The PETRA (Perinatal Emergency Team Response Assessment) Scale: A High-Fidelity Simulation Validation Study.

OBJECTIVE: The objective of this study was to establish the validity and reliability of a new interdisciplinary teamwork assessment scale, the Perinatal Emergency Team Response Assessment (PETRA), to assess team dynamics during a simulated obstetric crisis. METHODS: This observational cohort study was conducted using high-fidelity simulation and multidisciplinary obstetric teams in order to evaluate the validity and reliability of the previously developed PETRA scale for the assessment of teamwork in the management of obstetric crises. Two high-fidelity simulations of preeclampsia and postpartum hemorrhage (PPH) were conducted 50 times; 42 were performed by multidisciplinary teams and eight (four "good," four "poor") were performed by actors. Five raters used the PETRA tool to assess the simulation video recordings. Three additional raters assessed each performance without the use of PETRA as "good" or "poor" in order to provide an overall rating (referred to as the standardized score). The primary outcome measure was the PETRA score. Cronbach's alpha and intra-class correlation coefficients (2,1) with 95% CIs were calculated to examine internal consistency of the scale and level of agreement among raters, respectively. Construct validity was established by comparing the assessments of the raters with the standardized scores. Generalizability theory analysis was performed to demonstrate PETRA's reliability and to investigate the sources of variation in scores. RESULTS: The simulated emergencies were performed by 119 participants. There was overall high consistency (Cronbach's alpha [95% CI] 0.984 [0.981 to 0.987]) and moderate agreement (intra-class correlation coefficients [95% CI] 0.49 [0.35 to 0.63]) among raters. Significantly higher PETRA scores (mean [standard deviation]) were recorded with "good" versus "poor" performing teams (real scenarios 3.8 [0.7] vs. 2.9 [0.7]; P < 0.001; acted scenarios 4.7 [0.5] vs. 2.2 [0.7]; P < 0.001), suggesting strong construct validity. The overall PETRA scores were not different between the PPH (3.7 [0.7]) and preeclampsia (3.7 [0.8]) scenarios (P = 0.49). Generalizability coefficients were 0.83 for PPH and 0.76 for preeclampsia. CONCLUSION: PETRA is a valid and reliable scale that may be a valuable tool in the assessment and training of multidisciplinary teams in their management of obstetric crises.

Systematic review, meta-analysis and economic modelling of molecular diagnostic tests for antibiotic resistance in tuberculosis.

