Medical research Books

Book SynopsisPraise for the First Edition . . . an excellent textbook . . . an indispensable reference for biostatisticians and epidemiologists. International Statistical Institute A new edition of the definitive guide to classical and modern methods of biostatistics Biostatistics consists of various quantitative techniques that are essential to the description and evaluation of relationships among biologic and medical phenomena. Biostatistical Methods: The Assessment of Relative Risks, Second Edition develops basic concepts and derives an expanded array of biostatistical methods through the application of both classical statistical tools and more modern likelihood-based theories. With its fluid and balanced presentation, the book guides readers through the important statistical methods for the assessment of absolute and relative risks in epidemiologic studies and clinical trials with categorical, count, and event-time data. Presenting a brTrade Review"Biostatistical methods, second edition is an excellent book for biostatistics courses at the graduate level. It is also an invaluable reference for biostatisticians, applied statisticians, and epidemiologists." (Mathematical Reviews, 2011) "The author of this book has made a tremendous effort in covering a gamut of tests, methods, and ideas for biostatistical problem solving . . . In conclusion, the book is recommended to all in biostatistics as a technical reference." (Journal of Biopharmaceutical Statistics, 1 September 2012) "...Biostatistics is set apart from other statistics specialties by its focus on the assessment of risks and relative risks through clinical research," states Lachin (George Washington U.) in the preface to the first edition (2001). He developed this graduate text to support a course he launched as a joint initiative of the university's department of statistics, its Biostatistics Center, and the School of Public Health and Health Services. Coverage includes discussion of biostatistics and biomedical science, relative risk estimates and tests for independent groups, sample size, stratified adjusted analysis, case-control and matched studies, applications of maximum likelihood and efficient scores, among other topics." (Book News Inc., February 2011) Table of ContentsPreface. Preface to First Edition. 1 Biostatistics and Biomedical Science. 1.1 Statistics and the Scientific Method. 1.2 Biostatistics. 1.3 Natural History of Disease Progression. 1.4 Types of Biomedical Studies. 1.5 Studies of Diabetic Nephropathy. 2 Relative Risk Estimates and Tests for Independent Groups. 2.1 Probability As a Measure of Risk. 2.2 Measures of Relative Risk. 2.3 Large Sample Distribution. 2.4 Sampling Models Likelihoods. 2.5 Exact Inference. 2.6 Large Sample Inferences. 2.7 SAS PROC FREQ. 2.8 Other Measures of Differential Risk. 2.9 Polychotomous and Ordinal Data. 2.10 Two Independent Groups With Polychotomous Response. 2.11 Multiple Independent Groups. 2.12 Problems. 3 Sample Size, Power, and Efficiency. 3.1 Estimation Precision. 3.2 Power of Z-Tests. 3.3 Test for Two Proportions. 3.4 Power of Chi-Square Tests. 3.5 SAS PROC POWER. 3.6 Efficiency. 3.7 Problems. 4 Stratified-Adjusted Analysis for Independent Groups. 4.1 Introduction. 4.2 Mantel-Haenszel Test and Cochran’s Test. 4.3 Stratified-Adjusted Estimators. 4.4 Nature of Covariate Adjustment. 4.5 Multivariate Tests of Hypotheses. 4.6 Tests of Homogeneity. 4.7 Efficient Tests of No Partial Association. 4.8 Asymptotic Relative Efficiency of Competing Tests. 4.9 Maximin-Efficient Robust Tests. 4.10 Random Effects Model. 4.11 Power and Sample Size for Tests of Association. 4.12 Polychotomous and Ordinal Data. 4.13 Problems. 5 Case-Control and Matched Studies. 5.1 Unmatched Case-Control (Retrospective) Sampling. 5.2 Matching. 5.3 Tests of Association for Matched Pairs. 5.4 Measures of Association for Matched Pairs. 5.5 Pair-Matched Retrospective Study. 5.6 Power Function of McNemar’s Test. 5.7 Stratified Analysis of Pair-Matched Tables. 5.8 Multiple Matching-Mantel-Haenszel Analysis. 5.9 Matched Polychotomous Data. 5.10 Kappa Index of Agreement. 5.11 Problems. 6 Applications of Maximum Likelihood and Efficient Scores. 6.1 Binomial. 6.2 2x2 Table: Product Binomial (Unconditionally). 6.3 2x2 Table, Conditionally. 6.4 Score-Based Estimate. 6.5 Stratified Score Analysis of Independent 2x2 Tables. 6.6 Matched Pairs. 6.7 Iterative Maximum Likelihood. 6.8 Problems. 7 Logistic Regression Models. 7.1 Unconditional Logistic Regression Model. 7.2 Interpretation of the Logistic Regression Model. 7.3 Tests of Significance. 7.4 Interactions. 7.5 Measures of the Strength of Association. 7.6 Conditional Logistic Regression Model for Matched Sets. 7.7 Models for Polychotomous or Ordinal Data. 7.8 Random Effects and Mixed Models. 7.9 Models for Multivariate or Repeated Measures. 7.10 Problems. 8 Analysis of Count Data. 8.1 Event Rates and the Homogeneous Poisson Model. 8.2 Over Dispersed Poisson Model. 8.3 Poisson Regression Model. 8.4 Over Dispersed and Robust Poisson Regression. 8.5 Conditional Poisson Regression for Matched Sets. 8.6 Negative Binomial Models. 8.7 Power and Sample Size. 8.8 Multiple Outcomes. 8.9 Problems. 9 Analysis of Event-Time Data. 9.1 Introduction to Survival Analysis. 9.2 Lifetable Construction. 9.3 Family of Weighted Mantel-Haenszel Tests. 9.4 Proportional Hazards Models. 9.5 Evaluation of Sample Size and Power. 9.6 Additional Models. 9.7 Analysis of Recurrent Events. 9.8 Problems. Appendix Statistical Theory. A.1 Introduction. A.2 Central Limit Theorem and the Law of Large Numbers. A.3 Delta Method. A.4 Slutsky’s Convergence Theorem. A.5 Least Squares Estimation. A.6 Maximum Likelihood Estimation and Efficient Scores. A.7 Tests of Significance. A.8 Explained Variation. A.9 Robust Inference. A.10 Generalized Linear Models and Quasi-Likelihood. A.11 Generalized Estimating Equations (GEE). References. Author Index. Subject Index.

