Dataset Information

Ancillary Care: From Theory to Practice in International Clinical Research.

ABSTRACT: How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research on the Shoklo Malaria Research Unit's (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU's dual role as a research unit and medical non-governmental organization.

SUBMITTER: Pratt B

PROVIDER: S-EPMC3712402 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Ancillary Care: From Theory to Practice in International Clinical Research.

Pratt Bridget B Zion Deborah D Lwin Khin Maung KM Cheah Phaik Yeong PY Nosten Francois F Loff Bebe B

Public health ethics 20130613 2

How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international <i>clinical</i> research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger's health capability paradigm requires the delivery of ancillary care to trial participants for a limited subs ...[more]

PMID: 23864908

Similar Datasets

Project description:Background Management of schizophrenia is sub-optimal in many patients. Targeting negative symptoms, among the most debilitating aspects of schizophrenia, together with positive symptoms, can result in significant functional benefits and dramatically improve quality of life for patients and their carers. Cariprazine, a partial agonist of the dopamine receptors D2/D3 has demonstrated effectiveness across symptom domains in clinical trials, particularly on negative symptoms. Objective To obtain a broader insight from clinicians with specific experience with cariprazine, on how it affects patient populations outside the clinical trial setting. Methods The panel addressed a series of psychopharmacologic topics not comprehensively addressed by the evidence-based literature, including characteristics of patients treated, dosing and switching strategies, duration of therapy, role of concomitant medications and tolerability as well as recommendations on how to individualize cariprazine treatment for patients with schizophrenia. Results Patients recommended for cariprazine treatment are those with first episodes of psychosis, predominant negative symptoms (maintenance/acute phase) and significant side effects (metabolic side effects, hyperprolactinemia, sedation) with other antipsychotics. When the long-term treatment of a lifetime illness is adequately weighted, cariprazine becomes one of the first-line medications, not only for patients with predominant negative symptoms but also for those with relatively severe positive symptoms, especially if they are at the first episodes and if a specific medication is added for symptoms such as agitation or insomnia. For instance, patients with agitation may also benefit from the combination of cariprazine and a benzodiazepine or another sedating agent. Cariprazine may be prescribed as add-on to medications such as clozapine, when that medication alone is ineffective for negative symptoms, and sometimes the first may be discontinued or its dose lowered, after a period of stability, leaving the patient on a better tolerated antipsychotic regimen. Conclusions Based on real-world clinical experience, the panel considered that cariprazine, with its distinct advantages including pharmacokinetics/pharmacodynamics, good efficacy and tolerability, represents a drug of choice in the long-term management of schizophrenia not only for patients with predominant negative symptoms but also for those with positive symptoms.

Project description:BackgroundJuvenile dermatomyositis (JDM) is a rare but severe autoimmune inflammatory myositis of childhood. International collaboration is essential in order to undertake clinical trials, understand the disease and improve long-term outcome. The aim of this study was to propose from existing collaborative initiatives a preliminary minimal dataset for JDM. This will form the basis of the future development of an international consensus-approved minimum core dataset to be used both in clinical care and inform research, allowing integration of data between centres.MethodsA working group of internationally-representative JDM experts was formed to develop a provisional minimal dataset. Clinical and laboratory variables contained within current national and international collaborative databases of patients with idiopathic inflammatory myopathies were scrutinised. Judgements were informed by published literature and a more detailed analysis of the Juvenile Dermatomyositis Cohort Biomarker Study and Repository, UK and Ireland.ResultsA provisional minimal JDM dataset has been produced, with an associated glossary of definitions. The provisional minimal dataset will request information at time of patient diagnosis and during on-going prospective follow up. At time of patient diagnosis, information will be requested on patient demographics, diagnostic criteria and treatments given prior to diagnosis. During on-going prospective follow-up, variables will include the presence of active muscle or skin disease, major organ involvement or constitutional symptoms, investigations, treatment, physician global assessments and patient reported outcome measures.ConclusionsAn internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. This preliminary dataset can now be developed into a consensus-approved minimum core dataset and tested in a wider setting with the aim of achieving international agreement.

Project description:Objectives: In several high-income countries, family-focused practice programs have been introduced in adult mental health care settings to identify and support children whose parents live with mental health problems. Whilst their common goal is to reduce the impact of parental mental illness on children, the mechanisms by which they improve outcomes in different systems and settings are less well known. This kind of knowledge can importantly contribute to ensuring that practice programs achieve pre-defined impacts. Methods: The aim of this study was to develop knowledge about relationships between contextual factors, mechanisms and impact that could inform a program theory for developing, implementing, and evaluating family-focused practice. Principles of a realist evaluation approach and complex system thinking were used to conceptualize the design of semi-structured in-depth interviews with individuals who led the implementation of programs. Seventeen individuals from eight countries participated in the study. Results: Interviewees provided rich accounts of the components that programs should include, contextual factors in which they operated, as well as the behavior changes in practitioners that programs needed to achieve. Together with information from the literature, we developed an initial program theory, which illustrates the interconnectedness between changes that need to co-occur in practitioners, parents, and children, many of which related to a more open communication about parental mental health problems. Stigma, risk-focused and fragmented health systems, and a lack of management commitment were the root causes explaining, for example, why conversations about parents' mental illness did not take place, or not in a way that they could help children. Enabling practitioners to focus on parents' strengths was assumed to trigger changes in knowledge, emotions and behaviors in parents that would subsequently benefit children, by reducing feelings of guilt and improving self-esteem. Conclusion: To our knowledge, this is the first research, which synthesizes knowledge about how family-focused practice programs works in a way that it can inform the design, implementation, and evaluation of programs. Stakeholder, who fund, design, implement or evaluate programs should start co-developing and using program theories like the one presented in this paper to strengthen the design and delivery of family-focused practice.

Dataset Information

Ancillary Care: From Theory to Practice in International Clinical Research.

Publications

Ancillary Care: From Theory to Practice in International Clinical Research.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets