%0 Generic %1 MtIsa2014 %A Mt-Isa, Shahrul %A Hallgreen, Christine E %A Wang, Nan %A Callréus, Torbjörn %A Genov, Georgy %A Hirsch, Ian %A Hobbiger, Stephen F %A Hockley, Kimberley S %A Luciani, Davide %A Phillips, Lawrence D %A Quartey, George %A Sarac, Sinan B %A Stoeckert, Isabelle %A Tzoulaki, Ioanna %A Micaleff, Alain %A Ashby, Deborah %A Amzal, Billy %A Ashworth, Simon %A Asiimwe, Alex %A Bring, Johan %A Callreus, Torbjorn %A Chan, Edmond Kakit %A Dierig, Christoph %A Downey, Gerald %A Gelb, David %A Goginsky, Alesia %A Hallgreen, Christine %A Hermann, Richard %A Hobbiger, Steve %A Hockley, Kimberley %A Hughes, Diana %A Juhaeri, Juhaeri %A Kuhls, Silvia %A Lieftucht, Alfons %A Metcalf, Marilyn %A Mwangi, Jeremiah %A Nixon, Richard %A Noel, Rebecca %A Pears, John %A Peters, Ruth %A Phillips, Lawrence %A Shepherd, Susan %A J., Elizabeth J. Swain %A Thomson, Andrew %A Titeux, Laurence %A van den Ham, Rianne %A van Staa, Tjeerd %A Waddingham, Edward %A Wise, Lesley %D 2014 %J Pharmacoepidemiology and Drug Safety %K Benefit-risk Decision-making Framework Medicines Pharmacoepidemiology Qualitative Quantitative Review %N 7 %P 667-678 %R 10.1002/pds.3636 %T Balancing benefit and risk of medicines: A systematic review and classification of available methodologies %U http://www.ncbi.nlm.nih.gov/pubmed/24821575 %V 23 %X BACKGROUND: The need for formal and structured approaches for benefit-risk assessment of medicines is increasing, as is the complexity of the scientific questions addressed before making decisions on the benefit-risk balance of medicines. We systematically collected, appraised and classified available benefit-risk methodologies to facilitate and inform their future use. METHODS: A systematic review of publications identified benefit-risk assessment methodologies. Methodologies were appraised on their fundamental principles, features, graphical representations, assessability and accessibility. We created a taxonomy of methodologies to facilitate understanding and choice. RESULTS: We identified 49 methodologies, critically appraised and classified them into four categories: frameworks, metrics, estimation techniques and utility survey techniques. Eight frameworks describe qualitative steps in benefit-risk assessment and eight quantify benefit-risk balance. Nine metric indices include threshold indices to measure either benefit or risk; health indices measure quality-of-life over time; and trade-off indices integrate benefits and risks. Six estimation techniques support benefit-risk modelling and evidence synthesis. Four utility survey techniques elicit robust value preferences from relevant stakeholders to the benefit-risk decisions. CONCLUSIONS: Methodologies to help benefit-risk assessments of medicines are diverse and each is associated with different limitations and strengths. There is not a 'one-size-fits-all' method, and a combination of methods may be needed for each benefit-risk assessment. The taxonomy introduced herein may guide choice of adequate methodologies. Finally, we recommend 13 of 49 methodologies for further appraisal for use in the real-life benefit-risk assessment of medicines. Copyright © 2014 John Wiley & Sons, Ltd.

@generic{MtIsa2014, abstract = {BACKGROUND: The need for formal and structured approaches for benefit-risk assessment of medicines is increasing, as is the complexity of the scientific questions addressed before making decisions on the benefit-risk balance of medicines. We systematically collected, appraised and classified available benefit-risk methodologies to facilitate and inform their future use. METHODS: A systematic review of publications identified benefit-risk assessment methodologies. Methodologies were appraised on their fundamental principles, features, graphical representations, assessability and accessibility. We created a taxonomy of methodologies to facilitate understanding and choice. RESULTS: We identified 49 methodologies, critically appraised and classified them into four categories: frameworks, metrics, estimation techniques and utility survey techniques. Eight frameworks describe qualitative steps in benefit-risk assessment and eight quantify benefit-risk balance. Nine metric indices include threshold indices to measure either benefit or risk; health indices measure quality-of-life over time; and trade-off indices integrate benefits and risks. Six estimation techniques support benefit-risk modelling and evidence synthesis. Four utility survey techniques elicit robust value preferences from relevant stakeholders to the benefit-risk decisions. CONCLUSIONS: Methodologies to help benefit-risk assessments of medicines are diverse and each is associated with different limitations and strengths. There is not a 'one-size-fits-all' method, and a combination of methods may be needed for each benefit-risk assessment. The taxonomy introduced herein may guide choice of adequate methodologies. Finally, we recommend 13 of 49 methodologies for further appraisal for use in the real-life benefit-risk assessment of medicines. Copyright © 2014 John Wiley & Sons, Ltd.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Mt-Isa, Shahrul and Hallgreen, Christine E and Wang, Nan and Callréus, Torbjörn and Genov, Georgy and Hirsch, Ian and Hobbiger, Stephen F and Hockley, Kimberley S and Luciani, Davide and Phillips, Lawrence D and Quartey, George and Sarac, Sinan B and Stoeckert, Isabelle and Tzoulaki, Ioanna and Micaleff, Alain and Ashby, Deborah and Amzal, Billy and Ashworth, Simon and Asiimwe, Alex and Bring, Johan and Callreus, Torbjorn and Chan, Edmond Kakit and Dierig, Christoph and Downey, Gerald and Gelb, David and Goginsky, Alesia and Hallgreen, Christine and Hermann, Richard and Hobbiger, Steve and Hockley, Kimberley and Hughes, Diana and Juhaeri, Juhaeri and Kuhls, Silvia and Lieftucht, Alfons and Metcalf, Marilyn and Mwangi, Jeremiah and Nixon, Richard and Noel, Rebecca and Pears, John and Peters, Ruth and Phillips, Lawrence and Shepherd, Susan and J., Elizabeth J. Swain and Thomson, Andrew and Titeux, Laurence and van den Ham, Rianne and van Staa, Tjeerd and Waddingham, Edward and Wise, Lesley}, biburl = {https://www.bibsonomy.org/bibtex/225a3b928d6c53b90a7026523a7aaf5cf/jepcastel}, doi = {10.1002/pds.3636}, interhash = {ede2740dfb120dae4ea4a48aaade34b5}, intrahash = {25a3b928d6c53b90a7026523a7aaf5cf}, issn = {10991557}, journal = {Pharmacoepidemiology and Drug Safety}, keywords = {Benefit-risk Decision-making Framework Medicines Pharmacoepidemiology Qualitative Quantitative Review}, month = {7}, note = {Relació benefici/risc; Introductori}, number = 7, pages = {667-678}, pmid = {24821575}, timestamp = {2023-02-03T11:44:35.000+0100}, title = {Balancing benefit and risk of medicines: A systematic review and classification of available methodologies}, url = {http://www.ncbi.nlm.nih.gov/pubmed/24821575}, volume = 23, year = 2014 }