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BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. OBJECTIVE: This study investigated public preferences for digital health data sharing. METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; bein, The last two authors contributed equally., Governance of health data in cyberspace

The application of multiple omics technologies in biomedical cohorts has the potential to reveal patient-level disease characteristics and individualized response to treatment. However, the scale and heterogeneous nature of multi-modal data makes integration and inference a non-trivial task. We developed a deep-learning-based framework, multi-omics variational autoencoders (MOVE), to integrate such data and applied it to a cohort of 789 people with newly diagnosed type 2 diabetes with deep multi-omics phenotyping from the DIRECT consortium. Using in silico perturbations, we identified drug–omics associations across the multi-modal datasets for the 20 most prevalent drugs given to people with type 2 diabetes with substantially higher sensitivity than univariate statistical tests. From these, we among others, identified novel associations between metformin and the gut microbiota as well as opposite molecular responses for the two statins, simvastatin and atorvastatin. We used the associations to quantify drug–drug similarities, assess the degree of polypharmacy and conclude that drug effects are distributed across the multi-omics modalities., Correction in DOI 10.1038/s41587-023-01805-9QC 20230626

BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. OBJECTIVE: This study investigated public preferences for digital health data sharing. METHODS:A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most accep

We evaluate the shared genetic regulation of mRNA molecules, proteins and metabolites derived from whole blood from 3029 human donors. We find abundant allelic heterogeneity, where multiple variants regulate a particular molecular phenotype, and pleiotropy, where a single variant associates with multiple molecular phenotypes over multiple genomic regions. The highest proportion of share genetic regulation is detected between gene expression and proteins (66.6%), with a further median shared genetic associations across 49 different tissues of 78.3% and 62.4% between plasma proteins and gene expression. We represent the genetic and molecular associations in networks including 2828 known GWAS variants, showing that GWAS variants are more often connected to gene expression in trans than other molecular phenotypes in the network. Our work provides a roadmap to understanding molecular networks and deriving the underlying mechanism of action of GWAS variants using different molecular phenotypes in an accessible tissue.

Background: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public’s views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. Objective: This study investigated public preferences for digital health data sharing. Methods: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes (“data collector,” “data user,” “reason for data use,” “information on data sharing and consent,” and “availability of review process”), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class’s pooled and regional data sets. Results: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or acade, BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level.OBJECTIVE: This study investigated public preferences for digital health data sharing.METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets.RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project a

We evaluate the shared genetic regulation of mRNA molecules, proteins and metabolites derived from whole blood from 3029 human donors. We find abundant allelic heterogeneity, where multiple variants regulate a particular molecular phenotype, and pleiotropy, where a single variant associates with multiple molecular phenotypes over multiple genomic regions. The highest proportion of share genetic regulation is detected between gene expression and proteins (66.6%), with a further median shared genetic associations across 49 different tissues of 78.3% and 62.4% between plasma proteins and gene expression. We represent the genetic and molecular associations in networks including 2828 known GWAS variants, showing that GWAS variants are more often connected to gene expression in trans than other molecular phenotypes in the network. Our work provides a roadmap to understanding molecular networks and deriving the underlying mechanism of action of GWAS variants using different molecular phenotypes in an accessible tissue.

Background: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public’s views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. Objective: This study investigated public preferences for digital health data sharing. Methods: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes (“data collector,” “data user,” “reason for data use,” “information on data sharing and consent,” and “availability of review process”), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class’s pooled and regional data sets. Results: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or acade, BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level.OBJECTIVE: This study investigated public preferences for digital health data sharing.METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets.RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project a

