SATURN: assessing the feasibility of utilising existing registries for real-world evidence data collection to meet patients, regulatory, health technology assessment and payer requirements

Background: SATURN (Systematic Accumulation of Treatment practices and Utilisation, Real world evidence, and Natural history data) for the rare condition osteogenesis imperfecta (OI) has the objective to create a common core dataset by utilising existing, well-established data sources to meet the needs of the various stakeholders (physicians, registry/dataset owners, patients and patient associations, OI community leaders, European [EU] policymakers, regulators, health technology assessments [HTA]s, and healthcare systems including payers). This paper describes the steps taken to assess the feasibility of one existing OI registry (i.e., the Registry of OI [ROI]) as a candidate for SATURN. The same methodology will be applied to other existing OI registries in the future and this same concept could be utilised for other rare disease registries. Methods: The approach to assessing the feasibility of the ROI registry consisted of three steps: (1) an assessment of the registry characteristics using the Registry Evaluation and Quality Standards Tool (REQueST); (2) a gap analysis comparing SATURN required Core Variables to those being captured in the registry’s Case Report Form (CRF); and (3) a compliance check on the data exchange process following the Title 21 of Code of Federal Regulations (CFR) Part 11/EudraLex Annex 11 Compliance Checklist. The first registry that SATURN has assessed is the ROI database at the Istituto Ortopedico Rizzoli (IOR) in Italy. Results: The results from the ROI REQueST have demonstrated satisfactory complete responses in terms of methodology, essential standards, interpretability, and interoperability—readiness for data linkage, data sources, and ethics to meet the needs of data customers. However, the ROI data is from a tertiary referral centre which may limit the ability to understand the full patient journey. The gap analysis has revealed that an exact or logical match between SATURN requested variables and the ROI current variables exists for the following items: patient characteristics, treatment of OI (medical and surgical) and treatment of pain (with the exception of frequency of treatment and reasons for discontinuation), fracture history and bone density. However, data on safety was missing. The compliance check has implied that the ROI implemented appropriate controls for the web-based platform (i.e., Genotype–phenotype Data Integration Platform [GeDI]) that is involved in processing the electronic patient data, and GeDI is a validated/compliant application that follows relevant 21 CFR Part 11/EudraLex Annex 11 regulations. Conclusions: This robust feasibility process highlights potential limitations and opportunities to develop and to refine the collaboration with the ROI as the SATURN programme moves forward. It also ensures that the existing datasets in the rare condition OI are being maximised to respond to the needs of patients, data customers and decision-makers. This feasibility process has allowed SATURN to build a compliant methodology that aligns with the requirements from the European Medicines Agency (EMA) and HTAs. More data variables will continue to be developed and refined along the way with more registries participating in SATURN. As a result, SATURN will become a meaningful and truly collaborative core dataset, which will also contribute to advancing understanding of OI diagnosis, treatment, and care

Data collection on rare bone and mineral conditions in Europe: the landscape of registries and databases

