Research Ethics for Clinical Researchers.

This chapter deals with the fundamental principles of ethical research. Although there is particular emphasis on the process of initial ethical review of research, it is important to note that the ethical obligations of researchers continue throughout the entire continuum of the research process. The paramount importance of protecting the privacy and confidentiality of research participants is discussed. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of inclusivity in research is touched upon, and suggestions are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards.

Morbidity and mortality following pelvic ramus fractures in an older Atlantic Canadian cohort

Background: Pelvic ramus fractures in older patients are associated with substantial morbidity and mortality. There is a paucity of literature on fractures of the pelvis in this age group. The purpose of this study was to report mortality rates following such injuries. In addition, we aimed to describe and quantify the important resultant morbidity in this vulnerable population. Methods: We performed a retrospective chart review of all low-energy pelvic ramus fractures in patients more than age 60 years that occurred between January 2000 and December 2005. Data on survival, hospital length of stay, ambulatory status and place of residence were recorded. For comparison, we calculated the mortality rate for a surrogate age- and sex-matched group using Statistics Canada survival data for use as an uninjured control group. Results: We identified 43 patients (32 women [74%]; mean age 79.4 yr) with isolated low-energy pelvic ramus fractures over the study period. The 1- and 5-year mortality rates were 16.3% (95% confidence interval [CI] 7.8%­30.3%) and 58.1% (95% CI 43.3%­71.6%), respectively, both significantly higher than the point estimates for the control group (6.6% and 31.3%, respectively). Following injury, 14/39 patients (36%) permanently required increased ambulatory aids, and 8 (20%) required a permanent increase in everyday level of care. Conclusion: The results suggest that there may be increased mortality and morbidity following low-energy pattern pelvic ramus fractures in an older population compared to age- and sex-matched uninjured control subjects.

Contexte: Les fractures du bassin chez les personnes âgées sont associées à une morbidité et une mortalité substantielles. La littérature sur les fractures du bassin dans ce groupe d'âge est peu abondante. Le but de cette étude était donc de faire état des taux de mortalité suite à de telles blessures. Nous avons aussi voulu décrire et quantifier l'importante morbidité qui en résulte chez cette population vulnérable. Méhodes: Nous avons effectué une revue rétrospective de tous les cas de fractures du bassin consécutives à un traumatisme de faible énergie chez des patients de plus de 60 ans survenues entre janvier 2000 et décembre 2005. Les données de survie, la durée de l'hospitalisation, le statut ambulatoire et le lieu de résidence ont été notées. À des fins de comparaison, nous avons calculé le taux de mortalité pour un groupe témoin indemme assorti selon l'âge et le sexe en nous servant des données de survie de Statistique Canada. Résultats: Nous avons recensé 43 patients (32 femmes [74 %]; âge moyen 79,4 ans) porteurs de fractures du bassin isolées consécutives à un traumatisme de faible énergie pour la période de l'étude. Les taux de mortalité à 1 an et à 5 ans ont été de 16,3 % (intervalle confiance [IC] de 95 % 7,8 %­30,3 %) et 58,1 % (IC de 95 % 43,3 %­71,6 %), respectivement, tous deux significativement plus élevés que les estimations ponctuelles pour le groupe témoin (6,6 % et 31,3 %, respectivement). Après le traumatisme, 14 patients sur 39 (36 %) ont eu besoin de façon permanente et croissante de dispositifs d'aide à la marche et 8 (20 %) ont eu besoin de façon permanente d'un niveau de soins quotidiens accru. Conclusion: Les résultats donnent à penser que la mortalité et la morbidité pourraient être plus marquées après une fracture de la hanche consécutive à un traumatisme de faible énergie chez la population âgée, comparativement à des témoins assortis selon l'âge et le sexe.

Research ethics for clinical researchers.

This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

Research ethics for clinical researchers.

This paper describes the history of the development of modern research ethics. The governance of research ethics varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. Protection of the privacy and confidentiality of research participants is of paramount importance. The process of informed consent and step-by-step practical guidelines are described. The issue of research in vulnerable populations is discussed and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards.

Serial change in echocardiographic parameters and cardiac failure in end-stage renal disease.

Echocardiographic abnormalities are the rule in patients starting dialysis therapy and are associated with the development of cardiac failure and death. It is unknown, however, whether regression of these abnormalities is associated with an improvement in prognosis. As part of a prospective cohort study with mean follow-up of 41 mo, 227 patients had echocardiography at inception and after 1 yr of dialysis therapy. Improvements in left ventricular (LV) mass index, volume index, and fractional shortening were seen in 48, 48, and 46%, respectively. Ninety patients had developed cardiac failure by 1 yr of dialysis therapy. Twenty-six percent of the remaining 137 patients subsequently developed new-onset cardiac failure. The mean changes in LV mass index were 17 g/m(2) in those who subsequently developed cardiac failure compared with 0 g/m(2) among those who did not (P = 0.05). The corresponding values were -8 versus 0% for fractional shortening (P < 0.0001). The associations between serial change in both LV mass index and fractional shortening and subsequent cardiac failure persisted after adjusting for baseline age, diabetes, ischemic heart disease, and the corresponding baseline echocardiographic parameter. Regression of LV abnormalities is associated with an improved cardiac outcome in dialysis patients. Serial echocardiography adds prognostic information to one performed at baseline.