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What type of clinical evidence is needed to assess medical devices?
Rosanna Tarricone, Paola Roberta Boscolo, Patrizio Armeni
European Respiratory Review 2016 25: 259-265; DOI: 10.1183/16000617.0016-2016
Rosanna Tarricone
1CERGAS, Centre for Research on Social and Healthcare Management, Bocconi University, Milan, Italy
2Dept of Policy Analysis and Public Management, Bocconi University, Milan, Italy
For correspondence: rosanna.tarricone@unibocconi.it
Paola Roberta Boscolo
Patrizio Armeni
The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable.
We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction.
We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30 000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies.
Real-world data are a valid complement and/or alternative to RCTs to support policy decisions on medical devices http://ow.ly/SHsZ300pfCB
Limited resources and limitless health needs require policy makers to choose amongst several treatment options and to prioritise technological innovations. Economic evaluation analysis in healthcare are consolidated practices in most countries (www.inahta.org), and serve to support the decision-making process to formulate evidence-based guidelines, and adopt or reject recommendations.
In the last few decades, the faster escalation of technologies other than drugs (e.g. diagnostics and medical devices), representing >10 000 patent applications filed in 2012 to the European Patent Office versus ∼5400 applications filed for drugs and ∼5300 for biotechnologies [1], convinced health analysts that economic evaluation methods and techniques, originally developed with pharmaceuticals in mind, may not always be appropriate to assess technologies with several different characteristics. Six reasons that make the assessment of medical devices more challenging than that of drugs have been identified [2]. Further work has focussed mainly on one of these six reasons, i.e. the source and role of clinical evidence [3]. In some cases, experimental clinical studies for medical devices (i.e. randomised controlled studies) are difficult, impossible or unethical. Randomising patients to invasive surgeries is always a challenge when the alternative is noninvasive treatments. For the same reason, blinding might not be possible. Randomisation is not ethical when large differences have already emerged between the new device and the standard of care. This may occur because current regulation of medical devices (European directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2007/47/EC) allows their use in clinical practice well before, or in the absence of, any experimental clinical study. Moreover, health outcomes of procedures with medical devices (e.g. surgical procedures and implantable medical devices) highly depend upon end-users' experience, which makes the time of assessment crucial for medical devices, as eloquently explained by Buxton's law: "it is always too early […] until, unfortunately, it is suddenly too late" [4].
There is increasing recognition that, in the case of medical devices, experimental clinical studies might be less relevant than real-world data to making policy decisions on, for example, reimbursement and coverage [5].
Since the early diffusion of medical devices generally precedes formal health technology assessment (HTA) recommendations and, if at all, experimental evidence, decision making cannot ignore that some physicians' and healthcare organisations are already familiar with the technology. Given this framework, the questions therefore become, can we decide on coverage and reimbursement of new devices in the absence of randomised controlled trial (RCT) data? Are real-world data accumulated on the new device usable to inform decision making? If so, under which circumstances? The answer to these questions is yes, provided real-world data are robustly analysed and elaborated, because there is no other option unless we prevent end-users from using new devices until experimental evidence makes itself available, if ever.
The objective of this mini-review is to discuss the role and use of experimental and real-world evidence to support the healthcare-related decision-making process as to the allocation of scarce resources (i.e. in the HTA of medical devices).
Under certain conditions, real-world studies can provide relevant evidence to decision makers, even in absence of RCTs, therefore becoming not only a complementary source of evidence but also a low-cost, rapid and valuable substitute for technologies whose diffusion process has already started. To this purpose, we use a case study concerning a cost-effectiveness analysis (CEA) based on real-world data of a technology already in use. The case study is about the CEA of Mitraclip (Abbott Vascular, Menlo Park, CA, USA) versus optimal medical therapy (OMT) in patients with moderate-to-severe mitral regurgitation. Although some RCTs on the Mitraclip procedure are available, none published so far compared it with medical therapy alone, which resulted as the only appropriate comparator. In order to reach its objective, this mini-review is organised as follows. In the next section, we explain under what circumstances real-world studies can be helpful in addition to or instead of experimental studies. We then illustrate current available methods to control for selection bias, i.e. the most important weakness of real-world studies. The case of Mitraclip is used to exemplify one of our suggested methods, propensity score-based regression adjustment.
The role of real-world studies as a source of clinical evidence
The gold-standard research designs, such as systematic reviews and meta-analysis, double-blind controlled trials, and cohort prospective studies, often cannot offer prompt information to decision makers. Often, medical devices are under assessment by governments and HTA organisations while diffusing in medical practice. A common challenge for most countries is therefore finding the appropriate balance between assessing the efficacy and safety on the one hand, and allowing rapid access to patients on the other [3].
