Observational Cross-Sectional Study to Estimate Population Norms in Eight Countries: the POPUP Study Protocol

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Janssen doi: https://doi.org/10.1101/2025.03.24.25324318 Sarah Dewilde 1 Services in Health Economics (SHE) , Brussels, Belgium PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Sarah Dewilde For correspondence: sd{at}she-consulting.be Nafthali Hananja Tollenaar 1 Services in Health Economics (SHE) , Brussels, Belgium Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Nafthali Hananja Tollenaar Glenn Phillips 2 Argenx BV , Ghent, Belgium PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Glenn Phillips Sandra Paci 2 Argenx BV , Ghent, Belgium PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site Mathieu F. Janssen 3 Section Medical Psychology and Psychotherapy, Department of Psychiatry , Erasmus MC, Rotterdam, The Netherlands PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Mathieu F. Janssen Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract This study protocol outlines the Population Norms Study (POPUP), a multinational digital survey aimed at establishing general population norms for medical resource use, comorbidities, sick leave, caregiver support, quality of life, and functioning across eight countries: United States (US), Canada, United Kingdom (UK), the Netherlands, Belgium, Spain, Italy, and Germany. Data will be collected through an online self-administered survey in two waves: the first in Q1 2021 and the second in Q1 2023, when first-wave responders will be recontacted. A total of 15,500 responses will be gathered across both waves: 9,000 in the first wave and 4,500 re-contacts in the second, with an additional 2,000 new contacts if needed. Representative panels will be recruited by a research company from each country based on age, gender, education, and region. Participants will complete the survey after providing informed consent. No personal identifiers will be recorded. The observational study involves no medical interventions, drugs, or devices, and will be submitted for Ethical Committee approval in each country. Descriptive statistics will be used for data analysis. The results are expected to provide a baseline for comparing health outcomes in specific patient populations and quantifying disease burden. 1. Background Health-related quality of life (HRQoL), functioning, and the health and economic burden have become key outcomes in healthcare and public health interventions. Several instruments have been developed to assess these outcomes. Population norms for these measures serve as a baseline for comparing health outcomes in populations with specific health conditions, allowing for the quantification of disease burden. Methods used to obtain national or regional population norms include face-to-face interviews, computer-assisted personal interviews, postal surveys, computer-assisted telephone interviews, and, more recently, web surveys. 1 Increasingly, patients who participate in studies fill out the quality of life instruments electronically. 2 A review of papers studying the agreement between electronic and paper administration of patient-reported outcome measures in disease populations, found that the two modes of administration had a high level of equivalence. 3 A Norwegian study compared a postal and a web survey to obtain general population norms for the EQ-5D-3L instrument. Results of this study supports the use of web surveys when collecting data for health-related quality of life population norms. 1 National general population norms can be used as reference data to assess the burden of disease of patients with specific conditions. 4 2. Objectives of the study The objective of the Population Norms Study (POPUP) is to report general population norms for assessing medical resource use, comorbidities, sick leave, caregiver support, quality of life, and functioning across eight countries (US, Canada, UK, the Netherlands, Belgium, Spain, Italy, and Germany). 3. Study design This observational multinational cross-sectional study that will collect data through an online self-administered survey in two waves. The first wave will be conducted in Q1 2021, and the second wave in Q1 2023, when first-wave responders were recontacted. 4. Study population Representative panels of the general population from eight different countries (US, Canada, UK, the Netherlands, Belgium, Spain, Italy, and Germany) will be recruited. Participants will be recruited by a research company through online panels in each country. These panels are usually regularly updated, and low-quality respondents will be filtered out. Participants will be invited via email and incentivized with points redeemable for gifts. 