[Show abstract][Hide abstract] ABSTRACT: The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is ”honest, professional disagreement in the community of expert practitioners as to the preferred treatment”. Empirical data are sparse about how clinicians apply the principles of equipoise to the justification of future RCTs. For example, selective decontamination of the digestive tract (SDD) is not widely used in critical care practice despite the strength of the evidence base and therefore provides a unique opportunity to learn how clinicians think about the ethics of further RCTs in critical care.
In an international interview study of views of healthcare professionals about SDD, we undertook a secondary analysis of qualitative data collected using a Theoretical Domains Framework of clinical behaviour. We adopted a general descriptive approach to explore how physicians determined whether another RCT of SDD is ethical. Following a constant comparison approach, three investigators reviewed 54 purposively chosen transcripts from three international regions. We interpreted the data using thematic analysis.
We grouped participants’ responses into four inter-related themes: 1) cultural norms about evidence and practice within healthcare; 2) personal views about what evidence is current or applicable; 3) the interpersonal and relational nature of professional decision making locally; and 4) an a priori commitment to future trials. The analysis also identified several unresolved tensions regarding when a future RCT should be pursued. These tensions focused on a clash between potential benefits to current individual patients and potential future harms to patients more broadly.
Our study suggests that ethical decision making about future RCTs in the field of SDD does not rely strongly on appeals to evidence, even when the quality of the evidence is reasonably high. Rather, “extra-evidential” reasons, including social, professional, and relational factors, seem to influence opinions regarding the ethics of future trials. Further work is required to see if these conclusions are applicable to other clinical topics and settings.
[Show abstract][Hide abstract] ABSTRACT: Background:
The care of patients with severe traumatic brain injury (TBI) is complex and confounded by uncertainty in prognoses. Studies have demonstrated significant unexplained variation in mortality between centers. Possible explanations include differences in the quality and intensity of care across centers, including the appropriateness and timing of withdrawal of life-sustaining therapies. We postulated that centers with a preponderance of early deaths might have a more pessimistic approach to the TBI patient, which would be reflected in an increased hospital TBI-related mortality.
This is a retrospective cohort study. Time to death was used as a proxy for time to withdrawal of life-sustaining therapies. Centers were classified as early or late based on when the majority (75 percentile) of their TBI-related deaths occurred. We evaluated the association between adjusted mortality and center classification using a hierarchical multivariable model. Two hundred trauma centers contributing data to the American College of Surgeons Trauma Quality Improvement Program from 2010 through 2013. The cohort included 17,505 patients with severe isolated TBI.
One hundred and eight centers were classified as early centers. The 75 percentile for time to death was 4 days among early centers versus 7 days in late centers. Mortality was 34% and 33%, respectively. After adjustment for case mix, care in an early center was not associated with increased odds of death (adjusted OR 0.95; 95% CI 0.83-1.09). Higher odds of death were independently associated with age, Glasgow Coma Scale score, head Abbreviated Injury Score, multiple comorbidities, traumatic subarachnoid hemorrhage, intracerebral mass lesions, brainstem lesions and signs of compressed or absent basal cisterns.
Centers rendering early decisions related to withdrawal of life-sustaining therapies in TBI patients, as measured by time until death, do not have worse outcomes than those making later decisions. How and when these decisions are made requires further exploration to balance an opportunity for clinical improvement with appropriate resource utilization.
Level of evidence:
Prognostic and epidemiologic study, level III.
No preview · Article · Nov 2015 · Journal of Trauma and Acute Care Surgery
[Show abstract][Hide abstract] ABSTRACT: This ethnography explores communication around critically ill surgical patients in three surgical intensive care units (ICUs) in Canada. A boundary framework is used to articulate how surgeons', intensivists', and nurses' communication practices shape and are shaped by their respective disciplinary perspectives and experiences. Through 50 hours of observations and 43 interviews, these health care providers are found to engage in seven communication behaviors that either mitigate or magnify three contested symbolic boundaries: expertise, patient ownership, and decisional authority. Where these boundaries are successfully mitigated, experiences of collaborative, high-quality patient care are produced; by contrast, boundary magnification produces conflict and perceptions of unsafe patient care. Findings reveal that high quality and safe patient care are produced through complex social and cultural interactions among surgeons, intensivists, and nurses that are also expressions of knowledge and power. This enhances our understanding of why current quality improvement efforts targeting communication may be ineffective.
