Big data in medical science and healthcare management : diagnosis, therapy, side effects / / published by Dr. med. Peter Langkafel, MBA |
Pubbl/distr/stampa | Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 |
Descrizione fisica | 1 online resource (258 p.) |
Disciplina | 610.72/4 |
Soggetto topico |
Medicine - Research
Data mining |
Soggetto genere / forma | Electronic books. |
ISBN | 3-11-044574-3 |
Classificazione | ST 265 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front matter -- Autopilot and "Doctor Algorithm"? / Langkafel, Peter -- Contents -- 1. Intro Big Data for Healthcare? / Langkafel, Peter -- 2. Information Management for Systems Medicine - on the Next Digital Threshold / Josef, Schepers / Peuker, Martin -- 3. Some Philosophical Thoughts on Big Data / Müller, Albrecht von -- 4. Big Data from a Health Insurance Company's Point of View / Brunner, Thomas -- 5. Big Data and the Family Doctor / Kamps, Harald -- 6. How Value is Created from Data: Experiences from the Integrated Health Care System, "Gesundes Kinzigtal" (Healthy Kinzigtal) / Pimperl, Alexander / Dittmann, Birger / Fischer, Alexander / Schulte, Timo / Wendel, Pascal / Wetzel, Martin / Hildebrandt, Helmut -- 7. Ethics / Röhrig, Rainer / Weigand, Markus A. -- 8. The New Data-Supported Quality Assurance of the Federal Joint Committee: Opportunities and Challenges / Pötter-Kirchner, Karola / Höchstetter, Renate / Grüning, Thilo -- 9. Big Data in Healthcare: Fields of Application and Benefits of SAP Technologies / Eberhardt, Werner -- 10. Big Data - More Risks than Benefits for Healthcare? / Wehmeier, Axel / Baumann, Timo -- 11. Big Data - An Efficiency Boost in the Healthcare Sector / Zimmermann-Rittereiser, Marcus / Schaper, Hartmut -- 12. Medical Big Data and Data Protection / Weichert, Thilo -- 13. Big Data in Healthcare from a Business Consulting (Accenture) Point of View / Krolop, Sebastian / Souchon, Henri -- 14. Influence of Big Pharma on Medicine, Logistics and Data Technology in a State of Transition / Laslo, Peer -- 15. Semantics and Big Data Semantic Methods for Data Processing and Searching Large Amounts of Data / Engelhorn, Michael -- 16. Quantified Self, Wearable Technologies and Personal Data / Schumacher, Florian -- 17. "For the Benefit of the Patient" ... What Does the Patient Say to That? / Mühlbacher, Axel / Kaczynski, Anika -- 18. Visualization - What Does Big Data Actually Look Like? / Langkafel, Peter -- 19. The Digital Patient? / Langkafel, Peter -- Publisher and Index of Authors -- Glossary -- Testimonials |
Record Nr. | UNINA-9910460830203321 |
Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Big data in medical science and healthcare management : diagnosis, therapy, side effects / / published by Dr. med. Peter Langkafel, MBA |
Pubbl/distr/stampa | Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 |
Descrizione fisica | 1 online resource (258 p.) |
Disciplina | 610.72/4 |
Soggetto topico |
Medicine - Research
Data mining |
Soggetto non controllato |
Big Data
data protection healthcare management |
ISBN | 3-11-044574-3 |
Classificazione | ST 265 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front matter -- Autopilot and "Doctor Algorithm"? / Langkafel, Peter -- Contents -- 1. Intro Big Data for Healthcare? / Langkafel, Peter -- 2. Information Management for Systems Medicine - on the Next Digital Threshold / Josef, Schepers / Peuker, Martin -- 3. Some Philosophical Thoughts on Big Data / Müller, Albrecht von -- 4. Big Data from a Health Insurance Company's Point of View / Brunner, Thomas -- 5. Big Data and the Family Doctor / Kamps, Harald -- 6. How Value is Created from Data: Experiences from the Integrated Health Care System, "Gesundes Kinzigtal" (Healthy Kinzigtal) / Pimperl, Alexander / Dittmann, Birger / Fischer, Alexander / Schulte, Timo / Wendel, Pascal / Wetzel, Martin / Hildebrandt, Helmut -- 7. Ethics / Röhrig, Rainer / Weigand, Markus A. -- 8. The New Data-Supported Quality Assurance of the Federal Joint Committee: Opportunities and Challenges / Pötter-Kirchner, Karola / Höchstetter, Renate / Grüning, Thilo -- 9. Big Data in Healthcare: Fields of Application and