5. Data collection The following data will be collected from all panel participants. The first wave of data collection is expected to take one month. One year later, respondents will be contacted again for the second wave, which is also expected to take one month. To minimize missing data, the survey will be programmed to prevent skipped or unanswered questions. Licenses for the questionnaires will be purchased when applicable, and the surveys will be programmed using LimeSurvey. The time expected to complete the online questionnaire is 15 minutes. 5.1 Demographic data Age, gender, level of education and current work situation. 5.2 Health and medical resource use related data The presence of comorbidities and the number of days sick leave during the past month. The medical resources used during the past month: the need of a caregiver use of medical services (hospital, general practitioner, specialist) 5.3 Health-related quality of life and functioning HRQoL and functioning will be measured using the following self-administered, validated instruments, each of which has been validated in the respective countries and languages: ➢ Health Utilities Index 3 (HUI3) is a generic, preference-based, comprehensive system for measuring health status and health-related quality of life. The HUI3 classification system is comprised of eight attributes – Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain – each with 5 or 6 levels of ability/disability. In this study the assessment period is current health and the assessment period the past 1-week. 5 ➢ Myasthenia gravis activities of daily living (MG-ADL) is an eight-question survey focussing on common symptoms of myasthenia gravis. Each item (respiratory function, the ability to brush teeth or comb hair, ability to rise from a chair, talking, chewing, vision and eyelid droop) is graded from 3 to 3. 6 ➢ Myasthenia gravis quality of life measure, revised (MG-QoLr) is a tool to assess aspects of life related to myasthenia gravis. The survey contains 15 items with 3 response options each. 7 ➢ Hospital Anxiety and depression scale (HADS) is a simple and reliable tool to assess anxiety and depression. Seven items in the questionnaire reflect depression and seven items anxiety. Each item has a 4-point response category. 8 ➢ EQ-5D is one of the most widely used instruments to describe and value health. The original questionnaire (EQ-5D-3L) contains five questions dealing with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. All questions are answered on a scale ranging from 1 (best QoL) to 3 (worst QoL). The questionnaire contains a thermometer-like visual analogue scale (VAS) ranging from 0 to 100 (the EQ-VAS), where the endpoints are labelled ‘The best health you can imagine’ and ‘The worst health you can imagine’. The new EQ-5D-5L version expanded the response scale from three to five levels. 9 Bolt-ons are dimension(s) that can be appended to another instrument. 6 bolt-ons (vision, breathing, sleep, tiredness, social relationships and self-confidence) in reference to EQ-5D-3L and EQ-5D-5L will be used in the survey. 10 5.4 COVID-19 related questions The impact of COVID-19 on the personal current situation will be evaluated through 7 short questions. 6. Sample size The sample size for this observational study is not based on a formal calculation but is determined by the aim of ensuring representativeness of the general population and feasibility. However, a sample size of 1,000 provides a margin of error (ME) of 3.16% (ME% = 100 / √N), which is generally acceptable for surveys of the general population ( Table 1 ). 11 The total sample size consists of 15,500 responses across eight countries over two waves: 9,000 respondents in the first wave and 4,500 re-contacts in the second wave, supplemented with new contacts if the target sample size for the second wave is not reached. In all eight countries, samples will be drawn from representative panels based on age, gender, education, and region. View this table: View inline View popup Download powerpoint Table 1. POPUP Study Sample Size for Waves 1 and 2 7. Analyses The study is purely descriptive. There is no formal hypothesis. Descriptive statistical methods will be used to analyse and describe the data. Pooled results for all the countries will be presented as well as results per country. The differences between countries will be explored. Results stratified by demographic characteristics such as age and gender will also be reported. Population norms for each of the research areas and instruments will be estimated for the different countries. It is planned to use the statistical analysis software SAS and R to analyse the collected data. 8. Procedures 8.1 Recruitment Potential participants will be invited to participate through an e-mail invitation, with a link to the questionnaire. The sample of potential participants is aimed to be representative for the general population in each country. The sample will be drawn from a representative panel of survey participants willing to participate. 