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Participants' informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable

Dal-Ré, Rafael; Caplan, Arthur L; Voo, Teck Chuan
PMCID:9236980
PMID: 35780073
ISSN: 1879-0828
CID: 5281572

Navigating parent-child disagreement about fertility preservation in minors: scoping review and ethical considerations

Bayefsky, Michelle; Vieira, Dorice; Caplan, Arthur; Quinn, Gwendolyn
BACKGROUND:Offering fertility preservation (FP) prior to gonadotoxic therapy, including cancer care and gender-affirming treatment, is now considered standard of care. Periodically, parents and children disagree about whether to pursue FP. However, it is unknown how often this occurs and how disagreement is handled when it arises. Moreover, there is no clear guidance on how to resolve these difficult situations. OBJECTIVE AND RATIONALE/OBJECTIVE:The purpose of this scoping review is to provide an overview of available research evidence about parent-child disagreement regarding FP in order to establish that disagreement occurs in practice, understand the basis for disagreement and explore suggestions for how such disputes could be resolved. Based on our findings, we offer a discussion of the ethical principles at stake when disagreement occurs, which can be used to guide clinicians' approaches when these challenging scenarios present. SEARCH METHODS/METHODS:A comprehensive literature search was run in several databases, including PubMed/Medline, Embase and the Cochrane Library. The search was performed in February 2021 and updated in August 2021. Articles were included in the final review if they discussed how parents or children wanted their views on FP taken into account, presented evidence that parent-child discordance regarding FP exists, discussed how to handle disagreement in a particular case or offered general suggestions for how to approach parent-child discordance about FP. Studies were excluded if the patients were adult only (age 18 years and older), pertained to fertility-sparing treatments (e.g. gonad shielding, gonadopexy) rather than fertility-preserving treatments (e.g. testicular tissue cryopreservation, ovarian tissue cryopreservation, oocyte cryopreservation or sperm cryopreservation) or explored the views of clinicians but not patients or parents. Meta-synthesis was used to synthesize and interpret data across included studies and thematic analysis was used to identify common patterns and themes. OUTCOMES/RESULTS:In total, 755 publications were screened, 118 studies underwent full-text review and 35 studies were included in the final review. Of these studies, 7 discussed how parents or children wanted their opinions to be incorporated, 11 presented evidence that discordance exists between parents and children regarding FP, 4 discussed how disagreement was handled in a particular case and 21 offered general suggestions for how to approach parent-child disagreement. There was a range of study designs, including quantitative and qualitative studies, case studies, ethical analyses and commentaries. From the thematic analysis, four general themes regarding FP disagreement emerged, and four themes relating to the ethical principles at stake in parent-child disagreement were identified. The general themes were: adolescents typically desire to participate in FP decision-making; some parents prefer not to involve their children; minors may feel more favorably about FP than their parents; and transgender minors and their parents may have unique reasons for disagreement. The ethical principles that were identified were: minor's best interest; right to an open future; minor's autonomy; and parental autonomy. WIDER IMPLICATIONS/CONCLUSIONS:This study offers an overview of available research on the topic of parent-child disagreement regarding FP and discusses the ethical considerations at stake when disagreement occurs. The findings can be used to inform guidance for clinicians presented with FP disagreement in practice.
PMID: 35468184
ISSN: 1460-2369
CID: 5205482

Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA

Mello, Michelle M; Opel, Douglas J; Benjamin, Regina M; Callaghan, Timothy; DiResta, Renee; Elharake, Jad A; Flowers, Lisa C; Galvani, Alison P; Salmon, Daniel A; Schwartz, Jason L; Brewer, Noel T; Buttenheim, Alison M; Carpiano, Richard M; Clinton, Chelsea; Hotez, Peter J; Lakshmanan, Rekha; Maldonado, Yvonne A; Omer, Saad B; Sharfstein, Joshua M; Caplan, Arthur
PMCID:9270060
PMID: 35817078
ISSN: 1474-547x
CID: 5269032

Priority vaccination for mental illness, developmental or intellectual disability

