In the last years, artificial intelligence (AI) safety gained international recognition in the light of heterogeneous safety-critical and ethical issues that risk overshadowing the broad beneficial impacts of AI. In this context, the implementation of AI observatory endeavors represents one key research direction. This paper motivates the need for an inherently _transdisciplinary_ AI observatory approach integrating diverse retrospective and counterfactual views. We delineate aims and limitations while providing hands-on-advice utilizing _concrete practical examples_. Distinguishing between unintentionally and intentionally (...) triggered AI risks with diverse socio-psycho-technological impacts, we exemplify a _retrospective descriptive analysis_ followed by a _retrospective counterfactual risk analysis_. Building on these AI observatory tools, we present near-term transdisciplinary guidelines for AI safety. As further contribution, we discuss _differentiated_ and tailored long-term directions through the lens of two disparate modern AI safety paradigms. For simplicity, we refer to these two different paradigms with the terms _artificial stupidity_ (AS) and _eternal creativity_ (EC) respectively. While both AS and EC acknowledge the need for a hybrid cognitive-affective approach to AI safety and overlap with regard to many short-term considerations, they differ fundamentally in the nature of multiple envisaged long-term solution patterns. By compiling relevant underlying _contradistinctions_, we aim to provide _future-oriented_ incentives for constructive dialectics in practical and theoretical AI safety research. (shrink)

Risk prediction in emergency medicine (EM) holds unique challenges due to issues surrounding urgency, blurry research-practise distinctions, and the high-pressure environment in emergency departments (ED). Artificial intelligence (AI) risk prediction tools have been developed with the aim of streamlining triaging processes and mitigating perennial issues affecting EDs globally, such as overcrowding and delays. The implementation of these tools is complicated by the potential risks associated with over-triage and under-triage, untraceable false positives, as well as the potential for the (...) biases of healthcare professionals toward technology leading to the incorrect usage of such tools. This paper explores risk surrounding these issues in an analysis of a case study involving a machine learning triage tool called the Score for Emergency Risk Prediction (SERP) in Singapore. This tool is used for estimating mortality risk in presentation at the ED. After two successful retrospective studies demonstrating SERP’s strong predictive accuracy, researchers decided that the pre-implementation randomised controlled trial (RCT) would not be feasible due to how the tool interacts with clinical judgement, complicating the blinded arm of the trial. This led them to consider other methods of testing SERP’s real-world capabilities, such as ongoing-evaluation type studies. We discuss the outcomes of a risk–benefit analysis to argue that the proposed implementation strategy is ethically appropriate and aligns with improvement-focused and systemic approaches to implementation, especially the learning health systems framework (LHS) to ensure safety, efficacy, and ongoing learning. (shrink)

© 2015, Springer-Verlag Berlin Heidelberg.Genetic studies have identified single nucleotide polymorphisms associated with the risk of prostate cancer. It remains unclear whether such genetic variants are associated with disease aggressiveness. The NCI-SPORE Genetics Working Group retrospectively collected clinicopathologic information and genotype data for 36 SNPs which at the time had been validated to be associated with PC risk from 25,674 cases with PC. Cases were grouped according to race, Gleason score and aggressiveness. Statistical analyses were used to compare (...) the frequency of the SNPs between different disease cohorts. After adjusting for multiple testing, only PC-risk SNP rs2735839 was significantly and inversely associated with aggressive and high-grade disease in European men. Similar associations with aggressive and high-grade disease were documented in African-American subjects. The G allele of rs2735839 was associated with disease aggressiveness even at low PSA levels in both European and African-American men. Our results provide further support that a PC-risk SNP rs2735839 near the KLK3 gene on chromosome 19q13 may be associated with aggressive and high-grade PC. Future prospectively designed, case-case GWAS are needed to identify additional SNPs associated with PC aggressiveness. (shrink)

Restrictive visitation policies produce inequities in healthcare that have meaningful consequences for patients’ health and well-being. There is a surplus of existing literature exploring the consequences of reduced visitation in the setting of pediatric patients lacking decision-making capacity, but relatively little scholarship addressing visitation restriction for less vulnerable adults possessing capacity. Here, we present the case of a patient who suffered serious complications of childbirth, during the delivery of her healthy newborn, leading to prolonged hospitalization. During her treatment course, she (...) was subsequently denied visitation with her newborn, who had been discharged from the hospital, and this had detrimental effects on her recovery. Hospital policies restricting visitation during the COVID-19 pandemic were intended to reduce the risk of disease exposure for both patients and staff, despite conflicting evidence demonstrating this benefit. In contrast, they often have negative effects on patient stress, mood, and physical recovery. The sequelae of this US-based case study argue the need for more holistic hospital visitation policies, placing a specific lens on adult patients receiving a visitation from their newborn children. (shrink)

IntroductionCerebral visual impairment results from damage to cerebral visual processing structures. It is the most common cause of pediatric visual impairment in developed countries and rising in prevalence in developing nations. There is currently limited understanding on how neurologic, developmental, and ophthalmic factors predict outcome for pediatric CVI.MethodA retrospective manual chart review of pediatric CVI patients seen at the tertiary pediatric hospital neurology and neuro-ophthalmology service between 2010 and 2019 was conducted. Patients were stratified into severity groups, and followed (...) over time to identify outcome predictors. Collected baseline characteristics included perinatal, genetic, developmental, and neurologic history, along with neuroimaging and fundoscopic findings on examination. Longitudinal data collected included age, seizure control, and type of therapy received. Linear mixed-effect models were used for longitudinal CVI grade outcome analysis.ResultsA total of 249 individuals spanning 779 patient visits were identified. Mean age at diagnosis was 18.8 ± 16.8 months. About 64.3% were born at term age. Perinatal history revealed hypoxic ischemic encephalopathy in 16.5%, intraventricular hemorrhage in 11.6%, and seizures in 21.7%. At presentation, 60.3% had a diagnosis of cerebral palsy and 84.7% had developmental delay. Among all subjects, 78.6% had epilepsy; 33.8% had an epileptic encephalopathy, with spasms/hypsarrhythmia being most common. Abnormal neuroimaging was present in 93.8%. Genetic anomalies were present in 26.9%. Baseline visual examination revealed no blink-to-light in 24.5%; only BTL in 34.5%, fixation/tracking in 26.5%, and optokinetic drum follow in 14.4%. Longitudinal data analysis showed that perinatal history of HIE, a positive epilepsy history, using multiple epilepsy medications, cerebral palsy, and abnormal fundoscopic findings were all negatively associated with CVI grade change over time. After controlling for significant confounders, receiving any type of therapy [early childhood intervention, physical and occupational therapy, refractive error correction or glasses] was significantly associated with longitudinal improvement in CVI grade compared to patients who did not receive any therapy, with glasses yielding the largest benefit.ConclusionThis study offers extensive insights into neurologic, developmental and ophthalmologic features in patients with moderate to severe CVI. In concordance with previous findings, aspects of perinatal history and epilepsy/seizure control may help inform severity and prognosis in the general neurology or ophthalmology clinic. Conversely, these aspects, as well as genetic and specific epilepsy traits may alert vision health care providers in the clinic to pursue visual evaluation in at-risk individuals. Longitudinal follow-up of CVI patients showed that interventional therapies demonstrated vision function improvement greater than no therapy and maturational development. (shrink)

