Validity and usability testing of a health systems guidance appraisal tool, the AGREE-HS.

BACKGROUND: Health systems guidance (HSG) provides recommendations to address health systems challenges. No tools exist to inform HSG developers and users about the components of high quality HSG and to differentiate between HSG of varying quality. In response, we developed a tool to assist with the development, reporting and appraisal of HSG - the Appraisal of Guidelines for Research and Evaluation-Health Systems (AGREE-HS). This paper reports on the validity, usability and initial measurement properties of the AGREE-HS. METHODS: To establish face validity (Study 1), stakeholders completed a survey about the AGREE-HS and provided feedback on its content and structure. Revisions to the tool were made in response. To establish usability (Study 2), the revised tool was applied to 85 HSG documents and the appraisers provided feedback about their experiences via an online survey. An initial test of the revised tool's measurement properties, including internal consistency, inter-rater reliability and criterion validity, was conducted. Additional revisions to the tool were made in response. RESULTS: In Study 1, the AGREE-HS Overview, User Manual, quality item content and structure, and overall assessment questions were rated favourably. Participants indicated that the AGREE-HS would be useful, feasible to use, and that they would apply it in their context. In Study 2, participants indicated that the quality items were easy to understand and apply, and the User Manual, usefulness and usability of the tool were rated favourably. Study 2 participants also indicated intentions to use the AGREE-HS. CONCLUSIONS: The AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org.

Exploring the evidence base for national and regional policy interventions to combat resistance.

The effectiveness of existing policies to control antimicrobial resistance is not yet fully understood. A strengthened evidence base is needed to inform effective policy interventions across countries with different income levels and the human health and animal sectors. We examine three policy domains-responsible use, surveillance, and infection prevention and control-and consider which will be the most effective at national and regional levels. Many complexities exist in the implementation of such policies across sectors and in varying political and regulatory environments. Therefore, we make recommendations for policy action, calling for comprehensive policy assessments, using standardised frameworks, of cost-effectiveness and generalisability. Such assessments are especially important in low-income and middle-income countries, and in the animal and environmental sectors. We also advocate a One Health approach that will enable the development of sensitive policies, accommodating the needs of each sector involved, and addressing concerns of specific countries and regions.

Placing Trust at the Heart of Health Policy and Systems.

Trusted interactions are crucial in health systems. Trust facilitates effective healthcare by encouraging patients to seek and adhere to treatment, enabling teamwork among health professionals, reducing miscommunication and medical errors, and fostering innovation and resilience. The COVID-19 pandemic underscored the importance of trust, highlighting the challenges in establishing and maintaining it, especially during crises when trust in authorities and health systems is vital for compliance and safety. However, trust is complex, varying with context and experiences, and is dynamic, easily lost but hard to regain. Despite its importance, trust is often overlooked in health policy and difficult to measure. Health systems and policy-makers must recognize the importance of trust, measure it effectively, understand how it is built or eroded, and act to maintain and restore it. This involves acknowledging the past experiences of marginalized groups, involving communities in decision-making, and ensuring transparency and integrity in health practices and policies.

Transformations in the landscape of primary health care during COVID-19: Themes from the European region.

The COVID-19 pandemic has dramatically impacted primary health care (PHC) across Europe. Since March 2020, the COVID-19 Health System Response Monitor (HSRM) has documented country-level responses using a structured template distributed to country experts. We extracted all PHC-relevant data from the HSRM and iteratively developed an analysis framework examining the models of PHC delivery employed by PHC providers in response to the pandemic, as well as the government enablers supporting these models. Despite the heterogenous PHC structures and capacities across European countries, we identified three prevalent models of PHC delivery employed: (1) multi-disciplinary primary care teams coordinating with public health to deliver the emergency response and essential services; (2) PHC providers defining and identifying vulnerable populations for medical and social outreach; and (3) PHC providers employing digital solutions for remote triage, consultation, monitoring and prescriptions to avoid unnecessary contact. These were supported by government enablers such as increasing workforce numbers, managing demand through public-facing risk communications, and prioritising pandemic response efforts linked to vulnerable populations and digital solutions. We discuss the importance of PHC systems maintaining and building on these models of PHC delivery to strengthen preparedness for future outbreaks and better respond to the contemporary health challenges.

Drawing light from the pandemic: Rethinking strategies for health policy and beyond.

