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The authors of “The anglerfish deception” respond to the criticism of their article.EMBO reports (2012) advanced online publication; doi: 10.1038/embor.2012.70EMBO reports (2012) 13
2, 100–105; doi: 10.1038/embor.2011.254Our respondents, eight current or former members of the EFSA GMO panel, focus on defending the EFSA''s environmental risk assessment (ERA) procedures. In our article for EMBO reports, we actually focused on the proposed EU GMO legislative reform, especially the European Commission (EC) proposal''s false political inflation of science, which denies the normative commitments inevitable in risk assessment (RA). Unfortunately the respondents do not address this problem. Indeed, by insisting that Member States enjoy freedom over risk management (RM) decisions despite the EFSA''s central control over RA, they entirely miss the relevant point. This is the unacknowledged policy—normative commitments being made before, and during, not only after, scientific ERA. They therefore only highlight, and extend, the problem we identified.The respondents complain that we misunderstood the distinction between RA and RM. We did not. We challenged it as misconceived and fundamentally misleading—as though only objective science defined RA, with normative choices cleanly confined to RM. Our point was that (i) the processes of scientific RA are inevitably shaped by normative commitments, which (ii) as a matter of institutional, policy and scientific integrity must be acknowledged and inclusively deliberated. They seem unaware that many authorities [1,2,3,4] have recognized such normative choices as prior matters, of RA policy, which should be established in a broadly deliberative manner “in advance of risk assessment to ensure that [RA] is systematic, complete, unbiased and transparent” [1]. This was neither recognized nor permitted in the proposed EC reform—a central point that our respondents fail to recognize.In dismissing our criticism that comparative safety assessment appears as a ‘first step'' in defining ERA, according to the new EFSA ERA guidelines, which we correctly referred to in our text but incorrectly referenced in the bibliography [5], our respondents again ignore this widely accepted ‘framing'' or ‘problem formulation'' point for science. The choice of comparator has normative implications as it immediately commits to a definition of what is normal and, implicitly, acceptable. Therefore the specific form and purpose of the comparison(s) is part of the validity question. Their claim that we are against comparison as a scientific step is incorrect—of course comparison is necessary. This simply acts as a shield behind which to avoid our and others'' [6] challenge to their self-appointed discretion to define—or worse, allow applicants to define—what counts in the comparative frame. Denying these realities and their difficult but inevitable implications, our respondents instead try to justify their own particular choices as ‘science''. First, they deny the first-step status of comparative safety assessment, despite its clear appearance in their own ERA Guidance Document [5]—in both the representational figure (p.11) and the text “the outcome of the comparative safety assessment allows the determination of those ‘identified'' characteristics that need to be assessed [...] and will further structure the ERA” (p.13). Second, despite their claims to the contrary, ‘comparative safety assessment'', effectively a resurrection of substantial equivalence, is a concept taken from consumer health RA, controversially applied to the more open-ended processes of ERA, and one that has in fact been long-discredited if used as a bottleneck or endpoint for rigorous RA processes [7,8,9,10]. The key point is that normative commitments are being embodied, yet not acknowledged, in RA science. This occurs through a range of similar unaccountable RA steps introduced into the ERA Guidance, such as judgement of ‘biological relevance'', ‘ecological relevance'', or ‘familiarity''. We cannot address these here, but our basic point is that such endless ‘methodological'' elaborations of the kind that our EFSA colleagues perform, only obscure the institutional changes needed to properly address the normative questions for policy-engaged science.Our respondents deny our claim concerning the singular form of science the EC is attempting to impose on GM policy and debate, by citing formal EFSA procedures for consultations with Member States and non-governmental organizations. However, they directly refute themselves by emphasizing that all Member State GM cultivation bans, permitted only on scientific grounds, have been deemed invalid by EFSA. They cannot have it both ways. We have addressed the importance of unacknowledged normativity in quality assessments of science for policy in Europe elsewhere [11]. However, it is the ‘one door, one key'' policy framework for science, deriving from the Single Market logic, which forces such singularity. While this might be legitimate policy, it is not scientific. It is political economy.Our respondents conclude by saying that the paramount concern of the EFSA GMO panel is the quality of its science. We share this concern. However, they avoid our main point that the EC-proposed legislative reform would only exacerbate their problem. Ignoring the normative dimensions of regulatory science and siphoning-off scientific debate and its normative issues to a select expert panel—which despite claiming independence faces an EU Ombudsman challenge [12] and European Parliament refusal to discharge their 2010 budget, because of continuing questions over conflicts of interests [13,14]—will not achieve quality science. What is required are effective institutional mechanisms and cultural norms that identify, and deliberatively address, otherwise unnoticed normative choices shaping risk science and its interpretive judgements. It is not the EFSA''s sole responsibility to achieve this, but it does need to recognize and press the point, against resistance, to develop better EU science and policy. 相似文献
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Elucidating the temporal order of silencing 总被引:1,自引:0,他引:1
Izaurralde E 《EMBO reports》2012,13(8):662-663
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Background:Very little research has described risk of suicidal ideation and suicide attempt among transgender youth using high-quality, nationally representative data. We aimed to assess risk of suicidality among transgender and sexual minority adolescents in Canada.Methods:We analyzed a subsample of adolescents aged 15–17 years from the 2019 Canadian Health Survey on Children and Youth, a nationally representative, cross-sectional survey. We defined participants’ transgender identity (self-reported gender different from sex assigned at birth) and sexual minority status (self-reported attraction to people of the same gender) as exposures, and their self-reported previous-year suicidal ideation and lifetime suicide attempt as outcomes.Results:We included 6800 adolescents aged 15–17 years, including 1130 (16.5%) who indicated some degree of same-gender attraction, 265 (4.3%) who were unsure of their attraction and 50 (0.6%) who reported a transgender identity. Compared with cisgender, heterosexual adolescents, transgender adolescents showed 5 times the risk of suicidal ideation (95% confidence interval [CI] 3.63 to 6.75; 58% v. 10%) and 7.6 times the risk of suicide attempt (95% CI 4.76 to 12.10; 40% v. 5%). Among cisgender adolescents, girls attracted to girls had 3.6 times the risk of previous-year suicidal ideation (95% CI 2.59 to 5.08) and 3.3 times the risk of having ever attempted suicide (95% CI 1.81 to 6.06), compared with their heterosexual peers. Adolescents attracted to multiple genders had 2.5 times the risk of suicidal ideation (95% CI 2.12 to 2.98) and 2.8 times the risk of suicide attempt (95% CI 2.18 to 3.68). Youth questioning their sexual orientation had twice the risk of having attempted suicide in their lifetime (95% CI 1.23 to 3.36).Interpretation:We observed that transgender and sexual minority adolescents were at increased risk of suicidal ideation and attempt compared with their cisgender and heterosexual peers. These findings highlight the need for inclusive prevention approaches to address suicidality among Canada’s diverse youth population.Suicide is the second leading cause of death among adolescents and young adults aged 15–24 years in Canada.1,2 Suicidal ideation and suicide attempt are common among adolescents3 and are risk factors for death by suicide.4 Sexual minority youth (i.e., youth who are attracted to the same gender or multiple genders, or who identify as lesbian, gay, bisexual or queer)5 are known to be at increased risk of poor mental health,6–8 including suicidal ideation and attempt.5–10 Over the previous 2 decades, stigma around identifying as a sexual minority has reduced;7 however, the risk of poor mental health and of suicidality remains high among sexual minority youth.7,11 This population is still more likely to experience bullying and peer victimization,9,12,13 which is associated with suicidality among sexual minority adolescents.5Transgender youth are those whose gender identity does not match their sex assigned at birth.14 Among other terms, gender-nonconforming, nonbinary, genderqueer and genderfluid are used to describe the gender identity of a subset of young people who identify outside the gender binary (i.e., as neither male nor female) or who experience fluidity between genders.9 Suicidality among transgender and gender-nonconforming adolescents is not as well studied. In a Canadian survey of transgender and gender-nonconforming youth aged 14–25 years, 64% of participants reported that they had seriously considered suicide in the previous 12 months.15 Transgender and gender-nonconforming youth seem to have a higher probability of many risk factors for suicidality, including peer victimization,8,16 family dysfunction7,17 and barriers to accessing mental health care.18 However, the epidemiology of suicidality among transgender and gender-nonconforming youth remains understudied in population-based samples; most research on the mental health of transgender youth comes from small community samples of help-seeking youth or targeted surveys of transgender adolescents.5,19,20 Two population-based studies from California21 and New Zealand22 suggested that transgender youth are at increased risk of suicidal ideation and suicide attempt. However, only the New Zealand study22 used the gold-standard measure of gender identity, contrasting adolescents’ sex assigned at birth with their self-identified gender.23Further epidemiological research employing large, representative samples and adequate measures of gender identity is needed to understand the burden of suicidality among lesbian, gay, bisexual, transgender and queer youth. We sought to build on existing evidence to assess risk of suicidal ideation and attempt among transgender and sexual minority adolescents in Canada, as compared with their cisgender and heterosexual peers, as well as to explore the relation between suicidality and experience of bullying. 相似文献