Electroacupuncture (EA) and electroconvulsive therapy (ECT) are often used in the management of schizophrenia. This study sought to determine whether additional EA and ECT could augment antipsychotic response and reduce related side effects. In this retrospective controlled study, 287 hospitalized schizophrenic patients who received antipsychotics (controls, n = 50) alone or combined with EA (n = 101), ECT (n = 55) or both (EA+ECT, n = 81) were identified. EA and ECT were conducted for 5 and 3 sessions per (...) week, respectively, with a maximum of 12 sessions for ECT during hospitalization. The Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the severity of psychotic symptoms. Clinical response on SAPS and SANS, weight gain, and adverse events were compared. Survival analysis revealed that the ECT and EA+ECT groups had markedly greater clinical response rate than controls on SAPS [72.7% and 90.1% vs. 64.0%; relative risk (RR), 1.974 and 2.628, respectively, P ≤ 0.004] and on SANS (67.3% and 70.4% vs. 42.0%; RR, 1.951 and 2.009, respectively, P ≤ 0.015). A significantly greater response rate on SANS than controls was also observed in the EA group (64.4% versus 42.0%; RR = 1.938, P = 0.008). EA-containing regimens remarkably reduced weight gain and incidences of headache, insomnia, dry mouth, and electrocardiographic abnormalities. These results suggest that EA and ECT can serve as additional treatment for enhancing antipsychotic response and reduce the side effects in hospitalized patients with schizophrenia. (shrink)

BackgroundThis study aimed to elucidate the influence of dementia etiologies on the degree of caregiver burden and determine which factors predict a high caregiving burden.MethodsThis 18-month retrospective cohort study enrolled 630 patients and their caregivers from the Dementia Center of Changhua Christian Hospital. The care team performed face-to-face interviews every 6 months, for 18 months from when a diagnosis of dementia was made. The primary outcome was the change in Zarit Burden Interview scores. Generalized estimating equations were used for (...) the longitudinal data analysis.ResultsParticipants with Lewy body disease had a significantly higher caregiving burden compared with those with Alzheimer's disease after adjusting for patient and caregiver features. Caregivers of mixed-type dementia and frontotemporal dementia experienced a greater burden than caregivers of AD, at 6- and 18-month follow-up. Patients with more severe dementia, neuropsychiatric symptoms, being cared for by more than two caregivers, or utilizing social resources were associated with higher ZBI scores; the depressive mood of caregiver also predicted higher ZBI scores.ConclusionThis longitudinal study demonstrated that caregiver burden was influenced by the underlying dementia etiology of patients. The dementia care team should provide personalized education and transfer patients and caregivers to appropriate resources, especially for high-risk populations. (shrink)

Available methods such as technology assessment and risk analysis have failed to predict the effects of technological choices. We need to give up the futile predictive ambitions of previous approaches and instead base decisions on systematic studies of alternative future developments. It will then be necessary to cope with mere possibility arguments, i.e., arguments in which a conclusion is drawn from a mere possibility that a course of action may have certain consequences. A five-step procedure is proposed for (...) the assessment of such arguments. It includes a search for mere possibility arguments pointing in different directions, a scientific evaluation that may lead to the specification or refutation of some of these arguments, two symmetry tests, evaluation of the seriousness of the arguments in terms of novelty, spatio-temporal unlimitedness and interference with complex systems, and hypothetical retrospection that aims at finding a course of action that will be defensible in retrospect. (shrink)

The strict lockdown experienced in Spain during March–June 2020 as a consequence of the COVID-19 crisis has led to strong negative emotions. Music can contribute to enhancing wellbeing, but the extent of this effect may be modulated by both personal and context-related variables. This study aimed to analyze the impact of the two types of variables on the perceived efficacy of musical behaviors to fulfill adults’ emotional wellbeing-related goals during the lockdown established in Spain. Personal variables included age, gender, musical (...) training, personality, resilience, and perception of music’s importance. Contextual variables referred to living in a region with a high COVID-19 impact, perception of belonging to a risk group, being alone, having caring responsibilities during confinement, and amount of time of music listening as compared to prior to the crisis. The study was conducted retrospectively during August–December 2020, when the strict lockdown was over in Spain. An online survey was disseminated among the general population and groups of musicians, and the answers of 507 adults were analyzed. Only personal, but not COVID-19 context-related variables, showed an impact on music’s efficacy. The youngest age group of adults and those with musical training reported the highest efficacy of music for wellbeing enhancement, and music’s importance was found to be the main significant predictor of music’s perceived efficacy. Our findings suggest that the people who have been reported to be emotionally more vulnerable during the lockdown, due to either a strong impact on their daily lives or their lower resilience, perceive a higher benefit from musical behaviors. Being musically trained, even for a small number of years, also leads to a perception of higher efficacy of music for the achievement of emotional wellbeing goals. However, this effect is explained by the musically trained individuals’ higher perception of music’s importance. Although musical behaviors can be generally considered as important for wellbeing enhancement, our study highlights who are the potential individuals who could benefit the most from music-related activities for obtaining better levels of wellbeing, at least within the current context of the COVID-19 crisis. (shrink)

The dynamic of changes in the rules in team games materialize from research and debate between experts and coaches before being implemented by the International Federations. In Handball, the last changes occurred in 2016, and one of them was to substitute the goalkeeper with an additional field player allowing teams to play “empty goal” while using the additional field player.This study aimed to analyze and characterize the use of the 7 vs. 6 strategical-tactical option for the attack in the 2020 (...) Men’s European Championship. We also analyzed whether the game time and partial score influenced the use of 7 vs. 6 and its efficiency. Observational methodology and a mixed ad hoc instrument combining field format and category systems validated by experts were used. Data were taken from 28 matches involving teams in the first 12 positions in the 2020 Men’s European Championship. The total number of offensive sequences in an organized attack method in 7 vs. 6 with an empty goal were analyzed. Sequential analysis techniques with lags, prospective and retrospective, and polar coordinate analysis were used. The results showed that these solutions had poor efficiency, except for the Portuguese National Team; teams using the 7 vs. 6 tactic option had no negative consequences or increased risk with the opponent response; partial score influenced the decision to use 7 vs. 6 strategic option, and game time was associated with 7 vs. 6 play options and detected patterns. (shrink)

