Utilisation of real-world data from heart failure registries in OECD countries - A systematic review

Abstract

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.

Sakubitril/walsartan w praktyce klinicznej

“…Choć brak grupy porównawczej ogranicza interpretację, to wyniki wskazują na potencjalną poprawę wyników uzyskanych w dwóch z trzech zatwierdzonych kwestionariuszy jakości życia (MLHFQ; Minnesota Living with HF Questionnaire) w pierwszych 12 tygodniach RWD i RWE dla modelu opieki oraz leczenia farmakologicznego w HF RWD to dane pochodzące z badań prowadzonych w warunkach rzeczywistej praktyki klinicznej, natomiast RWE to dowody skuteczności pochodzące z badań prowadzonych w warunkach rzeczywistej praktyki klinicznej [8]. Dowody skuteczności pochodzące z badań prowadzonych w warunkach rzeczywistej praktyki klinicznej są coraz częściej wykorzystywane wraz z danymi z randomizowanych badań klinicznych (RCT, randomised clinical trial) do podejmowania decyzji dotyczących leczenia [9,10]. Większość z 202 badań opublikowanych w latach 2013-2016 miało charakter badań obserwacyjnych przeprowadzonych w warunkach rzeczywistej praktyki kardiologicznej.…”

Building medical knowledge from real world registries: The case of heart failure

“…In the present issue of the Journal, Du and Colleagues review existing observational studies from HF registries carried out in at least one of the 35 Organization for Economic Co-operation and Development (OECD) members, i.e. from high-income countries [ 5 ]. Two hundred and two observational studies were published from 2002 to March 2017, with a number increasing over years.…”

“…The Authors also propose that “existing observational studies from HF registries in OECD countries apply a number of advanced statistical methods to enable the minimization of bias and limitations of RWD [real world data], which in turn improve their validity and reliability,” although the information provided in the paper (number of studies performing Kaplan-Meier curves, Chi-square test, etc.) does not actually allow the reader to come to the same conclusions [ 5 ].…”

“…The Authors should be congratulated for their attempt to provide a comprehensive view on HF registries through the screening of 6706 titles from five electronic databases [ 5 ]. However, several limitations can be outlined.…”

“…For example, the choice to focus on wealthy countries is not explained by the Authors, and led to the exclusion of important registries such as the Indian Trivandrum Heart Failure Registry [ 6 ] and the Sub-Saharan Africa Survey of Heart Failure (THESUS-HF) [ 7 ], representative of diverse medical realities. Moreover, study classification lacks in detail: most notably, chronic and acute HF, despite being very different conditions, could not be clearly distinguished based on the information provided in the original manuscripts [ 5 ]. Even more important, the analysis was basically not informative on the impact of HF registries on healthcare organization, clinical research, therapy decision-making and patients quality of care improvement process.…”