Showing papers on "Informed consent published in 2017"

Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline

Abstract: Objective To update the "Endocrine Treatment of Transsexual Persons: An Endocrine Society Clinical Practice Guideline," published by the Endocrine Society in 2009. Participants The participants include an Endocrine Society-appointed task force of nine experts, a methodologist, and a medical writer. Evidence This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus process Group meetings, conference calls, and e-mail communications enabled consensus. Endocrine Society committees, members and cosponsoring organizations reviewed and commented on preliminary drafts of the guidelines. Conclusion Gender affirmation is multidisciplinary treatment in which endocrinologists play an important role. Gender-dysphoric/gender-incongruent persons seek and/or are referred to endocrinologists to develop the physical characteristics of the affirmed gender. They require a safe and effective hormone regimen that will (1) suppress endogenous sex hormone secretion determined by the person's genetic/gonadal sex and (2) maintain sex hormone levels within the normal range for the person's affirmed gender. Hormone treatment is not recommended for prepubertal gender-dysphoric/gender-incongruent persons. Those clinicians who recommend gender-affirming endocrine treatments-appropriately trained diagnosing clinicians (required), a mental health provider for adolescents (required) and mental health professional for adults (recommended)-should be knowledgeable about the diagnostic criteria and criteria for gender-affirming treatment, have sufficient training and experience in assessing psychopathology, and be willing to participate in the ongoing care throughout the endocrine transition. We recommend treating gender-dysphoric/gender-incongruent adolescents who have entered puberty at Tanner Stage G2/B2 by suppression with gonadotropin-releasing hormone agonists. Clinicians may add gender-affirming hormones after a multidisciplinary team has confirmed the persistence of gender dysphoria/gender incongruence and sufficient mental capacity to give informed consent to this partially irreversible treatment. Most adolescents have this capacity by age 16 years old. We recognize that there may be compelling reasons to initiate sex hormone treatment prior to age 16 years, although there is minimal published experience treating prior to 13.5 to 14 years of age. For the care of peripubertal youths and older adolescents, we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents. For adult gender-dysphoric/gender-incongruent persons, the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient. We suggest maintaining physiologic levels of gender-appropriate hormones and monitoring for known risks and complications. When high doses of sex steroids are required to suppress endogenous sex steroids and/or in advanced age, clinicians may consider surgically removing natal gonads along with reducing sex steroid treatment. Clinicians should monitor both transgender males (female to male) and transgender females (male to female) for reproductive organ cancer risk when surgical removal is incomplete. Additionally, clinicians should persistently monitor adverse effects of sex steroids. For gender-affirming surgeries in adults, the treating physician must collaborate with and confirm the criteria for treatment used by the referring physician. Clinicians should avoid harming individuals (via hormone treatment) who have conditions other than gender dysphoria/gender incongruence and who may not benefit from the physical changes associated with this treatment.

Standards for Ethics in Sport and Exercise Science Research: 2018 Update

Abstract: For publication in the International Journal of Sports Medicine (IJSM), studies involving human participants or animals must have been conducted in accordance with recognised ethical standards and national/international laws. At the very first stage of paper submission, authors are required to adhere to these and all other relevant standards and laws. In the 21st Century, research opportunities, approaches and environments are in a continual state of flux, and this is also the case for the associated ethical issues. In the original 2009 IJSM editorial [2], we described the ethical considerations embedded into national/international laws and provided specific guidance on the ethical issues which commonly arise in Sports Medicine research. In 2011, this information was updated to recognise the ethical principles of other professional associations and treaties when conducting research involving human participants [3]. Additional information was also provided on the use of Laboratory Animals in research, and on the links between sample size and research ethics. In the second update, published in 2013, we elaborated on the ethical issues relating to the investigation of doping agents; the use of animals for answering research questions that appear to be solely focussed on the enhancement of athletic performance; and sample size in the context of the burden to individual research participants [4]. In 2015, we updated some of the guidelines to account for the changes made to the Declaration of Helsinki in 2013, covered the use of social media in research, provided guidance on how researchers can feed back their incidental and pertinent findings to research participants, covered some of the issues relating to studies involving children, and outlined the difference between a full and pilot study in terms of desired number of participants [5]. In this, our new update for 2018 onwards, we provide the following revisions and additions, labelled with the word “Update” in bold text at various points in this paper; ▪ Clarification of the issues surrounding the use of a gatekeeper for accessing personal information on participants. ▪ Clarification of some of the requirements for research with participants who are either too young to give a valid consent (under relevant local Statute) themselves and/or who lack the mental capacity to give an informed consent. ▪ Clarification of the expectations for the presentation and content of information given to facilitate informed consent/ assent. ▪ Highlighting of the obligation to breach confidentiality in certain circumstances and the importance of communicating all relevant process to the potential participant. ▪ Clarification on the use of person identifiable information including a reminder of the upcoming (May 2018) changes to legislation governing how personal data may be accessed and processed in research in the European Union (https://www. eugdpr.org/). ▪ Provision of advice surrounding the increasing calls for open access data, including the resulting data storage issues. ▪ Update on the ethical and legal considerations involved in secondary analysis (retrospective data) studies. ▪ Clarification on the use of placebos in research. ▪ Coverage of the expectations for studies that involve participant deception (i. e. where fully informed consent is not obtained in advance of participation). ▪ Elaboration of the sample size issues relevant to research ethics. Harriss DJ et al. Standards for Ethics in ... Int J Sports Med 2017; 00: 00–00