나노과학 낙관론자들은 나노과학이 환경오염을 정화하도록 도울 뿐만 아니라 환경을 보호하여 지속가능한 발전을 유도할 것이라는 기대감을 나타낸다. 반면에, 나노과학 비관론자들은 나노과학이 환경을 파괴하고 궁극적으로 인류를 멸망시킬 것이라는 우려를 제기한다. 이러한 상반된 전망 아래, 나노과학이 환경 문제에 있어서 축복이 될지, 아니면 재앙이 될지는 나노과학에 대한 윤리적 대응이 얼마나 철저하고 신중하게 준비되는가에 달려 있다. 본 논문의 목적은, 이러한 준비의 일환으로 나노과학에 적합한 리스크 논의와 이에 대한 윤리적 대응 방안을 제시하는 것이다. 나노과학은 다른 과학기술보다 불확실성과 무지의 영역이 더 넓을 뿐만 아니라, 그 리스크가 더 (...) 장기적이고 지속적이라는 특성 때문에 기존의 리스크 논의를 적용하기에는 부적합해 보인다. 이러한 나노과학의 불확실성(그리고 무지)과 시간성의 특성을 포괄하기 위해, 필자는 기존의 논의들 가운데 태너트(Christof Tannert) 그룹의 리스크 논의를 수정하여, “닫힌 지식 영역”, “열린 지식 영역”, “열린 무지 영역”, “판단 유보의 무지 영역”, “닫힌 무지 영역”을 포괄할 수 있는 리스크 논의를 제시한다. 또한 이러한 리스크 논의를 토대로 스털링(Andy Sterling)의 다층적 대응 논의를 수정하여 나노과학의 발전 단계에 따라 윤리적으로 대응할 수 있도록 “이익-리스크 손해 분석 방법”, “심의 민주주의 방법”, “사전주의 원칙 방법”, “철저하고 공개적인 감시 방법”의 다층적이고 동적인 리스크 대응 방식을 제시한다. 이러한 리스크 대응 방식은, 새로운 과학기술인 나노과학의 리스크가 인류와 환경에 불가역적인 심각성을 갖고 있다고 예견된다면 “중지”(moratorium)를 선언할 만큼 철저하고 공개적으로 관리되어, 나노과학이 인류의 발전과 번영을 위해서 지속가능한 방식으로 발전되어야 한다는 입장을 대변한다. 본 연구의 성과물이 나노과학이 환경을 보존하여 지속가능한 발전을 추구하도록 돕는 윤리적 토대가 될 것으로 기대한다. (shrink)

Precaution is a relevant and much-invoked value in environmental risk analysis, as witnessed by the ongoing vivid discussion about the precautionary principle (PP). This article argues (i) against purely decision-theoretic explications of PP; (ii) that the construction, evaluation, and use of scientific models falls under the scope of PP; and (iii) that epistemic and decision-theoretic robustness are essential for precautionary policy making. These claims are elaborated and defended by means of case studies from climate science and conservation biology.

Digital currency is considered a form of currency which is used in the digital world such as digital forms or electronic devices. Several terms are synonyms for digital currency like digital money, electronic money, and cyber cash. Accurate prediction of the digital currency is an urgent necessity due to its impacts on the economic community. The electronic economy is very dangerous and must be approached with great caution, so as to avoid or minimize the risks that occur in such cases. (...) Deep neural network algorithm was improved to predict the Bitcoin price and then achieve the main goal of reducing financial risks to proceed with electronic business, and good estimation was achieved by using informative data such as transactions and currency return. The proposed method extracted features of related Bitcoin and used the informative ones. Transaction plan considered building nodes in terms of network. Development of deep learning algorithms opens the horizons for the development of electronic businesses that use digital currency. The proposed method achieved worthy results in terms of accuracy and correct prediction and offers the prospect of other research in this area. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how (...) non-utilitarian principles are prominent in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

Mainstream risk analysis deviates in at least two important respects from the rationality ideal of mainstream economics. First, expected utility maximization is not applied in a consistent way. It is applied to endodoxastic uncertainty, i.e. the uncertainty (or risk) expressed in a risk assessment, but in many cases not to metadoxastic uncertainty, i.e. uncertainty about which of several competing assessments is correct. Instead, a common approach to metadoxastic uncertainty is to only take the most plausible assessment (...) into account. This will typically lead to risk-prone deviations from risk-neutrality. Secondly, risks and benefits for different persons are added to form a total value of risk. Such calculations are used to support the view that one should accept being exposed to a risk if it brings greater benefits for others. This is in stark contrast to modern Paretian welfare economics, that refrains from interindividual comparisons and does not require people to accept a disadvantage because it brings a larger advantage for others. (Published Online July 11 2006). (shrink)

The relatively new discipline of risk analysis promises to provide objective guidance in some of the most controversial issues in modern high‐technology societies. Four conditions are discussed that must be satisfied for this promise to be fulfilled. Since none of these conditions is satisfied, risk analysis does not keep its promise. In its attempts to reduce genuinely political issues to technocratic calculations, it neglects many of the factors that should influence decisions on risk acceptance. A (...) list of tentative guidelines is given for numerical decision support that encourages democratic decision‐making instead of trying to evade it. (shrink)

Recommender systems are recently developed computer-assisted tools that support social and informational needs of various communities and help users exploit huge amounts of data for making optimal decisions. In this study, we present a new recommender system for assessment and risk prediction in child welfare institutions in Israel. The system exploits a large diachronic repository of manually completed questionnaires on functioning of welfare institutions and proposes two different rule-based computational models. The system accepts users’ requests via a simple graphical (...) interface, calculates the institutions’ profiles according to user preferences, and presents assessment scores, trends and comparative analyses of the corresponding data using assorted visual aids. Based on the analysis, the system offers three different strategies for objective assessment of the institutions’ functioning and risks. Qualitative and quantitative evaluation of the system’s effectiveness and accuracy demonstrates that it substantially improves the assessment process of a welfare institution. Moreover, it provides an effective tool for objective large-scale analysis of the institution’s overall state and trends, which were previously based primarily on the institution supervisors’ subjective judgment and intuition. In addition, the proposed recommender system has great practical and social impact as it may help identify and avert potential problems, malfunctions, flaws, risks and even tragic incidents in child welfare institutions, as well as increase their overall functioning levels. As a result, as a long-term social implication, the system may also help reduce inequality and social gaps in the Israeli society. (shrink)