The COVID-19 pandemic is a catastrophe. It was also preventable. The potential impacts of a novel pathogen were foreseen and for decades scientists and commentators around the world warned of the threat. Most governments and global institutions failed to heed the warnings or to pay enough attention to risks emerging at the interface of human, animal, and environmental health. We were not ready for COVID-19, and people, economies, and governments around the world have suffered as a result. We must learn from these experiences now and implement transformational changes so that we can prevent future crises, and if and when emergencies do emerge, we can respond in more timely, robust and equitable ways, and minimize immediate and longer-term impacts. In 2020-21 the Pan-European Commission on Health and Sustainable Development assessed the challenges posed by COVID-19 in the WHO European region and the lessons from the response. The Commissioners have addressed health in its entirety, analyzing the interactions between health and sustainable development and considering how other policy priorities can contribute to achieving both. The Commission's final report makes a series of policy recommendations that are evidence-informed and above all actionable. Adopting them would achieve seven key objectives and help build truly sustainable health systems and fairer societies.

SUPPORT Tools for evidence-informed health Policymaking (STP) 13: Preparing and using policy briefs to support evidence-informed policymaking.

This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers. Policy briefs are a relatively new approach to packaging research evidence for policymakers. The first step in a policy brief is to prioritise a policy issue. Once an issue is prioritised, the focus then turns to mobilising the full range of research evidence relevant to the various features of the issue. Drawing on available systematic reviews makes the process of mobilising evidence feasible in a way that would not otherwise be possible if individual relevant studies had to be identified and synthesised for every feature of the issue under consideration. In this article, we suggest questions that can be used to guide those preparing and using policy briefs to support evidence-informed policymaking. These are: 1. Does the policy brief address a high-priority issue and describe the relevant context of the issue being addressed? 2. Does the policy brief describe the problem, costs and consequences of options to address the problem, and the key implementation considerations? 3. Does the policy brief employ systematic and transparent methods to identify, select, and assess synthesised research evidence? 4. Does the policy brief take quality, local applicability, and equity considerations into account when discussing the synthesised research evidence? 5. Does the policy brief employ a graded-entry format? 6. Was the policy brief reviewed for both scientific quality and system relevance?

Strengthening global health security by embedding the International Health Regulations requirements into national health systems.

The International Health Regulations (IHR) 2005, as the overarching instrument for global health security, are designed to prevent and cope with major international public health threats. But poor implementation in countries hampers their effectiveness. In the wake of a number of major international health crises, such as the 2014 Ebola and 2016 Zika outbreaks, and the findings of a number of high-level assessments of the global response to these crises, it has become clear that there is a need for more joined-up thinking between health system strengthening activities and health security efforts for prevention, alert and response. WHO is working directly with its Member States to promote this approach, more specifically around how to better embed the IHR (2005) core capacities into the main health system functions. This paper looks at how and where the intersections between the IHR and the health system can be best leveraged towards developing greater health system resilience. This merging of approaches is a key component in pursuit of Universal Health Coverage and strengthened global health security as two mutually reinforcing agendas.

Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.

Following a review process lasting almost four years, and culminating in several pieces of new European legislation, adjustments have been made to the European Union's (EU) regulatory framework for pharmaceuticals. The European Commission laid out its priorities for the review as: simplifying the authorisation system, ensuring a high quality of public health, completing the internal market in medicines, and preparing for the enlargement of the Union. Amongst the most important changes brought about by the new rules are those relating to the European drug approval procedures, the functions and operational transparency of the European Medicines Agency (EMEA), and the EU's pharmacovigilance system. This article provides a brief examination of key elements of these changes, and considers the extent to which they serve the goal of improved public health protection within the EU.

Responding to the COVID-19 pandemic in Europe: towards stronger policy that incorporates the impact of social disparities

The impact of the COVID-19 pandemic on countries in theEuropean Region has been devastating with substantial morbidity and mortality and broader societal and economic effects. This in part reflects poor public health leadership and politicised responses but more importantly, a failure to account for social disparities. The stop- start pattern of Public Health and Social Measures further exacerbates the disproportionate impact on those most vulnerable. A Health in All Policies lens offers an indication of the type of coherent multisectoral thinking needed to address these social disparities in the COVID-19 context as well as in pandemic planning measures going forwards.