No preview · Article · Oct 2015 · Qualitative Health Research
[Show abstract][Hide abstract] ABSTRACT: Patients with the acute respiratory distress syndrome (ARDS) require artificial ventilation but this treatment may produce secondary lung damage. High-frequency oscillatory ventilation (HFOV) may reduce this damage.
To determine the clinical benefit and cost-effectiveness of HFOV in patients with ARDS compared with standard mechanical ventilation.
A parallel, randomised, unblinded clinical trial.
UK intensive care units.
Mechanically ventilated patients with a partial pressure of oxygen in arterial blood/fractional concentration of inspired oxygen (P : F) ratio of 26.7 kPa (200 mmHg) or less and an expected duration of ventilation of at least 2 days at recruitment.
Treatment arm HFOV using a Novalung R100(®) ventilator (Metran Co. Ltd, Saitama, Japan) ventilator until the start of weaning. Control arm Conventional mechanical ventilation using the devices available in the participating centres.
The primary clinical outcome was all-cause mortality at 30 days after randomisation. The primary health economic outcome was the cost per quality-adjusted life-year (QALY) gained.
One hundred and sixty-six of 398 patients (41.7%) randomised to the HFOV group and 163 of 397 patients (41.1%) randomised to the conventional mechanical ventilation group died within 30 days of randomisation (p = 0.85), for an absolute difference of 0.6% [95% confidence interval (CI) -6.1% to 7.5%]. After adjustment for study centre, sex, Acute Physiology and Chronic Health Evaluation II score, and the initial P : F ratio, the odds ratio for survival in the conventional ventilation group was 1.03 (95% CI 0.75 to 1.40; p = 0.87 logistic regression). Survival analysis showed no difference in the probability of survival up to 12 months after randomisation. The average QALY at 1 year in the HFOV group was 0.302 compared to 0.246. This gives an incremental cost-effectiveness ratio (ICER) for the cost to society per QALY of £88,790 and an ICER for the cost to the NHS per QALY of £78,260.
The use of HFOV had no effect on 30-day mortality in adult patients undergoing mechanical ventilation for ARDS and no economic advantage. We suggest that further research into avoiding ventilator-induced lung injury should concentrate on ventilatory strategies other than HFOV.
Current Controlled Trials ISRCTN10416500.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 23. See the NIHR Journals Library website for further project information.
[Show abstract][Hide abstract] ABSTRACT: Purpose
Selective Decontamination of the Digestive tract (SDD) as a prophylactic intervention improves hospital-acquired infection and survival rates. Uptake of SDD is low and remains controversial. This study applied the Theoretical Domains Framework (TDF) to assess ICU clinicians’ views about SDD in regions with limited or no adoption of SDD.
Materials and Methods
Participants were health professionals with ‘decisional authority’ for the adoption of SDD. Semi-structured interviews were conducted as the first round of a Delphi study. Views about SDD adoption, delivery and further SDD research were explored. Directed content analysis of interview data identified sub-themes which informed item development for subsequent Delphi rounds. Linguistic features of interview data were also explored.
141 participants provided interview data. Fifty-six sub-themes were identified; 46 were common across regions. Beliefs about consequences was the most widely elaborated theme. Linguistic features of how participants discussed SDD included caution expressed when discussing the risks and benefits and words such as worry, anxiety and fear when discussing potential antibiotic resistance associated with SDD.
We identified salient beliefs, barriers and facilitators to SDD adoption and delivery. What participants said about SDD and the way in which they said it demonstrated the degree of clinical caution, uncertainty and concern that SDD evokes.
