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1. Cost-effectiveness of adding oseltamivir to primary care for influenza-like-illness: economic evaluation alongside the randomised controlled ALIC4E trial in 15 European countries

Author

Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bruyndonckx, Robin, Coenen, Samuel, Bongard, Emily, de Paor, Muirrean, Chlabicz, Slawomir, Godycki-Cwirko, Maciek, Francis, Nick, Aabenhus, Rune, Bucher, Heiner C., Colliers, Annelies, De Sutter, An, Garcia-Sangenis, Ana, Glinz, Dominik, Harbin, Nicolay J., Kosiek, Katarzyna, Lindbæk, Morten, Lionis, Christos, Llor, Carl, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Sundvall, Pär-Daniel, Touboul Lundgren, Pia, Tsakountakis, Nikolaos, Verheij, Theo J., Goossens, Herman, Butler, Christopher C., and Beutels, Philippe

Published
2023
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2. Direct and Indirect Costs of Influenza-Like Illness Treated with and Without Oseltamivir in 15 European Countries: A Descriptive Analysis Alongside the Randomised Controlled ALIC4E Trial

Author

Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Pär-Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., and Beutels, Philippe

Published
2021
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3. Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial

Author

Butler, Christopher C, van der Velden, Alike W, Bongard, Emily, Saville, Benjamin R, Holmes, Jane, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Lewis, Roger J, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Sławomir, Lionis, Christos, Seifert, Bohumil, Sundvall, Pär-Daniel, Colliers, Annelies, Aabenhus, Rune, Bjerrum, Lars, Jonassen Harbin, Nicolay, Lindbæk, Morten, Glinz, Dominik, Bucher, Heiner C, Kovács, Bernadett, Radzeviciene Jurgute, Ruta, Touboul Lundgren, Pia, Little, Paul, Murphy, Andrew W, De Sutter, An, Openshaw, Peter, de Jong, Menno D, Connor, Jason T, Matheeussen, Veerle, Ieven, Margareta, Goossens, Herman, and Verheij, Theo J

Published
2020
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4. Cost-effectiveness of adding oseltamivir to primary care for influenza-like-illness: economic evaluation alongside the randomised controlled ALIC4E trial in 15 European countries.

Author

HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Li, Xiao, Bilcke, Joke, van der Velden, Alike W, Bruyndonckx, Robin, Coenen, Samuel, Bongard, Emily, de Paor, Muirrean, Chlabicz, Slawomir, Godycki-Cwirko, Maciek, Francis, Nick, Aabenhus, Rune, Bucher, Heiner C, Colliers, Annelies, De Sutter, An, Garcia-Sangenis, Ana, Glinz, Dominik, Harbin, Nicolay J, Kosiek, Katarzyna, Lindbæk, Morten, Lionis, Christos, Llor, Carl, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Sundvall, Pär-Daniel, Touboul Lundgren, Pia, Tsakountakis, Nikolaos, Verheij, Theo J, Goossens, Herman, Butler, Christopher C, Beutels, Philippe, ALIC4Etrial investigators, HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Li, Xiao, Bilcke, Joke, van der Velden, Alike W, Bruyndonckx, Robin, Coenen, Samuel, Bongard, Emily, de Paor, Muirrean, Chlabicz, Slawomir, Godycki-Cwirko, Maciek, Francis, Nick, Aabenhus, Rune, Bucher, Heiner C, Colliers, Annelies, De Sutter, An, Garcia-Sangenis, Ana, Glinz, Dominik, Harbin, Nicolay J, Kosiek, Katarzyna, Lindbæk, Morten, Lionis, Christos, Llor, Carl, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Sundvall, Pär-Daniel, Touboul Lundgren, Pia, Tsakountakis, Nikolaos, Verheij, Theo J, Goossens, Herman, Butler, Christopher C, Beutels, Philippe, and ALIC4Etrial investigators

Published
2023

6. Clinical presentation and disease course in patients with flu-like illness:does microbiological aetiology matter?

Author

Verheij, Theo, Cianci, Daniela, van der Velden, Alike, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Colliers, Annelies, Francis, Nick, Little, Paul, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Slawomir, Lionis, Christos, Sundvall, Pär-Daniel, Bjerrum, Lars, De Sutter, An, Aabenhus, Rune, Jonassen Harbin, Nicolay, Lindbaek, Morten, Glinz, Dominik, Bucher, Heiner, Kovacs, Bernadett, Seifert, Bohumil, Touboul Lundgren, Pia, de Paor, Muireann, Radzeviciene JUrgute, Ruta, Matheeussen, Veerle, Goossens, Herman, Ieven, Margareta, Verheij, Theo, Cianci, Daniela, van der Velden, Alike, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Colliers, Annelies, Francis, Nick, Little, Paul, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Slawomir, Lionis, Christos, Sundvall, Pär-Daniel, Bjerrum, Lars, De Sutter, An, Aabenhus, Rune, Jonassen Harbin, Nicolay, Lindbaek, Morten, Glinz, Dominik, Bucher, Heiner, Kovacs, Bernadett, Seifert, Bohumil, Touboul Lundgren, Pia, de Paor, Muireann, Radzeviciene JUrgute, Ruta, Matheeussen, Veerle, Goossens, Herman, and Ieven, Margareta