There is little information about the content of ethics consultations in pediatrics. We sought to describe the reasons for consultation and ethical principles addressed during EC in pediatrics through retrospective review and directed content analysis of EC records at St. Jude Children's Research Hospital. Patient-based EC were highly complex and often involved evaluation of parental decision making, particularly consideration of the risks and benefits of a proposed medical intervention, and the physician's fiduciary responsibility to the patient. Nonpatient consultations (...) provided guidance in the development of institutional policies that would broadly affect patients and families. This is one of the few existing reviews of the content of pediatric EC and indicates that the distribution of ethical issues and reasons for moral distress are different than with adults. Pediatric EC often facilitates complex decision making among multiple stakeholders, and further prospective research is need.. (shrink)

Discussions of socioeconomic liability and compensation must necessarily start from an understanding of the socioeconomic, legal, and scientific basis for identifying, assessing, managing, and apportioning blame for hazards related to innovations. Public discussions about the nature of the liability challenge related to genetically modified (GM) crops and other modified organisms have focused less on direct, traditional health, public safety, technical, or environmental failures (e.g., innovations that generate hazards directly for users or indirectly to bystanders) and more on socioeconomic concerns, such (...) as comingled product that offends product quality standards. This article examines the theoretical and legal underpinnings of the current risk analysis framework used in most Organization for Economic Cooperation and Development countries and uses it to assess two areas of significant controversy—the release of herbicide-tolerant canola and flax varieties in Western Canada. The article offers lessons for the management of liabilities arising from the introduction of GM crops. (shrink)

With the development of distributed networks, the remote controllability of the distributed energy objects and the vulnerability of user-side information security protection measures make distributed energy objects extremely vulnerable to malicious control by attackers. Hence, the large-scale loads may produce abnormal operation performance, such as load casting/dropping synchronously or frequent and synchronous casting and dropping, and hence, it can threaten the security and stable operation of the distribution networks. First, we analyze the security threats faced by industrial controllable load, civil (...) controllable load, and the gains and losses of attacks on the distribution networks. Considering the factors of cyber attacks, we propose a control model and cyber attack model in active distribution networks. And, three types of attacks that the target suffered are defined on the basis of “on” and “off” modes for control. Then, the controllable load was maliciously controlled as the research object, and a suitable scenario is selected. The impact of malicious control of the controllable load on the power supply reliability and power quality of the distribution networks are simulated and analyzed, and risk consequences for different types of attacks are provided. (shrink)

In recent years, risk management and analysis has attracted a great deal of attention from both researchers and practitioners. Enterprise risk management has become an important topic in today’s more complex, interrelated global business environment, replete with threats from natural, political, economic, and technical sources. This survey and introductory article addresses computerized tools used for risk management and analysis. Risks are studied from perspectives of different disciplines, with a discussion of how various methods and tools (...) are used to optimize risk management. (shrink)

A capability approach has been proposed to risk analysis, where risk is conceptualized as the probability that capabilities are reduced. Capabilities refer to the genuine opportunities of individuals to achieve valuable doings and beings, such as being adequately nourished. Such doings and beings are called functionings. A current debate in risk analysis and other fields where a capability approach has been developed concerns whether capabilities or actual achieved functionings should be used. This paper argues that (...) in risk analysis the consequences of hazardous scenarios should be conceptualized in terms of capabilities, not achieved functionings. Furthermore, the paper proposes a method for assessing capabilities, which considers the levels of achieved functionings of other individuals with similar boundary conditions. The capability of an individual can then be captured statistically based on the variability of the achieved functionings over the considered population. (shrink)

Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organisations with an operationalisation gap. To successfully implement such guidance, they must find ways to translate high-level ethics frameworks into practical methods and tools that match their specific workflows and needs. Here, we describe the development of a standardised risk assessment tool, the Principle-at-Risk Analysis (PaRA), as a means to close this operationalisation gap for a key level of the (...) ethics infrastructure at many organisations – the work of an interdisciplinary ethics panel. The PaRA tool serves to guide and harmonise the work of the Digital Ethics Advisory Panel at the multinational science and technology company Merck KGaA in alignment with the principles outlined in the company’s Code of Digital Ethics. We examine how such a tool can be used as part of a multifaceted approach to operationalise high-level principles at an organisational level and provide general requirements for its implementation. We showcase its application in an example case dealing with the comprehensibility of consent forms in a data-sharing context at Syntropy, a collaborative technology platform for clinical research. (shrink)

When faced with an urgent and credible threat of grave harm, we should take proportionate precautions. But what is it for a precaution to be “proportionate”? I construct a pragmatic analysis of consisting of four tests—permissibility-in-principle, adequacy, reasonable necessity and consistency—that could realistically be applied by a citizens’ assembly meeting online or in person. I apply these tests retrospectively to two examples from the COVID-19 pandemic—border closures and school closures—arguing that my account captures the key questions on which it (...) is both feasible and important to integrate expert input with democratic input. I then consider how we might try to manage the risk of future pandemics in a proportionate way. (shrink)

According to psychological research, people are more eager to help identified individuals than unidentified ones. This phenomenon significantly influences many important decisions, both individual and public, regarding, for example, vaccinations or the distribution of healthcare resources. This paper aims at presenting definitions of various levels of identifiability as well as a critical analysis of the main philosophical arguments regarding the normative significance of the identifiability effect, which refer to: (1) ex ante contractualism; (2) fair distribution of chances and risks; (...) (3) anti-aggregationist principles that recommend the distribution of bad effects and the concentration of good ones. I will show that these arguments, although connected with interesting philosophical problems regarding e.g. counterfactuals, aggregation, or probability, are unconvincing. (shrink)

The potential negative impacts of biological pest control on non-target species have become the focus of a contentious debate. In this article, we use examples from both classical and augmentative biological control of fruit fly pests in Hawaii to address several important factors in assessing non-target risks of fruit fly parasitoids. Several fruit fly parasitoids have been introduced to Hawaii and contribute substantially to the reduction of pest populations in the state's farms and forests. However, an historical lack of host-specificity (...) testing of these parasitoids with non-target species has raised concerns about their impact on non-pest fruit flies, including some flies deliberately introduced for biological control of weeds and others that are endemic Hawaiian species. When developing protocols to assess risks of introduced fruit fly parasitoids, we need first to define an appropriate range of species against which host specificity should be tested. For assessing susceptibility of a non-target species to parasitoids, behavioral tests are as important as suitability tests. Experimental factors, such as host-exposure substrate, absence or presence of preferred hosts, and laboratory vs. natural conditions, are shown to affect the results of host-specificity tests and risk analysis. Still, assessing long-term, indirect ecological impacts of parasitoids and weighing potential risks and benefits in multiple dimensions (besides dollar values) remains a challenge to environmentalists, conservationists, applied ecologists, and biocontrol practitioners. (shrink)