Background: Discrete Choice Experiment (DCE) is a well-established technique to elicit individual preferences, but it has rarely been used to elicit governance preferences for health data sharing. Objectives: The aim of this article was to describe the process of identifying attributes for a DCE study aiming to elicit preferences of citizens in Sweden, Iceland and the UK for governance mechanisms for digitally sharing different kinds of health data in different contexts. Methods: A three-step approach was utilised to inform the attribute and level selection: 1) Attribute identification, 2) Attribute development and 3) Attribute refinement. First, we developed an initial set of potential attributes from a literature review and a workshop with experts. To further develop attributes, focus group discussions with citizens (n = 13), ranking exercises among focus group participants (n = 48) and expert interviews (n = 18) were performed. Thereafter, attributes were refined using group discussion (n = 3) with experts as well as cognitive interviews with citizens (n = 11). Results: The results led to the selection of seven attributes for further development: 1) level of identification, 2) the purpose of data use, 3) type of information, 4) consent, 5) new data user, 6) collector and 7) the oversight of data sharing. Differences were found between countries regarding the order of top three attributes. The process outlined participants' conceptualisation of the chosen attributes, and what we learned for our attribute development phase. Conclusions: This study demonstrates a process for selection of attributes for a (multi-country) DCE involving three stages: Attribute identification, Attribute development and Attribute refinement. This study can contribute to improve the ethical aspects and good practice of this phase in DCE studies. Specifically, it can contribute to the development of governance mechanisms in the digital world, where people's health data are shared for multi

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people’s preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents’ willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred

Background: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people's preferences for sharing digital health data. Objective: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. Methods: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. Results: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents' willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. Conclusions: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most prefer

Under the banner of martial empiricism, we advance a distinctive set of theoretical and methodological commitments for the study of war. Previous efforts to wrestle with this most recalcitrant of phenomena have sought to ground research upon primary definitions or foundational ontologies of war. By contrast, we propose to embrace war’s incessant becoming, making its creativity, mutability and polyvalence central to our enquiry. Leaving behind the interminable quest for its essence, we embrace war as mystery. We draw on a tradition of radical empiricism to devise a conceptual and contextual mode of enquiry that can follow the processes and operations of war wherever they lead us. Moving beyond the instrumental appropriations of strategic thought and the normative strictures typical of critical approaches, martial empiricism calls for an unbounded investigation into the emergent and generative character of war. Framing the accompanying special issue, we outline three domains around which to orient future research: mobilization, design and encounter. Martial empiricism is no idle exercise in philosophical speculation. It holds the promise of a research agenda apposite to the task of fully contending with the momentous possibilities and dangers of war in our time.

Dopamine (DA) neurons in the ventral tegmental area (VTA) and substantia nigra (SNc) encode reward prediction errors (RPEs) and are proposed to mediate error-driven learning. However, the learning strategy engaged by DA-RPEs remains controversial. RPEs might imbue predictive cues with pure value, independently of representations of their associated outcome. Alternatively, RPEs might promote learning about the sensory features (the identity) of the rewarding outcome. Here, we show that, although both VTA and SNc DA neuron activation reinforces instrumental responding, only VTA DA neuron activation during consumption of expected sucrose reward restores error-driven learning and promotes formation of a new cue→sucrose association. Critically, expression of VTA DA-dependent Pavlovian associations is abolished following sucrose devaluation, a signature of identity-based learning. These findings reveal that activation of VTA- or SNc-DA neurons engages largely dissociable learning processes with VTA-DA neurons capable of participating in outcome-specific predictive learning, and the role of SNc-DA neurons appears limited to reinforcement of instrumental responses.

PURPOSE: Biomedical data governance strategies should ensure that data are collected, stored, and used ethically and lawfully. However, research participants' preferences for how data should be governed is least studied. The Diabetes Research on Patient Stratification (DIRECT) project collected substantial amounts of health and genetic information from patients at risk of, and with type II diabetes. We conducted a survey to understand participants' future data governance preferences. Results will inform the postproject data governance strategy.METHODS: A survey was distributed in Denmark, Sweden, The Netherlands, and the United Kingdom.RESULTS: In total 855 surveys were returned. Ninety-seven percent were supportive of sharing data postproject, and 90% were happy to share data with universities, and 56% with commercial companies. The top three priorities for data sharing were highly secure database, DIRECT researchers to monitor data used by other researchers, and researchers cannot identify participants. Respondents frequently suggested that a postproject Data Access Committee should involve a DIRECT researcher, diabetes clinician, patient representative, and a DIRECT participant.CONCLUSION: Preferences of how data should be governed, and what data could be shared and with whom varied between countries. Researchers are considered as key custodians of participant data. Engaging participants aids in designing governance to support their choices.