Benefits of SAP Technologies / Eberhardt, Werner -- 10. Big Data - More Risks than Benefits for Healthcare? / Wehmeier, Axel / Baumann, Timo -- 11. Big Data - An Efficiency Boost in the Healthcare Sector / Zimmermann-Rittereiser, Marcus / Schaper, Hartmut -- 12. Medical Big Data and Data Protection / Weichert, Thilo -- 13. Big Data in Healthcare from a Business Consulting (Accenture) Point of View / Krolop, Sebastian / Souchon, Henri -- 14. Influence of Big Pharma on Medicine, Logistics and Data Technology in a State of Transition / Laslo, Peer -- 15. Semantics and Big Data Semantic Methods for Data Processing and Searching Large Amounts of Data / Engelhorn, Michael -- 16. Quantified Self, Wearable Technologies and Personal Data / Schumacher, Florian -- 17. "For the Benefit of the Patient" ... What Does the Patient Say to That? / Mühlbacher, Axel / Kaczynski, Anika -- 18. Visualization - What Does Big Data Actually Look Like? / Langkafel, Peter -- 19. The Digital Patient? / Langkafel, Peter -- Publisher and Index of Authors -- Glossary -- Testimonials |
Record Nr. | UNINA-9910797817003321 |
Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Big data in medical science and healthcare management : diagnosis, therapy, side effects / / published by Dr. med. Peter Langkafel, MBA |
Pubbl/distr/stampa | Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 |
Descrizione fisica | 1 online resource (258 p.) |
Disciplina | 610.72/4 |
Soggetto topico |
Medicine - Research
Data mining |
Soggetto non controllato |
Big Data
data protection healthcare management |
ISBN | 3-11-044574-3 |
Classificazione | ST 265 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Front matter -- Autopilot and "Doctor Algorithm"? / Langkafel, Peter -- Contents -- 1. Intro Big Data for Healthcare? / Langkafel, Peter -- 2. Information Management for Systems Medicine - on the Next Digital Threshold / Josef, Schepers / Peuker, Martin -- 3. Some Philosophical Thoughts on Big Data / Müller, Albrecht von -- 4. Big Data from a Health Insurance Company's Point of View / Brunner, Thomas -- 5. Big Data and the Family Doctor / Kamps, Harald -- 6. How Value is Created from Data: Experiences from the Integrated Health Care System, "Gesundes Kinzigtal" (Healthy Kinzigtal) / Pimperl, Alexander / Dittmann, Birger / Fischer, Alexander / Schulte, Timo / Wendel, Pascal / Wetzel, Martin / Hildebrandt, Helmut -- 7. Ethics / Röhrig, Rainer / Weigand, Markus A. -- 8. The New Data-Supported Quality Assurance of the Federal Joint Committee: Opportunities and Challenges / Pötter-Kirchner, Karola / Höchstetter, Renate / Grüning, Thilo -- 9. Big Data in Healthcare: Fields of Application and Benefits of SAP Technologies / Eberhardt, Werner -- 10. Big Data - More Risks than Benefits for Healthcare? / Wehmeier, Axel / Baumann, Timo -- 11. Big Data - An Efficiency Boost in the Healthcare Sector / Zimmermann-Rittereiser, Marcus / Schaper, Hartmut -- 12. Medical Big Data and Data Protection / Weichert, Thilo -- 13. Big Data in Healthcare from a Business Consulting (Accenture) Point of View / Krolop, Sebastian / Souchon, Henri -- 14. Influence of Big Pharma on Medicine, Logistics and Data Technology in a State of Transition / Laslo, Peer -- 15. Semantics and Big Data Semantic Methods for Data Processing and Searching Large Amounts of Data / Engelhorn, Michael -- 16. Quantified Self, Wearable Technologies and Personal Data / Schumacher, Florian -- 17. "For the Benefit of the Patient" ... What Does the Patient Say to That? / Mühlbacher, Axel / Kaczynski, Anika -- 18. Visualization - What Does Big Data Actually Look Like? / Langkafel, Peter -- 19. The Digital Patient? / Langkafel, Peter -- Publisher and Index of Authors -- Glossary -- Testimonials |
Record Nr. | UNINA-9910827402603321 |
Berlin, Germany ; ; Boston, [Massachusetts] : , : De Gruyter Oldenbourg, , 2016 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trial design [[electronic resource] ] : Bayesian and frequentist adaptive methods / / Guosheng Yin |
Autore | Yin Guosheng |
Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
Descrizione fisica | 1 online resource (366 p.) |
Disciplina | 610.72/4 |