For more than 10 years, Ulrich Beck has dominated discussion of risk issues in the social sciences. We argue that Beck's criticisms of the theory and practise of risk analysis are groundless. His understanding of what risk is is badly flawed. His attempt to identify risk and risk perception fails. He misunderstands and distorts the use of probability in risk analysis. His comments about the insurance industry show that he does not understand (...) some of the basics of that industry. And his assertions about the wrongness of allowing acceptable levels of exposure to toxic chemicals do not stand up to scrutiny. Key Words: Beck • risk analysis • risk perception • probability • insurance. (shrink)

Ecological and social systems are complex and entwined. Complex social-ecological systems interact in a multitude of ways at many spatial scales across time. Their interactions can contribute both positive and negative consequences in terms of sustainability and the context in which they exist affecting future landscape change. Non-metropolitan landscapes are the major theatre of interactions where large-scale alteration occurs precipitated by local to global forces of economic, social, and environmental change. Such regional landscape effects are critical also to local natural (...) resource and social sustainability. The institutions contributing pressures and responses consequently shape future landscapes and in turn influence how social systems, resource users, governments, and policy makers perceive those landscapes and their future. Science and policy for "sustainable" futures need to be integrated at the applied "on-ground" level where products and effects of system interactions are fully included, even if unobserved. Government agencies and funding bodies often consider such research as "high-risk". This paper provides some examples of interdisciplinary research that has provided a level of holistic integration through close engagement with landholders and communities or through deliberately implementing integrative and innovative on-ground experimental models. In retrospect, such projects have to some degree integrated through spatial synthesis, policy analysis, and institutional arrangements that are relevant locally and acceptable in business, as well as at broader levels of government and geography. This has provided transferable outcomes that can contribute real options and adaptive capacity for suitable positive futures. (shrink)

