TY - JOUR A1 - Heneghan, Carl A1 - Ward, Alison A1 - Perera, Rafael A1 - Bankhead, Clare A1 - Fuller, Alice A1 - Stevens, Richard A1 - Bradford, Kairen A1 - Tyndel, Sally A1 - Alonso-Coello, Pablo A1 - Ansell, Jack A1 - Beyth, Rebecca A1 - Bernardo, Artur A1 - Christensen, Thomas Decker A1 - Cromheecke, Manon A1 - Edson, Robert G A1 - Fitzmaurice, David A1 - Gadisseur, Alain PA A1 - Garcia-Alamino, Josep M A1 - Gardiner, Chris A1 - Hasenkam, Michael A1 - Jacobson, Alan A1 - Kaatz, Scott A1 - Kamali, Farhad A1 - Khan, Tayyaba Irfan A1 - Knight, Eve A1 - Kortke, Heinrich A1 - Levi, Marcel A1 - Matchar, David Bruce A1 - Menendez-Jandula, Barbara A1 - Rakovac, Ivo A1 - Schaefer, Christian A1 - Siebenhofer, Andrea A1 - Souto, Juan Carlos A1 - Sunderji, Rubina A1 - Gin, Kenneth A1 - Shalansky, Karen A1 - Völler, Heinz A1 - Wagner, Otto A1 - Zittermann, Armin T1 - Self-monitoring of oral anticoagulation systematic review and meta-analysis of individual patient data JF - The lancet N2 - Background Uptake of self-testing and self-management of oral coagulation has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. Methods We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. Findings Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12 800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0.51; 95% CI 0.31-0.85) but not for major haemorrhagic events (0.88, 0.74-1.06) or death (0.82, 0.62-1.09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0.33, 95% CI 0.17-0.66), as did participants with mechanical heart valve (0.52, 0.35-0.77). Analysis of major outcomes in the very elderly (age >= 85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. Interpretation Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. Y1 - 2012 U6 - https://doi.org/10.1016/S0140-6736(11)61294-4 SN - 0140-6736 VL - 379 IS - 9813 SP - 322 EP - 334 PB - Elsevier CY - New York ER - TY - JOUR A1 - Kroke, Anja A1 - Schmidt, Annemarie A1 - Amini, Anna M. A1 - Kalotai, Nicole A1 - Lehmann, Andreas A1 - Haardt, Julia A1 - Bauer, Jürgen M. A1 - Bischoff-Ferrari, Heike A. A1 - Boeing, Heiner A1 - Egert, Sarah A1 - Ellinger, Sabine A1 - Kühn, Tilman A1 - Louis, Sandrine A1 - Lorkowski, Stefan A1 - Nimptsch, Katharina A1 - Remer, Thomas A1 - Schulze, Matthias B. A1 - Siener, Roswitha A1 - Stangl, Gabriele A1 - Volkert, Dorothee A1 - Zittermann, Armin A1 - Buyken, Anette E. A1 - Watzl, Bernhard A1 - Schwingshackl, Lukas T1 - Dietary protein intake and health-related outcomes: a methodological protocol for the evidence evaluation and the outline of an evidence to decision framework underlying the evidence-based guideline of the German Nutrition Society JF - European journal of nutrition N2 - Purpose: The present work aimed to delineate (i) a revised protocol according to recent methodological developments in evidence generation, to (ii) describe its interpretation, the assessment of the overall certainty of evidence and to (iii) outline an Evidence to Decision framework for deriving an evidence-based guideline on quantitative and qualitative aspects of dietary protein intake. Methods A methodological protocol to systematically investigate the association between dietary protein intake and several health outcomes and for deriving dietary protein intake recommendations for the primary prevention of various non-communicable diseases in the general adult population was developed. Results The developed methodological protocol relies on umbrella reviews including systematic reviews with or without meta-analyses. Systematic literature searches in three databases will be performed for each health-related outcome. The methodological quality of all selected systematic reviews will be evaluated using a modified version of AMSTAR 2, and the outcome-specific certainty of evidence for systematic reviews with or without meta-analysis will be assessed with NutriGrade. The general outline of the Evidence to Decision framework foresees that recommendations in the derived guideline will be given based on the overall certainty of evidence as well as on additional criteria such as sustainability. Conclusion The methodological protocol permits a systematic evaluation of published systematic reviews on dietary protein intake and its association with selected health-related outcomes. An Evidence to Decision framework will be the basis for the overall conclusions and the resulting recommendations for dietary protein intake. KW - Evidence-based guideline KW - Protein intake KW - Method KW - Prevention KW - Nutrition-related diseases Y1 - 2022 U6 - https://doi.org/10.1007/s00394-021-02789-5 SN - 1436-6207 SN - 1436-6215 VL - 61 IS - 4 SP - 2091 EP - 2101 PB - Springer Nature CY - Heidelberg ER -