Thin line between research and audit

Choo, Vivien

doi:10.1016/s0140-6736(05)60461-8

Cited by 28 publications

(16 citation statements)

References 11 publications

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“…[67][68][69] Cognitive impairment occurs in 10-40% of patients in the final months and in up to 85% of patients in the last days of life. 68,70 Cognitive impairment may be difficult to identify in palliative care research because decision-making capacity varies over time, 71 and because impairment may result from the experimental or therapeutic medications themselves, such as opioids, benzodiazepines, or corticosteroids. Investigators who conduct trials of medications will encounter these challenges even more frequently if trials are designed to evaluate treatments for delirium, for which cognitive impairment is an inclusion criterion.…”

Section: Ethics In End-of-life Care and Research S-155mentioning

confidence: 99%

Ethical Considerations in End-of-Life Care and Research

Casarett

2005

Journal of Palliative Medicine

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The goal of good palliative care is to relieve suffering and to improve quality of life. However, it is clear that access to palliative care is inconsistent. At least in part, these deficiencies exist because of a lack of solid evidence on which to base clinical decisions. Therefore, there is an urgent need for research that can define the standard of care and can increase access to quality care. This paper discusses six ethical aspects of end-of-life research that investigators and clinicians should consider in designing and conducting palliative care research. These include: (1) whether a study is research or quality improvement; (2) the study's potential benefits to future patients; (3) the study's potential benefits to subjects; (4) the study's risks to subjects; (5) subjects' decision-making capacity; and (6) the voluntariness of subjects' choices to participate in research.

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Section: Ethics In End-of-life Care and Research S-155mentioning

confidence: 99%

Ethical Considerations in End-of-Life Care and Research

Casarett

2005

Journal of Palliative Medicine

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“…Differentiating between research and audit can be difficult 2,3,4 . We considered studies that generated new knowledge as research and studies that brought about improvement in standard of care as audits and concluded that several research projects were in fact audits.…”

Section: Discussionmentioning

confidence: 99%

A profile of research presented at the Sri Lanka College of Paediatricians (1997- 2007)

Senanayake

Karunarathne²,

Chathurangana³

2011

Sri Lanka J Child Health

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The main forum at which paediatricians in Sri Lanka disseminate their research findings is provided by the annual scientific sessions of the Sri Lanka College of Paediatricians (SLCP). Peer reviewed research papers, published in abstract form provided us with a ready resource for identifying priorities and trends in research, carried out locally. We describe a profile of research, which was presented at the SLCP, between 1997 and 2007. ObjectivesTo identify research topics, research methodologies and institutional affiliations of authors whose work was presented at the SLCP from 1997 to 2007. MethodA descriptive retrospective study was undertaken of oral and poster presentations published in abstract form by the SLCP from 1997 to 2007. A database created using SPSS version 15.0 helped analyze study design, setting, data collection method, topic of study, authorship, institutional affiliations, international collaboration, ethical approval and the subsequent publication rate. Categorization of projects into audits and research was attempted using NICE guidelines 1 . ResultsTen scientific sessions were held during the eleven years under study. This included two international conventions hosted by the SLCP. Of a total of 298 published abstracts, 278 were based on research projects and 20 were case series. Plenary lectures were excluded.Cross sectional descriptive observational surveys were the commonest study design (233/278) and _________________________________________ Three fourths (211/278) of the studies were hospital based and a fifth (55/278) was community based. Of the 55 community based studies 20 (36%) were conducted in school settings.Teaching hospitals were the setting for most of the hospital based studies (180/211) and research subjects were hospitalized patients 177 (84%), clinic patients (from specialized clinics or accident and emergency departments) and health care personnel (doctors, nurses, family health workers and medical students). The latter comprised the research subjects in 12 (4%) studies.Data was quantitative (57%) and qualitative (43%); and was collected using questionnaires 167 (60%) either self administered 127 (76%), or interviewer administered 40 (24%). Postal questionnaires and telephone interviews were not employed to collect information. Hospital records were the source of data in 40 (14%) of studies.Outcome measures were clinical features 55 (20%), biochemical or microbiological results 16 (6%), growth parameters, morbidity patterns, student performance and patient's responses. Interventional studies were few and involved behaviour modification (2), assessment of body composition (2), pain relief (2) and therapeutic regimes (5).

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“…Review bodies that have been envisaged for student research include, for example, specific inner-departmental review processes for undergraduate student projects (CIhR et al, 1998(CIhR et al, /2005 Frequently, exemptions or alternative fast-track review pathways are in place for certain low-risk research protocols with non-vulnerable populations, the parameters of which are discussed in some detail by relevant REC guidelines (CIhR et al, 1998(CIhR et al, /2005hhS, 2005;ICB, 2004;NhMRC, 2007;WhO, 2000). The distinction between research, on the one hand, and audit, quality improvement or evaluation, on the other, together with the question of the inclusion or exclusion of the latter in the ethics review process, has been another issue that has received significant attention (Candib, 2007;Casarett et al, 2000;Choo, 1998;Cretin et al, 2000;Doyal, 1997 andGrady, 2007;hauswald, 2002;Lynn, 2004;Mold and Peterson, 2005;NEaC, 2003;NhMRC, 2003b;Perneger, 2004;Prideaux and Rogers, 2006;Wilson et al, 1999). Similar questions have been raised regarding research into medical education (Brown et al, 2007).…”

Section: Remit Workload and Functions Of International Recsmentioning

confidence: 99%