8.2 Data Quality Monitoring Data in the e-platform will be checked for validity and internal consistency, to ensure high data quality and completeness. 8.3 Data protection Names or other personal identifiers will not be recorded and therefore not be included in any database. 8.4 Funding The research is sponsored by the pharmaceutical company Argenx BVBA. 8.5 Economic conditions Individuals participating in the study will receive a small compensation for participating; a voucher or points for a lottery depending on the country. 8.6 Publication and data sharing policy The results of this study will be published as individual papers. The publications will be aimed towards high impact peer-reviewed journals. 8.7 Timetable and end of the study It is planned to start data collection in September 2020. The period needed to collect data from 4.500 individuals is estimated to be one month and will end when all data have been collected. It is aimed to obtain all data by December 2020. 8.8 Ethical considerations Participants can only complete the online survey after agreeing to the informed consent form. No personal identifiers, including names, addresses, email addresses, phone numbers, postal codes, dates of birth, or national register numbers, will be recorded or included in any database. The participants are members of the general public, not individuals with a specific disease. This study is purely observational, with no medical interventions, drugs, or medical devices involved. The study will be submitted for Ethical Committee approval in each country. 9. Study organisation 9.1 Co-ordinating office SHE BV, Boulevard Lambermont 418, 1030 Brussels, Belgium Mobile telephone: 0032 484 064 210. Data Availability Anonymized, aggregated study data is available upon reasonable request through the corresponding author. References 1. ↵ Stavem K , Augestad LA , Kristiansen IS , Rand K ( 2018 ) General population norms for the EQ-5D-3 L in Norway: comparison of postal and web surveys . Health and quality of life outcomes 16 ( 1 ): 204 . doi: 10.1186/s12955-018-1029-1 OpenUrl CrossRef PubMed 2. ↵ Oppe M , Rand-Hendriksen K , Shah K , Ramos-Goni JM , Luo N ( 2016 ) EuroQol Protocols for Time Trade-Off Valuation of Health Outcomes . PharmacoEconomics 34 ( 10 ): 993 – 1004 . doi: 10.1007/s40273-016-0404-1 OpenUrl CrossRef PubMed 3. ↵ Muehlhausen W , Doll H , Quadri N , Fordham B , O’Donohoe P , Dogar N , Wild DJ ( 2015 ) Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013 . Health and quality of life outcomes 13 : 167 . doi: 10.1186/s12955-015-0362-x OpenUrl CrossRef PubMed 4. ↵ Janssen MF , Szende A , Cabases J , Ramos-Goni JM , Vilagut G , Konig HH ( 2019 ) Population norms for the EQ-5D-3L: a cross-country analysis of population surveys for 20 countries . The European journal of health economics : HEPAC : health economics in prevention and care 20 ( 2 ): 205 – 216 . doi: 10.1007/s10198-018-0955-5 OpenUrl CrossRef PubMed 5. ↵ Horsman J , Furlong W , Feeny D , Torrance G ( 2003 ) The Health Utilities Index (HUI): concepts, measurement properties and applications . Health and quality of life outcomes 1 : 54 . doi: 10.1186/1477-7525-1-54 OpenUrl CrossRef PubMed 6. ↵ de Meel RHP , Raadsheer WF , van Zwet EW , Verschuuren J , Tannemaat MR ( 2019 ) Sensitivity of MG-ADL for generalized weakness in myasthenia gravis . European journal of neurology 26 ( 6 ): 947 – 950 . doi: 10.1111/ene.13867 OpenUrl CrossRef PubMed 7. ↵ Burns TM , Sadjadi R , Utsugisawa K , Gwathmey KG , Joshi A , Jones S , Bril V , Barnett C , Guptill JT , Sanders DB , Hobson-Webb L , Juel VC , Massey J , Gable KL , Silvestri NJ , Wolfe G , Cutter G , Nagane Y , Murai H , Masuda M , Farrugia ME , Carmichael C , Birnbaum S , Hogrel JY , Nafissi S , Fatehi F , Ou C , Liu W , Conaway M ( 2016 ) International clinimetric evaluation of the MG-QOL15, resulting in slight revision and subsequent validation of the MG-QOL15r . Muscle & nerve 54 ( 6 ): 1015 – 1022 . doi: 10.1002/mus.25198 OpenUrl CrossRef PubMed 8. ↵ Buchholz I , Janssen MF , Kohlmann T , Feng YS ( 2018 ) A Systematic Review of Studies Comparing the Measurement Properties of the Three-Level and Five-Level Versions of the EQ-5D . PharmacoEconomics 36 ( 6 ): 645 – 661 . doi: 10.1007/s40273-018-0642-5 OpenUrl CrossRef PubMed 9. ↵ Finch AP , Brazier JE , Mukuria C ( 2019 ) Selecting Bolt-On Dimensions for the EQ-5D: Examining Their Contribution to Health-Related Quality of Life . Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 22 ( 1 ): 50 – 61 . doi: 10.1016/j.jval.2018.07.001 OpenUrl CrossRef View the discussion thread. Back to top Previous Next Posted March 24, 2025. Download PDF Data/Code Email Thank you for your interest in spreading the word about medRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. 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