Background: knowledge on the natural history of rare diseases is necessary to improve outcomes. Disease registries may play a key role in covering these unmet needs in the rare bone and mineral community.Objective: to map existing bone and mineral conditions registries in Europe and their characteristics.Methods: online survey about the use of registries/databases and their characteristics. This survey was disseminated among members of the European Reference Network on Rare Bone Diseases (ERN BOND) and non-ERN experts in the field of bone and mineral conditions as well as patient organisations.Results: sixty-three responses from health care providers (HCPs) and 10 responses from patient groups (PGs) were collected. The response rate for ERN BOND members was 55%. Of 63 HCPs, 37 declared using a registry. Osteogenesis imperfecta (OI) was the most registered condition. We mapped 3 international registries, all were disease-specific.Conclusions: There is a need for developing a common high-quality platform for registering rare bone and mineral conditions.Metabolic health: pathophysiological trajectories and therap

Deregulated intracellular pathways define novel molecular targets for HBV-specific CD8 T cell reconstitution in chronic hepatitis B

Background & Aims: In chronic HBV infection, elevated reactive oxygen species levels derived from dysfunctional mitochondria can cause increased protein oxidation and DNA damage in exhausted virus-specific CD8 T cells. The aim of this study was to understand how these defects are mechanistically interconnected to further elucidate T cell exhaustion pathogenesis and, doing so, to devise novel T cell-based therapies. Methods: DNA damage and repair mechanisms, including parylation, CD38 expression, and telomere length were studied in HBV- specific CD8 T cells from chronic HBV patients. Correction of intracellular signalling alterations and improvement of antiviral T cell functions by the NAD precursor nicotinamide mononucleotide and by CD38 inhibition was assessed. Results: Elevated DNA damage was associated with defective DNA repair processes, including NAD-dependent parylation, in HBV-specific CD8 cells of chronic HBV patients. NAD depletion was indicated by the overexpression of CD38, the major NAD consumer, and by the significant improvement of DNA repair mechanisms, and mitochondrial and proteostasis functions by NAD supplementation, which could also improve the HBV-specific antiviral CD8 T cell function. Conclusions: Our study delineates a model of CD8 T cell exhaustion whereby multiple interconnected intracellular defects, including telomere shortening, are causally related to NAD depletion suggesting similarities between T cell exhaustion and cell senescence. Correction of these deregulated intracellular functions by NAD supplementation can also restore antiviral CD8 T cell activity and thus represents a promising potential therapeutic strategy for chronic HBV infection

Evolution of private returns to tertiary education during transition: evidence from Slovenia

This paper analyzes the evolution of private returns to tertiary education during the period of transition from a socialist to a market economy using the personal income tax data of all Slovenian workers employed between 1994 and 2008. We document a rich interplay between supply and demand in the labor markets of high school and university graduates. We show that, in spite of signi cant increases in the labor supply, the demand for university graduates dominated and increased the rates of return in the early period of transition (1994-2001), while in the later period (2001-2008) the opposite was the case. We also provide evidence on considerable heterogeneity in the rates of return between genders, levels, and elds of study, with particularly large (low) returns to the elds that were suppressed (favored) during socialism. These initial di erences in returns have, however, gradually declined

Wellbeing indicators affecting female entrepreneurship in OECD countries

