Better conduct of clinical trials: the control group in critical care trials

OBJECTIVE: To review trial design issues related to control groups. DESIGN: Review of the literature with specific reference to critical care trials. MAIN RESULTS AND CONCLUSIONS: Performing randomized controlled trials in the critical care setting presents specific problems: studies include patients with rapidly lethal conditions, the majority of intensive care patients suffer from syndromes rather than from well-definable diseases, the severity of such syndromes cannot be precisely assessed, and the treatment consists of interacting therapies. Interactions between physiology, pathophysiology, and therapies are at best marginally understood and may have a major impact on study design and interpretation of results. Selection of the right control group is crucial for the interpretation and clinical implementation of results. Studies comparing new interventions with current ones or different levels of current treatments have the problem of the necessity of defining "usual care." Usual care controls without any constraints typically include substantial heterogeneity. Constraints in the usual therapy may help to reduce some variation. Inclusion of unrestricted usual care groups may help to enhance safety. Practice misalignment is a novel problem in which patients receive a treatment that is the direct opposite of usual care, and occurs when fixed-dose interventions are used in situations where care is normally titrated. Practice misalignment should be considered in the design and interpretation of studies on titrated therapies.

Controversies in the use of hydroxyethyl starch solutions in small animal emergency and critical care

OBJECTIVES: To (1) review the development and medical applications of hydroxyethyl starch (HES) solutions with particular emphasis on its physiochemical properties; (2) critically appraise the available evidence in human and veterinary medicine, and (3) evaluate the potential risks and benefits associated with their use in critically ill small animals. DATA SOURCES: Human and veterinary original research articles, scientific reviews, and textbook sources from 1950 to the present. HUMAN DATA SYNTHESIS: HES solutions have been used extensively in people for over 30 years and ever since its introduction there has been a great deal of debate over its safety and efficacy. Recently, results of seminal trials and meta-analyses showing increased risks related to kidney dysfunction and mortality in septic and critically ill patients, have led to the restriction of HES use in these patient populations by European regulatory authorities. Although the initial ban on the use of HES in Europe has been eased, proof regarding the benefits and safety profile of HES in trauma and surgical patient populations has been requested by these same European regulatory authorities. VETERINARY DATA SYNTHESIS: The veterinary literature is limited mostly to experimental studies and clinical investigations with small populations of patients with short-term end points and there is insufficient evidence to generate recommendations. CONCLUSIONS: Currently, there are no consensus recommendations regarding the use of HES in veterinary medicine. Veterinarians and institutions affected by the HES restrictions have had to critically reassess the risks and benefits related to HES usage based on the available information and sometimes adapt their procedures and policies based on their reassessment. Meanwhile, large, prospective, randomized veterinary studies evaluating HES use are needed to achieve relevant levels of evidence to enable formulation of specific veterinary guidelines.

An automatic critical care urine meter

Nowadays patients admitted to critical care units have most of their physiological parameters measured automatically by sophisticated commercial monitoring devices. More often than not, these devices supervise whether the values of the parameters they measure lie within a pre-established range, and issue warning of deviations from this range by triggering alarms. The automation of measuring and supervising tasks not only discharges the healthcare staff of a considerable workload but also avoids human errors in these repetitive and monotonous tasks. Arguably, the most relevant physiological parameter that is still measured and supervised manually by critical care unit staff is urine output (UO). In this paper we present a patent-pending device that provides continuous and accurate measurements of patient’s UO. The device uses capacitive sensors to take continuous measurements of the height of the column of liquid accumulated in two chambers that make up a plastic container. The first chamber, where the urine inputs, has a small volume. Once it has been filled it overflows into a second bigger chamber. The first chamber provides accurate UO measures of patients whose UO has to be closely supervised, while the second one avoids the need for frequent interventions by the nursing staff to empty the container

A comparative study to evaluate surface microbial contamination associated with copper-containing and stainless steel pens used by nurses in the critical care unit

A clinical study was undertaken to compare the surface microbial contamination associated with pens constructed of either a copper alloy or stainless steel used by nurses on intensive care units. A significantly lower level of microbial contamination was found on the copper alloy pens. Copyright © 2011 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Factors affecting emergency department length of stay of patients admitted to telemetry and critical care units

The purpose of this study was to determine the emergency department (ED) length of stay (LOS) of patients admitted to inpatient telemetry and critical care units and to identify the factors that contribute to a prolonged ED LOS. It also examined whether there was a difference in ED LOS between clients evaluated by an ED physician, an Advanced Registered Nurse Practitioner (ARNP) or a Physician's Assistant (PA).^ A data collection tool was devised and used to record data obtained by retrospectively reviewing 110 charts of patients from this sample. The mean ED LOS was 286.75 minutes. Multiple factors were recorded as affecting the ED LOS of this sample, including: age, diagnosis, consultations, multiple radiographs, pending admission orders, nurse unable to call report/busy, relatives at bedside, observation or stabilization necessary, bed not ready and infusion in progress. No significant difference in ED LOS was noted between subjects initially evaluated by a physician, an ARNP or a PA. ^

Factors associated with critical care nurses' communication with non-communicative patients in the ICU

Hospitalized individuals are isolated from their familiar environment at the onset of illness. Those individuals who are non-communicative are detached from the world and from life, as they previously knew it. Although nurses have long since recognized the importance of communication, patients still report the lack of iy. This study was done to identify factors influencing critical care nurses to communicate with their noncommunicative patients. The overall results of the study indicate that nurses are aware of the importance of verbal communication with patients who may be intubated, paralyzed, unconscious, comatose or neurologically impaired and are not deterred by them. Despite these results, some significant observations emerged identified. CCRN certified nurses and nurses with more years of experience were less likely to have verbal communication with noncommunicative patients. Nurses with children, spouses and those working full-time were more likely to communicate with non-communicative patients.