Abstract

BACKGROUND: There is little evidence about the relation between aetiology, illness severity and clinical course of respiratory tract infections (RTI) in primary care. Understanding these associations would aid to develop effective management strategies for these infections.AIM: To investigate whether the clinical presentation and illness course differ between RTI in whom a viral pathogen was detected and those in whom a potential bacterial pathogen was found.DESIGN AND SETTING: Post hoc analysis of data from a pragmatic randomised trial on the effects of oseltamivir in patients with influenza-like illness (ILI) in primary care (n=3266) in 15 European countries.METHODS: Patient characteristics, signs and symptoms were registered at baseline. Naso-pharyngeal (adults) or nasal and pharyngeal (children) swabs were taken for PCR analysis. Patients were followed up until 28 days after inclusion. Regression models and Kaplan-Meier curves were used to analyse the relation between aetiology, clinical presentation at baseline and course of disease including complications.RESULTS: Except for a less prominent congested nose (OR 0.55, CI 0.35 - 0.86) and acute cough (OR 0.52, CI 0.27 - 0.65) in ILI patients in whom a possible bacterial pathogen was isolated, there were no clear clinical differences in presentations between those with a possible bacterial aetiology than in those with a viral one. Also the course of disease and complications were not related to aetiology.CONCLUSION: Given the currently available microbiological tests and antimicrobial treatments, and outside pandemics like COVID-19, microbiological testing in primary care patients with ILI seems to have limited value.

Published
2022

7. Clinical prediction of laboratory-confirmed influenza in adults with influenza-like illness in primary care:A randomized controlled trial secondary analysis in 15 European countries

Author

Ouchi, Dan, García-Sangenís, Ana, Moragas, Ana, van der Velden, Alike W, Verheij, Theo J, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Godycki-Cwirko, Maciek, Lundgren, Pia Touboul, Lionis, Christos, Radzeviciene Jurgute, Ruta, Chlabicz, Sławomir, De Sutter, An, Bucher, Heiner C, Seifert, Bohumil, Kovács, Bernadett, de Paor, Muireann, Sundvall, Pär-Daniel, Aabenhus, Rune, Harbin, Nicolay Jonassen, Ieven, Greet, Goossens, Herman, Lindbæk, Morten, Bjerrum, Lars, Llor, Carl, Ouchi, Dan, García-Sangenís, Ana, Moragas, Ana, van der Velden, Alike W, Verheij, Theo J, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Godycki-Cwirko, Maciek, Lundgren, Pia Touboul, Lionis, Christos, Radzeviciene Jurgute, Ruta, Chlabicz, Sławomir, De Sutter, An, Bucher, Heiner C, Seifert, Bohumil, Kovács, Bernadett, de Paor, Muireann, Sundvall, Pär-Daniel, Aabenhus, Rune, Harbin, Nicolay Jonassen, Ieven, Greet, Goossens, Herman, Lindbæk, Morten, Bjerrum, Lars, and Llor, Carl

Abstract

BACKGROUND: Clinical findings do not accurately predict laboratory diagnosis of influenza. Early identification of influenza is considered useful for proper management decisions in primary care.OBJECTIVE: We evaluated the diagnostic value of the presence and the severity of symptoms for the diagnosis of laboratory-confirmed influenza infection among adults presenting with influenza-like illness (ILI) in primary care.METHODS: Secondary analysis of patients with ILI who participated in a clinical trial from 2015 to 2018 in 15 European countries. Patients rated signs and symptoms as absent, minor, moderate, or major problem. A nasopharyngeal swab was taken for microbiological identification of influenza and other microorganisms. Models were generated considering (i) the presence of individual symptoms and (ii) the severity rating of symptoms.RESULTS: A total of 2,639 patients aged 18 or older were included in the analysis. The mean age was 41.8 ± 14.7 years, and 1,099 were men (42.1%). Influenza was microbiologically confirmed in 1,337 patients (51.1%). The area under the curve (AUC) of the model for the presence of any of seven symptoms for detecting influenza was 0.66 (95% confidence interval [CI]: 0.65-0.68), whereas the AUC of the symptom severity model, which included eight variables-cough, fever, muscle aches, sweating and/or chills, moderate to severe overall disease, age, abdominal pain, and sore throat-was 0.70 (95% CI: 0.69-0.72).CONCLUSION: Clinical prediction of microbiologically confirmed influenza in adults with ILI is slightly more accurate when based on patient reported symptom severity than when based on the presence or absence of symptoms.

Published
2022

8. Clinical presentation, microbiological aetiology and disease course in patients with flu-like illness: a post hoc analysis of randomised controlled trial data

Author

HAG Infectieziekten, CTM & Statistical consultation, Biostatistiek Onderzoek, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Verheij, Theo, Cianci, Daniela, van der Velden, Alike, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Colliers, Annelies, Francis, Nick, Little, Paul, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Slawomir, Lionis, Christos, Sundvall, Pär-Daniel, Bjerrum, Lars, De Sutter, An, Aabenhus, Rune, Jonassen Harbin, Nicolay, Lindbaek, Morten, Glinz, Dominik, Bucher, Heiner, Kovacs, Bernadett, Seifert, Bohumil, Radzeviciene JUrgute, Ruta, Touboul Lundgren, Pia, de Paor, Muireann, Matheeussen, Veerle, Goossens, Herman, Ieven, Margareta, HAG Infectieziekten, CTM & Statistical consultation, Biostatistiek Onderzoek, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Verheij, Theo, Cianci, Daniela, van der Velden, Alike, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Colliers, Annelies, Francis, Nick, Little, Paul, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Slawomir, Lionis, Christos, Sundvall, Pär-Daniel, Bjerrum, Lars, De Sutter, An, Aabenhus, Rune, Jonassen Harbin, Nicolay, Lindbaek, Morten, Glinz, Dominik, Bucher, Heiner, Kovacs, Bernadett, Seifert, Bohumil, Radzeviciene JUrgute, Ruta, Touboul Lundgren, Pia, de Paor, Muireann, Matheeussen, Veerle, Goossens, Herman, and Ieven, Margareta

Published
2022

9. Clinical prediction of laboratory-confirmed influenza in adults with influenza-like illness in primary care. A randomized controlled trial secondary analysis in 15 European countries

Author

HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Ouchi, Dan, García-Sangenís, Ana, Moragas, Ana, van der Velden, Alike W, Verheij, Theo J, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Godycki-Cwirko, Maciek, Lundgren, Pia Touboul, Lionis, Christos, Radzeviciene Jurgute, Ruta, Chlabicz, Sławomir, De Sutter, An, Bucher, Heiner C, Seifert, Bohumil, Kovács, Bernadett, de Paor, Muireann, Sundvall, Pär-Daniel, Aabenhus, Rune, Harbin, Nicolay Jonassen, Ieven, Greet, Goossens, Herman, Lindbæk, Morten, Bjerrum, Lars, Llor, Carl, HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Ouchi, Dan, García-Sangenís, Ana, Moragas, Ana, van der Velden, Alike W, Verheij, Theo J, Butler, Christopher C, Bongard, Emily, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Godycki-Cwirko, Maciek, Lundgren, Pia Touboul, Lionis, Christos, Radzeviciene Jurgute, Ruta, Chlabicz, Sławomir, De Sutter, An, Bucher, Heiner C, Seifert, Bohumil, Kovács, Bernadett, de Paor, Muireann, Sundvall, Pär-Daniel, Aabenhus, Rune, Harbin, Nicolay Jonassen, Ieven, Greet, Goossens, Herman, Lindbæk, Morten, Bjerrum, Lars, and Llor, Carl

Published
2022

10. Clinical prediction of laboratory-confirmed influenza in adults with influenza-like illness in primary care. A randomized controlled trial secondary analysis in 15 European countries

Author

Ouchi, Dan, primary, García-Sangenís, Ana, additional, Moragas, Ana, additional, van der Velden, Alike W, additional, Verheij, Theo J, additional, Butler, Christopher C, additional, Bongard, Emily, additional, Coenen, Samuel, additional, Cook, Johanna, additional, Francis, Nick A, additional, Godycki-Cwirko, Maciek, additional, Lundgren, Pia Touboul, additional, Lionis, Christos, additional, Radzeviciene Jurgute, Ruta, additional, Chlabicz, Sławomir, additional, De Sutter, An, additional, Bucher, Heiner C, additional, Seifert, Bohumil, additional, Kovács, Bernadett, additional, de Paor, Muireann, additional, Sundvall, Pär-Daniel, additional, Aabenhus, Rune, additional, Harbin, Nicolay Jonassen, additional, Ieven, Greet, additional, Goossens, Herman, additional, Lindbæk, Morten, additional, Bjerrum, Lars, additional, and Llor, Carl, additional

Published
2021
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11. Direct and Indirect Costs of Influenza-Like Illness Treated with and Without Oseltamivir in 15 European Countries:A Descriptive Analysis Alongside the Randomised Controlled ALIC(4)E Trial

Author

Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Par-Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Miko-Pauer, Reka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., Beutels, Philippe, Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Par-Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Miko-Pauer, Reka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., and Beutels, Philippe

Abstract

Background and Objective Influenza-like illness (ILI) leads to a substantial disease burden every winter in Europe; however, oseltamivir is not frequently prescribed to ILI patients in the primary-care setting. An open-label, multi-country, multi-season, randomised controlled trial investigated the effectiveness of oseltamivir for treating ILI in 15 European countries. We aimed to evaluate whether patients presenting with ILI in primary care and being managed with the addition of oseltamivir to usual care had lower average direct and indirect costs compared to patients with usual care alone. Methods Resource use data were extracted from participants' daily diaries. Itemised country-specific unit costs were collected through official tariffs, pharmacies or literature. Costs were converted to 2018 values. The null hypothesis was tested based on one-sided credible intervals (CrIs) obtained by bootstrapping. Base-case analysis estimated direct cost and productivity losses using itemised costed resource use and the human capital approach. Scenario analyses with self-reported spending rather than itemised costing were also performed. Results Patients receiving oseltamivir (N = 1306) reported fewer healthcare visits, medication uses, hospital attendances and paid-work hours lost than the other patients (N = 1298). Excluding the oseltamivir cost, the average direct costs were lower in patients treated with oseltamivir from all perspectives, but these differences were not statistically significant (perspective of patient: euro17 [0-95% Crl: 16-19] vs. euro24 [5-100% Crl: 18-29]; healthcare provider: euro37 [28-67] vs. euro44 [25-55]; healthcare payers: euro54 [45-85] vs. euro68 [45-81]; and society: euro423 [399-478] vs. euro451 [390-478]). Scenario and age-group analyses confirmed these findings, but with some between-country differences. Conclusion The average direct and indirect costs were consistently lower in patients treated with oseltamivir than in patients without

Published
2021

12. Direct and Indirect Costs of Influenza-Like Illness Treated with and Without Oseltamivir in 15 European Countries: A Descriptive Analysis Alongside the Randomised Controlled ALIC4E Trial

Author

HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Pär Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., Beutels, Philippe, HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Pär Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., and Beutels, Philippe

Published
2021

13. Oseltamivir plus usual care versus usual care for influenza-like illness in primary care:an open-label, pragmatic, randomised controlled trial

Author

Butler, Christopher C, van der Velden, Alike W, Bongard, Emily, Saville, Benjamin R, Holmes, Jane, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Lewis, Roger J, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Sławomir, Lionis, Christos, Seifert, Bohumil, Sundvall, Pär-Daniel, Colliers, Annelies, Aabenhus, Rune, Bjerrum, Lars, Jonassen Harbin, Nicolay, Lindbæk, Morten, Glinz, Dominik, Bucher, Heiner C, Kovács, Bernadett, Radzeviciene Jurgute, Ruta, Touboul Lundgren, Pia, Little, Paul, Murphy, Andrew W, De Sutter, An, Openshaw, Peter, de Jong, Menno D, Connor, Jason T, Matheeussen, Veerle, Ieven, Margareta, Goossens, Herman, Verheij, Theo J, Butler, Christopher C, van der Velden, Alike W, Bongard, Emily, Saville, Benjamin R, Holmes, Jane, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Lewis, Roger J, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Sławomir, Lionis, Christos, Seifert, Bohumil, Sundvall, Pär-Daniel, Colliers, Annelies, Aabenhus, Rune, Bjerrum, Lars, Jonassen Harbin, Nicolay, Lindbæk, Morten, Glinz, Dominik, Bucher, Heiner C, Kovács, Bernadett, Radzeviciene Jurgute, Ruta, Touboul Lundgren, Pia, Little, Paul, Murphy, Andrew W, De Sutter, An, Openshaw, Peter, de Jong, Menno D, Connor, Jason T, Matheeussen, Veerle, Ieven, Margareta, Goossens, Herman, and Verheij, Theo J

Abstract

BACKGROUND: Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.METHODS: We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.FINDINGS: Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and sho

Published
2020

14. Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial

Author

HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Butler, Christopher C, van der Velden, Alike W, Bongard, Emily, Saville, Benjamin R, Holmes, Jane, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Lewis, Roger J, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Sławomir, Lionis, Christos, Seifert, Bohumil, Sundvall, Pär-Daniel, Colliers, Annelies, Aabenhus, Rune, Bjerrum, Lars, Jonassen Harbin, Nicolay, Lindbæk, Morten, Glinz, Dominik, Bucher, Heiner C, Kovács, Bernadett, Radzeviciene Jurgute, Ruta, Touboul Lundgren, Pia, Little, Paul, Murphy, Andrew W, De Sutter, An, Openshaw, Peter, de Jong, Menno D, Connor, Jason T, Matheeussen, Veerle, Ieven, Margareta, Goossens, Herman, Verheij, Theo J, HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, Butler, Christopher C, van der Velden, Alike W, Bongard, Emily, Saville, Benjamin R, Holmes, Jane, Coenen, Samuel, Cook, Johanna, Francis, Nick A, Lewis, Roger J, Godycki-Cwirko, Maciek, Llor, Carl, Chlabicz, Sławomir, Lionis, Christos, Seifert, Bohumil, Sundvall, Pär-Daniel, Colliers, Annelies, Aabenhus, Rune, Bjerrum, Lars, Jonassen Harbin, Nicolay, Lindbæk, Morten, Glinz, Dominik, Bucher, Heiner C, Kovács, Bernadett, Radzeviciene Jurgute, Ruta, Touboul Lundgren, Pia, Little, Paul, Murphy, Andrew W, De Sutter, An, Openshaw, Peter, de Jong, Menno D, Connor, Jason T, Matheeussen, Veerle, Ieven, Margareta, Goossens, Herman, and Verheij, Theo J

