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1.  Influenza Aerosols in UK Hospitals during the H1N1 (2009) Pandemic – The Risk of Aerosol Generation during Medical Procedures 
PLoS ONE  2013;8(2):e56278.
Nosocomial infection of health-care workers (HCWs) during outbreaks of respiratory infections (e.g. Influenza A H1N1 (2009)) is a significant concern for public health policy makers. World Health Organization (WHO)-defined ‘aerosol generating procedures’ (AGPs) are thought to increase the risk of aerosol transmission to HCWs, but there are presently insufficient data to quantify risk accurately or establish a hierarchy of risk-prone procedures.
Methodology/Principal Findings
This study measured the amount of H1N1 (2009) RNA in aerosols in the vicinity of H1N1 positive patients undergoing AGPs to help quantify the potential risk of transmission to HCWs. There were 99 sampling occasions (windows) producing a total of 198 May stages for analysis in the size ranges 0.86–7.3 µm. Considering stages 2 (4–7.3 µm) and 3 (0.86–4 µm) as comprising one sample, viral RNA was detected in 14 (14.1%) air samples from 10 (25.6%) patients. Twenty three air samples were collected while potential AGPs were being performed of which 6 (26.1%) contained viral RNA; in contrast, 76 May samples were collected when no WHO 2009 defined AGP was being performed of which 8 (10.5%) contained viral RNA (unadjusted OR = 2.84 (95% CI 1.11–7.24) adjusted OR = 4.31 (0.83–22.5)).
With our small sample size we found that AGPs do not significantly increase the probability of sampling an H1N1 (2009) positive aerosol (OR (95% CI) = 4.31 (0.83–22.5). Although the probability of detecting positive H1N1 (2009) positive aerosols when performing various AGPs on intensive care patients above the baseline rate (i.e. in the absence of AGPs) did not reach significance, there was a trend towards hierarchy of AGPs, placing bronchoscopy and respiratory and airway suctioning above baseline (background) values. Further, larger studies are required but these preliminary findings may be of benefit to infection control teams.
PMCID: PMC3571988  PMID: 23418548
2.  Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial 
BMC Neurology  2012;12:74.
Motor neurone disease (MND) is a devastating illness which leads to muscle weakness and death, usually within 2-3 years of symptom onset. Respiratory insufficiency is a common cause of morbidity, particularly in later stages of MND and respiratory complications are the leading cause of mortality in MND patients. Non Invasive Ventilation (NIV) is the current standard therapy to manage respiratory insufficiency. Some MND patients however do not tolerate NIV due to a number of issues including mask interface problems and claustrophobia. In those that do tolerate NIV, eventually respiratory muscle weakness will progress to a point at which intermittent/overnight NIV is ineffective. The NeuRx RA/4 Diaphragm Pacing System was originally developed for patients with respiratory insufficiency and diaphragm paralysis secondary to stable high spinal cord injuries. The DiPALS study will assess the effect of diaphragm pacing (DP) when used to treat patients with MND and respiratory insufficiency.
108 patients will be recruited to the study at 5 sites in the UK. Patients will be randomised to either receive NIV (current standard care) or receive DP in addition to NIV. Study participants will be required to complete outcome measures at 5 follow up time points (2, 3, 6, 9 and 12 months) plus an additional surgery and 1 week post operative visit for those in the DP group. 12 patients (and their carers) from the DP group will also be asked to complete 2 qualitative interviews.
The primary objective of this trial will be to evaluate the effect of Diaphragm Pacing (DP) on survival over the study duration in patients with MND with respiratory muscle weakness. The project is funded by the National Institute for Health Research, Health Technology Assessment (HTA) Programme (project number 09/55/33) and the Motor Neurone Disease Association and the Henry Smith Charity. Trial Registration: Current controlled trials ISRCTN53817913. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.
PMCID: PMC3462709  PMID: 22897892
3.  Tissue sampling methods and standards for vertebrate genomics 
GigaScience  2012;1:8.
The recent rise in speed and efficiency of new sequencing technologies have facilitated high-throughput sequencing, assembly and analyses of genomes, advancing ongoing efforts to analyze genetic sequences across major vertebrate groups. Standardized procedures in acquiring high quality DNA and RNA and establishing cell lines from target species will facilitate these initiatives. We provide a legal and methodological guide according to four standards of acquiring and storing tissue for the Genome 10K Project and similar initiatives as follows: four-star (banked tissue/cell cultures, RNA from multiple types of tissue for transcriptomes, and sufficient flash-frozen tissue for 1 mg of DNA, all from a single individual); three-star (RNA as above and frozen tissue for 1 mg of DNA); two-star (frozen tissue for at least 700 μg of DNA); and one-star (ethanol-preserved tissue for 700 μg of DNA or less of mixed quality). At a minimum, all tissues collected for the Genome 10K and other genomic projects should consider each species’ natural history and follow institutional and legal requirements. Associated documentation should detail as much information as possible about provenance to ensure representative sampling and subsequent sequencing. Hopefully, the procedures outlined here will not only encourage success in the Genome 10K Project but also inspire the adaptation of standards by other genomic projects, including those involving other biota.
