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8. Statistical analysis of quantitative seroepidemiological data

Author

Kafatos, George

Subjects
610.21
Abstract

The material for this thesis is based on the European Sero-Epidemiology Network 2 (ESEN2), a study funded by the European Commission. As part of the ESEN2 project, age-specific population seroprevalence of 8 antigens tested in 22 national laboratories was estimated and compared between countries. To achieve harmonised serological results, a reference panel was tested by each participant laboratory. Each laboratory's panel results were regressed against the reference centre, thus obtaining standardisation equations. These equations were used to convert the quantitative measurements of the serosurveys into common units that were subsequently classified into negative (susceptible) or positive (protected) according to a serological cut-off. The aim of this thesis was to further develop and validate the methodology for standardising serological outcomes, and to propose alternative methods for achieving comparable population seroprevalence. As part of this thesis, a statistical algorithm was established to standardise serological results. Censored regression methods were considered to account for measurements outside the assay detection range. The impact of standardisation on seroprevalence was examined. Mixture modelling of the serological results was proposed as an alternative method to standardisation for estimating seroprevalence. Although mixture modelling may provide better seroprevalence estimates in certain situations, it is heavily dependent on model assumptions, mainly of well-separated underlying distributions. In terms of seroprevalence estimation using standardisation, the validity of the assay cut-off point was examined. A method for re-estimating cut-offs was proposed based on mixture modelling that improved seroprevalence estimates under certain distributional assumptions. The impact of variability occurring due to serum testing in batches (plate-to-plate variability) on seroprevalence was assessed. The method currently used by the laboratories was examined, and a new method was proposed to adjust for this based on mixture models. In conclusion, the standardisation method used for the ESEN2 project was validated and some improvements were proposed.

Published
2011
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13. Presence of Breast Cancer Information Recorded in United Kingdom Primary Care Databases: Comparison of CPRD Aurum and CPRD GOLD (Companion Paper 1).

Author

Hagberg, Katrina Wilcox, Vasilakis-Scaramozza, Catherine, Persson, Rebecca, Neasham, David, Kafatos, George, and Jick, Susan

Subjects
BREAST cancer, PRIMARY care, MEDICAL record databases, CANCER diagnosis, BREAST cancer research, GOLD, FORCEPS
Abstract

Purpose: To evaluate the presence of data elements related to diagnosis and treatment of malignant breast cancer in CPRD Aurum compared to those in the previously validated CPRD GOLD.Methods: Females in CPRD Aurum or GOLD with a first-time code for malignant breast cancer, mastectomy, or ≥ 1 prescription for tamoxifen or aromatase inhibitors (2004– 2019) were selected. We compared the presence of the codes for breast cancer diagnosis, surgeries (mastectomy, lumpectomy), tamoxifen and aromatase inhibitor prescriptions, radiation, chemotherapy, and supporting clinical codes (suspected breast cancer, lump symptoms, biopsy, lumpectomy, cancer care, referral/visit to specialist, palliative care). Age standardized incidence rates of breast cancer diagnosis in CPRD Aurum and GOLD were calculated.Results: There were 131,936 eligible patients in CPRD Aurum and 69,102 patients in GOLD. A similar proportion of patients in CPRD Aurum and GOLD had codes for breast cancer diagnosis, mastectomy, drug prescriptions, lump, biopsy, lumpectomy, chemotherapy, and cancer and palliative care coded in their electronic record during follow-up. However, suspected breast cancer, radiation, and referral/visits to specialists were coded more frequently in patients in CPRD Aurum compared to GOLD. Age-standardized incidence rates were similar for CPRD Aurum and GOLD.Conclusion: Overall, there was consistency between data elements related to malignant breast cancer recorded in CPRD Aurum and GOLD, particularly for the most informative clinical details. These findings provide reassurance that breast cancer information recorded in CPRD Aurum is generally comparable to that recorded in the previously validated CPRD GOLD and support the use of CPRD Aurum for breast cancer research. [ABSTRACT FROM AUTHOR]

Published
2023
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14. Correctness and Completeness of Breast Cancer Diagnoses Recorded in UK CPRD Aurum and CPRD GOLD Databases: Comparison to Hospital Episode Statistics and Cancer Registry (Companion Paper 2)

Author

Hagberg,Katrina, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, Jick,Susan, Hagberg,Katrina, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, and Jick,Susan

Abstract

Katrina Wilcox Hagberg,1 Catherine Vasilakis-Scaramozza,2 Rebecca Persson,1 David Neasham,2 George Kafatos,2 Susan Jick1,3 1Epidemiology, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA; 2Center for Observational Research, Amgen Ltd, Uxbridge, UK; 3Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Susan Jick, Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA, 02421, USA, Tel +1 781 862 6660, Fax +1 781 862 1680, Email sjick@bu.eduPurpose: To evaluate the new Clinical Practice Research Datalink (CPRD) Aurum database, we estimated ‘correctness’ (ie accuracy, validity) and ‘completeness’ (ie presence, missingness) of malignant breast cancer diagnoses recorded in CPRD Aurum compared to external linked data sources: Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Outpatient (OP), and Cancer Registry (CR), and to the previously validated CPRD GOLD.Methods: Linkage-eligible, female patients with incident malignant breast cancer diagnosis recorded in at least one study data source were selected. Correctness was the proportion of malignant breast cancer cases recorded in CPRD Aurum or GOLD who also had a diagnosis recorded in HES APC/OP (2004– 2019) or CR (2004– 2016). Completeness was estimated by identifying all malignant breast cancer diagnoses in HES APC/OP or CR and calculating the proportion with a concordant diagnosis in CPRD Aurum or GOLD.Results: Compared to HES APC/OP, there were 85,659 and 31,452 eligible patients in CPRD Aurum and GOLD, respectively. Correctness estimates were high (CPRD Aurum 83.5%, GOLD 81.7%). Compared to CR, there were 70,190 and 29,597 eligible patients in CPRD Aurum and GOLD, respectively: correctness was 89.1% for CPRD Aurum and 88.2% for GOLD. Completeness estimates for CPRD Aurum and GOLD were high (> 90%). Diagnoses were recorded in CPRD Aurum within − 7 to

Published
2023

15. Comparison of Rheumatoid Arthritis Information Recorded in UK CPRD Aurum and CPRD GOLD Databases (Companion Paper 3)

Author

Vasilakis-Scaramozza,Catherine, Hagberg,Katrina, Persson,Rebecca, Kafatos,George, Maskell,Joe, Neasham,David, Jick,Susan, Vasilakis-Scaramozza,Catherine, Hagberg,Katrina, Persson,Rebecca, Kafatos,George, Maskell,Joe, Neasham,David, and Jick,Susan

Abstract

Catherine Vasilakis-Scaramozza,1 Katrina Wilcox Hagberg,1 Rebecca Persson,1 George Kafatos,2 Joe Maskell,2 David Neasham,2 Susan Jick1,3 1Epidemiology, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA; 2Center for Observational Research, Amgen Ltd, Uxbridge, UK; 3Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Susan Jick, Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA, 02421, USA, Tel +1 781 862 6660, Fax +1 781 862 1680, Email sjick@bu.eduPurpose: To report distribution of codes associated with a rheumatoid arthritis (RA) diagnosis recorded in Clinical Practice Research Datalink (CPRD) Aurum compared to the previously validated CPRD GOLD database as a critical step toward making decisions about CPRD Aurum’s suitability for medical research.Patients and Methods: We analyzed the distribution of codes for RA diagnoses, labs, and treatments in the new CPRD Aurum database, compared to the CPRD GOLD database by selecting relevant indicators of RA diagnosis, treatment, and clinical care. We included all patients in England in CPRD Aurum and CPRD GOLD with an incident diagnosis code for RA on or after 1 January 2005 and at least two years recorded data before first RA diagnosis.Results: We found 53,083 and 18,167 patients with a new diagnosis code for RA in CPRD Aurum and CPRD GOLD, respectively. In both databases approximately 67% were female with similar mean ages at first diagnosis. There were few differences in RA-related recording patterns between the two data sources. Before first RA diagnosis, CPRD Aurum patients had more RA-specific labs and other supporting clinical codes. After diagnosis, CPRD Aurum patients had more RA diagnoses coded and more often had 10+ general RA labs than patients in CPRD GOLD. More CPRD GOLD patients had 10+ prescriptions for conventional disease-modifying antirheumatic drugs (cDMARD) compared to CPRD Aurum. Otherwise, the distribution of

