A comparison of methods for fixed effects meta-analysis of individual patient data with time to event outcomes

2007 ◽  
Vol 4 (6) ◽  
pp. 621-630 ◽  
Author(s):  
Catrin Tudur Smith ◽  
Paula Ruth Williamson
Keyword(s):  
Fixed Effects ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Comparison Of Methods ◽  
Time To Event

scholarly journals Mortality in trials on transcatheter aortic valve implantation versus surgical aortic valve replacement: a pooled meta-analysis of Kaplan–Meier-derived individual patient data

2020 ◽  
Vol 58 (2) ◽  
pp. 221-229 ◽  
Author(s):  
Fabio Barili ◽  
Nicholas Freemantle ◽  
Alberto Pilozzi Casado ◽  
Mauro Rinaldi ◽  
Thierry Folliguet ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Time Varying ◽  
Time To Event ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Kaplan Meier ◽  
Valve Implantation

Abstract OBJECTIVES This meta-analysis of Kaplan–Meier-estimated individual patient data was designed to evaluate the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on the long-term all-cause mortality rate, to examine the potential time-varying effect and to model their hazard ratios (HRs) over time. Moreover, we sought to compare traditional meta-analytic tools and estimated individual patient data meta-analyses. METHODS Trials comparing TAVI versus SAVR were identified through Medline, Embase, Cochrane databases and specialist websites. The primary outcome was death from any cause at follow-up. Enhanced secondary analyses of survival curves were performed estimating individual patient time-to-event data from published Kaplan–Meier curves. Treatments were compared with the random effect Cox model in a landmark framework and fully parametric models. RESULTS We identified 6 eligible trials that included 6367 participants, randomly assigned to undergo TAVI (3252) or SAVR (3115). According to the landmark analysis, the incidence of death in the first year after implantation was significantly lower in the TAVI group [risk-profile stratified HR 0.85, 95% confidence interval (CI) 0.73–0.99; P = 0.04], whereas there was a reversal of the HR after 40 months (risk-profile stratified HR 1.31, 95% CI 1.01–1.68; P = 0.04) favouring SAVR over TAVI. This time-varying trend of HRs was also confirmed by a fully parametric time-to-event model. Traditional meta-analytic tools were shown to be biased because they did not intercept heterogeneity and the time-varying effect. CONCLUSIONS The mortality rates in trials of TAVI versus SAVR are affected by treatments with a time-varying effect. TAVI is related to better survival in the first months after implantation whereas, after 40 months, it is a risk factor for all-cause mortality.

Abstract WP410: Hemoglobin Levels and Poor Outcome in Intracerebral Hemorrhage: An Exploratory Analysis of Individual Patient Data Across Multiple Studies

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Julian N Acosta ◽  
Audrey C Leasure ◽  
Lindsey Kuohn ◽  
Nils Petersen ◽  
Lauren Sansing ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Intracerebral Hemorrhage ◽  
Fixed Effects ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Outcome Data ◽  
Patient Data ◽  
Multicenter Studies ◽  
Poor Outcome ◽  
Ich Score

Introduction: Observational evidence from single center studies indicates that lower admission hemoglobin (Hb) levels are associated with poor outcome after spontaneous intracerebral hemorrhage (ICH). We combined data from three multicenter studies to test the hypothesis that Hb levels inversely correlate with functional outcome in ICH. Methods: We conducted a meta-analysis of individual patient data from the clinical trials ATACH-II and FAST and the multi-ethnic study ERICH. We included participants with available Hb and outcome data. We used multivariable logistic regression to test for association between admission Hb levels and 3-month dichotomized (0-3 versus 4-6) modified Rankin Scale (mRS), adjusting for the variables contained in the ICH score. We pooled study-specific estimates using inverse-variance weighted, fixed effects meta-analysis. Results: A total of 4106 ICH patients were included in the analysis. Each additional g/dL of admission Hb was associated with a 12% (OR 0.88, 95%CI 0.85-0.91; p<0.001) and 8% (OR 0.92, 95%CI 0.88-0.96; p<0.001) reduction in the odds of poor outcome in unadjusted and adjusted analyses, respectively (Table 1). Dose-response analyses indicated a linear relationship between Hb levels and poor outcome across the entire evaluated range (Figure 1, test-for-trend p<0.001). In metanalysis, there were not significant associations between Hb and ICH volume or expansion (both p>0.05). Conclusion: Lower hemoglobin levels are associated with poor outcome in ICH. Further studies of the underlying biological mechanisms are warranted. If replicated, this pathway could become an appealing target to be tested in clinical trials.

Investigating heterogeneity in an individual patient data meta-analysis of time to event outcomes

2005 ◽  
Vol 24 (9) ◽  
pp. 1307-1319 ◽  
Author(s):  
Catrin Tudur Smith ◽  
Paula R. Williamson ◽  
Anthony G. Marson
Keyword(s):  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Time To Event

Meta-analysis when only the median survival times are known: A comparison with individual patient data results

2005 ◽  
Vol 21 (1) ◽  
pp. 119-125 ◽  
Author(s):  
Stefan Michiels ◽  
Pascal Piedbois ◽  
Sarah Burdett ◽  
Nathalie Syz ◽  
Lesley Stewart ◽  
...  
Keyword(s):  
Median Survival ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Survival Rates ◽  
Patient Data ◽  
Survival Times ◽  
Time To Event ◽  
Sufficient Detail ◽  
Meta Analyses ◽  
Surrogate Measures