BACKGROUND: Drug-resistant tuberculosis (TB), especially multidrug-resistant (MDR, resistance to rifampicin and isoniazid) disease, is associated with a worse patient outcome. Drug resistance diagnosed using microbiological culture takes days to weeks, as TB bacteria grow slowly. Rapid molecular tests for drug resistance detection (1 day) are commercially available and may promote faster initiation of appropriate treatment. OBJECTIVES: To (1) conduct a systematic review of evidence regarding diagnostic accuracy of molecular genetic tests for drug resistance, (2) conduct a health-economic evaluation of screening and diagnostic strategies, including comparison of alternative models of service provision and assessment of the value of targeting rapid testing at high-risk subgroups, and (3) construct a transmission-dynamic mathematical model that translates the estimates of diagnostic accuracy into estimates of clinical impact. REVIEW METHODS AND DATA SOURCES: A standardised search strategy identified relevant studies from EMBASE, PubMed, MEDLINE, Bioscience Information Service (BIOSIS), System for Information on Grey Literature in Europe Social Policy & Practice (SIGLE) and Web of Science, published between 1 January 2000 and 15 August 2013. Additional 'grey' sources were included. Quality was assessed using quality assessment of diagnostic accuracy studies version 2 (QUADAS-2). For each diagnostic strategy and population subgroup, a care pathway was constructed to specify which medical treatments and health services that individuals would receive from presentation to the point where they either did or did not complete TB treatment successfully. A total cost was estimated from a health service perspective for each care pathway, and the health impact was estimated in terms of the mean discounted quality-adjusted life-years (QALYs) lost as a result of disease and treatment. Costs and QALYs were both discounted at 3.5% per year. An integrated transmission-dynamic and economic model was used to evaluate the cost-effectiveness of introducing rapid molecular testing (in addition to culture and drug sensitivity testing). Probabilistic sensitivity analysis was performed to evaluate the impact on cost-effectiveness of diagnostic and treatment time delays, diagnosis and treatment costs, and associated QALYs. RESULTS: A total of 8922 titles and abstracts were identified, with 557 papers being potentially eligible. Of these, 56 studies contained sufficient test information for analysis. All three commercial tests performed well when detecting drug resistance in clinical samples, although with evidence of heterogeneity between studies. Pooled sensitivity for GenoType® MTBDRplus (Hain Lifescience, Nehren, Germany) (isoniazid and rifampicin resistance), INNO-LiPA Rif.TB® (Fujirebio Europe, Ghent, Belgium) (rifampicin resistance) and Xpert® MTB/RIF (Cepheid Inc., Sunnyvale, CA, USA) (rifampicin resistance) was 83.4%, 94.6%, 95.4% and 96.8%, respectively; equivalent pooled specificity was 99.6%, 98.2%, 99.7% and 98.4%, respectively. Results of the transmission model suggest that all of the rapid assays considered here, if added to the current diagnostic pathway, would be cost-saving and achieve a reduction in expected QALY loss compared with current practice. GenoType MTBDRplus appeared to be the most cost-effective of the rapid tests in the South Asian population, although results were similar for GeneXpert. In all other scenarios GeneXpert appeared to be the most cost-effective strategy. CONCLUSIONS: Rapid molecular tests for rifampicin and isoniazid resistance were sensitive and specific. They may also be cost-effective when added to culture drug susceptibility testing in the UK. There is global interest in point-of-care testing and further work is needed to review the performance of emerging tests and the wider health-economic impact of decentralised testing in clinics and primary care, as well as non-health-care settings, such as shelters and prisons. STUDY REGISTRATION: This study is registered as PROSPERO CRD42011001537. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Funding infectious disease research: a systematic analysis of UK research investments by funders 1997-2010.

BACKGROUND: Research investments are essential to address the burden of disease, however allocation of limited resources is poorly documented. We systematically reviewed the investments awarded by funding organisations to UK institutions and their global partners for infectious disease research. METHODOLOGY/PRINCIPAL FINDINGS: Public and philanthropic investments for the period 1997 to 2010 were included. We categorised studies by infectious disease, cross-cutting theme, and by research and development value chain, reflecting the type of science. We identified 6165 funded studies, with a total research investment of UK £2.6 billion. Public organisations provided £1.4 billion (54.0%) of investments compared with £1.1 billion (42.4%) by philanthropic organisations. Global health studies represented an investment of £928 million (35.7%). The Wellcome Trust was the leading investor with £688 million (26.5%), closely followed by the UK Medical Research Council (MRC) with £673 million (25.9%). Funding over time was volatile, ranging from ∼£40 million to ∼£160 million per year for philanthropic organisations and ∼£30 million to ∼£230 million for public funders. CONCLUSIONS/SIGNIFICANCE: Infectious disease research funding requires global coordination and strategic long-term vision. Our analysis demonstrates the diversity and inconsistent patterns in investment, with volatility in annual funding amounts and limited investment for product development and clinical trials.

Investments in respiratory infectious disease research 1997-2010: a systematic analysis of UK funding.