Collana | Wiley series in probability and statistics |
Soggetto topico |
Clinical trials - Statistical methods
Bayesian statistical decision theory Mathematical statistics |
ISBN |
1-283-42514-9
9786613425140 1-118-18332-0 1-118-18333-9 1-118-18330-4 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Fundamentals of clinical trials -- Frequentist versus Bayesian statistics -- Phase I trial design -- Phase II trial design -- Phase III trial design -- Adaptive randomization -- Late onset toxicity -- Drug combination trials -- Targeted therapy design. |
Record Nr. | UNINA-9910139297803321 |
Yin Guosheng | ||
Hoboken, N.J., : John Wiley & Sons, c2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trial design : Bayesian and frequentist adaptive methods / / Guosheng Yin |
Autore | Yin Guosheng |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
Descrizione fisica | 1 online resource (366 p.) |
Disciplina | 610.72/4 |
Collana | Wiley series in probability and statistics |
Soggetto topico |
Clinical trials - Statistical methods
Bayesian statistical decision theory Mathematical statistics |
ISBN |
1-283-42514-9
9786613425140 1-118-18332-0 1-118-18333-9 1-118-18330-4 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Fundamentals of clinical trials -- Frequentist versus Bayesian statistics -- Phase I trial design -- Phase II trial design -- Phase III trial design -- Adaptive randomization -- Late onset toxicity -- Drug combination trials -- Targeted therapy design. |
Record Nr. | UNINA-9910812048003321 |
Yin Guosheng | ||
Hoboken, N.J., : John Wiley & Sons, c2012 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trials explained [[electronic resource] ] : a guide to clinical trials in the NHS for healthcare professionals / / editors, Derek Stewart ... et al. ; produced by the British Medical Journal (BMJ), in association with the National Translational Cancer Research Network (NTRAC) and Emergency Care Research Institute (ECRI) |
Pubbl/distr/stampa | Malden, MA, : Blackwell Pub., c2006 |
Descrizione fisica | 1 online resource (114 p.) |
Disciplina |
610.72/4
615.50724 |
Altri autori (Persone) | StewartDerek <1951-> |
Soggetto topico |
Clinical trials - Great Britain
Clinical trials - Decision making National health services - Great Britain |
ISBN |
1-281-32201-6
9786611322014 0-470-75061-8 0-470-75022-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals; Contents; Preface; Acknowledgements; Chapter 1 Overview and Purpose of this Guide to Clinical Trials in the NHS; Overview and purpose of this guide; Who should use this guide to clinical trials in the NHS?; Chapter 2 Clinical Trials Explained; What are clinical trials?; Why are clinical trials needed?; Who is involved in a clinical trial?; How are clinical trials designed and approved?; Progression of a medical intervention through the clinical trial phases; Summary
Chapter 3 Clinical Trial Approval, Regulation and FundingHow are clinical trials approved and regulated?; Ethical approval; Informed consent; How are trials managed?; Who pays for a clinical trial?; Summary; Chapter 4 Understanding Clinical Trial Design and Results; Understanding randomisation and blinding in clinical trials; Understanding controls and placebos; Why are placebos used in clinical trials?; What about trials that are not controlled or blinded?; Understanding clinical trial results; Summary; Chapter 5 Questions About Clinical Trials: A Framework for Discussion What are patients' rights?Why do patients take part in clinical trials?; Why do patients decline to take part in a clinical trial or withdraw from a clinical trial they are involved in?; How can patients be empowered during their involvement in a clinical trial?; Will patients involved in clinical trials need extra help and support from their carers?; What are the likely costs of and reimbursement for patients participating in clinical trials?; Summary; Appendix A Finding Out About Clinical Trials that are Currently or Soon to be Recruiting Appendix B ECRI Evidence Report: Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient OutcomesGlossary; Index |
Record Nr. | UNINA-9910145291403321 |
