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      Effects of transdermal versus oral hormone replacement therapy in postmenopause: a systematic review

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          Abstract

          Purpose

          To summarize available evidence comparing the transdermal and the oral administration routes of hormone replacement therapy (HRT) in postmenopausal women.

          Methods

          We performed a systematic review of the literature on multiple databases between January 1990 and December 2021. We included randomized controlled trials and observational studies comparing the transdermal and oral administration routes of estrogens for HRT in postmenopausal women regarding at least one of the outcomes of interest: cardiovascular risk, venous thromboembolism (VTE), lipid metabolism, carbohydrate metabolism, bone mineral density (BMD), and risk of pre-malignant and malignant endometrial lesions, or breast cancer.

          Results

          The systematic literature search identified a total of 1369 manuscripts, of which 51 were included. Most studies were observational and of good quality, whereas the majority of randomized controlled trials presented a high or medium risk of bias. Oral and transdermal administration routes are similar regarding BMD, glucose metabolism, and lipid profile improvements, as well as do not appear different regarding breast cancer, endometrial disease, and cardiovascular risk. Identified literature provides clear evidence only for the VTE risk, which is higher with the oral administration route.

          Conclusions

          Available evidence comparing the transdermal and oral administration routes for HRT is limited and of low quality, recommending further investigations. VTE risk can be considered the clearest and strongest clinical difference between the two administration routes, supporting the transdermal HRT as safer than the oral administration route.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s00404-022-06647-5.

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          Most cited references93

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          RoB 2: a revised tool for assessing risk of bias in randomised trials

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            Newcastle-Ottawa Scale: comparing reviewers’ to authors’ assessments

            Background Lack of appropriate reporting of methodological details has previously been shown to distort risk of bias assessments in randomized controlled trials. The same might be true for observational studies. The goal of this study was to compare the Newcastle-Ottawa Scale (NOS) assessment for risk of bias between reviewers and authors of cohort studies included in a published systematic review on risk factors for severe outcomes in patients infected with influenza. Methods Cohort studies included in the systematic review and published between 2008–2011 were included. The corresponding or first authors completed a survey covering all NOS items. Results were compared with the NOS assessment applied by reviewers of the systematic review. Inter-rater reliability was calculated using kappa (K) statistics. Results Authors of 65/182 (36%) studies completed the survey. The overall NOS score was significantly higher (p < 0.001) in the reviewers’ assessment (median = 6; interquartile range [IQR] 6–6) compared with those by authors (median = 5, IQR 4–6). Inter-rater reliability by item ranged from slight (K = 0.15, 95% confidence interval [CI] = −0.19, 0.48) to poor (K = −0.06, 95% CI = −0.22, 0.10). Reliability for the overall score was poor (K = −0.004, 95% CI = −0.11, 0.11). Conclusions Differences in assessment and low agreement between reviewers and authors suggest the need to contact authors for information not published in studies when applying the NOS in systematic reviews.
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              Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement.

              Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach. PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.
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                Author and article information

                Contributors
                ferrarifilippoalberto@gmail.com
                Journal
                Arch Gynecol Obstet
                Arch Gynecol Obstet
                Archives of Gynecology and Obstetrics
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0932-0067
                1432-0711
                17 June 2022
                17 June 2022
                2023
                : 307
                : 6
                : 1727-1745
                Affiliations
                [1 ]GRID grid.412688.1, ISNI 0000 0004 0397 9648, Department of Obstetrics and Gynecology, , University Hospital Centre, ; Zagreb, Croatia
                [2 ]GRID grid.4808.4, ISNI 0000 0001 0657 4636, School of Medicine, , University of Zagreb, ; Zagreb, Croatia
                [3 ]GRID grid.5611.3, ISNI 0000 0004 1763 1124, Department of Obstetrics and Gynecology, AOUI Verona, , University of Verona, ; Verona, Italy
                [4 ]GRID grid.5608.b, ISNI 0000 0004 1757 3470, Department of Women and Children’s Health, Clinic of Gynecology and Obstetrics, , University of Padua, ; Padua, Italy
                [5 ]GRID grid.7122.6, ISNI 0000 0001 1088 8582, Faculty of Medicine, Institute of Obstetrics and Gynecology, , University of Debrecen, ; Debrecen, Hungary
                [6 ]GRID grid.428191.7, ISNI 0000 0004 0495 7803, Department of Medicine, School of Medicine, , Nazarbayev University, ; Nur-Sultan, 010000 Kazakhstan
                [7 ]GRID grid.10776.37, ISNI 0000 0004 1762 5517, Unit of Gynecologic Oncology, ARNAS “Civico – Di Cristina – Benfratelli”, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), , University of Palermo, ; Palermo, Italy
                Author information
                http://orcid.org/0000-0003-0726-1687
                Article
                6647
                10.1007/s00404-022-06647-5
                10147786
                35713694
                ab4e0279-68c8-422f-bcb2-45d72c4efc95
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 10 February 2022
                : 25 May 2022
                Funding
                Funded by: Università degli Studi di Verona
                Categories
                Review
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2023

                Obstetrics & Gynecology
                hormone replacement therapy,administration route,postmenopausal,venous thromboembolism,metabolism,cancer,cardiovascular risk

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