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Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA.
We conducted a scoping review (Medline and EMBASE, 2000–2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters.
Our final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.
This study suggests an alternative approach to ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.
Parasites directly and indirectly influence the important interactions among hosts such as competition and predation through modifications of behaviour, reproduction and survival. Such impacts can affect local biodiversity, relative abundance of host species and structuring of communities and ecosystems. Despite having a firm theoretical basis for the potential effects of parasites on ecosystems, there is a scarcity of experimental data to validate these hypotheses, making our inferences about this topic more circumstantial. To quantitatively test parasites' role in structuring host communities, we set up a controlled, multigenerational mesocosm experiment involving four sympatric freshwater crustacean species that share up to four parasite species. Mesocosms were assigned to either of two different treatments, low or high parasite exposure. We found that the trematode Maritrema poulini differentially influenced the population dynamics of these hosts. For example, survival and recruitment of the amphipod Paracalliope fluviatilis were dramatically reduced compared to other host species, suggesting that parasites may affect their long-term persistence in the community. Relative abundances of crustacean species were influenced by parasites, demonstrating their role in host community structure. As parasites are ubiquitous across all communities and ecosystems, we suggest that the asymmetrical effects we observed are likely widespread structuring forces.
Online self-reported 24-h dietary recall systems promise increased feasibility of dietary assessment. Comparison against interviewer-led recalls established their convergent validity; however, reliability and criterion-validity information is lacking. The validity of energy intakes (EI) reported using Intake24, an online 24-h recall system, was assessed against concurrent measurement of total energy expenditure (TEE) using doubly labelled water in ninety-eight UK adults (40–65 years). Accuracy and precision of EI were assessed using correlation and Bland–Altman analysis. Test–retest reliability of energy and nutrient intakes was assessed using data from three further UK studies where participants (11–88 years) completed Intake24 at least four times; reliability was assessed using intra-class correlations (ICC). Compared with TEE, participants under-reported EI by 25 % (95 % limits of agreement −73 % to +68 %) in the first recall, 22 % (−61 % to +41 %) for average of first two, and 25 % (−60 % to +28 %) for first three recalls. Correlations between EI and TEE were 0·31 (first), 0·47 (first two) and 0·39 (first three recalls), respectively. ICC for a single recall was 0·35 for EI and ranged from 0·31 for Fe to 0·43 for non-milk extrinsic sugars (NMES). Considering pairs of recalls (first two v. third and fourth recalls), ICC was 0·52 for EI and ranged from 0·37 for fat to 0·63 for NMES. EI reported with Intake24 was moderately correlated with objectively measured TEE and underestimated on average to the same extent as seen with interviewer-led 24-h recalls and estimated weight food diaries. Online 24-h recall systems may offer low-cost, low-burden alternatives for collecting dietary information.
The self-report of some autistic individuals that they experience social motivation should not be interpreted as a refutation of neuroimaging evidence supporting the social motivation hypothesis of autism. Neuroimaging evidence supports subtle differences in unconscious reward processing, which emerge at the group level and which may not be perceptible to individuals, but which may nonetheless impact an individual's behavior.
The completion of a laser safety course remains a core surgical curriculum requirement for otolaryngologists training in the UK. This project aimed to develop a comprehensive laser safety course utilising both technical and non-technical skills simulation.
Otolaryngology trainees and consultants from the West of Scotland Deanery attended a 1-day course comprising lectures, two high-fidelity simulation scenarios and a technical simulation of safe laser use in practice.
The course, and in particular the use of simulation training, received excellent feedback from otolaryngology trainees and consultants who participated. Both simulation scenarios were validated for future use in laser simulation.
The course has been recognised as a laser safety course sufficient for the otolaryngology Certificate of Completion of Training. To the authors’ knowledge, this article represents the first description of using in situ non-technical skills simulation training for teaching laser use in otolaryngology.
