Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Background: Although ethics consultation has been introduced to clinical practice for many years, the results of empirical studies to evaluate the effectiveness of ethics consultation are still controversial. The design of randomised controlled trials is considered the best research design to evaluate the effect of a clinical practice on the outcomes of interests. In order to understand the effects of ethics consultation, we conducted this search for studies with the design of randomised controlled trials to evaluate ethics consultation.Objective: To provide (...) an integrated review of studies with the design of randomised controlled trials to evaluate the effectiveness of ethics consultation.Methods: PubMed was used to search for studies using the randomised controlled trial design to evaluate the effectiveness of ethics consultation. The search term used was “ethics consultation”. The selection criterion was limited to “randomised controlled trial”.Results: Four articles that met both search criteria were retrieved. One of these articles reported a study that did not actually use the design of a randomised controlled trial and is excluded from the following discussion.Conclusions: To apply randomised controlled trials to evaluate the effectiveness of ethics consultation is extremely difficult as long as two issues are not resolved: the standardisation of ethics consultation and a placebo for ethics consultation to eliminate the placebo effect. Thus, the results generated by the design of randomised controlled trials are always problematic. Furthermore, as long as the two issues exist, the results generated by the design of quantitative research methods always pose problems. (shrink)

Wowbagger has a problem: how to make an infinitely long life meaningful. His answer to this problem is studiedly perverse. Presumably, part of his reason for taking on the project he does is that everyone likes a challenge—and the project of insulting everyone in the universe, in alphabetical order, is really challenging even if you’re immortal. Still, his response to the question ‘How shall I make my life meaningful?’ seems to be not so much an attempt to answer it as (...) to stick two fingers up at it. Can anyone find anything less perverse to say about that question? If the late and lamented Douglas Adams is to be believed, some beings can. The non-accidental immortals, the ‘serene bastards’ of Wowbagger’s envy, have no trouble coping with everlasting life. Adams does not tell us how they manage to cope; which is a pity, because many contemporary philosophers, notably Bernard Williams and Adrian Moore, see a conceptual problem here. They cannot conceive how anyone could cope with immortality, even in the rather minimal sense of ‘cope’ that Wowbagger manages. This paper argues that their arguments fail. An eternal life, I argue, can be meaningful, and under the right circumstances, will be more meaningful than any finite life could be, because free from a threat to meaningfulness that cannot be removed from any finite life. We therefore have reason to want eternal life lived under these circumstances. (shrink)

ObjectiveThis study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents’ decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit. The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.SettingSingle centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from February (...) to May 2016.DesignAncillary study to a randomised clinical trial: Prettineo. Records of interviews for consent. Population: parents and physicians. Mixed study including qualitative and quantitative interview data about participants’ recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.ResultsParents’ recall and understanding of the study’s main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding was the main reason for refusal.Before birth, three situations can compromise parents’ consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby’s birth is not an imminent possibility.ConclusionsConfronting parents and physicians’ perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way. (shrink)

While new generations of implantable brain computer interface devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. (...) Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent—predictive and advisory—BCI technologies essential to prevent potential iatrogenic harms. (shrink)

BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of (...) consent.Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)

This paper considers dimensions of animate life that are readily “embodied” by phenomenologists and by other philosophy and science researchers as well. The paper demonstrates how the practice of “embodying” short-circuits veritable phenomenological accounts of experience through a neglect of attention to Husserl’s basic conception of, and consistent concern with, animate organism. The paper specifies how in doing so, the practice muddies a clear distinction between the body ‘I have’ and the body ‘I am’, and a clear account of their (...) lived conjunction in existential fit. In turn, the paper shows how the practice falls short of recognizing synergies of meaningful movement created by animate organisms; how it is tethered to talk of posture and sensation over kinesthesia and dynamics; and how, in general, the practice of embodying generates static rather than dynamic understandings of everyday life. The paper then critically considers how such liabilities preclude in-depth phenomenological insights into topics such as ‘ownership’ and ‘agency,’ and why inquiries into the nature of animate organisms require nothing less than fine-tuned attention to foundational experiences of animate life, including foundational ontogenetical experiences that undergird adult proficiencies and abilities, and hence fine-tuned attention to learning and to retaining what is learned in kinesthetic memory. (shrink)

Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded (...) six themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent. (shrink)

I begin by discussing the ways in which a would-be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her. This provides the basis for an examination of a particular kind of 'bar to trial' in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct of the state or its officials. The examination (...) of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage. (shrink)

I begin by discussing the ways in which a would‐be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her (to call her to account for her wrongdoing). This provides the basis for an examination of a particular kind of ‘bar to trial’ in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct (...) of the state or its officials. The examination of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria (...) for participants, in an... (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.MethodsWe conducted a qualitative study among (...) volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.ResultsVolunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.ConclusionEngagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. (shrink)

