Carolyn Ells

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context

Introduction Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. Methods and analysis SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500–2000 patients from centres across the world within a period of 5 years (2013–2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once interventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. Ethics and dissemination The use of the cmRCT design, the development of self-guided online interventions and partnerships with patient organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc.

Adults With Intellectual and Developmental Disabilities and Participation in Decision Making: Ethical Considerations for Professional–Client Practice

In this article, the authors challenge professionals to re-examine assumptions about basic concepts and their implications in supporting adults with intellectual and developmental disabilities. The authors focus on decisions with significant implications, such as planning transition from school to adult life, changing living environments, and managing health issues. The analysis highlights important concepts that are less often addressed: autonomy, empowerment, participation in decision making, asymmetrical power, outer-directedness, and respect for persons. The authors suggest that professionals adopt a moral principle of respect for persons as an overarching guiding principle in their work with adults with intellectual and developmental disabilities. The value of self-determination and person-centered planning processes are placed in the larger scope of ethical practice. The authors offer a set of practical considerations that encourage respect for these individuals by involving them in the decision-making process in situations that have a large impact on them.

Hopes for Helsinki: reconsidering “vulnerability”

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries. Although it has undergone five revisions,1 and most recently incorporated (albeit controversial) language aimed at addressing concerns over research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour. In light of the current effort of the World Medical Association (WMA) to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated. In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups (such as children, prisoners, indigenous people, those who are ill and the poor) that …

Foucault, Feminism, and Informed Choice

The purpose of this paper is to show that the standard notion of informed choice is unacceptable and must be replaced. To do so, I examine Foucaults analysis of people in contemporary society, drawing attention to the ways power relations act upon us, and to the possibility of resistance. I show how feminist moral theory can be enriched by Foucaults analysis. Applying this new understanding of people and moral theory to an analysis of informed choice, I claim that the standard notion of informed choice is unacceptable, in part because it relies on a false conception of people. Its “necessary” features—intention, understanding, and absence of controlling influences—are much more difficult, if not impossible, to obtain than proponents of the standard notion believe. I end by offering direction for creating a new, Foucault-inspired, feminist theory of informed choice.

Transforming mental health services: a participatory mixed methods study to promote and evaluate the implementation of recovery-oriented services

BackgroundSince 2007, the Mental Health Commission of Canada has worked collaboratively across all provinces to publish a framework and strategy for recovery and well-being. This federal document is now mandated as policy for implementation between 2012 and 2017. The proposed strategies have been written into provincial health plans, hospital accreditation standards, and annual objectives of psychiatric departments and community organizations. The core premise is: to empower persons with mental illness and their families to become participants in designing their own care, while meeting the needs of a diverse Canadian population. However, recovery principles do not come with an implementation guide to fit the variability of different local contexts. How can policy recommendations and accreditation standards be effectively tailored to support a diversity of stakeholder values? To our knowledge, there is little evidence indicating the most effective manner to accelerate the uptake of recovery-oriented services among providers in a given/particular mental health treatment setting.Methods/DesignThis three-year Canadian Institute of Health Research Partnership in Health System Improvement and The Rx&D Health Research Foundation (HRF) Fostering Canadian Innovation in Research study (2013 to 2017) proposed participatory approaches to implementing recovery principles in a Department of Psychiatry serving a highly diverse Canadian and immigrant population. This project will be conducted in overlapping and recursive phases: I) Conduct formative research to (a) measure the current knowledge and attitudes toward recovery and recovery-oriented practices among service providers, while concurrently (b) exploring the experiential knowledge of recovery service-users and family members; II) Collaborate with service-users and the network-identified opinion leaders among providers to tailor Recovery-in-Action Initiatives to fit the needs and resources of a Department of Psychiatry; and III) Conduct a systematic theory-based evaluation of changes in attitudes and practices within the service-user/service-provider partnership group relative to the overall provider network of the department and identify the barriers and supports within the local context.DiscussionOur anticipated outcome is a participatory toolkit to tailor recovery-oriented services, which will be disseminated to the Mental Health Commission of Canada and Accreditation Canada at the federal level, agencies at the provincial levels, and local knowledge end-users.

The Declaration of Helsinki through a feminist lens

This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included (1) a description of feminist research ethics, (2) suggestions for specific revisions to the Declaration, and (3) elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: (1) conceptualizes issues of vulnerability in richer and more nuanced ways, (2) resists the influence of profit motives, and (3) extends the scope of responsibility for ethical research more broadly.1

A patient-centered care ethics analysis model for rehabilitation.

ABSTRACTThere exists a paucity of ethics resources tailored to rehabilitation. To help fill this ethics resource gap, the authors developed an ethics analysis model specifically for use in rehabilitation care. The Patient-Centered Care Ethics Analysis Model for Rehabilitation is a process model to guide careful moral reasoning for particularly complex or challenging matters in rehabilitation. The Patient-Centered Care Ethics Analysis Model for Rehabilitation was developed over several iterations, with feedback at different stages from rehabilitation professionals and bioethics experts. Development of the model was explicitly informed by the theoretical grounding of patient-centered care and the context of rehabilitation, including the International Classification of Functioning, Disability and Health. Being patient centered, the model encourages (1) shared control of consultations, decisions about interventions, and management of the health problems with the patient and (2) understanding the patient as a whole person who has individual preferences situated within social contexts. Although the major process headings of the Patient-Centered Care Ethics Analysis Model for Rehabilitation resemble typical ethical decision-making and problem-solving models, the probes under those headings direct attention to considerations relevant to rehabilitation care. The Patient-Centered Care Ethics Analysis Model for Rehabilitation is a suitable tool for rehabilitation professionals to use (in real time, for retrospective review, and for training purposes) to help arrive at ethical outcomes.

Fresh thinking about the Declaration of Helsinki

A comprehensive approach to ethical research

Research Ethics Review of Drug Trials Targeting Medical Conditions of Pregnant Women

In this chapter we examine ways in which research ethics committees can appropriately conduct ethics review of clinically important trials pertaining to the management of medical conditions of pregnant women. Given the well-documented variability of research ethics committees’ decision-making, it is reasonable to predict variability among committees regarding their reviews and decisions of research involving pregnant women. At least some of this variability is due to a lack of sufficient guidance on the part of national and international research guidelines, which results in a reluctance to approve clinical research involving pregnant women. After summarising the problems inherent in the relevant guidelines, we propose additional considerations and recommendations to guide research ethics committees, researchers, trial sponsors, and funding agencies in the review and oversight of such research.

Contradictions in client-centred discharge planning: through the lens of relational autonomy

Abstract Background: While client-centred practice has received wide support, it remains difficult to apply in many practice settings. Identified barriers include constraints on time, resources, and services imposed by healthcare policies. Healthcare professionals’ prioritizing of client safety over (other) interests that clients may name may further restrict the application of client-centred practice. Discharge planning is one area where such considerations can conflict. Aim: This paper presents a secondary analysis of data examining the process of discharge in one Canadian rehabilitation setting. It examines how discourses of client-centred practice and of prioritizing safety were reflected in discharge planning with older adults and considers the implications of potential conflicts between these discourses. Method: Taking a critical bioethics perspective informed by relational autonomy theory, microethnographic case studies were used to examine discharge planning from the perspectives of older adult clients and healthcare professionals. Results: Healthcare professionals interpreted client-centred practice to require abiding by client wishes, as long as this was safe; furthermore prioritizing safety took precedence over other considerations in discharge planning. Conclusion and significance: Client-centred practice was not promoted in discharge planning processes in the research setting. Applying a relational autonomy lens to practice could promote approaches that better facilitate client-centred practice.