Clinical trial NCT03011411: Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation
Official title: Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthcare Consumption
Keywords: methods, qualitative research
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an initial hospital stay during which the innovative treatment strategy was implemented

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Among patients of the source population, patients were included if:

* Their initial hospital stay (the one during which the innovative treatment strategy was implemented) was found in the local PMSI
* A probabilistic matching with the national PMSI is possible with a probability equal to 1 (in order to compare the data from the usual collections to the gold standard methods).

Exclusion Criteria:

* We excluded patients whose initial hospital stay found in the national PMSI was not linkable with other admissions due to a coding error.

Primary outcomes:
measure: the average ratio of the number of hospital stays collected by the usual method / number collected by the gold standard method
timeFrame: 1 day
measure: the average ratio of the number of ambulatory acts performed for a patient collected by the usual method / number collected by the gold standard method.
timeFrame: 1 day
Secondary outcomes:
measure: Ratio of the cost estimated with the conventional method / estimated with the gold standard
timeFrame: 1 day
measure: Variation in the ICER with both methods (%)
timeFrame: 1 day
measure: Proportion of studies in which the conclusion would change
timeFrame: 1day
measure: Investigation of the "center" effect and/or "study" effect in the data corresponding to the primary endpoint using intraclass coefficient
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital HOTEL DIEU
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karine CHEVREUL, Pr MD PhD
role: PRINCIPAL_INVESTIGATOR
References: