Blockchain Papers

Peter Haastrup, Anne Møller, Jette Kolding Kristensen, Linda Huibers

Denmark is known for its good population health, largely attributable to its effective healthcare system. This analysis of the Danish primary healthcare system with focus on general practice describes the system's overall structure, function, and financing. Further, it reviews some of the recent developments in organization and decentralization from secondary to primary care. Finally, we discuss some of the key challenges that primary care faces and potential areas for improvement to ensure a sustainable Danish healthcare system of high quality.

Precilia Kong, Chang Lu, C. Reyes-de la Cruz

No abstract is available for this record.

Christopher R. Carpenter, Lucas Oliveira J. e Silva, Suneel Upadhye, Joshua Broder · 5 authors

Emergency medicine is often a specialty defined by diagnostic uncertainty when worried patients present with constellations of symptoms seeking explanation and relief. Abdominal pain is a common chief complaint among adult emergency department (ED) patients, with recurrent symptoms in the subsequent days, weeks, months, and even years, sometimes prompting repeat evaluations.1 The differential diagnosis is broad and diverse, including multiple organs and systems and extraabdominal causes. Ideally, clinical practice guidelines (CPGs) synthesize the entirety of evidence for questions relevant to an explicitly defined patient population and outcomes, but until now no CPG existed for the scenario of recurrent abdominal pain. Consequently, significant practice variation exists in the diagnostic and therapeutic approach to this clinical condition.2 The Society for Academic Emergency Medicine (SAEM) second "Guidelines for Reasonable and Appropriate Care in the Emergency Department 2 (GRACE-2)" article provides that CPG with adherence to Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology including incorporation of patient priorities and external stakeholders.3 Through adherence to the GRADE methodology we aimed to create rigorous and trustworthy guidelines. The GRACE-2 writing team deliberated to select topics and questions and to explicitly define a clinically meaningful population, ultimately settling on definitions of recurrence within 30 days and adults with "low-risk" abdominal pain. Identifying no well-accepted or validated definition of "low risk" (as opposed to a risk model like the HEART score for chest pain4), the GRACE-2 writing team devised a definition of "low risk" that resonated with our clinical intuition and excluded populations that emergency physicians would routinely identify as moderate or high risk. Subsequently, the GRACE-2 writing team worked with medical librarians to focus searches based on the patient-intervention-control-outcome-time (PICOT) template5 and completed systematic reviews for each question before developing the recommendations.6, 7 The PICOT-oriented literature search revealed no studies that aligned with our definition of low risk and few that defined recurrence within our predefined time frame. However, that does not mean that our search rendered zero published evidence around which GRACE-2 could contemplate actionable recommendations via the GRADE Evidence to Decision (EtD) framework.8, 9 We had to make a decision about how to classify and incorporate the published research that we did identify. GRADE provides a framework for evidence synthesis and development of clinical guidelines and recommends inclusion of both direct and indirect evidence into CPGs, while providing guidance around the distinction between the two.8-12 Therefore, we decided to classify evidence as "direct" if each element of the PICOT question matched the study's inclusion criteria and outcomes assessed. "Indirect" evidence was defined by deviation from any component of the PICOT question (Table 1). These definitions are necessary for guideline developers who need to evaluate the domain of indirectness when rating the certainty of evidence.10, 12 Since the overall value of CPGs rests upon the rigor and transparency of the evidentiary search, quality assessment, and synthesis in conjunction with an explicit and representative assessment of anticipated benefits or potential harms of the subsequent recommendations, weighing the pros and cons of including indirect evidence is merited while considering if and how to incorporate the GRACE-2 recommendations into ED practice. Not emergency department Not adult Not recurrent Not undifferentiated abdominal pain Not low risk Initial CT identified explanatory pathology like kidney stone Repeat CT >12 months after initial CT GRADE recognizes indirectness as a key domain in the assessment of certainty of evidence.10, 12 Whenever systematic review authors or guideline developers identify important indirectness issues from a body of evidence that deviates from the original PICOT question, the certainty of evidence must be downgraded by one or two levels.10, 12 Despite such guidance from GRADE, conceptualization of what type of indirect evidence could be synthesized and used by CPGs remains debatable, especially when there is insufficient direct evidence.13 Also, a second layer of complexity is added when guideline developers need to evaluate the directness of research evidence for all criteria of the GRADE EtD framework including values, resources, cost-effectiveness, equity, acceptability, and feasibility. This cognitive framework can quickly diffuse into uncertainties. Nonetheless, indirect evidence is not fundamentally or inevitably flawed. For example, a study might be rated as indirect because the age range of enrolled subjects does not perfectly match the intended population or because the time frame of follow-up slightly exceeds the desired target. Such evidence may provide a very reasonable estimate of the range of expected outcomes in the intended population. In addition, many randomized controlled trials employ so many exclusion criteria and carefully controlled experimental conditions that the results may not predict outcomes in a broader ED population. GRADE attempts to distill value from the broad range of available evidence, rather than taking a nihilistic attitude that rejects evidence on the basis of any imperfection. Nihilism suggests "we know nothing" and have no basis for any decision—but emergency medicine requires that physicians make the best decision possible based on the available, if imperfect, evidence in a more pragmatic approach. GRADE recommends that if a large body of indirect evidence that can be convincingly linked to the PICOT support the management strategy, recommendations should be made.14 Specifically, GRADE states that "clinicians will rarely explore the evidence as thoroughly as a guideline panel, nor devote as much thought to the trade-offs, or the possible underlying values and preferences in the population. We therefore encourage panels to deal with their discomfort and to make recommendations even when confidence in effect estimate is low and/or desirable and undesirable consequences are closely balanced."15 The ideal strategy to dealing with absent direct evidence for a certain question during CPG development is not fully established among guideline developers, and each panel along with their methodologists need to individualize such decisions according to resource availability (e.g., methodological expertise, funding) and feasibility. Murad et al.,13 for example, suggest five strategies for supplementing systematic review findings when evidence on benefits or harms is found to be insufficient, including: (1) reconsider eligible study designs, (2) summarize indirect evidence, (3) summarize contextual and implementation evidence, (4) consider modeling, and (5) incorporate unpublished health system data in the evidence synthesis. In GRACE-2, summary of indirect evidence was chosen as the main approach and different "bodies of indirect evidence" were systematically synthesized.6, 7 As three out of four questions in GRACE-2 were related to diagnostic tests, we also faced the reality that direct evidence evaluating the impact of different testing strategies on patient-important outcomes (i.e., diagnostic randomized trials) seldom exists, which ultimately leads to the use of different types of indirect evidence such as diagnostic accuracy.16-18 Even within the adaptive framework of GRADE, indirect evidence may leave the PICOT question unanswered, and subsequent recommendations are often necessarily weak or nonexistent. Strong and definitive recommendations necessitate multiple studies evaluating the identical patient population and diagnostic approach quantifying the same outcomes in similar time frames with minimal concerns about health inequities, resource consumption, imprecision, or feasibility. Indirect evidence alone is unlikely to justify strong recommendations, but does provide substantive proof of the scope of the problem relative to the paucity of evidence. If the indirect evidence was excluded, CPG stakeholders would not be cognizant that this research was identified and reviewed in developing the recommendations. Clinicians, educators, and researchers would remain unaware of how little empiric evidence exists around which to shape decision making or how future investigators could more directly address the knowledge void. GRACE-2 is not alone in identifying a painfully surprising gap between what emergency medicine thinks is common knowledge and high-quality research to justify those beliefs. One reflection of this is that the majority of American College of Emergency Physician Clinical Policy recommendations are not level A.19 Ultimately, concerns about the directness of evidence for CPGs represent an existential crisis for emergency medicine. As society's safety net for potentially life-threatening medical, surgical, or psychiatric illness, emergency medicine's breadth of knowledge must remain broad and open-ended as clinical science continues to expand the horizons of possibility. The hierarchy of evidence-based medicine places CPGs at the top of the information pyramid, yet guidelines for common syndromic presentations like acute abdominal pain do not exist in emergency medicine. Certainly, our specialty could await others to create CPGs for these conditions, but those organizations are most likely to view patient encounters through the lens of an established or highly suspected diagnosis. In contrast, emergency physicians confront undifferentiated patients with constellations of signs and symptoms in a chaotic environment. We navigate the challenges of accurate and timely diagnosis, often with imperfect data. Paradoxically, we face expectations of constraint with testing—often without evidence-based guidance for when to safely limit workups—while avoiding critical misses. Experience with other organization's CPGs has shown that ED clinicians are often noncompliant with their recommendations, which commonly do not account for the real-life conditions of emergency care. The consequence is an unfair judgment that emergency physicians engage in inferior, non–evidence-based, and excessively costly health care by external stakeholders.20-23 The Association of Academic Chairs of Emergency Medicine's 2030 research goals focus on increasing the proportion of NIH R01-funded emergency medicine investigators, who will someday close the knowledge gap for prevalent conditions that currently remain underinvestigated.24 The absence of direct evidence and the imperfection of indirect evidence for high-priority emergency medicine CPGs illustrates the importance of forming a National Institute of Emergency Care. In addition to supporting the next generation of independent health-outcomes researchers, a central prioritizing body could ensure that the most pertinent questions affecting patient care on a daily basis are the focus of funding opportunities.19, 25 Until that day, GRACE-2 provides a synthesis of evidence and corresponding recommendations derived using GRADE methodology upon which to guide imaging and therapy decisions for adults with low-risk and recurrent abdominal pain. Medicine is equal parts science and art with clinical judgment based on hermeneutic thinking to generate a holistic understanding of an individual patient's current condition.26 Our vision is for the inclusion of direct and indirect evidence in this CPG to ground that decision making in a realistic understanding of our current state of knowledge, while catalyzing more pertinent research in the near future.

Maja Mrkić, Violeta Ilić-Todorović, Jasmina Jovanović-Mirković, Dragan Radosavljević · 6 authors

Health care is the most important activity and human kind is dealing with its organization for centuries. Public health policies and functional health care systems have as their primary objectives the preservation and improvement of public health. Problems of intensive aging of the population, continuous growth of health spending, ensuring sustainable financing of health systems and efficient use of resources are present in all world health systems. Health care system reforms have become a global phenomenon for the last twenty years of the last century. The goal of this review paper is to point out the importance and need for timely modifications of the strategy of the health care optimization plan in Serbia by 2035, so that the health care system of Serbia would be ready to respond to potential global health crises in the future. The Plan for optimizing the health care institutions network by 2035 as a key document of the Master Plan will be briefly presented with an analysis of key parameters of health care effectiveness and above all improvement of the implementation of basic principles of health care - uniformity and availability of health services on the territory of Republic of Serbia. In order to present future key changes in the health system, it is necessary to take into account the current situation, as well as the potential consequences of the global pandemic of COVID-19 virus on health systems. Databases were used for analysis: WHO, OECD, World Bank Reports. The tendency of increasing the share of health care costs in GDP, with the problems of efficient use of health care resources, is becoming the most important reason for reforming health insurance and health care in almost all countries in the world. Numerous researches of eminent experts in the field of economy and finance indicate that the introduction of compulsory health insurance with a clearly defined package of health conditions is the most rational choice in the implementation of the World Health Organization project: "Health for all in the 21st century". A health system could be said to be effective if it provides health care of maximum quality in terms of medical outcome, with minimal costs in relation to the allocated funds. Health care systems around the world today face very similar problems, and the COVID-19 pandemic has shown how "vulnerable" it is not only the health system but all of humanity when faced with such challenges.