The European Forum "Relative Effectiveness" Working group has defined real-world studies as "a measure in understanding health care data collected under real life practice circumstances" [6] and at the payer level, a real-life study has been defined as "anything that is not interventional". Real-world studies are increasingly recognised as a valuable source of clinical evidence [5, 7, 8], especially when clinical trials are either not available, difficult to realise, unethical or available but not providing a clear aid for decision making, lacking a deep understanding of a drug or device implications on current management in a specific real-life setting [5, 7–10].
Clinical evidence for devices can vary notably due to differences in providers' training, and users' skills and experiences [2]. Real-world studies can monitor variations in clinical evidence over time, accounting for a learning curve, and across different users, with multicentre research designs.
From this, real-world studies are likely to provide prompter and more relevant information for decision makers than RCTs. In other words, if the design of RCTs remains the gold standard for identifying the causal relationship between the use of a technology and a variation in the clinical conditions of patients (something that a real-world study will never replace), real-world studies might be preferred when: 1) the effectiveness of a technology is likely to differ largely from its efficacy due to use-specific effects, like the presence of a learning curve that dramatically impacts patient selection and health outcomes; 2) the realisation of an experimental study does not grant the elimination of biases from selection or awareness (lack of blinding); 3) the regulation of the technology makes its diffusion in clinical practice not binding to experimental studies, which compels decision-makers to decide upon other evidence; 4) the RCT does not provide an acceptable representation of the economic consequences of use (e.g. protocol-driven consumption of resources for implantations and follow-ups hugely differ from actual clinical practice); and 5) the technology is constantly improving. Innovation of medical devices is often incremental, which makes repeated RCTs simply unbearable.
The possible sources of real-world data (databases, surveys, patient chart reviews, pragmatic clinical trials, observational data from cohort studies, and registries prospectively collecting information and then retrospectively analysing patients' data per specific centre and given conditions) and the phases when real-world studies can support decision-making process of multiple stakeholders are different before the launch at the early development stage, when demonstrating the value, and at and after the launch to support clinical practice.
Real-world studies and selection bias: is there any chance of escaping it?
Often, real-world studies have been accused of suffering of different types of bias leading to erroneous results. One of the main reasons for selection bias in real-world studies is the allocation of patients to either the treatment or the control group that is not random, and can therefore be dependent on patients' observable baseline characteristics and on unobservable factors like tacit component of clinical knowledge, i.e. a mix of holistic evaluation, medical experience and the intuition of physicians. As a consequence, the observed outcome can be endogenous with respect to the selection of the treatment and the control group. Nevertheless, several techniques have been applied to reduce the impact of selection bias like multivariate regression or nonparametric techniques based on the propensity score (the ex ante probability that a patient is assigned to treatment given their baseline characteristics). The goal of all propensity-score methods is to achieve a balance in observed covariates for the treated and control subjects [11, 12]. Among the main methods, two are particularly important: propensity score matching and propensity score-based regression adjustment. The former is a nonparametric method where the propensity score (logit or probit post-estimation of the ex ante probability of being treated) is used to group individuals into small groups and compare their outcome. After having compared the outcome of small groups (difference between the outcome of treated and untreated patients), the average difference is calculated and tested for significance [11]. As Rosenbaum and Rubin [13] stated in 1985, matched sampling is a method for selecting units from a large reservoir of potential controls to produce a control group of modest size that is similar to a treated group with respect to the distribution of observed covariates. Matching on the propensity score is a parsimonious way to reduce selection bias deriving from observational factors, only leaving space for selection bias based on unobservable factors. Some studies have discussed the contingent convenience of the specific matching technique [14–18]. The latter uses the propensity score as a covariate in the standard regression: in this way, a covariate in the regression adjusts the estimation for potential selection bias. Matching is not the only way of using propensity scores. In fact, regression adjustment and weighting are other techniques used to reduce selection bias [19]. This mini-review will focus on the general characteristics of bias reduction techniques that allow real-world studies to provide sound evidence that is qualitatively different from that of RCTs but often more useful and timely [20–22].
Table 1 describes in details the main differences between RCTs and real-world studies as to pros and cons of different sources of clinical evidence. In synthesis, real-world studies can substantially reduce the bias due to the lack of randomisation through matching techniques and can provide additional benefits to or in absence of RCTs, i.e. when RCTs are unethical, not possible or difficult to conduct [2], accounting for the learning curve, adhering to real-world clinical practice, implying cheaper and easier data collection methods, often relying on large existing samples, raising fewer ethical issues, and with research protocols potentially able to provide timely evidence to decision makers.