On 22 July, 2011, we were confronted with the horror of the actions of Anders Behring Breivik. The instant reaction, as we have seen with similar incidents in the past—such as the Oklahoma City bombings—was to attempt to explain the incident. Whether the reasons given were true or not were irrelevant: the fact that there was a reason was better than if there were none. We should not dismiss those that continue to cling on to the initial claims of a (...) wider Jihadist plot behind the actions of Timothy McVeigh and Terry Nichols as Islamophobes (or merely lacking common sense): for, it is often easier to rely on reason—no matter how fictional—than not to have anything to cling on at all. In many ways, it is even better if the reason is fictional: for, if grounded in a certain fact, or reality, it can then go away. However, if it is in the realm of the imaginary, it is then always already metaphorical: thus, can be applied to any and every situation. And it is this, if we echo Friedrich Nietzsche, that gives us our “metaphysical comfort”; that we can know what is going on. This is why conspiracy theories are so popular: underlying them is the logic that someone—no matter how implausible—is in control of the situation. One would rather believe that all acts of terror stemmed from Osama bin Laden (and the narrative worked even better when he was in a ‘cave in Afghanistan’) than if they were the actions, and decisions, of singular individuals. For, if there is a head organizing everything, it can be cut off; there is no controlling a mass of singularities. As Jean Baudrillard continues to teach us, the term ‘mass’ is not a concept. It is a leitmotif of political demagogy, a soft, sticky, lumpen-analytical notion. A good sociology would attempt to surpass it with ‘more subtle’ categories: socio-professional ones, categories of class, cultural status, etc. This is wrong: it is by prowling around these soft and acritical notions (like ‘mana’ once was) that one can go further than intelligent critical sociology. Besides, it will be noticed retrospectively that the concepts ‘class’, ‘social relations’, ‘power’, ‘status’, ‘institution’, and ‘social’ itself—all these too-explicit concepts which are the glory of the legitimate sciences—but also only ever been muddled notions themselves, but notions upon which agreement has nevertheless been reached for mysterious ends: those of preserving a certain code of analysis. To want to specify the term ‘mass’ is a mistake—it is to provide meaning for that which has none.1 And it is this lack of meaning—this nothingness of not only the mass, but our inability to know in general—that truly scares us. For, if we are never able to legitimately make a generalizing statement, this suggests that we can never actually posit beyond a singular, situational, moment. Hence, we can never claim to know anyone: at best, we can only catch momentary glimpses. It is for this very reason that the insanity plea Breivik’s lawyer will attempt is the one that horrifies us the most. For, if Breivik is insane, this foregrounds our inability to understand, know. And as Aristotle has taught us, it is more important that something is plausible than if something were probable—in this context, we would rather have Breivik as a calculating mass murderer than someone who was completely out of his mind. This is especially ironic in the light of the fact that none of us would say that we have any similarity with Breivik. If that were so, the declaration that he was mad should be no more than a logical consequence. However, we also want Breivik to be accountable for his actions. And in order for that to be so, we need him to be of sound mind. But if that were true, we can then no longer distinguish ourselves from him. And it is precisely this that scares us. For, we are horrified not when there are abnormalities to our way of life. There are usually two different reactions to this—either oppose and destroy it; or subsume it under the dominant logic. We see this most clearly in reactions to immigration: there are either calls for immigrants to ‘pack up and leave’ or pseudo-liberal notions of ‘we are all alike’. Both of which are merely version of “all men are brothers”—the brutal translation of which is that you are my brother if you live the same way as me; otherwise not only are you not my brother, you are also potentially not part of mankind (you might as well be, to echo Giorgio Agamben, bare life ). This is played out in our age of what is commonly termed post-political bio-politics —an instance of horribly awkward theoretical jargon that Slavoj Žižek channeling Agamben unpacks rather elegantly: “ post-politics is a politics which claims to leave behind old ideological struggles and, instead, focus[es] on expert management and administration, while bio-politics designates the regulation of the security and welfare of human lives as its primary goal.”2 Žižek continues: Post-political bio-politics also has two aspects which cannot but appear to belong to two opposite ideological spaces: that of the reduction of humans to ‘bare life,’ to Homo sacer , that so-called sacred being who is the object of expert caretaking knowledge, but is excluded, like prisoners at Guantanamo or Holocaust victims, from all rights; and that of respect for the vulnerable Other brought to an extreme through an attitude of narcissistic subjectivity which experiences the self as vulnerable, constantly exposed to a multitude of potential harassments [….] What these two poles share is precisely the underlying refusal of any higher causes, the notion that the ultimate goal of our lives is life itself. That is why there is no contradiction between the respect for the vulnerable Other and […] the extreme expression of treating individuals as Homini sacer .3 This is why the ones that are harshest towards new immigrants are the recently naturalized citizens of any country. For, if there is no longer any “ideological struggle” and all life is reduced to mere automaton-living, there is the realization that we are all the same—not in a tree-hugging hippie sense—but that the immigrant is the same as us precisely because we are all immigrants. And since all nations, and by extension peoples in a nation (especially those who believe in the notion of nationality, and national identity), have to find some manner, no matter from where or what it is, to distinguish themselves from those around them, the other (in spite, and especially in the light, of its absence) is the most crucial aspect of the discourse of nationality. More precisely, in the interests of what Baudrillard calls “preserving a certain code of analysis” (nationality in this case), what has to be maintained is the absolute otherness of the other. Very rarely is Boris Johnson right: “it is not enough to say he is mad. Anders Breivik is patently mad.”4 However, much like Breivik in his manifesto, he should have stopped whilst he was ahead. By attempting to diagnose Breivik—“the fundamental reasons for their callous behavior lie deep in their own sense of rejection and alienation. It is the ideology that gives them the ostensible cause … that gives them an excuse to dramatize the resentment … and to kill.”—Johnson falls into the same trap that he accuses others of: “to try to advance any other explanation for their actions … is simply to play their self-important game.” More crucially, and this is the point that Johnson completely misses, attempting to rationalize Breivik’s actions—to rehabilitate reason—is a desperate attempt at maintaining his otherness. In fact, we’ll end up going one step further, insist on Breivik’s sanity, put him on the stand, and hope that he will display such a difference from all of us that we can rest safe that we are unlike him and his kind. That, in itself, is a dangerous game to play. One should not forget that the turning point in Mary Shelley’s Frankenstein is in the central part of her novel where she lets the monster speak. At that moment, the monster moves from an ‘it’ to a fully subjectivized person; with his own stories, historicities, emotions, and so on. In Slavoj Žižek’s reading of Frankenstein , this is the moment where “the ultimate criminal is thus allowed to present himself as the ultimate victim. The monstrous murderer reveals himself to be a deeply hurt and desperate individual, yearning for company and love.”5 But, in the case of Breivik, this goes beyond just a risk of us feeling for him: for, no right-minded person should ever deny another the opportunity to put forth her or his own case. The problem lies with us trying to deny the madness of Breivik’s act by putting him back under reason. The problem is in our inability to differentiate the act from the person; the singular from the universal.6 In our desperation to preserve the notion that we are rational beings incapable of becoming monsters, we’ve had to deny the meaninglessness—in the strict sense of it lying outside of reason—of Breivik’ act; we’ve had to “provide meaning where there is none.” For, if this act were a moment of madness—a moment that comes from elsewhere—we cannot say that it will not descend upon us one day. If Breivik’s actions were that of a sane person, one who is in control of his being, his self, we can then locate the otherness in his being. More importantly, this would allow us to distinguish ourselves from that said being. Breivik’s sanity is the only thing that allows us to say that ‘this act of terror is borne out of one with an ultra-right ideology’; and ‘since I am not of that ideology, I would never do such a thing’. By doing that, we attempt to protect ourselves by claiming that people who share Breivik’s ideology are foreign to us, other to us. However, if Breivik’s act was a moment of insanity, his otherness is no longer locatable: and the notion of ‘us and them’ shifts from a geographical, physical, religious, or cultural notion, to one in the realm of ideas. And this is what truly scares us. For, if what is foreign is not phenomenological, then it cannot be seen, detected, sensed. Anders Behring Breivik, Timothy McVeigh, and Terry Nichols, terrify us not merely for the fact that they were white in a white society, but more pertinently that their skin color did not matter: we would not be able to spot them even if they were blue, even if they were right next to us, even if we had known them all our lives. Even as we are grappling with holding Breivik accountable by declaring him of sound mind, what truly terrifies us is that deep down we know that Breivik’s act is a moment of madness; beyond all comprehensibility. And this means that we would not be able to spot the idea; even if it were in our heads at this very moment. We have gone to lengths to rehabilitate Breivik, McVeigh, Nichols, and such perpetrators of massive incomprehensible violence, in order to preserve our difference from them. What we have really been trying to deny is the fact that everyone, at any given moment, could have a moment of madness. And this is the true radicality of Mary Shelley: in allowing us to momentarily enter the head of the monster, she shows us not just the fact that he is like any one of us, but that any one of us could, in the right (or wrong) circumstance, be like him. Perhaps here, there is a lesson to be learned from Wes Craven’s A Nightmare on Elm Street . The most dangerous thing that one could do on Elm Street was to mention Freddy’s name—once you had knowledge of him, you were open to the possibility of a visit during your dreams. This suggests that Freddy is a combination of externalities (after all, when you die, he survives) and your self (if you have never heard of him, he cannot come for you). In this sense, Freddy would be the manifestation par excellence of what Avital Ronell calls a “killer text”—it is one’s relationality with the text (and the ideas, notions, in the said text) that opens oneself to it, to the lessons of the text, to being changed, affected, even to the dangers of the text. After all, one should never forget Plato’s warning that ideas can corrupt, can be perilous. To compound matters, as Ronell reminds us, “the connection to the other is a reading—not an interpretation, assimilation, or even a hermeneutic understanding, but a reading.”7 Thus, in attempting to differentiate ourselves from Breivik by concocting some reason(s) why we are not like him, we have done nothing but read him, open a connection to him. *** Bang bang, he shot me down Bang bang, I hit the ground Bang bang, that awful sound Bang bang, my baby shot me down. “Bang Bang (My Baby Shot Me Down)” Sonny Bono, 1966. This is the part that we all know and remember. Whilst never quite remembering that this is a song that is not so much about violence, love, but about remembering. For, after the bridge comes the accusatory stanza: “Now he's gone, I don't know why/ And till this day, sometimes I cry/ He didn't even say goodbye/ He didn't take the time to lie.” Bang Bang is a game that the two lovers used to play; and all she has now is the memory of the game to remember him by. And the only reason she has to recall this game is: he never provided her a reason for his leaving, his death. Not that she will, can, ever get that satisfactory answer. This is precisely the game we are playing with Anders Behring Breivik. Even though he has left a 1500 page manifesto, even though we will allow him to use the court-room as his platform, we will continue screaming at him “tell me why …” For, what we want him to say is that we are not like him: what we really want him to do is, “take the time to lie …” Perhaps here, we should allow the echo of the infans to resound in baby . As Christopher Fynsk reminds us, the infans is one that is pre-language, pre-knowing, pre-understanding: it is the very finitude, and exteriority, of relationality itself.8 And thus, it is a position of openness to the fullness of possibility—and nothing else. This would be, in Ronell’s terms, a “connection to the other” that knows nothing other than the fact that it is a connection. The true horror of 22 July, 2011, is the fact that it is not Anders Behring Breivik who is mad, but the act itself that is. And this is precisely why only “my baby” that could have “shot me down.” For, it is an act that is from beyond, a sheer act of madness that—as Plato warns us—is whispered into our ears (and can so easily be mistaken for inspiration, and even wisdom), an act that can both seize, and cease, us at the same time. And what can this utter openness to an other, the other, be but a moment of love, a true ‘falling in love’. At the moment of whispering, nothing can be known as we are babies as our baby shoots us down …. Hence, all attempts at analyzing this event (including this one) are not only futile, but border on the farcical. The real tragedy is that we forget that all of us have the possibility of becoming Breivik. NOTES Jean Baudrillard. In the Shadow of the Silent Majorities . Trans. Paul Foss, John Johnston, Paul Patton, & Andrew Berardini. Los Angeles: Semiotext(e), 2007. p. 37. Slavoj Žižek. Violence: Six Sideway Reflections . London: Profile Books, 2009. p. 34 Ibid: 35-36. Boris Johnson. “ Anders Breivik: There is nothing to study in the mind of Norway’s mass killer .” The Telegraph . (25 July, 2011): Slavoj Žižek. Violence: Six Sideway Reflections . London: Profile Books, 2009. p.39. What is killing us is the notion that Breivik’s act is beyond reason, beyond knowing, outside understanding itself. This is why Boris Johnson’s plea was for us to ignore Breivik as a madman. But to do so, Johnson conflates the notion of the act and the person; the singular and the universal. This is exactly the same gesture as insisting on his sanity: the ‘madman’ is merely the absolute other, one that we are not. Avital Ronell. The Telephone Book: Technology, Schizophrenia, Electric Speech . Lincoln: University of Nebraska Press, 1989: 380. Christopher Fynsk. Infant Figures: The Death of the Infans and Other Scenes of Origin . Stanford, CA: Stanford University Press, 2000.  . (shrink)