Published
2023

16. Use of the CPRD Aurum Database: Insights Gained from New Data Quality Assessments

Author

Jick,Susan, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, Hagberg,Katrina, Jick,Susan, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, and Hagberg,Katrina

Abstract

Susan Jick,1,2 Catherine Vasilakis-Scaramozza,1 Rebecca Persson,1 David Neasham,3 George Kafatos,3 Katrina Wilcox Hagberg1 1Epidemiology, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA; 2Epidemiology, Boston University School of Public Health, Boston, MA, USA; 3Center for Observational Research, Amgen Ltd, Uxbridge, UKCorrespondence: Susan Jick, Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA, 02421, USA, Tel +1 781 862 6660, Fax +1 781 862 1680, Email sjick@bu.eduAbstract: Ongoing evaluation of any electronic health data source is critical to assess suitability for its use in medical research. In addition, familiarity with a data source’s history and recording practices is important for making informed data source selection, study design choices, and interpretation of results. In this commentary, the authors discuss three studies that assessed different aspects of the quality and completeness of information contained in Clinical Practice Research Datalink (CPRD) Aurum compared to the well-established CPRD GOLD and to other linked data sources, with the aim to describe insights gained through these data quality assessments. Our findings support the view that CPRD Aurum and GOLD are both valuable tools for studies based on information recorded in primary care but should not be used without critical consideration of strengths and limitations. Further, use of linked data should be considered for some studies, after taking into account all relevant factors.Keywords: clinical practice research datalink, CPRD Aurum, CPRD GOLD, validation, data quality

Published
2023

17. Presence of Breast Cancer Information Recorded in United Kingdom Primary Care Databases: Comparison of CPRD Aurum and CPRD GOLD (Companion Paper 1)

Author

Hagberg,Katrina, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, Jick,Susan, Hagberg,Katrina, Vasilakis-Scaramozza,Catherine, Persson,Rebecca, Neasham,David, Kafatos,George, and Jick,Susan

Abstract

Katrina Wilcox Hagberg,1 Catherine Vasilakis-Scaramozza,2 Rebecca Persson,1 David Neasham,2 George Kafatos,2 Susan Jick1,3 1Epidemiology, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA; 2Center for Observational Research, Amgen Ltd, Uxbridge, UK; 3Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Susan Jick, Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA, 02421, USA, Tel +1 781 862 6660, Fax +1 781 862 1680, Email sjick@bu.eduPurpose: To evaluate the presence of data elements related to diagnosis and treatment of malignant breast cancer in CPRD Aurum compared to those in the previously validated CPRD GOLD.Methods: Females in CPRD Aurum or GOLD with a first-time code for malignant breast cancer, mastectomy, or ≥ 1 prescription for tamoxifen or aromatase inhibitors (2004– 2019) were selected. We compared the presence of the codes for breast cancer diagnosis, surgeries (mastectomy, lumpectomy), tamoxifen and aromatase inhibitor prescriptions, radiation, chemotherapy, and supporting clinical codes (suspected breast cancer, lump symptoms, biopsy, lumpectomy, cancer care, referral/visit to specialist, palliative care). Age standardized incidence rates of breast cancer diagnosis in CPRD Aurum and GOLD were calculated.Results: There were 131,936 eligible patients in CPRD Aurum and 69,102 patients in GOLD. A similar proportion of patients in CPRD Aurum and GOLD had codes for breast cancer diagnosis, mastectomy, drug prescriptions, lump, biopsy, lumpectomy, chemotherapy, and cancer and palliative care coded in their electronic record during follow-up. However, suspected breast cancer, radiation, and referral/visits to specialists were coded more frequently in patients in CPRD Aurum compared to GOLD. Age-standardized incidence rates were similar for CPRD Aurum and GOLD.Conclusion: Overall, there was consistency between data elements related to malignant breast cancer rec

