By Daniel Rodger, Nicholas Colgrove, Bruce P. Blackshaw
Artificial womb technology may one day permit a fetus to be surgically removed from its mother's body and placed into an artificial environment, mimicking life in utero. Following Elizabeth Chloe Romanis, let's call the subjects living inside artificial wombs 'gestatelings.' An important question that arises is how should gestatelings be treated?
Debates over this question are already underway, and we have been actively involved in them. For example, Colgrove argues that gestatelings should generally be treated like newborns. This, he argues, is because they are newborns (see articles here and here, as well as blogs here and here). Romanis and Elselijn Kingma disagree (see here and here, respectively). While the question of whether or not gestatelings are newborns is an important one, this paper builds upon the views listed here without declaring any one in particular the winner.
Specifically, we center our essay around answering two questions:
When (if ever) is it permissible to kill the gestateling (an act Rodger terms, 'gestaticide'), and
When (if ever) is it permissible to let the gestateling die (e.g., by withdrawing life-sustaining care)?
We argue that (1) gestaticide is as hard to justify (morally speaking) as standard cases of infanticide and (2) letting gestatelings die will be justifiable only under the same conditions in which it is permissible to remove life-sustaining treatment from newborns in the NICU or nursery. In other words, we show that gestaticide is as impermissible as infanticide and that it is permissible to withdraw life-sustaining treatment from gestatelings only when continued treatment is futile, death is imminent and unavoidable, and/or treatment itself is overly burdensome. Importantly, these claims hold whether Colgrove is right (when claiming that gestatelings are newborns) or Romanis and Kingma are right (when denying that claim).
Defending these claims is critical, because as artificial womb technology becomes available, we believe it is inevitable that people will defend the permissibility of gestaticide. Already Räsänen, for example, has defended the right of (genetic) parents to commit gestaticide (though Blackshaw and Rodger; Kaczor and others have provided responses).
Our project serves as a preventive measure against gestaticide and against letting gestatelings die for arbitrary reasons. Gestatelings, like newborns, must not be killed for economic reasons, or because biological parents change their mind about raising a child, and so on. Put differently, legal authorities and healthcare professionals have good reason to protect the lives of gestatelings as they would protect the lives of newborns in the NICU. Our case places the burden of proof on those who would argue that gestaticide should be permissible.
Antibiotic resistance is a growing concern, with some predictions suggesting that routine surgery could be unacceptably risky in a future where many antibiotics have become obsolete. Part of the problem lies in the time it takes clinicians to diagnose an antibiotic-resistant infection. Current techniques involve lab technicians culturing a bacterial sample until it can be analyzed for drug resistance. The whole process takes days, and by the time the test provides an answer, a patient could be dead from sepsis.
To address this, clinicians typically administer broad-spectrum antibiotics in an effort to bring an infection under control. However, this does not always work if the bacteria present are resistant, and can result in further drug resistance. Administering targeted treatments requires rapid diagnosis.
These issues have inspired Day Zero Diagnostics, a company based in Boston, MA, to develop a suite of technologies to enable rapid identification of drug-resistant bugs. These include sample preparation technology for bacterial DNA-enrichment from blood samples, sequencing technology, and proprietary machine learning algorithms to identify the presence of drug resistant bacteria.
Medgadget had the opportunity to talk to Jong Lee, CEO at Day Zero Diagnostics, about the company's technology.
Conn Hastings, Medgadget: Please give us an overview of antibiotic resistance and the threat that it poses.
Jong Lee, Day Zero Diagnostics: Antibiotic resistance is an escalating public health crisis, where the spread of drug resistance is outpacing the development of new antibiotics. Antibiotic resistance causes at least 700,000 global deaths annually. By 2050, this figure is expected to grow to 10 million—more than deaths due to cancer—if current trends continue. Infections due to antibiotic-resistant bacteria are more dangerous for patients and more difficult and expensive to treat. They often require extended hospital stays, additional follow-up doctor visits, more costly and toxic alternative treatments, and have an increased risk of mortality.
Additionally, the rising prevalence of antibiotic-resistant organisms has dramatically increased the risks of healthcare-associated infections (HAIs), which already affect 4-5% of hospitalized patients in the U.S. and result in 99,000 patient deaths per year. As drug resistant bacteria become more and more common, so will deaths from life-threatening infections like sepsis, which is the body's unregulated immune response to a severe bloodstream infection. Recent studies show that 20% of deaths globally are already associated with sepsis. In the United States, sepsis is estimated to be responsible for one third of hospital deaths.
