Establishing the shadowline: the border between legally acceptable and unacceptable standards of surgical practice.

INTRODUCTION: Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. METHODS: We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. RESULTS: There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. DISCUSSION AND CONCLUSION: We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.

Establishing a Baseline: Evidence-Supported State Laws to Advance Stroke Care.

OBJECTIVE: Approximately 800 000 strokes occur annually in the United States. Stroke systems of care policies addressing prehospital and in-hospital care have been proposed to improve access to time-sensitive, lifesaving treatments for stroke. Policy surveillance of stroke systems of care laws supported by best available evidence could reveal potential strengths and weaknesses in how stroke care delivery is regulated across the nation. DESIGN: This study linked the results of an early evidence assessment of 15 stroke systems of care policy interventions supported by best available evidence to a legal data set of the body of law in effect on January 1, 2018, for the 50 states and Washington, District of Columbia. RESULTS: As of January 1, 2018, 39 states addressed 1 or more aspects of prehospital or in-hospital stroke care in law; 36 recognized at least 1 type of stroke center. Thirty states recognizing stroke centers also had evidence-supported prehospital policy interventions authorized in law. Four states authorized 10 or more of 15 evidence-supported policy interventions. Some combinations of prehospital and in-hospital policy interventions were more prevalent than other combinations. CONCLUSION: The analysis revealed that many states had a stroke regulatory infrastructure for in-hospital care that is supported by best available evidence. However, there are gaps in how state law integrates evidence-supported prehospital and in-hospital care that warrant further study. This study provides a baseline for ongoing policy surveillance and serves as a basis for subsequent stroke systems of care policy implementation and policy impact studies.

Policy impact: When policy fails.

The best policies are evidence-based, providing feasible solutions to healthcare issues to prevent unintended consequences. Nurse researchers need to generate evidence with which to create policy. The obligation to monitor the impact of policies and standards rests on nurse leaders who have the duty to advocate when policies fail. Nurses providing direct care are beholden to report failed policies. Advocacy in the situation of a failed policy often requires moral courage to prevent moral distress amongst the ranks of nurses who enact policies at the intersect of care. In this article, the impact of three healthcare policy issues on nursing end-users will be evaluated: aid in dying, titration of vasoactive medications, and the Center for Medicare and Medicaid Services 30-minute rule.

Academic Advocacy: Opportunities to Influence Health and Science Policy Under U.S. Lobbying Law.

Medical school faculty and their colleagues in schools of nursing, public health, social work, and elsewhere often research issues of critical importance to health and science policy. When academics engage with government policymakers to advocate for change based on their research, however, they may find themselves engaged in "lobbying," thereby entering a complex environment of legal requirements and institutional policies that they may not fully understand. To promote academic advocacy, this article explains what is and is not legally permitted when it comes to engaging with policymakers and encourages academic institutions to facilitate permissible advocacy activities.U.S. law permits academic researchers to conduct certain types of policy-focused advocacy without running afoul of legal restrictions on lobbying. Academics acting in their personal capacities and with their own resources may freely engage with policymakers in any branch of government to provide their expertise and advocate for desired outcomes. When acting in their professional capacities, academics are free to engage in most advocacy activities directed to the executive and judicial branches, and they also may advocate to influence legislation and legislators within certain limits that are particularly relevant to academic work. In all cases, academics must take care to not use restricted funds for lobbying.Academic researchers have an important role to play in advancing evidence-based health and science policy. They should familiarize themselves with legal restrictions and opportunities to influence policy based on their research, and their institutions should actively support them in doing so.

The role of the outer setting in implementation: associations between state demographic, fiscal, and policy factors and use of evidence-based treatments in mental healthcare.

BACKGROUND: Despite consistent recognition of their influence, empirical study of how outer setting factors (e.g., policies, financing, stakeholder relationships) influence public systems' investment in and adoption of evidence-based treatment (EBT) is limited. This study examined associations among unmodifiable (e.g., demographic, economic, political, structural factors) and modifiable (e.g., allocation of resources, social processes, policies, and regulations) outer setting factors and adoption of behavioral health EBT by US states. METHODS: Multilevel models examined relationships between state characteristics, an array of funding and policy variables, and state adoption of behavioral health EBTs for adults and children across years 2002-2012, using data from the National Association for State Mental Health Program Directors Research Institute and other sources. RESULTS: Several unmodifiable state factors, including per capita income, controlling political party, and Medicaid expansion, predicted level of state fiscal investments in EBT. By contrast, modifiable factors, such as interagency collaboration and investment in research centers, were more predictive of state policies supportive of EBT. Interestingly, level of adult EBT adoption was associated with state fiscal supports for EBT, while child EBT adoption was predicted more by supportive policies. State per capita debt and direct state operation of services (versus contracting for services) predicted both child and adult EBT adoption. CONCLUSIONS: State-level EBT adoption and associated implementation support is associated with an interpretable array of policy, financing, and oversight factors. Such information expands our knowledge base of the role of the outer setting in implementation and may provide insight into how best to focus efforts to promote EBT for behavioral health disorders.