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Book SynopsisAt last a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials.Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First EdiTrade Review"A book to read from beginning to end.... Clinical Trials in Psychiatry covers all the most important issues and will be useful to all clinicians who are involved in conducting, or using the results of, clinical trials. It provides a highly persuasive account of the unique scientific advantages of randomised trials for those who remain unconvinced. It is very readable." (British Journal of Psychiatry, February 2009) "On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009) "On balance, readers looking for a practical text to introduce them to the key issues will be well-satisfied with Clinical Trials in Psychiatry." (Journal of Biopharmaceutical Statistics, Volume 19, Issue 1, 2009)Table of ContentsPreface to the first edition. Preface to the second edition. 1. Treatments, good, bad or worthless – and how do we tell? 1.1 Treatments worthless – and worse. 1.2 A brief history of treating the mentally ill. 1.3 Summary. 2. The randomized clinical trial. 2.1 Introduction. 2.2 The clinical trial. 2.3 Ethical issues in clinical trials. 2.4 Informed consent. 2.5 Compliance. 2.6 Summary. 3. Design issues in clinical trials. 3.1 Introduction. 3.2 Clinical trial designs. 3.3 Methods of randomization. 3.4 Methods of masking treatments. 3.5 The size of a clinical trial. 3.6 Interim analysis. 3.7 Summary. 4. Special problems of trials in psychiatry. 4.1 Introduction. 4.2 Explanatory versus pragmatic trials. 4.3 Complex interventions. 4.4 Outcome measures in psychiatry. 4.5 Summary. 5. Some statistical issues in the analysis of psychiatric trials. 5.1 Introduction. 5.2 P-values and confidence intervals. 5.3 Using baseline data. 5.4 Longitudinal data. 5.5 Missing values and dropouts in longitudinal data. 5.6 Multiple outcome measures. 5.7 Intention-to-treat. 5.8 Economic evaluation of trials. 5.9 Number needed to treat. 6. Analysing data from a psychiatric trial: an example. 6.1 Introduction. 6.2 Beating the Blues. 6.3 Analysis of the post-treatment BDI scores. 6.4 Graphical displays and summary measure analysis of longitudinal data. 6.5 Random effects models for the BtB data. 6.6 The dropout problem in the BtB data. 6.7 Summary. 7. Systematic reviews and meta-analysis. 7.1 Introduction. 7.2 Study selection. 7.3 Publication bias. 7.4 The statistics of meta-analysis. 7.5 Some examples of meta-analysis of psychiatric trials. 7.6 Summary. 8. RCTs in psychiatry: threats, challenges and the future. 8.1 Introduction. 8.2 Can randomized clinical trials in psychiatry be justified? 8.3 Are randomized clinical trials really necessary? 8.4 Conflicts of interest. 8.5 Scandals, trials and tribulations. 8.6 The future of psychiatric trials. 8.7 Defending the clinical trial. 8.8 Summary. Appendix A. Issues in the management of clinical trials- 'how to do it'. A.1 Introduction. A.2 Clinical trial protocols. A.3 Getting the costs right. A.4 Collecting and managing the data. A.5 Writing the patient information sheet. A.6 Getting informed consent. A.7 Maintaining recruitment. A.8 Useful web sites. Appendix B. Writing a trial report. B.1 Introduction. Appendix C. Useful software for clinical trials. C.1 Introduction. C.2 Data management. C.3Design. C.4 Analysis. Bibliography. Index.