The purpose of this study was to explore and compare different countries in what motivated research participants’ decisions whether to share their de-identified data. We investigated European DIRECT (Diabetes Research on Patient Stratification) research project participants’ desire for control over sharing different types of their de-identified data, and with who data could be shared in the future after the project ends. A cross-sectional survey was disseminated among DIRECT project participants. The results found that there was a significant association between country and attitudes towards advancing research, protecting privacy, and beliefs about risks and benefits to sharing data. When given the choice to have control, some participants (<50% overall) indicated that having control over what data is shared and with whom was important; and control over what data types are shared was less important than respondents deciding who data are shared with. Danish respondents indicated higher odds of desire to control data types shared, and Dutch respondents showed higher odds of desire to control who data will be shared with. Overall, what research participants expect in terms of control over data sharing needs to be considered and aligned with sharing for future research and re-use of data. Our findings show that even with de-identified data, respondents prioritise privacy above all else. This study argues to move research participants from passive participation in biomedical research to considering their opinions about data sharing and control of de-identified biomedical data.

PURPOSE: Biomedical data governance strategies should ensure that data are collected, stored, and used ethically and lawfully. However, research participants' preferences for how data should be governed is least studied. The Diabetes Research on Patient Stratification (DIRECT) project collected substantial amounts of health and genetic information from patients at risk of, and with type II diabetes. We conducted a survey to understand participants' future data governance preferences. Results will inform the postproject data governance strategy.METHODS: A survey was distributed in Denmark, Sweden, The Netherlands, and the United Kingdom.RESULTS: In total 855 surveys were returned. Ninety-seven percent were supportive of sharing data postproject, and 90% were happy to share data with universities, and 56% with commercial companies. The top three priorities for data sharing were highly secure database, DIRECT researchers to monitor data used by other researchers, and researchers cannot identify participants. Respondents frequently suggested that a postproject Data Access Committee should involve a DIRECT researcher, diabetes clinician, patient representative, and a DIRECT participant.CONCLUSION: Preferences of how data should be governed, and what data could be shared and with whom varied between countries. Researchers are considered as key custodians of participant data. Engaging participants aids in designing governance to support their choices.

ObjectiveTo evaluate the prevalence of anal cytology (ACyt) abnormalities among HIV-infected and HIV-uninfected men who have sex with men (MSM).DesignMulticenter cohort study of 723 HIV-infected and 788 HIV-uninfected MSM with ACyt, with a second ACyt collected 2 years later. A referral for high-resolution anoscopy was suggested for abnormal ACyt.MethodsACyt samples were collected using a polyester swab and liquid cytology media and read in a central laboratory.ResultsPrevalence of any abnormal ACyt was 25% in HIV-uninfected MSM and increased to 38%, 41%, and 47% among HIV-infected MSM with current CD4 T-cell counts ≥500, 350-499, and <350 cells/mm (P < 0.001), respectively. Anal HPV16 DNA was also more common in HIV-infected than HIV-uninfected MSM (25% versus 16%, P < 0.001). Abnormal baseline ACyt together with prevalent HPV16 DNA detection was present in only 7% of HIV-uninfected MSM compared to 18% of HIV-infected MSM with current CD4 < 350, P < 0.001. Among HIV-infected men, 56% of the men with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions ASCs-US/LSILs and 81% of men with atypical squamous cells cannot exclude high-grade (ASC-H/)/high-grade squamous intraepithelial lesions (HSIL) had lower grade ACyt findings 18-30 months later ("regressed"). However, 19% of untreated HIV-infected men with ASC-H/HSIL cytology maintained that same grade of cytology in their second test approximately 2 years later, and 15% with ASC-US/LSIL "progressed" to ASC-H/HSIL. Abnormal ACyt had high sensitivity (96%) but low specificity (17%) for biopsy-proven HSIL.ConclusionsPrevalence of abnormal ACyt remains elevated in HIV-infected men during the current antiretroviral therapy era.