Background:The hazard ratio (HR) is the most appropriate measure for time to event outcomes such as survival. In systematic reviews, HRs can be calculated either from the raw trial data obtained as part of an individual patient data (IPD) meta-analysis or from the appropriate trial-level summary statistics. However, the information required for the latter are seldom reported in sufficient detail to allow reviewers to calculate HRs. In contrast, the median survival and survival rates at specific time points are frequently presented. We aimed to evaluate retrospectively the performance of meta-analyses using median survival times and survival rates by comparing them with meta-analyses using IPD to calculate HRs.Methods:IPD from thirteen published meta-analyses (MAs) in cancers with high mortality rates were used. Median survival and survival rates were calculated from the IPD rather than taken from publications so that the same trials, patients, and extended follow-up are used in each analysis.Results and Conclusions:We show that using median survival times or survival rates at a particular point in time are not reasonable surrogate measures for meta-analyses of survival outcomes and that, wherever possible, HRs should be calculated. Individual trial publications reporting on time to event outcomes, therefore, should provide more detailed statistical information, preferably logHRs and their variances, or their estimators.

Weniger Erwerbsminderungsrenten nach der kardiologischen Rehabilitation durch intensivierte Nachsorge?

2021 ◽  
Author(s):  
Sarah Schröer ◽  
Wolfgang Mayer-Berger ◽  
Claudia Pieper
Keyword(s):  
Fixed Effects ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Odds Ratios ◽  
Two Stage ◽  
Kardiologische Rehabilitation ◽  
One Stage

Zusammenfassung Ziel Ziel war es die Daten aus 3 randomisierten kontrollierten Studien, in denen Nachsorgekonzepte im Rahmen der kardiologischen Rehabilitation evaluiert wurden, in Form einer Pooling-Studie zusammenzufassen, um stärker belastbare Erkenntnisse über den nachsorgeassoziierten weiteren Verlauf der Patienten und Patientinnen im Anschluss an die Rehabilitation zu gewinnen. Nachfolgend werden die Auswirkungen von poststationärer Nachsorge auf das Erwerbsminderungsrisiko kardiologischer Rehabilitanden und Rehabilitandinnen vorgestellt. Methodik Aus 3 randomisierten kontrollierten Primärstudien (SeKoNa, Sinko, OptiHyp), in denen als Intervention jeweils ein intensiviertes (telefongestütztes) poststationäres Nachsorgekonzept mit einer unbehandelten Kontrollgruppe verglichen wurde, stehen umfangreiche Daten zu soziodemografischen, klinischen und diagnostischen Charakteristika auf Individualebene zur Verfügung. Mittels einer im August 2019 durchgeführten Sekundärdatenanalyse von Routinedaten der Deutschen Rentenversicherung Rheinland wurden als primäre Outcomeparameter Mortalität (alle Ursachen), bewilligte Erwerbsminderungsrenten sowie bewilligte Anträge auf eine erneute kardiologische Rehabilitation zum individuellen Stichtag 3 Jahre nach Rehabilitationsende als Endpunkte erhoben. Die Daten wurden als Meta-Analyse für individuelle Patientendaten (Individual Patient Data Meta-Analysis IPD-MA) unter Verwendung klassischer meta-analytischer Techniken (One-Stage Approach mittels gemischter Modelle und Two-Stage Approach mit inverser Varianzschätzung als Fixed Effects Modell) gepoolt und über Risiko-Odds-Ratios vergleichend ausgewertet. Ergebnisse Das Gesamtkollektiv besteht aus insgesamt 1058 kardiologischen Rehabilitanden und Rehabilitandinnen, die im Zeitraum zwischen 2004 und 2015 stationäre rehabilitative Leistungen der Deutschen Rentenversicherung Rheinland in der kardiologischen Rehabilitationseinrichtung Klinik Roderbirken in Leichlingen in Anspruch genommen haben. Die gepoolte Interventionsgruppe (poststationäre Nachsorge) und die gepoolte Kontrollgruppe (Standardbehandlung) unterschieden sich zum Ausgangspunkt (Entlassung nach 3-wöchiger Rehabilitation) nicht. Hinweise auf statistische Heterogenität liegt nicht vor. Drei Jahre nach Rehabilitationsende betrug die inzidente Erwerbsminderungsrentenquote 11,8% der Gesamtstichprobe. Bei Teilnahme an einem poststationären Nachsorgekonzept war das Erwerbsminderungsrisiko gegenüber der Kontrollgruppe um rund 60% reduziert (OR: 0,43; 95% CI: 0,36–0,51). Schlussfolgerung Rehabilitation und Wiedereingliederung gewinnen weiter an Bedeutung, um die Gefahr von gesundheitlich bedingten vorzeitigen Erwerbsausstiegen mit erheblichen sozioökonomischen Folgen für Betroffene und das Sozialversicherungssystem zu vermeiden. Nachsorgeaktivitäten, die Rehabilitationserfolge über Dauer einer mehrwöchigen Rehabilitation hinaus erhalten, unterstützen die Prävention von gesundheitlich bedingten vorzeitigen Erwerbsminderungsrenten effektiv und nachhaltig und sollten das bestehende Rehabilitationsangebot komplettieren. Aus unseren Ergebnissen folgern wir, dass Nachsorge lange genug (mindestens ein Jahr) und im persönlichen Kontakt erfolgen muss.

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