OBJECTIVES: Respiratory infections are responsible for a large global burden of disease. We assessed the public and philanthropic investments awarded to UK institutions for respiratory infectious disease research to identify areas of underinvestment. We aimed to identify projects and categorise them by pathogen, disease and position along the research and development value chain. SETTING: The UK. PARTICIPANTS: Institutions that host and carry out infectious disease research. PRIMARY AND SECONDARY OUTCOME MEASURES: The total amount spent and number of studies with a focus on several different respiratory pathogens or diseases, and to correlate these against the global burden of disease; also the total amount spent and number of studies relating to the type of science, the predominant funder in each category and the mean and median award size. RESULTS: We identified 6165 infectious disease studies with a total investment of £2·6 billion. Respiratory research received £419 million (16.1%) across 1192 (19.3%) studies. The Wellcome Trust provided greatest investment (£135.2 million; 32.3%). Tuberculosis received £155 million (37.1%), influenza £80 million (19.1%) and pneumonia £27.8 million (6.6%). Despite high burden, there was relatively little investment in vaccine-preventable diseases including diphtheria (£0.1 million, 0.03%), measles (£5.0 million, 1.2%) and drug-resistant tuberculosis. There were 802 preclinical studies (67.3%) receiving £273 million (65.2%), while implementation research received £81 million (19.3%) across 274 studies (23%). There were comparatively few phase I-IV trials or product development studies. Global health research received £68.3 million (16.3%). Relative investment was strongly correlated with 2010 disease burden. CONCLUSIONS: The UK predominantly funds preclinical science. Tuberculosis is the most studied respiratory disease. The high global burden of pneumonia-related disease warrants greater investment than it has historically received. Other priority areas include antimicrobial resistance (particularly within tuberculosis), economics and proactive investments for emerging infectious threats.

Systematic analysis of funding awarded for antimicrobial resistance research to institutions in the UK, 1997-2010.

OBJECTIVES: To assess the level of research funding awarded to UK institutions specifically for antimicrobial resistance-related research and how closely the topics funded relate to the clinical and public health burden of resistance. METHODS: Databases and web sites were systematically searched for information on how infectious disease research studies were funded for the period 1997-2010. Studies specifically related to antimicrobial resistance, including bacteriology, virology, mycology and parasitology research, were identified and categorized in terms of funding by pathogen and disease and by a research and development value chain describing the type of science. RESULTS: The overall dataset included 6165 studies receiving a total investment of £2.6 billion, of which £102 million was directed towards antimicrobial resistance research (5.5% of total studies, 3.9% of total spend). Of 337 resistance-related projects, 175 studies focused on bacteriology (40.2% of total resistance-related spending), 42 focused on antiviral resistance (17.2% of funding) and 51 focused on parasitology (27.4% of funding). Mean annual funding ranged from £1.9 million in 1997 to £22.1 million in 2009. CONCLUSIONS: Despite the fact that the emergence of antimicrobial resistance threatens our future ability to treat many infections, the proportion of the UK infection-research spend targeting this important area is small. There are encouraging signs of increased investment in this area, but it is important that this is sustained and targeted at areas of projected greatest burden. Two areas of particular concern requiring more investment are tuberculosis and multidrug-resistant Gram-negative bacteria.

UK investments in global infectious disease research 1997-2010: a case study.

BACKGROUND: Infectious diseases account for 15 million deaths per year worldwide, and disproportionately affect young people, elderly people, and the poorest sections of society. We aimed to describe the investments awarded to UK institutions for infectious disease research. METHODS: We systematically searched databases and websites for information on research studies from funding institutions and created a comprehensive database of infectious disease research projects for the period 1997-2010. We categorised studies and funding by disease, cross-cutting theme, and by a research and development value chain describing the type of science. Regression analyses were reported with Spearman's rank correlation coefficient to establish the relation between research investment, mortality, and disease burden as measured by disability-adjusted life years (DALYs). FINDINGS: We identified 6170 funded studies, with a total research investment of UK£2·6 billion. Studies with a clear global health component represented 35·6% of all funding (£927 million). By disease, HIV received £461 million (17·7%), malaria £346 million (13·3%), tuberculosis £149 million (5·7%), influenza £80 million (3·1%), and hepatitis C £60 million (2·3%). We compared funding with disease burden (DALYs and mortality) to show low levels of investment relative to burden for gastrointestinal infections (£254 million, 9·7%), some neglected tropical diseases (£184 million, 7·1%), and antimicrobial resistance (£96 million, 3·7%). Virology was the highest funded category (£1 billion, 38·4%). Leading funding sources were the Wellcome Trust (£688 million, 26·4%) and the Medical Research Council (£673 million, 25·8%). INTERPRETATION: Research funding has to be aligned with prevailing and projected global infectious disease burden. Funding agencies and industry need to openly document their research investments to redress any inequities in resource allocation. FUNDING: None.

Unanticipated difficult airway in obstetric patients: development of a new algorithm for formative assessment in high-fidelity simulation.