Perinatal psychiatry is a relatively new subspecialty and controversy exists about such specialist provision. Differences can occur in how mental illnesses present in pregnancy, and there is a need to take into account both mother and baby. The risks of not treating perinatal mental illness can be both acute and chronic, and suicide in the context of untreated illness remains a leading indirect cause of maternal mortality. Despite the government's agenda of preventive healthcare, service provision is inequitable across the UK. Advice regarding treatment continues to be complex, and perinatal psychiatrists need to keep abreast of a growing evidence base. This review offers an overview of some current issues in the care of patients in the perinatal period and shows how specialised perinatal services are uniquely placed to meet their needs. Hopefully, it will prove useful to all clinicians responsible for the perinatal care of women and their families.

ObjectiveTo evaluate the prevalence of anal cytology (ACyt) abnormalities among HIV-infected and HIV-uninfected men who have sex with men (MSM).DesignMulticenter cohort study of 723 HIV-infected and 788 HIV-uninfected MSM with ACyt, with a second ACyt collected 2 years later. A referral for high-resolution anoscopy was suggested for abnormal ACyt.MethodsACyt samples were collected using a polyester swab and liquid cytology media and read in a central laboratory.ResultsPrevalence of any abnormal ACyt was 25% in HIV-uninfected MSM and increased to 38%, 41%, and 47% among HIV-infected MSM with current CD4 T-cell counts ≥500, 350-499, and <350 cells/mm (P < 0.001), respectively. Anal HPV16 DNA was also more common in HIV-infected than HIV-uninfected MSM (25% versus 16%, P < 0.001). Abnormal baseline ACyt together with prevalent HPV16 DNA detection was present in only 7% of HIV-uninfected MSM compared to 18% of HIV-infected MSM with current CD4 < 350, P < 0.001. Among HIV-infected men, 56% of the men with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions ASCs-US/LSILs and 81% of men with atypical squamous cells cannot exclude high-grade (ASC-H/)/high-grade squamous intraepithelial lesions (HSIL) had lower grade ACyt findings 18-30 months later ("regressed"). However, 19% of untreated HIV-infected men with ASC-H/HSIL cytology maintained that same grade of cytology in their second test approximately 2 years later, and 15% with ASC-US/LSIL "progressed" to ASC-H/HSIL. Abnormal ACyt had high sensitivity (96%) but low specificity (17%) for biopsy-proven HSIL.ConclusionsPrevalence of abnormal ACyt remains elevated in HIV-infected men during the current antiretroviral therapy era.

ObjectiveTo evaluate the prevalence of anal cytology (ACyt) abnormalities among HIV-infected and HIV-uninfected men who have sex with men (MSM).DesignMulticenter cohort study of 723 HIV-infected and 788 HIV-uninfected MSM with ACyt, with a second ACyt collected 2 years later. A referral for high-resolution anoscopy was suggested for abnormal ACyt.MethodsACyt samples were collected using a polyester swab and liquid cytology media and read in a central laboratory.ResultsPrevalence of any abnormal ACyt was 25% in HIV-uninfected MSM and increased to 38%, 41%, and 47% among HIV-infected MSM with current CD4 T-cell counts ≥500, 350-499, and <350 cells/mm (P < 0.001), respectively. Anal HPV16 DNA was also more common in HIV-infected than HIV-uninfected MSM (25% versus 16%, P < 0.001). Abnormal baseline ACyt together with prevalent HPV16 DNA detection was present in only 7% of HIV-uninfected MSM compared to 18% of HIV-infected MSM with current CD4 < 350, P < 0.001. Among HIV-infected men, 56% of the men with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions ASCs-US/LSILs and 81% of men with atypical squamous cells cannot exclude high-grade (ASC-H/)/high-grade squamous intraepithelial lesions (HSIL) had lower grade ACyt findings 18-30 months later ("regressed"). However, 19% of untreated HIV-infected men with ASC-H/HSIL cytology maintained that same grade of cytology in their second test approximately 2 years later, and 15% with ASC-US/LSIL "progressed" to ASC-H/HSIL. Abnormal ACyt had high sensitivity (96%) but low specificity (17%) for biopsy-proven HSIL.ConclusionsPrevalence of abnormal ACyt remains elevated in HIV-infected men during the current antiretroviral therapy era.

