Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial.

INTRODUCTION: There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial. METHODS: We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios [HR] were calculated using Cox regression. RESULTS: In patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant. CONCLUSIONS: In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.

Relationship-centred care: antidote, guidepost or blind alley? The epistemology of 21st century health care.

Contemporary health care is increasing in complexity and lacks a unifying understanding of epistemology, methodology and goals. Lack of conceptual consistency in concepts such as 'patient-centred care' (PCC) typifies system-wide discordance. We contrast the fragmented descriptions of PCC and related tools to its own origins in the writings of Balint and to a subsequent construct, relationship-centred care (RCC). We identify the explicit and elaborated connection between RCC and a defined epistemological foundation as a distinguishing feature of the construct and we demonstrate that this makes possible the recognition of alignments between RCC and independently developed constructs. Among these, we emphasize Schon's reflective practice, Nonaka's theory of organizational knowledge creation and the research methodology of realist synthesis. We highlight the relational principles common to these domains and to their common epistemologies and illustrate unsatisfying consequences of adherence to less adequate epistemological frameworks such as positivism. We offer RCC not as an 'antidote' to the dilemmas identified at the outset but as an example that illuminates the value and importance of explicit identification of the premises and assumptions underlying approaches to improvement of the health care system. We stress the potential value of identifying epistemological affinities across otherwise disparate fields and disciplines.