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The temptation to silence dissenters whose non-mainstream views negatively affect public policies is powerful. However, silencing dissent, no matter how scientifically unsound it might be, can cause the public to mistrust science in general.Dissent is crucial for the advancement of science. Disagreement is at the heart of peer review and is important for uncovering unjustified assumptions, flawed methodologies and problematic reasoning. Enabling and encouraging dissent also helps to generate alternative hypotheses, models and explanations. Yet, despite the importance of dissent in science, there is growing concern that dissenting voices have a negative effect on the public perception of science, on policy-making and public health. In some cases, dissenting views are deliberately used to derail certain policies. For example, dissenting positions on climate change, environmental toxins or the hazards of tobacco smoke [1,2] seem to laypeople as equally valid conflicting opinions and thereby create or increase uncertainty. Critics often use legitimate scientific disagreements about narrow claims to reinforce the impression of uncertainty about general and widely accepted truths; for instance, that a given substance is harmful [3,4]. This impression of uncertainty about the evidence is then used to question particular policies [1,2,5,6].The negative effects of dissent on establishing public polices are present in cases in which the disagreements are scientifically well-grounded, but the significance of the dissent is misunderstood or blown out of proportion. A study showing that many factors affect the size of reef islands, to the effect that they will not necessarily be reduced in size as sea levels rise [7], was simplistically interpreted by the media as evidence that climate change will not have a negative impact on reef islands [8].In other instances, dissenting voices affect the public perception of and motivation to follow public-health policies or recommendations. For example, the publication of a now debunked link between the measles, mumps and rubella vaccine and autism [9], as well as the claim that the mercury preservative thimerosal, which was used in childhood vaccines, was a possible risk factor for autism [10,11], created public doubts about the safety of vaccinating children. Although later studies showed no evidence for these claims, doubts led many parents to reject vaccinations for their children, risking the herd immunity for diseases that had been largely eradicated from the industrialized world [12,13,14,15]. Many scientists have therefore come to regard dissent as problematic if it has the potential to affect public behaviour and policy-making. However, we argue that such concerns about dissent as an obstacle to public policy are both dangerous and misguided.Whether dissent is based on genuine scientific evidence or is unfounded, interested parties can use it to sow doubt, thwart public policies, promote problematic alternatives and lead the public to ignore sound advice. In response, scientists have adopted several strategies to limit these negative effects of dissent—masking dissent, silencing dissent and discrediting dissenters. The first strategy aims to present a united front to the public. Scientists mask existing disagreements among themselves by presenting only those claims or pieces of evidence about which they agree [16]. Although there is nearly universal agreement among scientists that average global temperatures are increasing, there are also legitimate disagreements about how much warming will occur, how quickly it will occur and the impact it might have [7,17,18,19]. As presenting these disagreements to the public probably creates more doubt and uncertainty than is warranted, scientists react by presenting only general claims [20].A second strategy is to silence dissenting views that might have negative consequences. This can take the form of self-censorship when scientists are reluctant to publish or publicly discuss research that might—incorrectly—be used to question existing scientific knowledge. For example, there are genuine disagreements about how best to model cloud formation, water vapour feedback and aerosols in general circulation paradigms, all of which have significant effects on the magnitude of global climate change predictions [17,19]. Yet, some scientists are hesitant to make these disagreements public, for fear that they will be accused of being denialists, faulted for confusing the public and policy-makers, censured for abating climate-change deniers, or criticized for undermining public policy [21,22,23,24].…there is growing concern that dissenting voices can have a negative effect on the public perception of science, on policy-making and public healthAnother strategy is to discredit dissenters, especially in cases in which the dissent seems to be ideologically motivated. This could involve publicizing the financial or political ties of the dissenters [2,6,25], which would call attention to their probable bias. In other cases, scientists might discredit the expertise of the dissenter. One such example concerns a 2007 study published in the Proceedings of the National Academy of Sciences USA, which claimed that cadis fly larvae consuming Bt maize pollen die at twice the rate of flies feeding on non-Bt maize pollen [26]. Immediately after publication, both the authors and the study itself became the target of relentless and sometimes scathing attacks from a group of scientists who were concerned that anti-GMO (genetically modified organism) interest groups would seize on the study to advance their agenda [27]. The article was criticized for its methodology and its conclusions, the Proceedings of the National Academy of Sciences USA was criticized for publishing the article and the US National Science Foundation was criticized for funding the study in the first place.Public policies, health advice and regulatory decisions should be based on the best available evidence and knowledge. As the public often lack the expertise to assess the quality of dissenting views, disagreements have the potential to cast doubt over the reliability of scientific knowledge and lead the public to question relevant policies. Strategies to block dissent therefore seem reasonable as a means to protect much needed or effective health policies, advice and regulations. However, even if the public were unable to evaluate the science appropriately, targeting dissent is not the most appropriate strategy to prevent negative side effects for several reasons. Chiefly, it contributes to the problems that the critics of dissent seek to address, namely increasing the cacophony of dissenting voices that only aim to create doubt. Focusing on dissent as a problematic activity sends the message to policy-makers and the public that any dissent undermines scientific knowledge. Reinforcing this false assumption further incentivizes those who seek merely to create doubt to thwart particular policies. Not surprisingly, think-tanks, industry and other organizations are willing to manufacture dissent simply to derail policies that they find economically or ideologically undesirable.Another danger of targeting dissent is that it probably stifles legitimate crucial voices that are needed for both advancing science and informing sound policy decisions. Attacking dissent makes scientists reluctant to voice genuine doubts, especially if they believe that doing so might harm their reputations, damage their careers and undermine prevailing theories or policies needed. For instance, a panel of scientists for the US National Academy of Sciences, when presenting a risk assessment of radiation in 1956, omitted wildly different predictions about the potential genetic harm of radiation [16]. They did not include this wide range of predictions in their final report precisely because they thought the differences would undermine confidence in their recommendations. Yet, this information could have been relevant to policy-makers. As such, targeting dissent as an obstacle to public policy might simply reinforce self-censorship and stifle legitimate and scientifically informed debate. If this happens, scientific progress is hindered.Second, even if the public has mistaken beliefs about science or the state of the knowledge of the science in question, focusing on dissent is not an effective way to protect public policy from false claims. It fails to address the presumed cause of the problem—the apparent lack of understanding of the science by the public. A better alternative would be to promote the public''s scientific literacy. If the public were educated to better assess the quality of the dissent and thus disregard instances of ideological, unsupported or unsound dissent, dissenting voices would not have such a negative effect. Of course, one might argue that educating the public would be costly and difficult, and that therefore, the public should simply listen to scientists about which dissent to ignore and which to consider. This is, however, a paternalistic attitude that requires the public to remain ignorant ‘for their own good''; a position that seems unjustified on many levels as there are better alternatives for addressing the problem.Moreover, silencing dissent, rather than promoting scientific literacy, risks undermining public trust in science even if the dissent is invalid. This was exemplified by the 2009 case of hacked e-mails from a computer server at the University of East Anglia''s Climate Research Unit (CRU). After the selective leaking of the e-mails, climate scientists at the CRU came under fire because some of the quotes, which were taken out of context, seemed to suggest that they were fudging data or suppressing dissenting views [28,29,30,31]. The stolen e-mails gave further ammunition to those opposing policies to reduce greenhouse emissions as they could use accusations of data ‘cover up'' as proof that climate scientists were not being honest with the public [29,30,31]. It also allowed critics to present climate scientists as conspirators who were trying to push a political agenda [32]. As a result, although there was nothing scientifically inappropriate revealed in the ‘climategate'' e-mails, it had the consequence of undermining the public''s trust in climate science [33,34,35,36].A significant amount of evidence shows that the ‘deficit model'' of public understanding of science, as described above, is too simplistic to account correctly for the public''s reluctance to accept particular policy decisions [37,38,39,40]. It ignores other important factors such as people''s attitudes towards science and technology, their social, political and ethical values, their past experiences and the public''s trust in governmental institutions [41,42,43,44]. The development of sound public policy depends not only on good science, but also on value judgements. One can agree with the scientific evidence for the safety of GMOs, for instance, but still disagree with the widespread use of GMOs because of social justice concerns about the developing world''s dependence on the interests of the global market. Similarly, one need not reject the scientific evidence about the harmful health effects of sugar to reject regulations on sugary drinks. One could rationally challenge such regulations on the grounds that informed citizens ought to be able to make free decisions about what they consume. Whether or not these value judgements are justified is an open question, but the focus on dissent hinders our ability to have that debate.Focusing on dissent as a problematic activity sends the message to policy-makers and the public that any dissent undermines scientific knowledgeAs such, targeting dissent completely fails to address the real issues. The focus on dissent, and the threat that it seems to pose to public policy, misdiagnoses the problem as one of the public misunderstanding science, its quality and its authority. It assumes that scientific or technological knowledge is the only relevant factor in the development of policy and it ignores the role of other factors, such as value judgements about social benefits and harms, and institutional trust and reliability [45,46]. The emphasis on dissent, and thus on scientific knowledge, as the only or main factor in public policy decisions does not give due attention to these legitimate considerations.Furthermore, by misdiagnosing the problem, targeting dissent also impedes more effective solutions and prevents an informed debate about the values that should guide public policy. By framing policy debates solely as debates over scientific facts, the normative aspects of public policy are hidden and neglected. Relevant ethical, social and political values fail to be publicly acknowledged and openly discussed.Controversies over GMOs and climate policies have called attention to the negative effects of dissent in the scientific community. Based on the assumption that the public''s reluctance to support particular policies is the result of their inability to properly understand scientific evidence, scientists have tried to limit dissenting views that create doubt. However, as outlined above, targeting dissent as an obstacle to public policy probably does more harm than good. It fails to focus on the real problem at stake—that science is not the only relevant factor in sound policy-making. Of course, we do not deny that scientific evidence is important to the develop.ment of public policy and behavioural decisions. Rather, our claim is that this role is misunderstood and often oversimplified in ways that actually contribute to problems in developing sound science-based policies.?
Open in a separate windowInmaculada de Melo-MartínOpen in a separate windowKristen Intemann 相似文献
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Adam T. Hancock Christian D. Mallen Sara Muller John Belcher Edward Roddy Toby Helliwell Samantha L. Hider 《CMAJ》2014,186(13):E495-E501
Background:
Polymyalgia rheumatica is one of the most common inflammatory rheumatologic conditions in older adults. Other inflammatory rheumatologic disorders are associated with an excess risk of vascular disease. We investigated whether polymyalgia rheumatica is associated with an increased risk of vascular events.Methods:
We used the General Practice Research Database to identify patients with a diagnosis of incident polymyalgia rheumatica between Jan. 1, 1987, and Dec. 31, 1999. Patients were matched by age, sex and practice with up to 5 patients without polymyalgia rheumatica. Patients were followed until their first vascular event (cardiovascular, cerebrovascular, peripheral vascular) or the end of available records (May 2011). All participants were free of vascular disease before the diagnosis of polymyalgia rheumatica (or matched date). We used Cox regression models to compare time to first vascular event in patients with and without polymyalgia rheumatica.Results:
A total of 3249 patients with polymyalgia rheumatica and 12 735 patients without were included in the final sample. Over a median follow-up period of 7.8 (interquartile range 3.3–12.4) years, the rate of vascular events was higher among patients with polymyalgia rheumatica than among those without (36.1 v. 12.2 per 1000 person-years; adjusted hazard ratio 2.6, 95% confidence interval 2.4–2.9). The increased risk of a vascular event was similar for each vascular disease end point. The magnitude of risk was higher in early disease and in patients younger than 60 years at diagnosis.Interpretation:
Patients with polymyalgia rheumatica have an increased risk of vascular events. This risk is greatest in the youngest age groups. As with other forms of inflammatory arthritis, patients with polymyalgia rheumatica should have their vascular risk factors identified and actively managed to reduce this excess risk.Inflammatory rheumatologic disorders such as rheumatoid arthritis,1,2 systemic lupus erythematosus,2,3 gout,4 psoriatic arthritis2,5 and ankylosing spondylitis2,6 are associated with an increased risk of vascular disease, especially cardiovascular disease, leading to substantial morbidity and premature death.2–6 Recognition of this excess vascular risk has led to management guidelines advocating screening for and management of vascular risk factors.7–9Polymyalgia rheumatica is one of the most common inflammatory rheumatologic conditions in older adults,10 with a lifetime risk of 2.4% for women and 1.7% for men.11 To date, evidence regarding the risk of vascular disease in patients with polymyalgia rheumatica is unclear. There are a number of biologically plausible mechanisms between polymyalgia rheumatica and vascular disease. These include the inflammatory burden of the disease,12,13 the association of the disease with giant cell arteritis (causing an inflammatory vasculopathy, which may lead to subclinical arteritis, stenosis or aneurysms),14 and the adverse effects of long-term corticosteroid treatment (e.g., diabetes, hypertension and dyslipidemia).15,16 Paradoxically, however, use of corticosteroids in patients with polymyalgia rheumatica may actually decrease vascular risk by controlling inflammation.17 A recent systematic review concluded that although some evidence exists to support an association between vascular disease and polymyalgia rheumatica,18 the existing literature presents conflicting results, with some studies reporting an excess risk of vascular disease19,20 and vascular death,21,22 and others reporting no association.23–26 Most current studies are limited by poor methodologic quality and small samples, and are based on secondary care cohorts, who may have more severe disease, yet most patients with polymyalgia rheumatica receive treatment exclusively in primary care.27The General Practice Research Database (GPRD), based in the United Kingdom, is a large electronic system for primary care records. It has been used as a data source for previous studies,28 including studies on the association of inflammatory conditions with vascular disease29 and on the epidemiology of polymyalgia rheumatica in the UK.30 The aim of the current study was to examine the association between polymyalgia rheumatica and vascular disease in a primary care population. 相似文献10.
Ian Williamson Jane Vennik Anthony Harnden Merryn Voysey Rafael Perera Sadie Kelly Guiqing Yao James Raftery David Mant Paul Little 《CMAJ》2015,187(13):961-969
Background:Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting.Methods:We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4–11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1–3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation.Results:Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score −0.42, 95% CI −0.63 to −0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups.Interpretation:Autoinflation in children aged 4–11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. Trial registration: ISRCTN, No. 55208702.Otitis media with effusion, also known as glue ear, is an accumulation of fluid in the middle ear, without symptoms or signs of an acute ear infection. It is often associated with viral infection.1–3 The prevalence rises to 46% in children aged 4–5 years,4 when hearing difficulty, other ear-related symptoms and broader developmental concerns often bring the condition to medical attention.3,5,6 Middle-ear fluid is associated with conductive hearing losses of about 15–45 dB HL.7 Resolution is clinically unpredictable,8–10 with about a third of cases showing recurrence.11 In the United Kingdom, about 200 000 children with the condition are seen annually in primary care.12,13 Research suggests some children seen in primary care are as badly affected as those seen in hospital.7,9,14,15 In the United States, there were 2.2 million diagnosed episodes in 2004, costing an estimated $4.0 billion.16 Rates of ventilation tube surgery show variability between countries,17–19 with a declining trend in the UK.20Initial clinical management consists of reasonable temporizing or delay before considering surgery.13 Unfortunately, all available medical treatments for otitis media with effusion such as antibiotics, antihistamines, decongestants and intranasal steroids are ineffective and have unwanted effects, and therefore cannot be recommended.21–23 Not only are antibiotics ineffective, but resistance to them poses a major threat to public health.24,25 Although surgery is effective for a carefully selected minority,13,26,27 a simple low-cost, nonsurgical treatment option could benefit a much larger group of symptomatic children, with the purpose of addressing legitimate clinical concerns without incurring excessive delays.Autoinflation using a nasal balloon device is a low-cost intervention with the potential to be used more widely in primary care, but current evidence of its effectiveness is limited to several small hospital-based trials28 that found a higher rate of tympanometric resolution of ear fluid at 1 month.29–31 Evidence of feasibility and effectiveness of autoinflation to inform wider clinical use is lacking.13,28 Thus we report here the findings of a large pragmatic trial of the clinical effectiveness of nasal balloon autoinflation in a spectrum of children with clinically confirmed otitis media with effusion identified from primary care. 相似文献
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The debate about GM crops in Europe holds valuable lessons about risk management and risk communication. These lessons will be helpful for the upcoming debate on GM animals.Biomedical research and biotechnology have grown enormously in the past decades, as nations have heavily invested time and money in these endeavours to reap the benefits of the so-called ‘bioeconomy''. Higher investments on research should increase knowledge, which is expected to translate into applied research and eventually give rise to new products and services that are of economic or social benefit. Many governments have developed ambitious strategies—both economic and political—to accelerate this process and fuel economic growth (http://www.oecd.org/futures/bioeconomy/2030). However, it turns out that social attitudes are a more important factor for translating scientific advances than previously realized; public resistance can effectively slow down or even halt technological progress, and some hoped-for developments have hit roadblocks. Addressing these difficulties has become a major challenge for policy-makers, who have to find the middle ground between promoting innovation and addressing ethical and cultural values.There are many examples of how scientific and technological advances raise broad societal concerns: research that uses human embryonic stem cells, nanotechnology, cloning and genetically modified (GM) organisms are perhaps the most contested ones. The prime example of a promising technology that has failed to reach its full potential owing to ethical, cultural and societal concerns is GM organisms (GMOs); specifically, GM crops. Intense lobbying and communication by ‘anti-GM'' groups, combined with poor public relations from industry and scientists, has turned consumers against GM crops and has largely hampered the application of this technology in most European countries. Despite this negative outcome, however, the decade-long debate has provided important lessons and insight for the management of other controversial technologies: in particular, the use of GM animals.During the early 1990s, ‘anti-GM'' non-governmental organizations (NGOs) and ‘pro-GM'' industry were the main culprits for the irreversible polarization of the GMO debate. Both groups lobbied policy-makers and politicians, but NGOs ultimately proved better at persuading the public, a crucial player in the debate. Nevertheless, the level of public outcry varied significantly, reaching its peak in the European Union (EU). In addition to the values of citizens and effective campaigning by NGOs, the structural organization of the EU had a crucial role in triggering the GMO crisis. Within the EU, the European Commission (EC) is an administrative body the decisions of which have a legal impact on the 27 Member States. The EC is well-aware of its unique position and has compensated its lack of democratic accountability by increasing transparency and making itself accessible to the third sector [1]. This strategy was an important factor in the GMO debate as the EC was willing to listen to the views of environmental groups and consumer organizations.