Today, preventing septic shock relies on treating patients with broad-spectrum antibiotics because the risk of death from sepsis increases by almost 8% for each hour an infection goes without appropriate treatment. This practice can make subsequent culture-based diagnostics less sensitive and can also contribute to the growth of antibiotic-resistant organisms.
Medgadget: How are antibiotic-resistant infections currently diagnosed and what problems do such approaches cause?
Jong Lee: Early and effective treatment of antibiotic resistant infections has been proven to save lives. However, current technologies cannot provide actionable information quickly enough to enable early, targeted antibiotic treatment.
Today, when a patient goes to the hospital with signs of an infection, samples are collected and sent to the lab, where they are cultured on various media to see if they grow. Only after the bacteria has been given time to grow (usually 1-2 days) can they be identified and tested for drug resistance. This outdated process can take 2-5 days to return a result when it works, but culture can also fail to grow in 30-50% of severe infection cases. In the meantime, every hour that a patient remains inadequately treated increases their risk of complications or death.
With little to no information to go on, physicians are forced to treat with empiric therapy: powerful, broad-spectrum antibiotics that are expensive, can have significant toxicity, and are increasingly less effective due to the spread of multidrug resistant pathogens.
Medgadget: Do you think that rapid diagnosis will be a key factor in fighting antibiotic-resistant infections and reducing the manifestation of further drug resistance?
Jong Lee: The world is in desperate need of a rapid diagnostics that can perform comprehensive antibiotic resistance profiling without the need for time-consuming cultures. Broad spectrum antibiotics are critical tools for fighting life-threatening bacterial infections and the best way to ensure they continue to be effective when needed is to avoid their overuse as a first line treatment. But without rapid diagnostics that can provide a comprehensive antibiotic resistance profile straight from a clinical sample like blood, it is nearly impossible for physicians to choose targeted antibiotic therapy. Instead, they must "carpet bomb" the infection using broad spectrum antibiotics that encourage the development of even more resistance.
Medgadget: Please give us an overview of the technology developed by Day Zero Diagnostics. What does it do and how does it work?
Jong Lee: Day Zero is pioneering a new class of infectious disease diagnostics using whole genome sequencing and machine learning.
We aim to change the way infectious diseases are diagnosed and treated by developing a sequencing-based rapid diagnostic that identifies, within hours, both the species and the antibiotic resistance profile of a bacterial pathogen. Our diagnostic technologies are focused on three major areas that work in tandem with commercially available whole genome sequencing technology: sample preparation, machine learning algorithms, and big data.
Day Zero's system is designed to extract bacterial DNA directly from a patient sample, such as blood, for whole genome sequencing with unprecedented sensitivity. Day Zero's proprietary machine-learning algorithm then analyzes the genomic data to rapidly identify the pathogen and determine its antibiotic susceptibility and resistance profile, allowing physicians to confidently and quickly prescribe the most effective antibiotic. Unlike current molecular diagnostic approaches that test just a handful of species and provide little to no information on antibiotic resistance, the new system would allow for the simultaneous testing of a broad range of bacterial species and their antibiotic susceptibility, along with the ability to identify novel resistance determinants as they emerge.
DZD's system is poised to help patients with severe infections receive the most effective antibiotic treatment on the first day they are admitted to the hospital—day zero—rather than being treated with multiple days of toxic broad-spectrum antibiotics. The system is intended to help physicians quickly and accurately diagnose and treat life-threatening superbug infections.
Medgadget: Please give us an overview of the results of the recent trial of the technology at the Boston Medical Center and the Blood2Bac validation study.
Jong Lee: Interim results from the Boston Medical Center Rapid Bacterial Identification Trial (BRABIT) and results from a separate validation study of Blood2Bac were recently presented at IDWeek 2020. Both studies demonstrate the promise of our new technology to quickly and accurately diagnose superbug infections. They suggest that our approach could improve the way physicians diagnose and treat life-threatening bacterial infections and most importantly, save lives.
The interim analysis of BRABIT included samples from the first cohort of patients enrolled in the study and evaluated our rapid, culture-free sequencing-based bacterial identification assay in patients with suspected bloodstream infections (BSIs). The assay is powered by Blood2Bac, a proprietary sample preparation technology for ultra-high enrichment of bacterial DNA from clinical blood samples and Keynome®, our machine learning algorithm for species identification and antibiotic resistance profiling.
The results showed that our culture-free assay for determining the presence of a bacterial infection and its species were concordant with clinical blood cultures in 96% of samples. They also suggest the assay is potentially more sensitive than culture-based diagnostics, with the ability to confirm an infection even when same-day blood cultures failed to grow. In addition, there have been no false-positive results to date. False positives occur when a diagnostic detects an infection that is not truly present. This type of error is often made by other sequencing and molecular diagnostics and makes relying on them for clinical decision making particularly challenging.
