Highlights Swedish strategy is evidence-based and in close partnership between the government and the society. No forced lockdown, but ‘soft measures’ built on trust with responsibility of the individual. The Swedish way has also been noticed by the WHO and proposed as a future model. Implemented measures have successfully flattened the curve. Limited ability to implement protective measures in some elderly homes.

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BackgroundHeart failure represents a major public health issue that impacts 26 million people globally. Currently, real-world data represents a key instrument for providing the verification of both internal and external validity, yet there is still a lack of understanding regarding its scope in complementing evidence of treatments for heart failure. This study aims to increase understanding of the utilisation of real-word data from heart failure registries in Organisation for Economic Co-operation and Development (OECD) countries.MethodThis was a systematic review of existing observational studies from heart failure registries in 35 OECD member countries. Studies from 2000 to March 2017 were identified through electronic databases (MEDLINE (Ovid), EMBASE, Web of Science Core Collection, CINAHL (Ebsco), Cochrane CENTRAL) and appraised according to eligibility criteria.ResultsTwo-hundred and two studies met the inclusion criteria, in which the majority were published from 2013 to 2016. All 202 studies were observational, among which 98% were cohort studies (198). The median sample size of all studies was 5152 (2417 to 32,890) and median study period 55 months (33.0 to 72.0). Swedish heart failure registry had the most publications (24, 12%).ConclusionSince 2000 there has been an upward trend in the number of published observational studies on heart failure registries in OECD countries with increasingly diverse outcomes and advanced statistical methods to improve their validity and reliability. This indicates that the utilisation of real-world data has experienced a significant upsurge in complementing the findings of clinical trials for improved research of heart failure treatments.

Keywords: comparative effectiveness research • evidence-based medicine • health technology assessmentReal world evidence (RWE) is defined as a form of evidence generated to answer a question or test a hypothesis using real world data (RWD) and using appropriate design and statistical analyses [1]. Others define RWE as the intersection between the randomized controlled trials (RCTs) and effectiveness of treatment in usual clinical practice [2]. To those with public health expertise, RWE is not totally a new phenomenon. Population-based studies using RWD are often conducted to evaluate the effectiveness and value of health programs and policies. Thus, RWE is an old wine in a new bottle. RWD characterized as patient registries have been a long tradition in the Nordic countries due to publicly financed healthcare and a unique person identifier, which enables linkage of data from different registries [3]. However, the impact of RWD/ RWE on health technology assessment (HTA) decision-making process regarding new treatments is not well assessed and the explanatory factors are not well known. Why RWE now?RWE has recently gained attention from patients, providers, payers, regulators and pharma industry. People are living longer in almost every part of the world with increasing demand for a healthy living. Technological advancement enables quick flow of data and information, thus increasing level of knowledge on health and on what works and what does not [4]. Patients have high expectations on health systems to offer safe and effective treatments.Parallel to this, global public health trends show increasing burden of noncommunicable diseases due to unhealthy lifestyle [5], implying a large proportion of people living a long unhealthy life about 30-40 years.Healthcare costs are rising at a much faster rate than gross domestic product (GDP), creating budget deficiencies [5]. This reinforces payers to ensure that they put money in treatments that are cost effective, add value to patients and improve population health.Thus, regulatory agencies begin to realize the benefit of RWE for regulatory decisionmaking for medicines and medical devices.Thus, in order for the industry to sell their products, they need RWE studies to address effectiveness, efficiency, value and safety of their products. Some companies have developed strategies to generate RWE, others are using ad hoc solutions, while the rest are waiting for the RWE wave to pass. Developing a new treatment is costly, yet a large proportion will never make it to the market. RWE is a potential cost-saver in various phases of the drug development lifecycle [6].RCTs are regarded as the gold standard for providing the scientific evidence of clinical Editorial Andersson & Kyhlstedt efficacy of treatments. However, evidence from the RCTs does not address real life conditions due to strict selection criteria with a limited study population, questionable external validity and generalizability [7]. RWE studies, on the other hand, demonstrate effectiveness in real world clinical pra...

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Background The initial policy response to the COVID-19 pandemic has differed widely across countries. Such variability in government interventions has made it difficult for policymakers and health research systems to compare what has happened and the effectiveness of interventions across nations. Timely information and analysis are crucial to addressing the lag between the pandemic and government responses to implement targeted interventions to alleviate the impact of the pandemic. Methods To examine the effect government interventions and technological responses have on epidemiological and economic outcomes, this policy paper proposes a conceptual framework that provides a qualitative taxonomy of government policy directives implemented in the immediate aftermath of a pandemic announcement and before vaccines are implementable. This framework assigns a gradient indicating the intensity and extent of the policy measures and applies the gradient to four countries that share similar institutional features but different COVID-19 experiences: Italy, New Zealand, the United Kingdom and the United States of America. Results Using the categorisation framework allows qualitative information to be presented, and more specifically the gradient can show the dynamic impact of policy interventions on specific outcomes. We have observed that the policy categorisation described here can be used by decision-makers to examine the impacts of major viral outbreaks such as SARS-CoV-2 on health and economic outcomes over time. The framework allows for a visualisation of the frequency and comparison of dominant policies and provides a conceptual tool to assess how dominant interventions (and innovations) affect different sets of health and non-health related outcomes during the response phase to the pandemic. Conclusions Policymakers and health researchers should converge toward an optimal set of policy interventions to minimize the costs of the pandemic (i.e., health and economic), and facilitate coordination across governance levels before effective vaccines are produced. The proposed framework provides a useful tool to direct health research system resources and build a policy benchmark for future viral outbreaks where vaccines are not readily available.