Randomised clinical trials (RCTs) and real-world (RW) studies: pros and cons
Policy makers are in fact supporting the use of real-world studies as a way to manage uncertainty and take locally grounded reimbursement decisions. Many countries have expressed commitment to considering the real value provided by new treatments so that effectiveness assessments can notably contribute to a new drug or device's market success through coverage and reimbursement decisions. Finally, members of the scientific community have also started to compare the evidence generated through real-world studies with RCTs, finding that "observational studies using [propensity score] methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant" [24].
The case of Mitraclip
Mitraclip is an implantable device ("clip") launched in 2008 allowing a fully percutaneous approach to mitral regurgitation. Four trials exist: COAPT, ISAR-CLIP, RESHAPE-HF and EVEREST II. The latter is the first RCT assessing Mitraclip's efficacy versus conventional mitral valve surgery. Only one RCT (ISAR-CLIP) has reached its conclusion while the others have only released preliminary data. To keep collecting safety and effectiveness data, two registries were created and linked to the EVEREST trials: EVEREST II High Risk Registry and EVEREST II REALISM–High Risk. The technology started being implanted as early as 2008 (well before the publication of the first trials in 2012). In 2013, 8000 patients were treated with Mitraclip in 40 countries [25, 26]. In the same year, Italy accounted for >12% of all implants, with a growth rate from 2009 to 2013 of 1260% [26]. In 2016, the total number of implants worldwide has more than doubled to 30 000 (Abbott Vascular; personal communication).
The high-risk study [27], based on EVEREST II, suggested that the technology was most effective when used for high-risk patients not eligible for surgery who would otherwise have been treated with medical care only. Therefore, the end-user should consider Mitraclip as an option when surgery is impossible. To the clinical efficacy, the policy maker needs to add the economic efficiency by estimating the cost per unit of effectiveness of such therapeutic option. A CEA [28] based on the high-risk study was the first attempt to help policy makers decide about Mitraclip reimbursement. However, a trial-based economic evaluation carried out when the technology is already in a post-adoption phase of diffusion fails to provide the policymaker with a credible representation of the reality: first, the high-risk trial compared Mitraclip (n=76) with a mix of medical management (n=33) and mitral valve surgery (n=5); second, the sample was considerably small and the obtained effect (76% 12-month survival in the treatment arm compared to 55% in the control arm) is not univocally referred to any of the comparators; third, the economic evaluation necessarily reflected an experimental design, thus failing to exploit the existing amount of observable evidence generated by >5 years of use in the clinical practice, with particular reference to the actual side-therapies and to the variation of effectiveness due to use-specific aspects. Despite the impressive use of the technology, as of today, only a few European governments and HTA bodies have explicitly issued a recommendation on coverage and reimbursement of Mitraclip: in the UK, the National Institute for Health and Care Excellence [29] advised not to fund Mitraclip routinely because of a lack of quality evidence; the Ludwig Boltzmann Institute in Austria [30] also suggested a negative recommendation due to lack of evidence; Osteba in Spain, despite underlining a low level of evidence, instead made a positive recommendation to include Mitraclip in the national health basket for high surgical risk patients currently undergoing medical therapy and presenting defined characteristics [31].
For this reason, a study group composed of health economists, cardiologists and cardiosurgeons has carried out an economic evaluation of Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate/severe mitral regurgitation and advanced heart failure [32]. The research team accepted the challenge of a real-world CEA. Since no data were collected with the intention of conducting an economic evaluation, a database had to be built putting together the set of clinical records of patients who received Mitraclip in two Italian centres at the time the study was initiated (n=232) and a sample of patients eligible for Mitraclip but who did not receive it (n=151) from the Italian Network on Acute and Chronic Heart Failure registry, a database promoted by the ANMCO (Italian Association of Hospital Cardiologists). Records of both the treatment and control groups were complete and detailed, and assumptions were made only for utility weights that were extracted from the literature for the inclusion of general age-related mortality in the Markov model and for some minor details regarding the causes of re-hospitalisations during the follow-up period. The two groups showed important differences at baseline, thus supporting the existence of selection bias. In a previous version of the manuscript, we adopted an unusual yet plausible approach, where the propensity score was estimated through a probit regression and used to match patients based on a 2/1 ratio. The idea was to exploit the data of the investigational group, similar to the randomisation approach of EVEREST II trial, using the same ratio. However, we recognised that using a propensity score for matching may have limited the power of the comparison. Indeed, when the sample size is medium, as in our case, using a propensity score for adjustment rather than for matching purposes may have been more instrumental in preserving the power of the comparison while addressing the impact of identified confounders [33]. For these reasons, we decided to use a different adjustment approach for our comparison. In particular, we re-calculated the propensity score and used it