[EN] The objective of this research is to know which wellbeing indicators, such as work-life balance, educational level, income or job security, are related to the rate of female entrepreneurship in 29 OECD countries. In addition, these countries have been classified according to the motivation of the entrepreneur either by necessity or by opportunity. The empiric study is focused on 29 OECD countries covering the different geographic areas (Western Europe, Central and Eastern Europe, Middle East, etc.) Due to the fact that the sample is relatively small, it is essential to use a selective approach when selecting the causal conditions. To this end, fsQCA is the most appropriate methodology for such a small data set. A total of 5 variables have been used: an independent variable (female TEA ratio), and four dependent variables (work life balance, educational level, sustainable household income and job security). Data measuring female TEA ratio have been obtained from Global Entrepreneur Monitor (GEM in Global report, 2015) data base, while data measuring wellbeing dimensions were taken from the Better Life Index (OECD in How¿s life? Measuring wellbeing, 2015. http://www.oecdbetterlifeindex.org). The results of this piece of research show that countries with high sustainable household income together with high level of education achieves high female entrepreneurship ratio with both, a good work-life balance (despite of a high unemployment probability), or a high labour-personal imbalance (in this latter, with a low probability of unemployment).This work has been funded by the R + D project for emerging research groups with reference (GVA) GV/2016/078.Ribes-Giner, G.; Moya Clemente, I.; Cervelló Royo, RE.; Perelló Marín, MR. (2019). Wellbeing indicators affecting female entrepreneurship in OECD countries. Quality & Quantity. 53(2):915-933. https://doi.org/10.1007/s11135-018-0796-4S915933532Ahl, H., Nelson, T.: How policy positions women entrepreneurs: a comparative analysis of state discourse in Sweden and the United States. J. Bus. Ventur. 30(2), 273–291 (2015). https://doi.org/10.1016/j.jbusvent.2014.08.002Andersson, P.: Happiness and health: wellbeing among the self-employed. J. Socio-Econ. 37(1), 213–236 (2008). https://doi.org/10.1016/j.socec.2007.03.003Bardasi, E., Sabarwal, S., Terrell, K.: How do female entrepreneurs perform? Evidence from three developing regions. Small Bus. Econ. 37(4), 417–441 (2011). https://doi.org/10.1007/s11187-011-9374-zBergheim, S., Schneider, S., Giesel, B., Walter, N.: Measures of Wellbeing. There is More to it Than GDP. Deutsche Bank Research, Frankfurt (2006)Berglund, H.: Between cognition and discourse: phenomenology and the study of entrepreneurship. Int. J. Entrep. Behav. Res. 21(3), 472–488 (2015). https://doi.org/10.1108/IJEBR-12-2013-0210Bianchi, M., Parisi, V., Salvatore, R.: Female entrepreneurs: motivations and constraints. An Italian regional study. Int. J. Gend. Entrep. 8(3), 198–220 (2016). https://doi.org/10.1108/IJGE-08-2015-0029Bittencourt Marconatto, D.A., Barin-Cruz, L., Pozzebon, M., Poitras, J.E.: Developing sustainable business models within BOP contexts: mobilizing native capability to cope with government programs. J. Clean. Prod. 129, 735–748 (2016). https://doi.org/10.1016/j.jclepro.2016.03.038Boarini, R., Comola, M., Smith, C., Manchin, R., de Keulenaer, F.: What makes for a better life? The determinants of subjective well-being in OECD countries—evidence from the Gallup World Poll. OECD statistics working papers, 2012(3), 0_1 (2012). https://doi.org/10.1787/5k9b9ltjm937-enBoarini, R., D’Ercole, M.M.: Going beyond GDP: an OECD perspective. Fisc. Stud. 34(3), 289–314 (2013). https://doi.org/10.1111/j.1475-5890.2013.12007.xBradshaw, J., Hoelscher, P., Richardson, D. (eds.): Comparing child well-being in OECD countries: Concepts and methods. Innocenti working paper, IWP-2006-03. UNICEF