Regulations designed to prevent global inequalities in the use of genetic resources apply to both commercial and non-commercial research. Conflating the two may have unintended consequences for collaboration between the Global North and biodiverse countries in the Global South, which may promote global injustice rather than mitigate it.

Indonesia consists of more than 17,000 islands separated for hundreds of thousands of years making both the biodiversity and culture diverse. Strong connection between people and biodiversity form a vast array of traditional knowledges retaliated to the conservation and use of biological diversity. During the last 3 decades, tremendous advancement on science and technology has been able to uncover the intrinsic value of biodiversity. Many lead chemical compounds have been isolated and identified, and has opened up huge opportunities in developing (...) new business based on biodiversity. International cooperation between Japan and Indonesia successfully isolated more than 1,000 species of actinomycetes from diverse ecosystems and more than 30% are new species. This group of microbe is important for future pharmaceutical industries. The consciousness on intrinsic value of biodiversity is, however, only being understood by countries having high science and technology capacity. The intrinsic value of biodiversity remains abstract to most of the people in the developing and less developed nations. The Convention on Biological Diversity (UN-CBD), Cartagena and Nagoya Protocol are legal documents to ensure conservation, sustainable use and sharing of the benefit from the utilization of biodiversity and its components. There is a high demand for the developed nations on access to biodiversity to uncover its benefit. The mechanism on access, fair and equitable sharing of the benefit from the utilization of biodiversity and its component are certainly full of ethical dilemma. For this, there is a great need for the developing country having rich biodiversity find the most appropriate way to manage biodiversity and traditional knowledge for their prosperity. Trust between countries rich in biodiversity and countries having high science and technology capacity is a crucial factor. Greater transparency and the recognition on comprehensive rights of people providing biodiversity is a key element in maintaining trust. Ethical standards cannot depend solely on rules or guidelines. (shrink)

The 2010 Nagoya Protocol is an international framework for access and benefit sharing (ABS) of the use of genetic and biological resources, with particular focus on indigenous communities. This is especially important in Africa, where local communities have a close reliance on environmental resources and ecosystems. However, national legislation and policies commonly lag behind international agreements, and this poses challenges for legal compliance as well as practical applications. This study reviews the academic literature on the Nagoya Protocol and (...) ABS applications, and then considers the implications of this analysis for research in Africa. Results show that there is uneven engagement with the principles of the Nagoya Protocol across different academic disciplines; local communities are sometimes sidelined in these studies; and only 8% of researchers in the literature analysed are located in Africa. Future developments should focus on ensuring national compliance with the Nagoya Protocol, and that researchers and industry work in partnership with local African communities on ABS issues. (shrink)

Crop genetic resources constitute a ‘new’ global commons, characterized by multiple layers of activities of farmers, genebanks, public and private research and development organizations, and regulatory agencies operating from local to global levels. This paper presents sui generis biocultural community protocols that were developed by four communities in Benin and Madagascar to improve their ability to contribute to, and benefit from, the crop commons. The communities were motivated in part by the fact that their national governments’ had recently ratified the (...) Plant Treaty and the Nagoya Protocol, which make commitments to promoting the rights of indigenous peoples, local communities and farmers, without being prescriptive as to how Contracting Parties should implement those commitments. The communities identified the protocols as useful means to advance their interests and/or rights under both the Plant Treaty and the Nagoya Protocol to be recognized as managers of local socio-ecological systems, to access genetic resources from outside the communities, and to control others’ access to resources managed by the community. (shrink)

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that (...) led to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa. (shrink)

This paper reviews the location of Responsible Research and Innovation approaches within the access and benefit sharing policy spaces of the Convention on Biological Diversity and Nagoya Protocol. We describe how a range of dialogues on ethical research practices found a home, almost inadvertently, within the ABS policy process. However, more recent RRI dialogues around emerging technologies have not been similarly absorbed into ABS policy, due in part to the original framing of ABS and associated definitional and scope issues. (...) Consideration is given to the challenges posed to these policy processes by the transformative and rapid nature of scientific and technological change today, including the emerging field of synthetic biology. Drawing on experiences from regulating ABS, we emphasize that the integration of RRI into policies for new, emerging, or poorly understood activities such as synthetic biology faces deficiencies such as limits to government capacity, jurisdictional confusion, shortages in funds, and an absence of strategic approaches. We conclude that a coordinated combination of diverse policy processes within the CBD might provide an invaluable space for RRI dialogues on social justice, sustainability, biosafety, and other issues raised by emerging technologies. (shrink)

The Convention on Biological Diversity and its Nagoya Protocol established an Access and Benefit Sharing system between utilizers and providers of genetic resources. ABS is understood as a tool that should promote commutative justice between the involved parties. This essay discusses what exactly it is that is being exchanged in the ABS process. It critically analyses moral claims to compensation that are implied by the ABS system for genetic resources. It argues that with the exception of cases in which (...) traditional knowledge is involved, states are not automatically entitled to compensation in return for the utilization of genetic resources growing within their territory. However, biodiversity-rich states that make an effort to protect biodiversity must be compensated for complying with the requests set out in the CBD. Although it acknowledges that the NP is a step towards recognizing this claim, this essay argues that ABS is not the appropriate method to compensate for biodivers... (shrink)

With the advent of synthetic biology, scientists are increasingly relying on digital sequence information, instead of physical genetic resources. This article examines the potential impact of this shift on the access and benefit-sharing (ABS) regime of the Convention on Biological Diversity (CBD) and the Nagoya Protocol. These treaties require benefit-sharing with the owners of genetic resources. However, whether “genetic resources” include digital sequence information is unsettled. The CBD conceives genetic resources as genetic material containing functional units of heredity. “Material” (...) implies tangibility, and for some scholars, “functional units of heredity,” undefined in both treaties, mean full-coding sequences. This article argues that digital sequence information obtained from physical genetic resources, full-coding or not, should be treated as genetic resources. Literal construction of the CBD risks eroding its usefulness and the ABS regime. This is because through bioinformatics, sequence information can easily be obtained from genetic resources for utilization, without physically moving them or concluding ABS agreement with owners. The CBD must evolve with scientific progress also because sequence functionality depends on the state of knowledge. These arguments are vindicated by domestic ABS laws equating genetic information with genetic resources; Nagoya Protocol provisions deeming research exploiting the genetic composition of genetic resources as utilization of genetic resources; and CBD provisions requiring the sharing of benefits from the utilization of genetic resources. Moreover, treaty interpretation and case law demand that generic, scientific terms, such as “genetic resources” and “functional units of heredity” be interpreted in an evolutionary manner to capture scientific developments. (shrink)

The use of protocol analysis in the traning of cognitive skills.

Substance-abusing women are vulnerable to specific kinds of epistemic injustice, including stigmatization and discrimination. This article examines the development of the epistemic agency of female substance abusers by asking: How does the use of a formal discussion protocol in community rehabilitation interaction alleviate epistemic injustice and strengthen the epistemic agency of substance abusers? The data were collected in a Finnish rehabilitation center by videotaping six group discussions between social workers, peer support workers, and rehabilitation clients with substance abuse problems. Of (...) these data, one recorded group discussion between four female participants—two rehabilitation clients, a peer support worker, and a social adviser—was used in this paper. Using conversational analysis, the findings indicate that, through the collaborative activities of sharing experiential knowledge about substance abuse and discussing the experiences of abuse in the rehabilitation interaction, substance abusers can develop novel ways to strengthen their epistemic agency by enhanced self-awareness. The discussion protocol is an epistemic tool that professionals and clients can learn to use in ethically and epistemologically successful ways in interaction. The use of a discussion protocol is an example of social professionals’ clinical knowledge of intensifying collaboration and sharing experiential knowledge in community rehabilitation and other substance abuse services. (shrink)

The experimental practice in contemporary molecular biology oscillates between the creativity of the researcher in tinkering with the experimental system, and the necessity of standardization of methods of inquiry. Experimental procedures, when standardized in lab protocols, might definitely be seen as actual recipes. Considering these protocols as recipes can help us understand some epistemological characteristics of current practice in molecular biology. On the one hand, protocols represent a common ground, i.e. the possibility of reproducibility, which constitutes one of the essential (...) properties for contemporary science to define an actual discovery. At the same time, however, protocols are flexible enough to be adapted by the individual researcher (within a space of maneuver given by the experimental system and by the practices that each individual discipline gives to itself) to his/her specific needs. These variations, just like the recipes, remind us that the legitimacy of an experimental practice, involves both objective and subjective constraints and it is articulated on a fuzzy background rather than a rigid and clear context. Moreover, looking at experiments according to this perspective can provide a key to understanding how different forms of science (which adopt different methodologies but which investigate the same phenomena), such as computational biology, are precisely different in the use of a different “cookbook”.Indeed, given the procedural/operational realism of biologists towards phenomena, the clash of different procedures has opened a discussion also about the nature and the meaning of the obtained results. Thus, according to the recipe-perspective that, the methodological struggle over the nature of biological phenomena (and their ways of discovery) among scientists, might be seen as a not always explicit, epistemological debate, however coming from the practice of science itself. (shrink)

