Clinical outcomes research

Additional research efforts conducted at the Medical Affairs divisions of pharmaceutical companies include the study of Health Economics and Clinical Outcomes Research, which examines the effect of drugs on the cost of healthcare delivery, as... 

Dabbous, Omar H. Health Economics Clinical Outcomes Research, Medical Affairs, Centocor Inc., 800 Ridgeview Drive, Horsham, PA 19044, USA. 

Bakst A, Meletiche D, Arnold R, et al. The Avandia Worldwide Awareness Registry (AWARe ) an Internet-based program for evaluation of clinical, humanistic and economic outcomes of patients with type 2 diabetes. International Society for Pharmacoeconomics and Outcomes Research Sixth Annual International Meeting. Philadelphia, Pennsylvania, 2001. 

Jollis JG, Ancukiewicz M, DeLong ER, et al. Discordance of databases designed for claims payment versus clinical information systems. Implications for outcomes research. Ann Intern Med 1993 119 844-50. 

Romano PS, Roos LL, Luft HS, et al. A comparison of administrative versus clinical data coronary artery bypass surgery as an example. Ischemic Heart Disease Patient Outcomes Research Team. / Clin Epidemiol 1994 47 249-60. 

Two large trials, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study and the Celecoxib Long-term Arthritis Safety Study (CLASS), compared selective COX-2 inhibitors and traditional, non-selective NSAID therapy in terms of their ability to prevent clinical PUD (i.e., symptomatic ulcers and ulcer complications). VIGOR (9-month median follow-up) demonstrated that rofecoxib (50 mg daily) therapy was significantly more efficacious than naproxen.28 The CLASS study (6-month median follow-up) found that high-dose celecoxib (400 mg twice daily) was superior to non-selective NSAID therapy (either ibuprofen 800 mg three times daily or diclofenac 75 mg twice daily).29... 

X. Bad i a Llach Consultant, Clinical Epidemiology and Public Health Department, Health Outcomes Research Unit, Sant Pau Hospital, Barcelona... 

Data from American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision. Washington, DC American Psychiatric Association, 2000 382-401 Goldberg JF, Harrow M, eds. Bipolar Disorders Clinical Course and Outcome. Washington, DC American Psychiatric Press, 1999 and Goodnick PJ, ed. Mania Clinical and Research Perspectives. Washington, DC American Psychiatric Press, 1998. 

Much of the research on myocardial viability has focused on measuring pathological changes, cellular metabolism, or myocardial contractility without defining how much of the myocardium is involved, its relation to LV systolic function, and clinical outcomes. PET currently provides the best answer to the following questions (a) How much myocardium is scarred or viable as a percent of the zone at risk distal to a stenosis and as a percent of the whole heart (b) What amount of viable tissue justifies revascularization ... 

One potential difficulty of cost-benefit analysis is that it requires researchers to express an intervention s costs and outcomes in the same units. Thus, monetary values must be associated with years of life lost and morbidity due to disease and with years of life gained and morbidity avoided due to intervention. Expressing costs in this way is obviously difficult in health care analyses. Outcomes (treatment benefits) may be difficult to measure in units of currency. Translating disease and treatment outcomes into monetary measures may be more difficult than translating them into clinical outcome measures, such as years of life saved or years of life saved adjusted for quality. 

An even less complex approach than cost-benefit or cost-effectiveness analysis would be simply to enumerate the costs involved in medical care and to ignore the outcomes that result from that care. This approach is known as cost-identification analysis. By performing cost-identification analysis, the researcher can determine alternative ways of providing a service. The analysis might be expressed in terms of the cost per unit of service provided. For example, a cost-identification study might measure the cost of a course of antibiotic treatment, but it would not calculate the clinical outcomes (cost-effectiveness... 

The use of intermediate endpoints to demonstrate clinical efficacy is common in clinical trials, because it reduces both the cost of the clinical development process and the time needed to demonstrate the efficacy of the therapy. Intermediate endpoints are most appropriate in clinical research if they have been shown to be related to the clinical outcome of interest, as in the following ... 

It should be noted that polypharmacy per se is not necessarily an inappropriate practice. Most medical disorders, from asthma to AIDS to allergies, are managed with medication combinations. However, it is important to note that the use of multiple concurrent medications appears to rising substantially, suggesting that there is a great need for research data and well-designed studies to inform this practice. In some instances, it may be that the combination, while popular, may be more likely to result in side effects and not particular advantages in treatment efficacy and clinical outcomes (Connor et ak, 2000). 

The effect of fluoroquinolone-resistance in Campylobacter on the clinical outcome of treatment with a fluoroquinolone is not yet clear. There are conflicting data on whether resistant Campylobacter can cause more severe disease. Although there has been little documented impact of this resistance on human health, current concern about the potential human health consequences if resistance were to increase and spread, is high. Tims, further research and data-gathering are essential to quantify this potential. In addition to quinolone resistance, coresistance... 

It is important to recognize that mission statements and strategic plans vary among types of organizations, especially within health care. The mission statement and strategic plan of a not-for-profit children s research hospital likely will be different from that of a for-profit pharmacy chain (Table 24-1). The aspects of a professional service that will need to be emphasized in a business plan will vary as well. The not-for-profit children s research hospital may want to see how a new professional service will result in enhanced clinical outcomes or benefit the greatest number of children at the lowest possible cost. On the other... 

Outcomes research is defined as studies that attempt to identify, measure, and evaluate the end results of health care services. Outcomes research may evaluate not only the clinical effects of health care services but also the economic and humanistic impact of these services. Proponents of outcomes research believe that we should measure not only the clinical and cost impacts of health care but also outcomes that take factors... 

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