Published
2023

18. The Healthcare Professionals’ Perspective on Impact and Actions Taken Following Severe Infusion Reaction Events in Oncology Centers in Europe

Author

Kafatos, George, Dube, Sabada, Burdon, Peter, Lowe, Kimberly, Leclerc, Marjorie, Flinois, Alain, and Demonty, Gaston

Abstract

Purpose: The study aim was to describe the management strategies used for severe infusion-related reactions (SIRs) and understand the impact of such events in oncology day hospitals in France, Germany, Spain, and the UK. Methods: The study was based on qualitative telephone interviews and quantitative self-completion questionnaires and asked healthcare professionals about the impact of SIRs and consequent actions taken. Results: The procedures to prevent and manage SIRs were similar across countries and settings. In all countries, they were part of a larger risk-assessment and adverse events-prevention process. Preventive measures included patient history, risk assessment, pre-medication, and close monitoring of high-risk patients. The management procedures comprised stopping the infusion, triggering of the emergency chain, administering corticosteroids ± antihistamines, and hospitalization if necessary. The recalled SIRs had important consequences to affected patients, healthcare providers, and hospital organizational plans. All affected patients needed to be monitored closely for a prolonged time, thus blocking hospital beds. 44% of patients needed to be hospitalized, 17% needed resuscitation, and one patient died of cardiac arrest immediately after the start of the infusion. Importantly, 82% of patients were not re-challenged with the presumedly SIR-causing regimen or re-challenged in a later line. Conclusion: SIRs are unpredictable in nature, may have an extremely rapid onset, and are potentially fatal. Such events have a profound impact on the affected and surrounding patients, the care team and the organizational plan of the day-hospitals. Specific tools to reliably identify high-risk patients and predict the occurrence of events are needed.

Published
2024
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20. Use of antiviral drugs to reduce household transmission of pandemic (H1N1) 2009, United Kingdom

Author

Pebody, Richard G., Harris, Ross, Kafatos, George, Chamberland, Mary, Campbell, Colin, Nguyen-Van-Tam, Jonathan S., McLean, Estelle, Andrews, Nick, White, Peter J., Wynne-Evans, Edward, Green, Jon, Ellis, Joanna, Wreghitt, Tim, Bracebridge, Sam, Ihekweazu, Chikwe, Oliver, Isabel, Smith, Gillian, Hawkins, Colin, Salmon, Roland, Smyth, Brian, McMenamin, Jim, Zambon, Maria, Phin, Nick, and Watson, John M.

Subjects
Medical research -- Health aspects -- Analysis -- Usage, Medicine, Experimental -- Health aspects -- Analysis -- Usage, Swine influenza -- Risk factors -- Health aspects -- Analysis, Avian influenza viruses -- Health aspects -- Analysis -- Usage, Antiviral agents -- Usage -- Health aspects -- Analysis, Public health -- Health aspects -- Analysis -- Usage, Disease transmission -- Risk factors -- Health aspects -- Analysis, Algorithms -- Health aspects -- Analysis -- Usage, Algorithm, Health
Abstract

Following emergence of pandemic influenza A (H1N1) 2009 in North America in spring 2009 (1,2), global spread of the virus was rapid (3,4). In the United Kingdom, the first confirmed [...]