BACKGROUND: The objective of this study was to develop a consensus-based algorithm for the management of the unanticipated difficult airway in obstetrics, and to use this algorithm for the assessment of anesthesia residents' performance during high-fidelity simulation. METHODS: An algorithm for unanticipated difficult airway in obstetrics, outlining the management of six generic clinical situations of "can and cannot ventilate" possibilities in three clinical contexts: elective cesarean section, emergency cesarean section for fetal distress, and emergency cesarean section for maternal distress, was used to create a critical skills checklist. The authors used four of these scenarios for high-fidelity simulation for residents. Their critical and crisis resource management skills were assessed independently by three raters using their checklist and the Ottawa Global rating scale. RESULTS: Sixteen residents participated. The checklist scores ranged from 64-80% and improved from scenario 1 to 4. Overall Global rating scale scores were marginal and not significantly different between scenarios. The intraclass correlation coefficient of 0.69 (95% CI: 0.58, 0.78) represents a good interrater reliability for the checklist. Multiple critical errors were identified, the most common being not calling for help or a difficult airway cart. CONCLUSIONS: Aside from identifying common critical errors, the authors noted that the residents' performance was poorest in two of our scenarios: "fetal distress and cannot intubate, cannot ventilate" and "maternal distress and cannot intubate, but can ventilate." More teaching emphasis may be warranted to avoid commonly identified critical errors and to improve overall management. Our study also suggests a potential for experiential learning with successive simulations.

Assessment of the validity of HLD (CalMod) in identifying orthodontic treatment need.

OBJECTIVE: The purpose of this study was to assess the validity of the Handicapped Labio-Lingual Deviation index with California modifications, HLD (CalMod), in identifying handicapping malocclusions. METHODS: A set of 153 study casts representing all types of malocclusion was utilized in this study. Models were randomly chosen the UCSF Division of Orthodontics clinic. Treatment need was determined by the HLD (CalMod) index and by a panel of 13 orthodontists, conventionally established as the 'gold standard'. Spearman Rank correlation analysis was used to evaluate the correlation between HLD (CalMod) and the gold standard. The Classification and Regression Tree (CART) modeling was used to determine the HLD (CalMod) cut-off point of orthodontic treatment need according to the gold standard. RESULTS: A Spearman Rank correlation Coefficient of 0.71 demonstrated a moderately high correlation between HLD (CalMod) and the gold standard. The CART modeling determined a value of 18.5 as the cut-off point of HLD (CalMod) for orthodontic treatment need, considerably lower than the cut-off point of 26 currently used by Medi-Cal. At a value of 26 points as the cut-off HLD (CalMod) displayed a low sensitivity (25.9%) and high specificity (96.8%).With a cut-off point of 18.5, specificity decreased to 55.6% while sensitivity increased dramatically to 92.9%. CONCLUSION: Our results show that the HLD (CalMod) with a cut-off point of 26 fails to indentify a considerable percentage of handicapping malocclusions. More studies should be done assessing the efficacy of the HLD (CalMod) in identifying handicapping malocclusion.

A case study exploring the ethical and policy dimensions of allocating acute care resources to a dying patient.

AIMS: We aimed to identify policy, process and ethical issues related to allocation of National Health Service resources when patients with end-of-life illness are referred to acute care services. BACKGROUND: Sharing healthcare decisions denotes a different partnership between professionals and patients when patients are empowered to define their needs. Implementation of a transition from professional to patient decision-making appears to be dependent upon its interpretation by personnel delivering care using the local trust policy. The outcome of this is a reformation of responsibility for budget allocation, choice of acute care provider and selecting services, currently in the realm of primary care; be it the general practitioner, community practitioners, or the patient. DESIGN: We used a 'lens' approach to case study analysis in which the lens is constructed of a model of policy analysis and four principles of biomedical ethics. A patient's decision to decline care proposed by an Accident and Emergency department nurse and the nurse's response to that decision expose a policy that restricts the use of ambulance transport and with that, flexibility in responses to patients' decisions. FINDINGS: End-of-life care partnership decisions require sensitivity and flexibility from all healthcare practitioners. We found that policy-based systems currently used to deliver care across the primary care - hospital care border are far from seamless and can lead to foreseeable problems. CONCLUSIONS: Health professionals responsible for the care of a patient at the end of life should consider the holistic outcomes of resource allocation decisions for patients. RELEVANCE TO CLINICAL PRACTICE: Government and health professional agenda suggest that patients should be given a greater element of control over their healthcare than has historically been the case. When patients take responsibility for their decisions, healthcare personnel should recognize that this signals a shift in the nature of the professional-patient relationship to one of partnership.