Organizational factors related to the adoption of an injury prevention program by U.S. children's hospitals.

Most childhood injuries can be prevented with the correct use of safety devices and appropriate supervision. Children's hospitals are well positioned to promote these behaviors with evidence-based programming; however, barriers exist to adopting such programs. The purpose of this study was to describe organizational and administrative factors related to the adoption of an efficacious injury prevention (IP) program by children's hospitals in the USA. IP specialists at 232 U.S. children's hospitals were invited to complete a baseline survey, and then offered Safe N' Sound (SNS), an efficacious computer IP program targeting parents of young children. Following this promotion period, specialists were surveyed again to assess their level of SNS adoption. Organizational and administrative factors associated with SNS adoption were identified using conditional random forest models (n = 93). Random forests identified a set of six predictors with potential utility for classifying hospitals as having SNS adoption activity or not; the final pruned classification tree indicated that four of these were best able to differentiate hospitals with and without adoption activity-having a medical director, having other hospital units that provided IP programming, the number of requests the IP unit received within the past year, and the belief of administrative leaders in their responsibility to develop programming all influence decisions. Hospitals without a medical director were most likely to demonstrate adoption activity. Medical directors, or other organizational leaders, can facilitate the adoption process for evidence-based intervention, but may need to be engaged intentionally when disseminating new products, tools, or approaches.

A proposed approach to accelerate evidence generation for genomic-based technologies in the context of a learning health system.

Genomic technologies should demonstrate analytical and clinical validity and clinical utility prior to wider adoption in clinical practice. However, the question of clinical utility remains unanswered for many genomic technologies. In this paper, we propose three building blocks for rapid generation of evidence on clinical utility of promising genomic technologies that underpin clinical and policy decisions. We define promising genomic tests as those that have proven analytical and clinical validity. First, risk-sharing agreements could be implemented between payers and manufacturers to enable temporary coverage that would help incorporate promising technologies into routine clinical care. Second, existing data networks, such as the Sentinel Initiative and the National Patient-Centered Clinical Research Network (PCORnet) could be leveraged, augmented with genomic information to track the use of genomic technologies and monitor clinical outcomes in millions of people. Third, endorsement and engagement from key stakeholders will be needed to establish this collaborative model for rapid evidence generation; all stakeholders will benefit from better information regarding the clinical utility of these technologies. This collaborative model can create a multipurpose and reusable national resource that generates knowledge from data gathered as part of routine care to drive evidence-based clinical practice and health system changes.

Mobilizing Community Health Workers to Address Mental Health Disparities for Underserved Populations: A Systematic Review.

This systematic review evaluates efforts to date to involve community health workers (CHWs) in delivering evidence-based mental health interventions to underserved communities in the United States and in low- and middle-income countries. Forty-three articles (39 trials) were reviewed to characterize the background characteristics of CHW, their role in intervention delivery, the types of interventions they delivered, and the implementation supports they received. The majority of trials found that CHW-delivered interventions led to symptom reduction. Training CHWs to support the delivery of evidence-based practices may help to address mental health disparities. Areas for future research as well as clinical and policy implications are discussed.

The strategic defense of physician autonomy: State public health agencies as countervailing powers.