The continuing philosophical interest in the famous 'Protocol Sentence Debate' in the Vienna Circle of Logical Positivists is, to a large measure, due to the focus on the epistemological issues in the dispute, and the neglect of differences among the leading players in their philosophical views of logic and language. In _Protocols, Truth and Convention_, the current understanding of the debate is advanced by developing the contemporaneous views of logic and language held by the principal disputants. Rudolf Carnap and Moritz (...) Schlick. It is argued - largely on the basis of unpublished manuscripts and correspondence - that, despite apparent differences in their respective conceptions of language, there are nonetheless striking similarities, particularly with respect to the conventionality of language. Nonetheless, one key issue - concerning the _syntacticism_ inherent in Carnap's early Thirties' philosophy - separates the two viewpoints in the clash over protocols. Finally, it is argued that Carnap's syntacticism is untenable, a conclusion that Carnap himself finally reached in the closing exchanges of the protocol sentence controversy. (shrink)

This paper presents a dialogue system called Lorenzen–Hamblin Natural Dialogue (LHND), in which participants can commit formal fallacies and have a method of both identifying and withdrawing formal fallacies. It therefore provides a tool for the dialectical evaluation of force of argument when players advance reasons which are deductively incorrect. The system is inspired by Hamblin’s formal dialectic and Lorenzen’s dialogical logic. It offers uniform protocols for Hamblin’s and Lorenzen’s dialogues and adds a protocol for embedding them. This unification required (...) a reformulation of the original description of Lorenzen’s system to distinguish “between different stances that a person might take in the discussion”, as suggested by Hodges. The LHND system is compared to Walton and Krabbe’s Complex Persuasion Dialogue using an example of a dialogue. (shrink)

The paper offers a solution to the problem of specifying computational systems that behave in accordance with a given set of ethical principles. The proposed solution is based on the concepts of ethical requirements and ethical protocols. A new conceptual tool, called the Control Closure of an operation, is defined and used to translate ethical principles into ethical requirements and protocols. The concept of Generalised Informational Privacy (GIP) is used as a paradigmatic example of an ethical principle. GIP is defined (...) in such a way as to (i) discriminate specific cases in which an individual’s GIP can be infringed without accessing the individual’s data; (ii) separate unauthorised accesses to data that do not respect the right to GIP from access that do; and (iii) distinguish different degrees of GIP. Finally a camera phone is used to illustrate the proposed solution. (shrink)

When agents know a protocol, this leads them to have expectations about future observations. Agents can update their knowledge by matching their actual observations with the expected ones. They eliminate states where they do not match. In this paper, we study how agents perceive protocols that are not commonly known, and propose a semantics-driven logical framework to reason about knowledge in such scenarios. In particular, we introduce the notion of epistemic expectation models and a propositional dynamic logic-style epistemic logic for (...) reasoning about knowledge via matching agentsÊ expectations to their observations. It is shown how epistemic expectation models can be obtained from epistemic protocols. Furthermore, a characterization is presented of the effective equivalence of epistemic protocols. We introduce a new logic that incorporates updates of protocols and that can model reasoning about knowledge and observations. Finally, the framework is extended to incorporate fact-changing actions, and a worked-out example is given. © 2013 Elsevier B.V. (shrink)

Contrary to a common opinion, some theses of scientific anarchism are historically connected not only to Popper's and "second" Wittgenstein's thoughts, but also to some ideas affirmed by the advocates of "physicalism" (like Neurath) during the neopositivistie debate on protocol sentences. The common basis of "physicalism" and "anarchism" is a repulse of the "atomistic" theory of meaning. That is making more adequate the epistemological description of knowledge. But both Neurath and Feyerabend err in thinking that this repulse entails a conception (...) of "truth" as "coherence" instead of "correspondence". Against such a conviction the "realistic" requirement expressed by SchHck through the concept of "Konstatiemng" is still very valid. (shrink)