Creative partnerships for community health improvement: a qualitative evaluation of the Healthy Carolinians community micro-grant project.

This qualitative study evaluated a recent innovative strategy used to involve community-based organizations (CBOs) in implementing health-related projects through locally administered microgrants. The purpose of this study was to identify key elements that enabled the success of the CBO projects, barriers and challenges to project success, and ways to effectively engage CBOs as partners in local health initiatives. In addition, this study sought to identify aspects of this approach that can be replicated. Study findings revealed that microfinancing CBOs aided in building partnerships, developing local leadership and expertise, and providing resources that enabled progress toward CBO missions and goals. These positive outcomes far out-weighed barriers and challenges faced by CBOs. Furthermore, the results of this study revealed ideas and information that provide useful guidelines for establishing and administering microgrant projects through local organizations that encourage community groups to design and implement community based health initiatives.

The value of microgrants for community-based health promotion: two models for practice and policy.

In 2001, the Office of Disease Prevention and Health Promotion in the US Department of Health and Human Services announced its intention to (1) identify innovative ways to increase public awareness and focus on Healthy People 2010 objectives and (2) broaden the participation of community-based organizations, including agencies new to public health. The mechanism selected, microfinancing, was modeled after small venture loans for economic stimulus in developing countries. The Office of Disease Prevention and Health Promotion selected one state health department and one academic research organization from 80 applicants to test models of awarding "microgrants" of 2,010 dollars to community agencies. This article describes the two models, the types of agencies that were funded, the primary Healthy People 2010 objectives targeted, examples of how the monies were used and leveraged by grantees, and the implications of microgrants for public health practice and policy.

Energizing community health improvement: the promise of microgrants.

BACKGROUND: The Healthy Carolinians community microgrants project provided microgrants to community-based organizations (CBOs) across North Carolina. These grants were made to serve as a catalyst to engage the CBOs in health promotion activities that addressed Healthy People 2010 objectives. The purpose of this initiative was to increase the awareness of Healthy People 2010 objectives, mobilize resources, and create new partners in community health improvement. CONTEXT: In 1993, Healthy Carolinians, a statewide network of public-private partnerships, was established at the county level to address North Carolina's health objectives that aligned with national Healthy People 2010 objectives. This network of Healthy Carolinians partnerships provided the vehicle for distributing the microgrants. METHODS: Funding was distributed to 32 Healthy Carolinians partnerships that, in turn, awarded 199 microgrants (2010 dollars each) to CBOs to address state and national health objectives. Each CBO selected its own objectives based on Healthy People 2010 objectives and designed its own interventions. Surveys of the CBO project managers and final reports were used for evaluation. A survey of the Healthy Carolinians partnership coordinators provided additional insight. CONSEQUENCES: Of the 199 surveys mailed to CBOs, 153 (77%) responded. Nearly half (43.7%) of the microgrants were used to focus on three major health risk factors: 27.1% on physical activity and fitness, 13.1% on nutrition and overweight, and 3.5% on tobacco use. At the end of the project, 96.1% of the respondents reported that they were familiar with the Healthy People 2010 objectives. Final reports showed that an estimated 52,739 hours of CBO staff and volunteer time were contributed to microgrant programs. All Healthy Carolinians partnership coordinators responded to a survey; 100% stated that they had new access to priority populations within their community. INTERPRETATION: The Healthy Carolinians microgrant project demonstrated a cost-effective, alternative approach to funding community-based health promotion and injury control activities. This model was decentralized, so it empowered communities and CBOs to be responsible for community health improvement. Public health professionals with limited funds should consider this alternative approach, which mobilized existing community organizations and effectively addressed national and state health objectives.