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5. Costs and Sources of Funding
Pages 107-119

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From page 107...
... FACTORS THAT AFFECT STUDY COSTS Remarkably little information is available on costs of studies of diagnoshc technology. Clinical teals have received more attention, in part because of their seemingly large price tags.
From page 108...
... The specific costs ova study depend on the technology under consideration and on Be coccal problem for which me technology is being used. Thus, rather than attempt to make detailed estimates, we win raise issues that warrant consideration by investigators and by the policymakers who must Bloc ate resources to support studies of diagnostic technology.
From page 109...
... Sample Size A critical activity during the planning phase is estimating the sample size needed to give the study adequate power to detect clinically mean~ngfiA differences in test performance. - Sample size win strongly affect the costs of the study: the cost of diagnostic tests and the cost of foDow-up win directly depend on the number of subjects in the study.
From page 110...
... Implementation Patient Accrual A number of costs, often unanticipated, relate to He process of recruiting and enrolling patients. (For a general model of predicting accrual costs in clinical trials see Piantadosi 1987.)
From page 111...
... Data Collection Costs will increase as more data are collected because this effort will require more time fimm study personnel. In addition, procedures to ensure undone data collection and accurate data entry, and to provide quality control, win become more complex and costly as the size of the study increases.
From page 112...
... Statistical consultation win be an impomnt element of the costs of data interpretation. UNREIMBURSED PATIENT COSTS Studies of diagnostic technology may involve costs to patients that are not reimbursed.
From page 113...
... Cost of Diagnostic Tests Reliable information about the Rue economic cost of diagnostic tests is difficult to obtain. Both direct and indirect costs should be considered CTravers and K~chmal 1988~.
From page 114...
... No money is budgeted for the tests or patient care, because third-party payers have agreed to fund the costs of the additional tests required for the comparative analysis. Multi-Institutional Studies The Prospective Investigation of Pulmonary Embolic Diagnosis project is one of the most ambitious diagnostic technology assessments ever attempted.
From page 115...
... Professional lab" Progranune2 1ab" Clencal labor Fnnge benefits Constants Travel Office equnpenent Computer services Building rent Office costs Indirect costs Total 230,000 321,000 241,000 140,000 140,000 57,000 35,000 125,000 66,000 54,000 415,000 1,824,000 _ .
From page 116...
... Much of the expense budgeted to the data analysis center was for personnel. In addition, development of the protocols took approximately 15 months; clearly, In studies of this size, the planning and protocol development phase win involve substantial effort and expense.
From page 117...
... The proposal recommended that an allocation of 0.2 percent of the Heath Care Financing Administration budget (about $100 minion in 1980) and a proportion of We budgets of private Bird pardes be earmarked for technology assessment.
From page 118...
... Some operational aspects of the Veterans Administration cooperative studies program from 1972 to 1979. Controlled Clinical Trials 1:209-226, 1980.
From page 119...
... Vreim, C Project officer, Prospective Investigation of Pulmonary Embolic Diagnosis project Q,IOPED)


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