How can We Increase the Quality and Value of Clinical Research?

Abstract

How can we increase the quali ty and value of c1inical research? Clinical research is researc h that answers or attempts to answer a eli nical question. Is this surgery effective for laryngeal cancer? What is the best way to treat snori ng? Clinica l research is va luab le because it can aid in improving patient care. Clinical research differs from basic science research in many fund amental ways. The most obvious differenc e is that real-life, elin ical practice and research , uniik e basic scie nce research , involve multitudes of variabies, ineluding diagnostic methods, stage of disease, age , sex , different surgeo ns, different procedures , and differences in per ioperative ca re. A "bench" research project can be designed to measure onlyone var iable, such as the dose of chemotherapy needed to kill 50% of cancer cells in vitro, Even a "sim ple," carefully controlled elinical trial-for example , one comparing an anti histam ine with placebo for the treatment of allerg ic rhinitis-invo lves fewer variables and is more likely to provide elear-cut resu its. The result s, however, may not be applicab le to the " usual" patient popu lation seen in practice and treate d in a standar d fashion; the study population may have more severe disease than the pat ients yo u see or may be younge r or older, etc. One way to make elini cal research findings mor e relevant to the practicing elini cian is to measure the outcomes as practiced in routine daily patient care. The scie nce of "outcornes research" was develop ed to evaluate the impa ct of healtheare on the health of patients and popul ations. Thi s impact may inelude the cost-effective ness ofan interventi on or its ability to affect the patient 's qu ality of life. "Quality of life" (QOL) is a measure ofthe patient' s percept ion offunctioning, pain , or other outcomes measures r elative to either general health or disease-specific measures. Standar dize d, statistica lly validated surveys comp leted by patients (or parents) can be used to assess these outcomes. Many elinicians/scientists mistakenly think that surveys do not provi de "objective" data and prefer to use "objective" resu lts, such as air-bone gaps , survival curves , recurre nce rates , etc. Outcomes surveys, although based on the patie nt's subjecti ve experience , are in fact stat istically validated objective measurements. As an analogy, a standard hearing test does not directly meas ure the "true" hearing leve l but indirec tly measures the patient's subjective perception ofwhat he/she hears as the tones are generated by the audiometer.

Functional and Cosmetic Outcomes of External Approach Septoplasty

“…10,11 It can be assessed by standardized, validated questionnaires. 12 An advantage of using general health status questionnaires for monitoring health is that comparisons can be made with other unrelated interventions. However, these instruments may lack the sensitivity to pick up small changes in health caused by a specific intervention.…”