Major depression etiopathogenesis is related to a wide variety of genetics, demographic and psychosocial factors, as well as to environmental factors. The objective of this study is to analyze sociodemographic and environmental variables that are related to the prevalence of depression through correlation analysis and to develop a regression model that explains the behavior of this disease from an ecological perspective. This is an ecological, retrospective, cross-sectional study. The target population was 1,148,430 individuals over the age of 16 (...) who were registered in Aragon (Spain) during 2010, with electronic medical records in the community’s primary health care centers. The spatial unit was the Basic Health Area (BHA). The dependent variable was the diagnosis of Depression and the ecological independent variables were: Demographic variables (gender and age), population distribution, typology of the entity, population structure by sex and age, by nationality, by education, by work, by salary, by marital status, structure of the household by number of members, and state of the buildings. The results show moderate and positive correlations appear with higher rates of depression in areas having a higher femininity index, higher population density, areas with a higher unemployment rate and higher average salary. The results of the linear regression show that aging +75 and rural entities act as protective factors for depression, while urban areas and deficient buildings act as risk factors. In conclusion, the ecological methodology may be a useful tool which, together with the statistical epidemiological analysis, can help in the political decision making process. (shrink)

A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance (...) and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved. (shrink)

Jeff Nisker describes his personal experience of a diagnosis of advanced prostate cancer and the kindnesses he received from friendly doctors. He claims that this narrative account supports the promotion of Prostate Specific Antigen (PSA) screening for asymptomatic men and impugns statisticians, mistakenly thinking that their opposition to PSA screening derives from concerns about financial cost. The account inadvertently demonstrates the danger of over-reliance on a single ethical tool for critical analysis. In the first part of this response, we (...) describe the statistical evidence. The most reliable Cochrane meta-analyses have not shown that PSA screening saves lives overall. Moreover, the high false positive rate of PSA screening leads to overinvestigation which results in unnecessary anxiety and increased cases of unnecessary sepsis, urinary incontinence and sexual dysfunction. Then we describe how narrative ethics alone is an insufficient tool to make claims about policies, such as PSA screening, which have hidden harms. Although Nisker’s story-telling is compelling and evokes emotions, narrative ethics of this sort have an inherent bias against people who would be harmed by the counterfactual. Particular care must be taken to look for and consider those untellable stories. Ethicists who only consider narratives which are readily at hand risk harming those who are voiceless or protected by the status quo. PSA screening is the wrong tool to reduce prostate cancer deaths and narrative ethics is the wrong tool to appraise this policy. It is vital that the correct theoretical tools are applied to the medical and ethical questions under scrutiny. (shrink)

Risks and benefit evaluation for controlled human infection studies, where healthy volunteers are deliberately exposed to infectious agents to evaluate vaccine efficacy, should be explicit, systematic, thorough, and non‐arbitrary. Decision analysis promotes these qualities using four steps: (1) determining explicit criteria and measures for evaluation, (2) identifying alternatives to the study, (3) defining the models used to estimate the measures for each alternative, and (4) running the models to produce the estimates and compare the alternatives. In this paper, we (...) describe how decision analysis might be applied by funders and regulators, as well as by others contemplating the use of novel controlled human infection studies for vaccine development and evaluation. (shrink)

In this paper, I raise a problem for standard precisifications of the Relational Analysis of attitude reports. The problem I raise involves counterfactual attitude verbs. such as ‘wish’. In short, the trouble is this: there are true attitude reports ‘ S wishes that P ’ but there is no suitable referent for the term ‘that P ’. The problematic reports illustrate that the content of a subject’s wish is intimately related to the content of their beliefs. I capture (...) this fact by moving to a framework in which ‘wish’ relates subjects to sets of pairs of worlds, or paired propositions, rather than—as is standardly assumed—sets of worlds. Although other types of counterfactual attitude reports, for example those involving ‘imagine’, may be similarly problematic, at this stage it is unclear whether they can be handled the same way. (shrink)