Perinatal psychiatry is a relatively new subspecialty and controversy exists about such specialist provision. Differences can occur in how mental illnesses present in pregnancy, and there is a need to take into account both mother and baby. The risks of not treating perinatal mental illness can be both acute and chronic, and suicide in the context of untreated illness remains a leading indirect cause of maternal mortality. Despite the government's agenda of preventive healthcare, service provision is inequitable across the UK. Advice regarding treatment continues to be complex, and perinatal psychiatrists need to keep abreast of a growing evidence base. This review offers an overview of some current issues in the care of patients in the perinatal period and shows how specialised perinatal services are uniquely placed to meet their needs. Hopefully, it will prove useful to all clinicians responsible for the perinatal care of women and their families.

Nisha A Shah, Dustin M Albert, Noah M Hall, Fouad J Moawad Department of Medicine, Gastroenterology Service, Walter Reed National Military Medical Center, Bethesda, MD, USA Abstract: Eosinophilic esophagitis (EoE) is a chronic and progressive immune-mediated condition defined by symptoms of esophageal dysfunction and dense eosinophilic infiltration of the esophageal mucosa. Therapies consist of anti-eosinophilic medications and specialized diets aimed to decrease the progression of EoE and alleviate its symptoms, namely, dysphagia and food impaction. Assessing response to therapy remains challenging, as treatment end points are not well defined and currently consist of clinical, histologic, and endoscopic features. Newer validated measures may help standardize treatment end points. Emerging data support the use of maintenance therapy, which may reduce disease progression. Optimal dosages, delivery techniques, and duration of treatment need to be determined. When features of fibrostenosis develop, esophageal dilation is a safe and effective adjunctive strategy for improving symptoms. In EoE cases refractory to conventional treatments, newer therapies targeting inflammatory mediators and cytokines are on the horizon. Keywords: eosinophilic esophagitis, esophagitis, eosinophilia, dysphagia, allergy, corticosteroids, dietary treatment, dilation&nbsp

Milena L Cavalcante,1 Victor M Villegas,2 Aaron S Gold,2 Ludimila L Cavalcante,1 Marcela Lonngi,1 Nisha V Shah,1 Timothy G Murray2 1Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; 2Murray Ocular Oncology and Retina, Miami, FL, USA Objective: To report the optical coherence tomography (OCT) findings of 27 eyes treated with intravitreal bevacizumab for intraretinal and subretinal vascular activity associated with atypical choroidal nevi.Methods: This was an Internal Review Board-approved retrospective review of 27 eyes of 27 patients with choroidal nevus treated for secondary vascular activity with intravitreal injections of bevacizumab, performed by a single surgeon (TGM) at the Bascom Palmer Eye Institute. All patients were rigorously evaluated before the procedure and followed thereafter with ophthalmic examinations, refractive analysis, fundus photos, optical coherence tomography (OCT), and ocular echography. Patient demographics, tumor characteristics, dates of bevacizumab injections, and spectral-domain (SD)-OCT findings at each injection were recorded. Macular edema was graded as per SD-OCT findings for the initial and final visit.Results: The mean age was 66.6 years (range, 40–86 years), with ten males and 17 females. Mean, median, and range baseline best corrected visual acuity (BCVA) were 20/53, 20/40, and 20/20–4/200, respectively. After a mean follow up of 29 months, the final BCVA mean, median, and range were 20/50, 20/40, and 20/20–20/400, respectively. The final BCVA ranged from 20/20 to 20/25 in nine eyes, while only six eyes had an initial BCVA within the same range. All patients demonstrated OCT findings of vascular activity suggestive of choroidal neovascularizatio