PMCID: PMC3626508  PMID: 23587255
Genome 10K; Sequencing; Vertebrates; Genomics; Tissue sampling; Tissue storage; Cell line; Tissue culture; RNA; DNA
4.  The clinical diagnostic accuracy of rapid detection of healthcare-associated bloodstream infection in intensive care using multipathogen real-time PCR technology 
BMJ Open  2011;1(1):e000181.
There is growing interest in the potential utility of real-time PCR in diagnosing bloodstream infection by detecting pathogen DNA in blood samples within a few hours. SeptiFast is a multipathogen probe-based real-time PCR system targeting ribosomal DNA sequences of bacteria and fungi. It detects and identifies the commonest pathogens causing bloodstream infection and has European regulatory approval. The SeptiFast pathogen panel is suited to identifying healthcare-associated bloodstream infection acquired during complex healthcare, and the authors report here the protocol for the first detailed health-technology assessment of multiplex real-time PCR in this setting.
A Phase III multicentre double-blinded diagnostic study will determine the clinical validity of SeptiFast for the rapid detection of healthcare-associated bloodstream infection, against the current service standard of microbiological culture, in an adequately sized population of critically ill adult patients. Results from SeptiFast and standard microbiological culture procedures in each patient will be compared at study conclusion and the metrics of clinical diagnostic accuracy of SeptiFast determined in this population setting. In addition, this study aims to assess further the preliminary evidence that the detection of pathogen DNA in the bloodstream using SeptiFast may have value in identifying the presence of infection elsewhere in the body. Furthermore, differences in circulating immune-inflammatory markers in patient groups differentiated by the presence/absence of culturable pathogens and pathogen DNA will help elucidate further the patho-physiology of infection developing in the critically ill.
Ethics and dissemination
Ethical approval has been granted by the North West 6 Research Ethics Committee (09/H1003/109). Based on the results of this first non-commercial study, independent recommendations will be made to The Department of Health (open-access health technology assessment report) as to whether SeptiFast has sufficient clinical diagnostic accuracy to move forward to efficacy testing during the provision of routine clinical care.
Article summary
Article focus
To highlight the unmet need for accurate and rapid infection diagnostics in the setting of life-threatening infection.
To describe the systematic plans of a clinical diagnostic validity study of a new real-time PCR technology, designed to detect circulating pathogen DNA associated with bloodstream infection.
To describe the clinical standards for sepsis and healthcare-associated infection diagnosis and identify how these standards will be utilised to determine the clinical validity of the new real-time PCR test in critically ill patients.
Key messages
The study will provide the first independent, systematic, clinical validity study of real-time PCR technologies in the focused setting of suspected life-threatening healthcare-associated infections during the provision of routine emergency critical care.
Based on the results of this study, independent recommendations will be made to the UK's Department of Health as to whether the real-time PCR technology has sufficient clinical diagnostic accuracy to move forward to efficacy testing during the provision of routine clinical care.
Strengths and limitations of this study
The study is focused on a carefully delineated clinical cohort at significant risk of developing life-threatening infection.
The study is non-commercial and has been planned systematically by a multidisciplinary team of experts and patient representatives, working on behalf of the key stakeholders within a nationalised healthcare system.
Current clinical infection diagnosis standards may not have a high diagnostic accuracy in all settings and with all infections.
There is a documented high rate of broad-spectrum antimicrobial therapies delivered to critically ill patients empirically which could confound the comparison between culture methods and pathogen DNA-detection methods.
PMCID: PMC3191580  PMID: 22021785
Intensive &critical care; adult intensive & critical care; molecular diagnostics; adult intensive & critical care; adult thoracic medicine; adult surgery; Colorectal surgery; inflammatory bowel disease; Nutritional support; wound management
5.  Mortality predictors are not triage scores 
Thorax  2007;62(11):1015.
PMCID: PMC2117113  PMID: 17965083
6.  Collecting Information About a CAM Practitioner’s Practice: A Preliminary Report of a Self-Interview Methodology 
To prepare allopathic providers to advise patients about complementary and alternative medicine (CAM) therapies, the University of Kentucky CAM curriculum integration project has identified and trained CAM practitioners to coteach, precept, and demonstrate their respective practices. This project is interested in integrating CAM practitioners as teachers into this university and has formed a multidisciplinary committee for advice. The committee has recognized the importance of increased understanding of CAM practices to enhance communication within itself and to decide to which CAM practices students should receive exposure. This article reports our attempt to create a CAM practice description, based on questions general to CAM practice and specific to a particular approach. Because there is limited existing systematic research on CAM practice characteristics, these questions may interest researchers conducting qualitative studies, especially those seeking an example of questions to ask CAM practitioners. We also believe this practice description will be of general interest.