Published
2020

15. Direct and Indirect Costs of Influenza-Like Illness Treated with and Without Oseltamivir in 15 European Countries: A Descriptive Analysis Alongside the Randomised Controlled ALIC4E Trial.

Author

Li, Xiao, Bilcke, Joke, van der Velden, Alike W., Bongard, Emily, Bruyndonckx, Robin, Sundvall, Pär-Daniel, Harbin, Nicolay J., Coenen, Samuel, Francis, Nick, Bruno, Pascale, Garcia-Sangenis, Ana, Glinz, Dominik, Kosiek, Katarzyna, Mikó-Pauer, Réka, Radzeviciene Jurgute, Ruta, Seifert, Bohumil, Tsakountakis, Nikolaos, Aabenhus, Rune, Butler, Christopher C., and Beutels, Philippe

Subjects
ECONOMIC aspects of diseases, DIRECT costing, RANDOMIZED controlled trials, MEDICAL care cost statistics, OSELTAMIVIR, PATIENTS' attitudes
Abstract

Background and Objective: Influenza-like illness (ILI) leads to a substantial disease burden every winter in Europe; however, oseltamivir is not frequently prescribed to ILI patients in the primary-care setting. An open-label, multi-country, multi-season, randomised controlled trial investigated the effectiveness of oseltamivir for treating ILI in 15 European countries. We aimed to evaluate whether patients presenting with ILI in primary care and being managed with the addition of oseltamivir to usual care had lower average direct and indirect costs compared to patients with usual care alone. Methods: Resource use data were extracted from participants' daily diaries. Itemised country-specific unit costs were collected through official tariffs, pharmacies or literature. Costs were converted to 2018 values. The null hypothesis was tested based on one-sided credible intervals (CrIs) obtained by bootstrapping. Base-case analysis estimated direct cost and productivity losses using itemised costed resource use and the human capital approach. Scenario analyses with self-reported spending rather than itemised costing were also performed. Results: Patients receiving oseltamivir (N = 1306) reported fewer healthcare visits, medication uses, hospital attendances and paid-work hours lost than the other patients (N = 1298). Excluding the oseltamivir cost, the average direct costs were lower in patients treated with oseltamivir from all perspectives, but these differences were not statistically significant (perspective of patient: €17 [0–95% Crl: 16–19] vs. €24 [5–100% Crl: 18–29]; healthcare provider: €37 [28–67] vs. €44 [25–55]; healthcare payers: €54 [45–85] vs. €68 [45–81]; and society: €423 [399–478] vs. €451 [390–478]). Scenario and age-group analyses confirmed these findings, but with some between-country differences. Conclusion: The average direct and indirect costs were consistently lower in patients treated with oseltamivir than in patients without from four perspectives (excluding the oseltamivir cost). However, these differences were not statistically significant. [ABSTRACT FROM AUTHOR]

Published
2021
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16. Antivirals for influenza-Like Illness? : A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC E): the ALIC E protocol

Author

van der Velden, Alike W, Bongard, Emily, Cook, Johanna, Saville, Ben, Beutels, Philippe, Munck Aabenhus, Rune, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A, Glinz, Dominik, Godycki-Ćwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón-Torres, Frederico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, and Butler, Christopher C

Abstract

INTRODUCTION: Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. METHODS AND ANALYSIS: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48-72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. ETHICS AND DISSEMINATION: Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN27908921; Pre-results.

Published
2018

17. Antivirals for influenza-Like Illness? : a randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC⁴E) : the ALIC⁴E protocol

Author

Bongard, Emily, van der Velden, Alike W, Cook, Johanna, Saville, Ben, Beutels, Philippe, Munck Aabenhus, Rune, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A, Glinz, Dominik, Godycki-ćwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón-Torres, Frederico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, and Butler, Christopher C

Subjects
adaptive clinical trial, PRESCRIBING STRATEGIES, primary healthcare, EUROPE, oseltamivir, cost-benefit analysis, SURVEILLANCE, Medicine and Health Sciences, influenza, RECOMMENDATIONS
Abstract

Introduction: Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. Methods and analysis: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5days. We aim to recruit at least 2500 participants 1year presenting with influenza-like illness (ILI), with symptom duration 72hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (48hours/>48-72hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. Ethics and dissemination: Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations.