Nisha V Shah,1 Samuel K Houston,1 Arnold Markoe,2 Timothy G Murray1,2,3 1Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; 2Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL, USA; 3Murray Ocular Oncology and Retina, Miami, FL, USA Purpose: To evaluate the role of intravitreal triamcinolone acetonide in patients who developed severe, visually compromising radiation maculopathy or progressed despite anti-angiogenic treatments. Methods: An Institutional Review Board approved, consecutive, retrospective study from 2006 to 2009 of patients who developed severe, visually compromising radiation retinopathy manifesting as macular edema secondary to iodine-125 plaque brachytherapy for posterior uveal melanoma, were treated with a combination of intravitreal bevacizumab and intravitreal triamcinolone. Patients were evaluated with spectral domain optical coherence tomography (SD-OCT) at 2–4 month intervals following plaque removal. Treatment with intravitreal bevacizumab commenced at the first signs of visually compromising macular edema diagnosed with SD-OCT. Triamcinolone acetonide was administered to patients with severe maculopathy as consolidative therapy, or for patients that were refractory to repeated bevacizumab injections with persistent or worsening cystoid macular edema and lack of improvement or progressive worsening of best corrected visual acuity (BCVA). Results: Twenty-five patients were evaluated after receiving a combination of intravitreal bevacizumab and triamcinolone. Initial treatment commenced at a mean of 14.5 (range of 2–42) months after plaque brachytherapy. Patients were given a mean of two injections (range 1–6) of triamcinolone acetonide, and a mean of 8.8 bevacizumab injections (range of 1–26) with a mean follow-up of 31.2 months. Radiation maculopathy upon first detection had a mean SD-OCT grade o

Samuel K Houston,1 Nisha V Shah,1 Christina Decatur,1 Marcela Lonngi,1 William Feuer,1 Arnold M Markoe,2 Timothy G Murray1–31Department of Ophthalmology, 2Department of Radiation Oncology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, 3Murray Ocular Oncology and Retina, Miami, FL, USABackground: The purpose of this study was to evaluate intravitreal bevacizumab as an adjuvant treatment to plaque brachytherapy in the treatment of choroidal melanoma.Methods: This was a retrospective, consecutive study of 124 patients treated from 2007 to 2009 for choroidal melanoma with plaque brachytherapy. Patients were treated with I-125 plaque brachytherapy with 2 mm margins and 85 Gy to the tumor apex. Consecutive patients were injected intravitreally with 2.5 mg/0.1 mL bevacizumab at a site away from the primary tumor and immediately following plaque removal. Choroidal melanomas were observed using indirect ophthalmoscopy, wide-angle photography, and ultrasound. The main outcome measures were tumor volume, resolution of exudative retinal detachment, and visual acuity.Results: One hundred and twenty-four patients met our inclusion criteria and were included in the analysis. The mean patient age was 65.7 years, and the mean apical tumor height was 4.0 ± 2.7 mm and basal diameter was 12.7 ± 3.0 mm. Mean follow-up was 24 months. Prior to treatment, 100% of tumors had exudative retinal detachment, and pretreatment visual acuity was 20/55 (median 20/40). Tumor control was 100%, metastasis was 0% at last follow-up, and 89.8% had complete resolution of exudative retinal detachment, with a mean time to resolution of 3.36 months. At one month, 43% had complete resolution of exudative retinal detachment, which increased to 73% at 4 months. Visual acuity was 20/62 (median 20/40) at 4 months, with stabilization to 20/57 (median 20/40) at 8 months, 20/56 (median 20/30) at 12 months, and 20/68 (median 20/50) at 24 months.

Nisha V Shah,1 Samuel K Houston,1 Arnold M Markoe,2 William Feuer,3 Timothy G Murray1,2,41Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 2Department of Radiation Oncology, University of Miami Miller School of Medicine, 3Department of Biostatistics, University of Miami, 4Murray Ocular Oncology and Retina, Miami, FL, USAPurpose: To evaluate the benefits of intravitreal bevacizumab in patients with visually compromising radiation maculopathy following iodine-125 plaque brachytherapy for uveal melanoma.Methods: In this Institutional Review Board-approved, consecutive, retrospective study from 2006–2009 of patients maintaining 20/50 or better vision following treatment for visually compromising radiation maculopathy, patients were evaluated with spectral domain optical coherence tomography at 2–4 month intervals following plaque removal. Treatment with intravitreal bevacizumab commenced at the first signs of radiation vasculopathy on spectral domain optical coherence tomography with associated decreased best corrected visual acuity, followed by repeat injections for recurrent or persistent vasculopathic changes.Results: At 3 years following plaque brachytherapy, 81 of 159 (50.9%) patients treated for radiation maculopathy demonstrated 20/50 or better vision at median follow up of 36 months, which demonstrates significant improvement in vision as compared to the Collaborative Ocular Melanoma Study (P < 0.0001). These 81 patients were given a mean of five injections (range 1–17) over a mean of 17.6 months (range 1–54 months), starting at 15.8 months (range 3–50 months) after plaque brachytherapy. For those eyes that maintained 20/50 or better vision at the final follow-up, pretreatment mean best corrected visual acuity of 20/43 improved to 20/31.Conclusion: This study demonstrates that spectral domain optical coherence tomography can detect early vasculopathic