Vishnu Subrahmanyam

Photo by Evgeni Tcherkasski on Unsplash
 ABSTRACT
 Public health ethics has been contingent on a political landscape leading to several operational hurdles, especially during global health emergencies. Several scholars have pointed out that liberal decision-making has prevented public health institutions from achieving their goals. Thus, the need for a substantive outlook on public health has never been stronger. First, this article highlights the ethical tension and limitations of a presumptive approach to public health that a vaccination policy might produce in a liberal political landscape. Second, influenced by the works of Angus Dawson, this article emphasizes the importance of a substantive approach to public health, especially in a post-COVID era. Last, it looks at how TM Scanlon’s theory of contractualism aids in framing a substantive approach to health policy design and the added advantages of the theory.
 INTRODUCTION
 A public health intervention like a vaccination program for COVID-19, let alone a mandatory one, faces difficulties in implementation as it presents a clash between the role of the government and liberty of its citizens.[1] The clash stems from public health operating in a liberal political landscape that accords great regard for individual liberty. The government, in good conscience, is right in feeling morally obligated to act in ways that serve to prevent the pandemic from escalating. To represent the citizens, governments and policymakers prioritize achieving and maintaining herd immunity. The tension of the state versus individual liberty questions the extent to which governments can go to implement a vaccination policy.
 In trying to balance the considerations of individual liberty and the scope of the state to impose an intervention, the Nuffield Council on Bioethics came up with a design known as the ‘intervention ladder.’[2] The takeaway from the intervention ladder is that the state has the burden of proof in justifying reasons for implementing a particular policy.[3] Such justified trade-offs envisioned from the intervention ladder have guided policymakers in their attempt to design and shape interventions. However, public health ethics and even the intervention ladder view public health through a presumptive or a moderate liberal lens.[4] In a presumptive approach or a moderate-liberal approach to public health, policymakers regard values like liberty or autonomy as more prominent when weighed against values like creation of public goods and their maintenance.[5] A libertarian approach favors liberty and autonomy even more strongly.
 The substantive view of public health holds that values, such as liberty and autonomy, do not automatically hold precedence over community-oriented values such as public goods creation.[6] Some have critiqued the intervention ladder endorsed by the Nuffield Council of Bioethics. Angus Dawson remarks that the intervention ladder as a metaphor prevents the act of climbing. He claims the ladder assumes that liberty is the only guiding principle in policymaking. Such a view neglects any responsibility the citizens have in achieving public goods and maintaining them.[7]
 The emphasis on the drawbacks of a presumptive approach, especially in a situation like the COVID-19 pandemic, leads us to question should public health undergo a redefinition? The approach in public health focusing on non-interference stems from traditional clinical bioethics.[8] However, I argue that public health ethics in a pandemic should accord less emphasis to individual liberty and evaluate every ethical value on a level playing field. Individual liberty provides less platform for action in situations where the community has not established herd immunity. Accountability for the harm principle and maintenance of public goods override concerns surrounding liberty.[9] Angus Dawson argues that with more participation in a vaccination program, protection of public goods from disease can be created faster.[10]
 Characterizing public health as an antagonist to individual liberty undermines the confidence in public health institutions and interventions for which public trust is vital. Although the government may propose a mandatory vaccination policy when voluntary measures fail to meet public health requirements, clear scientific evidence and accountability for public welfare should be the guiding principle. Thus, resetting the parameters gauging a public health intervention is the starting point to prepare for future pandemics.
 In Resetting the Parameters, Angus Dawson suggests that utilitarianism or contractualism could serve as philosophical frameworks that may aid in framing a substantive approach to public health.[11] Evaluating utilitarianism and contractualism according to the COVID-19 facts would help clarify which is better suited to framing a substantive public health approach.
 l. Is Utilitarianism Substantive?
 Under utilitarianism, the morbid circumstances of the COVID-19 pandemic urge us to act in ways that translate to maximizing the overall good. Utilitarianism is a philosophical theory that prides itself on maximizing the best of outcomes for the maximum number of people. In an ideal utilitarian framework, a morally right act does good for all. Utilitarians consider utility the single determining variable that should guide actions.[12] The actionable aspect of a utilitarian framework is its ability to quantify thresholds or markers that mostly dwell in the abstract.
 In Utilitarianism and the Pandemic, Savulescu et al. outline certain determinants as aids in applying utilitarianism.[13] Looking at the aids in the context of a mandatory vaccination policy in light of COVID-19, shows some pitfalls of utilitarianism. 
 The first utilitarian aid is to save the maximum number of lives.[14] Rightly so, an intuitive starting point in a pandemic with striking mortality rates is attempting to save the most lives. However, implementing and justifying a policy with the aim of saving the highest number of lives is complex. While a high number of deaths is a concern, it is reductionist to concentrate only on the end goal and not the means through which such a goal is attained.
 The second utilitarian aid is the length of life.[15] The length of benefit gained from an outcome is crucial for utilitarians. The duration of a benefit determines the quantity of good produced. As an extension, younger people should then, theoretically, count for more than older individuals in prioritizing benefits. Such prioritization has been a matter of concern during the COVID-19 pandemic. While it is true that younger people might tend to benefit more, the pathology of COVID-19 goes against such logic. Elderly populations have experienced disproportionately more severe cases. Therefore, prioritizing youth when the elderly are suffering more of the harm would be ethically contentious.[16]
 The third utilitarian aid is the quality-of-life post-intervention.[17] Through measures such as QALYs and DALYs,[18] utilitarians have attempted to quantify each individual's quality after an intervention. This quantification can result in connecting an individual’s quality of life to their social worth. From a utilitarian viewpoint, a person's ability to produce relevance in society becomes a key determinant in shaping public policy. By extension, people born with disabilities such as mental illness or late-stage dementia can be overlooked merely because they lack "social value.”[19] And yet, “taboo trade-offs occur when we are forced to put a finite monetary value on these sacred values [life, health, ability], when we acknowledge that there is a maximum ‘price’ that we want to pay to uphold values that should be of ‘infinite’ value.” [20]. As such, it is unethical to place a value on someone's life based on the duration or quality of life they may have after an intervention.
 Besides creating difficulty in assessing the quality of life, measures such as QALYs do not address the nuances in providing healthcare. In Economic Evaluation of Mental Health Interventions, Luyten et al. discuss several operational changes that account for these nuances.[21]
 Utilitarians believe in a moral indifference between actions and omissions as the fourth aid.[22] It does not matter how a result is achieved as long as it benefits the common good. Putting forward a bad policy is the same as not putting forward a policy. In the ever-changing and unpredictable dynamics of the COVID-19 pandemic, actions and omissions have different moral implications. Equating them often places an unfair burden on lawmakers, leaving them emotionally and morally exhausted as they weigh the advantages and risks of various outcomes.
 Actively avoiding social biases, feelings, intuitions, and heuristics is the fifth aid.[23] The pandemic elicits strong feelings and aggressively tests beliefs. During the pandemic, some profoundly troubling ethical dilemmas stemmed from bias. In a utilitarian system, a mandatory vaccination policy aimed at crossing the threshold for herd immunity may overlook groups of people who are vulnerable due to a lack of access to the social determinants of health. Attempting to avoid feelings and intuitions all the time does not always result in the creation of a fair policy. Anti-vaccination activists use emotion to further their cause, hence it is critical that politicians consider the feelings at stake for the general public when enacting a mandatory vaccination policy.
 While utilitarianism has benefits such as developing simple operationalizable concepts, providing a quantitative check, and a balance sheet of risks and benefits, it is based on an ethical dystopia. Utilitarian policies can treat people as a means to an end by focusing solely on outcomes. Utilitarianism rests on a presumptive outlook toward public h

Małgorzata Gałązka-Sobotka, Iwona Kowalska‐Bobko, Krzysztof Lach, Aneta Mela · 6 authors

Introduction: The main challenge of modern hospitals is purchasing medical technologies. Hospital-based health technology assessments (HB-HTAs) are used in healthcare facilities around the world to support management boards in providing relevant technologies for patients. Aim: This study was undertaken to update the existing body of knowledge on the characteristics of HB-HTA systems/models in the selected European countries. Insights gained from this study were used to provide an optimal approach for implementing HB-HTA in Poland. Materials and methods: Firstly, we carried out a systematic review in PubMed and embase. Secondly, we searched for gray literature via the AdHopHTA online handbook and the design book of the AdHopHTA project, as well as literature describing healthcare systems provided by the WHO. Then, we conducted in-depth interviews with HB-HTA experts from four countries. Finally, we selected ten countries from Europe and prepared frameworks for data collection and analyses. Results: The selected countries (Switzerland, Spain, France, Italy, Denmark, Finland, Sweden, the Netherlands, and Austria) are examples of decentralized or deconcentrated healthcare systems. In terms of HB-HTA, differences in organisational models (independent group, stand-alone, integrated-essential, integrated-specialised), type of financing (internally vs. externally), collaboration with an HTA National Agency and other stakeholders (e.g., Patients’ Associations) were identified. HB-HTA engages multi-skilled staff with various academic backgrounds and operates mainly on a voluntary basis. Conclusion: Strengths and weaknesses associated with various organisational models must be carefully considered in the context of support for decentralized or centralized models of implementation while embarking on HTA activities in Polish hospitals.

Dominique Vervoort, Camila R. Guetter, Alexander W. Peters

Health disparities remain vast around the world and are perpetuated by error-prone information technology systems, administrative inefficiencies and wasteful global health spending. Blockchain technology is a novel, distributed peer-to-peer ledger technology that uses unique, immutable and time-stamped blocks of records or sets of data that are linked as chains through cryptography to more reliably and transparently store and transfer data. Various industries have successfully leveraged blockchain technology to disintermediate and reduce costs, but its use in healthcare and global health has remained limited. In this narrative review, we describe blockchain technology and elaborate on the experiences and opportunities for leveraging blockchain within global health in terms of cryptocurrencies and health financing, supply chain management, health records, identification and verification, telehealth and misinformation. We conclude each section with an analysis of the restrictions imposed by the COVID-19 pandemic to highlight blockchain’s unique opportunities for improving healthcare services and access to care during future pandemics or natural disasters.

