Clinical economics study design

Methodologists have written whole books on research study design, and here it is possible only to touch on some of the issues they discuss. It is important to emphasize, however, that economic evaluations need sound designs just as much as any other analysis, clinical or otherwise. This is one reason why economic analyses are often supplementary to or integrated within clinical... 

The conclusions drawn from our review and evaluation of literature assessing the economic value of clinical pharmacy services published from 1988-1995 are multifocal. The total number of articles published on this topic has grown, as demonstrated by the number in this review (104, average 13/yr) versus the original prospectus (58, average 4/yr), which included articles published from 1974-1987. Although the number of published articles on this topic appears sufficient, an opportunity does exist for improvement in the quality of study design. 

Despite the limitations of many of the articles as true economic evaluations, this literature contains a wealth of information pertinent to the clinical practice of pharmacy that serves to document innovative and successful experiences and programs. Of importance, we did find that when studies were well conducted (considered true economic evaluations), the results were likely to be favorable that is, the studies were able to demonstrate net savings or positive benefit cost ratios. Because of lack of standardization in reporting of results and variability in study design, it is difficult to make a general statement as to the degree of benefit derived from clinical pharmacy services. However, we were able to abstract calculated benefit cost ratios from the seven applicable studies and describe a range of value from 1.08 1 to 75.84 1 (mean 16.70 1). In other words, for every... 

To compare the epidemiological, clinical, and economic impacts of the HIV epidemic in Italy prior to and after the introduction of HAART, Tramarin et al. (2004) conducted a prospective and observational study with a multi-center design. They used data collected on an AIDS cohort from 1994 and updated data from a comparable cohort in 1998. Mortality and medical costs of 251 patients were measured in 1994 and in 1998, respectively. A considerable difference was observed in mortality (33.9% in 1994 vs. 3.9% in 1998). The cost per patient per year was US 15,515 in 1994 and US 10,312 in 1998. Based on the comparison of the two cohorts between both years, the authors concluded that after the introduction of HAART, hospital-based provision shifted from an inpatient-based to an outpatient-based service, with major focus on pharmaceutical care. 

Ideally, a clinical trial would be designed to follow patients throughout their lives, assessing both clinical and economic variables, to allow an incremental assessment of the full impact of the therapy on patients over their lifetimes. Of course, this type of study is almost never performed. Instead, most... 

Clinical research can target the needs of those in economically developing nations and those who are medically underserved in the United States. Yet we must be cautious in the design and implementation of research studies to ensure that those who are the most vulnerable, whether locally or abroad, are offered the most protections and stand to gain proportionately from the studies in which they participate. Research must satisfy the needs of the population in which it is undertaken, and the products developed during the course of the research must subsequently be made reasonably available. 

In the Sect. 25.2 medical equipment design oriented to IPDP is introduced. Its relationship to CE environment is described in Sect. 25.3. Discussion on the use of CE and IPDP is given in Sect. 25.4. Three cases studies are presented in Sect. 25.5 to illustrate the whole development process and the value of the proposed methodology. At the end. Sect. 25.6 presents final considerations on the use of CE and IPDP oriented for medical equipment conception and development, the perspectives of engineering modular development and the interface between Health and Engineering information areas seeking an increase in the technical, clinical and economic quality. 

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