A Comparison of Voluntarily Stopping Eating and Drinking, Terminal Sedation, Physician-Assisted Suicide, and Voluntary Active Euthanasia

Abstract: Palliative care is generally agreed to be the standard of care for the dying, but there remain some patients for whom intolerable suffering persists. In the face of ethical and legal controversy about the acceptability of physicianassisted suicide and voluntary active euthanasia, voluntarily stopping eating and drinking and terminal sedation have been proposed as ethically superior responses of last resort that do not require changes in professional standards or the law. The clinical and ethical differences and similarities between these 4 practices are critically compared in light of the doctrine of double effect, the active/ passive distinction, patient voluntariness, proportionality between risks and benefits, and the physician's potential conflict of duties. Terminal sedation and voluntarily stopping eating and drinking would allow clinicians to remain responsive to a wide range of patient suffering, but they are ethically and clinically more complex and closer to physician-assisted suicide and voluntary active euthanasia than is ordinarily acknowledged. Safeguards are presented for any medical action that may hasten death, including determining that palliative care is ineffective, obtaining informed consent, ensuring diagnostic and prognostic clarity, obtaining an independent second opinion, and implementing reporting and monitoring processes. Explicit public policy about which of these practices are permissible would reassure the many patients who fear a bad death in their future and allow for a predictable response for the few whose suffering becomes intolerable in spite of optimal palliative care. JAMA. 1997;278:2099-2104

Dynamic Consent: a potential solution to some of the challenges of modern biomedical research

Abstract: Background Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment. Methods An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach. Results Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies. Conclusions Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

Montgomery and informed consent: where are we now?

Abstract: The Montgomery case in 2015 was a landmark for informed consent in the UK. Two years on, Sarah Chan and colleagues discuss the consequences for practising doctors The Montgomery v Lanarkshire case of March 20151 drew fresh attention to informed consent. Nadine Montgomery, a woman with diabetes and of small stature, delivered her son vaginally; he experienced complications owing to shoulder dystocia, resulting in hypoxic insult with consequent cerebral palsy. Her obstetrician had not disclosed the increased risk of this complication in vaginal delivery, despite Montgomery asking if the baby’s size was a potential problem. Montgomery sued for negligence, arguing that, if she had known of the increased risk, she would have requested a caesarean section. The Supreme Court of the UK announced judgment in her favour in March 2015. The ruling overturned a previous decision by the House of Lords,2 which had been law since at least the mid 1980s.3 It established that, rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told. Many organisations (in particular the General Medical Council, who intervened to make submissions in the case) said that the Montgomery decision had simply enabled UK law to catch up with current GMC guidance; others hailed it “the most important UK judgment on informed consent for 30 years.”4 Doctors have expressed their concerns about its potentially radical effects on patient care and clinical practice.5 We held a public debate in 2015, including doctors, lawyers, and medical students, which showed renewed tension between the professional discretion of doctors and patients’ choices6; indeed, the verdict has been characterised as supporting patient autonomy over medical paternalism.378 …

Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.

Abstract: Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%–69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%–87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%–55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants’ concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.

A Public Health Response to Opioid Use in Pregnancy.