Lucy Gilson, Bruno Marchal, Irene Ayepong, Edwine Barasa · 17 authors

To say that we live in turbulent times is a massive understatement. COVID-19 ruthlessly exposes the fault lines of health services and systems, and the responses put in place to prevent its spread or mitigate its effects may affect people more than the actual infection. The outbreak in Wuhan quickly grew to a pandemic that has affected countries and regions all over the world in many, and as of yet, little understood ways. This is a global infectious disease outbreak of a scale not seen since the Spanish Flu. For many countries, it is an extreme stress test of the health system and of society at large. All over the world, people, patients, providers, health service managers, health and other sectoral policymakers and politicians, are dealing with high levels of uncertainty and severe challenges to the resilience of their systems. The governance not only of health, at national and global levels, but also of trade, communication and globalization itself is under scrutiny. The virus exposes, yet again, the structural determinants that lead to health inequalities (Shadmi et al., 2020), including racism and colonial legacies. Many see this as a key moment of reckoning, nationally and globally: the pandemic and its responses have precipitated unprecedented economic, social and health crises that may shape the decades ahead. At the same time, the role of health systems in responding to COVID-19 and the need to (re-)invest in these systems through the state offers transformative opportunities. In the light of this, we outline how health policy and systems research (HPSR) can both address current short-term challenges, and support the system transformations needed to strengthen people-centred and equitable health systems over the long term. The HPSR community has responded to the COVID-19 pandemic quickly, following the wave of publications on epidemiological and clinical aspects of the disease. Initial studies have included those describing the capacity of hospitals, intensive care units and first line health services required to respond to the disease, and those reporting specific experiences at community and local levels, including the denial of care and the inequitable effects of disease control measures. Many commentaries and calls for action have been published (COVID-19 Clinical Research Coalition, 2020; English et al., 2020; Shamasunder et al., 2020). Inevitably, however, due to the acute nature of the crisis, few papers have yet focused on how health systems are coping with or adapting to the pandemic, or how health policy-making and decision-making has (or has not) changed in this time of crisis. Yet, there is an urgent need to develop a structured research agenda to inform health policy and system responses to COVID-19 that can move us beyond the current crisis, and into the future. This commentary makes proposals towards such an agenda. In line with the audience of Health Policy and Planning, we specifically focus on low- and middle-income country (LMIC) HPSR needs, drawing on our collective experience as a group of HPS researchers based around the world. The Health System Research and Health Policy Processes section editors initiated the process and purposefully sought inputs from HPS researchers in a range of LMICs . The process was also supported by both the Alliance for Health Policy and Systems Research and Health System Global. We organized an online consultation process, whereby the first authors invited the co-authors to identify research priorities, questions and themes. In a second round, these were compiled and categorized in themes and sent out for further comment. In a final round, the issues and questions within each theme were examined and gaps and overlaps eliminated. We consider, first, key dimensions of the overall approach of HPSR to frame the further work needed, and second, in an annex, we suggest an initial categorization and listing of possible research topics. We present these ideas to prompt wider reflection—and we conclude by proposing ways of engaging further with these ideas, acknowledging the fast-changing nature of the pandemic and the need to review research priorities regularly. We start by reviewing how the defining features of HPSR, including the systems approach, multi-disciplinarity and the emphasis on policy and power may be applied to the pandemic. One defining feature of HPSR is its systems approach. This frames COVID-19 and the responses to it in a critical–analytical perspective, zooming out from specific experiences to seek the root causes of the differential impact of the pandemic across individuals and population groups as a function of society’s power structures and dominant cultures—as reflected in their social, political and economic position, and their race, gender, caste, class and more. Groups that become vulnerable due to systemic and structural inequities include those living in informal settlements in cities or in geographically isolated areas, informal workers, migrant and refugee communities, people without citizenship rights, sex workers, single-women households, LGBTQI+ communities and indigenous peoples. The systems lens equips HPS researchers to understand how, for such groups, health system fault lines interact with the histories of discrimination and disenfranchisement that underpin other determinants of vulnerability, risks and infection. Some people have already faced worse effects from COVID-19 responses than from (the possibility of) infection itself, due to social exclusion, racism and human rights abuse. Meanwhile, privilege and social networks have largely allowed wealthy elites to avoid the negative social and economic effects of lockdowns, deepening inequalities. Health systems have, in turn, generally been poorly equipped to respond fast enough either to the medical and psychological demands of the pandemic or to the wider public and social action needed to address multiple disadvantage and vulnerability. HPSR is well placed to contribute in understanding the layered causes and effects of the pandemic on people and systems. Identifying how health system gaps and weaknesses interact with the root causes of vulnerability to COVID-19 is a vital responsibility that HPSR needs to shoulder—not only as an obligation of itself (referring to HPSR’s social justice agenda), but also as an opportunity to strengthen health systems in more just and inclusive ways than before. The multi-disciplinary approach of HPSR will be key to this task because of the complex nature of health and its determinants, as well as of health policies and health systems. This multi-disciplinary approach supports consideration of how agents and systems interact and of the inter-connections among the systems relevant to health. These include community, workplace and government systems; health and other government sectors; local, national and global systems and markets, corporate actors and the private sector in its full heterogeneity. HPSR can assist in distinguishing COVID-19-related challenges that are simple problems, from those that are better considered as complex problems and that demand appropriate context-sensitive response strategies. It can also nurture and sustain the systemic responses to COVID-19 and its impacts that are vital for the long-term. It supports a system-based approach in anticipating the collateral effects of policies aimed at responding to the pandemic, generating ideas about how mitigate the damages and optimize the gains. The pandemic specifically demands recognition of the interactions of human, animal and ecological systems. The spill-over of the virus from animal to human reservoirs inevitably calls for a critical exploration of how humans continue to interfere with fragile equilibria in the natural world through urbanization, deforestation and more. Beyond ‘one health’ research, attention should be paid to the dominant economic growth paradigm on health, development, trade, society and the natural world and the role of populist and isolationist ideologies in framing the response. Another defining feature of HPSR is its focus on policy, policy-making and how health systems are nested in and influenced by power dynamics and political forces, histories and cultures: the ‘p’ in HPSR. This is another vital lens for research in the time of COVID-19. It supports inquiry into governance, decision-making and health policy responses in times of crisis, as well as how both to inform and strengthen system change. It encourages consideration of the values driving decision-making and the ethical demands of leadership. In addition, this lens underpins investigation of the political economy of the pandemic response and whether and how health systems and political action align to address the structural determinants of ill health and inequity which COVID-19 exposes. It can expose the lack of accountability towards some marginalized groups and the focus on politically important constituencies, the lack of stewardship/leadership at multiple levels and how efforts towards decentralizing and commercializing health system responsibilities lead to fragmented health systems. It could focus on new forms of sub-national and national governance arrangements and investigate how that deepens community-level and inter-sectoral action for health and societal development. The pandemic forces us to consider governance not only at national level, but also at global level: Should we redefine global health? How can we promote better global leadership to coordinate and enforce efforts across countries, including the need for consideration of global public goods and global health ethics? Drawing on well-established bodies of knowledge and evidence from other disciplines (e.g. political science, policy studies, public administration, sociology, complexity theory, critical studies), HPSR can make major contributions to learning how better to deal with pandemics. But HPSR must also do more than help systems absorb future shocks. It must help establish the foundations of more just, equitable and better health systems—health systems that demonstrate resilience through their capacity to be transformative as they respond to shock and stress. Crucial in this effort will be research around how health systems can be transformed for the better during or in the wake of the pandemic. This includes work around adaptive governance as well as on other fundamental system drivers—such as the health workforce, and information and financing systems. Prioritizing among research topics is not straightforward. Such prioritization must, first, be informed by the views of vulnerable groups, community groups, health system decision-makers and health policymakers in the broadest sense and be situated in specific settings. Below, we discuss a few waypoints that may help in thinking about HPSR priorities in relation to COVID-19. As Marquette (2020) has argued for social science more generally, more immediate needs for research are likely to include understanding the root causes of vulnerability to support response activities and limit their negative effects. However, she notes that even mid- to longer-term research to understand secondary effects and long-term impacts and recovery must start now, accompanied by political analysis, and this will be needed to sustain recovery and support the emergence of new and better systems. Critical to this work will be revealing opportunity, agency and resilience, even in the midst of multi-layered challenges. For HPSR, we can also be guided by our understanding of people-centred health systems. This points, e.g. to the importance of understanding community-level COVID-19 experiences, including the experience of marginalized groups, and considering how system software (including power, trust and values) interacts with other system changes to influence the impacts of COVID-19; examining how health systems and COVID-19 responses may exclude people on the basis of their gender, race, income and other characteristics, and how histories of colonialism and racism underpin such exclusion; analysing the power and influence of ideas and framing, and the role of communication in decision-making at every level; and finally, purposefully considering the political economy influences driving COVID-19 and responses to it . Our research must offer new ideas for future health systems—building evidence around new ways of organizing, new ways of caring, new strategies of health development. In responding to COVID-19 and offering new ideas for future health systems, the HPSR community must also consider how to go about doing research. Issues to be reflected upon include the distribution of power within HPSR communities, the balance between global concerns and priorities on one hand and context-sensitivity on the other hand, the challenge of researching what is essentially a fast moving target, the practical problems induced by the control measures (such as social distancing) when collecting data, and finally the issue of research governance. Power-balancing strategies must be reflected in how the research is done—considering, e.g. with whom and how we collaborate, and what forms of knowledge are valued and enhanced through this work. Research responding to COVID-19 must also be relevant to the contexts in which it is located, and acknowledge the imperatives of this moment. In the short term, then, it must be conducted quickly to address immediate needs, and be fed-back into decision-making rapidly. Innovative knowledge translation efforts and new models of collaborations between research, policymaking and stakeholder organizations are of special interest. Being systematic and rigorous will always be important, but we must capture current experience even as we also develop longer-term research activities. To support such HPSR can on and new ways of doing research. These include research et al., action research et al., action learning 2020), research and policy and All multiple forms of knowledge and for researchers to through with in the response in ways of that for HPSR to help shape the world COVID-19. At the same time, in the response to COVID-19 it always important to consider the ethical dimensions and of ethical and In the we will also need to about research and that can be to and vulnerable groups by online and online from experiences, as they their is and social could be a relevant research forms offer other new ways of and such experience et al., other an online of and studies could be to support the HPSR of secondary and simple work can also important, immediate about social and among other evidence drawing on both and and is into the and process research will be important to out the of is also needed both to understand the current experience and from experience and work can offer into the experience of groups and into responses to inform future action 2020). The of will support understanding of system sub-national or can e.g. on critical governance influences over of experience will also always be important to understand the layered vulnerability of people and systems, and the agency and to and must become a of HPSR et al., it is critical to and research governance at all levels to important, research that supports social justice is possible and is and to identify and limit research. We must also and how research governance and the research that is are by COVID-19 and responses to the research of and is for it is of this will not only work but also papers by and by At another level, how can we contribute to global health for whom in the current research on COVID-19 challenges HPS researchers to and in research that to new health systems for the future. HPSR that current needs and experiences will offer important and both about how COVID-19 impacts on our and about the responses to the pandemic. It can help how these responses and or new for just health systems. The HPSR in LMICs must support in the place and capacity for and nationally research, with appropriate Health and research in LMICs must as needed, be to do Research for must also include communities, patients, providers, health service and health and other policy in to society and HPSR must be an as it is for global health more and these are in that the current a new COVID-19 has just been for the on Health Systems Research the of the HPSR are within its theme of health systems for better health and social and for of the political social, economic and forces and and social In the annex, we also present a of HPSR themes and topics the of importance we have already These range from studies the differential impact on people, disadvantage and to those focused on the impacts on health systems, including studies on governance and system of health system towards better and just health systems. We responses to our ideas and proposals for a HPSR in the of to be published in Health Policy and We also a future for papers for a special issue of this that may and the COVID-19 pandemic and the responses at sub-national and as well as responses by people, communities health and social providers, decision-makers including community and from a analysing COVID-19 responses in of health and social including and on the of decision-making in a time of to the impact of the pandemic and the responses at sub-national and through e.g. studies, policy and decision-making analysis, of is a of the Health and is for the views in the which do not the or policies of the Health ethical was required for this is the of the pandemic and the response on the and of first line services for and by vulnerable groups people with and the and health response services for and LGBTQI+ service is the differential impact of COVID-19 on and how it affect the health of people, and people work from are the impacts of COVID-19 How to sex in and systems to understand the of How to COVID-19 measures to impacts on vulnerable groups, such as those living in informal refugee the and the are the of and how can of those test for COVID-19 and those have from COVID-19 (including health be How in is to trust and of response to a disease How power out in the governance of COVID-19 responses and within new forms of governance and that How do power and the COVID-19 and evidence and knowledge is in decision-making around is the balance of political and and how do governance histories and structures shape this and how and or limit over the and how to address this COVID-19 global health in e.g. more emphasis on global health and from health will COVID-19 in the global political economy of health? COVID-19 to and collective to global health it to of and knowledge and are COVID-19 how this between countries, and what is How is within government and with private agents and and what are longer-term for action on the social determinants of health? are invited to support the what evidence and how is that and over histories and structures shape these is for what and is invited as an and is there policy or through policy in COVID-19 is the role and influence of of experience for including and from communities and health is the role of and and the impact on communication of the of is the of policy communication in a time of crisis, including the framing of the role of and and and the for trust in COVID-19 responses and in policies or that support or vulnerable in COVID-19 responses have been and what decision-making dynamics to the prioritization of these is the impact on the role of in global health How is the global new forms of global leadership are that can assist in and efforts across countries, including the need for consideration of global public goods and global health ethics? is the impact of COVID-19 responses on attention to and of to other health including effects are and how can these be How can critical services be the COVID-19 response in is the impact of COVID-19 on the and health of the health workforce, and of in ways of is the impact of COVID-19 on the of health in the in countries work is the role of including Health in the COVID-19 How is learning for health human How do COVID-19 responses impact on the of system and and with what for system How is the in systems of How are local and national for a pandemic as to natural the COVID-19 pandemic our views on is the impact on changes in global financing and in national health are the changes in and global in health, in health in health system is the role of public in the pandemic are the and of global pandemic financing To HPSR the system we include in this some issues to the and that are are the and gaps between levels of care care during the services during are the role private sector actors in service How can an balance of care be within the health system under How to strengthen workplace health for the health How to for the acknowledging is the place of public health within the wider health and how can it be is the role of national health in the COVID-19 response within is the place of in the health system and in the COVID-19 The issues of infection and control in the to and is the of health information systems in to COVID-19 responses (e.g. models and infectious disease models be with HPSR such as by health systems and the dominant are the ethical and of community based or The required to an COVID-19 and the challenges of and lines The challenges of and distribution of medical in the light of global and local of and The in demand for and information in health in bodies and to COVID-19 and How to address in for whom is and The of and is and with what Health during a pandemic how and which new forms of governance and leadership at local or other levels, work with community organizations and engaging and and and how they are or over is the for COVID-19 e.g. for or from the private sector health actors and and how, with what is the role and place of community-level action for to engaging with and responding to priorities and and beyond health? How can that have been transformative for vulnerable be and through health policy and system into the forms of local develop that address social the social determinants of what are the for more people-centred How the pandemic inform and wider action on and is the role of national and and research in and global health crises How can research governance during crises such as COVID-19 support important, research that supports social How is COVID-19 on is and is the role of global in research and research knowledge translation efforts and models of collaborations between research, policymaking and stakeholder organizations during

Lloyd W. Klein, James A. Goldstein, David E. Haines, Charles E. Chambers · 8 authors