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Book SynopsisThis book provides a user-friendly introduction to the qualitative methods most commonly used in the mental health and psychotherapy arena. Chapters are written by leading researchers and the editors are experienced qualitative researchers, clinical trainers, and mental health practitioners Provides chapter-by-chapter guidance on conducting a qualitative study from across a range of approaches Offers guidance on how to review and appraise existing qualitative literature, how to choose the most appropriate method, and how to consider ethical issues Demonstrates how specific methods have been applied to questions in mental health research Uses examples drawn from recent research, including research with service users, in mental health practice and in psychotherapy Trade Review“In a field that at times feels dominated by obfuscating jargon and a cult-like zeal, the editors have produced an accessible, illuminating text that will be of great value to those wishing to gain an introduction to this essential and developing area of mental health research.” (The British Journal of Psychiatry, 1 May 2012) "David Harper and Andrew Thompson’s book Qualitative Research Methods in Mental Health and Psychotherapy provides a reference for students and practitioners who are using qualitative research to explore topics related to mental health. The book provides a rich and comprehensive text, with contributions from specialized authors on a number of key themes and research methods relevant to qualitative research. Despite being specifically aimed at those researching mental health issues, this text would be useful for any student or practitioner who wishes to get to grips with ‘big q research’..." (Feminism and Psychology, 2013) “Since receiving this book for review, I have found myself repeatedly recommending it to fellow doctoral researchers from a range of professional backgrounds, at all stages of candidature. I do so because, in my opinion, this book addresses, in an accessible, clear, yet thorough manner, the issues which all students and practitioner-researchers face in aspiring to produce high quality, creative, qualitative research in mental health and psychotherapy.” (QMiP Bulletin Issue 15, Spring 2013)Table of ContentsAbout the Contributors. Acknowledgements. PART I Getting Started. 1 Introduction (Andrew R. Thompson and David Harper). 2 Identifying and Synthesizing Qualitative Literature (Rachel L. Shaw). 3 Ethical Issues in Qualitative Mental Health Research (Andrew R. Thompson and Eleni Chambers). 4 Participation and Service User Involvement (Alison Faulkner). 5 Qualitative Data Collection: Asking the Right Questions (Hannah Frith and Kate Gleeson). 6 Qualitative Methods for Studying Psychotherapy Change Processes (Robert Elliott). 7 Choosing a Qualitative Research Method (David Harper). PART II Methods. 8 Interpretative Phenomenological Analysis in Mental Health and Psychotherapy Research (Michael Larkin and Andrew R. Thompson). 9 Existentialist-Informed Hermeneutic Phenomenology (Carla Willig and Abigail Billin). 10 Grounded Theory Methods for Mental Health Practitioners (Alison Tweed and Kathy Charmaz). 11 Discourse Analysis (Eugenie Georgaca and Evrinomy Avdi). 12 Narrative Psychology (Michael Murray and Sally Sargeant). 13 Ethnomethodology/Conversation Analysis (Mark Rapley). 14 Q Methodological Research in Mental Health and Psychotherapy (Wendy Stainton Rogers and Phillip O. Dyson). 15 Thematic Analysis (Helene Joffe). PART III Establishing Good Quality Qualitative Research in Mental Health. 16 In Pursuit of Quality (Liz Spencer and Jane Ritchie). 17 Emerging Issues and Future Directions (David Harper and Andrew R. Thompson). Index.

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Book SynopsisWhile some research methods or techniques are applicable in several areas of medicine, research in cardiovascular diseases requires knowledge of an increasing array of procedures, techniques and measurements that are highly specialized and unique to this area of investigation.Table of ContentsList of Contributors ix Preface xix About the Companion Website xx Part 1 Electrophysiology 1 Measurement of calcium transient ex vivo 3 Kenneth R. Laurita and Bradley N. Plummer 2 Confocal imaging of intracellular calcium cycling in isolated cardiac myocytes 12 Søren Grubb, J. Andrew Wasserstrom, and Gary L. Aistrup 3 Generating a large animal model of persistent atrial fi brillation 20 Raphaël P. Martins and José Jalife 4 Confocal imaging of intracellular calcium cycling in the intact heart 32 Neha Singh, Manvinder Kumar, James E. Kelly, Gary L. Aistrup, and J. Andrew Wasserstrom 5 Recording and measurement of action potentials 41 Kenneth S. Ginsburg and Donald M. Bers 6 Patch-clamp recordings from isolated cardiac myocytes 50 Kai-Chien Yang, Wei Wang, and Jeanne M. Nerbonne 7 Optical mapping of the heart 60 Di Lang, Sarah Gutbrod, Jacob Laughner, and Igor R. Efi mov Part 2 Isolation and Maintenance of Primary Stem Cells 8 Isolation of colony-forming endothelial progenitor cells 71 Haruchika Masuda and Takayuki Asahara 9 Cardiac resident stem cells 87 João Ferreira-Martins, Fumihiro Sanada, and Marcello Rota 10 Cardiospheres 95 Rachel Ruckdeschel Smith 11 Mesenchymal stem cells 104 Jose S. Da Silva and Joshua M. Hare 12 Generation and differentiation of human iPS