This article investigates to what extent protocols for dynamicdisputes, i.e., disputes in which the information base can vary at differentstages, can be justified in terms of logics for defeasible argumentation. Firsta general framework is formulated for dialectical proof theories for suchlogics. Then this framework is adapted to serve as a framework for protocols fordynamic disputes, after which soundness and fairness properties are formulated for such protocols relative to dialectical proof theories. It then turns out that certaintypes of protocols that are (...) perfectly fine with a static information base, arenot sound or fair in a dynamic setting. Finally, a natural dynamic protocolis defined for which soundness and fairness can be established. (shrink)

This article investigates to what extent protocols for dynamicdisputes, i.e., disputes in which the information base can vary at differentstages, can be justified in terms of logics for defeasible argumentation. Firsta general framework is formulated for dialectical proof theories for suchlogics. Then this framework is adapted to serve as a framework for protocols fordynamic disputes, after which soundness and fairness properties are formulated for such protocols relative to dialectical proof theories. It then turns out that certaintypes of protocols that are (...) perfectly fine with a static information base, arenot sound or fair in a dynamic setting. Finally, a natural dynamic protocolis defined for which soundness and fairness can be established. (shrink)

Contrary to a common opinion, some theses of scientific anarchism are historically connected not only to Popper's and "second" Wittgenstein's thoughts, but also to some ideas affirmed by the advocates of "physicalism" (like Neurath) during the neopositivistie debate on protocol sentences. The common basis of "physicalism" and "anarchism" is a repulse of the "atomistic" theory of meaning. That is making more adequate the epistemological description of knowledge. But both Neurath and Feyerabend err in thinking that this repulse entails a conception (...) of "truth" as "coherence" instead of "correspondence". Against such a conviction the "realistic" requirement expressed by SchHck through the concept of "Konstatiemng" is still very valid. (shrink)

Descriptive accounts of the nature of explanation in neuroscience and the global goals of such explanation have recently proliferated in the philosophy of neuroscience and with them new understandings of the experimental practices of neuroscientists have emerged. In this paper, I consider two models of such practices; one that takes them to be reductive; another that takes them to be integrative. I investigate those areas of the neuroscience of learning and memory from which the examples used to substantiate these models (...) are culled, and argue that the multiplicity of experimental protocols used in these research areas presents specific challenges for both models. In my view, these challenges have been overlooked largely because philosophers have hitherto failed to pay sufficient attention to fundamental features of experimental practice. I demonstrate that when we do pay attention to such features, evidence for reduction and integrative unity in neuroscience is simply not borne out. I end by suggesting some new directions for the philosophy of neuroscience that pertain to taking a closer look at the nature of neuroscientific experiments. (shrink)

This note comments on the paper ‘Dialogue protocols for formal fallacies’ by Kacprzak and Yaskorska (this issue). Points discussed include the use of the notions of ‘claiming’, ‘conceding’ and ‘commitment’, and the role of Lorenzen dialogues as a device for checking whether a proposition is a tautology.

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)

This paper presents a communication protocol to reach consensus. In our setting, every player has asymmetric information and evaluates a fixed event on his information. According to the protocol, the sender sends non-partitional messages that he believes the event with a probability of at least his evaluation. We show that the posteriors for the event must be equal among the players after the communication. Journal of Economic Literature Classification: C62, C78.

The Groningen Protocol, introduced in the Netherlands in 2005 and accompanied by revised guidelines published in a report commissioned by the Royal Dutch Medical Association in 2014, specifies conditions under which the lives of severely ill newborns may be deliberately ended. Its publication came four years after the Netherlands became the first nation to legalize the voluntary active euthanasia of adults, and the Netherlands remains the only country to offer a pathway to protecting physicians who might engage in deliberately ending (...) the life of a newborn. In this paper, I offer two lines of argument. The first is a positive argument for the Protocol, grounded in the good of the newborn as unanimously determined by those in a position to determine it. The second addresses the widely shared belief that the killing of newborns is morally prohibited, where I offer two arguments—one grounded in the fact that the kinds of cases the Protocol is meant to govern are very rare and highly unusual, and the other focused more broadly on the role of pre-theoretical beliefs in moral reasoning—meant to undermine the strong role that the critic of the Protocol affords this belief. I argue that, given this second line of argument, the beliefs underlying my positive argument for the Protocol are in fact more secure than the widely shared belief underlying the critic’s position. (shrink)