Innocenti Research Centre, Florence, Italy (2007)Brindley, C.: Barriers to women achieving their entrepreneurial potential. Int. J. Entrep. Behav. Res. Emerald Group Publishing Limited (2005). Retrieved from http://www.emeraldinsight.com/doi/full/10.1108/13552550510590554Burke, A.E., Fitzroy, F.R., Nolan, M.A.: What makes a die-hard entrepreneur? Beyond the “employee or entrepreneur” dichotomy. Small Bus. Econ. 31(2), 93–115 (2008). https://doi.org/10.1007/s11187-007-9086-6Buttner, H.E., Moore, D.P.: Women’s organizational exodus to entrepreneurship: self-reported motivations and correlates with success. J. Small Bus. Manag. 35(1), 34–46 (1997). Retrieved from http://search.ebscohost.comCarter, S.: The rewards of entrepreneurship: exploring the incomes, wealth, and economic wellbeing of entrepreneurial households. Entrep. Theory Pract. 35(1), 39–55 (2011)Castaño, M.-S., Méndez, M.-T., Galindo, M.Á.: The effect of social, cultural, and economic factors on entrepreneurship. J. Bus. Res. 68(7), 1496–1500 (2015). https://doi.org/10.1016/j.jbusres.2015.01.040Castellano, R., Musella, G., Punzo, G.: Structure of the labour market and wage inequality: evidence from European countries. Qual. Quant. 51(5), 2191–2218 (2017)Cervelló-Royo, R., Moya-Clemente, I., Ribes-Giner, G.: Microfinance Institutions (MFIs) in Latin America: Who should finance the entrepreneurial ventures of the less privileged? In: Peris-Ortiz, M., Sahut, J.-M. (eds.) New Challenges in Entrepreneurship and Finance, pp. 235–245. Springer, Cham (2015)Cervelló-Royo, R., Guijarro, F., Martinez-Gomez, V.: Social performance considered within the global performance of Microfinance Institutions: a new approach. Oper. Res. (2017). https://doi.org/10.1007/s12351-017-0360-3Chaaban, J., Irani, A., Khoury, A.: The composite global wellbeing index (CGWBI): a new multi-dimensional measure of human development. Soc. Indic. Res. 129(1), 465–487 (2016). https://doi.org/10.1007/s11205-015-1112-5Chapple, S.: Child wellbeing and sole-parent family structure in the OECD: an analysis. OECD. Social, employment, and migration working papers (82), 0_1 (2009)Christofides, L.N., Polycarpou, A., Vrachimis, K.: Gender wage gaps, “sticky floors” and “glass ceilings” in Europe. Labour Econ. 21, 86–102 (2013). https://doi.org/10.1016/j.labeco.2013.01.003Cumming, D., Hou, W., Lee, E.: Sustainable and ethical entrepreneurship, corporate finance and governance, and institutional reform in China. J. Bus. Ethics 134(4), 505–508 (2016). https://doi.org/10.1007/s10551-014-2381-7Cummins, R.A., Eckersley, R., Pallant, J., Van Vugt, J., Misajon, R.: Developing a national index of subjective wellbeing: the Australian Unity Wellbeing Index. Soc. Indic. Res. 64(2), 159–190 (2003). https://doi.org/10.1023/A:1024704320683De la Cruz Sánchez-Escobedo, M., Díaz-Casero, J.C., Díaz-Aunión, Á.M., Hernández-Mogollón, R.: Gender analysis of entrepreneurial intentions as a function of economic development across three groups of countries. Int. Entrep. Manag. J. 10(4), 747–765 (2014). https://doi.org/10.1007/s11365-014-0314-7Diener, E.: Subjective wellbeing. In: Diener, E. (ed.) The Sicence of Wellbeing, pp. 11–58. Springer, Dordrecht (2009). https://doi.org/10.1007/978-90-481-2350-6_2Dodge, R., Daly, A., Huyton, J., Sanders, L.: The challenge of defining wellbeing. Int. J. Wellbeing 2(3), 222–235 (2012). https://doi.org/10.5502/ijw.v2i3.4Fiss, P.C.: Building better casual theories: a fuzzy set approach to typologies in organization research. Acad. Manag. J. 54(2), 393–420 (2011)Fleche, S., Smith, C., Sorsa, P.: Exploring determinants of subjective wellbeing in OECD countries (2011)Fleche, S., Smith, C., Sorsa, P.: Exploring determinants of subjective wellbeing in OECD countries evidence from the world value survey. Working papers, OECD Statistics (2012). https://doi.org/10.1787/5kg0k6zlcm5k-enFoley, A., Griffith, B.: Education, training and the promotion of high quality entrepreneurs in the Republic of Ireland. In: Scott, M.G., Rosa, P., Klandt, H. (eds.) Educating Entrepreneurs for Wealth Creation. Ashgate, Aldershot (1998)Garikipati, S.: Microcredit and women’s empowerment: through the lens of time-use data from rural India. Dev. Change 43(3), 719–750 (2012). https://doi.org/10.1111/j.1467-7660.2012.01780.xGEM (Global Entrepreneurship Monitor): Global report (2015)Harter, J.K., Schmidt, F.L., Keyes, C.L.M.: Wellbeing in the workplace and its relationship to business outcomes. A review of the Gallup studies. In: Keyes, C.L.M., Haidt, J. (eds.) Flourishing: The Positive Person and the Good Life, pp. 205–224. American Psychologi cal Association, Washington (2003)Henry, C., Foss, L., Ahl, H.: Gender and entrepreneurship research: a review of methodological approaches. Int. Small Bus. J. 34(3), 217–241 (2015). https://doi.org/10.1177/0266242614549779Hessels, J., Van Gelderen, M., Thurik, R.: Entrepreneurial aspirations, motivations, and their drivers”. Small Bus. Econ. 31(3), 323–339 (2008). https://doi.org/10.1007/s11187-008-9134-xIezzi, D.F., Deriu, F.: Women active citizenship and wellbeing: the Italian case. Qual. Quant. 48(2), 845–862 (2014)Jansson, T.: Housing choices and labor income risk. J. Urban Econ. 99, 107–119 (2017). https://doi.org/10.1016/j.jue.2016.12.006Johansen, V., Foss, L.: The effects of entrepreneurship education—does gender matter? Int. J. Entrep. Small Bus. 20(3), 255–271 (2013). https://doi.org/10.1504/IJESB.2013.056889Judge, W.Q., Hu, H.W., Gabrielsson, J., Talaulicar, T., Witt, M.A., Zattoni, A., Kibler, B.: Configurations of capacity for change in entrepreneurial threshold firms: imprinting and strategic choice perspectives. J. Manag. Stud. 52(4), 506–530 (2015). https://doi.org/10.1111/joms.12121Kautonen, T., Kibler, E., Minniti, M.: Late-career entrepreneurship, income and quality of life. J. Bus. Ventur. 32(3), 318–333 (2017). https://doi.org/10.1016/j.jbusvent.2017.02.005Kephart, P., Schumacher, L.: Has the “glass ceiling” cracked? An exploration of women entrepreneurship. J. Leadersh. Organ. Stud. 12(1), 2–15 (2005). https://doi.org/10.1177/107179190501200102Kirkwood, J.: Motivational factors in a push–pull theory of entrepreneurship. Gend. Manag. Int. J. 24(5), 346–364 (2009). https://doi.org/10.1108/17542410910968805Kobeissi, N.: Gender factors and female entrepreneurship: International evidence and policy implications. J. Int. Entrep. 8, 1–35 (2010). Retrieved from https://doi.org/10.1007/s10843-010-0045-yKuckertz, A., Berger, E.S.C., Allmendinger, M.P.: What drives entrepreneurship? A configurational analysis of the determinants of entrepreneurship in innovation-driven economies. Die Betriebswirtschaft/Bus. Adm. Rev. 75(4), 273–288 (2015). https://doi.org/10.1017/cbo9781107415324.004La Placa, V., McNaught, A., Knight, A.: Discourse on wellbeing in research and practice. Int. J. Wellbeing 3, 116–125 (2013). https://doi.org/10.5502/ijw.v3i1.7Langowitz, N., Minniti, M.: The entrepreneurial propensity of women. Entrep. Theory Pract. 31(3), 341–364 (2007). https://doi.org/10.1111/j.1540-6520.2007.00177.xLee, S.S.Y.: Examining policy configurations as conditions for long-term unemployment and non-standard employment in OECD countries using fuzzy-set analysis. Qual. Quant. 47(6), 3521–3536 (2013)Leffler, E., Svedberg, G.: Enterprise learning: a challenge to education? Eur. Educ. Res. J. 4(3), 219–227 (2005)Levie, J., Autio, E.: A theoretical grounding and test of the GEM model. Small Bus. Econ. 31(3), 235–263 (2008). https://doi.org/10.1007/s11187-008-9136-8Maccagnan, A., Wren-Lewis, S., Brown, H., Taylor, T.: Wellbeing and society: towards quantification of the co-benefits of wellbeing. Soc. Indic. Res. 1–27 (2018)Mandl, C., Berger, E.S.C., Kuckertz, A.: Do you plead guilty? Exploring entrepreneurs’ sensemaking-behavior link after business failure. J. Bus. Ventur. Insights 5, 9–13 (2016). https://doi.org/10.1016/j.jbvi.2015.12.002Martin, B.C., McNally, J.J., Kay, M.J.: Examining the formation of human capital in entrepreneurship: a meta-analysis of entrepreneurship education outcomes. J. Bus. Ventur. 