Using population-based critical care data to evaluate trauma outcomes

Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. Acknowledgements We would like to thank the Scottish Intensive Care Society Audit Group (SICSAG) for providing the data for this study. Mr Jan Jansen is in receipt of an NHS Research Scotland fellowship which includes salary funding.

Using population-based critical care data to evaluate trauma outcomes

Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. Acknowledgements We would like to thank the Scottish Intensive Care Society Audit Group (SICSAG) for providing the data for this study. Mr Jan Jansen is in receipt of an NHS Research Scotland fellowship which includes salary funding.

Fluid resuscitation practice patterns in intensive care units of the USA: a cross-sectional survey of critical care physicians.

BACKGROUND: Fluid resuscitation is a cornerstone of intensive care treatment, yet there is a lack of agreement on how various types of fluids should be used in critically ill patients with different disease states. Therefore, our goal was to investigate the practice patterns of fluid utilization for resuscitation of adult patients in intensive care units (ICUs) within the USA. METHODS: We conducted a cross-sectional online survey of 502 physicians practicing in medical and surgical ICUs. Survey questions were designed to assess clinical decision-making processes for 3 types of patients who need volume expansion: (1) not bleeding and not septic, (2) bleeding but not septic, (3) requiring resuscitation for sepsis. First-choice fluid used in fluid boluses for these 3 patient types was requested from the respondents. Descriptive statistics were performed using a Kruskal-Wallis test to evaluate differences among the physician groups. Follow-up tests, including t tests, were conducted to evaluate differences between ICU types, hospital settings, and bolus volume. RESULTS: Fluid resuscitation varied with respect to preferences for the factors to determine volume status and preferences for fluid types. The 3 most frequently preferred volume indicators were blood pressure, urine output, and central venous pressure. Regardless of the patient type, the most preferred fluid type was crystalloid, followed by 5 % albumin and then 6 % hydroxyethyl starches (HES) 450/0.70 and 6 % HES 600/0.75. Surprisingly, up to 10 % of physicians still chose HES as the first choice of fluid for resuscitation in sepsis. The clinical specialty and the practice setting of the treating physicians also influenced fluid choices. CONCLUSIONS: Practice patterns of fluid resuscitation varied in the USA, depending on patient characteristics, clinical specialties, and practice settings of the treating physicians.

Health-related quality of life: implications for critical care interventional studies and why we need to collaborate with patients.

Purpose of review: Health-related quality of life (HRQoL) is an important patient-reported outcome measure following critical illness. ‘Validated’ and professionally endorsed generic measures are widely used to evaluate critical care intervention and guide practice, policy and research. Although recognizing that they are ‘here to stay’, leading QoL researchers are beginning to question their ‘fitness for purpose’. It is therefore timely to review critiques of their limitations in the wider healthcare and social science literatures and to examine the implications for critical care research including, in particular, emerging interventional studies in which HRQoL is the primary outcome of interest. Recent findings: Generic HRQoL measures have provided important yet limited insights into HRQoL among survivors of critical illness. They are rarely developed or validated in collaboration with patients and cannot therefore be assumed to reflect their experiences and perspectives. Summary: Collaboration with patients is advocated in order to improve the interpretation and utility of such data. Failure to do so may result in important study effects being overlooked and the dismissal of potentially useful interventions.

Intensive care survivors’ experiences of ward-based care: Meleis’ theory of nursing transitions and role development among critical care outreach services.

Aims and objectives. To explore the psychosocial needs of patients discharged from intensive care, the extent to which they are captured using existing theory on transitions in care and the potential role development of critical care outreach, follow-up and liaison services. Background. Intensive care patients are at an increased risk of adverse events, deterioration or death following ward transfer. Nurse-led critical care outreach, follow-up or liaison services have been adopted internationally to prevent these potentially avoidable sequelae. The need to provide patients with psychosocial support during the transition to ward-based care has also been identified, but the evidence base for role development is currently limited. Design and methods. Twenty participants were invited to discuss their experiences of ward-based care as part of a broader study on recovery following prolonged critical illness. Psychosocial distress was a prominent feature of their accounts, prompting secondary data analysis using Meleis et al.’s mid-range theory on experiencing transitions. Results. Participants described a sense of disconnection in relation to profound debilitation and dependency and were often distressed by a perceived lack of understanding, indifference or insensitivity among ward staff to their basic care needs. Negotiating the transition between dependence and independence was identified as a significant source of distress following ward transfer. Participants varied in the extent to which they were able to express their needs and negotiate recovery within professionally mediated boundaries. Conclusion. These data provide new insights into the putative origins of the psychosocial distress that patients experience following ward transfer. Relevance to clinical practice. Meleis et al.’s work has resonance in terms of explicating intensive care patients’ experiences of psychosocial distress throughout the transition to general ward–based care, such that the future role development of critical care outreach, follow-up and liaison services may be more theoretically informed.

Plain reasons why neither Dr. Watts' Imitations of the Psalms, nor his other poems, nor any other human composition, ought to be used in the praises of the great God our Saviour--but, that a metre version of the book of Psalms, examined, with wise and critical care by pious and learned divines, and found by them to be as near the Hebrew metre Psalms, as the idiom of the English language would admit, ought to be used.

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