WP 11: Health Economic study


  • Evaluate the Incremental Cost Effectiveness of the treatment (Task 1-4).
  • Complete a cost-utility analysis informing decision makers about the cost / QALY (Task 3).
  • Analyze and prepare the reports and manuscripts covering the results of the Health Economic analysis (Task4,5).

Work package Description

The Health Economic Study Work Package will be led by Prof. Isabelle Durand-Zaleski (UPEV), who will be collaborating with Dr. Livio Garattini (CESAV) and the team from the Mario Negri Institute for Pharmacological Research. They will be integrated into the overall effort associated to the performance of the EuroHYP-1-1 trial with the help and collaboration of MSc. Istvan Szabo, from EuroHYP-1. Task 1: Finalize the content of the patient diary (M01-02).Prof. Isabelle Durand Zaleski and Dr. Livio Garattini will review the proposals generated in Work Package 2 –"Patient, carer and citizen involvement" and provide in-puts about the required content from Health Economic perspective. Responsible for the task: Prof. Isabelle Durand-Zaleski (UPEC).Task 2: Estimation of the full cost of cooling by micro costing (M01-60).Health care services will be monetized by exploiting the unit costs available in each participating country, whose sources could vary significantly from a country to another depending on the type of health care systems. For instance, hospital tariffs could be used if available to monetize inpatient costs (excluding the cost of cooling).Alternatively, ICU costs could be obtained from a sub sample of participating centres selected according to the availability of advanced cost accounting systems. The full cost of cooling is made up of the costs of the technology, the patient‘s management and long-term out-patient care. First we will estimate the cost of the technology that includes: (1) “Entry costs” or training costs needed to acquire skills to use the technology; (2) Time cost spent to use the technology: quantity of time spent x unit cost of time; (3) Equipment cost that includes all materials & supplies used to cool each patient. Then we will estimate the cost of the patient ‘s management during the initial event, which includes:(1) Initial stay cost: hospital admission (initial x tariff + cooling); and (2) hospital follow-up costs, including repeat admissions: acute, rehab x tariff. We will estimate follow up cost (at 90 days) for expensive out-patient care based on the patient diary (or centralized health services databases, if available), aiming to identify and to quantify: (1) Time spent in rehabilitation unit(s) and at home; (2) Long-term nursing and rehabilitative time (by week, personnel qualification and number); (3) Expensive medical goods: prescribed medicines (dosage, time of prescription) and medico-technical devices (number and type of wheelchairs, therapeutic and orthopedic appliances…); and (4)Patient transport: number, cost, type of vehicle. The economic data associated to (A) initial hospitalisation and(B) 90 day follow up costs will be collected and analyzed for both patient groups: those treated with hypothermia and also the group receiving standard care. Moreover, an estimation will be made based on published data and expert opinion (stroke neurologists from EuroHYP-1), about the expected costs in a 4 year period following hospital discharge. The micro-costing estimate will require in-trial data collection of the resources used (supplies, equipment and labour). This collection will be done by investigators in the eCRF. Moreover - in case the data could not be collected via advanced accounting systems or a self-report from the participating sites - a research assistant


(RA) will do on-site visits in the largest eight centres of recruitment from the eight countries with the largest patient enrolment numbers (assumed to be): Denmark, Germany, France, Italy, Poland, Spain, Turkey and UK(or Netherlands), in order to collect unit costs (billing information for hospitals and community care, personnel time salary...) and help investigators by in-trial data collection. The two types of cooling devices will be covered via the eight centres, as much as possible in equal proportions. In addition to the eight largest countries, data collection will be completed in an additional two centres, however only via self-reported forms (or an advanced accounting system) and not via a visit from a research assistant (countries planned to be covered are The Netherlands (or UK) and Austria. The cost data collection is likely to differ between countries because some centres will be unable to provide information beyond discharge, except via the patient diary developed (see Task 1). All centres will be asked to provide billing information on the initial admission and repeated hospitalizations during the follow up period. Responsible: Dr. Livio Garattini (CESAV), Prof. Isabelle Durand-Zaleski (UPEC) and EuroHYP-1 (MSc. Istvan Szabo).Task 3: Collection of the quality of life (QoL) data (M04-55).The Health Econ sub-study can be ideally divided in two phases. The first one will follow the design of the clinical trial and will be aimed at collecting all the relevant information on the health care services used by recruited patients. The second phase will try to assess resources consumption in the medium/long-term and should include the estimate of relevant non health care costs too, according to the societal perspective. The incremental cost effectiveness of the intervention will be ascertained by measuring the lives saved and the survival gains shown by the clinical trial. A further type of economic evaluation, i.e. cost-utility analysis, will be conducted by substituting clinical endpoints with improvements in the quality of life of the individuals treated with hypothermia. Utility will be estimated from the EQ-5D (and/or other adequate instruments and methods) by country. Data of QoL will be transformed in utility using specific countries scales standardized by age and sex. Then we will estimate the increased cost due to hypothermia to gain one point of utility for a patient. Specifically, the QoL information will be collected from the EQ-5D questionnaire (and/or other suitable instruments usually used in neurology), included in the eCRF and filled out by investigators upon admission and at 3 months. QoL data will be encoded in utilities from country-specific scale (age/sex adjusted).Responsible: Prof. Isabelle Durand-Zaleski (UPEC) and Dr. Livio Garattini (CESAV).Task 4: Analysis and reporting of the results from the study (M09-57)Economic data will be cleaned by the economic staff and validated with country leaders and investigators from the ten largest countries( from patient enrolment perspective) . Then cost-effectiveness and cost-utility analysis will be conducted by country (for countries where cost data are available). At the end a comparison among countries will be done, involving up to ten countries. Where country-specific estimates on the burden of stroke by level of disability are available, they will be used to validate our results and provide information of potential long-term benefits of the intervention. The analysis will cover the inputs collected via the patient diaries, providing information about the time spent at home and at the different care facilities: nursing homes, hospitals, rehabilition centres, etc. Responsible: Prof. Isabelle Durand-Zaleski (UPEC), Dr. Livio Garattini (CESAV) and Istvan Szabo (EuroHYP-1).Task 5: Preparation of the manuscript for publication of the results in a specialist journal. (M52-59).The team of experts working on the project, led by Prof. Isabelle Durand-Zaleski will develop the manuscript for the study, based on the analysis completed. Responsible: Prof. Isabelle Durand-Zaleski (UPEC), Dr. Livio Garattini (CESAV) and Istvan Szabo (EuroHYP-1).


Participating Partners

European Stroke Research Network for Hypothermia ASBL
Universite Paris XII - Val De Marne
Istituto di Ricerche Farmacologiche Mario Negri