop feasible and effective strategies for implementing new health policies in jail settings.
The opt-out approach to infectious diseases testing is a recommended strategy to increase diagnosis and prevention of disease. We engaged stakeholders within jail healthcare to understand barriers and facilitators to the implementation of opt-out for vaccination in jails.
Journal Article
Modeling Customer Opt-In and Opt-Out in a Permission-Based Marketing Context
by
ZHANG, XI (ALAN)
,
LUO, ANITA
,
KUMAR, V.
in
Comparative analysis
,
Decision making models
,
E-mail marketing
2014
The rise of new media is helping marketers evolve from digital to interactive marketing, which facilitates a two-way communication between marketers and customers without intruding on their privacy. However, while research has examined the drivers of customers' opt-in and opt-out decisions, it has investigated neither the timing of the two decisions nor the influence of transactional activity on the length of time a customer stays with an e-mail program. In this study, the authors adopt a multivariate copula model using a pair-copula construction method to jointly model opt-in time (from a customer's first purchase to the opt-in decision), optout time (from the opt-in decision to the opt-out decision), and average transaction amount. Through such multivariate dependences, this model significantly improves the predictive performance of the opt-out time in comparison with several benchmark models. The study offers several important findings: (1) marketing intensity affects opt-in and opt-out times, (2) customers with certain characteristics are more or less likely to opt in or opt out, and (3) firms can extend customer opt-out time and increase customer spending level by strategically allocating resources.
Journal Article
meaning of default options for potential organ donors
2012
Rates of participation in organ donation programs are known to be powerfully influenced by the relevant default policy in effect (“opt-in” vs. “opt-out”). Three studies provide evidence that this difference in participation may occur in part because the requirement to opt-in or opt-out results in large differences in the meaning that individuals attach to participation. American participants in Study 1 rated participation as a significantly more substantial action when agreement was purportedly obtained under opt-in rather than opt-out conditions, and nonagreement as a greater abrogation of responsibility when that decision was made under opt-out rather than under opt-in conditions. Study 2 replicated these findings with respondents who live in Germany, which employs an opt-in donation policy, and in Austria, which has an opt-out policy. Study 3 required American participants to rate various actions that differ in the effort and self-sacrifice they demand. As predicted, the placement of organ donation on the resulting multidimensional scaling dimension differed significantly depending on whether it purportedly was made in an opt-in country (where it was considered roughly akin to giving away half of one’s wealth to charity upon one’s death) or an opt-out country (where it fell between letting others get ahead of one in line and volunteering some time to help the poor). We discuss the relationship between this change of meaning account and two other mechanisms—behavioral inertia and implicit norms—that we believe underlie the default effect in decision making and other effects of policies designed to influence decision-makers.
Journal Article
Dynamic Photoresponse of a DNTT Organic Phototransistor
by
Campajola, Marcello
,
Branchini, Paolo
,
Aloisio, Alberto
in
Design and construction
,
dinaphtho-thieno-thiophene (DNTT)
,
Dosimetry
2023
The photosensitivity, responsivity, and signal-to-noise ratio of organic phototransistors depend on the timing characteristics of light pulses. However, in the literature, such figures of merit (FoM) are typically extracted in stationary conditions, very often from IV curves taken under constant light exposure. In this work, we studied the most relevant FoM of a DNTT-based organic phototransistor as a function of the timing parameters of light pulses, to assess the device suitability for real-time applications. The dynamic response to light pulse bursts at ~470 nm (close to the DNTT absorption peak) was characterized at different irradiances under various working conditions, such as pulse width and duty cycle. Several bias voltages were explored to allow for a trade-off to be made between operating points. Amplitude distortion in response to light pulse bursts was also addressed.
Journal Article