The results of a separate validation study of Blood2Bac evaluated the technology's ability to recover the whole genomes of pathogens and tested it across 50 bacterial species spiked into whole blood at concentrations as low as 1 CFU/mL (colony-forming unit per milliliter).
The results demonstrated that Blood2Bac, when paired with Keynome, was able to achieve an average of 95% whole-genome coverage and correctly identify all 50 species with 100% accuracy even at single-digit bacterial concentrations. The ability to test for a broad range of infections and recover almost the entirety of the pathogen's genome directly from whole blood represents a significant advancement over current molecular diagnostic approaches that are limited to testing just a handful of species and only recover a very small portion of the pathogen's genetic code.
Medgadget: When do you anticipate that such technology will be available and widely adopted?
Jong Lee: We already offer services to hospitals today that make use of certain elements of our technology. For example, our epiXact service for investigating suspected hospital-acquired infection outbreaks using whole genome sequencing is already available commercially. We are exploring making other elements of our technology available for clinical use in the near future. But designing, building and testing our fully integrated in vitro diagnostic will be the focus of our company for the next few years now that we have completed development of our core technologies. We will ultimately plan to pursue FDA clearance to introduce the system in the United States, as well as a CE Mark.
We will continue to collaborate with leading institutions to test our diagnostic approach in clinical studies over the next several years. Those studies will allow us to demonstrate how our diagnostic could impact clinical decision making and educate clinicians about our potential performance so the use case is well understood by the time our system is introduced.
In addition, we anticipate doing some pilots with leading academic medical centers on the use of sequencing to provide a big data view of the flow of pathogens through the microbiology lab. These pilots are designed to start articulating a vision for the future of hospital microbiology that we think will be transformative.
Pneumonia kills people, young and old. The world has been reminded of the toll of pneumonia as countries struggle to control the COVID-19 pandemic. COVID-19 has claimed more than 1 million lives so far in 2020,1 but other infectious diseases have caused pneumonia-related mortality for decades. Although there has been a commendable 54% decline in pneumonia-related deaths among children younger than 5 years since 2000, pneumonia is still the leading infectious cause of child deaths and claims more than 800 000 children's lives every year (WHO Maternal and Child Epidemiology Estimation, unpublished).
Bariatric surgery (BS) is the most effective technique used to help patients with obesity achieve long-term weight loss. Although many patients report high levels of postoperative satisfaction after BS, some remain unsatisfied with their outcome. Studies of factors that predict postoperative satisfaction have yielded varying results. Weight loss has been identified as a predictor of satisfaction after BS, but debate remains concerning the impact of preoperative expectations and psychological variables. Furthermore, the relevance of attribution and perception of equity to postoperative satisfaction has not been evaluated in patients undergoing BS.
Materials and Methods
We assessed preoperative expectations and the levels of body dissatisfaction, anxiety, and depression in 80 patients undergoing BS. Satisfaction, attribution, feeling of equity, and psychological variables were evaluated 6 months, 1 year, and 2 years after BS.
Results
Weight loss and equity were the two predictors of satisfaction 6 months after BS. Body dissatisfaction was the main factor predicting satisfaction 1 year after BS, with equity and anxiety having smaller influences. Weight loss and equity were the factors predicting satisfaction 2 years after BS.
Conclusion
Our findings support previous results concerning the influence of weight loss on satisfaction after BS. The identification of equity as a factor associated with postoperative satisfaction raises questions regarding the impact of the comparisons made by the patient with others and the consequences of the messages they receive about BS. Moreover, our results underscore the importance of considering the patient's personal experience after BS and not just their weight loss.
Older adults with cancer are increasingly inquiring about and using cannabis. Despite this, few studies have examined cannabis use in patients with cancer aged 65 years and older as a separate group and identified characteristics associated with use. The current study sought to determine the rate of cannabis use in older adult patients with cancer and to identify demographic and clinical correlates of use.
Methods
We conducted a retrospective review of patients with cancer referred for specialised sy mptom management between January 2014 and May 2017 who underwent routine urine drug testing for tetrahydrocannabinol as part of their initial clinic visit.
Results
Approximately 8% (n=24) of patients with cancer aged 65 years and older tested positive for tetrahydrocannabinol compared with 30% (n=51) of young adults and 21% (n=154) of adults. At the univariate level, more cannabis users had lower performance status than non-users (p=0.02, Fisher's exact test). There were no other demographic and clinical characteristics significantly associated with cannabis use in older adults.