28(2), 211–224 (2013). https://doi.org/10.1016/j.jbusvent.2012.03.002McClelland, E., Swail, J., Bell, J., Ibbotson, P.: Following the pathway of female entrepreneurs. Int. J. Entrep. Behav. Res. 11(2), 84–107 (2005). https://doi.org/10.1108/13552550510590527Millán, J.M., Hessels, J., Thurik, R., Aguado, R.: Determinants of job satisfaction: a European comparison of self-employed and paid employees. Small Bus. Econ. 40(3), 651–670 (2013). https://doi.org/10.1007/s11187-011-9380-1Minniti, M., Nardone, C.: Being in someone else’s shoes: the role of gender in nascent entrepreneurship. Small Bus. Econ. 28(2–3), 223–238 (2007). https://doi.org/10.1007/s11187-006-9017-yMishra, V., Nielsen, I., Smyth, R.: How does relative income and variations in short-run wellbeing affect wellbeing in the long run? Empirical evidence from China’s Korean minority. Soc. Indic. Res. 115(1), 67–91 (2014)Murias, P., Martinez, F., de Miguel, C.: An economic wellbeing index for the Spanish provinces: a data envelopment analysis approach. Soc. Indic. Res. 77(3), 395–417 (2006). https://doi.org/10.1007/s11205-005-2613-4Naudé, W., Amorós, J.E., Cisti, O.: Surfeiting, the appetite may sticken: entrepreneurship and happiness. Small Bus. Econ. 42(3), 523–540 (2014)Ng, T.W.H., Feldman, D.C.: Re-examining the relationship between age and voluntary turnover. J. Vocat. Behav. 74(3), 283–294 (2009). https://doi.org/10.1016/j.jvb.2009.01.004O’Connor, A.: A conceptual framework for entrepreneurship education policy: meeting government and economic purposes. J. Bus. Ventur. 28(4), 546–563 (2013). https://doi.org/10.1016/j.jbusvent.2012.07.003Organisation for Economic Co-operation and Development (OECD): OECD guidelines on measuring subjective well-being (2013)Organization for Economic Cooperation and Development: How’s Life? Measuring Wellbeing (2015). http://www.oecdbetterlifeindex.org . Accessed 28 May 2017Orlova, L.V., Sakhabieva, G.A., Vasyaycheva, V.A., Pronina, N.N.: Impact of educational attainment on the development of female entrepreneurship in Kazakhstan. Indian J. Sci. Technol. (2016). https://doi.org/10.17485/ijst/2016/v9i11/89427Osberg, L., Sharpe, A.: An index of economic wellbeing for selected OECD countries. Rev. Income Wealth 5(3), 291–316 (2002). https://doi.org/10.1111/1475-4991.00056Osberg, L., Sharpe, A.: New Estimates of the Index of Economic Wellbeing for Selected OECD Countries, 1980–2007. Centre for the Study of Living Standards, Ottawa (2009)Parasuraman, S., Purohit, Y.S., Godshalk, V.M., Beutell, N.J.: Work and family variables, entrepreneurial career success, and psychological wellbeing. J. Vocat. Behav. 48(3), 275–300 (1996). https://doi.org/10.1006/jvbe.1996.0025Parasuraman, S., & Simmers, C.A.: Type of employment, work–family conflict and well-being: a comparative study. J. Organ. Behav.: Int. J Ind., Occup. Organ. Psychol. Behav. 22(5), 551–568 (2001)Patrick, C., Stephens, H., Weinstein, A.: Where are all the self-employed women? Push and pull factors influencing female labor market decisions. Small Bus. Econ. 46(3), 365–390 (2016). https://doi.org/10.1007/s11187-015-9697-2Poggesi, S., Mari, M., De Vita, L.: What’s new in female entrepreneurship research? Answers from the literature. Int. Entrep. Manag. J. 12(3), 735–764 (2015). https://doi.org/10.1007/s11365-015-0364-5Ragin, C.: The Comparative Method: Moving Beyond Qualitative and Quantitative Strategies. University of California Press, Berkeley (1987)Ragin, C.C.: New directions in comparative research. In: Kohn, M.L. (ed.) Cross-National Research in Sociology, pp. 