Advances in genetic testing and the aggressive marketing of genetic tests by commercial diagnostic laboratories have driven both consumer demand and the need for unbiased information about how tests should guide healthcare delivery. This paper uses the countervailing powers framework to explore the role of state public health agencies as arbiters of quality and safety, specifically through their efforts to encourage physicians to follow evidence-based recommendations for screening for hereditary cancers. Social scientists have often viewed actions by the state to regulate cost, quality, or safety as a threat to physician autonomy. This paper draws on case studies from two US states-Michigan and Connecticut-to better understand the specific role of state public health agencies, and especially whether their activities to encourage adherence to evidence-based recommendations bolster or subvert the interests of other parties in the healthcare arena. We find that lacking authority to compel provider to follow evidence-based recommendations, they improvised ways to foster compliance voluntarily, for example, by emphasizing the role of the physician as gatekeeper, thus affirming the importance of physician autonomy and clinical judgment. Both states also used public health surveillance data to make rare diseases visible and illustrate gaps between recommendations and practice. Finally, they both showed that following evidence-based recommendations could align the professional and market interests of healthcare stakeholders. Both states employed similar strategies with similar effects, despite substantial differences in the regulatory climate and organizational capacity. Taken as a whole, their activities orchestrated a countervailing response that checked the profit-seeking motives of commercial laboratories. Our findings demonstrate that rather than eroding physician autonomy, state action to monitor healthcare quality and encourage adherence to evidence-based recommendations can actually reinforce physician authority.

Evidence-based policy responses to strengthen health, community and legislative systems that care for women in Australia with female genital mutilation / cutting.

BACKGROUND: The physical and psychological impact of female genital mutilation / cutting (FGM/C) can be substantial, long term, and irreversible. Parts of the health sector in Australia have developed guidelines in the management of FGM/C, but large gaps exist in community and professional knowledge of the consequences and treatment of FGM/C. The prevalence of FGM/C amongst Australian women is unknown. Our article reviews the literature on research on FGM/C in Australia, which focuses on health system response to women and girls with FGM/C. Recommendations are made for policy reform in health, legislation, and community programs to provide the best healthcare, protect children, and help communities abandon this harmful practice. MAIN BODY: Midwives and doctors in Australia acknowledged a lack of knowledge on FGM/C, clinical guidelines and consequences for maternity care. In a metropolitan Australian hospital with specialised FGM/C care, women with FGM/C had similar obstetric outcomes as women without FGM/C, underlining the importance of holistic FGM/C clinics. Greater focus on integration of refugee and migrant populations into their new cultures may be an important way of facilitating the abandonment of this practice, as is education of communities that practise FGM/C, and experts involved in the care and protection of children. Men could be important advocates for protecting women and girls from violence and FGM/C through a man-to-man strategy with programs focussing on men's health and other personal issues, education, and communication. The Australian Government has identified gender-based violence as an area of priority and has been implementing a National plan to reduce violence against women and their children 2010-2022. A multidisciplinary network of experts on FGM/C could be established within this taskforce to develop well-defined and rapid referral pathways to care for and protect these children, as well as coordinate education and prevention programs to help communities abandon this harmful practice. CONCLUSION: Countries of migration can be part of the solution for abandonment of FGM/C through community interventions and implementation of national and coordinated training in FGM/C of experts involved in the care and protection of children and women. The global focus on collaboration on research, training and prevention programs should be fostered between countries of FGM/C prevalence and migration.

Supporting a Culture of Evidence-Based Policy: Federal Funding for Public Health Law Evaluation Research, 1985-2014.

OBJECTIVE: Law powerfully influences health and can be a critical tool for promoting population well-being. Evaluation research is needed to measure the health effects of law and guide policy making and implementation. The purpose of this study was to assess trends in National Institutes of Health (NIH) funding for scientific public health law research (PHLR). METHODS: Using data from the UberResearch NIH grant repository, we collected and coded all grants with a focus on health law between FY'85 and FY'14 and then analyzed the grants by funding agency and topic areas. RESULTS: Between FY'85 and FY'14, NIH funded 510 research grants on health policy making, the health effects of laws or enforcement practices. On average, 4 PHLR grants were funded annually with a median total funding of $545 956 (range: $2535-$44 052 300) and a median annual funding of $205 223 (range: $2535-$7 019 517). CONCLUSIONS: National Institutes of Health has supported important PHLR but not nearly to the extent necessary to ensure that public health laws affecting the population are evaluated in a rigorous and timely manner. In addition to greater funding evaluation research, NIH can increase its support for creating legal datasets, fund training in PHLR, and work with the National Library of Medicine to create Medical Subject Headings (MeSH) terms related to PHLR.

¿Es tiempo de exigir publicidad basada en la evidencia?

Claims made in current advertising for medical products is not necessarily scientifically proven, yet at the same time clinicians are required to adopt evidence-based practices and undergo periodic certifications. This is a clear contradiction. It is crucial to begin to reflect on the need to regulate information presented in the media and to place greater emphasis on patient well-being and safety instead of on third-party interests. The medical community must demand stricter regulations and evidence-based advertising policies.