Malden, MA, : Blackwell Pub., c2006 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trials explained [[electronic resource] ] : a guide to clinical trials in the NHS for healthcare professionals / / editors, Derek Stewart ... et al. ; produced by the British Medical Journal (BMJ), in association with the National Translational Cancer Research Network (NTRAC) and Emergency Care Research Institute (ECRI) |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Malden, MA, : Blackwell Pub., c2006 |
Descrizione fisica | 1 online resource (114 p.) |
Disciplina |
610.72/4
615.50724 |
Altri autori (Persone) | StewartDerek <1951-> |
Soggetto topico |
Clinical trials - Great Britain
Clinical trials - Decision making National health services - Great Britain |
ISBN |
1-281-32201-6
9786611322014 0-470-75061-8 0-470-75022-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals; Contents; Preface; Acknowledgements; Chapter 1 Overview and Purpose of this Guide to Clinical Trials in the NHS; Overview and purpose of this guide; Who should use this guide to clinical trials in the NHS?; Chapter 2 Clinical Trials Explained; What are clinical trials?; Why are clinical trials needed?; Who is involved in a clinical trial?; How are clinical trials designed and approved?; Progression of a medical intervention through the clinical trial phases; Summary
Chapter 3 Clinical Trial Approval, Regulation and FundingHow are clinical trials approved and regulated?; Ethical approval; Informed consent; How are trials managed?; Who pays for a clinical trial?; Summary; Chapter 4 Understanding Clinical Trial Design and Results; Understanding randomisation and blinding in clinical trials; Understanding controls and placebos; Why are placebos used in clinical trials?; What about trials that are not controlled or blinded?; Understanding clinical trial results; Summary; Chapter 5 Questions About Clinical Trials: A Framework for Discussion What are patients' rights?Why do patients take part in clinical trials?; Why do patients decline to take part in a clinical trial or withdraw from a clinical trial they are involved in?; How can patients be empowered during their involvement in a clinical trial?; Will patients involved in clinical trials need extra help and support from their carers?; What are the likely costs of and reimbursement for patients participating in clinical trials?; Summary; Appendix A Finding Out About Clinical Trials that are Currently or Soon to be Recruiting Appendix B ECRI Evidence Report: Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient OutcomesGlossary; Index |
Record Nr. | UNISA-996218269803316 |
Malden, MA, : Blackwell Pub., c2006 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. di Salerno | ||
|
Clinical trials explained : a guide to clinical trials in the NHS for healthcare professionals / / editors, Derek Stewart ... et al. ; produced by the British Medical Journal (BMJ), in association with the National Translational Cancer Research Network (NTRAC) and Emergency Care Research Institute (ECRI) |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Malden, MA, : Blackwell Pub., c2006 |
Descrizione fisica | 1 online resource (114 p.) |
Disciplina |
610.72/4
615.50724 |
Altri autori (Persone) | StewartDerek <1951-> |
Soggetto topico |
Clinical trials - Great Britain
Clinical trials - Decision making National health services - Great Britain |
ISBN |
1-281-32201-6
9786611322014 0-470-75061-8 0-470-75022-7 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals; Contents; Preface; Acknowledgements; Chapter 1 Overview and Purpose of this Guide to Clinical Trials in the NHS; Overview and purpose of this guide; Who should use this guide to clinical trials in the NHS?; Chapter 2 Clinical Trials Explained; What are clinical trials?; Why are clinical trials needed?; Who is involved in a clinical trial?; How are clinical trials designed and approved?; Progression of a medical intervention through the clinical trial phases; Summary