Shevzov-Zebrun, Nina; Caplan, Arthur L
Coronavirus vaccines have made their debut. Now, allocation practices have stepped into the spotlight. Following Centers for Disease Control and Prevention guidelines, states and healthcare institutions initially prioritised healthcare personnel and elderly residents of congregant facilities; other groups at elevated risk for severe complications are now becoming eligible through locally administered programmes. The question remains, however: who else should be prioritised for immunisation? Here, we call attention to individuals institutionalised with severe mental illnesses and/or developmental or intellectual disabilities-a group highly susceptible to the damages of COVID-19, recent research shows, and critical to consider for priority vaccination. The language describing both federal-level and state-level intentions for this population remains largely vague, despite the population's diversity across age, diagnosis, functional status and living arrangement. Such absence of specificity, in turn, leaves room for confusion and even neglect of various subgroups. We review data stressing this group's vulnerability, as well as select state plans for priority vaccination, highlighting the importance of clarity when describing intentions to vaccinate, or even generally care for, diverse populations composed of distinct subgroups in need.
PMCID:8029041
PMID: 33827909
ISSN: 1473-4257
CID: 4868052

Questions of accountability and transparency in the US organ donation and transplantation system [Letter]

Levan, Macey L; Klitenic, Samantha; Massie, Allan; Parent, Brendan; Caplan, Arthur; Gentry, Sommer; Segev, Dorry
PMID: 35710989
ISSN: 1546-170x
CID: 5282752

Should Compensation for Organ Donation Be Allowed?

Caplan, Arthur; Rhodes, Rosamond
The need for organs to transplant is clear. Due to the lack of transplants, people suffer, they die, and the cost of taking care of them until they die is huge. There is general agreement that it would be good to increase the supply of organs in order to meet the demand for organ transplantation.
PMID: 35899546
ISSN: 1469-2147
CID: 5276742

Evaluating Expanded Noninvasive Prenatal Screening

Bayefsky, Michelle J; Caplan, Arthur L; Hoskins, Iffath A
Public attention has been drawn recently to the commercial availability of noninvasive prenatal screening for rare genetic conditions, despite estimates that the positive predictive value of such tests is low. Many have focused on the importance of educating patients on the difference between screening and diagnostic testing so that they are adequately prepared for the possibility of a false-positive result. Even so, we question whether expanded noninvasive prenatal screening is ready to be used a screening tool. We argue that established public health criteria for evaluating the risks and benefits of a screening tool should be applied to expanded noninvasive prenatal screening. If a test fails to meet accepted standards, governmental agencies should consider regulating the accuracy and promotional claims of commercially available tests.
PMID: 35675597
ISSN: 1873-233x
CID: 5244822

"Should Patients Who Refuse COVID Vaccination Be Denied Transplantation Eligibility?"

Parent, Brendan; Yang, Y Tony; Caplan, Arthur
PMID: 35150871
ISSN: 1532-8414
CID: 5156282

Regarding normothermic regional perfusion: Arguing by insistence is not a strong argument [Letter]

Parent, Brendan; Caplan, Arthur; Moazami, Nader; Montgomery, Robert A
PMID: 35352473
ISSN: 1600-6143
CID: 5201132

Virtual surgical planning and data ownership: Navigating the provider-patient-vendor relationship

Konicki, William S; Wasmuht-Perroud, Vivian; Aaron, Chase A; Caplan, Arthur L
The practice of modern craniomaxillofacial surgery has been defined by emergent technologies allowing for the acquisition, storage, utilization, and transfer of massive amounts of sensitive and identifiable patient data. This alone has thrust providers into an unlikely and unprecedented role as the stewards of vast databases of digital information. This data powers the potent surgical tool of virtual surgical planning, a method by which craniomaxillofacial surgeons plan and simulate procedural outcomes in a digital environment. Further complicating this new terrain is the involvement of third-party contractors-a necessary presence in bringing raw data to bear in the office, virtual space, and operating room. The individual privileges and responsibilities of patients, providers, and vendors towards data are situated within the most recent U.S. court rulings and regulations. This paper offers guidance for overseeing the safe and responsible transfer to third-party contractors, and provides suggestions for negotiating the trinary relationship between physicians, their patients, and the vendors offering this transformative technology.
PMID: 35451098
ISSN: 1467-8519
CID: 5206312