57–76. Sage, Newbury Park (1989)Ragin, C.C.: Fuzzy-Set Social Science. University of Chicago Press, Chicago (2000)Ragin, Charles C., Sonnett, J.: Between complexity and parsimony: limited diversity, counterfactual cases, and comparative analysis. In: Ragin, Charles C. (ed.) Redesigning Social Inquiry. University of Chicago Press, Chicago (2004)Ragin, C.C.: Redesigning Social Inquiry: Fuzzy Sets and Beyond, vol. 240. University of Chicago Pres, Chicago (2008)Rahman, S.A., Amran, A., Ahmad, N.H., Taghizadeh, S.K.: Enhancing the wellbeing of base of the pyramid entrepreneurs through business success: the role of private organizations. Soc. Indic. Res. 127(1), 195–216 (2016). https://doi.org/10.1007/s11205-015-0951-4Renee Baptiste, N.: Tightening the link between employee wellbeing at work and performance. Manag. Decis. 46(2), 284–309 (2008). https://doi.org/10.1108/00251740810854168Rey-Martí, A., Tur Porcar, A., Mas-Tur, A.: Linking female entrepreneurs’ motivation to business survival. J. Bus. Res. 68(4), 810–814 (2015). https://doi.org/10.1016/j.jbusres.2014.11.033Reynolds, P.D., Bygrave, W.D., Autio, E., Cox, L.W., Hay, M.: Global entrepreneurship monitor, 2002 executive report. London (2002)Ribes-Giner, G., Moya-Clemente, I., Cervelló-Royo, R., Perello-Marin, M.R.: Domestic economic and social conditions empowering female entrepreneurship. J. Bus. Res. 89, 182–189 (2018)Ruth Eikhof, D., Summers, J., Carter, S., Eikhof, D.R., Summers, J., Carter, S.: Women doing their own thing: media representations of female entrepreneurship. Int. J. Entrep. Behav. Res. 19(5), 547–564 (2013). https://doi.org/10.1108/IJEBR-09-2011-0107Sampedro Gallego, R., Camarero Rioja, L.: Female entrepreneurs in rural Spain—the failed subject of development. Rev. Int. Sociol. 65(48), 121–146 (2007)Saridakis, G., Marlow, S., Storey, D.J.: Do different factors explain male and female self-employment rates? J. Bus. Ventur. 29(3), 345–362 (2014). https://doi.org/10.1016/j.jbusvent.2013.04.004Shepherd, D.A., Douglas, E.J., Shanley, M.: New venture survival: ignorance, external shocks, and risk reduction strategies. J. Bus. Ventur. 15(5), 393–410 (2000). https://doi.org/10.1016/S0883-9026(98)00008-1Shepherd, D., Haynie, J.M.: Birds of a feather don’t always flock together: identity management in entrepreneurship. J. Bus. Ventur. 24(4), 316–337 (2009). https://doi.org/10.1016/j.jbusvent.2007.10.005Shinnar, R.S., Hsu, D.K., Powell, B.C.: Self-efficacy, entrepreneurial intentions, and gender: assessing the impact of entrepreneurship education longitudinally. Int. J. Manag. Educ. 12(3), 561–570 (2014). https://doi.org/10.1016/j.ijme.2014.09.005Shir, N.: Entrepreneurial Wellbeing: The Payoff Structure of Business Creation. Stockholm School of Economics, Stockholm (2015)Thiem, A., Dusa, A.: QCA: a package for qualitative comparative analysis. R package version 2.0. R J. 5, 87–97 (2013). Retrieved from https://cran.r-project.org/web/packages/QCA/index.htmlTorri, M.M.C., Martinez, A.: Women’s empowerment and micro-entrepreneurship in India: constructing a new development paradigm? Prog. Dev. Stud. 14(1), 31–48 (2014). https://doi.org/10.1177/1464993413504347Tur-Porcar, A., Mas-Tur, A., Belso, J.A.: Barriers to women entrepreneurship. Different methods, different results? Qual. Quant. 51(5), 2019–2034 (2017)Uy, M.A., Foo, M.Der, Song, Z.: Joint effects of prior start-up experience and coping strategies on entrepreneurs’ psychological wellbeing. J. Bus. Ventur. 28(5), 583–597 (2013). https://doi.org/10.1016/j.jbusvent.2012.04.003Uy, M.A., Sun, S., Foo, M.Der: Affect spin, entrepreneurs’ wellbeing, and venture goal progress: the moderating role of goal orientation. J. Bus. Ventur. 