Published
2011
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21. European Sero-Epidemiology Network 2: Standardisation of immunoassay results for pertussis requires homogeneity in the antigenic preparations

Author

Giammanco, Anna, Nardone, Antony, Pebody, Richard, Kafatos, George, Andrews, Nick, Chiarini, Alfredo, Taormina, Susanna, de Ory, Fernando, Prosenc, Katarina, Krize, Bohumir, Hallander, Hans, Ljungman, Margaretha, Marva, Esther, Tsakris, Athanassios, O’Flanagan, Darina, Schneider, François, Griskevicius, Algirdas, Vranckx, Robert, and Karacs, Ildiko

Published
2008
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22. Hepatitis E outbreak on cruise ship

Author

Said, Bengu, Ijaz, Samreen, Kafatos, George, Booth, Linda, Thomas, H. Lucy, Walsh, Amanda, Ramsay, Mary, and Morgan, Dilys

Subjects
Company distribution practices, Immunoglobulin G -- Health aspects, Immunoglobulin G -- Genetic aspects, Immunoglobulin G -- Research, Disease transmission -- Health aspects, Disease transmission -- Research, Hepatitis E -- Risk factors, Hepatitis E -- Distribution, Hepatitis E -- Genetic aspects, Hepatitis E -- Prevention, Hepatitis E -- Research
Abstract

In 1980, hepatitis E virus (HEV) was recognized as a cause of human disease (1,2). HEV infections can be asymptomatic or they can induce clinical hepatitis, which may be severe [...]

Published
2009
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25. Evolution of RAS testing over time: factors influencing mutation rates in metastatic colorectal cancer patients

Author

Dufraing, K., Keppens, C., Tack, V., Siebers, A.G., Kafatos, George, Dube, Sabada, Kroeze, L., Ligtenberg, M.J., Krieken, J.H. van, Dequeker, E.M., Dufraing, K., Keppens, C., Tack, V., Siebers, A.G., Kafatos, George, Dube, Sabada, Kroeze, L., Ligtenberg, M.J., Krieken, J.H. van, and Dequeker, E.M.

Abstract

Contains fulltext : 219102.pdf (publisher's version ) (Open Access)

Published
2020

26. Social behavior and meningococcal carriage in British teenagers

Author

MacLennan, Jenny, Kafatos, George, Neal, Keith, Andrews, Nick, Cameron, J. Claire, Roberts, Richard, Evans, Meirion R., Cann, Kathy, Baxter, David N., Maiden, Martin C.J., and Stuart, James M.

Subjects
Communicable diseases -- Research, Meningococcal infections -- Research, Teenagers -- Health aspects, Teenagers -- Social aspects, Teenagers -- Research, Youth -- Health aspects, Youth -- Social aspects, Youth -- Research, Public health -- Research, United Kingdom -- Health aspects, United Kingdom -- Research
Abstract

Understanding predisposing factors for meningococcal carriage may identify targets for public health interventions. Before mass vaccination with meningococcal group C conjugate vaccine began in autumn 1999, we took pharyngeal swabs [...]

Published
2006

29. European seroepidemiology network 2: Standardisation of assays for seroepidemiology of varicella zoster virus

Author

de Ory, Fernando, Echevarría, José Manuel, Kafatos, George, Anastassopoulou, Cleo, Andrews, Nick, Backhouse, Josephine, Berbers, Guy, Bruckova, Blazena, Cohen, Daniel I., de Melker, Hester, Davidkin, Irja, Gabutti, Giovanni, Hesketh, Louise M., Johansen, Kari, Jokinen, Sari, Jones, Lindsay, Linde, Anika, Miller, Elisabeth, Mossong, Joël, Nardone, Anthony, Rota, Maria Cristina, Sauerbrei, Andreas, Schneider, François, Smetana, Zahava, Tischer, Annedore, Tsakris, Athanassios, and Vranckx, Robert

Published
2006
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30. Real‐world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK ‐based electronic health records database

Author

Seesaghur, Anouchka, primary, Petruski‐Ivleva, Natalia, additional, Banks, Victoria, additional, Wang, Jocelyn Ruoyi, additional, Mattox, Pattra, additional, Hoeben, Edwin, additional, Maskell, Joe, additional, Neasham, David, additional, Reynolds, Shannon L., additional, and Kafatos, George, additional