Introduction: We previously derived (N = 559) and validated (N = 1,100) the 10-item Ottawa Heart Failure Risk Scale (OHFRS), to assist with disposition decisions for patients with acute heart failure (AHF) in the emergency department (ED). In the current study we sought to use a larger dataset to develop a more concise and more accurate risk scale. Methods: We analyzed data from the prior two studies and from a new cohort. For all 3 groups we conducted prospective cohort studies that enrolled patients who required treatment for AHF at 8 tertiary care hospital EDs. Patients were followed for 30 days. The primary outcome was short-term serious outcome (SSO), defined as death within 30 days, intubation or non-invasive ventilation (NIV) after admission, myocardial infarction, or relapse resulting in hospital admission within 14 days. The fully pre-specified logistic regression model with 13 predictors (where age, pCO2, and SaO2 were modeled using spline functions) was fitted to 10 multiple imputation datasets. Harrell's fast stepdown procedure reduced the number of variables. We calculated the potential impact on sensitivity (95% CI) for SSO and hospital admissions, and estimated a sample size of 2,000 patients. Results: The 1,986 patients had mean age 77.3 years, male 54.1%, EMS arrival 41.2%, IV NTG 3.3%, ED NIV 5.4%, admission on initial visit 49.5%. Overall there were 236 (11.9%) SSOs including 61 deaths (3.1%), meaning that current admission practice sensitivity for SSO was only 59.7%. The final HEARTRISK6 scale is comprised of 6 variables (points) (C-statistic 0.68): Valvular heart disease (2) Antiarrhythmic medication (2) ED non-invasive ventilation (3) Creatinine 80–150 (1); ≥150 (3) Troponin ≥3x URL (2) Walk test failed (1). The probability of SSO ranged from 4.8% for a total score of 0 to 62.4% for a score of 10, showing good calibration. Choosing a HEARTRISK6 total point admission threshold of ≥3 would yield sensitivity of 70.8% (95%CI 64.5-76.5) for SSO with a slight decrease in admissions to 47.9%. Choosing a threshold of ≥2 would yield a sensitivity of 84.3% (95%CI 79.0-88.7) but require 66.6% admissions. Conclusion: Using a large prospectively collected dataset, we created a more concise and more sensitive risk scale to assist with admission decisions for patients with AHF in the ED. Implementation of the HEARTRISK6 scale should lead to safer and more efficient disposition decisions, with more high-risk patients being admitted and more low-risk patients being discharged.
Introduction: For rhythm control of acute atrial fibrillation (AAF) in the emergency department (ED), choices include initial drug therapy or initial electrical cardioversion (ECV). We compared the strategies of pharmacological cardioversion followed by ECV if necessary (Drug-Shock), and ECV alone (Shock Only). Methods: We conducted a randomized, blinded, placebo-controlled trial (1:1 allocation) comparing two rhythm control strategies at 11 academic EDs. We included stable adult patients with AAF, where onset of symptoms was <48 hours. Patients underwent central web-based randomization stratified by site. The Drug-Shock group received an infusion of procainamide (15mg/kg over 30 minutes) followed 30 minutes later, if necessary, by ECV at 200 joules x 3 shocks. The Shock Only group received an infusion of saline followed, if necessary, by ECV x 3 shocks. The primary outcome was conversion to sinus rhythm for ≥30 minutes at any time following onset of infusion. Patients were followed for 14 days. The primary outcome was evaluated on an apriori-specified modified intention-to-treat (MITT) basis excluding patients who never received the study infusion (e.g. spontaneous conversion). Data were analyzed using chi-squared tests and logistic regression. Our target sample size was 374 evaluable patients. Results: Of 395 randomized patients, 18 were excluded from the MITT analysis; none were lost to follow-up. The Drug-Shock (N = 198) and Shock Only (N = 180) groups (total = 378) were similar for all characteristics including mean age (60.0 vs 59.5 yrs), duration of AAF (10.1 vs 10.8 hrs), previous AF (67.2% vs 68.3%), median CHADS2 score (0 vs 0), and mean initial heart rate (119.9 vs 118.0 bpm). More patients converted to normal sinus rhythm in the Drug-Shock group (97.0% vs 92.2%; absolute difference 4.8%, 95% CI 0.2-9.9; P = 0.04). The multivariable analyses confirmed the Drug-Shock strategy superiority (P = 0.04). There were no statistically significant differences for time to conversion (91.4 vs 85.4 minutes), total ED length of stay (7.1 vs 7.7 hours), disposition home (97.0% vs 96.1%), and stroke within 14 days (0 vs 0). Premature discontinuation of infusion was more common in the Drug-Shock group (8.1% vs 0.6%) but there were no serious adverse events. Conclusion: Both the Drug-Shock and Shock Only strategies were highly effective and safe in allowing AAF patients to go home in sinus rhythm. A strategy of initial cardioversion with procainamide was superior to a strategy of immediate ECV.