Renewed attention has focused on the occupational health hazards posed by working in the fluoroscopic laboratory.1-6 Accumulated occupational radiation exposure is associated with health risks to physicians, nurses, and technologists working in this environment. Health care workers are subject to insidious health effects of radiation exposure over many years. Adverse effects include the established predilection to posterior subcapsular cataracts, as well as worrisome signals of lifetime risks of cancer induction, particularly in the unprotected brain.7-12 A further consequence is the extensively documented incidence of orthopedic illnesses reported in physicians as well as nurses and technologists and injuries linked to the cumulative burden of bearing the weight of only partly protective lead aprons mandatory to reduce radiation risk.13-16 The increased volume and complexity of procedures, together with the physical stresses inherent in procedural performance, have exacerbated the prevalence and magnitude of such orthopedic injuries.17 The high prevalence of orthopedic afflictions not only affects individual health but also could be potential career ending, with workforce implications for both the profession as well as for society.15 Advances in interventional imaging techniques and treatments over the last three decades have achieved significant success with clear benefits to our patients18; yet protective measures for workers have unfortunately lagged the pace, magnitude, and impact of this therapeutic progress. The purpose of this position statement is to review the data documenting occupational health injuries, summarize current equipment and processes that can be widely applied to optimize protection, emphasize the importance of investment by hospitals and health systems in protective equipment established to enhance workplace safety, examine barriers that need to be overcome to spur advances to enhance the occupational safety of the fluoroscopic laboratory environment, and propose enhanced advocacy for innovation. Future processes and proposals to improve the fluoroscopic laboratory environment should be based on the following precepts: (a) there is ample clinical data documenting the prevalence of serious occupational health risks engendered by the fluoroscopic laboratory environment; (b) sufficient attention to these occupational health issues has been drawn in annual meetings and published clinical scientific studies; (c) despite these data and advocacy efforts, advances to improve worker safety in the fluoroscopic laboratory remain inadequate; and (d) a concerted effort by all stakeholders (physicians, catheterization laboratory nurses, and technologists, sonographers, hospitals, professional societies, and industry) in the fluoroscopic laboratory is necessary to further advance occupational safety and health. Radiation exposure is inherent to procedural performance in the fluoroscopic laboratory. Exposure to ionizing radiation imposes health risks to both patients and operators, resulting in an increased likelihood of numerous illnesses and diseases.1-8 The association with posterior subcapsular cataracts is well documented.11, 12 There are growing concerns for cancer induction,7, 8 with recent reports of a cluster of predominantly left-sided brain cancers in interventionists,9, 10 as well as a signal for increased breast19-22 and skin cancers.23-26 Radiation exposure generally, not necessarily as part of occupational exposure, is associated with leukemia/lymphoma, myeloma, numerous gastrointestinal and bone cancers, and thyroid and parathyroid adenomas. These disquieting signals fuel the increasing anxiety regarding radiation exposure-related oncogenesis, though no mortality impact has been proven.27 Recent studies have also suggested that occupational radiation exposure is associated with hypertension, hypercholesterolemia, and possibly atherosclerosis.28-30 Evidence of lengthening sarcomere length and early vascular aging in epidemiologic studies suggests that workers who are occupationally exposed to radiation during interventional procedures may be at increased risk to develop these same illnesses.30, 31 There is now overwhelming evidence demonstrating that working in the interventional laboratory is associated with an increased incidence of orthopedic illnesses, particularly those related to the cervical and lumbar spine. These orthopedic injuries have been linked to the cumulative effects of bearing the weight of leaded aprons.5, 15, 16 Additionally, the design of the catheterization laboratory environment promotes awkward orthopedic ergonomic postures (e.g., monitors placed out of the line of natural working sight views). As procedures become increasingly complex and prolonged, and their volume increase in number, it should not be surprising that interventional practice is attended by a high rate (40–50%) of occupational-induced orthopedic injuries.15-17 Over a career's duration, the likelihood of suffering such illnesses are 2–7 times27, 28 higher than other medical occupations. Studies report substantial differences in orthopedic injuries between those wearing lead aprons working in the fluoroscopic laboratory compared to colleagues working in the same department not working in the fluoroscopic laboratory and thus not bearing the burden of wearing lead aprons.27-29 These occupational-related injuries not uncommonly result in missed days of work, surgery, and, in some cases, curtailed careers. This issue has significant implications for the interventional workforce, particularly in view of the aging of the population and anticipated increased procedural demand concomitant with aging of the operators who pioneered these advances.17, 27-29 These occupational health concerns potentially affect several medical specialties, including cardiologists, radiologists, and surgeons working with fluoroscopy, as well as pain management specialists performing nonvascular fluoroscopic procedures. Importantly, all such issues also pertain to the other personnel who are essential members of the “interventional team” (e.g., nurses and technologists, interventional imagers, and cardiac anesthesiologists) who are exposed to the harmful effects of scattered ionizing radiation.30-33 Electrophysiologists and their team are also exposed to radiologic risks and orthopedic injury34 and perhaps even more so, given the duration of their procedures and lack of upper torso shielding during device cases (e.g., implantable defibrillators and cardiac resynchronization therapy). These issues also have particular importance to women; although radiation effects on the fetus have not been demonstrated, women report concerns for adverse effects during reproduction as an obstacle to choice of an interventional career. These radiation exposure concerns have sometimes been considered a reason for disproportionately low representation of women in the field.35 As noninvasive cardiologists specialized in imaging are now required to guide interventions in the catheterization and electrophysiology laboratories, pursuing career in imaging is no longer radiation free and a safer choice for women. This may result in shifts in gender distribution in various cardiology subspecialties, further impacting strategies to improve diversity and inclusion in out profession. The past three decades have witnessed astounding progress in interventional equipment, technique, therapeutics, and the clinical research that catalyzed these advances. Progress in interventional laboratory protection and safety has comparatively lagged, despite the growing mounting data emphasizing occupational health concerns. A paradigm shift to dramatically improve the occupational safety for all stakeholders in the fluoroscopic laboratory (members of the interventional team, professional societies, hospitals, and industry) is required. In particular, there is an opportunity and obligation for industry and hospitals, who clearly benefit from the workers' commitment to their profession, to play a leadership role in correcting these deficiencies. A template exists based on the collaboration established by recent FDA-led efforts aimed to reduce patient exposure.36 Leveraging the concept and practice of the “Image Wisely” and “Image Gently” campaigns codified by Radiological Society of North America37 and Pediatric Cardiology community38 to minimize radiation exposure to patients, in 2010, the FDA Center for Devices and Radiological Health launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. As part of this initiative, the FDA held a public meeting on ways to improve devices to reduce unnecessary radiation exposure to help the agency decide on any new, targeted requirements for manufacturers of computed tomographic and fluoroscopic devices. This effort resulted in an industry-driven enhanced awareness, with mandates to recognize both the needs for and market potential of innovations focused on minimizing patient radiation exposure. These initiatives rapidly resulted in dramatic changes to improve the X-ray systems. Examples of these improvements include minimizing radiation exposure through lower emission X-ray systems as well as monitoring, recording of each procedure's patient exposure, and standardization in laboratory reports and patient charts. These efforts have also stimulated industry to develop X-ray systems that provide high-quality imaging at low-radiation exposure dose levels. Hospitals should be encouraged to invest in adopting such platforms that have potential to mitigate occupational risk. Physicians working with our professional societies should strive to establish a culture of safety encompassing both patients and catheterization laboratory personnel (Table 1). The pathway forward should be focused to assure: (1) consistent application and adherence to established and procedural processes; (2) widespread adoption and utilization of novel commercially available protection systems; and (3) encouragement and support to further develop even more effective equipment and processes that facilitate enhanced safety and protection in the workspace. Our professional societies must support individual physicians, teams, and practices, especially those that are hospital owned. It is critical that clinician leaders speak authoritatively to hospital administration and industry partners regarding these concerns without fear of reprisal; societal support could be influential in these situations. The following specific steps should be endorsed by our professional societies to enhance hospital and physician compliance: Whether or not to comply with appropriate shielding and other safety measures should not be at the discretion of the operator. The imaging team (physician, sonographer, radiologic technologist, physicist, and other medical personnel) should be responsible for developing optimized protocols, implementing regular equipment quality control tests, and monitoring radiation doses to patients and members of the team. This group and their products should be recognized as an essential part of the quality assurance program, present in all laboratories, for emphasizing radiation management. Operator dose is directly proportional to patient dose; thus, reducing the dose to the patient will benefit the operator. Knowledge of radiation and methods to reduce risk should be stressed to all operators who perform fluoroscopically guided interventions, practiced routinely, and all staff educated in these measures and assuring they are adhered. These methods and concepts have been well described previously.1-7 Recently, publications from the Society of Cardiovascular Angiography and Interventions, The Heart Rhythm Society, and the American College of Cardiology/multi-society consensus document18 articulate detailed procedural systems and processes, as well as practical approaches, to assist cardiac catheterization laboratories in establishing optimal radiation safety program. The components of a radiation safety program include essential personnel, radiation monitoring, protective shielding (at minimum strict adherence to protective aprons and leaded glasses), imaging equipment, and training/education.39-41 Fundamental principles of radiation safety teach the tenet that radiation exposure should be “as low as reasonably achievable (ALARA)”, with monitoring to assure individuals do not exceed annual or lifetime “safe limits.” Unfortunately, the term “reasonably achievable” is ambiguous and not actionable, and may unintentionally inhibit innovative strides to improve safety both for patients who require medically necessary procedures and for workers in radiation-exposed environments. The phrase might incorrectly imply that as long as one's exposure is “minimized,” then that is all that need to be accomplished. Rather, the ultimate goal of innovation efforts should strive to achieve a completely safe environment wherein the ultimate definition of ALARA translates to as close to a zero radiation exposure work environment as possible. Meticulous application of established prudent radiation techniques is obvious and essential. Standard shielding combines laboratory based (e.g., movable ceiling suspended and fixed table-side shielding). Personal protective aprons and eyewear should be properly fitted and maintained, and hospitals should finance these protective devices for all of their employees, including trainees. Newer personal protective choices, including two-piece aprons that are much lighter, may be beneficial; accessory sleeves for arm protection are also available. Despite these advances, the orthopedic burden of only partially protective leaded apparel continues. Institutions and operators must partner to develop a program specific for their laboratory that will result in the adoption of appropriate recent innovations to reduce radiation exposure. Strategies should also include usage of adjunctive devices for which there is substantial data documenting their capability to reduce exposure. Specifically, there is now compelling data demonstrating reductions in exposure with accessory drapes42 (Supplementary Tables); such disposable radiation shielding pads should NOT be refused by hospitals due to their expense. The use of leaded caps has been proposed with mixed results regarding reduction in exposure.43, 44 Simple accessory mobile shields afford significant protection to both nurses and technologists45 as well as to the interventional imaging team.30 More expansive and encompassing lead shielding systems are commercially available,46 and there is a need for more clinical research data supporting their capabilities to reduce exposure. Robotic systems developed to enhance procedural performance also provide protection from radiation exposure to the physician and reduce leaded apron orthopedic burden.47 Thus far, robotics has had limited adoption, due mostly to cost considerations but also fear from the loss of a “hands-on” sensibility. In electrophysiology, intracardiac navigation systems48 have shown efficacy to navigate catheters for ablation procedures with lesser exposure. Simultaneously, industry and physicians must partner to expedite development of a fluoroless catheterization laboratory, using echocardiography, magnetic resonance imaging, 3D mapping, or other technologies. Removing the necessity of lead aprons should be the ultimate goal. Although the proximate cause of many orthopedic complications may be wearing lead, there are other important factors, such as screen height and position, and other ergonometric considerations, which may account for much cervical spine pathology.49 This growing portfolio of enhanced/innovative protective technology will continue to yield a growing pipeline of solutions providing optimism for a healthier work environment. Table 1 summarizes the responsibilities of professional societies going forward. A direct role is a necessity to coordinate the policy matters raised in this document. Table 2 lists the specific future directions recommended for all stakeholders to achieve. It is essential to emphasize that the operator has the responsibility to understand how to use protective equipment optimally to minimize exposure to both patients and personnel.50 Education in this area is already part of cardiology trainee education and is tested in certification exams. Nevertheless, formal training for those who are planning to be interventional operators and imagers should be considered, and compliance monitored on site. Real-time radiation dose monitoring should become standard. Further, physicians must accept the challenge to adopt new technologies for the reduction of occupational hazards. Expense is one reason that new innovations are often not adopted, as it is difficult to advocate for expensive nonrevenue-enhancing equipment in the current fiscal environment. Other obstacles to overcome include potential discomfort with the design modifications and the resistance to making changes in familiar techniques even if there are improvements. The question always arises as to “proof” as to whether the changes are really beneficial, which sometimes become a justification to maintain an unsatisfactory status quo. Therefore, it is incumbent on our profession to continue to produce high-quality clinical research that documents the capabilities of novel imaging equipment, protective devices, and processes designed to improve workplace safety and health. As previously discussed, structural heart interventions depend on procedural image guidance/interventional echocardiography using transthoracic (TTE) or transesophageal echocardiography (TEE) in addition to fluoroscopy. Interventional imagers who operate the TTE or TEE probe and echo console are highly exposed to the harmful effects of scattered ionizing radiation. Protection for these workers also needs to be incorporated and mandated.30, 45, 46 Professional societies should develop programs to assist hospitals and health systems to address occupational safety. It is in everyone's interest to assure the health of medical caregivers.17 The establishment of new, and coordination with existing, comprehensive programs for clinician health in the catheterization and electrophysiology laboratories consistent with recommended wellness programs are an opportunity to highlight this problem. This may include an on-site physical or massage therapist, programs for core strengthening and stretching, and improved posture techniques to prevent orthopedic injury.34 Moreover, this issue can be an opportunity for societies to share and collaborate with international colleagues, who face similar problems. Since the inception of radiologic imaging, the biomedical industry has taken primary responsibility for development and refinement of catheterization laboratory equipment with associated financial benefits. As this equipment engenders intrinsic radiation exposure hazards, industry should assume a level of fiduciary responsibility to optimize the safety of the equipment they design and sell. It is our role to communicate the cardiology community's widespread support for innovations and catheterization laboratory design reformation. Though definite progress has occurred in the past two decades, particularly the advent of high-quality X-ray systems that produce high-quality imaging at lower radiation dose, further innovations are needed to achieve maximal operator radiation protection. The goal is a laboratory design that achieves a completely environment that the need for personal protective apparel and the orthopedic progress has been by the FDA to industry and medical to improve equipment and processes designed to achieve radiation exposure to are that efforts can be to enhance operator safety by providing a template by which this may be innovation will be that market are to such of worker health to increase worker is both the to and a workforce (physicians, nurses, and Hospitals and health care systems should recognize that protective equipment and wellness processes to at the of the health of their workers is more it increased more and increased training Hospitals have the responsibility to and assure worker safety and optimal occupational radiation exposure. radiation provide training and monitoring of personnel and It that hospitals have a responsibility for those working in their and an responsibility not only to maintain and present imaging systems but also to catheterization laboratories with the equipment and established to benefits to the safety and of their of the X-ray with of imaging and equipment are the responsibilities of the will if (e.g., Health and might in on these occupational safety issues and issue that require a for of imaging and protective In this of and commitment on the part of hospitals is critical to industry to invest in research and development of in the that there is an and In our professional societies play a role to help establish is considered and necessary for practice in radiation safety and clinician The is not responsible for the or of any supporting by the than should be to the for the

Ketan Paranjape, Mitchell Parker, David Houlding, Josip Car

Objective: This article aims to provide a primer on blockchain technology and implementation considerations for blockchain at healthcare institutions.  Results: After research and interviews, we developed a primer and a high-level implementation guide for healthcare systems exploring the use of blockchain technology.  Conclusions: The use of blockchain technology in health care is at a promising stage in development but blockchain-based applications are yet to be demonstrated as a viable platform for exchanging and reviewing information. Healthcare systems should be cautiously optimistic regarding the potential of blockchain and do a thorough business and technical diligence that is driven by targeted use cases to be successful. 