as a covariate in a Cox proportional hazard regression. In this way, we maintained the number of patients in the original groups, reducing the possibility of Type II error (i.e. false-negative results). Notably, our results for the main clinical outcome of interest (survival) did not change compared with the previous version of the manuscript and thereby did not influence significantly the outcomes of the CEA where survival is just one piece of the puzzle. Since the propensity score showed a good ability to control confounding (c-statistic >0.8), the regression adjustment was able to significantly reduce the component of selection bias relative to observable factors. The selection bias relative to unobservable factors, instead, remained in the data as a noneliminable bias. Several journals rejected the paper based on this limitation (i.e. the inherent difference between an RCT and an observational study), arguing that in the absence of experimental evidence, an economic evaluation was premature.
In brief, the scientific community showed a negative position towards the acceptance of a real-world study. Cost-effectiveness, according to reviewers, is reliable if based upon experimental evidence, although the latter has not been claimed to implant the device. No one agreed to consider observational evidence different but not inferior to experimental evidence with respect to the objective of the evaluation. For policy decisions (e.g. coverage and reimbursement), external validity, adherence to real clinical practice and prompt evidence (real-world studies) are as valuable as internal validity (RCTs), and certainly more relevant than experimental study designs.
Innovation of medical devices is different enough from other technologies, namely drugs, to require different approaches to be assessed. Large investments in research are being made by several stakeholders, including the European Union (www.medtechta.eu/wps/wcm/connect/Site/MedtecHTA/Home, www.adhophta.eu and www.advance-hta.eu), to deepen our knowledge on current methods for assessing medical devices, especially dealing with clinical evidence. The debate on regulation of medical devices has very often focussed on the type and role of clinical evidence [3, 34–36]. Clinical evidence for medical devices is often more challenging to collect through traditional experimental studies such as RCTs and, although RCTs rank high in terms of internal validity, other sources of data can be relevant and reliable to take policy decisions [37], especially when the adoption and diffusion of new devices largely precede any RCTs. Real-world data represent a valid complement and/or alternative to RCTs when the latter are unable to measure the intrinsic characteristics (e.g. learning curve, incremental innovation, organisational impact and price dynamics) of medical devices and to estimate their impact on the final decisions in terms of coverage and reimbursement. Nevertheless, real-world data are not problem-free and selection bias can invalidate the final results if not correctly handled. There are several statistical techniques proven to be effective to reduce selection bias and extensively used in this field [19–22].
Our CEA analysis of Mitraclip plus OMT versus OMT alone made use of propensity score-based regression adjustment to inform decision-makers, including clinicians, as to whether its incremental costs outweigh incremental effectiveness [31].
Clinical evidence drawn from real-world studies will never be as reliable as that drawn from a perfect RCT in identifying the causal relationship between intervention and changes in clinical conditions. However, when RCTs are not possible or there is the potential to alter the randomisation because blinding is not possible, their internal validity is lower and there is no reason to argue that the selection bias reintroduced in this way is less severe than that inherent in real-world studies.
Real-world studies do not aim to show whether a technology works but, instead, if it can work in actual clinical practice. From a policy perspective, the message of a real-world study is different but not inferior to the message of a RCT. Policy makers should assess whether the technology is worth investing (incremental clinical value coupled with sustainability) and should, therefore, be more concerned with evidence produced in real settings rather than experimental ones.
Comparative RCTs for medical devices often follow the product's launch and may be available after a considerable amount of time. However, this does not delay the diffusion process, which means that real-world data can be collected and promptly assessed in the meantime so to support policy makers to provide recommendations, although not necessarily conclusive at first instance (e.g. coverage with evidence development), to control diffusion while waiting for additional evidence. If, conversely, HTA and policy recommendations are not timely, the risk is that they might be ineffective or less incisive since when they become available, the technology has already been integrated in clinical practice. Finally, we believe there is a need to acknowledge the importance of real-world studies and engage the scientific community, especially those physicians keen to adopt innovative technologies, in the promotion and use of clinical evidence produced through observational studies.
If, in the absence of RCTs, we do not believe in methodologically sound real-world data to produce clinical and economic recommendations on technological innovations, how can we dare to implant even one of these innovations in real patients?
Editorial comment in Eur Respir Rev 2016; 25: 221–222 and 223–226.
Conflict of interest: Disclosures can be found alongside this article at err.ersjournals.com
Provenance: Submitted article, peer reviewed.
Received February 26, 2016.
Accepted May 7, 2016.
ERR articles are open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.
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Q: run python script in VS code works with run python file button, but not F5 key I can run a python script by pressing the run python file button:

but unable to run the same when pressing the F5 key or run from the dropdown menu.

I can also run in the interactive window fine:

And likewise i can run a notebook fine.
other checks:
I can verify that it doesn't debug by adding a breakpoint and running.
Would there be a key-binding that is missing perhaps ?
What is causing this and how can one fix the issue please ?

A: It turns out that the error is a bug in the Python extension.
If you go to the Extensions tab, select the Python extension, then click on the little arrow next to Uninstall > Install Another Version... and install 2021.12.1559732655 the debugger should work again.
Here is the link to the fix:   https://learn.microsoft.com/en-us/answers/questions/724858/vscode-debugger-not-working-for-python.html
In the meantime disable automatic updates to make it stick until they fix that.
To do this going to settings, typing python.terminal.activateEnvironment into the search bar and deactivating the checkbox.

redpajama_set_name: RedPajamaStackExchange


text:
Animal Services: Cockfighting ring busted; animals euthanized
Group: 75 game birds found at Shingle Springs home
When a search warrant was served at a Shingle Springs property, officials found 75 game birds involved in what appears to be an illegal cockfighting operation, according to El Dorado County Animal Services.The warrant was executed at the home Wednesday, a news release from Animal Services says.Often, other crimes are associated in situations such as these, according to the release.All of the birds from Wednesday's raid were removed. Some were saved but others had to be euthanized.One man was sentenced to jail and another was deported in a hidden cockfighting operation out of El Dorado County last year, according to the release.The home in that case was located in Garden Valley.If convicted of the misdemeanor in California, penalties can include jail time and fines of up to $5,000 for a first offense and $25,000 for a second offense.
SACRAMENTO, Calif. (KCRA) —
When a search warrant was served at a Shingle Springs property, officials found 75 game birds involved in what appears to be an illegal cockfighting operation, according to El Dorado County Animal Services.
The warrant was executed at the home Wednesday, a news release from Animal Services says.
Often, other crimes are associated in situations such as these, according to the release.
All of the birds from Wednesday's raid were removed. Some were saved but others had to be euthanized.
One man was sentenced to jail and another was deported in a hidden cockfighting operation out of El Dorado County last year, according to the release.
The home in that case was located in Garden Valley.
If convicted of the misdemeanor in California, penalties can include jail time and fines of up to $5,000 for a first offense and $25,000 for a second offense.