…it turns out that social attitudes are a more important factor for translating scientific advances than previously realized…Environmental NGOs successfully exploited this gap between the European electorate and the EC, and assumed to speak as the vox populi in debates. At the same time, politicians in EU Member States were faced with aggressive anti-GMO campaigns and increasingly polarized debates. To avoid the lobbying pressure and alleviate public concerns, they chose to hide behind science: the result was a proliferation of ‘scientific committees'' charged with assessing the health and environmental risks of GM crops.Scientists soon realized that their so-called ‘expert consultation'' was only a political smoke screen in most cases. Their reports and advice were used as arguments to justify policies—rather than tools for determining policy—that sometimes ignored the actual evidence and scientific results [2,3]. For example, in 2008, French President Nikolas Sarkozy announced that he would not authorize GM pest-resistant MON810 maize for cultivation in France if ‘the experts'' had any concerns over its safety. However, although the scientific committee appointed to assess MON810 concluded that the maize was safe for cultivation, the government''s version of the report eventually claimed that scientists had “serious doubts” on MON810 safety, which was then used as an argument to ban its cultivation. Francoise Hollande''s government has adopted a similar strategy to maintain the ban on MON810 [4].In addition to the values of citizens and effective campaigning by NGOs, the structural organization of the EU had a crucial role in triggering the GMO crisisSuch unilateral decisions by Member States challenged the EC''s authority to approve the cultivation of GM crops in the EU. After intense discussions, the EC and the Member States agreed on a centralized procedure for the approval of GMOs and the distribution of responsibilities for the three stages of the risk management process: risk assessment, risk management and risk communication (Fig 1). The European Food Safety Authority (EFSA) alone would be responsible for carrying out risk assessment, whilst the Member States would deal with risk management through the standard EU comitology procedure, by which policy-makers from Member States reach consensus on existing laws. Finally, both the EC and Member States committed to engage with European citizens in an attempt to gain credibility and promote transparency.Open in a separate windowFigure 1Risk assessment and risk management for GM crops in the EU. The new process for GM crop approval under Regulation (EC) No. 1829/2003, which defines the responsibilities for risk assessment and risk management. EC, European Community; EU, European Union; GM, genetically modified.More than 20 years after this debate, the claims made both for and against GM crops have failed to materialize. GMOs have neither reduced world hunger, nor destroyed entire ecosystems or poisoned humankind, even after widespread cultivation. Most of the negative effects have occurred in international food trade [5], partly owing to a lack of harmonization in international governance. More importantly, given that the EU is the largest commodity market in the world, this is caused by the EU''s chronic resistance to GM crops. The agreed centralized procedure has not been implemented satisfactorily and the blame is laid at the door of risk management (http://ec.europa.eu/food/food/biotechnology/evaluation/index_en.htm). Indeed, the 27 Member States have never reached a consensus on GM crops, which is the only non-functional comitology procedure in the EU [2]. Moreover, even after a GM crop was approved, some member states refused to allow its cultivation, which prompted the USA, Canada and Argentina to file a dispute at the World Trade Organization (WTO) against the EU.The inability to reach agreement through the comitology procedure, has forced the EC to make the final decision for all GMO applications. Given that the EC is an administrative body with no scientific expertise, it has relied heavily on EFSA''s opinion. This has created a peculiar situation in which the EFSA performs both risk assessment and management. Anti-GM groups have therefore focused their efforts on discrediting the EFSA as an expert body. Faced with regular questions related to agricultural management or globalization, EFSA scientists are forced to respond to issues that are more linked to risk management than risk assessment [5]. By repeatedly mixing socio-economic and cultural values with scientific opinions, NGOs have questioned the expertise of EFSA scientists and portrayed them as having vested interests in GMOs.Nevertheless, there is no doubt that science has accumulated enormous knowledge on GM crops, which are the most studied crops in human history [6]. In the EU alone, about 270 million euros have been spent through the Framework Programme to study health and environmental risks [5]. Framework Programme funding is approved by Member State consensus and benefits have never been on the agenda of these studies. Despite this bias in funding, the results show that GM crops do not pose a greater threat to human health and the environment than traditional crops [5,6,7]. In addition, scientists have reached international consensus on the methodology to perform risk assessment of GMOs under the umbrella of the Codex Alimentarius [8]. One might therefore conclude that the scientific risk assessment is solid and, contrary to the views of NGOs, that science has done its homework. However, attention still remains fixed on risk assessment in an attempt to fix risk management. But what about the third stage? Have the EC and Member States done their homework on risk communication?It is generally accepted that risk management in food safety crucially depends on efficient risk communication [9]. However, risk communication has remained the stepchild of the three risk management stages [6]. A review of the GM Food/Feed Regulations noted that public communication by EU authorities had been sparse and sometimes inconsistent between the EC and Member States. Similarly, a review of the EC Directive for the release of GMOs to the environment described the information provided to the public as inadequate because it is highly technical and only published in English (http://ec.europa.eu/food/food/biotechnology/evaluation/index_en.htm). Accordingly, it is not surprising that EU citizens remain averse to GMOs. Moreover, a Eurobarometer poll lists GMOs as one of the top five environmental issues for which EU citizens feel they lack sufficient information [10]. Despite the overwhelming proliferation of scientific evidence, politicians and policy-makers have ignored the most important stakeholder: society. Indeed, the reviews mentioned above recommend that the EC and Member States should improve their risk communication activities.What have we learned from the experience? Is it prudent and realistic to gauge the public''s views on a new technology before it is put into use? Can we move towards a bioeconomy and continue to ignore society? To address these questions, we focus on GM animals, as these organisms are beginning to reach the market, raise many similar issues to GM plants and thus have the potential to re-open the GM debate. GM animals, if brought into use, will involve a similar range and distribution of stakeholders in the EU, with two significant differences: animal welfare organizations will probably take the lead over environmental NGOs in the anti-GM side, and the breeding industry is far more cautious in adopting GM animals than the plant seed industry was to adopt GM crops [11].It is generally accepted that risk management in food safety crucially depends on efficient risk communicationGloFish®—a GM fish that glows when illuminated with UV light and is being sold as a novelty pet—serves as an illustrative example. GloFish® was the first GM animal to reach the market and, more importantly, did so without any negative media coverage. It is also a controversial application of GM technology, as animal welfare organizations and scientists alike consider it a frivolous use of GM, describing it as “complete nonsense” [18]. The GloFish® is not allowed in the EU, but it is commercially available throughout the USA, except in California. One might imagine that consumers in general would not be that interested in GloFish®, as research indicates that consumer acceptance of a new product is usually higher when there are clear perceived benefits [13,14]. It is difficult to imagine the benefit of GloFish® beyond its novelty, and yet it has been found illegally in the Netherlands, Germany and the UK [15]. This highlights the futility of predicting the public''s views without consulting them.Consumer attitudes and behaviour—including in regard to GMOs—are complex and change over time [13,14]. During the past years, the perception from academia and governments of the public has moved away from portraying them as a ‘victim'' of industry towards recognizing consumers as an important factor for change. Still, such arguments put citizens at the end of the production chain where they can only exert their influence by choosing to buy or to ignore certain products. Indeed, one of the strongest arguments against GM crops has been that the public never asked for them in the first place.With GM animals, the use of recombinant DNA technologies in animal breeding would rekindle an old battle between animal welfare organizations and the meat industryWith GM animals, the use of recombinant DNA technologies in animal breeding would rekindle an old battle between animal welfare organizations and the meat industry. Animal welfare organizations claim that European consumers demand better treatment for farm animals, whilst industry maintains that price remains one of the most important factors for consumers [12]. Both sides have facts to support their claims: animal welfare issues take a prominent role in the political agenda and animal welfare organizations are growing in both number and influence; industry can demonstrate a competitive disadvantage over countries in which animal welfare regulations are more relaxed and prices are lower, such as Argentina. However, the public is absent in this debate.Consumers have been described as wearing two hats: one that supports animal welfare and one that looks at the price ticket at the supermarket [16]. This situation has an impact on the breeding of livestock and the meat industry, which sees consumer prices decreasing whilst production costs increase. This trend is believed to reflect the increasing detachment of consumers from the food production chain [17]. Higher demands on animal welfare standards, environmental protection and competing international meat producers all influence the final price of meat. To remain competitive, the meat industry has to increase production per unit; it can therefore be argued that one of the main impetuses to develop GM animals was created by the behaviour—not belief—of consumers. This second example illustrates once again that society cannot be ignored when discussing any strategy to move towards the bioeconomy.The EU''s obsession with assessing risk and side-lining benefits has not facilitated an open dialogueIn conclusion, we believe that functional risk management requires all three components, including risk communication. For applications of biotechnology, a disproportionate amount of emphasis has been placed on risk assessment. The result is that the GMO debate has been framed as black and white, as either safe or unsafe, leaving policy-makers with the difficult task of educating the public about the many shades of grey. However, there are a wide range of issues that a citizen will want take into account when deciding about GM, and not all of them can be answered by science. Citizens might trust what scientists say, but “when scientists and politicians are brought together, we may well not trust that the quality of science will remain intact” [18]. By reducing the debate to scientific matters, it is a free card for the misuse of science and has a negative impact on science itself. Whilst scientists publishing pro-GM results have been attacked by NGOs, scientific publications that highlighted potential risks of GM crops came under disproportionate attacks from the scientific community [19].Flexible governance and context need to work hand-in-hand if investments in biotechnology are ultimately to benefit society. The EU''s obsession with assessing risk and side-lining benefits has not facilitated an open dialogue. The GMO experience has also shown that science cannot provide all the answers. Democratically elected governments should therefore take the lead in communicating the risks and benefits of technological advances to their electorate, and should discuss what the bioeconomy really means and the role of new technologies, including GMOs. We need to move the spotlight away from the science alone to take in the bigger picture. Ultimately, do consumers feel that paying a few extra cents for a dozen eggs is worth it if they know the chicken is happy whether it is so-called ‘natural'' or GM??
Open in a separate windowNúria Vàzquez-SalatOpen in a separate windowLouis-Marie Houdebine 相似文献
12.
Chun-Sick Eom Christie Y. Jeon Ju-Won Lim Eun-Geol Cho Sang Min Park Kang-Sook Lee 《CMAJ》2011,183(3):310-319
Background
Observational studies and randomized controlled trials have yielded inconsistent findings about the association between the use of acid-suppressive drugs and the risk of pneumonia. We performed a systematic review and meta-analysis to summarize this association.Methods
We searched three electronic databases (MEDLINE [PubMed], Embase and the Cochrane Library) from inception to Aug. 28, 2009. Two evaluators independently extracted data. Because of heterogeneity, we used random-effects meta-analysis to obtain pooled estimates of effect.Results
We identified 31 studies: five case–control studies, three cohort studies and 23 randomized controlled trials. A meta-analysis of the eight observational studies showed that the overall risk of pneumonia was higher among people using proton pump inhibitors (adjusted odds ratio [OR] 1.27, 95% confidence interval [CI] 1.11–1.46, I2 90.5%) and histamine2 receptor antagonists (adjusted OR 1.22, 95% CI 1.09–1.36, I2 0.0%). In the randomized controlled trials, use of histamine2 receptor antagonists was associated with an elevated risk of hospital-acquired pneumonia (relative risk 1.22, 95% CI 1.01–1.48, I2 30.6%).Interpretation
Use of a proton pump inhibitor or histamine2 receptor antagonist may be associated with an increased risk of both community- and hospital-acquired pneumonia. Given these potential adverse effects, clinicians should use caution in prescribing acid-suppressive drugs for patients at risk.Recently, the medical literature has paid considerable attention to unrecognized adverse effects of commonly used medications and their potential public health impact.1 One group of medications in widespread use is acid-suppressive drugs, which represent the second leading category of medication worldwide, with sales totalling US$26.9 billion in 2005.2Over the past 40 years, the development of potent acid-suppressive drugs, including proton pump inhibitors, has led to considerable improvements in the treatment of acid-related disorders of the upper gastrointestinal tract.3 Experts have generally viewed proton pump inhibitors as safe.4 However, potential complications such as gastrointestinal neoplasia, malabsorption of nutrients and increased susceptibility to infection have caused concern.5Of special interest is the possibility that acid-suppressive drugs could increase susceptibility to respiratory infections because these drugs increase gastric pH, thus allowing bacterial colonization.6,7 Several previous studies have shown that treatment with acid-suppressive drugs might be associated with an increased risk of respiratory tract infections8 and community-acquired pneumonia in adults6,7 and children.9 However, the association between use of acid-suppressive drugs and risk of pneumonia has been inconsistent.10–13Given the widespread use of proton pump inhibitors and histamine2 receptor antagonists, clarifying the potential impact of acid-suppressive therapy on the risk of pneumonia is of great importance to public health.14 Previous meta-analyses have focused on the role of acid-suppressive drugs in preventing stress ulcer,11,13,15 but none have examined pneumonia as the primary outcome.The aim of this study was to summarize the association between the use of acid-suppressive drugs and the risk of pneumonia in observational studies and randomized controlled trials. 相似文献13.
Hilary K. Brown Sudipta Saha Timothy C.Y. Chan Angela M. Cheung Michael Fralick Marzyeh Ghassemi Margaret Herridge Janice Kwan Shail Rawal Laura Rosella Terence Tang Adina Weinerman Yona Lunsky Fahad Razak Amol A. Verma 《CMAJ》2022,194(4):E112
Background:Disability-related considerations have largely been absent from the COVID-19 response, despite evidence that people with disabilities are at elevated risk for acquiring COVID-19. We evaluated clinical outcomes in patients who were admitted to hospital with COVID-19 with a disability compared with patients without a disability.Methods:We conducted a retrospective cohort study that included adults with COVID-19 who were admitted to hospital and discharged between Jan. 1, 2020, and Nov. 30, 2020, at 7 hospitals in Ontario, Canada. We compared in-hospital death, admission to the intensive care unit (ICU), hospital length of stay and unplanned 30-day readmission among patients with and without a physical disability, hearing or vision impairment, traumatic brain injury, or intellectual or developmental disability, overall and stratified by age (≤ 64 and ≥ 65 yr) using multivariable regression, controlling for sex, residence in a long-term care facility and comorbidity.Results:Among 1279 admissions to hospital for COVID-19, 22.3% had a disability. We found that patients with a disability were more likely to die than those without a disability (28.1% v. 17.6%), had longer hospital stays (median 13.9 v. 7.8 d) and more readmissions (17.6% v. 7.9%), but had lower ICU admission rates (22.5% v. 28.3%). After adjustment, there were no statistically significant differences between those with and without disabilities for in-hospital death or admission to ICU. After adjustment, patients with a disability had longer hospital stays (rate ratio 1.36, 95% confidence interval [CI] 1.19–1.56) and greater risk of readmission (relative risk 1.77, 95% CI 1.14–2.75). In age-stratified analyses, we observed longer hospital stays among patients with a disability than in those without, in both younger and older subgroups; readmission risk was driven by younger patients with a disability.Interpretation:Patients with a disability who were admitted to hospital with COVID-19 had longer stays and elevated readmission risk than those without disabilities. Disability-related needs should be addressed to support these patients in hospital and after discharge.A successful public health response to the COVID-19 pandemic requires accurate and timely identification of, and support for, high-risk groups. There is increasing recognition that marginalized groups, including congregate care residents, racial and ethnic minorities, and people experiencing poverty, have elevated incidence of COVID-19.1,2 Older age and comorbidities such as diabetes are also risk factors for severe COVID-19 outcomes.3,4 One potential high-risk group that has received relatively little attention is people with disabilities.The World Health Organization estimates there are 1 billion people with disabilities globally.5 In North America, the prevalence of disability is 20%, with one-third of people older than 65 years having a disability.6 Disabilities include physical disabilities, hearing and vision impairments, traumatic brain injury and intellectual or developmental disabilities.5,6 Although activity limitations experienced by people with disabilities are heterogeneous,5,6 people with disabilities share high rates of risk factors for acquiring COVID-19, including poverty, residence in congregate care and being members of racialized communities.7–9 People with disabilities may be more reliant on close contact with others to meet their daily needs, and some people with disabilities, especially intellectual developmental disabilities, may have difficulty following public health rules. Once they acquire SARS-CoV-2 infection, people with disabilities may be at risk for severe outcomes because they have elevated rates of comorbidities.10 Some disabilities (e.g., spinal cord injuries and neurologic disabilities) result in physiologic changes that increase vulnerability to respiratory diseases and may mask symptoms of acute respiratory disease, which may delay diagnosis.11–13 There have also been reports of barriers to high-quality hospital care for patients with disabilities who have COVID-19, including communication issues caused by the use of masks and restricted access to support persons.14–17Some studies have suggested that patients with disabilities and COVID-19 are at elevated risk for severe disease and death, with most evaluating intellectual or developmental disability.13,18–26 Yet, consideration of disability-related needs has largely been absent from the COVID-19 response, with vaccine eligibility driven primarily by age and medical comorbidity, limited accommodations made for patients with disabilities who are in hospital, and disability data often not being captured in surveillance programs.14–17 To inform equitable pandemic supports, there is a need for data on patients with a broad range of disabilities who have COVID-19. We sought to evaluate standard clinical outcomes in patients admitted to hospital with COVID-1927 (i.e., in-hospital death, intensive care unit [ICU] admission, hospital length of stay and unplanned 30-d readmission) for patients with and without a disability, overall and stratified by age. We hypothesized that patients with a disability would have worse outcomes because of a greater prevalence of comorbidities,10 physiologic characteristics that increase morbidity risk11–13 and barriers to high-quality hospital care.14–17 相似文献
14.