Chapter 3 Clinical Trial Approval, Regulation and FundingHow are clinical trials approved and regulated?; Ethical approval; Informed consent; How are trials managed?; Who pays for a clinical trial?; Summary; Chapter 4 Understanding Clinical Trial Design and Results; Understanding randomisation and blinding in clinical trials; Understanding controls and placebos; Why are placebos used in clinical trials?; What about trials that are not controlled or blinded?; Understanding clinical trial results; Summary; Chapter 5 Questions About Clinical Trials: A Framework for Discussion What are patients' rights?Why do patients take part in clinical trials?; Why do patients decline to take part in a clinical trial or withdraw from a clinical trial they are involved in?; How can patients be empowered during their involvement in a clinical trial?; Will patients involved in clinical trials need extra help and support from their carers?; What are the likely costs of and reimbursement for patients participating in clinical trials?; Summary; Appendix A Finding Out About Clinical Trials that are Currently or Soon to be Recruiting Appendix B ECRI Evidence Report: Patients' Reasons for Participation in Clinical Trials and Effect of Trial Participation on Patient OutcomesGlossary; Index |
Record Nr. | UNINA-9910814864403321 |
Malden, MA, : Blackwell Pub., c2006 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch |
Autore | O'Kelly Michael |
Pubbl/distr/stampa | Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 |
Descrizione fisica | 1 online resource (473 p.) |
Disciplina | 610.72/4 |
Altri autori (Persone) | RatitchBohdana |
Collana | Statistics in practice |
Soggetto topico |
Clinical trials
Clinical trials - Statistical methods |
ISBN |
1-118-76253-3
1-118-76251-7 1-118-76250-9 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Clinical Trials with Missing Data; Contents; Preface; References; Acknowledgments; Notation; Table of SAS code fragments; Contributors; 1 Whats the problem with missing data?; 1.1 What do we mean by missing data?; 1.1.1 Monotone and non-monotone missing data; 1.1.2 Modeling missingness, modeling the missing value and ignorability; 1.1.3 Types of missingness (MCAR, MAR and MNAR); 1.1.4 Missing data and study objectives; 1.2 An illustration; 1.3 Why cant I use only the available primary endpoint data?; 1.4 Whats the problem with using last observation carried forward?
1.5 Can we just assume that data are missing at random?1.6 What can be done if data may be missing not at random?; 1.7 Stress-testing study results for robustness to missing data; 1.8 How the pattern of dropouts can bias the outcome; 1.9 How do we formulate a strategy for missing data?; 1.10 Description of example datasets; 1.10.1 Example dataset in Parkinsons disease treatment; 1.10.2 Example dataset in insomnia treatment; 1.10.3 Example dataset in mania treatment; Appendix 1.A: Formal definitions of MCAR, MAR and MNAR; References; 2 The prevention of missing data; 2.1 Introduction 2.2 The impact of "too much" missing data 2.2.1 Example from human immunodeficiency virus; 2.2.2 Example from acute coronary syndrome; 2.2.3 Example from studies in pain; 2.3 The role of the statistician in the prevention of missing data; 2.3.1 Illustrative example from HIV; 2.4 Methods for increasing subject retention; 2.5 Improving understanding of reasons for subject withdrawal; Acknowledgments; Appendix 2.A: Example protocol text for missing data prevention; Section X Subject retention; References; 3 Regulatory guidance - a quicktour 3.1 International conference on harmonization guideline: Statistical principles for clinical trials: E93.2 The US and EU regulatory documents; 3.3 Key points in the regulatory documents on missing data; 3.4 Regulatory guidance on particular statistical approaches; 3.4.1 Available cases; 3.4.2 Single imputation methods; 3.4.3 Methods that generally assume MAR; 3.4.4 Methods that are used assuming MNAR; 3.5 Guidance about how to plan for missing data in a study; 3.6 Differences in emphasis between the NRC report and EU guidance documents; 3.6.1 The term "conservative" 3.6.2 Last observation carried forward 3.6.3 Post hoc analyses; 3.6.4 Non-monotone or intermittently missing data; 3.6.5 Assumptions should be readily interpretable; 3.6.6 Study report; 3.6.7 Training; 3.7 Other technical points from the NRC report; 3.7.1 Time-to-event analyses; 3.7.2 Tipping point sensitivity analyses; 3.8 Other US/EU/international guidance documents that refer to missing data; 3.8.1 Committee for medicinal products for human use guideline on anti-cancer products, recommendations on survival analysis 3.8.2 US guidance on considerations when research supported by office of human research protections is discontinued |