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During your public speaking course you will learn how to properly use props throughout your presentation. The term "prop" is actually a shortened version of the theatrical word "property," which is used to describe any object handled or used by an actor in a performance. Professional speaking is technically a performance art, and as a speaker you have an obligation to use whatever means necessary to get your message across to the audience the best way possible.
points you are trying to make along with illustrating them for you. Using props can help you make better connections than your words to the visually oriented members of your audience. Props create interest, add variety, and make your points more memorable.
make on my computer. The puzzles make especially great icebreakers because the members of the group get together to help each other with the solutions.
sections independently as you learned in a previous issue. When you participate in my public speaking course you will see how all of these things come into practice.
minds of your audience, with words, with tone, with timing, with movements, and with props.
make. People can zone out easily on your words, but a unique prop is hard to ignore. Also, the visually oriented people in your audience will perk up and get more value when you use props. That way you are "painting the picture" for people in the audience who are more visual learners.
pictures far longer than words. Good public speakers know that the images will be remembered when the words are long forgotten. If you are not a great storyteller yet, you can use props to help create these pictures.
brushes and a palette to paint a picture, a good public speaker uses words and props or much more to paint pictures for the mind's eye to see.
is only about 8 inches in diameter). In your public speaking course you will learn how to creatively use props to convey a message.
holding the device near the microphone). He got his point across.
fashion. Making a point, and making it memorable, are key aspects to interesting presentations.


Draw Better uses simple text and hundreds of stunning illustrations to lead students to practical, foolproof drawing skills. Sequential drawings demonstrate the use of geometric solids, perspective, and shading. Beginners will be delighted with their results and experienced artists will discover structures they only guessed at before. The electronic version includes video sequences and an interactive glossary.