cells 110 Sebastian Diecke, Lei Ye, Sophia Zhang, and Jianyi Zhang 13 Isolation of neonatal and adult rat cardiomyocytes 117 Md. Abdur Razzaque and Jeffrey Robbins 14 Isolation and culture of vascular smooth muscle cells 125 Milton Hamblin, Lin Chang, and Y. Eugene Chen 15 Isolation and culture of cardiac endothelial cells 131 Asish K. Ghosh, Joseph W. Covington, and Douglas E. Vaughan 16 Isolation and culture of cardiac fi broblasts 140 Asish K. Ghosh, Joseph W. Covington and Douglas E. Vaughan 17 Murine bone marrow transplantation model 146 Prasanna Krishnamurthy, Suresh Kumar Verma, and Raj Kishore 18 In vitro differentiation and expansion of vascular endothelial cells derived from mouse embryonic stem cells 149 Anees Fatima, Carey Nassano-Miller, and Tsutomu Kume Part 3 Manipulation of the Heart and Vessels in Vivo and ex Vivo 19 Coronary ligation 157 Alexander R. Mackie and Hossein Ardehali 20 Transverse aortic constriction: a model to study heart failure in small animals 164 Suresh Kumar Verma, Prasanna Krishnamurthy, and Raj Kishore 21 Pharmacological models of hypertrophy and failure 170 Angela C. deAlmeida, Tariq Hamid, and Sumanth D. Prabhu 22 Hindlimb ischemia 177 Jerry C. Lee, Ngan F. Huang, and John P. Cooke 23 The Langendorff preparation 187 Hugh Clements-Jewery and Michael J. Curtis 24 Myocarditis and other immunological models of cardiac disease 197 Daniela C¡ iháková and Noel R. Rose 25 Models of pacing-induced heart failure 203 James A. Shuman, Rupak Mukherjee, and Francis G. Spinale 26 Porcine myocardial ischemia models 215 Xian-Liang Tang and Roberto Bolli 27 Angiogenesis assays 225 Susmita Sahoo and Douglas W. Losordo 28 Immunohistochemical analysis of cardiac tissue 232 Barbara Ogórek, Donato Cappetta, and Jan Kajstura 29 A murine model of cardiac arrest by exsanguination 237 Guangming Cheng, Yiru Guo, Harold K. Elias, Carrie M. Quinn, Arash Davani, Yanjuan Yang, Magdy Girgis, Roberto Bolli, and Buddhadeb Dawn Part 4 Small Animal Imaging 30 Blood pressure, telemetry, and vascular measurements in the rodent model 245 Robert S. Danziger 31 The setting: imaging conscious, sedated, or anesthetized rodents 250 Gene H. Kim and Roberto M. Lang 32 Echocardiography: standard techniques (M-mode, two-dimensional imaging, and Doppler) 254 Gene H. Kim, Lauren Beussink-Nelson, Sanjiv J. Shah, and Roberto M. Lang 33 Echocardiography: advanced techniques (tissue Doppler, speckle tracking, and three-dimensional imaging) 275 Lauren Beussink-Nelson, Gene H. Kim, Roberto M. Lang, and Sanjiv J. Shah 34 In vivo tomographic cardiac imaging: positron emission tomography and magnetic resonance imaging 287 Bruno C. Huber, Patricia K. Nguyen, and Joseph C. Wu 35 In vivo hemodynamics 295 Alexander R. Mackie, Kyle K. Henderson, Sol Misener, and Hossein Ardehali Part 5 Metabolism, Mitochondria, and Cell Death 36 Fractionation of cardiomyocytes and isolation of mitochondria 307 Christopher P. Baines 37 Assessment of glucose and fatty acid metabolism ex vivo 313 Darrell D. Belke and E. Dale Abel 38 Quantification and characterization of atherosclerotic lesions in mice 320 Abhinav Agarwal, Millicent G. Winner, Srinivas D. Sithu, and Sanjay Srivastava 39 Assessment of cell death in the heart 332 Russell S. Whelan, Klitos Konstantinidis, and Richard N. Kitsis 40 Assessment of mitochondrial function in isolated cells 343 Amy K. Rines and Hossein Ardehali 41 Multinuclear NMR spectroscopy of myocardial energetics and substrate utilization in isolated perfused mouse hearts 351 Stephen C. Kolwicz, Jr. and Rong Tian 42 Measurement of reactive oxygen species in cardiovascular disease 359 Mahmood Khan, Fatemat Hassan, Sashwati Roy, and Chandan K. Sen 43 Assessing autophagy 371 Roberta A. Gottlieb 44 Assessment of cardiomyocyte size 378 A. Martin Gerdes and Alessandro Pingitore Part 6 Manipulation of Gene Expression in Vitro and in Vivo 45 Generation of Cre-loxP mouse models for conditional knockout and overexpression of genes in various heart cells 389 Marisa Z. Jackson and Warren G. Tourtellotte 46 Modulation of myocardial genes via use of adenoviral vectors and RNA interference approaches 397 Qianhong Li 47 Overexpression and downregulation of proteins in vitro 407 Marina Bayeva and Hossein Ardehali 48 In vivo microRNA studies 416 Eva van Rooij Part 7 Model Systems 49 Vascular and cardiac studies in zebrafi sh 425 Hans-Georg Simon, Molly Ahrens, and Brandon Holtrup 50 Vascular and cardiac studies in Drosophila 432 Lin Yu, Joseph P. Daniels, and Matthew J. Wolf Index 441

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Book SynopsisMissing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches.Trade Review?Overall, this is an excellent text on missing data that is engaging for practitioners while being rigorous enoughfor use in the graduate biostatistics courses.?(Biometrics , September 2009)" "Missing Data in Clinical Studies does an excellent job of presenting essential ideas on modern concepts and techniques relevant to missing data in clinical studies." (Journal of the American Statistician, December 2008) "?this book is reasonably well organized and covers all the relevant theory and much of the practical applications of the field." (Journal of the American Chemical Association, August 6, 2008) "Missing Data in Clinical Studies does an excellent job of presenting essential ideas on modern concepts and techniques relevant to missing data in clinical studies." (Journal of the American Statistician, December 2008) "Clear, generally accessible and well written, and the content is rich. This text is a highly recommendable addition to the shelves of practicing statisticians." (Journal of Applied Statistics, August 2008) "The authors give key examples in the form of several clinical trials and their analyses using the appropriate remedial techniques." (Journal of Tropical Pediatrics, August 2007)Table of ContentsPreface. Acknowledgements. I Preliminaries. 