Published
2018

18. Antivirals for influenza-like illness? a randomised controlled trial of clinical and cost effectiveness in primary carE (ALIC4 E): the ALIC4 E protocol

Author

Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Bongard, Emily, Van der Velden, Alike W., Cook, Johanna, Saville, Ben, Beutels, Philippe, Aabenhus, Rune Munck, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A., Glinz, Dominik, Godycki-ćwirko, Maciek, Goossens, Hermann, Holmes, Jane, Ieven, Margareta, De Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón Torres, Federico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, Butler, Christopher C., Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Bongard, Emily, Van der Velden, Alike W., Cook, Johanna, Saville, Ben, Beutels, Philippe, Aabenhus, Rune Munck, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A., Glinz, Dominik, Godycki-ćwirko, Maciek, Goossens, Hermann, Holmes, Jane, Ieven, Margareta, De Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón Torres, Federico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, and Butler, Christopher C.

Abstract

Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies

Published
2018

19. Antivirals for influenza-Like Illness?: A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC E): the ALIC E protocol

Author

HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, van der Velden, Alike W, Bongard, Emily, Cook, Johanna, Saville, Ben, Beutels, Philippe, Munck Aabenhus, Rune, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A, Glinz, Dominik, Godycki-Ćwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón-Torres, Frederico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, Butler, Christopher C, HAG Infectieziekten, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, van der Velden, Alike W, Bongard, Emily, Cook, Johanna, Saville, Ben, Beutels, Philippe, Munck Aabenhus, Rune, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A, Glinz, Dominik, Godycki-Ćwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinón-Torres, Frederico, Moragas, Ana, Pauer, József, Pfeiferová, Markéta, Radzeviciene-Jurgute, Ruta, Sundvall, Pär-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, and Butler, Christopher C

Published
2018

20. Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E):the ALIC4 E protocol

Author

Bongard, Emily, van der Velden, Alike W., Cook, Johanna, Saville, Ben, Beutels, Philippe, Aabenhus, Rune Munck, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A., Glinz, Dominik, Godycki-cwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinon-Torres, Frederico, Moragas, Ana, Pauer, Jozsef, Pfeiferova, Marketa, Radzeviciene-Jurgute, Ruta, Sundvall, Paer-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, Butler, Christopher C., Bongard, Emily, van der Velden, Alike W., Cook, Johanna, Saville, Ben, Beutels, Philippe, Aabenhus, Rune Munck, Brugman, Curt, Chlabicz, Slawomir, Coenen, Samuel, Colliers, Annelies, Davies, Melanie, De Paor, Muireann, De Sutter, An, Francis, Nick A., Glinz, Dominik, Godycki-cwirko, Maciek, Goossens, Herman, Holmes, Jane, Ieven, Margareta, de Jong, Menno, Lindbaek, Morten, Little, Paul, Martinon-Torres, Frederico, Moragas, Ana, Pauer, Jozsef, Pfeiferova, Marketa, Radzeviciene-Jurgute, Ruta, Sundvall, Paer-Daniel, Torres, Antoni, Touboul, Pia, Varthalis, Dionyssios, Verheij, Theo, and Butler, Christopher C.

Published
2018

21. Enabling factors for antibiotic prescribing for upper respiratory tract infections:Perspectives of Lithuanian and Russian general practitioners

Author

Jaruseviciene, Lina, Radzeviciene Jurgute, Ruta, Bjerrum, Lars, Jurgutis, Arnoldas, Jarusevicius, Gediminas, Lazarus, Jeff, Jaruseviciene, Lina, Radzeviciene Jurgute, Ruta, Bjerrum, Lars, Jurgutis, Arnoldas, Jarusevicius, Gediminas, and Lazarus, Jeff

Abstract

Introduction. General practitioners (GPs) write about 80% of all antibiotic prescriptions, the greatest number of them for patients with respiratory tract infections. However, there is a lack of research targeting the influence of external factors on antibiotic prescribing by physicians. This study aimed to explore experiences of GPs in Lithuania and the Russian Federation with regard to antibiotic prescription for upper respiratory tract infections. By such means it might be possible to reveal external enabling factors that influence antibiotic prescribing in these countries. Method. Five focus groups were performed with 22 GPs from Lithuania and 29 GPs from the Kaliningrad Region of the Russian Federation; then, thematic analysis of data was performed. Results. Six thematic categories were identified that are related to external forces enabling antibiotic prescription: the necessity for political leadership to encourage clinically grounded antibiotic use; over-the-counter sale of antibiotics; designation of antibiotics as reimbursable medications; supervision by external oversight institutions; lack of guidelines for the treatment of upper respiratory tract infections; and pharmaceutical company activities. Conclusions. Comprehensive efforts to reduce the burden of non-clinically grounded antibiotic prescription should go beyond addressing factors at the physician-patient level and take into account important factors in the enabling environment as well.