text:
Raising a Rare Girl (Paperback, NEW)
 978-0525559658
Raising a Rare Girl, Lanier explores how to defy the tyranny of normal and embrace parenthood as a spiritual practice.
"A remarkable book . . . I found myself thinking that all expectant and new parents should read it." —Michelle Slater
A New York Times Book Review Editors' Choice
Like many women of her generation, when Heather Lanier was expecting her first child she did everything by the book in the hope that she could create a SuperBaby, a supremely healthy human destined for a high-achieving future.
But her daughter Fiona challenged all of Lanier's preconceptions. Born with an ultra-rare syndrome known as Wolf-Hirschhorn, Fiona received a daunting prognosis: she would experience significant developmental delays and might not reach her second birthday. The diagnosis obliterated Lanier's perfectionist tendencies, along with her most closely held beliefs about certainty, vulnerability, God, and love.
With tiny bits of mozzarella cheese, a walker rolled to library story time, a talking iPad app, and a whole lot of pop and reggae, mother and daughter spend their days doing whatever it takes to give Fiona nourishment, movement, and language. Loving Fiona opens Lanier up to new understandings of what it means to be human, what it takes to be a mother, and above all, the aching joy and wonder that come from embracing the unique life of her rare girl.
"Lanier's memoir is now on the short list of books I'll give, when the time comes, to my own pregnant daughters. It's not just because a wise woman ought, in this as in all else, to be prepared for disaster even as she hopes for delight. It's not even because Lanier's writing is clean and beautiful. . . Lanier shines a clear light on what we sign up for when we allow a human soul to come through us and into the world, in whatever 'interesting and beautiful package' that soul might find. . . [She] teases out the glory, charm and humor of these moments, letting us adore her child with her." —Kate Braestrup, New York Times Book Review
" Raising a Rare Girl, a memoir by Heather Kirn Lanier, is a remarkable book…I found myself thinking that all expectant and new parents should read it. Lanier's thoughtful, complex, loving account of raising her daughter Fiona—now 8—who was born with an extremely rare genetic deletion that results in a syndrome called Wolf-Hirschhorn, is a beautiful and hopeful book that is also unflinching about the day-to-day challenges of her family's life. While every family's experience of raising a child with disabilities will come with its own specific challenges, Lanier's ultimate realization that the question to ask herself was not Will my daughter ever walk or talk? but How can I best love her, just as she is?" —Michelle Herman, Slate
"This is an intensely reflective and honest account….Readers share moments of anguish, terror, laughter, and triumph, as feisty Fiona grows and conquers milestones in her own unique ways. The book ends as Fiona enters Kindergarten, confident, quirky, and rare, indeed."— Booklist
"Moving and insightful . . . Lanier struggles with the attitudes of physicians and others who regard her daughter as 'damaged' and beautifully details her own acceptance. . . This intimate, powerful memoir will resonate with parents, whether of 'superbabies' or not." —Publishers Weekly
"Lanier writes with powerful humanity as she charts her course. . . Her abiding love for Fiona is clear throughout, and it's heartening to watch her learn to reject the idea that disability is deficit. . . A book of pluck, spirit, and great emotion with an appealing perspective on the value of each human life." —Kirkus Reviews
"Heather Lanier has written an exquisite narrative that is full of joy, honesty, and pain, as she details the unexpected change in her life as a new mother when her daughter is born with a rare syndrome. In Raising a Rare Girl, Lanier writes with passion in each line, infusing wisdom in her stunning prose as she shares the most intimate moments of new motherhood. Lanier has created a book that could only be written by someone with the skill of poet and heart of an optimist. And at a time when mothers are expected to be perfect as parents, advocates, professionals, and partners, Lanier redefines the word perfect, and in doing so, teaches us all to find beauty in the necessary imperfections of our lives."— Elizabeth L Silver, author of The Tincture of Time
"This gem of a memoir reminds us that when we become parents, we are signing up for the precarious vulnerability of being human. Gorgeously written, and simultaneously as warm and intimate as a conversation with your wisest friend, Raising a Rare Girl is a moving testament to the transcendence of unconditional love."— Liane Kupferberg Carter, author of Ketchup is My Favorite Vegetable
"Heather Lanier has written a brave and beautiful memoir on her journey in early pregnancy as she hoped to create a SuperBaby, and then as she coped with the shocking news that her newborn daughter had been born with a rare syndrome that would require ongoing interventions for walking and talking. Lanier's prose is dazzling, and her honesty is crushing. In Raising a Rare Girl, she demonstrates the depths of maternal love—and, in our historically perfectionistic society, the true meaning of triumph." —Gabrielle Glaser, author of American Baby
"Heather Lanier's Raising a Rare Girl is that rare soaring book: a gripping read that delivers spiritual reflection and serious cultural analysis on disability and parenthood. These sentences are sheer poetry, and in the service of dissecting the ableism in our culture, they are also piercing and necessary." —Sonya Huber, author of Pain Woman Takes Your Keys and Other Essays from a Nervous System
"Heather Lanier has crafted a provocative examination of the difference between who we think we are and our being. Raising a Rare Girl is, at turns, heartbreaking and heart-soaring. It's a hard-earned, generous, and insightful investigation of our bodies and our souls, grief and joy, holding on tight and letting go, as well as the worlds that take shape around us and the worlds we create from within."— Julianna Baggott, author of Harriet Wolf's Seventh Book of Wonders
" Raising a Rare Girl is not just a memoir about Heather Lanier's first few years as a mother, nor is it only about the challenges of raising a child with a rare syndrome in a world that does not welcome differences. It's a tender and powerful book that asks us to look honestly at what we expect of our children, each other, and ourselves, and explores the unexpected joy that comes when we release those expectations. Lanier had no choice but to let go of her expectations of motherhood, herself, and her baby when Fiona came into this world, and we are the lucky recipients of the loving wisdom she gained in doing so." —Kerry Egan, author of On Living
"What does it mean to be a 'good' parent in an age of over-parenting? And why do so many of us assume if we just do everything 'right,' we can make the 'perfect,' baby? With immense tenderness, intelligence, and humor, Heather Lanier explores these questions in her memoir about raising a rare girl. The result is an arresting and beautiful book about the transformative power of unconditional love. Everyone should read it." —Kim Brooks, author of Small Animals
"With Raising a Rare Girl, Heather Lanier has written a luminous memoir about disability, life, and ardor. There is wholeheartedness and passion in this tale of parental joy and wisdom." —Stephen Kuusisto, author of Have Dog, Will Travel
Heather Lanier is an essayist, memoirist, and poet. She's the author of two award-winning poetry chapbooks: Heart-Shaped Bed in Hiroshima and The Story You Tell Yourself, winner of the Wick Poetry Open Chapbook Competition. Her nonfiction has appeared in Salon, The Southern Review, The Threepenny Review, Fourth Genre, Brevity, Vela, and elsewhere. She has received an Ohio Arts Council Individual Excellence Award and a Vermont Creation Grant. A graduate of Ohio State University's MFA program, she's now an Assistant Professor of Creative Nonfiction at Rowan University. Her TED talk, "'Good' and 'Bad' Are Incomplete Stories We Tell Ourselves," has been viewed over two million times.
Publisher  :  Penguin Books; Reprint edition (July 6, 2021)
Dimensions  :  5.51 x 0.81 x 8.24 inches