Full-text · Article · Aug 2014 · Journal of critical care
[Show abstract][Hide abstract] ABSTRACT: Background: Abdominal infections are frequent causes of sepsis and septic shock in the intensive care unit (ICU) and are associated with adverse outcomes. We analyzed the characteristics, treatments and outcome of ICU patients with abdominal infections using data extracted from a one-day point prevalence study, the Extended Prevalence of Infection in the ICU (EPIC) II. Methods: EPIC II included 13,796 adult patients from 1,265 ICUs in 75 countries. Infection was defined using the International Sepsis Forum criteria. Microbiological analyses were performed locally. Participating ICUs provided patient follow-up until hospital discharge or for 60 days. Results: Of the 7,087 infected patients, 1,392 (19.6%) had an abdominal infection on the study day (60% male, mean age 62 +/- 16 years, SAPS II score 39 +/- 16, SOFA score 7.6 +/- 4.6). Microbiological cultures were positive in 931 (67%) patients, most commonly Gram-negative bacteria (48.0%). Antibiotics were administered to 1366 (98.1%) patients. Patients who had been in the ICU for <= 2 days prior to the study day had more Escherichia coli, methicillin-sensitive Staphylococcus aureus and anaerobic isolates, and fewer enterococci than patients who had been in the ICU longer. ICU and hospital mortality rates were 29.4% and 36.3%, respectively. ICU mortality was higher in patients with abdominal infections than in those with other infections (29.4% vs. 24.4%, p < 0.001). In multivariable analysis, hematological malignancy, mechanical ventilation, cirrhosis, need for renal replacement therapy and SAPS II score were independently associated with increased mortality. Conclusions: The characteristics, microbiology and antibiotic treatment of abdominal infections in critically ill patients are diverse. Mortality in patients with isolated abdominal infections was higher than in those who had other infections.
[Show abstract][Hide abstract] ABSTRACT: Evidence supporting selective decontamination of the digestive tract (SDD) is reasonably strong. We set out to determine use in UK critical care units and to compare patient outcomes between units that do and those that do not use SDD.
A total of 250 UK general critical care units were surveyed. Case mix, outcomes, and lengths of stay for admissions to SDD units (with and without an i.v. component) and non-SDD units were compared using data from the Intensive Care National Audit & Research Centre Case Mix Programme database.
A response was received from all the 250 critical care units surveyed. Of these, 13 (5.2%) reported using SDD on some or all admissions, and of these, 3 reported using an i.v. component. Data on 284 690 admissions (April 2008-March 2011) from units reporting to the ICNARC Case Mix Programme (CMP) were included in the analyses. Admissions to SDD (n=196) and non-SDD (n=9) units were a similar case mix with similar infection rates and average lengths of stay in the unit and hospital. There was no difference in risk-adjusted unit or hospital mortality. The rate of unit-acquired infections in blood was significantly lower in SDD units using an i.v. component.
Use of SDD in UK critical care is very low. The rate of unit-acquired infections in blood was significantly lower in SDD units using an i.v. component, but did not translate into a difference in acute hospital mortality or length of stay. There is a need to better understand the barriers to adoption of SDD into clinical practice and such work is underway.
Preview · Article · May 2014 · BJA British Journal of Anaesthesia
[Show abstract][Hide abstract] ABSTRACT: Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate.
The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs).
A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research.
Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs.
(1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials.
SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics.
Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates).
(1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial.
There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.
[Show abstract][Hide abstract] ABSTRACT: Percutaneous dilatational tracheostomies have become one of the most frequently performed surgical procedures in the ICU, and are believed to offer a variety of advantages over open tracheostomies, including increased convenience. Recent publications have established that the risk of fatal complications related to the procedure is low. However, clinicians must still weigh these risks against expected but largely unproven benefits. More research is needed to establish the indications for the procedure, including the optimal patient selection and timing during a course of mechanical ventilation. Such studies should also seek to improve our ability to accurately identify which patients will require prolonged mechanical ventilation, and to quantify the potential benefits of tracheostomy compared with prolonged translaryngeal intubation.