Liran Hiersch Joel G. Ray Jon Barrett Howard Berger Michael Geary Sarah D. McDonald Christina Diong Sima Gandhi Jun Guan Beth Murray-Davis Nir Melamed 《CMAJ》2021,193(37):E1448
Background:People whose singleton pregnancy is affected by hypertensive disorders of pregnancy (HDP) are at risk of future cardiovascular disease. It is unclear, however, whether this association can be extrapolated to twin pregnancies. We aimed to compare the association between HDP and future cardiovascular disease after twin and singleton pregnancies.Methods:We conducted a population-based retrospective cohort study that included nulliparous people in Ontario, Canada, 1992–2017. We compared the future risk of cardiovascular disease among pregnant people from the following 4 groups: those who delivered a singleton without HDP (referent) and with HDP, and those who delivered twins either with or without HDP.Results:The populations of the 4 groups were as follows: 1 431 651 pregnant people in the singleton birth without HDP group; 98 631 singleton birth with HDP; 21 046 twin birth without HDP; and 4283 twin birth with HDP. The median duration of follow-up was 13 (interquartile range 7–20) years. The incidence rate of cardiovascular disease was lowest among those with a singleton or twin birth without HDP (0.72 and 0.74 per 1000 person-years, respectively). Compared with people with a singleton birth without HDP, the risk of cardiovascular disease was highest among those with a singleton birth and HDP (1.47 per 1000 person-years; adjusted hazard ratio [HR] 1.81 [95% confidence interval (CI) 1.72–1.90]), followed by people with a twin pregnancy and HDP (1.07 per 1000 person-years; adjusted HR 1.36 [95% CI 1.04–1.77]). The risk of the primary outcome after a twin pregnancy with HDP was lower than that after a singleton pregnancy with HDP (adjusted HR 0.74 [95% CI 0.57–0.97]), when compared directly.Interpretation:In a twin pregnancy, HDP are weaker risk factors for postpartum cardiovascular disease than in a singleton pregnancy.Cardiovascular disease has been shown to be the leading cause of death among women.1–3 Classic risk factors for cardiovascular disease include obesity, diabetes mellitus, hypertension and family history of cardiovascular disease. 3 More recently, an association has been established between a history of hypertensive disorders of pregnancy (HDP) — gestational hypertension and pre-eclampsia — and future risk of cardiovascular disease.1,4–11 Consequently, some recommend using a history of HDP for cardiovascular disease risk stratification in women.3,12The leading hypothesis for the pathogenesis of HDP is that it results from abnormal placentation due to impaired trophoblast invasion,13–16 resulting in reduced placental perfusion.17–19 This, in turn, leads to abnormal secretion of the angiogenic factors soluble FMS-like tyrosine kinase 1 (sFlt1) and soluble endoglin (sEng),20 which induce endothelial dysfunction and the clinical manifestations of HDP.19,21–24 The mechanisms underlying the association between HDP and future cardiovascular disease are under debate.25 One hypothesis is that HDP are merely a marker of underlying subclinical or clinical vascular risk factors that predispose a person to both HDP and future cardiovascular disease.A person who is pregnant with twins is at about 3–4 times higher risk of HDP than a person with a singleton pregnancy,26–33 with rates of 14% and 5%, respectively.34 The higher risk of HDP in twin pregnancies may be due to higher circulating sFlt1 and sEng owing to greater placental mass in twin pregnancies, 35–37 and less related to the classic vascular risk factors for HDP in a singleton pregnancy. Therefore, a logical question is whether the established higher risk of future cardiovascular disease after singleton pregnancies with HDP also occurs in twin pregnancies with HDP. Limited data are available to answer this question.38 In the current study, we aimed to test the hypothesis that the association between HDP and future cardiovascular disease is less pronounced in twin versus singleton pregnancies. 相似文献
15.
Ekaterina Mishanina Ewelina Rogozinska Tej Thatthi Rehan Uddin-Khan Khalid S. Khan Catherine Meads 《CMAJ》2014,186(9):665-673
Background:
Induction of labour is common, and cesarean delivery is regarded as its major complication. We conducted a systematic review and meta-analysis to investigate whether the risk of cesarean delivery is higher or lower following labour induction compared with expectant management.Methods:
We searched 6 electronic databases for relevant articles published through April 2012 to identify randomized controlled trials (RCTs) in which labour induction was compared with placebo or expectant management among women with a viable singleton pregnancy. We assessed risk of bias and obtained data on rates of cesarean delivery. We used regression analysis techniques to explore the effect of patient characteristics, induction methods and study quality on risk of cesarean delivery.Results:
We identified 157 eligible RCTs (n = 31 085). Overall, the risk of cesarean delivery was 12% lower with labour induction than with expectant management (pooled relative risk [RR] 0.88, 95% confidence interval [CI] 0.84–0.93; I2 = 0%). The effect was significant in term and post-term gestations but not in preterm gestations. Meta-regression analysis showed that initial cervical score, indication for induction and method of induction did not alter the main result. There was a reduced risk of fetal death (RR 0.50, 95% CI 0.25–0.99; I2 = 0%) and admission to a neonatal intensive care unit (RR 0.86, 95% CI 0.79–0.94), and no impact on maternal death (RR 1.00, 95% CI 0.10–9.57; I2 = 0%) with labour induction.Interpretation:
The risk of cesarean delivery was lower among women whose labour was induced than among those managed expectantly in term and post-term gestations. There were benefits for the fetus and no increased risk of maternal death.Labour is induced in 1 of 5 births1,2 for maternal reasons (e.g., preeclampsia, cardiac or renal disease), fetal reasons (e.g., intrauterine growth restriction) or a combination (e.g., poorly controlled diabetes, preterm rupture of the membranes or post-term pregnancy).3 Induction of labour artificially ripens the cervix and initiates uterine contractions in women who are not already in labour, leading to progressive dilation of the cervix to achieve vaginal birth of a baby at any gestation beyond the legal definition of fetal viability.4Although induction of labour has been criticized for an associated increased risk of cesarean delivery, recent studies have shown that there are fewer cesarean deliveries with induction than without it. However, the findings have not had much impact on practice, in part because the systematic reviews5–8 investigated subsets of induction and included few randomized controlled trials (RCTs), and because observational data in a cohort study9 had risk of confounding. Consumer organizations,10 guidelines11 and textbooks12,13 have given contradictory information about cesarean risk, which can lead to confusion over decision-making, particularly given a desire to support normal birth in the face of increasing cesarean rates worldwide. Cesarean delivery carries multiple risks to mother and baby, including maternal death,14 infection and postnatal depression,15,16 and respiratory distress syndrome in neonates.14 Accurate, precise information about cesarean risk is therefore needed for decision-making regarding labour induction.We conducted a systematic review and meta-analysis of RCTs to investigate the risk of cesarean delivery associated with labour induction compared with expectant management. We also explored the effects of clinical characteristics and study quality on the overall result using subgroup and meta-regression analyses. 相似文献16.
