Meta-analyses using real-world data to generate clinical and epidemiological evidence: a systematic literature review of existing recommendations

Brière, J; Bowrin, Kevin; Taieb, V.; Millier, A.; Toumi, Mondher; Coleman, Craig I.

doi:10.1080/03007995.2018.1524751

Cited by 34 publications

(46 citation statements)

References 17 publications

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“…Algorithms require testing with real-world evidence (RWE) that includes randomized controlled trials and observational research with real-world data. [7][8][9] To evaluate estimates of effects, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology explicitly considers all types of study designs from randomized controlled trials to case reports, although guideline developers often restrict guidelines to randomized controlled trials. [10][11][12] GRADE also considers evidence on prognosis, diagnosis, values and preferences, acceptability, and feasibility or directness of findings.…”

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confidence: 99%

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

Bousquet

Schünemann

Togias

et al. 2020

Journal of Allergy and Clinical Immunology

340

246

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Selection of pharmacotherapy for patients with allergic rhinitis aims to control the disease and depends on (1) patient empowerment, preferences, and age; (2) prominent symptoms, symptom severity, and multimorbidity; (3) efficacy and safety of treatment 1 ; (4) speed of onset of action of treatment; (5) current treatment; (6) historic response to treatment; (7) effect on sleep and work productivity 2,3 ; (8) self-management strategies; and (9) resource use. 4,5 An algorithm was devised 5 and digitalized 6 to step up or step down allergic rhinitis treatment based on control. However, its

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mentioning

confidence: 99%

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

Bousquet

Schünemann

Togias

et al. 2020

Journal of Allergy and Clinical Immunology

340

246

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“…It is expected that methodologies used to analyse and synthesize RWE will continue to evolve. However, little guidance is available on the relative merits of using RWE in the modelling context [43][44][45].…”

Section: Discussionmentioning

confidence: 99%

Real-world cost-effectiveness of rivaroxaban compared with vitamin K antagonists in the context of stroke prevention in atrial fibrillation in France

et al. 2020

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ObjectiveThe objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective.Funding: LF, CC and PL received honorarium from Bayer AG for critical input into study design and results analysis. Bayer Plc. provided support in the form of salaries for author KB; Bayer AG provided support in the form of salaries for author JBB. Bayer AG sponsored the study, and Bayer AG as well as Bayer Plc had a role in the study design, ConclusionsAlthough there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective. Introduction/BackgroundAtrial fibrillation (AF) is a cardiac arrhythmia with structural and/or electrophysiological abnormalities that induce remodelling in the atria; it is the most common cardiac arrhythmia [1][2][3]. Worldwide, an estimated 3% of adults aged 20 years or older suffer from AF, approximately 20.9 million men and 12.6 million women [2]. Due to the aging of the population, the worldwide prevalence is predicted to at least double in many countries during the next several decades [4,5].AF is associated with substantial morbidity and mortality [2]. Compared to otherwise healthy individuals, men and women with AF are at a 1.5-fold and 2-fold increased risk for allcause mortality, respectively [2], and the risk for strokes increased by 2-to-7-fold [4]. Strokes are associated with significant financial burden [6]; in 2015, the total costs of stroke care in the European Union (EU) was estimated to be €45 billion euros [7]. It is expected that between 2015 and 2035, there will be a 34% increase in total number of stroke events in the European Union [7].Oral anticoagulants including vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban, have been established as a cornerstone of management in patients with AF and to reduce stroke incidence and mortality [2] in randomized clinical trials (RCTs) [2].Many uncertainties remain regarding the relevance of the results of RCTs in a real-world setting. Real-world evidence (RWE) may provide additional information to decision-makers [8]. Indeed, RWE sample size is not limited as it is the case of RCTs. RCTs have to respect inclusion/exclusion criteria regarding population selection. Also, RWE can offer long-term outcomes while the timeframe of RCT is usually shorter with only a few outcomes [9].A meta-analysis comparing NOACs with VKAs and reporting effectiveness, safety, and persistence using RWE has recently been published [10]. It confirmed the findings of rivaroxaban pivotal RCT [11] and concluded that rivaroxaban is a suitable alternative to VKAs in routine clinical practice. Health Technology Assessment (HTA) agencies are frequently requesting manufacturers to prove the benefits of their hea...

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“…Even though the health system data can, in some instances, provide more applicable evidence, 29 caution needs to be applied in deriving conclusions from nonsystematically collected, and non-peer reviewed data. Therefore, healthcare decisions that are informed by selective unpublished data need to be considered in the context of the systematically reviewed evidence (i.e., the totality of the evidence base) as well as the potential biases and limitations of the unpublished data analyses.…”

Section: Limitations and Considerations When Using Unpublished Primarmentioning

confidence: 99%

“…Even though there are numerous critical appraisal tools for NRS of healthcare interventions (e.g., ROBINS-I, Newcastle-Ottowa Scale, Downs and Black, SIGN 50 checklists), consensus is lacking about which tools are valid and should be preferentially used; additionally, none have been developed specifically with the use of health system data in mind. [29][30][31] While most critical appraisal tools for NRS evaluate some components of data quality (e.g., missing data), it may not be robust enough to understand all the important limitations of the data not designed for research purposes and thus may be more prone other limitations (e.g., measurement error, misclassification). 32 Understanding the limitations of the data source, its relevance and integrity, in addition to study design limitations (e.g., confounding, selection bias) is an important part of the critical appraisal process.…”

Section: Limitations and Considerations When Using Unpublished Primarmentioning

confidence: 99%

Integrating Health System Data With Systematic Reviews: A Framework for When and How Unpublished Health System Data Can Be Used With Systematic Reviews

Lin¹,

Murad²,

Leas³

et al. 2020

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ii Key MessagesPurpose of Report Given that health-system decision making would benefit from both traditional systematic reviews and health-system-specific data, this report investigates when and how to use primary data from health systems in real time with systematic reviews and articulates a framework for using health system data with systematic reviews to support health system decision making. Key MessagesBased on our review of examples and methodologic guidance, as well as our experience conducting systematic reviews for various stakeholders, we recommend five basic principles regarding when and how to use unpublished health system data alongside of systematically reviewed data.• Explicitly state the rationale for using unpublished data (i.e., to improve the strength and applicability of evidence, and/or to inform its implementation).

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Meta-analyses using real-world data to generate clinical and epidemiological evidence: a systematic literature review of existing recommendations

Cited by 34 publications

References 17 publications

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

Real-world cost-effectiveness of rivaroxaban compared with vitamin K antagonists in the context of stroke prevention in atrial fibrillation in France

Integrating Health System Data With Systematic Reviews: A Framework for When and How Unpublished Health System Data Can Be Used With Systematic Reviews

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