No preview · Article · Mar 2014 · Critical care (London, England)
[Show abstract][Hide abstract] ABSTRACT: Background: Bloodstream infections resulting from intravascular catheters (catheter-BSI) in critical care increase patients’ length of stay, morbidity and mortality, and the management of these infections and their complications has been estimated to cost the NHS annually £19.1–36.2M. Catheter-BSI are thought to be largely preventable using educational interventions, but guidance as to which types of intervention might be most clinically effective is lacking.
Objective: To assess the effectiveness and cost-effectiveness of educational interventions for preventing catheter-BSI in critical care units in England.
Data sources: Sixteen electronic bibliographic databases – including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health Literature (CINAHL), NHS Economic Evaluation Database (NHS EED), EMBASE and The Cochrane Library databases – were searched from database inception to February 2011, with searches updated in March 2012. Bibliographies of systematic reviews and related papers were screened and experts contacted to identify any additional references.
Review methods: References were screened independently by two reviewers using a priori selection criteria. A descriptive map was created to summarise the characteristics of relevant studies. Further selection criteria developed in consultation with the project Advisory Group were used to prioritise a subset of studies relevant to NHS practice and policy for systematic review. A decision-analytic economic model was developed to investigate the cost-effectiveness of educational interventions for preventing catheter-BSI.
Results: Seventy-four studies were included in the descriptive map, of which 24 were prioritised for systematic review. Studies have predominantly been conducted in the USA, using single-cohort before-and-after study designs. Diverse types of educational intervention appear effective at reducing the incidence density of catheter-BSI (risk ratios statistically significantly < 1.0), but single lectures were not effective. The economic model showed that implementing an educational intervention in critical care units in England would be cost-effective and potentially cost-saving, with incremental cost-effectiveness ratios under worst-case sensitivity analyses of < £5000/quality-adjusted life-year.
Limitations: Low-quality primary studies cannot definitively prove that the planned interventions were responsible for observed changes in catheter-BSI incidence. Poor reporting gave unclear estimates of risk of bias. Some model parameters were sourced from other locations owing to a lack of UK data.
Conclusions: Our results suggest that it would be cost-effective and may be cost-saving for the NHS to implement educational interventions in critical care units. However, more robust primary studies are needed to exclude the possible influence of secular trends on observed reductions in catheter-BSI.
[Show abstract][Hide abstract] ABSTRACT: Bloodstream infections resulting from intravascular catheters (catheter-BSI) in critical care increase patients' length of stay, morbidity and mortality, and the management of these infections and their complications has been estimated to cost the NHS annually £19.1-36.2M. Catheter-BSI are thought to be largely preventable using educational interventions, but guidance as to which types of intervention might be most clinically effective is lacking.
To assess the effectiveness and cost-effectiveness of educational interventions for preventing catheter-BSI in critical care units in England.
Sixteen electronic bibliographic databases - including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health Literature (CINAHL), NHS Economic Evaluation Database (NHS EED), EMBASE and The Cochrane Library databases - were searched from database inception to February 2011, with searches updated in March 2012. Bibliographies of systematic reviews and related papers were screened and experts contacted to identify any additional references.
References were screened independently by two reviewers using a priori selection criteria. A descriptive map was created to summarise the characteristics of relevant studies. Further selection criteria developed in consultation with the project Advisory Group were used to prioritise a subset of studies relevant to NHS practice and policy for systematic review. A decision-analytic economic model was developed to investigate the cost-effectiveness of educational interventions for preventing catheter-BSI.
Seventy-four studies were included in the descriptive map, of which 24 were prioritised for systematic review. Studies have predominantly been conducted in the USA, using single-cohort before-and-after study designs. Diverse types of educational intervention appear effective at reducing the incidence density of catheter-BSI (risk ratios statistically significantly < 1.0), but single lectures were not effective. The economic model showed that implementing an educational intervention in critical care units in England would be cost-effective and potentially cost-saving, with incremental cost-effectiveness ratios under worst-case sensitivity analyses of < £5000/quality-adjusted life-year.
Low-quality primary studies cannot definitively prove that the planned interventions were responsible for observed changes in catheter-BSI incidence. Poor reporting gave unclear estimates of risk of bias. Some model parameters were sourced from other locations owing to a lack of UK data.
Our results suggest that it would be cost-effective and may be cost-saving for the NHS to implement educational interventions in critical care units. However, more robust primary studies are needed to exclude the possible influence of secular trends on observed reductions in catheter-BSI.
The study is registered with PROSPERO as CRD42012001840.
The National Institute for Health Research Health Technology Assessment programme.
[Show abstract][Hide abstract] ABSTRACT: Effective multidisciplinary teamwork and team leadership have been shown as essential for the safe management of patients in intensive care medicine (ICM). Solutions to improve teamwork and leadership have been developed, but with mixed success. It is observed that to improve teamwork in ICM, interventions must reflect (1) the demands and constraints of ICM, and how they influence team behaviour and (2) the specific teamwork skills and behaviours that are associated with safe patient care. Research in ICM shows that effective team leadership is the key determinant of team functioning, and that interventions should focus on enhancing leadership. Yet, simply applying leadership solutions developed in other domains (e.g. aviation) is not appropriate. Specifically, the flow and nature of work, and the changeable and complex construction of teams, means that tools for improving and assessing leadership need to be designed to reflect the very specific constraints of ICM.
[Show abstract][Hide abstract] ABSTRACT: To describe factors senior critical care nurses identify as being important to address when introducing selective digestive tract decontamination (SDD) in the clinical setting.
Critically ill patients are at risk of developing ventilator-associated pneumonia (VAP). SDD is one strategy shown to prevent VAP and possibly improve survival in the critically ill.
We performed a secondary analysis of qualitative data obtained from 20 interviews. An inductive thematic analysis approach was applied to data obtained from senior critical care nurses during phase two of a multi-methods study.
There were four primary considerations identified that should be addressed or considered prior to implementation of SDD. These considerations included education of health care professionals, patient comfort, compatibility of SDD with existing practices, and cost.
Despite a lack of experience with, or knowledge of SDD, nurses were able to articulate factors that may influence its implementation and delivery. Organizations or researchers considering implementation of SDD should include nurses as key members of the implementation team.
Full-text · Article · Nov 2013 · Heart & lung: the journal of critical care
[Show abstract][Hide abstract] ABSTRACT: Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic regimen that is not widely used in practice. We aimed to describe the opinions of key 'stakeholders' about the validity of the existing evidence base, likely consequences of implementation, relative importance of their opinions in influencing overall practice, likely barriers to implementation and perceptions of the requirement for further research to inform the decision about whether to embark on a further large randomised controlled trial.
This was a Delphi study informed by comprehensive framework of possible determinants of health professionals' behaviour to study Critical Care practice in four countries. There were four key stakeholder participant groups including ICU physicians, pharmacists, clinical leads, and clinical microbiologists/ infectious disease physicians. Round one comprised participant interviews and Rounds two and three were online questionnaires using Delphi method.
In this study, 141 participants were recruited of whom 82% were retained. Participants rated themselves as knowledgeable about SDD. Antibiotic resistance was identified as the most important issue. SDD was seen as a low clinical priority but few participants reported strong opposition. There was moderate agreement that research to date has not adequately addressed concerns about antibiotic resistance and lacks generalizability. Participants indicated equipoise with regard to benefits and harms of SDD, and indicated strong support for a further randomised trial.
Clinicians have clinical equipoise about the effectiveness of SDD. Future research requires longer follow up to assess antibiotic resistance as well as greater validity/generalizability to provide definitive answers on the effectiveness of decontamination and effects on antibiotic resistance. SDD was regarded as not being a high clinical priority, which may limit future trial participation. These results have identified that a further large randomised controlled trial of SDD in critical care is both warranted and appropriate.
Full-text · Article · Nov 2013 · Critical care (London, England)