Abstract: The use of opioids during pregnancy has grown rapidly in the past decade. As opioid use during pregnancy increased, so did complications from their use, including neonatal abstinence syndrome. Several state governments responded to this increase by prosecuting and incarcerating pregnant women with substance use disorders; however, this approach has no proven benefits for maternal or infant health and may lead to avoidance of prenatal care and a decreased willingness to engage in substance use disorder treatment programs. A public health response, rather than a punitive approach to the opioid epidemic and substance use during pregnancy, is critical, including the following: a focus on preventing unintended pregnancies and improving access to contraception; universal screening for alcohol and other drug use in women of childbearing age; knowledge and informed consent of maternal drug testing and reporting practices; improved access to comprehensive obstetric care, including opioid-replacement therapy; gender-specific substance use treatment programs; and improved funding for social services and child welfare systems. The American College of Obstetricians and Gynecologists supports the value of this clinical document as an educational tool (December 2016).

Prime Time for Shared Decision Making

Abstract: The recognition that informed patients often choose more conservative and hence less expensive medical options has made shared decision making a focus of value-based care.1 In 2007, Washington State passed legislation incentivizing shared decision making as an alternative to traditional informed consent procedures and forms for preference-based treatment decisions that include an elective procedure, such as joint replacement for hip or knee osteoarthritis.2 To qualify as this alternative to traditional informed consent, clinicians are required to use a certified decision aid to facilitate discussion about the different treatment options and patients need to sign an attestation that they reviewed the decision aid with the clinician, discussed the alternatives, risks, and benefits, and decided on a specific course of action. Clinicians who practice shared decision making will be presumed to have engaged patients in an informed consent process regarding the elective procedure and will be provided with increased protection against potential ensuing litigation based on failure to inform. Specifically, the use of the tools and the process associated with this use would shift the burden in litigation to patients to demonstrate clear and convincing evidence that they were not informed.2 In 2016, Washington State certified the first decision aids in maternal-fetal care related to decisions for birth options after cesarean delivery, for amniocentesis, and for genetic screening.

Guidance and ethical considerations for undertaking transgender health research and institutional review boards adjudicating this research

Abstract: The purpose of this review is to create a set of provisional criteria for Institutional Review Boards (IRBs) to refer to when assessing the ethical orientation of transgender health research proposals. We began by searching for literature on this topic using databases and the reference lists of key articles, resulting in a preliminary set of criteria. We then collaborated to develop the following nine guidelines: (1) Whenever possible, research should be grounded, from inception to dissemination, in a meaningful collaboration with community stakeholders; (2) language and framing of transgender health research should be non-stigmatizing; (3) research should be disseminated back to the community; (4) the diversity of the transgender and gender diverse (TGGD) community should be accurately reflected and sensitively reflected; (5) informed consent must be meaningful, without coercion or undue influence; (6) the protection of participant confidentiality should be paramount; (7) alternative consent procedures should be considered for TGGD minors; (8) research should align with current professional standards that refute conversion, reorientation, or reparative therapy; and (9) IRBs should guard against the temptation to avoid, limit, or delay research on this subject.

Blockchain protocols in clinical trials: Transparency and traceability of consent.

Abstract: Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

Informed consent-It's more than a signature on a piece of paper.

Abstract: Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent.

Reframing Consent for Clinical Research: A Function-Based Approach

Abstract: Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.

Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention

Abstract: Objective To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention. Design A multicentre cluster randomised controlled trial. Setting Clusters were 33 hospital wards within five hospitals in the UK. Participants All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition. Intervention The ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings. Measurements Primary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS). Results Intervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention. Limitations Adherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure. Conclusions Patients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components. Trial registration number ISRCTN07689702; pre-results.

Biomedical Big Data: New Models of Control Over Access, Use and Governance.

Abstract: Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it.

Clinical medical ethics.