George Ioannidis Alexandra Papaioannou Wilma M. Hopman Noori Akhtar-Danesh Tassos Anastassiades Laura Pickard Courtney C. Kennedy Jerilynn C. Prior Wojciech P. Olszynski Kenneth S. Davison David Goltzman Lehana Thabane Amiran Gafni Emmanuel A. Papadimitropoulos Jacques P. Brown Robert G. Josse David A. Hanley Jonathan D. Adachi 《CMAJ》2009,181(5):265-271
Background
Fractures have largely been assessed by their impact on quality of life or health care costs. We conducted this study to evaluate the relation between fractures and mortality.Methods
A total of 7753 randomly selected people (2187 men and 5566 women) aged 50 years and older from across Canada participated in a 5-year observational cohort study. Incident fractures were identified on the basis of validated self-report and were classified by type (vertebral, pelvic, forearm or wrist, rib, hip and “other”). We subdivided fracture groups by the year in which the fracture occurred during follow-up; those occurring in the fourth and fifth years were grouped together. We examined the relation between the time of the incident fracture and death.Results
Compared with participants who had no fracture during follow-up, those who had a vertebral fracture in the second year were at increased risk of death (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.1–6.6); also at risk were those who had a hip fracture during the first year (adjusted HR 3.2, 95% CI 1.4–7.4). Among women, the risk of death was increased for those with a vertebral fracture during the first year (adjusted HR 3.7, 95% CI 1.1–12.8) or the second year of follow-up (adjusted HR 3.2, 95% CI 1.2–8.1). The risk of death was also increased among women with hip fracture during the first year of follow-up (adjusted HR 3.0, 95% CI 1.0–8.7).Interpretation
Vertebral and hip fractures are associated with an increased risk of death. Interventions that reduce the incidence of these fractures need to be implemented to improve survival.Osteoporosis-related fractures are a major health concern, affecting a growing number of individuals worldwide. The burden of fracture has largely been assessed by the impact on health-related quality of life and health care costs.1,2 Fractures can also be associated with death. However, trials that have examined the relation between fractures and mortality have had limitations that may influence their results and the generalizability of the studies, including small samples,3,4 the examination of only 1 type of fracture,4–10 the inclusion of only women,8,11 the enrolment of participants from specific areas (i.e., hospitals or certain geographic regions),3,4,7,8,10,12 the nonrandom selection of participants3–11 and the lack of statistical adjustment for confounding factors that may influence mortality.3,5–7,12We evaluated the relation between incident fractures and mortality over a 5-year period in a cohort of men and women 50 years of age and older. In addition, we examined whether other characteristics of participants were risk factors for death. 相似文献17.
Background:Head injuries have been associated with subsequent suicide among military personnel, but outcomes after a concussion in the community are uncertain. We assessed the long-term risk of suicide after concussions occurring on weekends or weekdays in the community.Methods:We performed a longitudinal cohort analysis of adults with diagnosis of a concussion in Ontario, Canada, from Apr. 1, 1992, to Mar. 31, 2012 (a 20-yr period), excluding severe cases that resulted in hospital admission. The primary outcome was the long-term risk of suicide after a weekend or weekday concussion.Results:We identified 235 110 patients with a concussion. Their mean age was 41 years, 52% were men, and most (86%) lived in an urban location. A total of 667 subsequent suicides occurred over a median follow-up of 9.3 years, equivalent to 31 deaths per 100 000 patients annually or 3 times the population norm. Weekend concussions were associated with a one-third further increased risk of suicide compared with weekday concussions (relative risk 1.36, 95% confidence interval 1.14–1.64). The increased risk applied regardless of patients’ demographic characteristics, was independent of past psychiatric conditions, became accentuated with time and exceeded the risk among military personnel. Half of these patients had visited a physician in the last week of life.Interpretation:Adults with a diagnosis of concussion had an increased long-term risk of suicide, particularly after concussions on weekends. Greater attention to the long-term care of patients after a concussion in the community might save lives because deaths from suicide can be prevented.Suicide is a leading cause of death in both military and community settings.1 During 2010, 3951 suicide deaths occurred in Canada2 and 38 364 in the United States.3 The frequency of attempted suicide is about 25 times higher, and the financial costs in the US equate to about US$40 billion annually.4 The losses from suicide in Canada are comparable to those in other countries when adjusted for population size.5 Suicide deaths can be devastating to surviving family and friends.6 Suicide in the community is almost always related to a psychiatric illness (e.g., depression, substance abuse), whereas suicide in the military is sometimes linked to a concussion from combat injury.7–10Concussion is the most common brain injury in young adults and is defined as a transient disturbance of mental function caused by acute trauma.11 About 4 million concussion cases occur in the US each year, equivalent to a rate of about 1 per 1000 adults annually;12 direct Canadian data are not available. The majority lead to self-limited symptoms, and only a small proportion have a protracted course.13 However, the frequency of depression after concussion can be high,14,15 and traumatic brain injury in the military has been associated with subsequent suicide.8,16 Severe head trauma resulting in admission to hospital has also been associated with an increased risk of suicide, whereas mild concussion in ambulatory adults is an uncertain risk factor.17–20The aim of this study was to determine whether concussion was associated with an increased long-term risk of suicide and, if so, whether the day of the concussion (weekend v. weekday) could be used to identify patients at further increased risk. The severity and mechanism of injury may differ by day of the week because recreational injuries are more common on weekends and occupational injuries are more common on weekdays.21–27 The risk of a second concussion, use of protective safeguards, propensity to seek care, subsequent oversight, sense of responsibility and other nuances may also differ for concussions acquired from weekend recreation rather than weekday work.28–31 Medical care on weekends may also be limited because of shortfalls in staffing.32 相似文献
18.
Derek R. Manis Jeffrey W. Poss Aaron Jones Paula A. Rochon Susan E. Bronskill Michael A. Campitelli Richard Perez Nathan M. Stall Ahmad Rahim Glenda Babe Jean-ric Tarride Julia Abelson Andrew P. Costa 《CMAJ》2022,194(21):E730
Background:Because there are no standardized reporting systems specific to residents of retirement homes in North America, little is known about the health of this distinct population of older adults. We evaluated rates of health services use by residents of retirement homes relative to those of residents of long-term care homes and other populations of older adults.Methods:We conducted a retrospective cohort study using population health administrative data from 2018 on adults 65 years or older in Ontario. We matched the postal codes of individuals to those of licensed retirement homes to identify residents of retirement homes. Outcomes included rates of hospital-based care and physician visits.Results:We identified 54 733 residents of 757 retirement homes (mean age 86.7 years, 69.0% female) and 2 354 385 residents of other settings. Compared to residents of long-term care homes, residents of retirement homes had significantly higher rates per 1000 person months of emergency department visits (10.62 v. 4.48, adjusted relative rate [RR] 2.61, 95% confidence interval [CI] 2.55 to 2.67), hospital admissions (5.42 v. 2.08, adjusted RR 2.77, 95% CI 2.71 to 2.82), alternate level of care (ALC) days (6.01 v. 2.96, adjusted RR 1.51, 95% CI 1.48 to 1.54), and specialist physician visits (6.27 v. 3.21, adjusted RR 1.64, 95% CI 1.61 to 1.68), but a significantly lower rate of primary care visits (16.71 v. 108.47, adjusted RR 0.13, 95% CI 0.13 to 0.14).Interpretation:Residents of retirement homes are a distinct population with higher rates of hospital-based care. Our findings can help to inform policy debates about the need for more coordinated primary and supportive health care in privately operated congregate care homes.In the continuum of care services and settings for older adults lies home care at one end and long-term care at the other.1 Home care services may include, but are not limited to, nursing care, personal care, homemaking services, and physiotherapy and occupational therapy for older adults who live independently in their community. Home care services are publicly funded under the Ontario Health Insurance Plan (OHIP).2,3 Long-term care homes provide access to 24-hour nursing and personal care and operate at full capacity in Ontario, with waiting lists of 6 months or longer before an older adult in the community could receive an offer for a bed.2,4 Retirement homes are thought to fit between home care and long-term care in this continuum.1Retirement homes are referred to as assisted-living facilities in other North American jurisdictions, and they are private, congregate living environments that deliver supportive care to adults who are 65 years of age and older.3,5,6 These homes are often marketed to provide a lifestyle and community, and they provide a range of assisted-living care services (e.g., meals, nursing services, etc.).5,7 Retirement homes predominately operate on a private, for-profit business model, and the room, board and services are purchased by residents.3,5 In Ontario, retirement homes are regulated through an independent, not-for-profit regulator (i.e., Retirement Homes Regulatory Authority [RHRA]).5 There are more than 700 licensed retirement homes in Ontario with over 70 000 available beds occupied by over 55 000 residents, which is comparable to the number of available beds in the long-term care sector.3,5,6,8 Retirement homes are legislated differently from long-term care homes and primarily cater to adults who do not require 24-hour nursing care.1,5,9 Unlike long-term care homes, no standardized reporting system is available to identify and describe residents of retirement homes.10 These residents are conceptualized as having fewer needs for care because they reside in a congregate care home to support independent living; however, this has been difficult to verify given there are no population-level data.A body of literature from the United States has described residents of assisted-living facilities and the sector,11–17 but Canadian literature is comparatively nascent. Canadian studies have investigated transitions to a long-term care home, risk of hospital admission among those who live with dementia, and life events and health conditions associated with the transition to a congregate care setting.7,9,18–20 At present, a Canadian population-level cohort of residents of retirement homes that describes the individual-level characteristics and use of health services of the older adults who reside in these homes appears to be lacking. Therefore, it is difficult to position this sector in the gradient of services and housing options for older adults in Canada.We created a population-level cohort of residents in retirement homes and sought to evaluate their rates of health services utilization relative to residents of long-term care homes and other populations of older adults (i.e., home care recipients and community-dwelling older adults) in Ontario. 相似文献
19.