Published
2013

22. A study of antibiotic prescribing: the experience of Lithuanian and Russian GPs

Author

Jaruseviciene, Lina, Radzeviciene-Jurgute, Ruta, Lazarus, Jeffrey V., Jurgutis, Arnoldas, Ovhed, Ingvar, Strandberg, Eva-Lena, Bjerrum, Lars, Jaruseviciene, Lina, Radzeviciene-Jurgute, Ruta, Lazarus, Jeffrey V., Jurgutis, Arnoldas, Ovhed, Ingvar, Strandberg, Eva-Lena, and Bjerrum, Lars

Abstract

Background. Globally, general practitioners (GPs) write more than 90% of all antibiotic prescriptions. This study examines the experiences of Lithuanian and Russian GPs in antibiotic prescription for upper respiratory tract infections, including their perceptions of when it is not indicated clinically or pharmacologically. Methods. 22 Lithuanian and 29 Russian GPs participated in five focus group discussions. Thematic analysis was used to analyse the data. Results. We identified four main thematic categories: patients' faith in antibiotics as medication for upper respiratory tract infections; patient potential to influence a GP's decision to prescribe antibiotics for upper respiratory tract infections; impediments perceived by GPs in advocating clinically grounded antibiotic prescribing with their patients, and strategies applied in physician-patient negotiation about antibiotic prescribing for upper respiratory tract infections. Conclusions. Understanding the nature of physician-patient interaction is critical to the effective pursuit of clinically grounded antibiotic use as this study undertaken in Lithuania and the Russian Federation has shown. Both physicians and patients must be targeted to ensure correct antibiotic use. Further, GPs should be supported in enhancing their communication skills about antibiotic use with their patients and encouraged to implement a shared decision-making model in their practices.

Published
2012

24. Improving Antibiotic Use in Nursing Homes by Infection Prevention and Control and Antibiotic Stewardship (IMAGINE): Protocol for a Before-and-After Intervention and Implementation Study.

Author

García-Sangenís A, Modena D, Jensen JN, Chalkidou A, Antsupova VS, Marloth T, Theut AM, González López-Valcárcel B, Raynal F, Vallejo-Torres L, Lykkegaard J, Hansen MP, Søndergaard J, Olsen JK, Munck A, Balint A, Benko R, Petek D, Sodja N, Kowalczyk A, Godycki-Cwirko M, Glasová H, Glasa J, Radzeviciene Jurgute R, Jaruseviciene L, Lionis C, Anastasaki M, Angelaki A, Petelos E, Alvarez L, Ricart M, Briones S, Ruppe G, Monfà R, Bjerrum A, and Llor C

Subjects
Humans, Europe epidemiology, Infection Control methods, Cross Infection prevention & control, Cross Infection epidemiology, Nursing Homes, Anti-Bacterial Agents therapeutic use, Antimicrobial Stewardship, Urinary Tract Infections prevention & control, Urinary Tract Infections drug therapy, Urinary Tract Infections epidemiology
Abstract

Background: Despite the extensive use of antibiotics and the growing challenge of antimicrobial resistance, there has been a lack of substantial initiatives aimed at diminishing the prevalence of infections in nursing homes and enhancing the detection of urinary tract infections (UTIs)., Objective: This study aims to systematize and enhance efforts to prevent health care-associated infections, mainly UTIs and reduce antibiotic inappropriateness by implementing a multifaceted intervention targeting health care professionals in nursing homes., Methods: A before-and-after intervention study carried out in a minimum of 10 nursing homes in each of the 8 European participating countries (Denmark, Greece, Hungary, Lithuania, Poland, Slovakia, Slovenia, and Spain). A team of 4 professionals consisting of nurses, doctors, health care assistants, or health care helpers are actively involved in each nursing home. Over the initial 3-month period, professionals in each nursing home are registering information on UTIs as well as infection and prevention control measures by means of the Audit Project Odense method. The audit will be repeated after implementing a multifaceted intervention. The intervention will consist of feedback and discussion of the results from the first registration, training on the implementation of infection and prevention control techniques provided by experts, appropriateness of the diagnostic approach and antibiotic prescribing for UTIs, and provision of information materials on infection control and antimicrobial stewardship targeted to staff, residents, and relatives. We will compare the pre- and postintervention audit results using chi-square test for prescription appropriateness and Student t test for implemented hygiene elements., Results: A total of 109 nursing homes have participated in the pilot study and the first registration audit. The results of the first audit registration are expected to be published in autumn of 2024. The final results will be published by the end of 2025., Conclusions: This is a European Union-funded project aimed at contributing to the battle against antimicrobial resistance through improvement of the quality of management of common infections based on evidence-based interventions tailored to the nursing home setting and a diverse range of professionals. We expect the intervention to result in a significant increase in the number of hygiene activities implemented by health care providers and residents. Additionally, we anticipate a marked reduction in the number of inappropriately managed UTIs, as well as a substantial decrease in the overall incidence of infections following the intervention., International Registered Report Identifier (irrid): DERR1-10.2196/60099., (©Ana García-Sangenís, Daniela Modena, Jette Nygaard Jensen, Athina Chalkidou, Valeria S Antsupova, Tina Marloth, Anna Marie Theut, Beatriz González López-Valcárcel, Fabiana Raynal, Laura Vallejo-Torres, Jesper Lykkegaard, Malene Plejdrup Hansen, Jens Søndergaard, Jonas Kanstrup Olsen, Anders Munck, András Balint, Ria Benko, Davorina Petek, Nina Sodja, Anna Kowalczyk, Maciej Godycki-Cwirko, Helena Glasová, Jozef Glasa, Ruta Radzeviciene Jurgute, Lina Jaruseviciene, Christos Lionis, Marilena Anastasaki, Agapi Angelaki, Elena Petelos, Laura Alvarez, Marta Ricart, Sergi Briones, Georg Ruppe, Ramon Monfà, Anders Bjerrum, Carl Llor. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.09.2024.)