Abstract: Clinical medical ethics is a new medical field, developed and named in the 1970s, that helps patients, families, physicians, and other health professionals reach good clinical decisions by taking into account both the specific clinical situation and the patient’s values and preferences. The field of clinical medical ethics is much broader and encompassing than its component of ethics consultations; it applies across the entire spectrum of routine, daily medical practice. For clinicians today, applying clinical medical ethics standards in patient care is not an elective matter but rather has become the standard of care in the United States and is mandated legally and professionally. For example, in caring for their patients, physicians must apply clinical ethics standards such as speaking truthfully to their patients, negotiating informed consent for clinical decisions, protecting patient confidentiality, assessing the patient’s decisional capacity, and, when appropriate, working with surrogates or proxies to reach clinical decisions. In contrast to the 1970s, clinical medical ethics discussions have now become a part of everyday clinical discourse and are used to reach clinical decisions in outpatient and inpatient settings across the country. The goal of clinical medical ethics is to improve patient care and patient outcomes. The MacLean Center for Clinical Medical Ethics at the University of Chicago is one of the leading clinical medical ethics programs in the world and has helped to create, name, and develop this new field.

Informed consent process: A step further towards making it meaningful!

Abstract: Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process.

Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

Abstract: Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15–5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16–0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve care for patients with LEP; however, these improvements did not eliminate the language-based disparity. Additional clinician educational interventions and more language-concordant care may be necessary for informed consent to equal that for English speakers.

Integrated collaborative care teams to enhance service delivery to youth with mental health and substance use challenges: protocol for a pragmatic randomised controlled trial.

Abstract: Introduction Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access evidence-based services in a timely fashion. To address MHA system gaps, this study tests the benefits of an Integrated Collaborative Care Team (ICCT) model for youth with MHA challenges. A rapid, stepped-care approach geared to need in a youth-friendly environment is expected to result in better youth MHA outcomes. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth-friendly and family-friendly, and be more cost-effective, providing substantial public health benefits. Methods and analysis In partnership with four community agencies, four adolescent psychiatry hospital departments, youth and family members with lived experience of MHA service use, and other stakeholders, we have developed an innovative model of collaborative, community-based service provision involving rapid access to needs-based MHA services. A total of 500 youth presenting for hospital-based, outpatient psychiatric service will be randomised to ICCT services or hospital-based treatment as usual, following a pragmatic randomised controlled trial design. The primary outcome variable will be the youth9s functioning, assessed at intake, 6 months and 12 months. Secondary outcomes will include clinical change, youth/family satisfaction and perception of care, empowerment, engagement and the incremental cost-effectiveness ratio (ICER). Intent-to-treat analyses will be used on repeated-measures data, along with cost-effectiveness and cost-utility analyses, to determine intervention effectiveness. Ethics and dissemination Research Ethics Board approval has been received from the Centre for Addiction and Mental Health, as well as institutional ethical approval from participating community sites. This study will be conducted according to Good Clinical Practice guidelines. Participants will provide informed consent prior to study participation and data confidentiality will be ensured. A data safety monitoring panel will monitor the study. Results will be disseminated through community and peer-reviewed academic channels. Trial registration number Clinicaltrials.gov NCT02836080.

AGS Position Statement: Making Medical Treatment Decisions for Unbefriended Older Adults

Abstract: In this position statement, we define unbefriended older adults as patients who: (1) lack decisional capacity to provide informed consent to the medical treatment at hand; (2) have not executed an advance directive that addresses the medical treatment at hand and lack capacity to do so; and (3) lack family, friends or a legally authorized surrogate to assist in the medical decision-making process. Given the vulnerable nature of this population, clinicians, health care teams, ethics committees and other stakeholders working with unbefriended older adults must be diligent when formulating treatment decisions on their behalf. The process of arriving at a treatment decision for an unbefriended older adult should be conducted according to standards of procedural fairness and include capacity assessment, a search for potentially unidentified surrogate decision makers (including non-traditional surrogates) and a team-based effort to ascertain the unbefriended older adult's preferences by synthesizing all available evidence. A concerted national effort is needed to help reduce the significant state-to-state variability in legal approaches to unbefriended patients. Proactive efforts are also needed to identify older adults, including “adult orphans,” at risk for becoming unbefriended and to develop alternative approaches to medical decision making for unbefriended older adults. This document updates the 1996 AGS position statement on unbefriended older adults.

Willingness to participate and take risks in HIV cure research: survey results from 400 people living with HIV in the US.