Nisha V Shah1, Samuel K Houston1, Timothy G Murray1,2, Arnold M Markoe21Department of Ophthalmology, Bascom Palmer Eye Institute, 2Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL, USAPurpose: To evaluate the surgical learning curve in episceral plaque brachytherapy placement in the management of posterior uveal melanoma.Methods: A retrospective chart review of two cohorts of 250 consecutive patients undergoing plaque placement for posterior uveal melanoma from 2002 to 2004 and from 2008 to 2009 was conducted. The plaque–tumor apposition rates verified by intraoperative echography were evaluated and correlated with surgical volume over a 19-year period.Results: In an initial study of 29 consecutive patients undergoing plaque placement from January 1992 to January 1995, a suboptimal plaque placement rate of 21% (n = 29) was identified. This percentage declined to 12% (n = 100) from January 2002 to January 2004, and further declined to 4% (n = 150) from June 2008 to August 2009. The tumor–plaque apposition rates for these three groups were 79% (1992–1995), 88% (2002–2004), and 96% (2008–2009). An estimated surgical volume of 1275 cases was performed to achieve a >90% precision rate for first application of primary plaque centration.Conclusion: There are challenges to mastering the precise placement of radioactive plaques for posterior uveal melanoma. We have demonstrated a significant learning curve for plaque placement techniques, and have emphasized the importance of intraoperative ultrasound in the verification of plaque placement, thus allowing for intraoperative repositioning.Keywords: intraoperative ultrasound, brachytherapy, ocular oncology

Thesis (B.S.)--Massachusetts Institute of Technology, Dept. of Physics, 1986., MICROFICHE COPY AVAILABLE IN ARCHIVES AND SCIENCE, Bibliography: leaf 26., by Nisha N. Shah., B.S.

Thesis (B.S.)--Massachusetts Institute of Technology, Dept. of Physics, 1986., MICROFICHE COPY AVAILABLE IN ARCHIVES AND SCIENCE, Bibliography: leaf 26., by Nisha N. Shah., B.S.

The version of record of this article, first published in Asian Bioethics Review, is available online at Publisher’s website: https://doi.org/10.1007/s41649-024-00300-w., Discussion around the increasing use of AI in healthcare tends to focus on the technical aspects of the technology rather than the socio-technical issues associated with implementation. In this paper, we argue for the development of a sustained societal dialogue between stakeholders around the use of AI in healthcare. We contend that a more human-centred approach to AI implementation in healthcare is needed which is inclusive of the views of a range of stakeholders. We identify four key areas to support stakeholder involvement that would enhance the development, implementation, and evaluation of AI in healthcare leading to greater levels of trust. These are as follows: (1) aligning AI development practices with social values, (2) appropriate and proportionate involvement of stakeholders, (3) understanding the importance of building trust in AI, (4) embedding stakeholder-driven governance to support these activities.

The version of record of this article, first published in Asian Bioethics Review, is available online at Publisher’s website: https://doi.org/10.1007/s41649-024-00300-w., Discussion around the increasing use of AI in healthcare tends to focus on the technical aspects of the technology rather than the socio-technical issues associated with implementation. In this paper, we argue for the development of a sustained societal dialogue between stakeholders around the use of AI in healthcare. We contend that a more human-centred approach to AI implementation in healthcare is needed which is inclusive of the views of a range of stakeholders. We identify four key areas to support stakeholder involvement that would enhance the development, implementation, and evaluation of AI in healthcare leading to greater levels of trust. These are as follows: (1) aligning AI development practices with social values, (2) appropriate and proportionate involvement of stakeholders, (3) understanding the importance of building trust in AI, (4) embedding stakeholder-driven governance to support these activities.