Literature DB >> 1925166

Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials.

C Chuang-Stein1, N R Mohberg, M S Sinkula.   

Abstract

Randomized clinical trials are typically conducted to compare the efficacy (benefits) and side effects (risks) of two or more treatments. One can use results from such trials to decide on a preferable treatment that reflects one's own evaluation of the benefits and risks. To facilitate the necessary decision making, we propose in this paper three measures for simultaneously assessing benefits and risks. All three measures use weights that reflect the relative importance of the various treatment outcomes to an individual. Two of them carry the flavour of benefit/risk ratios, while the third generalizes Hilden's measure which incorporates patients' preferences. The proposed measures and procedures are illustrated using data from a phase III clinical trial of antihypertensive compounds.

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Year:  1991        PMID: 1925166     DOI: 10.1002/sim.4780100904

Source DB:  PubMed          Journal:  Stat Med        ISSN: 0277-6715            Impact factor:   2.373


  10 in total

Review 1.  Benefit-risk analysis : a brief review and proposed quantitative approaches.

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Journal:  Drug Saf       Date:  2003       Impact factor: 5.606

2.  Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

Authors:  Scott R Evans; Gene Pennello; Norberto Pantoja-Galicia; Hongyu Jiang; Andrea M Hujer; Kristine M Hujer; Claudia Manca; Carol Hill; Michael R Jacobs; Liang Chen; Robin Patel; Barry N Kreiswirth; Robert A Bonomo
Journal:  Clin Infect Dis       Date:  2016-05-18       Impact factor: 9.079

3.  Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

Authors:  Scott R Evans; Dean Follmann
Journal:  Stat Biopharm Res       Date:  2016-12-06       Impact factor: 1.452

4.  Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis.

Authors:  Tsung Yu; Janet T Holbrook; Jennifer E Thorne; Milo A Puhan
Journal:  Pharmacoepidemiol Drug Saf       Date:  2016-01-22       Impact factor: 2.890

5.  Model-based assessment of the benefits and risks of recombinant tissue plasminogen activator treatment in acute ischaemic stroke.

Authors:  Jinju Guk; Dongwoo Chae; Hankil Son; Joonsang Yoo; Ji Hoe Heo; Kyungsoo Park
Journal:  Br J Clin Pharmacol       Date:  2018-08-21       Impact factor: 4.335

6.  Using a Composite Maternal-Infant Outcome Measure in Tuberculosis-Prevention Studies Among Pregnant Women.

Authors:  Grace Montepiedra; Soyeon Kim; Adriana Weinberg; Gerhard Theron; Timothy R Sterling; Sylvia M LaCourse; Sarah Bradford; Nahida Chakhtoura; Patrick Jean-Philippe; Scott Evans; Amita Gupta
Journal:  Clin Infect Dis       Date:  2021-08-02       Impact factor: 9.079

7.  A framework for considering the risk-benefit trade-off in designing noninferiority trials using composite outcome approaches.

Authors:  Grace Montepiedra; Ritesh Ramchandani; Sachiko Miyahara; Soyeon Kim
Journal:  Stat Med       Date:  2020-10-26       Impact factor: 2.373

8.  Joint distribution approaches to simultaneously quantifying benefit and risk.

Authors:  Michele L Shaffer; Kristi L Watterberg
Journal:  BMC Med Res Methodol       Date:  2006-10-12       Impact factor: 4.615

9.  Totality of outcomes: A different paradigm in assessing interventions for treatment of tuberculosis.

Authors:  Grace Montepiedra; Courtney M Yuen; Michael L Rich; Scott R Evans
Journal:  J Clin Tuberc Other Mycobact Dis       Date:  2016-08

10.  Net efficacy adjusted for risk (NEAR): a simple procedure for measuring risk:benefit balance.

Authors:  José N Boada; Carlos Boada; Mar García-Sáiz; Marcelino García; Eduardo Fernández; Eugenio Gómez
Journal:  PLoS One       Date:  2008-10-31       Impact factor: 3.240

  10 in total

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