The Jetmarine Bridge Plate allows flush positioning of platforms where door sills extend beyond the threshold.
Jetmarine bridge plates allow flush positioning of platforms where door sills extend beyond the threshold. British made. GRP construction. White colour ramp with non-slip surface in a choice of contrasting colour.


text:
Q: Ошибка при запуске в IntelliJ IDEA При запуске любой программы высвечивается ошибка (на скрине). Подскажите, пожалуйста, как это исправить

A:
Перенес config в папку IdeaConfig (предварительно создал на диске C), но ничего не изменилось

Вам недостаточно перенести папку в другое место. Нужно изменять конфигурацию IDEA.

*

*Открываете файл: path/to/idea/bin/idea.properties

*Вам нужны пункты idea.config.path и idea.system.pathУберите от них комментарии и установите путь, в котором не будет кириллических символов. (Требуется использовать прямые слеши)

*Желательно также изменить idea.plugins.path и idea.log.path

*Сохраняете файл и перезапускаете IDEA

P.S
Это может решить не все ваши проблемы (у меня, например, после этих действий заработала отладка, но режим Run with coverage так и не запустился).
Так что лучше использовать имя пользователя на латинице.


Pack of 4 heavy duty base pods to keep your gazebo on the ground. The two halves easily secure together, wrapping around your gazebo leg, by thumb screw. You can fill these beauties with either sand or water.
Alternatively, you can also have a look at the Sand Bag Kit or the Deluxe Sand Bag Kit (heavier duty fabric). These are flexible canvas fabric bags which are filled with sand only.
A: When you say Gazebo Weights do you mean the Base Pod Kit? The Base Pods weight 8 - 11 kg when filled with water or sand (as opposed to 3 - 5 kg for the sand bags) so they do tend to be sturdier due to the extra weight. They are however a little bit wider when on the feet of the gazebo and do take up a bit more space when packed away, which some people see as a negative.
A: Unfortunately we don't do any printing at all. The Removable Awning Kit is only available with Navy Blue fabric. The 3m x 3m Gazebo is available in White. There is also a Corporate 3m x 3m Gazebo in white which is a little bit heavier duty. OZtrail don't have water bags as such, we do however have Base Pods which you can fill with water. There are quite a few different walls available too.


Last semester was a whirlwind that, in hindsight, went by so fast. It was filled with many firsts, from my first day of college to my first OSU football game as a Buckeye. I entered as a criminology major and I'm glad that this has proven to work out for me so far. I love learning and with this major it's been really intriguing to learn some of the processes behind why we behave the way we do and the theory of crime along with crime statistics.
The start of college also signified my start as a Mount Leadership Society Scholar and Morrill Scholar. My whole life I've been involved in different advocacy, community service, and leadership experiences that I was glad to continue it with these two incredible programs. From going to retreat to attending Leadership Summit, it's been a blast. I loved volunteering for various service events and even joining the R.O.W. (Recruitment, Outreach, and Welcoming) committee for Mount.
I also started my Girl's Circle journey with participating in Women's Circle. To prepare us for working with Columbus area girls and help us learn about ourselves, we were in small groups to discuss our own experiences as women. I found this to be very powerful and motivating just to have a place where I could go during the week, leave whatever else I was dealing with at the door, and just have open dialogue with other women. Every week that time was so therapeutic and refreshing to be able to release my feelings from different life experiences I've had, while learning more about myself and the women around me. I look forward to leading a Girl's Circle this semester and not only make an impact on these young women, but also continue to learn more about myself.
This semester I hope to continue my academic progress and drive. I'm excited to pursue new academic and career focused opportunities along with continuing to develop my leadership and interpersonal skills. I can't wait to see what's ahead and I look forward to more experiences with my fellow Mounties, MSP, and Girl's Circle!
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