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Active-comparator design and new-user design in observational studies.

ABSTRACT: Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of treatments for rheumatoid arthritis. Unlike randomized controlled trials (RCTs), however, observational studies of drug effects have methodological limitations such as confounding by indication. Active-comparator designs and new-user designs can help mitigate such biases in observational studies and improve the validity of their findings by making them more closely approximate RCTs. In an active-comparator study, the drug of interest is compared with another agent commonly used for the same indication, rather than with no treatment (a 'non-user' group). This principle helps to ensure that treatment groups have similar treatment indications, attenuating both measured and unmeasured differences in patient characteristics. The new-user study includes a cohort of patients from the time of treatment initiation, enabling assessment of patients' pretreatment characteristics and capture of all events occurring during follow-up. These two principles should be considered when designing or reviewing observational studies of drug effects.

SUBMITTER: Yoshida K

PROVIDER: S-EPMC4486631 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Active-comparator design and new-user design in observational studies.

Yoshida Kazuki K Solomon Daniel H DH Kim Seoyoung C SC

Nature reviews. Rheumatology 20150324 7

Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of treatments for rheumatoid arthritis. Unlike randomized controlled trials (RCTs), however, observational studies of drug effects have methodological limitations such as confounding by indication. Active-comparator designs and new-user designs can help mitigate such biases in observational studies and improve the validity of their findings by making them more closely approximate RCTs. I ...[more]

PMID: 25800216

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Project description:System design is recognized as one of the most critical components of a software system that bridges system requirements and coding. System design also has a significant impact on testing and maintenance activities, and on further improvements during the lifespan of the software system. Software design should reflect all necessary components of the requirements in a clear and understandable manner by all stakeholders of the software system. To distinguish system elements, separation of concerns in software design is suggested. In this respect, identification of the user tasks, i.e., the tasks that need to be performed by the user, is not currently reflected explicitly in system design documents. Our main assumption in this study is that software quality can be improved significantly by clearly identifying the user tasks from those that need to be performed by the computer system itself. Additionally, what we propose has the potential to better reflect the user requirements and main objectives of the system on the software design and thereby to improve software quality. The main aim of this study is to introduce a novel notation for software developers in the frame of UML Activity Diagram (UML-AD) that enables designers to identify the user tasks and define them separately from the system tasks. For this purpose, an extension of UML-AD, named UML-ADE (UML-Activity Diagram Extended) was proposed. Afterwards, it was implemented in a serious game case for which the specification of user tasks is extremely important. Finally, its effectiveness was analyzed and compared to UML-AD experimentally with 72 participants. The defect detection performance of the participants on both diagrams with two real-life serious game scenarios was evaluated. Results show a higher level of understandability for those using UML-ADE, which in turn may indicate a better design and higher software quality. The results encourage researchers to develop specific design representations dedicated to task design to improve system quality and to conduct further evaluations of the impact of these design on each of the above mentioned potential benefits for the software systems.

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Active-comparator design and new-user design in observational studies.

Publications

Active-comparator design and new-user design in observational studies.

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