Letter to the Editor
Comparative statistical analysis in observational epidemiological studies
Análisis estadísticos comparativos en los estudios epidemiológicos observacionales
A. Bosch-Gaya, L. Matute-Blanco, D. Fernández-Rodríguez
, F. Worner
Corresponding author
Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, Lérida, Spain
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Bosch-Gaya, L. Matute-Blanco, D. Fernández-Rodríguez, F. Worner" "autores" => array:4 [ 0 => array:2 [ "nombre" => "A." "apellidos" => "Bosch-Gaya" ] 1 => array:2 [ "nombre" => "L." "apellidos" => "Matute-Blanco" ] 2 => array:4 [ "nombre" => "D." "apellidos" => "Fernández-Rodríguez" "email" => array:1 [ 0 => "d.fernan.2@hotmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 3 => array:2 [ "nombre" => "F." "apellidos" => "Worner" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, Lérida, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Análisis estadísticos comparativos en los estudios epidemiológicos observacionales" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We wish to congratulate Socias et al.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> for their work on the prognostic impact of ST segment elevation acute coronary syndrome (STE-ACS) in Mallorca, Spain.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Subpopulations with STE-ACS from two observational registries were compared in different time frames. In the <span class="elsevierStyleItalic">IBERICA-Mallorca</span> registry, fibrinolysis was the main reperfusion therapy, while the <span class="elsevierStyleItalic">Código infarto-Illes Balears (CI-IB)</span> registry implemented one healthcare network for the management of STE-ACS based on primary angioplasty (PA). From both registries, only 49.7 and 58.8 per cent of the populations were included for the analysis. Features from both samples varied significantly in aspects such as history; clinical profile; and effective medical therapy in the management of STE-ACS (betablockers and ACE).<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The main conclusion from the study<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> is that the implementation of one PA network reduced mortality rate. However, the statistical analysis conducted deserves certain considerations:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">(a)</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Survival analysis</span>: in observational studies where the main goal is to assess the time elapsed until the occurrence of one event, <span class="elsevierStyleItalic">survival analyses</span><a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">3,4</span></a> are normally used. The most widely used statistical tool to know the effect of one independent variable in time is the <span class="elsevierStyleItalic">Kaplan</span>–<span class="elsevierStyleItalic">Meier method</span>. However, it is not good for the simultaneous assessment of more than one independent variable, or to estimate the effect size on the risk of occurrence of one event.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> In a setting where different variables coexist that may have an impact on the main goal, the survival analysis using the <span class="elsevierStyleItalic">Cox regression</span> model is key to assess to what extent multiple variables can modify the risk of occurrence of a single event.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> This study showed that the mortality rate at 28 days varied after the implementation of this network (<span class="elsevierStyleItalic">IBERICA-Mallorca</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>12.2 vs <span class="elsevierStyleItalic">CI-IB</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>7.2 per cent; HR<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.560; 95 per cent CI: 0.360–0.872; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.010) based on the <span class="elsevierStyleItalic">Kaplan</span>–<span class="elsevierStyleItalic">Meier method</span>. However, when the <span class="elsevierStyleItalic">Cox regression analysis</span> was conducted, no statistical significance was achieved in either model.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">(b)</span><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Propensity score matching</span>: one option for the inter-group comparison of one outcome variable is observational studies is the <span class="elsevierStyleItalic">Propensity score matching</span>.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> This statistical analysis assesses the effect that one treatment strategy has based on the covariables that predict that one patient will be assigned to the assessed treatment, and not the control group. Thus, by pairing patients based on the estimated propensity scores, we can make inter-group comparisons with an approximate balance on the relevant variables, instead of just one simple comparison between patients who received the treatment strategy, and those who did not.</p></li></ul></p><p id="par0030" class="elsevierStylePara elsevierViewall">In sum, even though the implementation of one PA network for the management of STE-ACS improved prognosis,<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> the <span class="elsevierStyleItalic">Kaplan</span>–<span class="elsevierStyleItalic">Meier</span> analysis was not powerful enough to confirm that the reported reduced mortality rate is exclusively due to the effect of such healthcare network. This is why we believe that conducting one <span class="elsevierStyleItalic">Cox regression analysis</span> to assess not only the baseline differences and type of reperfusion, but also different therapies received; or one <span class="elsevierStyleItalic">propensity score matching</span> analysis to balance all relevant covariables will make better evaluations of the real impact of this network on the prognosis of this population.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0035" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interests associated with this article whatsoever.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Bosch-Gaya A, Matute-Blanco L, Fernández-Rodríguez D, Worner F. Análisis estadísticos comparativos en los estudios epidemiológicos observacionales. Med Intensiva. 2018;42:134–135.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Comparative analysis between 2 periods of acute myocardial infarction after a decade in Mallorca. IBERIA Study (1996–1998) and Infarction-Code (2008–2010)" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "L. Socias" 1 => "G. Frontera" 2 => "C. Rubert" 3 => "A. Carrillo" 4 => "V. Peral" 5 => "A. Rodriguez" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.medin.2016.04.001" "Revista" => array:6 [ "tituloSerie" => "Med Intensiva" "fecha" => "2016" "volumen" => "40" "paginaInicial" => "541" "paginaFinal" => "549" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27298077" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "P.G. Steg" 1 => "S.K. James" 2 => "D. Atar" 3 => "L.P. Badano" 4 => "C. Blömstrom-Lundqvist" 5 => "M.A. Borger" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1093/eurheartj/ehs215" "Revista" => array:6 [ "tituloSerie" => "Eur Heart J" "fecha" => "2012" "volumen" => "33" "paginaInicial" => "2569" "paginaFinal" => "2619" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/22922416" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0040" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Non-parametric estimation from incomplete observations" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "E.L. Kaplan" 1 => "P. 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Cox" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "J R Stat Soc" "fecha" => "1972" "volumen" => "34" "paginaInicial" => "187" "paginaFinal" => "220" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "An introduction to propensity score methods for reducing the effects of confounding in observational studies" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "P.C. Austin" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1080/00273171.2011.568786" "Revista" => array:6 [ "tituloSerie" => "Multivariate Behav Res" "fecha" => "2011" "volumen" => "46" "paginaInicial" => "399" "paginaFinal" => "424" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/21818162" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/21735727/0000004200000002/v1_201803150431/S2173572718300080/v1_201803150431/en/main.assets" "Apartado" => array:4 [ "identificador" => "64604" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21735727/0000004200000002/v1_201803150431/S2173572718300080/v1_201803150431/en/main.pdf?idApp=WMIE&text.app=https://medintensiva.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173572718300080?idApp=WMIE" ]
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