Conclusions
Older adult patients made up nearly 25% (n=301) of the total sample and had a rate of cannabis use of 8%. As one of the first studies to assess cannabis use via objective testing rather than self-report, this study adds significantly to the emerging literature on cannabis use in people aged 65 years and older. Findings suggest the rate of use in older adults living with cancer is high er than that among older adults in the general population.
The unmet needs of patients with advanced disease are indicative of the patient centredness of healthcare. By tracking unmet needs in clinical practice, palliative interventions are aligned with patient priorities, and clinicians receive support in intervention delivery decisions for patients with overlapping, complex needs.
Objective
Identify tools used in everyday clinical practice for the purpose of identifying and addressing unmet healthcare needs for patients with advanced disease.
Methods
We conducted PubMed and Cumulative Index of Nursing and Allied Health Literature searches to include studies published between 1 January 2008 and 21 April 2020. Three concepts were used in constructing a search statement: (1) patient need, (2) validated instrument and (3) clinical practice. 2313 citations were reviewed according to predefined eligibility, exclusion and inclusion criteria. Data were collected from 17 tools in order to understand how instruments assess unmet need, who is involved in tool completion, the psychometric validation conducted, the tool's relationship to delivering defined palliative interventions, and the number of palliative care domains covered.
Results
The majority of the 17 tools assessed unmet healthcare needs and had been validated. However, most did not link directly to clinical intervention, nor did they facilitate interaction between clinicians and patients to ensure a patient-reported view of unmet needs. Half of the tools reviewed covered ≤ 3 dimensions of palliative care. Of the 17 tools evaluated, 4 were compared in depth, but all were determined to be insufficient for the specific clinical applications sought in this research.
Conclusion
A new, validated tool is needed to track unmet healthcare needs and guide interventions for patients with advanced disease.
This document is a summary of the French intergroup guidelines regarding the nutrition and physical activity (PA) management in digestive oncology. This collaborative work was produced under the auspices of all French medical and surgical societies involved in digestive oncology, nutrition and supportive care. It is based on published guidelines, recent literature review and expert opinions. Recommendations are graded according to the level of evidence. Malnutrition affects more than half of patients with digestive cancers and is often underdiagnosed. It has multiple negative consequences on survival, quality of life and risk of treatment complications. Consequently, in addition to anticancer treatments, supportive care including nutritional support and PA plays a central role in the management of digestive cancers. It is crucial to detect malnutrition (diagnostic criteria updated in 2019) early, to prevent it and to act against it at all stages of the cancer and at all times of the care pathway. In this context, we proposed recommendations for the evaluation and management in nutrition and PA in digestive oncology for each stage of the disease (perioperative setting, during radiation therapy, during systemic treatments, at the palliative phase, after cancer). Guidelines for nutrition and PA management aim at increasing awareness about malnutrition in oncology. They are continuously evolving and need to be regularly updated.
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COVID-19 has changed some of the dynamics (and even statics) of how we do our job in EMS. The way we train, the PPE we don and the equipment that we use have all been impacted by this global pandemic.
If anything has been a positive from this virus, it's been our comprehensive understanding of our need to either thoroughly clean our equipment, or better transition toward disposable items to perform any number of our clinical functions ... especially airway management procedures.
I'm not talking about disposable versus reusable/durable endotracheal tubes and supraglottic airways (those have always been disposable within our industry). Rather, laryngoscope blades and continuous positive airway pressure (CPAP) devices come to mind as some of the airway management products that have seen their transition toward being disposable goods, rather than durable ones, even over the past five-plus years.
If anything has been a positive from this virus, it's been our comprehensive understanding of our need to either thoroughly clean our equipment, or better transition toward disposable items to perform any number of our clinical functions ... especially airway management procedures. If anything has been a positive from this virus, it's been our comprehensive understanding of our need to either thoroughly clean our equipment, or better transition toward disposable items to perform any number of our clinical functions ... especially airway management procedures. (Photo/City of Mountain View Fire Department) While disposable goods are more commonplace today, there are still opportunities for agencies to transition from one disposable product to another – or even opportunities to add disposable protective devices into your mix of durable goods – and there a small handful of questions that one should ask their vendor(s) when considering a move toward a new (or different) disposable airway management tool. Disposability doesn't necessarily mean that you need to sacrifice durability, but it does bring up a few considerations that single-use airway management tools might otherwise require.
Following are 6 questions to ask vendors before purchasing disposable airway management tools.
