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104 Chapter 5 SUPPLEMENTARY MATERIAL CHAPTER 5 In the following pages supplemental data is provided, as referred to in chapter 5. Appendix 1s. Data stewardship statement The company behind the software is ISO27001 and NEN7510 compliant and has declared all the controls from ISO27002 as applicable. ISO27001 is an international standard for information security, while NEN7510 is a Dutch standard for healthcare, based on ISO27799 “Health informatics — Information security management in health using ISO/ IEC 27002”. This contains for example encryption of information at rest and in transit, access management and so on. As also required by the General Data Protection Regulation, patient information (and backups) are encrypted and access is logged and restricted to authorized users. Patient information is stored on EU servers. We are not allowed to divulge the precise strength of the encryption algorithms for security reasons. Appendix 2s. iMTA Productivity Cost Questionnaire In this trial, the iMTA Productivity Cost Questionnaire is used to evaluate the macroeconomic effect. For further explanation and to download the iMTA Productivity Cost Questionnaire and guiding manual, visit the iMTA website: https://www.imta.nl/ questionnaires Website based information: iMTA has developed several questionnaires over the past 25 years. These questionnaires are available for use by others to improve standardization in measurement in health economic evaluation. Productivity losses The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses. During the past years several questionnaires were developed for measuring productivity losses and several scientific papers were written on this topic including the valuation of productivity losses. These questionnaires contributed to the development of the iMTA Productivity Cost Questionnaire (iPCQ), bundling all relevant parts of the previously mentioned questionnaires into a short generic measurement instrument. Additionally, we developed a manual containing information on the modular structure of the iPCQ and its scoring- and valuation methods that are used for the cost calculations. The iPCQ is a generic questionnaire and is applicable to national and international studies. Currently, 16 translations are available, among which Dutch, English, German, Spanish and French. See below for a full list of translations. For the measurement of productivity losses, we recommend applying the iPCQ.
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