ABSTRACT
Off-label drug use is common, particularly in pediatric populations. In response, legislation requires and/or provides financial incentives for drug manufacturers to perform pediatric clinical trials. Using New Hampshire's all-payer claims database, we examine the impact of subsequent changes to drug labeling on pediatric drug utilization. To separate changes in utilization induced by labeling changes from other temporal factors, we estimate difference-in-differences models that compare utilization trends for pediatric patients to those of adults. We estimate that establishing safety and efficacy increases a drug's market share by (a statistically significant) 2.8 percentage points, whereas failure to do so decreases a drug's market share by (a statistically insignificant) 0.9 percentage points. We then interpret these estimates within the context of public and market incentives to conduct pediatric clinical trials.
Subject(s)
Drug Labeling , Drug Utilization , Off-Label Use , Pediatrics , Databases, Factual , Humans , New Hampshire , United States , United States Food and Drug AdministrationABSTRACT
INTRODUCTION: The benefits of cochlear implantation extend beyond improved speech recognition and into overall health-related quality of life (HRQoL). Several measures of HRQoL, categorized as generic or disease specific, have been used in the cochlear implant literature. The clinical utility of generic HRQoL measures have been reported to be variable by previous investigators. The degree to which HRQoL correlates to speech perception is largely unknown. METHODS: A prospective single-subject design at a large tertiary care center. Self-reported HRQoL was measured at the preoperative and 12-month post-activation test intervals. The measures of HRQoL included a generic form, (Medical Outcome Study Short Form; SF-36), and disease specific form (Nijmegen Cochlear Implant Questionnaire; NCIQ). Speech recognition was measured at the preoperative, 6- and 12-months post-activation test intervals using the Consonant-Nucleus-Consonant (CNC) monosyllabic word test. RESULTS: A total of 61 patients (mean 67 years; range 30-87 years) were included in the final analysis. Average speech recognition on the CNC word test was 10% pre-operatively, and 66.7% at 12-months post-activation. The HRQoL scores improved significantly for seven of the eight subdomains of the NCIQ, and one of the nine domains of the SF-36. CONCLUSION: Cochlear implantation significantly improves HRQoL, regardless of age. Disease specific measures, such as the NCIQ, are better able to demonstrate differences in HRQoL compared to general health surveys.
Subject(s)
Cochlear Implantation/psychology , Deafness/psychology , Health Status , Quality of Life , Adult , Aged , Aged, 80 and over , Cochlear Implantation/methods , Deafness/surgery , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Postoperative Period , Prospective Studies , Speech Perception , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Proponents of hospital consolidation claim that mergers lead to significant cost savings, but there is little systematic evidence backing these claims. For a large sample of hospital mergers between 2000 and 2010, I estimate difference-in-differences models that compare cost trends at acquired hospitals to cost trends at hospitals whose ownership did not change. I find evidence of economically and statistically significant cost reductions at acquired hospitals. On average, acquired hospitals realize cost savings between 4 and 7 percent in the years following the acquisition. These results are robust to a variety of different control strategies, and do not appear to be easily explained by post-merger changes in service and/or patient mix. I then explore several extensions of the results to examine (a) whether the acquiring hospital/system realizes cost savings post-merger and (b) if cost savings depend on the size of the acquirer and/or the geographic overlap of the merging hospitals.