1 Introduction. 1.1 From Imbalance to the Field of Missing Data Research. 1.2 Incomplete Data in Clinical Studies. 1.3 MAR, MNAR, and Sensitivity Analysis. 1.4 Outline of the Book. 2 Key Examples. 2.1 Introduction. 2.2 The Vorozole Study. 2.3 The Orthodontic Growth Data. 2.4 Mastitis in Dairy Cattle. 2.5 The Depression Trials. 2.6 The Fluvoxamine Trial. 2.7 The Toenail Data. 2.8 Age-Related Macular Degeneration Trial. 2.9 The Analgesic Trial. 2.10 The Slovenian Public Opinion Survey. 3 Terminology and Framework. 3.1 Modelling Incompleteness. 3.2 Terminology. 3.3 Missing Data Frameworks. 3.4 Missing Data Mechanisms. 3.5 Ignorability. 3.6 Pattern-Mixture Models. II Classical Techniques and the Need for Modelling. 4 A Perspective on Simple Methods. 4.1 Introduction. 4.2 Simple Methods. 4.3 Problems with Complete Case Analysis and Last Observation Carried Forward. 4.4 Using the Available Cases: a Frequentist versus a Likelihood Perspective. 4.5 Intention to Treat. 4.6 Concluding Remarks. 5 Analysis of the Orthodontic Growth Data. 5.1 Introduction and Models. 5.2 The Original, Complete Data. 5.3 Direct Likelihood. 5.4 Comparison of Analyses. 5.5 Example SAS Code for Multivariate Linear Models. 5.6 Comparative Power under Different Covariance Structures. 5.7 Concluding Remarks. 6 Analysis of the Depression Trials. 6.1 View 1: Longitudinal Analysis. 6.2 Views 2a and 2b and All versus Two Treatment Arms. III Missing at Random and Ignorability. 7 The Direct Likelihood Method. 7.1 Introduction. 7.2 Ignorable Analyses in Practice. 7.3 The Linear Mixed Model. 7.4 Analysis of the Toenail Data. 7.5 The Generalized Linear Mixed Model. 7.6 The Depression Trials. 7.7 The Analgesic Trial. 8 The Expectation–Maximization Algorithm. 8.1 Introduction. 8.2 The Algorithm. 8.3 Missing Information. 8.4 Rate of Convergence. 8.5 EM Acceleration. 8.6 Calculation of Precision Estimates. 8.7 A Simple Illustration. 8.8 Concluding Remarks. 9 Multiple Imputation. 9.1 Introduction. 9.2 The Basic Procedure. 9.3 Theoretical Justification. 9.4 Inference under Multiple Imputation. 9.5 Efficiency. 9.6 Making Proper Imputations. 9.7 Some Roles for Multiple Imputation. 9.8 Concluding Remarks. 10 Weighted Estimating Equations. 10.1 Introduction. 10.2 Inverse Probability Weighting. 10.3 Generalized Estimating Equations for Marginal Models. 10.4 Weighted Generalized Estimating Equations. 10.5 The Depression Trials. 10.6 The Analgesic Trial. 10.7 Double Robustness. 10.8 Concluding Remarks. 11 Combining GEE and MI. 11.1 Introduction. 11.2 Data Generation and Fitting. 11.3 MI-GEE and MI-Transition. 11.4 An Asymptotic Simulation Study. 11.5 Concluding Remarks. 12 Likelihood-Based Frequentist Inference. 12.1 Introduction. 12.2 Information and Sampling Distributions. 12.3 Bivariate Normal Data. 12.4 Bivariate Binary Data. 12.5 Implications for Standard Software. 12.6 Analysis of the Fluvoxamine Trial. 12.7 The Muscatine Coronary Risk Factor Study. 12.8 The Crépeau Data. 12.9 Concluding Remarks. 13 Analysis of the Age-Related Macular Degeneration Trial. 13.1 Introduction. 13.2 Direct Likelihood Analysis of the Continuous Outcome. 13.3 Weighted Generalized Estimating Equations. 13.4 Direct Likelihood Analysis of the Binary Outcome. 13.5 Multiple Imputation. 13.6 Concluding Remarks. 14 Incomplete Data and SAS. 14.1 Introduction. 14.2 Complete Case Analysis. 14.3 Last Observation Carried Forward. 14.4 Direct Likelihood. 14.5 Weighted Estimating Equations. 14.6 Multiple Imputation. IV Missing Not at Random. 15 Selection Models. 15.1 Introduction. 15.2 The Diggle–Kenward Model for Continuous Outcomes. 15.3 Illustration and SAS Implementation. 15.4 An MNAR Dale Model. 15.5 A Model for Non-monotone Missingness. 15.6 Concluding Remarks. 16 Pattern-Mixture Models. 16.1 Introduction. 16.2 A Simple Gaussian Illustration. 16.3 A Paradox. 16.4 Strategies to Fit Pattern-Mixture Models. 16.5 Applying Identifying Restrictions. 16.6 Pattern-Mixture Analysis of the Vorozole Study. 16.7 A Clinical Trial in Alzheimer’s Disease. 16.8 Analysis of the Fluvoxamine Trial. 16.9 Concluding Remarks. 17 Shared-Parameter Models. 18 Protective Estimation. 18.1 Introduction. 18.2 Brown’s Protective Estimator for Gaussian Data. 18.3 A Protective Estimator for Categorical Data. 18.4 A Protective Estimator for Gaussian Data. 18.5 Concluding Remarks. V Sensitivity Analysis. 19 MNAR, MAR, and the Nature of Sensitivity. 19.1 Introduction. 19.2 Every MNAR Model Has an MAR Bodyguard. 19.3 The General Case of Incomplete Contingency Tables. 19.4 The Slovenian Public Opinion Survey. 19.5 Implications for Formal and Informal Model Selection. 19.6 Behaviour of the Likelihood Ratio Test for MAR versus MNAR. 19.7 Concluding Remarks. 20 Sensitivity Happens. 20.1 Introduction. 20.2 A Range of MNAR Models. 20.3 Identifiability Problems. 20.4 Analysis of the Fluvoxamine Trial. 20.5 Concluding Remarks. 