Published
2020
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31. Management of EGFR Inhibitor-induced Skin Toxicity and Factors Impacting Patients’ Adherence to Skin Toxicity Treatment: Health Care Provider and Patient Surveys in European Oncology Centers

Author

Kafatos, George, primary, Dube, Sabada, additional, Burdon, Peter, additional, Demonty, Gaston, additional, Flinois, Alain, additional, Leclerc, Marjorie, additional, Lowe, Kimberly, additional, Feudjo-Tepie, Maurille, additional, and Segaert, Siegfried, additional

Published
2020
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32. Evolution of RAS testing over time: factors influencing mutation rates in metastatic colorectal cancer patients

Author

Dufraing, Kelly, primary, Keppens, Cleo, additional, Tack, Véronique, additional, Siebers, Albert Gerrit, additional, Kafatos, George, additional, Dube, Sabada, additional, Demonty, Gaston, additional, Lowe, Kimberly, additional, Kroeze, Leonie Ilse, additional, Ligtenberg, Marjolijn, additional, Normanno, Nicola, additional, Tembuyser, Lien, additional, Sara, Vander Borght, additional, van Krieken, Joannes Henricus, additional, and C Dequeker, Elisabeth Marie, additional

Published
2020
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35. Real‐world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK‐based electronic health records database.

Author

Seesaghur, Anouchka, Petruski‐Ivleva, Natalia, Banks, Victoria, Wang, Jocelyn Ruoyi, Mattox, Pattra, Hoeben, Edwin, Maskell, Joe, Neasham, David, Reynolds, Shannon L., and Kafatos, George

Abstract

Purpose We evaluated the reproducibility of a study characterizing newly‐diagnosed multiple myeloma (MM) patients within an electronic health records (EHR) database using different analytic tools. Methods: We reproduced the findings of a descriptive cohort study using an iterative two‐phase approach. In Phase I, a common protocol and statistical analysis plan (SAP) were implemented by independent investigators using the Aetion Evidence Platform® (AEP), a rapid‐cycle analytics tool, and SAS statistical software as a gold standard for statistical analyses. Using the UK Clinical Practice Research Datalink (CPRD) dataset, the study included patients newly diagnosed with MM within primary care setting and assessed baseline demographics, conditions, drug exposure, and laboratory procedures. Phase II incorporated analysis revisions based on our initial comparison of the Phase I findings. Reproducibility of findings was evaluate by calculating the match rate and absolute difference in prevalence between the SAS and AEP study results. Results: Phase I yielded slightly discrepant results, prompting amendments to SAP to add more clarity to operational decisions. After detailed specification of data and operational choices, exact concordance was achieved for the number of eligible patients (N = 2646), demographics, comorbidities (i.e., osteopenia, osteoporosis, cardiovascular disease [CVD], and hypertension), bone pain, skeletal‐related events, drug exposure, and laboratory investigations in the Phase II analyses. Conclusions: In this reproducibility study, a rapid‐cycle analytics tool and traditional statistical software achieved near‐exact findings after detailed specification of data and operational choices. Transparency and communication of the study design, operational and analytical choices between independent investigators were critical to achieve this reproducibility. [ABSTRACT FROM AUTHOR]

Published
2021
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36. Series: Pragmatic trials and real world evidence : Paper 8 Data collection and management Data collection in Pragmatic Trials

Author

Meinecke, Anna Katharina, Welsing, Paco, Kafatos, George, Burke, Des, Trelle, Sven, Kubin, Maria, Nachbaur, Gaelle, Egger, Matthias, Zuidgeest, Mira, and work package 3 of the GetReal consortium

Subjects
Journal Article, Electronic health records, Registries, Claims databases, eCRF, Pragmatic trial, Routinely collected data
Abstract

Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory and ethical implications. The present final paper of the series discusses the operational and methodological challenges of data collection in pragmatic trials. A more pragmatic data collection needs to balance the delivery of highly accurate and complete data with minimizing the level of interference that data entry and verification induce with clinical practice. Further it should allow for the involvement of a representative sample of practices, physicians and patients who prescribe/receive treatment in routine care. This paper discusses challenges that are related to the different methods of data collection and presents potential solutions where possible. No one-size-fits-all recommendation can be given for the collection of data in pragmatic trials, although in general the application of existing routinely used data collection systems and processes seem to best suit the pragmatic approach. However, data access and privacy, the time points of data collection, the level of detail in the data and the lack of a clear understanding of the data collection process were identified as main challenges for the usage of routinely collected data in pragmatic trials. A first step should be to determine to what extend existing healthcare databases provide the necessary study data and can accommodate data collection and management. When more elaborate or detailed data collection or more structured follow-up is required, data collection in a pragmatic trial will have to be tailor-made, often using a hybrid approach utilizing a dedicated electronic case report form (eCRF). In this case the eCRF should be kept as simple as possible to reduce the burden for practitioners and minimize influence on routine clinical practice.

Published
2017

37. Data collection in Pragmatic Trials

Author

Meinecke, Anna-Katharina, Welsing, Paco, Kafatos, George, Burke, Des, Trelle, Sven, Kubin, Maria, Nachbaur, Gaelle, Egger, Matthias, and Zuidgeest, Mira

Subjects
360 Social problems & social services, 610 Medicine & health
Abstract

Pragmatic trials can improve our understanding of how treatments will perform in routine practice. In a series of eight papers, the GetReal Consortium has evaluated the challenges in designing and conducting pragmatic trials and their specific methodological, operational, regulatory and ethical implications. The present final paper of the series discusses the operational and methodological challenges of data collection in pragmatic trials. A more pragmatic data collection needs to balance the delivery of highly accurate and complete data with minimizing the level of interference that data entry and verification induce with clinical practice. Further it should allow for the involvement of a representative sample of practices, physicians and patients who prescribe/receive treatment in routine care. This paper discusses challenges that are related to the different methods of data collection and presents potential solutions where possible. No one-size-fits-all recommendation can be given for the collection of data in pragmatic trials, although in general the application of existing routinely used data collection systems and processes seem to best suit the pragmatic approach. However, data access and privacy, the time points of data collection, the level of detail in the data and the lack of a clear understanding of the data collection process were identified as main challenges for the usage of routinely collected data in pragmatic trials. A first step should be to determine to what extend existing healthcare databases provide the necessary study data and can accommodate data collection and management. When more elaborate or detailed data collection or more structured follow-up is required, data collection in a pragmatic trial will have to be tailor-made, often using a hybrid approach utilizing a dedicated electronic case report form (eCRF). In this case the eCRF should be kept as simple as possible to reduce the burden for practitioners and minimize influence on routine clinical practice.

Published
2017
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38. Additional file 1: of Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review

Author

J. Han Van Krieken, Kafatos, George, Bennett, James, Mineur, Laurent, Jiří Tomášek, Rouleau, Etienne, Fabian, Pavel, Maglio, Giovanna De, García-Alfonso, Pilar, Aprile, Giuseppe, Parijan Parkar, Downey, Gerald, Demonty, Gaston, and Trojan, Jörg

Abstract

Interview guide/questionnaire used for the telephone interviews. (DOCX 61 kb)

Published
2017
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39. Additional file 2: of Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review

Author

J. Han Van Krieken, Kafatos, George, Bennett, James, Mineur, Laurent, Jiří Tomášek, Rouleau, Etienne, Fabian, Pavel, Maglio, Giovanna De, García-Alfonso, Pilar, Aprile, Giuseppe, Parijan Parkar, Downey, Gerald, Demonty, Gaston, and Trojan, Jörg

Abstract

List of all Ethical committees that approved the study. (DOCX 16 kb)

Published
2017
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41. Series: Pragmatic trials and real world evidence: Paper 8 Data collection and management Data collection in Pragmatic Trials

