Stated-preference methods are a class of evaluation techniques for studying the preferences of patients and other stakeholders. While these methods span a variety of techniques, conjoint-analysis methods-and particularly discrete-choice experiments (DCEs)-have become the most frequently applied approach in health care in recent years. Experimental design is an important stage in the development of such methods, but establishing a consensus on standards is hampered by lack of understanding of available techniques and software. This report builds on the previous ISPOR Conjoint Analysis Task Force Report: Conjoint Analysis Applications in Health-A Checklist: A Report of the ISPOR Good Research Practices for Conjoint Analysis Task Force. This report aims to assist researchers specifically in evaluating alternative approaches to experimental design, a difficult and important element of successful DCEs. While this report does not endorse any specific approach, it does provide a guide for choosing an approach that is appropriate for a particular study. In particular, it provides an overview of the role of experimental designs for the successful implementation of the DCE approach in health care studies, and it provides researchers with an introduction to constructing experimental designs on the basis of study objectives and the statistical model researchers have selected for the study. The report outlines the theoretical requirements for designs that identify choice-model preference parameters and summarizes and compares a number of available approaches for constructing experimental designs. The task-force leadership group met via bimonthly teleconferences and in person at ISPOR meetings in the United States and Europe. An international group of experimental-design experts was consulted during this process to discuss existing approaches for experimental design and to review the task force's draft reports. In addition, ISPOR members contributed to developing a consensus report by submitting written comments during the review process and oral comments during two forum presentations at the ISPOR 16th and 17th Annual International Meetings held in Baltimore (2011) and Washington, DC (2012).
In medical informatics, the quasi-experimental, sometimes called the pre-post intervention, design often is used to evaluate the benefits of specific interventions. The increasing capacity of health care institutions to collect routine clinical data has led to the growing use of quasi-experimental study designs in the field of medical informatics as well as in other medical disciplines. However, little is written about these study designs in the medical literature or in traditional epidemiology textbooks.1,2,3 In contrast, the social sciences literature is replete with examples of ways to implement and improve quasi-experimental studies.4,5,6
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Key advantages and disadvantages of quasi-experimental studies, as they pertain to the study of medical informatics, were identified. The potential methodological flaws of quasi-experimental medical informatics studies, which have the potential to introduce bias, were also identified. In addition, a summary table outlining a relative hierarchy and nomenclature of quasi-experimental study designs is described. In general, the higher the design is in the hierarchy, the greater the internal validity that the study traditionally possesses because the evidence of the potential causation between the intervention and the outcome is strengthened.4
Using this basic definition, it is evident that many published studies in medical informatics utilize the quasi-experimental design. Although the randomized controlled trial is generally considered to have the highest level of credibility with regard to assessing causality, in medical informatics, researchers often choose not to randomize the intervention for one or more reasons: (1) ethical considerations, (2) difficulty of randomizing subjects, (3) difficulty to randomize by locations (e.g., by wards), (4) small available sample size. Each of these reasons is discussed below.
Ethical considerations typically will not allow random withholding of an intervention with known efficacy. Thus, if the efficacy of an intervention has not been established, a randomized controlled trial is the design of choice to determine efficacy. But if the intervention under study incorporates an accepted, well-established therapeutic intervention, or if the intervention has either questionable efficacy or safety based on previously conducted studies, then the ethical issues of randomizing patients are sometimes raised. In the area of medical informatics, it is often believed prior to an implementation that an informatics intervention will likely be beneficial and thus medical informaticians and hospital administrators are often reluctant to randomize medical informatics interventions. In addition, there is often pressure to implement the intervention quickly because of its believed efficacy, thus not allowing researchers sufficient time to plan a randomized trial.
Similarly, informatics interventions often cannot be randomized to individual locations. Using the pharmacy order-entry system example, it may be difficult to randomize use of the system to only certain locations in a hospital or portions of certain locations. For example, if the pharmacy order-entry system involves an educational component, then people may apply the knowledge learned to nonintervention wards, thereby potentially masking the true effect of the intervention. When a design using randomized locations is employed successfully, the locations may be different in other respects (confounding variables), and this further complicates the analysis and interpretation.
Here, X is the intervention and O is the outcome variable (this notation is continued throughout the article). In this study design, an intervention (X) is implemented and a posttest observation (O1) is taken. For example, X could be the introduction of a pharmacy order-entry intervention and O1 could be the pharmacy costs following the intervention. This design is the weakest of the quasi-experimental designs that are discussed in this article. Without any pretest observations or a control group, there are multiple threats to internal validity. Unfortunately, this study design is often used in medical informatics when new software is introduced since it may be difficult to have pretest measurements due to time, technical, or cost constraints.
The advantage of this study design over A2 is that adding a second pretest prior to the intervention helps provide evidence that can be used to refute the phenomenon of regression to the mean and confounding as alternative explanations for any observed association between the intervention and the posttest outcome. For example, in a study where a pharmacy order-entry system led to lower pharmacy costs (O3
This design involves the inclusion of a nonequivalent dependent variable (b) in addition to the primary dependent variable (a). Variables a and b should assess similar constructs; that is, the two measures should be affected by similar factors and confounding variables except for the effect of the intervention. Variable a is expected to change because of the intervention X, whereas variable b is not. Taking our example, variable a could be pharmacy costs and variable b could be the length of stay of patients. If our informatics intervention is aimed at decreasing pharmacy costs, we would expect to observe a decrease in pharmacy costs but not in the average length of stay of patients. However, a number of important confounding variables, such as severity of illness and knowledge of software users, might affect both outcome measures. Thus, if the average length of stay did not change following the intervention but pharmacy costs did, then the data are more convincing than if just pharmacy costs were measured.
This design adds a third posttest measurement (O3) to the one-group pretest-posttest design and then removes the intervention before a final measure (O4) is made. The advantage of this design is that it allows one to test hypotheses about the outcome in the presence of the intervention and in the absence of the intervention. Thus, if one predicts a decrease in the outcome between O1 and O2 (after implementation of the intervention), then one would predict an increase in the outcome between O3 and O4 (after removal of the intervention). One caveat is that if the intervention is thought to have persistent effects, then O4 needs to be measured after these effects are likely to have disappeared. For example, a study would be more convincing if it demonstrated that pharmacy costs decreased after pharmacy order-entry system introduction (O2 and O3 less than O1) and that when the order-entry system was removed or disabled, the costs increased (O4 greater than O2 and O3 and closer to O1). In addition, there are often ethical issues in this design in terms of removing an intervention that may be providing benefit.
Despite their extensive clinical use, to our knowledge, no numerical models have been proposed to describe the performance of saline-linked RF electrodes. From an engineering point of view it is important to achieve a physical description in the form of the mathematical relations between the electrical and thermal variables involved. This would provide further information on, for instance, the role of the saline layer in creating thermal coagulation. Our aim in the present work was to develop a numerical model to describe the electrical and thermal performance of a monopolar saline-linked RF electrode designed to heat the tissue surface. In clinical terms this means to thermally coagulate the transection plane during a surgical resection or to thermally ablate surface tumors. 2ff7e9595c
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