21 Regions of Ignorance and Uncertainty. 21.1 Introduction. 21.2 Prevalence of HIV in Kenya. 21.3 Uncertainty and Sensitivity. 21.4 Models for Monotone Patterns. 21.5 Models for Non-monotone Patterns. 21.6 Formalizing Ignorance and Uncertainty. 21.7 Analysis of the Fluvoxamine Trial. 21.8 Artificial Examples. 21.9 The Slovenian Public Opinion Survey. 21.10 Some Theoretical Considerations. 21.11 Concluding Remarks. 22 Local and Global Influence Methods. 22.1 Introduction. 22.2 Gaussian Outcomes. 22.3 Mastitis in Dairy Cattle. 22.4 Alternative Local Influence Approaches. 22.5 The Milk Protein Content Trial. 22.6 Analysis of the Depression Trials. 22.7 A Local Influence Approach for Ordinal Data with Dropout. 22.8 Analysis of the Fluvoxamine Data. 22.9 A Local Influence Approach for Incomplete Binary Data. 22.10 Analysis of the Fluvoxamine Data. 22.11 Concluding Remarks. 23 The Nature of Local Influence. 23.1 Introduction. 23.2 The Rats Data. 23.3 Analysis and Sensitivity Analysis of the Rats Data. 23.4 Local Influence Methods and Their Behaviour. 23.5 Concluding Remarks. 24 A Latent-Class Mixture Model for Incomplete Longitudinal Gaussian Data. 24.1 Introduction. 24.2 Latent-Class Mixture Models. 24.3 The Likelihood Function and Estimation. 24.4 Classification. 24.5 Simulation Study. 24.6 Analysis of the Depression Trials. 24.7 Concluding Remarks. VI Case Studies. 25 The Age-Related Macular Degeneration Trial. 25.1 Selection Models and Local Influence. 25.2 Local Influence Analysis. 25.3 Pattern-Mixture Models. 25.4 Concluding Remarks. 26 The Vorozole Study. 26.1 Introduction. 26.2 Exploring the Vorozole Data. 26.3 A Selection Model for the Vorozole Study. 26.4 A Pattern-Mixture Model for the Vorozole Study. 26.5 Concluding Remarks. References. Index.

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Book SynopsisFirst published in 1986, this unique reference to clinical experimentation remains just as relevant today. Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs.Table of ContentsReliability of Measurement. Simple Linear Regression Analysis. The Parallel Groups Design. Special Cases of the Parallel Groups Study. Blocking to Control for Prognostic Variables. Stratification to Control for Prognostic Variables. Analysis of Covariance and the Study of Change. Repeated Measurements Studies. Latin and Greco-Latin Squares. The Crossover Study. Balanced Incomplete Block Designs. Factorial Experiments. Split-Plot Designs and Confounding. Appendix. Indexes.

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Book SynopsisPolycyclic aromatic hydrocarbons (PAHs) were one of the first chemicals discovered to cause cancer in humans. This work covers polycyclic aromatic hydrocarbons with larger than seven rings. It has chapters devoted to sample handling and preparation and methodology.Trade Review"...explains methods for analyzing chemical compounds with aromatic cores..." (SciTech Book News, March 2001)Table of ContentsThe Large PAHs. Ultraviolet/Visible Absorption Spectroscopy. Fluorescence Spectroscopy. Infrared Spectroscopy of LPAHs. Mass Spectrometry. Astrophysical Spectroscopy. Chromatography. LPAH Occurrence. Analytical Techniques for Structure Elucidation. Sample Preparation. Comparison of Methodologies. Appendix. Index.

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Book SynopsisWith meta-analysis methods playing a crucial role in health research in recent years, this important and clearly-written book provides a much-needed survey of the field. Meta-analysis provides a framework for combining the results of several clinical trials and drawing inferences about the effectiveness of medical treatments.Trade Review“Both books can be recommended for graduate training and are useful additions to the library of those interested in the meta-analytic accumulation of literatures on training, vocational learning, and education in the professions.” (Vocations and Learning, 15 December 2010) "This well-written book offers an exhaustive criticism and up-to-date references, illustrates effectively with real life examples and data…" (Journal of Statistical Computation & Simulation, July 2004) "this is an excellent book..." (Short Book Reviews, April 2001) "...recommended for mathematically skilled readers interested in getting an overview of the various methods and the existing literature..." (Statistics in Medicine, 15 October 2003) Table of ContentsPART A: META-ANALYSIS METHODOLOGY: THE BASICS Introduction: Meta-analysis: Its Development and Uses Defining Outcome Measures used for Combining via Meta-analysis Random Effects Models for Combining Study Estimates Exploring Between Study Heterogeneity Publication Bias Study Quality Sensitivity Analysis Reporting the Results of a Meta-analysis Fixed Effects Methods for Combining Study Estimates PART B: ADVANCED AND SPECIALIZED META-ANALYSIS TOPICS Bayesian Methods in Meta-analysis Meta Regression Meta-analysis of Different Types of Data Incorporating Study Quality into a Meta-analysis Meta-analysis of Multiple and Correlated Outcome Measures Meta-analysis of Epidemiological and other Observational Studies Generalised Synthesis of Evidence - Combining Different Sources of Evidence Meta-analysis of Survival Data Cumulative Meta-analysis Miscellaneous and Developing Areas of Applications in Meta-Analysis Appendix I: Software Used for the Examples in this Book