Published
2024
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25. Clinical prediction of laboratory-confirmed influenza in adults with influenza-like illness in primary care. A randomized controlled trial secondary analysis in 15 European countries.

Author

Ouchi D, García-Sangenís A, Moragas A, van der Velden AW, Verheij TJ, Butler CC, Bongard E, Coenen S, Cook J, Francis NA, Godycki-Cwirko M, Lundgren PT, Lionis C, Radzeviciene Jurgute R, Chlabicz S, De Sutter A, Bucher HC, Seifert B, Kovács B, de Paor M, Sundvall PD, Aabenhus R, Harbin NJ, Ieven G, Goossens H, Lindbæk M, Bjerrum L, and Llor C

Subjects
Adult, Clinical Laboratory Techniques, Cough, Female, Fever, Humans, Male, Middle Aged, Primary Health Care, Influenza, Human diagnosis, Influenza, Human epidemiology
Abstract

Background: Clinical findings do not accurately predict laboratory diagnosis of influenza. Early identification of influenza is considered useful for proper management decisions in primary care., Objective: We evaluated the diagnostic value of the presence and the severity of symptoms for the diagnosis of laboratory-confirmed influenza infection among adults presenting with influenza-like illness (ILI) in primary care., Methods: Secondary analysis of patients with ILI who participated in a clinical trial from 2015 to 2018 in 15 European countries. Patients rated signs and symptoms as absent, minor, moderate, or major problem. A nasopharyngeal swab was taken for microbiological identification of influenza and other microorganisms. Models were generated considering (i) the presence of individual symptoms and (ii) the severity rating of symptoms., Results: A total of 2,639 patients aged 18 or older were included in the analysis. The mean age was 41.8 ± 14.7 years, and 1,099 were men (42.1%). Influenza was microbiologically confirmed in 1,337 patients (51.1%). The area under the curve (AUC) of the model for the presence of any of seven symptoms for detecting influenza was 0.66 (95% confidence interval [CI]: 0.65-0.68), whereas the AUC of the symptom severity model, which included eight variables-cough, fever, muscle aches, sweating and/or chills, moderate to severe overall disease, age, abdominal pain, and sore throat-was 0.70 (95% CI: 0.69-0.72)., Conclusion: Clinical prediction of microbiologically confirmed influenza in adults with ILI is slightly more accurate when based on patient reported symptom severity than when based on the presence or absence of symptoms., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2022
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26. Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC 4 E): the ALIC 4 E protocol.

Author

Bongard E, van der Velden AW, Cook J, Saville B, Beutels P, Munck Aabenhus R, Brugman C, Chlabicz S, Coenen S, Colliers A, Davies M, De Paor M, De Sutter A, Francis NA, Glinz D, Godycki-Ćwirko M, Goossens H, Holmes J, Ieven M, de Jong M, Lindbaek M, Little P, Martinón-Torres F, Moragas A, Pauer J, Pfeiferová M, Radzeviciene-Jurgute R, Sundvall PD, Torres A, Touboul P, Varthalis D, Verheij T, and Butler CC

Subjects
Activities of Daily Living, Antiviral Agents economics, Cost-Benefit Analysis, Female, Fever virology, Headache virology, Hospitalization, Humans, Influenza, Human complications, Influenza, Human prevention & control, Male, Multicenter Studies as Topic, Myalgia virology, Nonprescription Drugs therapeutic use, Oseltamivir economics, Pneumonia virology, Prescription Drugs therapeutic use, Self Care, Symptom Assessment, Time Factors, Antiviral Agents therapeutic use, Influenza, Human drug therapy, Oseltamivir therapeutic use, Pragmatic Clinical Trials as Topic
Abstract

Introduction: Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies., Methods and Analysis: Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12-64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48-72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms., Ethics and Dissemination: Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations., Trial Registration Number: ISRCTN27908921; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2018
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