Eric Swanson, Tim Brown

THE PROBLEM Conflict of interest (COI) is a subject of intense interest, to the extent that an entire issue of the Journal of the American Medical Association was devoted to this subject last year.1 In 2014, the American Society of Plastic Surgeons created a task force to address this problem.2 Conflict of interest was the lead story of a recent issue of Plastic Surgery News.2 Remarkably, about half of U.S. physicians, and 61% of surgeons, received payments from the pharmaceutical and medical device industries in 2015, amounting to $2.4 billion, including 136 plastic surgeons who received >$10,000 each.3 Before the early 1980s, there was little intersection between medicine and industry. Collaboration between the medical profession and the corporate world has increased.4 The link between commercial funding and study conclusions is undeniable in plastic surgery.5,6 When industry-supported Continuing Medical Education programs are conducted at resort hotels and upscale restaurants, the boundary between education and industry marketing is blurred.7 At meetings, plastic surgeons often declare, “I have no relevant conflict of interest” or “I have no conflicts that would affect the content of my presentation.” Luce laments that sometimes the duration of the disclosure slide presentation could be measured in nanoseconds, as reported in Plastic Surgery News.2 The speaker usually decides whether a conflict is relevant. Presenters sometimes comment, wryly, “I have no conflict of interest, unfortunately,” recognizing, and trivializing, the financial benefit of a COI. Some speakers display a long list of conflicts and suggest that because they have so many, they are at least “equal opportunity conflicters.” Some investigators believe that if they previously received money but no longer receive payments, they are no longer conflicted. Is there an expiry date for financial conflicts? Although some journals specify a 3-year period before submission, full disclosure is preferred, allowing the reader to decide on the merits.8 DEFINITION Luce6 defines COI: “Conflicts in ethically problematic situations are those in which the practitioner participates in clinical investigation of new devices/technology, publishes that experience, and, in parallel, is paid a consultant’s fee by the manufacturer.” Fineberg9 believes that a COI exists when a reasonable person would interpret the financial circumstances as sufficient to influence a physician’s judgment. When the reasonable person standard is used, the “appearance of” a COI is redundant.9 Proof of patient harm is not a requisite for COI; there are no “potential” COIs.10 INDUSTRY PAYMENTS TO INDIVIDUALS The American Society of Plastic Surgeons recently introduced dollar ranges for reporting financial conflicts.2 However, no data are available regarding a monetary threshold for a COI.11 Using Open Payments data, a 2016 study found that receipt of industry-sponsored meals, even just a single meal, was associated with an increase in the rate of prescribing the promoted brand-name drug.12 The more money doctors receive, on average, the more brand-name medications they prescribe.13 The evidence shows that even small gifts induce unconscious feelings of gratitude and reciprocity. Gifts to physicians can perpetuate a mindset of entitlement.14 INDIRECT CONFLICTS OF INTEREST Incentives that are not directly financial but have financial implications such as career advancement may also represent potent COIs.15 Academic COIs may contribute to the disturbing prevalence of research irreproducibility.15 Preset convictions can cause investigators to overlook or selectively interpret data. The investigator who is so certain that the concept is correct may, even subconsciously, alter the eligibility criteria, or the number of subjects, to fit the data to the hypothesis, and reach the desired level of significance, a practice known as p hacking.16 A t test may be conducted on a tiny number of patients using data that are not normally distributed. The sample size may be kept small to ensure that adverse outcomes do not reach statistical significance. INDUSTRY PAYMENTS TO PROFESSIONAL SOCIETIES AND JOURNALS Many professional societies, including plastic surgery societies, accept large payments from industry (ie, >$1 million annually). A key recommendation of a 2009 consensus report was a preliminary reduction in industry support to <25% of the operating budget of the professional medical association, with an ultimate goal of complete freedom from industry funding.17 Companies partner with our societies and fund journal supplements, compromising the separation of science and advertising. Industry involvement may extend to writing the manuscript, called “writing support.” Many medical journals derive a substantial proportion of their operating revenue from advertising.18 Sponsored supplements are typically written to support the marketing goals of the sponsor,18 and lack counterpoint discussions written by nonconflicted plastic surgeons. Brand names are featured in the titles. Editors may argue that supplements are treated with the same degree of scrutiny as regular publications,19 but the potential for inappropriate influence cannot be excluded. Publication bias is a well-known problem.5 Researchers who are consultants, hold stock options, or receive royalties from companies, are much more likely to report positive results.5,20 Not surprisingly, industry is notoriously reluctant to publish negative findings.5,21 Some trial protocols include a provision for review of the manuscript by the funder before submission for publication, and the right to delay or even veto its publication.5,22 The timeline is pertinent. Plastic surgeons reporting on new products (eg, breast implants, implantable mesh, cryolipolysis, radiofrequency) may hold changing, often increasing, ownership stakes in successive publications, begging the question, when was this investment decision made and did it influence the research? EXAMPLES OF CONFLICT OF INTEREST IN PLASTIC SURGERY Breast Implants The promotion of shaped, textured breast implants reflects the quid pro quo between the industry and surgeons.23 The highly praised gummy bear implant was always an inferior product. Shaped implants malrotate in 42% of patients.24 These devices are firm, may have palpable edges, can cause double capsules and seromas25 and are much more costly than smooth round alternatives. Most importantly, textured implants are linked to breast implant-associated anaplastic large-cell lymphoma.26 Hidalgo and Weinstein27 and others28,29 report no aesthetic advantage. Yet for decades now, textured, shaped implants have been promoted as superior to less expensive alternatives. Hall-Findlay30 writes: “We listen to the manufacturer’s claims and then years later we find that we have been misled – both by the manufacturers themselves and by those surgeons who are burdened by a conflict of interest.” A study of nano-textured and micro-textured breast implants was recently published in a corporate-funded journal supplement.31 The authors report a complication rate of 0.3%, with 1 hematoma, no cases of implant malposition, no pain, no rippling, no ruptures, no redness, and no capsular contractures among 4,103 breast augmentations. The reoperation rate was <1%. The lead author reported no COI regarding this study, but accepted a position on the company’s medical advisory board immediately after submitting the article.31 Implantable Mesh The problem is not limited to breast implants. The COI regarding acellular dermal matrix is well documented.32 A recent article advocating the off-label use of implantable mesh in breast surgery was published by 2 authors who have a financial stake in the company that manufactures the mesh.33 A third author is a paid consultant and speaker. Galatea Surgical, a subsidiary of Tepha Inc. (Lexington, Ma.) financed the study, including medical writing, and referenced supplemental publications.33 Galatea is a corporate sponsor of the American Society for Aesthetic Plastic Surgery.34 The authors report that 100% of participating surgeons preferred to use mesh in all patients and the 1-year result was satisfactory in 100% of women.33 Such publications encourage plastic surgeons to adopt commercially driven practice patterns. A recent Continuing Medical Education article suggests that mesh support represents a paradigm shift.35 However, a nonconflicted analysis of mesh, and of the dated internal bra concept, finds no advantage.36 Radiofrequency Treatments A recent corporate-funded supplemental article, written by surgeons who are also shareholders, claims that radiofrequency-assisted liposuction (BodyTite, InMode Corp., Toronto, Canada) provides effective soft-tissue contraction, even creating an “internal brachioplasty scar.”37 This claim is based on a greater reduction in linear measurements than area measurements after radiofrequency-assisted liposuction compared with standard liposuction, a finding that is impossible to reconcile with basic geometry (the difference in area measurements must exceed linear changes).38 The authors offer a favorable return on investment analysis to justify the $205,000 purchase price, based on a $7,000 treatment fee.37 Conflicted author/investors frequently publish photographs that are not standardized in an effort to demonstrate a therapeutic benefit.33,36,39,40 A recent corporate-funded study on facial radiofrequency treatments with micro-needles was co-authored by a shareholder.39 The authors magnified the preoperative photograph of a nasolabial crease 58% to make it appear larger before treatment.40 Statistical errors included using a t test to compare nonparametric data, citing a P value of 1.00 for a comparison of nonidentical data, and a maximum range within 1 SD of the mean.40 DISCOUNTS TO INVESTIGATORS New transparency regulations help to inform the public about payments made to physicians.41 Unfortunately, it is not difficult to sidestep such reporting requirements. A well-known investigator may be given a device (eg, an ultrasonic liposuction machine) at a heavily discounted price. A breast implant manufacturer may provide its researchers with complimentary or discounted implants. There are many ways to reimburse surgeons indirectly. These considerations are substitutes for reportable cash payments, and they undermine the integrity of our research. COMPANY OFFICERS Investigators who are not only passive investors but company officers and shareholders42 have a financial obligation to the company. A fiduciary responsibility makes it impossible to remain objective.43 CLEARANCE BY U.S. FOOD AND DRUG ADMINISTRATION When a device receives clearance by the U.S. Food and Drug Administration, it is labeled with a stamp of authority that is reassuring to the public. This label also serves as a powerful marketing tool. Unfortunately, the approval process is not protected from commercial influence. For example, Coolsculpting (Allergan plc, Dublin, Ireland) gained Food and Drug Administration clearance for treatment of the thighs based on studies performed by investigators that received major financial reimbursement.44 The company itself was allowed to conduct vital ultrasound and photographic imaging.44 The lead investigator was at one time a Zeltiq Aesthetics Inc. (Pleasanton, Calif.) paid consultant and shareholder.44 Zeltiq was purchased in 2017 by Allergan plc (Dublin, Ireland) for $2.48 billion.45 HONEST REPORTING Corporate-funded studies consistently report unusually low complication rates, speedy recoveries, high rates of patient satisfaction, high “conversion rates,” and even the prospects for cross-selling.46 These sales-oriented characteristics undermine hard-won gains in honest reporting and the recognition of the importance of evidence-based medicine in our scientific journals. Adoption of unsound treatments and devices based on biased studies can have harmful long-term ramifications through a “rippling effect.”5 Biased studies may be referenced in practice guidelines.5 Physician disillusionment, especially after the purchase of an expensive yet underperforming device, may be a factor in physician burnout. CONSULTANTS Although physicians may consider themselves to be ethical professionals, many doctors remain unaware of the subconscious bias that industry relationships create.47 The practice of doctors accepting payments from companies has gone on for decades without a critical review. Are plastic surgeons truly acting as consultants, or is “consultant” a euphemism for receipt of a payment to shape one’s opinion in favor of the product and confer loyalty? Industry payments, which may be viewed as kickbacks, have created serious legal difficulties for physicians.2 Lopez et al.20 found that self-reported COIs have declined in recent years, but the proportion of consultantships has increased. In proposing an end to industry influence and regaining the public trust, a committee formed by the Institute of Medicine finds that continuing medical education “has become far too reliant on industry funding,” which “tends to promote a narrow focus on products.”48 The committee recommends restricting consultantships to the provision of objective technical advice paid at fair market value, documented in written contracts. Moreover, companies “should not involve physicians and patients in marketing projects that are presented as clinical research.”48 RECOMMENDATIONS The International Committee of Medical Journal Editors disclosure form insists that contributors disclose relevant financial relationships.49 In 2010, the Council of Medical Specialty Societies published a code for interactions with companies, with a provision that prohibits society officers and journal editors from accepting any compensation from industry.50 To facilitate transparency of disclosure, Congress passed the Physician Payments Sunshine Act, which requires commercial companies to report any “transfer of value” to any physician, with a $10 threshold.51 In October 2010, ProPublica introduced Dollars for Docs, a central search engine for physician payments.41 Luce6 proposes that plastic surgeons with conflicts be excused as manuscript discussants and reviewers. Lichter50 recommends that a presentation with a COI should be balanced by a nonconflicted counterpoint discussant. The American Society of Plastic Surgeons has adopted a requirement for disclosure of financial conflicts in dollar ranges (ie, $100–$1,000, $1,001–$5,000, $5,001–$10,000, etc.).2 These are reasonable first steps. Device evaluation does not necessarily require industry funding, as evidenced by the research efforts of investigators without financial conflicts.25,27 Publication of independent research in a highly respected peer-reviewed journal and the accolades that come with it provide more than adequate compensation, and potential for practice building and career advancement. It is impossible to reconcile corporate sponsorship with unbiased research. Physician investigators should consider declining any paid consultancies and all forms of indirect corporate reimbursement. Study design and implementation, and manuscript preparation should not be outsourced. RELINQUISHING INDUSTRY FINANCIAL SUPPORT Asking attendees to visit the exhibits, “without which none of this [i.e., the meeting] would be possible” is a familiar refrain at meetings. The physician-industry complex has gone on for so long that plastic surgeons may find it difficult to imagine an arms-length relationship. Without industry sponsorship, plastic surgeons can expect to pay more to attend meetings and Continuing Medical Education activities, but the prices of devices and implants are likely to fall as companies are relieved of the tremendous financial burden6 of payments to physicians and societies. The net overall financial effect to physicians is zero, but medical integrity is restored. Relinquishing industry financial support represents a bold step, but recent examples of the influence of financial conflicts underscore the magnitude of the problem. As reported by Rohrich et al.,52 when Goldwyn stepped down as the longtime former editor of Plastic and Reconstructive Surgery, he worried most about commercial influence and keeping the specialty “pure.” He cautioned the incoming managing editor that he would need a strong sense of ethics because “you’ll need them in this business.” Goldwyn,53 quoting his father, wrote: “It is amazing how easy it is to be truthful if one wants to be.” CONCLUSIONS It is impossible for investigators to function as highly paid consultants and remain unbiased. Disclosure, including the amount of money paid, allows the audience to determine the importance of the conflict. Separation of commerce and science in our journal publications is vital so that scientific publications do not become marketing tools. Plastic surgeons must be better advocates for our patients and their pocketbooks. Part of the privilege of caring for patients is to be mindful of their finances and their health.14 Most importantly, our societies need to reconsider corporate partnership. Editors are already aware of the professional positions of reviewers and the need to protect the article that upsets the apple cart. As Descartes famously observed, “doubt is the origin of wisdom.”54 Progress is only made possible by challenging the status quo.

Samik Chowdhury, Indrani Gupta, Mayur Trivedi, Shankar Prinja

BACKGROUND & OBJECTIVES: Numerous studies have highlighted the regressive and immiserating impact of out-of-pocket (OOP) health spending in India. However, most of these studies have explored this issue at the national or up to the State level, with an associated risk of overlooking intra-State diversities in the health system and health-seeking behaviour and their implication on the financial burden of healthcare. This study was aimed to address this issue by analyzing district level diversities in inequity, financial burden and impoverishing impact of OOP health spending. METHODS: A household survey of 62,335 individuals from 12,134 households, covering eight districts across three States, namely Gujarat, Haryana and Rajasthan was conducted during 2014-2015. Other than general household characteristics, the survey collected information on household OOP [sum total of expenditure on doctor consultation, drugs, diagnostic tests etc. on inpatient depatment (IPD), outpatient depatment (OPD) or chronic ailments] and household monthly consumption expenditure [sum total of monthly expenditure on food, clothing, education, healthcare (OOP) and others]. Gini index of consumption expenditure, concentration index and Kakwani index (KI) of progressivity of OOP, catastrophic burden (at 20% threshold) and poverty impact (using district-level poverty thresholds) were computed, for these eight districts using the survey data. The concentration curve (of OOP expenditure) and Lorenz curve (of consumption expenditure) for the eight districts were also drawn. RESULTS: The distribution of OOP was found to be regressive in all the districts, with significant inter-district variations in equity parameters within a State (KI ranges from -0.062 to -0.353). Chhota Udepur, the only tribal district within the sample was found to have the most regressive distribution (KI of -0.353) of OOP. Furthermore, the economic burden of OOP was more pronounced among the rural sample (CB of 19.2% and IM of 8.9%) compared to the urban sample (CB of 9.4% and IM of 3.7%). INTERPRETATION & CONCLUSIONS: The results indicate that greater decentralized planning taking into account district-level health financing patterns could be an effective way to tackle inequity and financial vulnerability emerging out of OOP expenses on healthcare.

Joshua C. Rubin

He rests his hand on a tree of knowledge as he points to a city in the distance. Here is the city on a high hill for all to see. This is a symbol of the Learning Health System… [The] patient is the great unknown variable as we climb the hill. He has not yet been activated and could do so much good… I guess [it] is kinda frightening trying something new. It is sort of chaordic. But that is the energy that we need to crest this hill.—Patient Activist and Artist Regina Holliday, 1 2012 (“Health Care's Rosa Parks”2) Welcome to Issue 3 of Learning Health Systems, focused on “Patient Empowerment and the Learning Health System.” As Guest Editor for this theme issue, I find this topic near and dear to my heart, as it would be to the heart of anyone who ever has been or will be a patient or caregiver. We all stand poised to benefit from a health system in which opportunities for learning engender empowerment of everyone. The contributing authors share perspectives from diverse backgrounds. Almost all of them are motivated in part by some personal experience as a patient or caregiver during which they learned something about themselves, about others, or about the health system that touched and changed their lives. Their efforts are driven by partnerships between patients themselves and other stakeholders, recognizing the paramount importance of putting people at the center of their collaborative work to protect and improve health, often driven through processes of learning. The papers illuminate how patient (as well as family and community) participation advances the vision for a Learning Health System (LHS)—and in turn how an LHS supports patient-empowering initiatives. Indeed, the National Academy of Medicine (NAM) sees “engaged, empowered patients” as a key characteristic of an LHS,3 and the multi-stakeholder consensus Core Values Underlying a National-Scale Person-Centered Continuous Learning Health System (endorsed by over 100 organizations globally4 and referenced in the United States Federal Health IT Strategic Planning5) begins with “Person-Focused” as the first shared LHS Core Value6 (see Table 1). The papers in this theme issue bring a participatory LHS vision to life and paint vivid pictures of what it could look like and be like. The distinct person-centered approach to transforming health embodied in each paper manifests itself as a use case for an LHS sociotechnical infrastructure. Many authors illuminate how an LHS will advance or transform their work. When Learning Health Systems issued a general call for papers, we received an overwhelming response from individuals and organizations spanning the health spectrum and sharing their interest in patient empowerment through learning. Several authors of papers in this issue bring years or decades of being a patient or caregiver as their expertise. Others bring professional training in varied professions that must collaborate to realize a person-centered LHS. Some have made careers as patient and caregiver activists. Others have built nonprofit organizations and for-profit startups aimed at advancing patient empowerment. Still, others serve as leaders within federal government regulatory agencies, public health organizations, health IT organizations, advocacy organizations, patient communities, and academia. All of these authors are extraordinary communicators; all have compelling research to share or powerful stories to tell. We are grateful they chose to share them with the world through our open access online journal. “Of all the forms of inequality, injustice in health is the most shocking and inhuman.”8 From seemingly unlikely places, such as a federal regulatory agency, a nonprofit association with many of large health IT vendors as members, and a global pharmaceutical/life sciences company, other authors exude comparable passion for empowering patients to protect and improve their health and the health of others. Recognized patient activist “e-Patient Dave” deBronkart, citing the half-century-old The Structure of Scientific Revolutions by Dr Thomas Kuhn, has been among the earliest advocates for envisioning a new science of patient engagement.9 His thinking on the subject points to a natural complementarity with the science of learning systems when one considers his proposed definition for empowerment. Referencing a 2002 World Bank definition, deBronkart states, “Empowerment is increasing the capacity of individuals and groups to make choices and transform those choices into effective actions and outcomes.”10 Consider the apparent synergy between an area of science anchored in increasing the capacity of individuals and groups to make decisions and a hallmark of an LHS that “health-related decisions by individual members of society, care providers, and managers and planners of health services” are themselves underpinned by timely, actionable, trustworthy, and routinely updated best practice knowledge of what works best gleaned from the study of “every patient's characteristics and experiences….”11 In realizing an LHS at a nationwide or at an international scale, the importance of this science of empowerment becomes even more paramount when one recognizes that an LHS is not only “human intensive” but also that, “The system as a whole – not just the digital infrastructure, but also networks of people and institutions – will have to be understood not just as users of a technological infrastructure, but also as parts of the information system itself.”12 … [When patients] participate more actively in the process of medical care, we can create a new healthcare system with higher quality services, better outcomes, lower costs, fewer medical mistakes, and happier, healthier patients. We must make this the new gold standard of healthcare quality and the ultimate goal of all our improvement efforts: Not better hospitals. Not better physician practices. Not more sophisticated electronic medical systems. Happier, healthier patients.13 In Issue 1 of Learning Health Systems, an allusion to the four system-level requirements of an LHS (including that an LHS be “trusted and valued by all stakeholders”) by Editor-in-Chief Dr Charles P. Friedman suggests that “Transcendent research challenges… may require new methods and new modes of thinking that evolve naturally from the admixture of (diverse social and technical sciences) disciplines.”11 In this issue, we evidence the importance of including among these research challenges those associated with the study and advancement of empowerment of patients, caregivers, families, communities, and other stakeholders, in part through learning. These papers show how the emerging research methodologies they share can and must contribute to the (sociotechnical) science of learning systems. There is a saying in policy circles that if one is not at the table, he/she is likely on the menu. Patient activist Sharon Terry of the Genetic Alliance (and PCORnet's Executive Committee) gave a speech on participant-driven research using a similar phrase in its title last year.14 Further investment in the development of the envisioned scientific components will contribute invaluably to giving a seat at the table and a powerful voice in the dialogue shaping the future of health to patients, families, and those who advocate for and benefit from patient empowerment. It will prepare us for a paradigm shift in which, as Dr Eric Topol writes (to patients), “The Future of Medicine is in Your Hands”.15 It will form the foundation underpinning a people-powered transformation of health care and health,16 and perhaps even a corresponding patient-driven health information economy.17 A web server is designed and engineered. The internet protocol, IP, and HTTP were designed and engineered. The World Wide Web (WWW) was not. Rather, it emerged from the decentralized and locally autonomous actions of many independent actors acting within the framework of the WWW architecture. A building is designed and engineered. A city is planned and governed, but it emerges largely outside the direct control of a designer or engineer. A garden plan is designed, but the garden emerges, without either the control or the need for actions by the gardener.18 As an ultra-large scale (cyber-social) system, an LHS, especially at a nationwide scale, will have the emergent characteristics of the aforementioned WWW and city (and garden). Realizing it in a way that engenders the qualities desired will require that patients, consumers, and individual citizens be a part of the system and invaluable contributors to it, not merely passive recipients of its envisioned benefits, however benevolent. Patient empowerment will be an outcome of a LHS, but also an important engine propelling it. Just as an LHS cannot simply be built from a blueprint,11 an LHS cannot simply be built by others for patients; it must be built with and by patients (and all other stakeholders). While the papers in this theme issue generally highlight positive paths to addressing challenges and advancing empowerment, there are myriad studies (and individuals and organizations) that highlight present failings in our health care system to empower patients. Hence, the papers in this issue also provide guidance toward a course correction. As the future of health care and health moves in the LHS direction, the importance of patients shaping the design of the system becomes paramount. Think for a moment, outside of health care, about your interactions as a consumer in any system that (often in the name of efficiency) was designed without considering the needs of (or input from) consumers and workers, rendering them cogs in a machine. One example would be a service experience where a person serving a consumer must use a tool or application that constrains any ability to utilize their own skill and judgment, necessitating a process that stands in the way of a human interaction with the consumer. To an observer, it appears that the worker serves the commands of the device he/she uses and that the consumer is merely a passenger lacking autonomy and “along for the ride.” Another example would be where both the consumer and the local worker must engage in a process involving another worker at a national call center; by design, the national worker lacks the local knowledge or engagement with the consumer to help meaningfully, the local worker lacks the authority to help, the consumer (and both workers) are disempowered, and knowledge fragmentation in the system results in a process lacking empathy. A key hallmark of any person-centered system is empathy: i.e., knowing what it is like to stand in the consumer's shoes based on personalized relevant data about that consumer and knowledge derived from the experiences of others. In these aforementioned examples, the key participants in the systems (consumers and workers) were very likely not involved in designing or shaping the systems, and best practices from the science of human-centered design principles were likely not applied. Beyond putting the patient in the driver's seat of his/her own health, empowering patients to shape the transformative future of health anchored in an LHS will be essential to realizing an LHS that embodies the LHS Core Values and delivers on the promise of the LHS vision. Together, we have moved the LHS from impossible to imperative to inevitable. A future of health that involves big data and analytics will happen; it is already happening. What I believe we're really fighting for is the soul of this future.19 While our open access journal is anchored in a science underpinning “both the cyber-social and ultra-large-scale systemic character of the LHS,”11 this theme issues serves to remind us that there is something distinctive about health. At that time of this issue's release in July 2017, many Americans will have already celebrated the anniversary of the adoption of the Declaration of Independence which is grounded in the notion that all people are endowed with certain unalienable rights including rights to life, liberty, and the pursuit of happiness.20 A principle underpinning the United States legal system is that, in theory, when a threat to one's exercise of these unalienable rights is triggered, an individual is afforded rights (and sometimes tools and capabilities) to vigorously advocate to protect these paramount human rights. It is easy to see how an individual's health is central to his/her ability to exercise his/her fundamental human rights to life, liberty, and the pursuit of happiness. Yet when disease threatens a person's liberty or life today, he/she is not regularly told that he/she has rights to the information and tools he/she needs to vigorously advocate to protect his/her health; in certain ways, a person-centered LHS takes important steps toward changing that dynamic by empowering people through learning. The papers in this theme issue showcase select mechanisms by which an LHS can empower patients—with information, health literacy, personalized tools, connections to communities, and more—to be, in collaboration with their caregivers and care teams (and other stakeholders), strong advocates and activists to leverage learning to protect and promote their health as well as the health of others. Learning Health Systems serves as a gathering point (and perhaps an infrastructure component) for the community interested in the science of cyber-social learning systems as applied to health. It can also be a catalyst for advancing the science that will be foundational in driving this change in the way individuals and society relate to safeguarding and advancing health. Hence, these themes are interwoven into people's exercising of their human rights. Many of the authors in this issue have not only been engaged in conducting rigorous research and in pioneering initiatives, but they have also fought courageously and sacrificed greatly to advance patient empowerment. Some have accumulated scars on their extensive journeys championing patient empowerment and the LHS. I hope that the thoughts I have shared with you in this commentary and especially the papers featured in this first theme issue of Learning Health Systems will help to illuminate how and why these contributors were so willing to work steadfastly to advance this urgently important cause, endeavoring to disruptively transform the future of health. I wish to close by recognizing the late Jerry Matczak, a co-author of the paper entitled “Patient-centered drug development and the Learning Health System,”21 who passed away earlier this year. A champion of patient empowerment who worked as a social media guru and leader of a Clinical Open Innovation team at a global pharmaceutical/life sciences company, Jerry was widely lauded for actively listening to and communicating with patients, to advance clinical research and drug development.22 A vocal advocate for open sharing to advance human health, he was personally recognized for sharing his “unique perspective among geek-minded people,” harnessing humanity to draw the types of connections in science that will be at the heart of advancing the science of learning systems.23 Jerry Matczak's commitment to open innovation and community provides a powerful lens from which to view the papers in this issue as well as the emerging science that will underpin the development and advancement of the fabric weaving together a patient-empowering LHS. With motivation stemming from deeply personal family health experience, Jerry stated in a 2012 interview: “[By] acting openly, with honesty, transparency and integrity we intend to foster a community that will make a difference in people's lives. When you think about it that way, it's easy to commit.” 22

Gregory P. Marchildon

No abstract is available for this record.