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Book SynopsisREAD ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society.Originating from the Medical Research Council's biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author's comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synTrade Review"This is a terrific book and should be on the shelf of every professional that works in clinical trials or health-care evaluation. It gives a thorough pragmatic introduction to Bayesian methods for health-care interventions, provides many example along with data and software to reproduce the analyses, guides readers to areas where Bayesian methods are particularly valuable, and includes an excellent set of exercises." (Journal of the American Statistical Association, June 2009) "Bayesian Approaches to Clinical Trials and Health-Care Evaluation' is a clear and comprehensive text for biostatisticians who want to understand and apply Bayesian statistical methods to clinical research." (Journal of Clinical Best Practices, Nov 2008) "…an indispensable resource for all students and investigators who plan to incorporate Bayesian methods into their research." (The Annals of Pharmacotherapy, January 2005) "...a valuable resource for libraries, and those who are involved in quantitative health care evaluation..." (Royal Statistical Society, Vol.168, No.1, January 2005) "...The technical material is presented in an accessible style, and the examples given clearly illustrate the principles under discussion..." (Short Book Reviews, Vol.24, No.3, December 2004) "...Bayesian analysis seems set to reach a wider audience with the publication of [this] introductory level text..." (Financial Times, 16 April 2004) "...very well laid-out and easy to follow...a very good resource for teaching students..." (Statistical Methods in Medical Research, Vol 14, 2005) "I would use with pleasure and interest this book as a textbook..." (Metron Journal, Vol.63, No.2, 2005) "...I can pay the authors no higher tribute than to say that I would be proud to have written this book. It is elegant and it is destined to becoming a classic in the field." (Statistics in Medicine, 15th July 2005) "...a generous supply of exercises...I recommend it very highly..." (Clinical Trials, No.1 2004) "...Bayesian analysis seems set to reach a wider audience with the publication of [this] introductory level text..." (Financial Times, 16 April 2004) "...a generous supply of exercises...I recommend it very highly..." (Clinical Trials, No.1 2004)Table of ContentsPreface. List of examples. 1. Introduction. 1.1 What are Bayesian methods? 1.2 What do we mean by ‘health-care evaluation’? 1.3 A Bayesian approach to evaluation. 1.4 The aim of this book and the intended audience. 1.5 Structure of the book. 2. Basic Concepts from Traditional Statistical Analysis. 2.1 Probability. 2.1.1 What is probability? 2.1.2 Odds and log-odds. 2.1.3 Bayes theorem for simple events. 2.2 Random variables, parameters and likelihood. 2.2.1 Random variables and their distributions. 2.2.2 Expectation, variance, covariance and correlation. 2.2.3 Parametric distributions and conditional independence. 2.2.4 Likelihoods. 2.3 The normal distribution. 2.4 Normal likelihoods. 2.4.1 Normal approximations for binary data. 2.4.2 Normal likelihoods for survival data. 2.4.3 Normal likelihoods for count responses. 2.4.4 Normal likelihoods for continuous responses. 2.5 Classical inference. 2.6 A catalogue of useful distributions*. 2.6.1 Binomial and Bernoulli. 2.6.2 Poisson. 2.6.3 Beta. 2.6.4 Uniform. 2.6.5 Gamma. 2.6.6 Root-inverse-gamma. 2.6.7 Half-normal. 2.6.8 Log-normal. 2.6.9 Student’s t. 2.6.10 Bivariate normal. 2.7 Key points. Exercises. 3. An Overview of the Bayesian Approach. 3.1 Subjectivity and context. 3.2 Bayes theorem for two hypotheses. 3.3 Comparing simple hypotheses: likelihood ratios and Bayes factors. 3.4 Exchangeability and parametric modelling*. 3.5 Bayes theorem for general quantities. 3.6 Bayesian analysis with binary data. 3.6.1 Binary data with a discrete prior distribution. 3.6.2 Conjugate analysis for binary data. 3.7 Bayesian analysis with normal distributions. 3.8 Point estimation, interval estimation and interval hypotheses. 3.9 The prior distribution. 3.10 How to use Bayes theorem to interpret trial results. 3.11 The ‘credibility’ of significant trial results*. 3.12 Sequential use of Bayes theorem*. 3.13 Predictions. 3.13.1 Predictions in the Bayesian framework. 3.13.2 Predictions for binary data*. 3.13.3 Predictions for normal data. 3.14 Decision-making. 3.15 Design. 3.16 Use of historical data. 3.17 Multiplicity, exchangeability and hierarchical models. 3.18 Dealing with nuisance parameters*. 3.18.1 Alternative methods for eliminating nuisance parameters*. 3.18.2 Profile likelihood in a hierarchical model*. 3.19 Computational issues. 3.19.1 Monte Carlo methods. 3.19.2 Markov chain Monte Carlo methods. 3.19.3 WinBUGS. 3.20 Schools of Bayesians. 3.21 A Bayesian checklist. 3.22 Further reading. 3.23 Key points. Exercises. 4. Comparison of Alternative Approaches to Inference. 4.1 A structure for alternative approaches. 4.2 Conventional statistical methods used in health-care evaluation. 4.3 The likelihood principle, sequential analysis and types of error. 4.3.1 The likelihood principle. 4.3.2 Sequential analysis. 4.3.3 Type I and Type II error. 4.4 P-values and Bayes factors*. 