BackgroundAs the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.DiscussionParents want to do their best for their children, and socially and legally their role is to (...) care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.SummaryDiscussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties. (shrink)

An emerging consensus regards domestic amnesties for international crimes as generally inconsistent with international law. This legal consensus rests on a norm against impunity: the chief role of international criminal law, and of the fledgling International Criminal Court , is to end impunity for violators of the worst of criminal acts. But the anti-impunity norm, and the anti-amnesty consensus that has arisen from it, now face serious difficulties. The ICC's role in the ongoing conflict in Northern Uganda illustrates the deadlock (...) that has now emerged between countries wishing to retain the power to use domestic politics and criminal law as tools for negotiation with current or outgoing perpetrators, on the one side, and the ICC's determination to apply a consistent international anti-impunity norm, on the other. The paper argues that the anti-impunity norm itself is based on a narrowly retributivist conception of criminal justice. A broader norm for democratic accountability, by contrast, would continue to prefer prosecutions over amnesties in international law, less for the opportunity for deserved retribution for perpetrators than for the public enactment of the deliberative procedures associated with the rule of law.Keywords: amnesty; impunity; international law; international criminal court. (shrink)

& The functional equivalence of overt movements and dynamic imagery is of fundamental importance in neuroscience. Here, we investigated the participation of the neocortical motor areas in a classic task of dynamic imagery, Shepard and Metzler's mental rotation task, by time-resolved single-trial functional Magnetic Resonance Imaging (fMRI). The subjects performed the mental-rotation task 16 times, each time with different object pairs. Functional images were acquired for each pair separately, and the onset times and..

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive‐compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post‐trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates the pain (...) of an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post‐trial access as a means to achieve social reintegration through this neurotechnological accommodation. (shrink)

Volume 19, Issue 10, October 2019, Page 97-98.

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document (...) did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists. (shrink)

Reduced Environmental Stimulation Therapy (REST) alters the balance of sensory input to the nervous system by systematically attenuating sensory signals from visual, auditory, thermal, tactile, vestibular, and proprioceptive channels. Previous research from our group has shown that REST via floatation acutely reduces anxiety and blood pressure while simultaneously heightening interoceptive awareness in clinically anxious populations. Anorexia nervosa (AN) is an eating disorder characterized by elevated anxiety, distorted body representation, and abnormal interoception, raising the question of whether REST might positively impact (...) these symptoms. However, this approach has never been studied in eating disorders and it is unknown whether exposure to REST might worsen AN symptoms. To examine these possibilities we conducted an open-label study to investigate the safety and tolerability of REST in AN. We also explored the impact of REST on affective symptoms, body image disturbance, and interoception. Twenty-one partially weight-restored AN outpatients completed a protocol involving four sequential sessions of REST: reclining in a zero-gravity chair, floating in an open pool, and two sessions of floating in an enclosed pool. All sessions were 90 minutes, approximately one week apart. We measured orthostatic blood pressure before and immediately after each session (primary outcome), in addition to collecting blood pressure readings every 10 minutes during the session using a wireless waterproof system as a secondary outcome measure. Each participant's affective state, awareness of interoceptive sensations, and body image was assessed before and after every session (exploratory outcomes). There was no evidence of orthostatic hypotension following floating, and no adverse events (primary outcome). Secondary analyses revealed that REST induced statistically significant reductions in blood pressure, anxiety and negative affect, heightened awareness of cardiorespiratory but not gastrointestinal sensations, and reduced body image dissatisfaction. The findings from this initial trial suggest that individuals with AN can safely tolerate the physical effects of REST via floatation. Future randomized controlled trials will need to investigate whether these initial observations of improved anxiety, interoception, and body image disturbance can be effectively extended to acutely ill AN populations. (shrink)

Abilities such as peripheral reaction are of special importance in soccer. Whether these abilities can be improved by sport-specific on-field interventions remains unclear. The aim of the present controlled trial was to investigate the effect of a soccer-specific perceptual-cognitive on-field training on peripheral reaction of highly talented soccer players aged 12 to 13 years. N = 38 male elite athletes from young talent centers were allocated to an intervention (n = 19) and a control group (n = 19). Computer-based (...) peripheral perception tests were conducted pre- and post-intervention. Combining a sport-specific and a juggling task, the intervention was performed once a week (8 weeks, 20 min. per week) in addition to team training. The control group exclusively underwent usual team training. Analyzes show significant differences between the two groups for Peripheral Reaction Time, with significant improvements for the intervention group and none for the control group. Furthermore, results indicate that improvements in peripheral reaction might be due to changes in the reaction time of right-footed players. Future studies should be conducted to clarify the effect of sport-specific on-field training approaches on peripheral reaction time. These analyzes should consider the influence of lateralization on effectivity of perceptual-cognitive on-field training approaches. (shrink)