PMCID: PMC2772081  PMID: 19890441
complementary and alternative medicine; practice characteristics; herbs; interview
7.  Can a score derived from the Critical Care Minimum Data Set be used as a marker of organ dysfunction? – a pilot study 
BMC Research Notes  2009;2:77.
The aim of this study was to develop a simple organ score derived from the Critical Care Minimum Data Set (CCMDS) to compare with the Sequential Organ Failure Assessment (SOFA) score, a previously validated score of organ dysfunction.
The CCMDS collects data regarding the support of seven organ systems. To create a CCMDS derived score each level of organ support was allocated a numerical value. SOFA scores were collected retrospectively from each patient in the study. Data was collected in 50 sequential admissions over the first 5 days of their admission. This generated a total of 147 pairs of data for comparison.
Scatter plots and Spearman's rank correlation coefficient suggest a weak positive association between our CCMDS-derived score and the SOFA score. Daily Bland-Altman plots reveal minimal bias between the score but wide limits of agreement.
Our CCMDS-derived score cannot be regarded as an indicator of severity of organ dysfunction and cannot replace SOFA scores when a daily marker of organ dysfunction is required.
PMCID: PMC2688517  PMID: 19419551
8.  National Athletic Trainers' Association Position Statement: Environmental Cold Injuries 
Journal of Athletic Training  2008;43(6):640-658.
To present recommendations for the prevention, recognition, and treatment of environmental cold injuries.
Individuals engaged in sport-related or work-related physical activity in cold, wet, or windy conditions are at risk for environmental cold injuries. An understanding of the physiology and pathophysiology, risk management, recognition, and immediate care of environmental cold injuries is an essential skill for certified athletic trainers and other health care providers working with individuals at risk.
These recommendations are intended to provide certified athletic trainers and others participating in athletic health care with the specific knowledge and problem-solving skills needed to address environmental cold injuries. Each recommendation has been graded (A, B, or C) according to the Strength of Recommendation Taxonomy criterion scale.
PMCID: PMC2582557  PMID: 19030143
environmental physiology; hypothermia; frostbite; frostnip; chilblain; pernio; immersion foot; trench foot
9.  Clinical review: Mass casualty triage – pandemic influenza and critical care 
Critical Care  2007;11(2):212.
Worst case scenarios for pandemic influenza planning in the US involve over 700,000 patients requiring mechanical ventilation. UK planning predicts a 231% occupancy of current level 3 (intensive care unit) bed capacity. Critical care planners need to recognise that mortality is likely to be high and the risk to healthcare workers significant. Contingency planning should, therefore, be multi-faceted, involving a robust health command structure, the facility to expand critical care provision in terms of space, equipment and staff and cohorting of affected patients in the early stages. It should also be recognised that despite this expansion of critical care, demand will exceed supply and a process for triage needs to be developed that is valid, reproducible, transparent and consistent with distributive justice. We advocate the development and validation of physiological scores for use as a triage tool, coupled with candid public discussion of the process.
PMCID: PMC2206465  PMID: 17490495
10.  Physiological-social score (PMEWS) vs. CURB-65 to triage pandemic influenza: a comparative validation study using community-acquired pneumonia as a proxy 
An influenza pandemic may increase Emergency Department attendance 7-fold. In the absence of a validated "flu score" to assess severity and assist triage decisions from primary into secondary care, current UK draft management recommendations have suggested the use of CURB-65 and chest X-ray as a proxy. We developed the Pandemic Medical Early Warning Score (PMEWS) to track and triage flu patients, taking into account physiological and social factors and without requiring laboratory or radiology services.
Validation of the PMEWS score against an unselected group of patients presenting and admitted to an urban UK teaching hospital with community acquired pneumonia. Comparison of PMEWS performance against CURB-65 for three outcome measures: need for admission, admission to high dependency or intensive care, and inpatient mortality using area under ROC curve (AUROC) and the Hanley-McNeil method of comparison.
PMEWS was a better predictor of need for admission (AUROC 0.944) and need of higher level of care (AUROC 0.83) compared with CURB-65 (AUROCs 0.881 and 0.640 respectively) but was not as good a predictor of subsequent inpatient mortality (AUROC 0.663).
Although further validation against other disease datasets as a proxy for pandemic flu is required, we show that PMEWS is rapidly applicable for triage of large numbers of flu patients to self-care, hospital admission or HDU/ICU care. It is scalable to reflect changing admission thresholds that will occur during a pandemic.
PMCID: PMC1819377  PMID: 17328822
11.  More on pneumonia 
BMJ : British Medical Journal  2006;332(7553):1333.
PMCID: PMC1473043  PMID: 16740568

Results 1-12 (12)