Support Services for the Management and Utilization of Monitoring and Assessment of the EIP - MAFEIP Tool Data Collection Codebook Overview of Questions and Input required http://mafeip.eu [email protected] MAFEIP Tool Overview of Questions and Input required Questions Input required Name/acronym of the intervention <free text input> Please select one of the following: Action group under which the intervention is registered A1 A2 A3 B3 C2 D4 Demographic characteristics of your target group (e.g. age, gender) <free text input> Geographic characteristics of your target group (e.g. country, region) <free text input> What is the condition that your intervention aims to prevent, improve or cure? <free text input> What are the typical disease characteristics of your target group (e.g. comorbidities)? <free text input> Your intervention relates to a: o o o Device Protocol/treatment method Other, please specify <free text input> 2 http://mafeip.eu [email protected] Brief description of the clinical implementation of your intervention (e.g. who uses it, when, in which setting, how often etc.) <free text input> Brief description of the current care situation without the intervention (e.g. current treatments provided, whether the intervention replaces or complements the current therapy, etc.) <free text input> Does your intervention have an impact on health and resource use compared to current care? (please describe briefly). <free text input> Stage of development of your intervention Do you collect empirical evidence on the effectiveness of your intervention? If effectiveness = Yes: 1) What is the study design with which evidence on effectiveness is gathered? 2) Was there a control group against which the effectiveness was assessed? If control group = Yes: o o o o o Pre-trial (e.g. proof of concept) Clinical trials ongoing Pilot implementation Routine use Other, please specify <free text input> o o Yes No o o o o o Randomized Controlled Trial Longitudinal observational Cross-sectional observational Case-control Other, please specify <free text input> o o Yes No <free text input> 3 http://mafeip.eu [email protected] 1) Number of patients intervention arm of study in 2) Number of patients in control <free text input> arm of study If control group = No: <free text input> Number of patients in the study Do you collect empirical evidence on the impact of your intervention on resource use? If resource use = Yes: o o Yes No o o o o Piggyback study with clinical trial Micro-costing study Patient records based study Other, please specify o o Yes No 1) What is the study design with which evidence on resource use is <free text input> gathered? 2) Was there a control group against which the effectiveness was assessed? If control group = Yes: 1) Number of patients intervention arm of study in <free text input> 2) Number of patients in control <free text input> arm of study If control group = No: Number of patients in the study If resource use = No: <free text input> o Yes 4 http://mafeip.eu [email protected] o Do you have alternative sources of resource use evidence to populate the model? No If alternative sources = Yes: Please specify your alternative sources for effectiveness evidence (literature, expert opinion, other) <free text input> Do you collect empirical evidence on the impact of your intervention on Health Related Quality of Life (HRQoL)? If HRQoL = Yes: 1) What is the study design with which evidence on HRQoL is gathered? 2) Was there a control group against which the effectiveness was assessed? o o Yes No o o o o o Randomized Controlled Trial Longitudinal observational Cross-sectional observational Case-control Other, please specify <free text input> o o Yes No If control group = Yes: 1) Number of patients intervention arm of study in <free text input> 2) Number of patients in control <free text input> arm of study If control group = No: <free text input> Number of patients in the study Discount factor for costs <free percentage input> 5 http://mafeip.eu [email protected] Discount factor for utilities <free percentage input> Target population Minimum age <free number input> Target population Maximum age <free number input> Please select one of the following: Target population Gender Both males and females Males only Females only Please select one of the following: Target population Country Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain 6 http://mafeip.eu [email protected] Sweden United Kingdom Please select one of the following: Target Population Currency Patient Flow through Model States Gender Euro Bulgarian lev British pound sterling Croatian kuna Czech koruna Danish krone Hungarian forint Polish zloty Romanian leu Swedish krona Swiss franc o o Male Female Patient Flow through Model States <free number input> Age Incidence Rate Control Group <free percentage input> Intervention Group <free percentage input> Recovery Rate Control Group <free percentage input> Intervention Group <free percentage input> Relative risk of mortality in baseline health <free number input> 7 http://mafeip.eu [email protected] Control Group <free number input> Intervention Group Relative risk of mortality in deteriorated health Control Group Intervention Group <free number input> <free number input> One-off intervention costs <free number input> Intervention costs per person per year <free number input> Healthcare costs baseline health Control Group <free number input> Intervention Group <free number input> Societal costs baseline health Control Group <free number input> Intervention Group <free number input> Healthcare costs deteriorated health Control Group <free number input> Intervention Group <free number input> Societal costs deteriorated health Control Group <free number input> Intervention Group <free number input> 8 http://mafeip.eu [email protected] Utility of baseline health Control Group <input between 0 to 1> Intervention Group <input between 0 to 1> Utility of deteriorated health Control Group <input between 0 to 1> Intervention Group <input between 0 to 1> Sensitivity Analysis (optional) The following fields are filled in only after the assessment has been made and the user wishes to perform a sensitivity analysis. Discount Factor for costs Base value <free percentage input> Min <free percentage input> Max <free percentage input> Discount Factor for utilities Base value <free percentage input> Min <free percentage input> Max <free percentage input> Incidence (control group) Base value <free percentage input> Min <free percentage input> Max <free percentage input> Recovery (control group) 9 http://mafeip.eu [email protected] Base value <free percentage input> Min <free percentage input> Max <free percentage input> Incidence (intervention group) Base value <free percentage input> Min <free percentage input> Max <free percentage input> Recovery (intervention group) Base value <free percentage input> Min <free percentage input> Max <free percentage input> Relative risk of mortality in baseline health (control group) Base value Min Max <free number input> <free number input> <free number input> Relative risk of mortality in deteriorated health (control group) Base value Min Max Relative risk of mortality in baseline health (intervention group) Base value <free number input> <free number input> <free number input> <free number input> <free number input> 10 http://mafeip.eu [email protected] Min <free number input> Max Relative risk of mortality in deteriorated health (intervention group) Base value Min Max <free number input> <free number input> <free number input> One-off intervention costs Base value <free number input> Min <free number input> Max <free number input> Intervention costs per person per year Base value <free number input> Min <free number input> Max <free number input> Healthcare costs baseline health (control group) Base value Min Max Societal costs baseline health (control group) <free number input> <free number input> <free number input> <free number input> Base value <free number input> Min <free number input> 11 http://mafeip.eu [email protected] Max Healthcare costs deteriorated health (control group) Base value Min Max <free number input> <free number input> <free number input> Societal costs deteriorated health (control group) Base value Min Max <free number input> <free number input> <free number input> Healthcare costs baseline health (intervention group) Base value Min Max <free number input> <free number input> <free number input> Societal costs baseline health (intervention group) Base value Min Max Healthcare costs deteriorated health (intervention group) <free number input> <free number input> <free number input> <free number input> Base value <free number input> Min <free number input> 12 http://mafeip.eu [email protected] Max Societal costs deteriorated health (intervention group) Base value Min Max <free number input> <free number input> <free number input> Utility of baseline health (control group) Base value <free number input> Min <free number input> Max <free number input> Utility of deteriorated health (control group) Base value Min Max <free number input> <free number input> <free number input> Utility of baseline health (intervention group) Base value Min Max <free number input> <free number input> <free number input> Utility of deteriorated health (intervention group) Base value Min Max <free number input> <free number input> <free number input> 13 http://mafeip.eu [email protected] 14
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