Healthcare Consumption Clinical Trial
Official title:
Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation
Pragmatic study comparing historical data from usual collection tools to medical
administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to
the data collection:
1. Collection of hospitalization data from the local PMSI and outpatient data from CRF
2. Collection of hospitalization data in the national PMSI with a probabilistic matching
between local and national PMSI data
3. Collection of outpatient consumption data from SNIIRAM after matching of data from the
national PMSI to the SNIIRAM.
In studies assessing therapeutic interventions, an economic evaluation requires the
collection of patients' healthcare consumption. Two methods are primarily used in accordance
with the recommendations of the National Authority for Health (HAS): case report forms (CRF)
for ambulatory care and the local hospital discharge databases (local PMSI) - extracted from
participating centers - for hospital care. However, these conventional methods have limits.
The first is a declarative and mostly retrospective collection, often misinformed and
unverifiable. The second provides high quality data but is far from exhaustive as it only
concerns hospitalizations that occurred in the participating center, not those that occurred
in other hospitals.
In France, medical administrative databases SNIIRAM (all care reimbursed by the statutory
health insurance) and national PMSI (all hospital care) are the "gold standards" for
collecting consumer personal care. However, the administrative difficulties associated with
accessing these databases prevent researchers from extracting routine care consumption data
from these databases for health economic studies, despite the fact that the unreliability of
the conventional methods has been objectified in a small number of studies in the
literature. These studies are few, have been conducted abroad and seek to compare
declarative collections to non-exhaustive medical and administrative data. Moreover, they
compare only the number of events collected and not the implication for economic evaluations
using those numbers, limiting the applicability of their results to economic assessments.
The main objective of this study is to evaluate the performance of usual collection tools
compared to the gold standards (medical and administrative databases) for estimating
consumption of inpatient and outpatient care in health economic evaluations. The secondary
objectives are to evaluate the impact of the potential underestimation of healthcare
consumption on the estimated costs and results of economic assessments by studying the
variation of the calculated incremental cost-effectiveness ratio (ICER) and the conclusion
of evaluation.
The COMERE population comes from studies in which an economic evaluation for an innovative
therapeutic strategy was conducted by the principal investigators's research unity. These
studies include at the minimum a collection of hospital care consumption. This data
collection must be over by the time for the start of the project. The procedure code and
studied pathology alone allow the investigators to identify patients in the national PMSI
with a probability greater than 0.9. When adding other information available in the local
PMSI, this probability reaches 0.99. The principal investigators of the studies agreed on
the use of data from their studies in the context of this research project. Overall, among
the studies carried out in our unit, 12 projects funded by the Ministry of Health's program
supporting funds for expensive innovative technology (STIC) and 1 national registry matched
the study's criteria and were retained. Of these 13 studies: 13 have collected data on
hospital care consumption and 8 collected data on ambulatory care consumption. In total,
these studies included 87 separate centers and 6,928 patients of which 2,661 have an
ambulatory care collection. Their data are completely anonymous.
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Time Perspective: Retrospective