Despite the presumed frequency of conflicts of interest in scientific peer review, there is a paucity of data in the literature reporting on the frequency and type of conflicts that occur, particularly with regard to the peer review of basic science applications. To address this gap, the American Institute of Biological Sciences conducted a retrospective analysis of conflict of interest data from the peer review of 282 biomedical research applications via several onsite review panels. The overall conflicted-ness of (...) these panels was significantly lower than that reported for regulatory review. In addition, the majority of identified conflicts were institutional or collaborative in nature. No direct financial conflicts were identified, although this is likely due to the relatively basic science nature of the research. It was also found that 65 % of identified conflicts were manually detected by AIBS staff searching reviewer CVs and application documents, with the remaining 35 % resulting from self-reporting. The lack of self-reporting may be in part attributed to a lack of perceived risk of the conflict. This result indicates that many potential conflicts go unreported in peer review, underscoring the importance of improving detection methods and standardizing the reporting of reviewer and applicant conflict of interest information. (shrink)

Many accounts of online trust are based upon mechanisms for building reputation. Trust is portrayed as desirable, and handing off trust is easier if trust is modelled to be transitive. But in the analysis of cyber-security protocols, trust is usually used as a substitute for certain knowledge: it follows that if there is no residual risk, then there is no need for trust. On this grimmer understanding, the less that users are required to trust, the better. Involuntary transitivity (...) of trust becomes corrosive, because it prevents participants from having control—or even knowledge—of the risks to which their trust assumptions expose them. In this paper, we take the stance that controlling the transitivity of trust requires us to recognise trust as a non-referentially transparent modality, similar to but significantly weaker than the epistemic modalities, and to accept the corollary that imaginary (indeed—even impossible) threats can have real consequences that adversely affect online security. An apparently paradoxical outcome is that the desire of principals to keep their trust assumptions private can actually assist the design of systems to satisfy multiple security agendas. However, this approach requires agents to have the capability to predicate accurately about states of affairs that are logically inconsistent with their beliefs, and consequently, designing systems in this way becomes more akin to diplomacy than engineering. (shrink)

We respond to recent comments on our proposal to improve justice in ventilator triage, in which we used as an example New Jersey’s publicly available and legally binding Directive Number 2020-03. We agree with Bernard Lo and Doug White that equity implications of triage frameworks should be continually reassessed, which is why we offered six concrete options for improvement, and called for monitoring the consequences of adopted triage models. We disagree with their assessment that we mis-characterised their Model Guidance, as (...) included in the NJ Directive, in ways that undermine our conclusions. They suggest we erroneously described their model as a two-criterion allocation framework; that recognising other operant criterion reveals it ‘likely mitigate[s] rather than exacerbate[s] racial disparities during triage’, and allege that concerns about inequitable outcomes are ‘without evidence’. We highlight two major studies robustly demonstrating why concerns about disparate outcomes are justified. We also show that White and Lo seek to retrospectively—and counterfactually—correct the version of the Model Guideline included in the NJ Directive. However, as our facsimile reproductions show, neither the alleged four-criteria form, nor other key changes, such as dropping the Sequential Organ Failure Assessment score, are found in the Directive. These points matter because our conclusions hence stand, because the public version of the Model Guidance had not been updated to reduce the risk of inequitable outcomes until June 2021 and NJ’s Directive still does not reflect these revisions, and, hence, represents a less equitable version, as acknowledged by its authors. We comment on broader policy implications and call for ways of ensuring accurate, transparent and timely updates for users of high-stakes guidelines. (shrink)

SummaryIn 1968, a prospective study was started in collaboration with the Family Planning Association to try to provide a balanced view of the beneficial and harmful effects of different methods of contraception. This investigation is now in progress at seventeen clinics and over 17,000 women are under observation. At the time of recruitment, all these women were married white British subjects, aged 25–39 years, who voluntarily agreed to participate. Fifty-six per cent were using oral contraceptives, 25% were using a diaphragm (...) and 19% were using an intrauterine device. During follow-up each woman is questioned at return visits to the clinic and a record of pregnancies and their outcome, hospital referrals, changes in contraceptive methods and the results of cervical smears, is accumulated. Women who default are sent a postal questionnaire and, if this is not returned, are telephoned or visited in their homes to collect the necessary information.So far, data obtained during 56,000 woman-years of observation are available for analysis. Follow-up has been maintained with an annual lapse rate of about 0.3%due to withdrawal of co-operation or loss of contact; adherence to the method of contraception in use at recruitment has been reasonably good, and the reporting of pregnancies and hospital admissions appears to have been both reliable and unbiased.The present data include only 24 deaths, so the mortality associated with different contraceptive methods cannot yet be estimated. With regard to morbidity, however, our preliminary results closely resemble those obtained in the prospective study carried out by the Royal College of General Practitioners and in the principal retrospective studies carried out in Britain and the United States. Women who used oral contraceptives at the start of the study experienced adeficiencyof hospital referrals for cancer, benign lesions of the breast, menstrual disorders other than amenorrhoea, duodenal ulcer, and retention cysts of the ovary; they showed anexcessof referrals for cerebrovascular disease, cervical erosion, skin disorders, self-poisoning, migraine, venous thrombosis and embolism, hayfever, gallbladder disease, amenorrhoea, and sterility. Women who used a diaphragm showed adeficiencyof hospital referrals for carcinoma-in-situ and dysplastic lesions of the cervix uteri and accidental injury; and anexcessof referrals for haemorrhoids and cystitis. Women who used an IUD experienced anexcessof hospital referrals for anaemia, varicose veins and salpingitis. About half of these differences were predicted from other studies while some suggestive evidence already existed for a further five. Of the remaining six, some probably reflect the influence of selective factors or chance.Multiple pregnancies, stillbirths, malformations, the sex ratio and birthweight showed no consistent relationship to method of contraception. The outcome of unplanned pregnancies occurring in women using an IUD, however, was remarkably unfavourable both in terms of ectopic gestation and miscarriage.Clear evidence was found of impairment of fertility after discontinuation of oral contraceptives. Whether this is likely to lead to permanent sterility in some women is uncertain.The study has provided data on the efficacy of a wide variety of contraceptive methods. In general the failure rates are in keeping with those obtained in other large-scale studies, save that those for the diaphragm and the sheath are much lower than those usually quoted.The available evidence does not yet allow a final balance to be struck between the benefits and risks associated with the new methods of contraception that have become widely used during the last two decades. It seems clear, however, that there are no material risks associated with the use of the diaphragm apart from the risk of pregnancy and that there may be some unintended benefits. (shrink)