Public health leadership and the COVID-19 pandemic in Europe

The COVID-19 pandemic has emphasised that calls for clearer mandates and leadership from health authorities has gone unheard for decades. Preventable occurrences in response to the pandemic depict that countries in the WHO European Region suffer from various issues that undermine public health leadership – a necessary capacity to navigate extraordinary times, such as these. What remains clear is that there is a dire need for public health to be reinforced and enabled to ensure effective public health responses. Furthermore, internal siloes within the field must be broken down and collaboration within and across sectors nurtured, to help build up resilience to handle future emergencies.

Health system stewardship of National Health Ministries in the WHO European region: concepts, functions and assessment framework.

OBJECTIVES: To propose an operational framework for assessing the completeness and consistency of the stewardship function of national health ministries. METHODS: The authors carried out a purposive and multidisciplinary review of the literature and derived an operational framework through iterative discussions and participatory methods. The results of the literature review were compared to the authors' observations of stewardship in action and key functions were matched with case examples from Europe and North America. RESULTS: The operational framework relates six functions of stewardship with national contexts, values and ultimate goals pursued by health systems: to define the vision for health and strategy to achieve better health; to exert influence across all sectors for better health; to govern the health system in a way that is consistent with prevailing values; to ensure that system design is aligned with health system goals; to better leverage available legal and regulatory instruments; and to compile, disseminate and apply intelligence. CONCLUSIONS: Challenges in the implementation of stewardship relate to: limitations to the role of health ministries; and to governance, operational and change implementation issues. The framework proposed seems flexible enough to help assess the health system stewardship function; however it should be further tested in practice.

Financing for health system transformation: spending more or spending better (or both)?

In the last 15 years, numerous countries in the WHO European Region have increased their priority for health within their governmental budgets. Nonetheless, some policy-makers may believe that the health system already receives an adequate share of fiscal resources, especially considering the significant surge in health expenditures prompted by the COVID-19 pandemic. Even before the pandemic, various factors, including price growth within the health system, demographic shifts and climate-related issues, among others, have increased pressure on health care budgets and will continue to do so in the future.Thus, countries are at a crucial moment to adapt and transform their systems and services to meet their objectives in light of these challenges. This naturally leads to questions around how to finance this, and what the appropriate level and distribution of health spending is in countries. This policy brief presents evidence on government health spending levels and trends in the WHO European Region and highlights what has been achieved with this; raises priority areas towards which countries can consider directing existing resources; and explores how health stakeholders can argue their cases for more public funds for health.

How can knowledge brokering be better supported across European health systems?

There is a general lack of support for knowledge brokering across European health systems. Four sets of interrelated issues contribute to this problem: (1) lack of use of health systems information in policy-making; (2) lack of use of promising knowledge-brokering mechanisms and models; (3) lack of support for knowledge brokering; and (4) limited reach of existing efforts to support knowledge brokering. Of the many potential options to inform future initiatives for supporting knowledge brokering across Europe, three exemplars are profiled in this policy brief: option 1: integrate knowledge-brokering incentives into research funding processes; option 2: extend initiatives focused on supporting knowledge brokering; and option 3: pilot a health systems knowledge-brokering partnership. Many implementation strategies could be considered for any given option. However, given that several options could be pursued simultaneously and thatoption elements could be combined in different and creative ways, identifying implementation strategies that cut across options could be an important first step. One possible such strategy could be the development, pilot testing and iterative redevelopment of a package of communication materials that highlight the ways in which knowledge brokering can support policy-making and innovative examples of knowledge-brokering mechanisms and models that others can adopt or adapt. The BRIDGE summaries are a step in this direction.

How can knowledge brokering be advanced in a country’s health system?

There is a general lack of attention given to ‘what to do next’ to advance knowledge brokering in many European countries’ health systems. Four sets of interrelated issues can contribute to this problem within any given country’s health system: (1) untapped potential for health systems information to inform policy-making; (2) missed opportunities to take stock and prioritize advancements in knowledge brokering; (3) lack of alignment of support for knowledge brokering; and (4) limited reach of existing efforts to advance knowledge brokering. Of the many potential options to inform future initiatives for advancing knowledge brokering within a country’s health system, three exemplars are profiled in this policy brief: option 1: establish a portal for knowledge-brokering mechanisms; option 2: convene a dialogue to coordinate advancements in knowledge brokering; and option 3: centralize knowledge-brokering mechanisms in a well designed organization. Many implementation strategies could be considered for any given option. However, given that several options could be pursued simultaneously and that option elements could be combined in different and creative ways, identifying implementation strategies that cut across options could be an important first step. One possible such strategy could be the development, pilot testing and iterative redevelopment of a package of communication materials that highlight the ways in which knowledge brokering can support policy-making and innovative examples of knowledge-brokering mechanisms and models that others can adopt or adapt. The BRIDGE summaries are a step in this direction.