32(4), 443–460 (2017). https://doi.org/10.1016/j.jbusvent.2016.12.001Van der Sluis, J., Van Praag, M., Vijverberg, W.: Education and entrepreneurship selection and performance: a review of empirical literature. J. Econ. Surv. 22(5), 795–841 (2008)Verheul, I., Stel, A.Van, Thurik, R.: Explaining female and male entrepreneurship at the country level. Entrep. Reg. Dev. 18(2), 151–183 (2006). https://doi.org/10.1080/08985620500532053Witbooi, M., Ukpere, W.: Indigenous female entrepreneurship: analytical study on access to finance for women entrepreneurs in South Africa. Afr. J. Bus. Manag. 5(14), 5646–5657 (2011)Woodside, A.G., Bernal, P.M., Coduras, A.: The general theory of culture, entrepreneurship, innovation, and quality-of-life: comparing nurturing versus thwarting enterprise start-ups in BRIC, Denmark, Germany, and the United States. Ind. Mark. Manag. (2015). https://doi.org/10.1016/j.indmarman.2015.11.00

Prolonged higher dose methylprednisolone versus conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS)

Background Dysregulated systemic inflammation is the primary driver of mortality in severe coronavirus disease 2019 (COVID-19) pneumonia. Current guidelines favour a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg daily. A comparative randomised controlled trial (RCT) with a higher dose and a longer duration of intervention was lacking. Methods We conducted a multicentre, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering versus dexamethasone 6 mg once daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. The primary outcome was reduction in 28-day mortality. Secondary outcomes were mechanical ventilation-free days at 28 days, need for intensive care unit (ICU) referral, length of hospitalisation, need for tracheostomy, and changes in C-reactive protein (CRP) levels, arterial oxygen tension/inspiratory oxygen fraction (PaO2/FIO2) ratio and World Health Organization Clinical Progression Scale at days 3, 7 and 14. Results 677 randomised patients were included. Findings are reported as methylprednisolone (n=337) versus dexamethasone (n=340). By day 28, there were no significant differences in mortality (35 (10.4%) versus 41 (12.1%); p=0.49) nor in median mechanical ventilation-free days (median (interquartile range (IQR)) 23 (14) versus 24 (16) days; p=0.49). ICU referral was necessary in 41 (12.2%) versus 45 (13.2%) (p=0.68) and tracheostomy in 8 (2.4%) versus 9 (2.6%) (p=0.82). Survivors in the methylprednisolone group required a longer median (IQR) hospitalisation (15 (11) versus 14 (11) days; p=0.005) and experienced an improvement in CRP levels, but not in PaO2/FIO2 ratio, at days 7 and 14. There were no differences in disease progression at the prespecified time-points. Conclusion Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared with conventional dexamethasone in COVID-19 pneumonia

Beyond GDP and Back: What is the Value-Added by Additional Components of Welfare Measurement?

Recently, building on the highly polarizing Stiglitz report, a growing literature suggests that statistical offices and applied researchers explore other aspects of human welfare apart from material well-being, such as job security, crime, health, environmental factors and subjective perceptions. To explore the additional information of these indicators, we analyze data on the macro level from the German Federal Statistical Office combined with micro level data from the German SOEP (1991-2008) on the personal work situation and subjective feelings concerning several aspects of life. Employing the indicators suggested by the Stiglitz Report, we find that much of the variation in many well-being measures can indeed be captured well by the hard economic indicators as used in the literature, especially by GDP and the unemployment rate. This suggests that the hard indicators are still a reasonable and quite robust gauge of well-being of a country. And yet, we also see that these correlations are far from perfect, thus giving considerable hope that there is room for a broader statistical reporting