A goal-oriented analysis of argument is presented based on Taylor's layered protocols, a theory of communication based on Powers' hierarchical perceptual control theory. Goals and beliefs are hierarchical, related in a precise way to sensory inputs an d motor outputs. This model is combined with Gilbert's theory of coalescent argumentation. Participants sketch out their own and their partner's goal diagrams as an aid to resolving the argument. For this to work, the argument must be viewed, not in pu rely linguistic (...) or logical terms, but in terms of the entire system of goals in which it is embedded. (shrink)

In dynamical multi-agent systems, agents are controlled by protocols. In choosing a class of formal protocols, an implicit choice is made concerning the types of agents, actions and dynamics representable. This paper investigates one such choice: An intensional protocol class for agent control in dynamic epistemic logic (DEL), called ‘DEL dynamical systems’. After illustrating how such protocols may be used in formalizing and analyzing information dynamics, the types of epistemic temporal models that they may generate are characterized. This facilitates a (...) formal comparison with the only other formal protocol framework in dynamic epistemic logic, namely the extensional ‘DEL protocols’. The paper concludes with a conceptual comparison, highlighting modeling tasks where DEL dynamical systems are natural. (shrink)

Objective—Consultation of another physician is an important method of review of the practice of euthanasia. For the project “support and consultation in euthanasia in Amsterdam” which is aimed at professionalising consultation, a protocol for consultation was developed to support the general practitioners who were going to work as consultants and to ensure uniformity. Participants—Ten experts (including general practitioners who were experienced in euthanasia and consultation, a psychiatrist, a social geriatrician, a professor in health law and a public prosecutor) and the (...) general practitioners who were going to use the protocol. Evidence—There is limited literature on consultation: discursive articles and empirical studies describing the practice of euthanasia. Consensus—An initial draft on the basis of the literature was commented on by the experts and general practitioners in two rounds. Finally, the protocol was amended after it had been used during the training of consultants. Conclusions—The protocol differentiates between steps that are necessary in a consultation and steps that are recommended. Guidelines about four important aspects of consultation were given: independence, expertise, tasks and judgment of the consultant. In 97% of 109 consultations in which the protocol was used the consultant considered the protocol to be useful to a greater or lesser extent. Although this protocol was developed locally, it also employs universal principles. Therefore it can be of use in the development of consultation elsewhere. (shrink)

BackgroundThe use of genetic test results in risk-rated insurance is a significant concern internationally, with many countries banning or restricting the use of genetic test results in underwriting. In Australia, life insurers’ use of genetic test results is legal and self-regulated by the insurance industry (Financial Services Council (FSC)). In 2018, an Australian Parliamentary Inquiry recommended that insurers’ use of genetic test results in underwriting should be prohibited. In 2019, the FSC introduced an industry self-regulated moratorium on the use of (...) genetic test results. In the absence of government oversight, it is critical that the impact, effectiveness and appropriateness of the moratorium is monitored. Here we describe the protocol of our government-funded research project, which will serve that critical function between 2020 and 2023.MethodsA realist evaluation framework was developed for the project, using a context-mechanism-outcome (CMO) approach, to systematically assess the impact of the moratorium for a range of stakeholders. Outcomes which need to be achieved for the moratorium to accomplish its intended aims were identified, and specific data collection measures methods were developed to gather the evidence from relevant stakeholder groups (consumers, health professionals, financial industry and genetic research community) to determine if aims are achieved. Results from each arm of the study will be analysed and published in peer-reviewed journals as they become available.DiscussionThe A-GLIMMER project will provide essential monitoring of the impact and effectiveness of the self-regulated insurance moratorium. On completion of the study (3 years) a Stakeholder Report will be compiled. The Stakeholder Report will synthesise the evidence gathered in each arm of the study and use the CMO framework to evaluate the extent to which each of the outcomes have been achieved, and make evidence-based recommendations to the Australian federal government, life insurance industry and other stakeholders. (shrink)

In dynamical multi-agent systems, agents are controlled by protocols. In choosing a class of formal protocols, an implicit choice is made concerning the types of agents, actions and dynamics representable. This paper investigates one such choice: An intensional protocol class for agent control in dynamic epistemic logic, called ‘DEL dynamical systems’. After illustrating how such protocols may be used in formalizing and analyzing information dynamics, the types of epistemic temporal models that they may generate are characterized. This facilitates a formal (...) comparison with the only other formal protocol framework in dynamic epistemic logic, namely the extensional ‘DEL protocols’. The paper concludes with a conceptual comparison, highlighting modeling tasks where DEL dynamical systems are natural. (shrink)

In the Netherlands fertility doctors increasingly formulate protocols, which oblige patients to quit their unhealthy lifestyle before they are admitted to IVF procedures. We argue that moral arguments could justify parenting protocols that concern all future parents. In the first part we argue that want-to-be parents have moral responsibilities towards their future children to prevent them from harm by diminishing or eliminating risk factors before as well as during the pregnancy. This is because of the future children's potential to become (...) of a certain type, more specifically: a person that will be the want-to-be parents' child. Want-to-be parents intend to become pregnant and therefore have an additional moral reason to diminish the risks. Also, people who become pregnant unintentionally have the responsibility to prevent their children from harm, unless they become pregnant due to contraception failure. All people not wanting to become pregnant should use contraception methods carefully.In the second part of this paper we translate the want-to-be parents' responsibilities into practice. We distinguish four determinants of risk factors: modifiability, chance, severity and effort. We examine some evidence-based risk factors based on these variables and deduce levels of responsibility.In conclusion, formulating informal requirements for want-to-be parents is morally required and therefore also for want-to-be parents in need of medical assistance. The protocols developed by fertility doctors in the Netherlands could be seen as the precursor for a general, informal Parenting Protocol that could be developed on the basis of an extended and thoroughly debated risk-responsibility analysis. (shrink)

Background: Both anxiety and depression in family caregivers of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction and psychological consultation guided by the needs (...) assessment tool in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale, the Self-Rating Depression Scale, Distress Thermometer, Zarit Burden Interview, Chinese version of the Medical Outcomes Study 12-item Short Form, and Family Carer Satisfaction with Palliative Care scale.Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in (...) a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

Background: People with traumatic brain injury face a range of mental health challenges during the adjustment process post-injury, but access to treatment can be difficult, particularly for those who live in regional and remote regions. eHealth provides the potential to improve access to evidence-based psychological therapy for people with a severe TBI. The aim of the current study is to assess the efficacy of a psychological intervention delivered via video consulting to reduce psychological distress in people with TBI.Methods: This paper (...) outlines the protocol for a multi-center, three-arm, parallel, non-inferiority randomized controlled trial of an evidence-based manualized psychological intervention, ACT-Adjust. ACT-Adjust provides nine sessions for adults with a moderate to severe TBI experiencing clinical levels of psychological distress. Fifty-six participants referred from Brain Injury Rehabilitation Units across New South Wales and the NSW icare scheme will be randomly allocated to three conditions; video consulting, face-to-face and, a waitlist control.Discussion: This is the first RCT to evaluate the efficacy of a psychological therapy delivered via video consulting for individuals with a moderate to severe TBI.Trial Registration:www.anzctr.org.au, Australian New Zealand Clinical Trials Registry ANZCTRN2619001602112. (shrink)

Verbal protocol methodology is used to examine how fourth-grade students construct meaning as they read and respond to two informational social studies texts. Results indicate most students are active readers, often engaging in higher-level comprehension strategies and critical thinking as they read independently. However, critical thinking and comprehension processes are not often captured in their responses to end-of-reading questions (ERQ), which as a result have limited scope and utility for guiding social studies instruction. Results also indicate that when students change (...) their patterns of strategy use for reading and responding to text in response to a change in text, they are more successful on the ERQ than when their strategy use remains stagnant. (shrink)

Sixteen Canadian men and women, part of eight intact couples who had experienced severe and recurrent wife assault, were interviewed individually regarding their worst experience of violence. The self-reports of both spouses of one of these couples is presented and analyzed with a view towards isolating the emerging constituents of their narratives. Additionally, preliminary findings resulting from the analysis of all of the couple's self-reports are presented in the second part of the paper. A gendered reconstruction of their narratives emerges (...) that mirrors the different positions men and women hold in experiences of wife assault. Finally, the main constituents derived from all the participant's selfreports are analyzed and discussed. (shrink)