Abstract: INTRODUCTION Participation in early-phase HIV cure studies includes clinical risks with little to no likelihood of clinical benefit. Examining the willingness of people living with HIV to participate is important to guide study design and informed consent. Our study examined the overall willingness of people living with HIV to participate in HIV cure research in the US, focusing on perceived risks and benefits of participation. METHODS We undertook an online survey of adults living with HIV in the US. Survey questions were developed based on previous research and a scoping review of the literature. We quantitatively assessed individuals' perceived risks and benefits of HIV cure-related research and respondents' willingness to participate in different modalities of HIV cure studies. RESULTS We recruited 409 study participants of whom 400 were eligible for the study and were included in the analysis (nine were not eligible due to self-declared HIV-negative status). We found >50% willingness to participate in 14 different types of HIV cure studies. Perceived clinical benefits and social benefits were important motivators, while personal clinical risks appeared to deter potential participation. Roughly two-thirds of survey respondents (68%) indicated that they were somewhat willing to stop treatment as part of HIV cure research. In the bivariate models, females, African Americans/blacks, Hispanics, individuals in the lowest income bracket, people living with HIV for longer periods of their lives, and people who were self-perceived 'very healthy' were less willing to participate in certain types of HIV cure studies than others. Multivariate results showed the perceived benefits (adjusted odds ratios >1) and perceived risks (adjusted odds ratios <1) acted as potential motivators and deterrents to participation, respectively. CONCLUSION Our study is the first attempt to quantify potential motivators and deterrents of participation in HIV cure research in the US using perceived risks and benefits. The results offer guidance to HIV cure researchers and developers of interventions about the beneficial and detrimental characteristics of HIV cure strategies that are most meaningful to people living with HIV. The study also highlights new potential lines of inquiry for further social science and ethics research.

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities.

Abstract: Due to issues related to informed research consent, older adults with cognitive impairments are often excluded from high-quality studies that are not directly related to cognitive impairment, which has led to a dearth of evidence for this population. The challenges to including cognitively impaired older adults in research and the implications of their exclusion are a transdisciplinary issue. The ethical challenges and logistical barriers to conducting research with cognitively impaired older adults are addressed from the perspectives of three different fields-social work, emergency medicine, and orthopaedic surgery. Issues related to funding, study design, intervention components, and outcomes are discussed through the unique experiences of three different providers. A fourth perspective-medical research ethics-provides alternatives to exclusion when conducting research with cognitively impaired older adults such as timing, corrective feedback and plain language, and capacity assessment and proxy appointments. Given the increasing aging population and the lack of evidence on cognitively impaired older adults, it is critical that researchers, funders, and institutional review boards not be dissuaded from including this population in research studies.

A 3-Arm randomised controlled trial of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants to prevent childhood obesity

Abstract: With an increasing prevalence of obesity in young children globally, there is an urgent need for the development of effective early interventions. A previous Healthy Beginnings Trial using a nurse-led home visiting program has demonstrated that providing mothers with evidence-based advice can improve maternal practice regarding obesity prevention, and can reduce Body Mass Index (BMI) in the first few years of life. However, the costs for scale-up of home visiting limit its population reach. This trial aims to determine the efficacy of Communicating Healthy Beginnings Advice by Telephone (CHAT) to mothers with infants in improving infant feeding practices and preventing the early onset of childhood overweight and obesity. We propose a 3-arm randomised controlled trial (RCT) with a consecutive sample of 1056 mothers with their newborn children in New South Wales (NSW) Australia. Pregnant women who are between weeks 28 and 34 of their pregnancy will be invited to participate in the CHAT trial. Informed consent will be obtained, and after baseline data collection, participants will be randomly allocated to the telephone intervention, text messaging intervention, or the control group. The intervention comprises telephone consultations or text messages, together with 6 intervention packages being mailed at specific times from the third trimester of pregnancy until 12 months post birth. The main trial outcome measures include a) duration of breastfeeding, b) timing of introduction of solids, c) nutrition behaviours, physical activity and television viewing, and d) weight and BMI z-score at 12 and 24 months, e) cost-effectiveness, as well as f) feasibility and acceptability of the interventions. The results will ascertain whether early intervention using telephone consultation or text messaging together with staged mailed intervention resources can be feasible and effective in improving infant feeding practices, physical activity and reducing children’s BMI in the early years of life. If proven to be feasible, effective as well as cost-effective, the trial results will inform a series of recommendations for policy and practice related to promoting healthy infant feeding and physical activity in young children in the first years of life. The CHAT Trial is registered with the Australian Clinical Trial Registry ( ACTRN12616001470482p ). It was registered on October 21, 2016.

A randomized study of multimedia informational AIDS for research on medical practices: Implications for informed consent

Abstract: Background/Aims:Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of th...