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally (...) divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable. (shrink)

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by (...) physician judgment or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution. (shrink)

The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of (...) the consent form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies.Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a “standard care” control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study. (shrink)

In this article, I seek to answer the following cluster of questions: What would a characteristically African, and specifically relational, conception of a criminal trial’s final end look like? What would the Afro-relational approach prescribe for sentencing? Would its implications for this matter forcefully rival the kinds of penalties that judges in South Africa and similar jurisdictions typically mete out? After pointing out how the southern African ethic of ubuntu is well understood as a relational ethic, I draw out (...) of it a certain conception of reconciliation that I advance as a strong candidate for being the proper final end of a criminal trial. I argue that, far from requiring forgiveness, seeking reconciliation can provide strong reason to punish offenders. Specifically, a reconciliatory sentence is one that roughly has offenders reform their characters and compensate their victims in ways the offenders find burdensome, thereby disavowing the crime and tending to foster cooperation and mutual aid. I argue that this novel account of punishment is a prima facie attractive alternative to more familiar retributive and deterrence rationales, and that it entails that widespread practices such as imprisonment and mandatory minimum sentences are unjust. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical (...) products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

ABSTRACTDespite being held in something approaching universal esteem for its capacity to promote prosocial behavior and inhibit antisocial behavior, empathy has recently become the recipient of strong criticism from some of today’s leading academics. Two of the more high-profile criticisms of empathy have come from philosopher Jesse Prinz and psychologist Paul Bloom, each of whom challenges the view that empathy has an overall beneficial influence on human behavior. In this essay, I discuss the basis of their criticisms as well as (...) why I am not compelled by their arguments to believe that empathy does more harm than good. In the process of responding to empathy’s critics, I discuss the important role that empathy plays in our moral lives. I argue that, rather than employing rational considerations to minimize the role that empathy plays in our moral and political judgments, such considerations are put to better use by expanding empathy when conducive to the common good and suppressing it when it opposes th... (shrink)

ObjectiveThis study aims to evaluate the effectiveness of the MotivAir program—a phone-based intervention based on Motivational Interviewing principles and techniques—in enhancing adherence to Continuous Positive Airway Pressure therapy among patients with Obstructive Sleep Apnea Syndrome.MethodsA multicenter randomized controlled trial design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients. A minimum (...) sample of 80 participants will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary and secondary outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation.DiscussionParticipants are expected to show an increased level of adherence to CPAP and to acquire the skills and self-confidence necessary to deal with the psychological consequences of their chronic condition. (shrink)

Intervention studies with developmental samples are difficult to implement, in particular when targeting demographically diverse communities. Online studies have the potential to examine the efficacy of highly scalable interventions aimed at enhancing development, and to address some of the barriers faced by underrepresented communities for participating in developmental research. During the COVID-19 pandemic, we executed a fully remote randomized controlled trial language intervention with third and fourth grade students from diverse backgrounds across the United States. Using this as a (...) case study, we discuss both challenges and solutions to conducting an intensive online intervention through the various phases of the study, including recruitment, data collection, and fidelity of intervention implementation. We provide comprehensive suggestions and takeaways, and conclude by summarizing some important tradeoffs for researchers interested in carrying out such studies. (shrink)

BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and (...) modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)

Physical activities are generally accepted as promoting important psychological benefits. However, studies examining martial arts as a form of physical activity and mental health have exhibited many methodological limitations in the past. Additionally, recent philosophical discussion has debated whether martial arts training promotes psychological wellbeing or illness. Self-efficacy has an important relationship with mental health and may be an important mechanism underpinning the potential of martial arts training to promote mental health. This study examined the effect of martial arts training (...) on the psychological construct of self-efficacy. A total of 283 secondary school students with a mean age of 12.76 (SD = 0.68) years were recruited to complete a time-limited (10-session) martial arts intervention, which was examined using a randomised controlled trial. Univariate ANOVAs found that the intervention improved the experimental group’s self-efficacy compared to the control group, which was sustained at follow-up. Regression analysis indicated that socio-educational status moderated this outcome. These findings support the martial arts-based intervention’s potential to improve self-efficacy and promote wellbeing through physical activity. Martial arts training may be an efficacious psychosocial treatment that can be used as a complementary approach to promote mental health. (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and (...) increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial RegistrationISRCTN89993391. (shrink)