Author

Lab Reumatologie/Klinische Immunologie, Infection & Immunity, JC onderzoeksprogramma Methodologie, Meinecke, Anna Katharina, Welsing, Paco, Kafatos, George, Burke, Des, Trelle, Sven, Kubin, Maria, Nachbaur, Gaelle, Egger, Matthias, Zuidgeest, Mira, Work Package 3 of the GetReal consortium, Lab Reumatologie/Klinische Immunologie, Infection & Immunity, JC onderzoeksprogramma Methodologie, Meinecke, Anna Katharina, Welsing, Paco, Kafatos, George, Burke, Des, Trelle, Sven, Kubin, Maria, Nachbaur, Gaelle, Egger, Matthias, Zuidgeest, Mira, and Work Package 3 of the GetReal consortium

Published
2017

42. Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review

Author

Han van Krieken, J., primary, Kafatos, George, additional, Bennett, James, additional, Mineur, Laurent, additional, Tomášek, Jiří, additional, Rouleau, Etienne, additional, Fabian, Pavel, additional, De Maglio, Giovanna, additional, García-Alfonso, Pilar, additional, Aprile, Giuseppe, additional, Parkar, Parijan, additional, Downey, Gerald, additional, Demonty, Gaston, additional, and Trojan, Jörg, additional

Published
2017
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43. RAS mutation prevalence among patients with metastatic colorectal cancer: a meta-analysis of real-world data

Author

Kafatos, George, primary, Niepel, Daniela, additional, Lowe, Kimberley, additional, Jenkins-Anderson, Sophie, additional, Westhead, Hal, additional, Garawin, Tamer, additional, Traugottová, Zuzana, additional, Bilalis, Antonios, additional, Molnar, Edit, additional, Timar, Jozsef, additional, Toth, Erika, additional, Gouvas, Nikolaos, additional, Papaxoinis, George, additional, Murray, Samuel, additional, Mokhtar, Nadia, additional, Vosmikova, Hana, additional, Fabian, Pavel, additional, Skalova, Alena, additional, Wójcik, Piotr, additional, Tysarowski, Andrzej, additional, Barugel, Mario, additional, van Krieken, J Han, additional, and Trojan, Jörg, additional

Published
2017
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49. An Outbreak of Cryptosporidium parvum across England & Scotland Associated with Consumption of Fresh Pre-Cut Salad Leaves, May 2012

Author

Kirk, Martyn, McKerr, Caoimhe, Adak, Goutam K., Nichols, Gordon, Gorton, Russell, Chalmers, Rachel M., Kafatos, George, Cosford, Paul, Charlett, Andre, Reacher, Mark, Pollock, Kevin G., Alexander, Claire L., and Morton, Stephen

Subjects
Adult, Male, medicine.medical_specialty, Veterinary medicine, Demographics, Adolescent, Science, Cryptosporidiosis, Disease Outbreaks, Foodborne Diseases, Young Adult, Environmental health, Epidemiology, medicine, Humans, Aged, Consumption (economics), Cryptosporidium parvum, Multidisciplinary, biology, L510, Foodborne outbreak, Outbreak, Cryptosporidium, Lettuce, Middle Aged, biology.organism_classification, B910, Plant Leaves, England, Scotland, Case-Control Studies, Medicine, Female, Research Article
Abstract

Background\ud We report a widespread foodborne outbreak of Cryptosporidium parvum in England and Scotland in May 2012. Cases were more common in female adults, and had no history of foreign travel. Over 300 excess cases were identified during the period of the outbreak. Speciation and microbiological typing revealed the outbreak strain to be C. parvum gp60 subtype IIaA15G2R1.\ud \ud Methods\ud Hypothesis generation questionnaires were administered and an unmatched case control study was undertaken to test the hypotheses raised. Cases and controls were interviewed by telephone. Controls were selected using sequential digit dialling. Information was gathered on demographics, foods consumed and retailers where foods were purchased.\ud \ud Results\ud Seventy-four laboratory confirmed cases and 74 controls were included in analyses. Infection was found to be strongly associated with the consumption of pre-cut mixed salad leaves sold by a single retailer. This is the largest documented outbreak of cryptosporidiosis attributed to a food vehicle.

Published
2015

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