Communicating clearly: enhancing information-packaging mechanisms to support knowledge brokering in European health systems

Policy-makers are faced daily with making decisions and need access to good-quality health systems information. Stakeholders may seek to influence health policy as well as make decisions in their own spheres of responsibility. Both groups want information products that they can easily understand and that are clearly based on systematically conducted and transparently reported research. And researchers want to know how to communicate their findings effectively so that health systems policy-making can make use of the best available health systems information.The purpose of this BRIDGE summary is to encourage debate and innovation about the ways in which information is prepared and packaged for policy-makers and stakeholders as one component of a broader knowledge-brokeringapproach. Current thinking about knowledge brokering is largely driven by anecdotal information; this document presents real-world insights from research on knowledge brokering, primarily from Europe but drawing on globalexperience as well. This summary is intended not only for knowledge brokers whose work is dedicated to this role, but also for funders, researchers, policy-makers and stakeholders, all of whom can help to steer knowledge brokering by helping to set expectations for this work.

Learning from one another: enriching interactive knowledge-sharing mechanisms to support knowledge brokering in European health systems

Policy-makers, stakeholders and knowledge brokers (including researchers) all have a great deal they can learn from one another. Policy-makers need access to good-quality health systems information that they can apply to a local issue. Stakeholders may seek to influence health policy as well as make decisions in their own spheres of responsibilities. Knowledge brokers need information about policy priorities and the policy context in order to produce, package and share health systems information that will be genuinely useful to decision-makers. The purpose of this BRIDGE summary is to encourage debate and innovation about the ways in which policy-makers, stakeholders and knowledge brokerscan, by working together, engage with health systems information so as to increase the likelihood that it will be understood and used. Current thinking about knowledge brokering is largely driven by anecdotal information; thisdocument presents real-world insights from research on knowledge brokering, primarily from Europe but drawing on global experience as well.This summary is intended not only for knowledge brokers whose work is dedicated to this role, but also for funders, researchers, policy-makers and stakeholders, all of whom can help to steer knowledge brokering by setting expectations for this work.

Matching form to function: designing organizational models to support knowledge brokering in European health systems

Knowledge-brokering organizations need to match form to function when designing organizational models that will best support well informed health systems decision-making. Their functions can include a range of information-packaging mechanisms (such as policy briefs) and interactive knowledge-sharing mechanisms (such as policy dialogues), as well as activities that are not knowledge brokering per se (such as the collection and analysis of healthsystems information). Maintaining a good grasp of the relevant policy-making context and matching knowledge-brokering mechanisms to this context should be considered a key function for any knowledge-brokering organization. Context can mean a range of elements in the national, regional (e.g. European) or sub-national policy-making environment, including policy-making institutions and processes, stakeholder capacities and opportunitiesfor engagement, and research institutions and their activities and outputs. An organizational model that works well for one organization using a particular set of knowledge-brokering mechanisms in a particular policy-making context may not be appropriate for another organization using different mechanisms ina different context. What is likely to be common across all contexts is that: policy-makers need timely access to good-quality health systems information; stakeholders may seek to influence health policy as well as make decisions in their sphere of responsibility, so they too need timely access to good-quality health systems information; and knowledge brokers (including researchers) need information about policypriorities and the policy context in order to produce, package and share health systems information that will be useful. An organizational model should ensure that all of these needs are met.The purpose of this BRIDGE summary is to encourage debate and innovation about the ways in which knowledge-brokering organizations organize themselves in order to increase the likelihood that health systems information will be understood and used by policy-makers and stakeholders. Current thinking about organizational models for knowledge brokering is largely driven by anecdotal information; this document presents real-world insights from research on organizational models, primarily from Europe but drawing on global experience as well. This summary is intended not only for knowledge brokers whose work is dedicated to this role, but also for funders, researchers, policy-makers and stakeholders, all of whom can help to steer knowledge brokering by setting expectationsfor this work.