Background:
Many hospitals have adopted smoke-free policies on their property. We examined the consequences of such polices at two Canadian tertiary acute-care hospitals.Methods:
We conducted a qualitative study using ethnographic techniques over a six-month period. Participants (n = 186) shared their perspectives on and experiences with tobacco dependence and managing the use of tobacco, as well as their impressions of the smoke-free policy. We interviewed inpatients individually from eight wards (n = 82), key policy-makers (n = 9) and support staff (n = 14) and held 16 focus groups with health care providers and ward staff (n = 81). We also reviewed ward documents relating to tobacco dependence and looked at smoking-related activities on hospital property.Results:
Noncompliance with the policy and exposure to secondhand smoke were ongoing concerns. Peoples’ impressions of the use of tobacco varied, including divergent opinions as to whether such use was a bad habit or an addiction. Treatment for tobacco dependence and the management of symptoms of withdrawal were offered inconsistently. Participants voiced concerns over patient safety and leaving the ward to smoke.Interpretation:
Policies mandating smoke-free hospital property have important consequences beyond noncompliance, including concerns over patient safety and disruptions to care. Without adequately available and accessible support for withdrawal from tobacco, patients will continue to face personal risk when they leave hospital property to smoke.Canadian cities and provinces have passed smoking bans with the goal of reducing people’s exposure to secondhand smoke in workplaces, public spaces and on the property adjacent to public buildings.1,2 In response, Canadian health authorities and hospitals began implementing policies mandating smoke-free hospital property, with the goals of reducing the exposure of workers, patients and visitors to tobacco smoke while delivering a public health message about the dangers of smoking.2–5 An additional anticipated outcome was the reduced use of tobacco among patients and staff. The impetuses for adopting smoke-free policies include public support for such legislation and the potential for litigation for exposure to second-hand smoke.2,4Tobacco use is a modifiable risk factor associated with a variety of cancers, cardiovascular diseases and respiratory conditions.6–11 Patients in hospital who use tobacco tend to have more surgical complications and exacerbations of acute and chronic health conditions than patients who do not use tobacco.6–11 Any policy aimed at reducing exposure to tobacco in hospitals is well supported by evidence, as is the integration of interventions targetting tobacco dependence.12 Unfortunately, most of the nearly five million Canadians who smoke will receive suboptimal treatment,13 as the routine provision of interventions for tobacco dependence in hospital settings is not a practice norm.14–16 In smoke-free hospitals, two studies suggest minimal support is offered for withdrawal, 17,18 and one reports an increased use of nicotine-replacement therapy after the implementation of the smoke-free policy.19Assessments of the effectiveness of smoke-free policies for hospital property tend to focus on noncompliance and related issues of enforcement.17,20,21 Although evidence of noncompliance and litter on hospital property2,17,20 implies ongoing exposure to tobacco smoke, half of the participating hospital sites in one study reported less exposure to tobacco smoke within hospital buildings and on the property.18 In addition, there is evidence to suggest some decline in smoking among staff.18,19,21,22We sought to determine the consequences of policies mandating smoke-free hospital property in two Canadian acute-care hospitals by eliciting lived experiences of the people faced with enacting the policies: patients and health care providers. In addition, we elicited stories from hospital support staff and administrators regarding the policies. 相似文献20.
Assisted reproductive technologies enable subfertile couples to have children. But there
are health risks attached for both mothers and children that need to be properly understood
and managed.Assisted reproductive technology (ART) has become a standard intervention for couples with
infertility problems, especially as ART is highly successful and overall carries low risks
[1,2]. The number of
infants born following ART has increased steadily worldwide, with more than 5,000,000 so far
[3]. In industrialized countries, 1–4% of
newborns have been conceived by using ART [4,5], probably owing to the fact that couples frequently delay
childbearing until their late 30s, when fertility decreases in both men and women
[2]. Considering the possibility that male fertility
might be declining, as Richard Sharpe has discussed in this series [6], it is likely that ART will be even more widely used in the future. Yet,
as the rate of ART and the total number of pregnancies has increased, it has become apparent
that ART is associated with potential risks to the mother and fetus. The most commonly cited
health problems pertain to multiple gestation pregnancies and multiple births. More recently,
however, concerns about the risks of birth defects and genetic disorders have been raised.
There are questions about whether the required manipulations and the artificial environments
of gametes and embryos are potentially creating short- and long-term health risks in mothers
and children by interfering with epigenetic reprogramming.Notwithstanding, ART represents a tremendous achievement in human reproductive medicine. The
birth of Louise Brown, the first ‘test tube baby'' in 1978, was the result of the
collaborative work of embryologist Robert Edwards and gynaecologist Patrick Steptoe
[7]. This success was a culmination of many years of
work at universities and clinics worldwide. An initial lack of support, as well as criticism
from ethicists and the church, delayed the opening of the first in vitro fertilization
(IVF) clinic in Bourn Hall near Cambridge until 1980. By 1986, 1,000 children conceived by IVF
at Bourn Hall had been born [8]. In 2010, Edwards
received the Nobel Prize in Medicine for the development of IVF. Regrettably, Steptoe had
passed away in 1988 and could not share the honour.…as the rate of ART and the total number of pregnancies has
increased, it has become apparent that ART is associated with potential risks to mother and
fetusOver the next decades, many improvements in IVF procedures were made to reduce the risks of
adverse effects and increase success rates, including controlled ovarian stimulation, timed
ovulation induction, ultrasound-guided egg retrieval, cryopreservation of embryos and
intracytoplasmic sperm injection (ICSI)—a technique in which a single sperm cell is
injected into an oocyte using a microneedle. In addition, there were further improvements such
as assisted hatching and in media composition, such as sequential media, which allow the in
vitro culture of the embryo to reach the blastocyst stage [8].Current IVF procedures involve multiple steps including ovarian stimulation and monitoring,
oocyte retrieval from the ovary, fertilization in vitro and embryo transfer to the
womb. Whereas the first IVF cycles, including the conception of Louise Brown, used natural
ovulatory cycles, which result in the retrieval of one or two oocytes, most IVF cycles
performed today rely on controlled ovarian stimulation using injectable
gonadotropins—follicle stimulating hormone and luteinizing hormone—in
supraphysiological concentrations for 10–14 days, followed by injection of human
chorionic gonadotropin (hCG) 38–40 h before egg retrieval to trigger ovulation. This
updated protocol makes it possible to grow multiple follicles and to retrieve 10–20
oocytes in one IVF cycle, thereby increasing the number of eggs available for
fertilization.Post-retrieval, the embryologist places an egg and sperm together in a test tube for
fertilization. Alternatively, a single sperm cell can be injected into an egg by using ICSI.
This procedure was initially developed for couples with poor sperm quality [9], but has become the predominant fertilization technique used in
many IVF clinics worldwide [8]. The developing embryos
are monitored by microscopy, and viable embryos are transferred into the woman''s womb for
implantation. Louise Brown, as with many embryos today, was transferred three days after egg
retrieval, at approximately the eight-cell stage. However, using sequential media, many
clinics advocate culturing embryos until day five when they reach the blastocyst stage. The
prolonged culture period allows self-selection of the most viable embryos for transfer and
increases the chance of a viable pregnancy. Excess embryos can be cryopreserved and
transferred at a later date by using a procedure known as frozen embryo transfer (FET). In
this article we use the term ART to refer to IVF procedures with or without ICSI and FET.