ABSTRACT
The results from randomized clinical trials are often adopted slowly. This practice potentially prevents many people from benefiting from more effective care. Provide a framework for analyzing clinical trial results to determine whether and when early adoption of novel interventions is appropriate. The framework includes the evaluation of three components: confidence in trial results, impact of early, and late adoption if trial results are reversed or sustained. The adverse impact of early adoption, and the opportunity cost of late adoption are determined using Markov modeling to simulate the impact of early and late adoption in terms of quality of life years and resources gained or lost. We applied the framework to the TARGIT-A randomized clinical trial comparing intraoperative radiation (IORT) to standard external beam radiation (EBRT) and considered these results in the context of trials comparing endocrine therapy with and without radiation therapy in postmenopausal women. Confidence in the TARGIT-A trial 4 year results is high because the peak hazard for local recurrence in the trial is between 2 and 3 years. This is consistent with most trials, and no second peak has been observed in similar patient populations, suggesting that the TARGIT-A trial results are stable. The interventions offer approximately equivalent life expectancy. If IORT local recurrences rate were as high as 10 % at 10 years (which is higher than expected), we would project only 0.002 fewer expected life years (less than 1 day) compared to EBRT if IORT is adopted early. However, there is a $1.7 billion opportunity cost of waiting an additional 5 years to adopt IORT in low risk, hormone-receptor-positive, postmenopausal women. EBRT costs an additional $1467 in indirect costs per patient. Applying an evaluative framework for the adoption of clinical trial results to the TARGIT-A IORT therapy trial results in the assessment that the trial results are stable, early adoption would lead to minimal adverse impact, and substantially less resource use. Both IORT and no radiation are reasonable strategies to adopt.
Subject(s)
Breast Neoplasms/therapy , Decision Support Techniques , Randomized Controlled Trials as Topic/methods , Aged , Aged, 80 and over , Animals , Breast Neoplasms/economics , Female , Humans , Intraoperative Care/economics , Intraoperative Care/methods , Markov Chains , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Postmenopause , Quality of Life , Radiotherapy, Adjuvant/economics , Radiotherapy, Adjuvant/methods , United StatesABSTRACT
Decision analysis may be useful to people facing Alzheimer disease (AD) decisions. The use of decision analysis in three such cases is reported. The first case involved a middle-aged person worried about early-onset AD and deciding whether to seek genetic testing. The analysis let the participant reject testing and consider innovative care options. The second case involved a middle-aged person concerned about later-onset AD. The analysis for her was more complex, and led to the assignment of some limited value on genetic testing for her. The third case revolved around a caregiver's treatment decisions for a patient with severe AD. It led her to recognize the importance of factors she had not previously considered. In each of the three cases, the intensive process of decision analysis appears to have improved the subject's decision.
Subject(s)
Alzheimer Disease/genetics , Decision Support Techniques , Genetic Predisposition to Disease , Genetic Testing , Adult , Aged , Alzheimer Disease/diagnosis , Alzheimer Disease/therapy , Caregivers/psychology , Female , Humans , Male , Middle AgedABSTRACT
Case management approaches in Australia were first introduced in the fields of intellectual disability and vocational rehabilitation in the 1970s and 1980s by major system reformers very much influenced by international trends in these particular fields. A broader diffusion occurred in the 1980s and 1990s with federal and state governments beginning to incorporate case management approaches into key policy documents, particularly in the fields of aging, mental health, and employment. The models of case management introduced have not been particularly sophisticated in terms of financial control nor have many models been specifically evaluated. They have, however, been introduced into a system in which they are underpinned by a basic safety net of universal health coverage and a noncontributory pension system funded out of general revenue. There is now fairly widespread diffusion of the concept and practice of case management across a broad range of client populations and an interest in more sophisticated implementation models.
