Comparison of oncological outcomes of uterine adenocarcinoma and grade 3 endometrial carcinoma: a meta-analysis of observational studies
Creators: name: Pergialiotis, Vasilios
name: Haidopoulos, Dimitrios
name: Alexandros, Rodolakis
Publisher: name: Open Science Framework
Year: 2022
Subjects: subject: Obstetrics and Gynecology
subject: Medicine and Health Sciences
subject: Medical Specialties

description: The present meta-analysis will be designed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All data will be retrieved in aggregated form from published studies in this field; hence, institutional board approval and patient consent will not be retrieved. Information sources and search methods We will use the Medline (1966–2021), Scopus (2004–2021), Clinicaltrials.gov (2008–2021), EMBASE (1980-2021), Cochrane Central Register of Controlled Trials CENTRAL (1999-2021) and Google Scholar (2004-2021) databases in our primary search along with the reference lists of electronically retrieved full-text papers. The date of our last search will be set at January February 10, 2021. Our search strategy will include the text words “carcinosarcoma; mixed Mullerian tumor; endometrioid adenocarcinoma; grade 3; uterine carcinoma” and is presented in brief in Figure 1. Studies will be selected in three consecutive stages. Following deduplication, the titles and abstracts of all electronic articles will be screened by two authors to assess their eligibility. The decision for inclusion of studies in the present meta-analysis will be taken after retrieving and reviewing the full text of articles that will be held potentially eligible. Possible discrepancies in this latter stage will be resolved by consensus from all authors. Types of studies and patients The eligibility criteria for the inclusion of studies will be predetermined. All observational studies (prospective and retrospective) and randomized controlled trials that compare survival outcomes of patients with uterine carcinosarcoma to those of patients with grade 3 endometrioid adenocarcinoma will be selected for inclusion. Published conference proceedings that were included in the databases that will be used in our search were also tabulated. Case reports as well as experimental animal studies and reviews will be excluded from the present systematic review. Following the completion of the article retrieval process we will select the data that are necessary for inclusion using a modified data form that isbased in Cochrane`s extraction form for intervention reviews for RCT`s and non-RCTs. Outcome measures Outcome measures will be predefined during the design of the present systematic review. Hazard ratios (OR) of survival rates (both DFS and OS) are defined as our primary outcome. Variables that influenced survival outcomes of patients were also retrieved and differences of their significance among patients with endometrioid adenocarcinoma and those with grade 3 adenocarcinoma will be documented. Quality assessment The methodological quality of the included studies will be assessed by two independent reviewers. The Newcastle-Ottawa Scale (NOS) will be used in this stage. The scale examines the risk of bias in observational studies by evaluating the selection of the study groups (maximum rating 4 points), the comparability of the groups (maximum rating 2 points – 1 for stage of the disease and another one for tumor size) and the ascertainment of the exposure or outcome of interest (maximum rating 3 points). Types of analyses Qualitative analysis will be performed for studies that did not provide sufficient data to perform quantitative analysis. Methodological as well as patient characteristics will be summarized in tables to complete this analysis. Statistical meta-analysis will be performed with the RevMan 5.3 software (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2011). Confidence intervals will be set at 95%. Statistical heterogeneity will be assessed using the I-square index (using the 50% cut-off to define increased heterogeneity and the 70% cut-off to define high heterogeneity) and the Tau-square test (using a cut-off of &gt;.10 to define high heterogeneity). We will calculate pooled odds ratios (OR), and 95% confidence intervals (CI) with the DerSimonian-Laird random effect model (REM) due to the significant methodological heterogeneity of included studies. When log(OR) and SEs will not be available among the included studies we will use the Cochrane`s tutorial on Meta-analysis time-to-event data to compute them. Publication bias will not assessed if the study number will be small [8].