1. SAMPLES AND DEMOS Before rolling a new product into the mix – or making a complete product switch – it's important to get some hands-on experience and perspective with whatever product you're looking to bring into your agency. Let your crews get their hands on a trial or demo, talk about its strengths and weaknesses, and even give them a chance to trial (break) it ... in a controlled environment, of course.
2. UP-FRONT COSTS A complete changeover from machine-driven CPAP equipment toward completely disposable options will require some up-front costs in order to stock each of your ambulances and supply cabinets. Especially when this is a new product for your agency, now may be the optimal time to capitalize on bulk pricing in order to outfit (or re-fit) your agency and its fleet.
3. MULTIPLE (NEW) SIZES Large is the new medium – just like how 40 is the new 30 – with some products, at least. Before you make a product switch, take a look at what the product's sizing options are and how they'll impact both your agency and your population base.
4. MAINTENANCE COSTS Not so much in the sense of fixing items (these products are disposable, after all) – but, more in the sense of product expiration dates and replacement costs. Factor in your product use – over time – to get a bigger picture on the long-term impact that your new tools will cost.
5. COINCIDING PRODUCTS Will transitioning to a new CPAP device require a new form of nebulizer for your agency, too? How about those disposable laryngoscope blades? Do they properly fit and work with your current laryngoscope handles? Does this new endotracheal tube come with a pre-loaded stylet, even if you're using a bougie for your intubations? Will changing one aspect of your supply chain affect another – for better, worse or indifferently?
6. PRODUCT TRAINING Many disposable airway management devices are pretty straight forward and can be implemented into your system without hardly a hiccup. Others, on the other hand, may necessitate a need for a brief in-service training session, or even a skills competency review before they're phased in. Does the vendor already have training tutorials, videos and hand-outs available, or will your agency have to learn with more of an on-the-job approach?
TRANSITIONING TO A NEW PRODUCT Change: this can be a cautionary or even dangerous word for some, even if it's just for a new brand of endotracheal tubes. How a product wrapper looks, its storage size or even a new stocking quantity all require communication; something that a successful transition or phase-in period absolutely needs. Communicate with your vendor about the potential benefits and disseminate this information to your providers.
About the author Tim Nowak, AAS, BS, NRP, CCEMTP, SPO, MPO, CADS, is the founder & CEO of Emergency Medical Solutions, LLC, an EMS training and consulting company that he developed in 2010. Through this venture, he is the editor-in-chief of "EMS Director" magazine, a webinar/app-based continued education content developer, a columnist and blog writer, a product developer, an instructor and speaker, a podcast guest and host, and a social media influencer on LinkedIn.
Tim is also the assistant chief of Special Operations with a county-wide EMS agency based in Florida, where he oversees the planning and logistics sections, special operations functions and community paramedicine programs for the agency.
From up-front and maintenance costs, to supply chain and accessory required changes, these questions will smooth the transition to a new disposable product
Due to the coronavirus outbreak, people around the world are facing various challenges in maintaining their well-being, which can be compromised due to risk of illness and harsh measures of social distancing. As proposed by the Self-Determination Theory, basic psychological needs are essential nutrients of well-being. The aim of this study was to examine the role of basic psychological needs in well-being during the pandemic. A sequential mediation model was examined, that links positive and negative affectivity to well-being (satisfaction with life and general distress) through satisfaction and frustration of the basic psychological needs (for autonomy, competence, and relatedness). The study involved 965 participants (Mage = 29; 57% females) from Serbia. The Basic Psychological Needs Satisfaction and Frustration scale, Satisfaction with Life Scale, Depression Anxiety Stress Scale 21, and The Serbian Inventory of Affect based on the Panas-X were used. All the tested models were statistically significant. Controlling for age, gender, having children, health, employment, and marital status, direct effects in all models were highly significant, explaining up to 59% of criteria variance. The proportion of the explained variance was even higher when accounting for indirect effects. Sequential mediation models revealed that the indirect relationships between positive and negative affectivity and satisfaction with life and general distress were serially mediated by autonomy satisfaction, competence frustration, relatedness satisfaction, and relatedness frustration. This study raised an important question on how the disposition to experience more positive or negative emotions affects the change in subjective well-being. These results, coherent with the Self-Determination Theory postulates, add to the understanding of human functioning in the times of extraordinary circumstances during a pandemic, by suggesting that satisfaction and frustration of basic psychological needs might have a key role in obtaining optimal well-being.
, a proprietary sample preparation technology for ultra-high enrichment of bacterial DNA from clinical blood samples and Keynome®, our machine learning algorithm for species identification and antibiotic resistance profiling.