Clostridium difficile infections (CDIs) affect patients in hospitals and in the community, but the relative importance of transmission in each setting is unknown. We developed a mathematical model of C. difficile transmission in a hospital and surrounding community that included infants, adults and transmission from animal reservoirs. We assessed the role of these transmission routes in maintaining disease and evaluated the recommended classification system for hospital- and community-acquired CDIs. The reproduction number in the hospital was <1 (range: 0.16–0.46) for all scenarios. Outside the hospital, the reproduction number was >1 for nearly all scenarios without transmission from animal reservoirs (range: 1.0–1.34). However, the reproduction number for the human population was <1 if a minority (>3.5–26.0%) of human exposures originated from animal reservoirs. Symptomatic adults accounted for <10% transmission in the community. Under conservative assumptions, infants accounted for 17% of community transmission. An estimated 33–40% of community-acquired cases were reported but 28–39% of these reported cases were misclassified as hospital-acquired by recommended definitions. Transmission could be plausibly sustained by asymptomatically colonised adults and infants in the community or exposure to animal reservoirs, but not hospital transmission alone. Under-reporting of community-onset cases and systematic misclassification underplays the role of community transmission.
With the recent discovery of a dozen dusty star-forming galaxies and around 30 quasars at z > 5 that are hyper-luminous in the infrared (μ LIR > 1013 L⊙, where μ is a lensing magnification factor), the possibility has opened up for SPICA, the proposed ESA M5 mid-/far-infrared mission, to extend its spectroscopic studies toward the epoch of reionisation and beyond. In this paper, we examine the feasibility and scientific potential of such observations with SPICA’s far-infrared spectrometer SAFARI, which will probe a spectral range (35–230 μm) that will be unexplored by ALMA and JWST. Our simulations show that SAFARI is capable of delivering good-quality spectra for hyper-luminous infrared galaxies at z = 5 − 10, allowing us to sample spectral features in the rest-frame mid-infrared and to investigate a host of key scientific issues, such as the relative importance of star formation versus AGN, the hardness of the radiation field, the level of chemical enrichment, and the properties of the molecular gas. From a broader perspective, SAFARI offers the potential to open up a new frontier in the study of the early Universe, providing access to uniquely powerful spectral features for probing first-generation objects, such as the key cooling lines of low-metallicity or metal-free forming galaxies (fine-structure and H2 lines) and emission features of solid compounds freshly synthesised by Population III supernovae. Ultimately, SAFARI’s ability to explore the high-redshift Universe will be determined by the availability of sufficiently bright targets (whether intrinsically luminous or gravitationally lensed). With its launch expected around 2030, SPICA is ideally positioned to take full advantage of upcoming wide-field surveys such as LSST, SKA, Euclid, and WFIRST, which are likely to provide extraordinary targets for SAFARI.
Cambodia supports populations of three Critically Endangered vulture species that are believed to have become isolated from the rest of the species’ global range. Until recently Cambodia’s vulture populations had remained stable. However a recent spike in the number of reports of the use of poisons in hunting practices suggests the need to re-evaluate the conservation situation in Cambodia. Population trend analysis showed that since 2010 populations of the White-rumped Vulture Gyps bengalensis and Red-headed Vulture Sarcogyps calvus have declined, while the Slender-billed Vulture Gyps tenuirostris may also have started to decline since 2013. These trends are supported by evidence of reduced nesting success. A survey of veterinary drug availability revealed that diclofenac, the non-steroid anti-inflammatory drug responsible for vulture declines in South Asia was not available for sale in any of the 74 pharmacies surveyed. However, a poisoned Slender-billed Vulture tested positive for carbofuran in toxicology tests. This provides the first evidence of a vulture mortality resulting from carbofuran in Cambodia. The findings suggest the urgent need to tackle use of carbamate pesticides in hunting. Proposed conservation actions are: a) prevention of poisoning through national bans on harmful carbamate pesticides and diclofenac and education campaigns to reduce demand and use; b) training of personnel in priority protected areas in detection and response to poisoning incidents; c) maintenance of a safe and reliable food source through vulture restaurants to ensure short-term survival, and d) protection and restoration of large areas of deciduous dipterocarp forests to enable long-term species recovery.