Joseph Bernstein

The American malpractice system is a mess, and in orthopaedic surgery, it is messier still. One problem is frivolous lawsuits. The Harvard Medical Practice Study [5] reviewed the hospitalization records of more than 30,000 patients and determined for each case whether negligence was committed and a suit was filed. The researchers found most of the events for which claims were made did not involve negligence. It is small consolation that physicians usually prevail at trial. Even when a doctor wins the case, defending a malpractice claim is a losing proposition. At best, the physician is portrayed by the plaintiff’s counsel as a bumbling incompetent. Also, malpractice insurance (which routinely exceeds USD 100,000 per year in some states) indemnifies against only financial damages; the losses of time, reputation, and serenity are for the physician alone to bear. The net drain on happiness probably exceeds what one experiences in contracting appendicitis or breaking an ankle. In response, the orthopaedic surgery community has pressed for change. The hallmark of the orthopaedic approach is limits on noneconomic damages. These so-called “caps” would mandate that while all medical expenses and lost wages caused by malpractice are compensable, no more than a given amount, say USD 250,000, can be awarded for “pain and suffering.” Caps are an appeal to logic and fairness. For one thing, the argument goes, it is impossible to place a precise dollar value on pain and suffering, and if any amount is to be arbitrary, why not keep the dollar values modest? In addition, limits on noneconomic damages mitigate the harm caused by “runaway” juries, making the system less volatile and therefore less expensive for all. But let’s face it: the real appeal of caps is that they limit the number of suits. Most cases are brought forward on a contingency basis; the lawyers get paid only if they win. If the payoff of a case is limited, its attractiveness to an attorney is, likewise, limited. Caps work. In general, malpractice premiums are much lower in those states (such as California) that have caps in place [10]. But the problem with caps is that they solve the wrong problem. While there is plenty amiss with the American medical malpractice system, the largest flaw is not having too many lawsuits. If anything, there are too few. The Harvard Medical Practice Study cited above, for example, reported only eight of the 280 patients (2.9%) who were the victims of medical negligence actually filed malpractice claims. As such, if we can agree a central purpose of a malpractice system is to compensate victims of negligence, we can also agree caps, which discourage litigation across the board, and not just the frivolous cases, undermine that purpose. And, if another central purpose of a malpractice system is to deter errors, then we might also agree any method that discourages litigation in general, benefiting bad physicians as well as good ones, similarly undermines deterrence. Orthopaedic surgeons should favor a system that minimizes physician pain yet allows victims of error unfettered access to fair compensation. Abraham and Weiler [1] have proposed such a system. They call it “enterprise liability.” Under this approach, it is the organization, not the physician, that is named as the defendant in a suit. The rationale is simple: because many medical errors are, in fact, systems failures, it stands to reason that the enterprise should bear primary responsibility for compensation and deterrence. Local enterprises, when held accountable in this way, should likewise do a better job of policing practice and eliminating bad practitioners, as opposed to the current approach to malpractice, which indiscriminately lumps (and punishes) many good surgeons along with the few bad players. There are, of course, impediments to applying enterprise liability. For one thing, even for procedure-oriented specialties like orthopaedic surgery, much health care is not delivered within the confines of a single enterprise. Also, it is not assured that enterprises themselves will avoid hunting for scapegoats. Even so, the advent of Accountable Care Organizations (as promoted by the 2010 Patient Protection and Affordable Care Act) and the heightened political awareness among physicians regarding liability rules will, respectively, mitigate those concerns. Enterprise liability is a practical option moving forward. We orthopaedic surgeons, as advocates for our patients, should favor a system that limits error and compensates victims when errors occur. As human beings, we can’t help but hate attacks on our competence and character. Thus, we are also right to favor a system that minimizes finger pointing. A system of enterprise liability meets all of those standards. Enterprise liability, not caps on noneconomic damages, should be our favored approach. Commentary James Herndon MD, MBA Chairman Emeritus, Department of Orthopaedic Surgery, Harvard Medical School; Partners Healthcare System, Boston, MA, USA Dr. Bernstein has raised an important issue: the use of a method of professional liability reform called enterprise liability. The US medicolegal system has not accepted it in the past, and it will be difficult to implement such a major culture change in the future. However, Dr. Bernstein raised this method of compensating injured patients because he sees a new opportunity for change under the Patient Protection and Affordable Care Act, with the new development of Accountable Care Organizations. I agree with him on this point and would argue it is also a desired method in the new practice model in which physicians are increasingly becoming paid employees of a hospital or hospital system. The best example of enterprise liability in practice that I know of involves the aviation industry. As in medicine, system errors can occur, but also individuals make mistakes. In the case of an airplane crash, the airline company is responsible for all damages. The pilots are not personally liable because their profession has agreed to full transparency and reporting of individual errors. However, the pilot does bear individual responsibility under two circumstances: when he or she is under the influence of drugs or alcohol at the time of the crash or if he or she did not follow the required checklist for flying the aircraft. This model seems perfect for surgeons and hospital systems to adopt. But I am pessimistic that it will happen. In the past, trial lawyers have mounted strong opposition to any professional liability reform; the courts and our legislators (most of whom are lawyers) likewise have not favored such change. There is too much money at stake. Also, I am pessimistic that even our own profession would support enterprise liability. For just as pilots have to admit and disclose their individual errors, so would surgeons under this approach. Physicians fear the loss of reputation, the resultant loss of income, and the difficulty of admitting to colleagues and patients that we erred and caused harm. I believe our profession would accept individual responsibility for errors committed while under the influence of drugs or alcohol, but the challenge for many surgeons will be the acceptance and use of required checklists before, during, and after surgery. Most changes in past attempts at healthcare reform have been at the margins: a small fix or BAND-AID® here, a small change there. It would be wonderful if leaders of the professions of medicine, law, and politics, along with our patients, would come together and implement enterprise liability in health care as it is used in the airline industry. Such are quixotic dreams. Only if state and federal leaders, along with physicians, agreed such reform was necessary because of the continued rise in healthcare costs, the continued threat of adverse events, and the importance of shared decision making, would such reform become a possibility. Even then, though, it would be but a small one. Commentary Christopher D. Stombaugh JD Laufenberg, Stombaugh & Jassak, SC, Milwaukee, WI, USA “It isn’t what we don’t know that gives us trouble, it’s what we know that ain’t so.” Will Rogers It is becoming more and more difficult to engage physicians and lawyers who represent patients in a productive dialogue about fixing what ails the medical liability system. Each group views the other with suspicion and distrust. Nonetheless, to have a productive dialogue, the participants must first agree about the nature of reality. Evidence-based liability reform, like evidence-based medicine, must look at the facts as they are, not as we assume them to be. The arguments in favor of medical liability reform are more faith-based than fact-driven. The author begins by rounding up the usual suspects: “frivolous lawsuits,” caps on “pain and suffering,” discouraging lawyers from bringing cases. These are driven by fears. The fears of plaintiff’s counsel, loss of reputation, rising liability insurance premiums, loss of time, loss of peace and enjoyment of life, runaway juries. Fears, although real, do not make the thing feared a reality. Truth should matter, especially when it comes to changing our laws to deny a person his or her right to full and fair compensation. That person would surely be awarded compensation if only he or she had been injured in a road wreck caused by driver error, rather than violation of the standard of medical care by a physician who commits medical errors. Review of the relevant literature shows the arguments made in support of so-called reform proposals are simply untrue [3]. An ambitious project of the nonprofit Center for Justice & Democracy at New York Law School [3] is an updated survey of the data every orthopaedic surgeon should read. This freely downloadable, heavily footnoted book leads to the conclusion that whatever the infirmities of the current system, they cannot be laid at the feet of the injured patients and their advocates. Rather, we learn the inconvenient truth: We are not inundated with frivolous medical lawsuits. “[P]ortraits of a malpractice system that is stricken with frivolous litigation are overblown” [7]. Capping pain and suffering damages does not reduce malpractice insurance premiums [9] and does not affect physician supply, but it does prevent legitimate cases from being filed [3]. Legitimate cases actually improve the cause of patient safety [3]. Dr. Bernstein’s contention that too few malpractice cases are being filed is also borne out by the literature [2]. Medical errors occur at an alarming number and are, largely, system failures [4]. Recently, there have been small steps in increasing acceptance for physicians to admit medical mistakes as part of the healing process. Most notable was the recent Technology, Entertainment, Design (TED) talk of Canadian emergency physician Brian Goldman MD [8]. This is also good for the overall cause of improving patient safety. In place of the current system, Dr. Bernstein advances the idea of enterprise liability. Enterprise liability has several advantages as a method of bearing the costs of medical errors, obtaining coverage in a pool, holding the system responsible for system failures, and making system wide improvements in the interest of patient safety. Additionally, the enterprise is in a better position to police the few bad, serial malpracticing physicians who create most of the medical negligence payouts and who receive shockingly little discipline from state medical boards [6]. An enterprise liability system would also have the benefit of depersonalizing the effects of litigation. Unfortunately, as of now, this is not the law anywhere in America. A reasonable, workable alternative is the Wisconsin system, The Injured Patients and Families Compensation Fund. Doctors in Wisconsin have unlimited coverage since every healthcare provider has that type of coverage. The fund has nearly USD 1 billion in assets and pays out only a small portion of that every year and is financed through assessments on healthcare providers. Commentary David Seligson MD Chief of Orthopedics, Department of Orthopedic Surgery, University of Louisville Hospital, Louisville, KY, USA Our current tort system resolves disputes through litigation. Dr. Bernstein notes researchers found most events for which claims were made did not involve negligence. This suggests the current system works, since most malpractice suits find for the defendants. Error is not the same thing as malpractice. Although malpractice litigation is demeaning, can be tedious, and certainly is expensive, the alternative—compensating those who allegedly suffer from medical misadventures—would be far worse. Prioritizing the business of medicine first and putting the patient with a bad result in charge are mistakes. Here’s why: Among the patients whose treatment could have been better are other people who think they have been mistreated, and worse, individuals who believe they deserve compensation for actual or imagined dysfunction. Our society, our hospitals, and our prisons are loaded with folks who feel they are entitled. Compensation for situations that are judged by some flawed process to have been caused by medical care will provide a whole new apparatus for undeserved rewards. In real life, few patients tell the whole truth about what happened to them, what they have taken, or what they have done. Review of the discovery process of any lawsuit makes this clear enough. Enterprise liability is a concept borrowed from manufacturing. If a part fails, the company issues a recall and fixes the problem. The underlying assumption is that there has been a flaw in the creation of the product somewhere from design to production and the process is at fault. This concept fits less well when applied to an unemployed motorcycle driver on alcohol and drugs who loses his leg in a high-speed injury that he or she caused. My wise accountant opined any audit will disclose discrepancies; similarly any chart review will find courses of action that might have led to better results. Where will the funds come from to compensate patients for damages they allege? Government? Healthcare insurers? Doctors? Surely a torrent of preferred pathways, algorithms for treatment, and computer-driven systems to control losses will follow; these will, almost necessarily, stifle innovation. We can develop a new system wherein a well-intentioned (though perhaps not well informed) someone will assert an adverse outcome could have been averted, and we even can compensate patients under such a system. But we will probably find ourselves with much more paperwork and in a much-less favorable atmosphere to treat patients as individuals and with dignity and kindness. Commentary Mark A. Geistfeld JD Sheila Lubetsky Birnbaum Professor of Civil Litigation, New York University School of Law, New York, NY, USA The claim that more tort liability could be a cure for our ailing system of medical malpractice liability will undoubtedly strike many physicians as preposterous. The logic of this proposed tort reform, however, is compellingly as laid out by Joseph Bernstein in this column on medical malpractice. Indeed, the case for enterprise liability—a system that shifts liability from physicians to the enterprises that supply health care—is even stronger than Dr. Bernstein shows. In sharp contrast to the current system, enterprise liability is triggered by the occurrence of medically caused injuries, regardless of fault. No-fault liability would result in more tort liability across the run of cases, but this expansion of tort liability could solve the malpractice problem by removing blame from the liability equation. No one likes to be sued, especially when the allegation is one of professional malpractice. Rather than having one’s competence impugned, many physicians understandably engage in defensive medicine or otherwise cover up their mistakes. These allegations can also be upsetting to patients who place faith in their physicians and feel grateful for the care that they have received, even when the physician ultimately is unable to provide a cure. These patients are often loath to sue their physicians, regardless of whether further investigation would support a malpractice claim, whereas others who feel their physicians have not been adequately sensitive can end up blaming the physician for the failure to provide a cure, even if malpractice is not involved. The resultant mismatch between the incidence of medical error and the incidence of malpractice claims is well described by Bernstein and more extensively documented by others [2]. To be sure, fault-based liability has a number of appealing attributes. It requires proof that the defendant was legally at fault for the plaintiff’s injury, enabling risky actors to avoid tort liability by exercising reasonable care. The failure to exercise reasonable care constitutes legal fault, a conclusion that can be quite different from the colloquial attribution of fault. No one can be blamed for not being perfect. We all make mistakes, but any misstep, whether the result of professional incompetence or a simple lapse of attention, can be sufficient to establish negligence liability. The frequency of these mistakes can be reduced by procedures or the design of systems for delivering health care, but fault-based liability largely ignores these issues by instead placing blame on the provider whose inadvertent mistake directly caused the patient’s harm. Requiring the patient to prove instead that the “fault” lies with the enterprise is no panacea because the optimal design of systems and procedures involves complexities that render such proof practically inaccessible to plaintiffs. Is the injured patient, or more precisely, the contingency-fee lawyer, really the party best able to identify the practices that ought to be utilized by the enterprise of health care? By placing responsibility for all medically caused injuries on the enterprise itself, tort liability would create financial incentives for these institutions to adopt procedures and systems that would both reduce the incidence of inadvertent error and provide internal mechanisms for addressing instances of professional incompetence. Eliminating blame from the liability inquiry could be the best way to address the problem of medical error, but doing so requires an expansion and redirection of tort liability, a reform quite different from the reduction of tort liability often championed by medical professionals.

Neil Pearce

I wanted to like this book, and tried hard, but ultimately failed. I have recently written several papers on inappropriate corporate influences on the funding and conduct of epidemiological research, and have discussed several examples of hazards where the epidemiologic findings were strongly, and unethically, opposed by industry and by academic epidemiologists funded by industry.1–3 This book provides ‘the other side of the coin’ and discusses in depth four examples (environmental causes of breast cancer, electromagnetic fields and cancer, residential radon exposure and lung cancer and passive smoking) where, in the author's opinion, the health risks were low or non-existent, but were hyped by researchers and policy makers thus resulting in unnecessary research, inappropriate funding decisions and unjustified public concern. Such things certainly happen, and we need books like this which attempt to discuss them objectively, and which point out that academic researchers may also be affected by a range of influences including career and funding opportunities, even if they only accept peer-reviewed government funding and do not accept corporate funding. Thus, they may have incentives to overstate the evidence, just as industry and industry-funded epidemiologists may have incentives to negate or understate the evidence of health risks from environmental exposures. The book states its case well, is clearly written and discusses complicated issues in a relatively simple and readable way. It makes the case that ‘each side tends to cite the evidence that supports its point of view in order to influence public policy’ (p. 6) and that ‘the tendency to overstate the evidence, for whatever purpose, actually strengthens the opposing party's hand. It sanctions the partisan use of science that should be rejected, no matter who is engaging in it.’ (p. 7) The book also makes the important points that: (i) we have to some extent reached the limits of ‘risk factor’ epidemiology and have identified the strong risks (e.g. active smoking and lung cancer) and are now trying to assess weak risks (e.g. passive smoking and lung cancer), which are much more difficult to assess and much more prone to be overwhelmed by bias; (ii) for many of these risks (e.g. residential radon exposure and lung cancer) it is not possible to directly estimate the risks from low exposures, and it is necessary to make theoretical assumptions to interpolate from the findings of studies of highly exposed occupational populations (e.g. miners exposed to radon); and (iii) many of these risks are very small and have received perhaps excessive funding and scientific attention in comparison with other public health risks. So far so good. I agree with all of the above statements, and started reading the book in a positive frame of mind, with the expectation that it was an important book that would be an essential antidote to the writings of myself and others who have tended to emphasize the hazards of corporate influences. However, I became more frustrated and less impressed as I worked my way through the book, particularly when coming to discussions of issues that I had been involved in (e.g. electromagnetic fields and cancer). This probably reflects my own influences and prejudices. However, it became increasingly difficult, as I worked my way through the book, to avoid the conclusion that the discussions of these issues were, for want of a better word, ‘biased’, as well as being rather ‘grumpy’ and unpleasant in parts. It seems that no one can get it right. No single study is good enough or big enough, but meta-analyses should be discouraged because they combine studies from different exposure settings and with different methodologies. Researchers are criticized for arguing that ‘one must rely upon the evaluation of the data as a whole using expert judgement and the meta-analyses as a guide’ (p. 101), because this simply reflects their vested interests to continue researching a topic when an individual study is inconclusive. The findings of individual studies are dismissed because they are ‘not statistically significant’, even if they are consistent with previous findings. Significant associations are dismissed because they involved multiple comparisons, even if the specific associations were the a priori reason for the study and had been found previously [e.g. ‘the reported association [of EMFs with childhood] leukaemia was one of a very large number of comparisons made by the researchers and hence could well have arisen by chance’ (p. 100)]. Studies that show interesting dose-response associations verging on statistical significance, such as the National Cancer Institute childhood leukaemia study,4 are not only dismissed, but also researchers are condemned for not accepting the findings as proof of lack of risk (‘it is hard to escape the impression that the reluctance of the NIEHS working group to close the door on the possibility of EMF as a cause of leukaemia had more to do with its members’ stake in this area of research than with scientific rigor’ (p. 101). While every academic researcher who wants to study these issues apparently has a vested interest, even if their university salary is already funded, critics of the research are apparently unbiased, reasonable and objective, even if their criticisms are directly or indirectly funded by industry. Researchers into radon and lung cancer are biased because they do not repeatedly emphasize that tobacco smoking is the major cause of lung cancer, and that most cases of radon-induced lung cancer involve joint effects with smoking (the corollary that some cases of lung cancer in smokers are due to joint effects with radon exposure is never mentioned, nor is it mentioned that the same arguments could be applied to many other important lung carcinogens such as asbestos). The book gives particular emphasis to issues of biological plausibility, even though there are many historical examples of associations that were not biologically plausible when they were first discovered by epidemiologists, and the aetiological mechanisms involved were only subsequently discovered in laboratory-based studies. This is why, for example, all of the 30–40 known occupational causes of cancer (as classified by the International Agency for Research on Cancer) were first discovered in epidemiological studies, not in the laboratory. If it had been plausible that these substances caused cancer, then they would not have been used in the workplace. So epidemiology will always be in front of mechanistic research with regards to discovering new environmental and occupational causes of disease. The book also fails to mention that there are many historical examples of risks (dioxin and cancer is one example) where the evidence was initially weak and inconsistent but has strengthened over time (leading to the classification of dioxin as a carcinogen by the International Agency for Research on Cancer in 1997). So what are we supposed to do about ubiquitous environmental exposures that may carry weak risks, but which may account for a substantial number of cases of disease on a population level? Kabat's solution is nihilistic, namely that we simply should not study such exposures, or at least not attempt to quantify their effects: ‘it is entirely plausible that in some cases exposure to ETS may account for a few cases of lung cancer in nonsmokers, but … it is not possible to quantify the excess risk with any certainty’ (p. 150). The argument is essentially that the risks are too small to quantify accurately, and therefore should not be studied, or at least should not be estimated quantitatively. We are never told how we should decide if a risk is too ‘small’ to be concerned about if we do not first attempt to estimate its magnitude. And how are we supposed to tell the public that the risks are small (and their concerns are unimportant) without attempting to estimate them? And who decides what is a ‘small’ risk? The book finishes, literally on the last page, by advocating a ‘broader/integrative vision of epidemiology—one that can accommodate social, economic, and ecological/environmental realities … as well as rapidly evolving knowledge of the mechanisms of disease at the molecular level’ (p. 186).5–8 Such developments are to be encouraged, but they are intended to be inclusive, not exclusive, and we will have to continue to grapple with problems of studying weak risks from ubiquitous environmental exposures, even if they receive less attention than they have in the past. It is important to consider the influences on such research, including influences on academic researchers with regards to career opportunities and funding, even though these will continue to be relatively minor compared with the massive and pervasive influences of corporate funding of research and of critics of research.1–3 This book could have made a major contribution in this regard, but its lack of balance means that it fails to make such a contribution.

Ulrike Neumann, Anja Hagen, Matthias P. Schönermark

Because great interest in an efficient range of effective medicinal innovations and achievements has arisen, many countries have introduced procedures to regulate the adoption of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances. With this as a background, this report will describe procedures for the adoption of innovative non-medicinal technologies by solidly financed health care insurances in Germany, England, Australia and Switzerland. This report was commissioned by the German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information.In order to find the relevant literature and information, systematic literature research, a hand search and a written survey were carried out. All the selected documents (chosen according to defined criteria for inclusion and exclusion) were qualitatively evaluated, summarized and presented on a chart using a framework developed for this purpose. All the countries in this report require that some innovative non-medicinal technologies undergo evaluation by a central governing body. This evaluation is a prerequisite for adoption into the benefit catalogue. The process of evaluation can differ (e. g. the people and institutions concerned, the division of the synthesis of evidence and overall evaluation, processing the evidence). Similarities do exist, such as the size and composition of the governing bodies or the overreaching criteria according to which institutions must make their recommendations. This is how all the countries examined in this report determine how the benefits and effectiveness of the innovations, as well as their cost-effectiveness, can be chosen as criteria for the evaluation. Furthermore, there are many criteria which differ from country to country (social and ethical aspects, possible effects on the health system, etc.) and which are also relevant to an evaluation. The preferred types of clinical studies for these evaluations are randomized controlled trials. However, all institutions do allow for other types of evidence (e. g. expert opinion) when no other study types of a higher evidence level are available. In addition, all the countries are willing to allow unpublished or confidential information (e. g. from manufacturers) to be included in an evaluation. It is important to remember that the decisions made by the central governing bodies do not necessarily become conditions for the introduction of innovative non-medicinal technologies. There is a host of other requirements which determine how these innovations can be introduced. This means that a large number of non-medicinal technologies make it into the medical care system via these other decision-making processes. Often, these innovations are unevaluated and differ from region to region. Every country has established a system of observation and registration for medicinal products. These systems are meant to document any incidents with the innovations and to confer responsibility on certain organizations. All in all, no country has a central authority which systematically investigates the effects of newly introduced innovative non-medicinal technologies on medical care in general. However, Australia and England both carry out a review of innovations in some areas (e. g. by means of special commissions). In principle, the starting point for improving regulations of innovative non-medicinal technologies lies in the extension of transparency, the shortening of decision-making time (especially the central decision-making processes), the further development of evaluation methods, more flexibility and increased capacity in the governing bodies' decision-making processes and also, if needed, in the creation of a single authority to act as contact for people who are interested in introducing an innovation into the benefit catalogue.More research is required, especially in the area of decentralized decision-makers and how they actually decide whether or not to introduce innovative technologies into the core care system (methods, criteria, etc.). In view of this, it would also be interesting to see how the application of innovations actually happens in practice once their adoption has been approved by the corresponding governing bodies.

Waleria Hryniewicz, Paweł Grzesiowski, Tomasz Ozorowski

No abstract is available for this record.

Rikard Lindqvist

Introduction Sweden, with about nine million inhabitants, has a decentralized public health care system. Three political and administrative levels – central government, county councils and local municipalities – are involved in financing, providing and evaluating health care activities. The central government has only a legislative supervisory role, while county councils and municipalities are responsible both for financing and providing health services (Figure 4.1). The county councils are entitled to collect direct income tax revenues as their major financial source, but they are also politically accountable through their directly elected political assemblies. The vast majority of Swedish hospitals are public, owned and financed by the county councils. Primary care settings are also financed by the county councils but they are both publicly and privately owned. Swedish hospitals have traditionally been financed via global budgeting. This is due to the fact that Sweden has a tradition of publicly owned hospitals and that cost control has been an important issue. Moreover, before the introduction of DRGs, there was no accepted system in use to describe performance. The counties had poor knowledge of hospital activity and productivity. There was a great need to find ways to measure productivity. In Sweden, DRGs have been used as a prospective payment system, to describe performance and increase the transparency of hospital activities, as an analyzing tool and to measure productivity.

G. John Chen, Steven R. Feldman

No abstract is available for this record.

Claudia Wild

The Austrian healthcare system relies mainly on physicians in private practice and on various services provided by hospitals. The social health insurance scheme is compulsory, covering 99% of the population. The system is very decentralized. While the federal state provides the framework, the nine autonomous provinces are responsible for administering health and social services. There is ongoing public discussion about centralizing the healthcare system to make it more efficient and to enforce structural reforms. Because of concerns about healthcare expenditures, in 1997 the Performance-Related Hospital Financing System (LKF), a system similar to the diagnosis-related group system, was introduced for hospitals, including a plan for large medical devices. It is too early to evaluate the success of this new system, although some effects of the LKF system that could have been anticipated, such as shortened lengths of stay and more hospitalizations, have been seen. Previously, health technologies have been almost uncontrolled in Austria. The evaluation of health technologies as an instrument to support or to control their dissemination and use or to help define policies is not institutionalized or systematically used. It seems clear that structural reforms of the Austrian healthcare system are needed. Health technology assessment should be part of such reforms.

Romuald K. Schicke

This article contends that the German social and economic situation is conductive to the rapid diffusion of innovative medical technology. While there is public control over hospital facilities, the pluralistic health care system and decentralized government responsibilities contribute to an essentially laissez faire regulatory environment. There is perfunctory planning and regulation for major medical expenditures, but the essential constraints are financial. This is no comprehensive program for the assessment of diagnostic technologies and the effective imposition of guidelines depends on the cooperative effort of various financing organizations, professional interests, and public pressure groups.