Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?

Malone, Daniel C.; Brown, Mary Louise; Hurwitz, Jason T.; Peters, Loretta; Graff, Jennifer

doi:10.1016/j.jval.2017.08.3013

Cited by 56 publications

(73 citation statements)

References 21 publications

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“…32 It has been recognized that sharing underlying programming code is less helpful, as few decision makers fully understand such complex code or possess the time or patience to work through several thousand lines of someone else's code. 11 In order to understand a study implementation and confirm that it is aligned with its intention as described in a protocol, a defined set of parameters fully describes design and analytic choices. 37 Adaptive rules systems produce look-up tables to verify the specifications, codes, and reference time windows used without the need to understand complex programming code.…”

Section: Transparency To Allow Reproducibility and Assess Validitymentioning

confidence: 99%

“…We identify three generic types of data models and assess how they may affect the efficiency (ease of use), transparency, and adaptability to fit a specific research question. Our intention is to present factors that improve the confidence decision makers have in real‐world evidence . Others have written more comprehensive and more technical reviews of data models in health care …”

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confidence: 99%

“…Our intention is to present factors that improve the confidence decision makers have in real-world evidence. 10,11 Others have written more comprehensive and more technical reviews of data models in health care. 6,12,13…”

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confidence: 99%

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Choosing Among Common Data Models for Real‐World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products

Schneeweiß

Brown

Bate

et al. 2019

Clin Pharma and Therapeutics

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Many real‐world data analyses use common data models (CDMs) to standardize terminologies for medication use, medical events and procedures, data structures, and interpretations of data to facilitate analyses across data sources. For decision makers, key aspects that influence the choice of a CDM may include (i) adaptability to a specific question; (ii) transparency to reproduce findings, assess validity, and instill confidence in findings; and (iii) ease and speed of use. Organizing CDMs preserve the original information from a data source and have maximum adaptability. Full mapping data models, or preconfigured rules systems, are easy to use, since all raw codes are mapped to medical constructs. Adaptive rule systems grow libraries of reusable measures that can easily adjust to preserve adaptability, expedite analyses, and ensure study‐specific transparency.

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Section: Transparency To Allow Reproducibility and Assess Validitymentioning

confidence: 99%

mentioning

confidence: 99%

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Choosing Among Common Data Models for Real‐World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products

Schneeweiß

Brown

Bate

et al. 2019

Clin Pharma and Therapeutics

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“…It is true that there are an ever increasing number of publications presenting RWD/RWE (930 publications in 2018 used RWE or RWD in either the title or abstract on PubMed, compared to 501 in 2017 and 326 in 2016) but there is very little evidence that it is having a significant impact on decision making. [8].…”

Section: Rwe: Its Use In Practicementioning

confidence: 99%

Real World Evidence: Can We Really Expect It to Have Much Influence?

Evans¹

2019

Drugs - Real World Outcomes

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“…Alguns autores têm se dedicado a entender como o processo de uso das evidências de mundo real está acontecendo. Em países da América do Norte, esse tipo de evidência tem sido utilizada especialmente para avaliação de segurança, manejo da utilização de tecnologias e análises de custo, porém, ainda em menor frequência, para a tomada de decisão sobre incorporação ou aprovação de novas tecnologias (Hampson et al, 2018;Husereau et al, 2019;Malone et al, 2018). No Oriente Médio, há ainda um entendimento de que o uso desses dados para a tomada de decisão é insuficiente, porém há um crescente interesse pelo tema (Akhras et al, 2019).…”

Section: Introductionunclassified

Dados de mundo real no processo de tomada de decisão: uma análise sob a perspectiva do sistema brasileiro de saúde suplementar

Ballalai¹,

Souza²,

Silva³

et al. 2019

JBES

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RESUMOO debate sobre a necessidade de melhoria da utilização de recursos em saúde fez aumentar o interesse em evidências do mundo real (EMR) nos últimos anos. No sétimo congresso Latino-Americano da Sociedade Internacional de Farmacoeconomia e Pesquisa de Desfechos, diferentes palestrantes exploraram como o manejo desses dados pode auxiliar no processo de tomada de decisão. Quatro membros representando diferentes segmentos do Sistema de Saúde Suplementar (SSS) brasileiro foram convidados a participar de um painel de especialistas, a fim de entender suas percepções sobre o assunto. O nível de confiança na informação atualmente disponível variou entre 70% e 90% e os dados são utilizados na rotina de tomada de decisão. Considerando a utilização de evidências para prever decisões, os especialistas relatam não existir uma matriz institucional, mas que as informações existentes são utilizadas na construção de modelos preditivos por meio da criação de pacotes de serviços. A priorização da tomada de decisão é hoje essencialmente baseada em estimativas de custos. Apesar disso, são observadas diferentes situações em que dados de mundo real podem balizar esse processo. Existiu consenso de que uma mudança de paradigmas está ocorrendo e que esses processos representam um futuro plausível. O uso de EMR é de grande importância no processo de tomada de decisão na perspectiva do SSS e, acima de tudo, no suporte de modelos de saúde baseados em valor, sendo recomendado pela Agência Nacional de Saúde Suplementar como um pilar estratégico para a sustentabilidade do sistema. ABSTRACTThe debate about the needs for healthcare resource utilization improvement has been soaring during the last years. As a result, discussions on enhancements of the decision-making process through the leverage of real-world evidence (RWE) has also been fostered. In the 7th Latin American congress of the International Society for Pharmacoeconomics and Outcomes Research, different speakers explored how the management of these data support real-life healthcare decisions. Four members representing different segments from the Brazilian Supplementary Healthcare System (SHS) were invited to participate on an expert panel in order to understand their perceptions on this subject. The confidence level on available data ranges from 70% to 90% and information is used on decision-making routine. When the use of real-world evidence to predict decision was considered, panelists reported the absence of an institutional decision matrix, but that existing information is used to build predictive models through the creation of service packages. The prioritization of decision-making today is essentially based on the estimation of costs. However, different situations in which real-world data can Recebido em: 19/11/2019 Aprovado para publicação em: 09/12/2019 1. IQVIA INC, USA 2. Sistema de Assistência à Saúde dos Servidores Públicos Estaduais (Planserv), Salvador, BA, Brasil 3. Unimed Curitiba, Curitiba, PR, Brasil 4. São Francisco, SP, Brasil 5. GEAP Saúde, Brasília, Brasil 6. J...

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Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?

Cited by 56 publications

References 21 publications

Choosing Among Common Data Models for Real‐World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products

Choosing Among Common Data Models for Real‐World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products

Real World Evidence: Can We Really Expect It to Have Much Influence?

Dados de mundo real no processo de tomada de decisão: uma análise sob a perspectiva do sistema brasileiro de saúde suplementar

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