Record Nr. | UNINA-9910132240603321 |
O'Kelly Michael | ||
Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|
Clinical trials with missing data : a guide for practitioners / / Michael O'Kelly, Bohdana Ratitch |
Autore | O'Kelly Michael |
Pubbl/distr/stampa | Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 |
Descrizione fisica | 1 online resource (473 p.) |
Disciplina | 610.72/4 |
Altri autori (Persone) | RatitchBohdana |
Collana | Statistics in practice |
Soggetto topico |
Clinical trials
Clinical trials - Statistical methods |
ISBN |
1-118-76253-3
1-118-76251-7 1-118-76250-9 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Clinical Trials with Missing Data; Contents; Preface; References; Acknowledgments; Notation; Table of SAS code fragments; Contributors; 1 Whats the problem with missing data?; 1.1 What do we mean by missing data?; 1.1.1 Monotone and non-monotone missing data; 1.1.2 Modeling missingness, modeling the missing value and ignorability; 1.1.3 Types of missingness (MCAR, MAR and MNAR); 1.1.4 Missing data and study objectives; 1.2 An illustration; 1.3 Why cant I use only the available primary endpoint data?; 1.4 Whats the problem with using last observation carried forward?
1.5 Can we just assume that data are missing at random?1.6 What can be done if data may be missing not at random?; 1.7 Stress-testing study results for robustness to missing data; 1.8 How the pattern of dropouts can bias the outcome; 1.9 How do we formulate a strategy for missing data?; 1.10 Description of example datasets; 1.10.1 Example dataset in Parkinsons disease treatment; 1.10.2 Example dataset in insomnia treatment; 1.10.3 Example dataset in mania treatment; Appendix 1.A: Formal definitions of MCAR, MAR and MNAR; References; 2 The prevention of missing data; 2.1 Introduction 2.2 The impact of "too much" missing data 2.2.1 Example from human immunodeficiency virus; 2.2.2 Example from acute coronary syndrome; 2.2.3 Example from studies in pain; 2.3 The role of the statistician in the prevention of missing data; 2.3.1 Illustrative example from HIV; 2.4 Methods for increasing subject retention; 2.5 Improving understanding of reasons for subject withdrawal; Acknowledgments; Appendix 2.A: Example protocol text for missing data prevention; Section X Subject retention; References; 3 Regulatory guidance - a quicktour 3.1 International conference on harmonization guideline: Statistical principles for clinical trials: E93.2 The US and EU regulatory documents; 3.3 Key points in the regulatory documents on missing data; 3.4 Regulatory guidance on particular statistical approaches; 3.4.1 Available cases; 3.4.2 Single imputation methods; 3.4.3 Methods that generally assume MAR; 3.4.4 Methods that are used assuming MNAR; 3.5 Guidance about how to plan for missing data in a study; 3.6 Differences in emphasis between the NRC report and EU guidance documents; 3.6.1 The term "conservative" 3.6.2 Last observation carried forward 3.6.3 Post hoc analyses; 3.6.4 Non-monotone or intermittently missing data; 3.6.5 Assumptions should be readily interpretable; 3.6.6 Study report; 3.6.7 Training; 3.7 Other technical points from the NRC report; 3.7.1 Time-to-event analyses; 3.7.2 Tipping point sensitivity analyses; 3.8 Other US/EU/international guidance documents that refer to missing data; 3.8.1 Committee for medicinal products for human use guideline on anti-cancer products, recommendations on survival analysis 3.8.2 US guidance on considerations when research supported by office of human research protections is discontinued |
Record Nr. | UNINA-9910819122203321 |
O'Kelly Michael | ||
Chichester, West Sussex : , : John Wiley & Sons Inc., , 2014 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
|