One of the seminar topics scheduled for the summer of 1955 by the Society for American Archaeology was “The American Southwest: A Problem in Cultural Isolation.” The assignment was to “… examine the assumption that these Southwestern cultures resulted from local acceptance and development of generalized and/or specific traits which can be isolated in distant cultural contexts at earlier times than their climactic developments can be observed in the Southwest.”
To identify predominant dietary patterns in four African populations and examine their association with obesity.
We used data from the Africa/Harvard School of Public Health Partnership for Cohort Research and Training (PaCT) pilot study established to investigate the feasibility of a multi-country longitudinal study of non-communicable chronic disease in sub-Saharan Africa. We applied principal component analysis to dietary intake data collected from an FFQ developed for PaCT to ascertain dietary patterns in Tanzania, South Africa, and peri-urban and rural Uganda. The sample consisted of 444 women and 294 men.
We identified two dietary patterns: the Mixed Diet pattern characterized by high intakes of unprocessed foods such as vegetables and fresh fish, but also cold cuts and refined grains; and the Processed Diet pattern characterized by high intakes of salad dressing, cold cuts and sweets. Women in the highest tertile of the Processed Diet pattern score were 3·00 times more likely to be overweight (95 % CI 1·66, 5·45; prevalence=74 %) and 4·24 times more likely to be obese (95 % CI 2·23, 8·05; prevalence=44 %) than women in this pattern’s lowest tertile (both P<0·0001; prevalence=47 and 14 %, respectively). We found similarly strong associations in men. There was no association between the Mixed Diet pattern and overweight or obesity.
We identified two major dietary patterns in several African populations, a Mixed Diet pattern and a Processed Diet pattern. The Processed Diet pattern was associated with obesity.
The SPICA mid- and far-infrared telescope will address fundamental issues in our understanding of star formation and ISM physics in galaxies. A particular hallmark of SPICA is the outstanding sensitivity enabled by the cold telescope, optimised detectors, and wide instantaneous bandwidth throughout the mid- and far-infrared. The spectroscopic, imaging, and polarimetric observations that SPICA will be able to collect will help in clarifying the complex physical mechanisms which underlie the baryon cycle of galaxies. In particular, (i) the access to a large suite of atomic and ionic fine-structure lines for large samples of galaxies will shed light on the origin of the observed spread in star-formation rates within and between galaxies, (ii) observations of HD rotational lines (out to ~10 Mpc) and fine structure lines such as [C ii] 158 μm (out to ~100 Mpc) will clarify the main reservoirs of interstellar matter in galaxies, including phases where CO does not emit, (iii) far-infrared spectroscopy of dust and ice features will address uncertainties in the mass and composition of dust in galaxies, and the contributions of supernovae to the interstellar dust budget will be quantified by photometry and monitoring of supernova remnants in nearby galaxies, (iv) observations of far-infrared cooling lines such as [O i] 63 μm from star-forming molecular clouds in our Galaxy will evaluate the importance of shocks to dissipate turbulent energy. The paper concludes with requirements for the telescope and instruments, and recommendations for the observing strategy.
IR spectroscopy in the range 12–230 μm with the SPace IR telescope for Cosmology and Astrophysics (SPICA) will reveal the physical processes governing the formation and evolution of galaxies and black holes through cosmic time, bridging the gap between the James Webb Space Telescope and the upcoming Extremely Large Telescopes at shorter wavelengths and the Atacama Large Millimeter Array at longer wavelengths. The SPICA, with its 2.5-m telescope actively cooled to below 8 K, will obtain the first spectroscopic determination, in the mid-IR rest-frame, of both the star-formation rate and black hole accretion rate histories of galaxies, reaching lookback times of 12 Gyr, for large statistically significant samples. Densities, temperatures, radiation fields, and gas-phase metallicities will be measured in dust-obscured galaxies and active galactic nuclei, sampling a large range in mass and luminosity, from faint local dwarf galaxies to luminous quasars in the distant Universe. Active galactic nuclei and starburst feedback and feeding mechanisms in distant galaxies will be uncovered through detailed measurements of molecular and atomic line profiles. The SPICA’s large-area deep spectrophotometric surveys will provide mid-IR spectra and continuum fluxes for unbiased samples of tens of thousands of galaxies, out to redshifts of z ~ 6.
