Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]

Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering...

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Main Authors: Nisa M Maruthur, Susan Joy, James Dolan, Jodi B Segal, Hasan M Shihab, Sonal Singh
Format: Article
Language:English
Published: F1000 Research Ltd 2013-07-01
Series:F1000Research
Subjects:
Online Access:http://f1000research.com/articles/2-160/v1
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author Nisa M Maruthur
Susan Joy
James Dolan
Jodi B Segal
Hasan M Shihab
Sonal Singh
author_facet Nisa M Maruthur
Susan Joy
James Dolan
Jodi B Segal
Hasan M Shihab
Sonal Singh
author_sort Nisa M Maruthur
collection DOAJ
description Background: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.
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spelling doaj.art-34bccc607c5b4b0d80e30c27a0c418572022-12-22T01:06:35ZengF1000 Research LtdF1000Research2046-14022013-07-01210.12688/f1000research.2-160.v11856Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]Nisa M Maruthur0Susan Joy1James Dolan2Jodi B Segal3Hasan M Shihab4Sonal Singh5The Welch Center for Prevention, Epidemiology, and Clinical Research, Baltimore MD, 21205, USADepartment of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USADepartment of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester NY, 14642, USADepartment of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USADepartment of Medicine, The Johns Hopkins University School of Medicine, Baltimore MD, 21205, USADepartment of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USABackground: Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.  Methods: This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.  Discussion: Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.http://f1000research.com/articles/2-160/v1Methods for Diagnostic & Therapeutic Studies
spellingShingle Nisa M Maruthur
Susan Joy
James Dolan
Jodi B Segal
Hasan M Shihab
Sonal Singh
Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
F1000Research
Methods for Diagnostic & Therapeutic Studies
title Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
title_full Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
title_fullStr Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
title_full_unstemmed Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
title_short Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research [v1; ref status: indexed, http://f1000r.es/1fk]
title_sort systematic assessment of benefits and risks study protocol for a multi criteria decision analysis using the analytic hierarchy process for comparative effectiveness research v1 ref status indexed http f1000r es 1fk
topic Methods for Diagnostic & Therapeutic Studies
url http://f1000research.com/articles/2-160/v1
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