Our current knowledge of star formation and accretion luminosity at high redshift (z > 3–4), as well as the possible connections between them, relies mostly on observations in the rest-frame ultraviolet, which are strongly affected by dust obscuration. Due to the lack of sensitivity of past and current infrared instrumentation, so far it has not been possible to get a glimpse into the early phases of the dust-obscured Universe. Among the next generation of infrared observatories, SPICA, observing in the 12–350 µm range, will be the only facility that can enable us to trace the evolution of the obscured star-formation rate and black-hole accretion rate densities over cosmic time, from the peak of their activity back to the reionisation epoch (i.e., 3 < z ≲ 6–7), where its predecessors had severe limitations. Here, we discuss the potential of photometric surveys performed with the SPICA mid-infrared instrument, enabled by the very low level of impact of dust obscuration in a band centred at 34 µm. These unique unbiased photometric surveys that SPICA will perform will fully characterise the evolution of AGNs and star-forming galaxies after reionisation.
Nurses and respiratory therapists are seldom allowed to use automated external defibrillators (AED) during in-hospital cardiac arrest. This can result in significant time delays before defibrillation occurs and lower survival for cardiac arrest victims. We sought to identify barriers and facilitators to AED use by nurses and respiratory therapists.
We conducted semi-structured qualitative interviews with a purposeful sample of nurses and respiratory therapists. We developed the interview guide based on the constructs of the theory of planned behaviour, which elicits salient attitudes, social influences, and control beliefs potentially influencing the intent to use an AED. Interviews were recorded, transcribed verbatim, and analysed until achieving data saturation. Two independent reviewers performed inductive analyses to identify emerging categories and themes, and ranked them by frequency of the number of participants stating the topic.
Demographics for the 24 interviewees include mean age 40.5, 79.2% female, 87.5% performed cardiopulmonary resuscitation (CPR), 29.2% defibrillated a patient. Identified attitudes pertained to the timeliness of defibrillation, patient survival, simplicity of AED use, accuracy of rhythm recognition, and harm to self or others. Social influences consisted of physician and hospital administration support of AED use. Control beliefs included training on AED use, policy allowing AED use, familiarity with AED, and task burden during resuscitation.
Most nurses and respiratory therapists intended to use an AED if permitted to do so by a medical directive. Successful implementation would require educational initiatives focusing on safety and efficacy of AEDs, support from physicians and hospital administrators, and additional training on AED use.
Population outbreaks of the coral-eating predator crown of thorns starfish (COTS), Acanthaster planci are responsible for large-scale disturbance of coral reefs throughout the Indo-Pacific. In response, attempts are often made to control COTS outbreaks in protected areas. For instance, volunteers remove thousands of sea stars every year in Malaysia. This study reports the status of the COTS population in the Pulau Tioman Marine Park and examines the effectiveness of the seasonal sea star removal programme. After the 2009 removal season, we monitored COTS densities and coral assemblages before and after a 6-month no-removal season at sites with and without COTS removal efforts. We recorded high COTS densities up to 330 ind. ha−1 at a few sites independent of removal effort. In fact, removal only temporarily reduced large individuals from local populations. Moreover, after the no-removal season, sites with COTS removal had increased live coral cover, but sites without COTS removal had a drastic decrease in live coral cover, with Acropora spp. being most affected. Therefore, this study suggests that the current seasonal removals could promote coral health, despite the high density of COTS.
There is some suggestion that infection with pandemic influenza may increase long-term mortality risks. Therefore we aimed to determine if exposure to a severe outbreak of pandemic influenza on a troopship in 1918 impacted on lifespan in the survivors. The troopship with the outbreak cohort had 1107 personnel and the comparison cohort was from two contemporaneous troopships (1108 randomly selected personnel). Data were collected from online individual military files. The main finding was that there was no statistically significant difference in the lifespan of the outbreak cohort and the comparison cohort (means of 71·5 and 71·0 years, respectively). Indeed, the outbreak cohort was actually more likely to survive into the period from 1950 onwards (P = 0·036) and to participate in the Second World War (P = 0·043). There were no significant differences between the cohorts in terms of occupational class, but the comparison cohort had a higher proportion of rural occupations (33·3% vs. 27·0%, P < 0·001) and was very slightly older in mid-1918 (27·8 vs. 27·2 years, P = 0·028). In conclusion, this study found no support for the hypothesis that exposure to the 1918 influenza pandemic adversely impacted on the lifespan in the survivors, at least in this male and military-age population.