4.4.1 Criticism of P-values. 4.4.2 Bayes factors as an alternative to P-values: simple hypotheses. 4.4.3 Bayes factors as an alternative to P-values: composite hypotheses. 4.4.4 Bayes factors in preference studies. 4.4.5 Lindley’s paradox. 4.5 Key points. Exercises. 5. Prior Distributions. 5.1 Introduction. 5.2 Elicitation of opinion: a brief review. 5.2.1 Background to elicitation. 5.2.2 Elicitation techniques. 5.2.3 Elicitation from multiple experts. 5.3 Critique of prior elicitation. 5.4 Summary of external evidence*. 5.5 Default priors. 5.5.1 ‘Non-informative’ or ‘reference’ priors: 5.5.2 ‘Sceptical’ priors. 5.5.3 ‘Enthusiastic’ priors. 5.5.4 Priors with a point mass at the null hypothesis (‘lump-and-smear’ priors)*. 5.6 Sensitivity analysis and ‘robust’ priors. 5.7 Hierarchical priors. 5.7.1 The judgement of exchangeability. 5.7.2 The form for the random-effects distribution. 5.7.3 The prior for the standard deviation of the random effects*. 5.8 Empirical criticism of priors. 5.9 Key points. Exercises. 6. Randomised Controlled Trials. 6.1 Introduction. 6.2 Use of a loss function: is a clinical trial for inference or decision? 6.3 Specification of null hypotheses. 6.4 Ethics and randomisation: a brief review. 6.4.1 Is randomisation necessary? 6.4.2 When is it ethical to randomise? 6.5 Sample size of non-sequential trials. 6.5.1 Alternative approaches to sample-size assessment. 6.5.2 ‘Classical power’: hybrid classical-Bayesian methods assuming normality. 6.5.3 ‘Bayesian power’. 6.5.4 Adjusting formulae for different hypotheses. 6.5.5 Predictive distribution of power and necessary sample size. 6.6 Monitoring of sequential trials. 6.6.1 Introduction. 6.6.2 Monitoring using the posterior distribution. 6.6.3 Monitoring using predictions: ‘interim power’. 6.6.4 Monitoring using a formal loss function. 6.6.5 Frequentist properties of sequential Bayesian methods. 6.6.6 Bayesian methods and data monitoring committees. 6.7 The role of ‘scepticism’ in confirmatory studies. 6.8 Multiplicity in randomised trials. 6.8.1 Subset analysis. 6.8.2 Multi-centre analysis. 6.8.3 Cluster randomization. 6.8.4 Multiple endpoints and treatments. 6.9 Using historical controls*. 6.10 Data-dependent allocation. 6.11 Trial designs other than two parallel groups. 6.12 Other aspects of drug development. 6.13 Further reading. 6.14 Key points. Exercises. 7. Observational Studies. 7.1 Introduction. 7.2 Alternative study designs. 7.3 Explicit modelling of biases. 7.4 Institutional comparisons. 7.5 Key points. Exercises. 8. Evidence Synthesis. 8.1 Introduction. 8.2 ‘Standard’ meta-analysis. 8.2.1 A Bayesian perspective. 8.2.2 Some delicate issues in Bayesian meta-analysis. 8.2.3 The relationship between treatment effect and underlying risk. 8.3 Indirect comparison studies. 8.4 Generalised evidence synthesis. 8.5 Further reading. 8.6 Key points. Exercises. 9. Cost-effectiveness, Policy-Making and Regulation. 9.1 Introduction. 9.2 Contexts. 9.3 ‘Standard’ cost-effectiveness analysis without uncertainty. 9.4 ‘Two-stage’ and integrated approaches to uncertainty in cost-effectiveness modeling. 9.5 Probabilistic analysis of sensitivity to uncertainty about parameters: two-stage approach. 9.6 Cost-effectiveness analyses of a single study: integrated approach. 9.7 Levels of uncertainty in cost-effectiveness models. 9.8 Complex cost-effectiveness models. 9.8.1 Discrete-time, discrete-state Markov models. 9.8.2 Micro-simulation in cost-effectiveness models. 9.8.3 Micro-simulation and probabilistic sensitivity analysis. 9.8.4 Comprehensive decision modeling. 9.9 Simultaneous evidence synthesis and complex cost-effectiveness modeling. 9.9.1 Generalised meta-analysis of evidence. 9.9.2 Comparison of integrated Bayesian and two-stage approach. 9.10 Cost-effectiveness of carrying out research: payback models. 9.10.1 Research planning in the public sector. 9.10.2 Research planning in the pharmaceutical industry. 9.10.3 Value of information. 9.11 Decision theory in cost-effectiveness analysis, regulation and policy. 9.12 Regulation and health policy. 9.12.1 The regulatory context. 9.12.2 Regulation of pharmaceuticals. 9.12.3 Regulation of medical devices. 9.13 Conclusions. 9.14 Key points. Exercises. 10. Conclusions and Implications for Future Research. 10.1 Introduction. 10.2 General advantages and problems of a Bayesian approach. 10.3 Future research and development. Appendix: Websites and Software. A.1 The site for this book. A.2 Bayesian methods in health-care evaluation. A.3 Bayesian software. A.4 General Bayesian sites. References. Index.

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Book SynopsisBridging the knowledge gap between scientists that develop and apply proteomics technologies and oncologists who focus on understanding the biological basis behind cancer manifestation and progression, this title provides an account of how the multiple facets of proteomics have been applied to cancer.Trade Review“By guiding readers through the latest proteomic technologies and their applications in cancer research, “Proteomic Applications in Cancer Detection and Discovery" enhances the ability of researchers in proteomics and researchers in oncology to collaborate in order to better understand cancer and develop strategies to prevent and treat it.” (Newbooks.lib, 11 September 2014Table of ContentsPreface vii Acknowledgments ix 1 Systems Biology 1 2 Mass Spectrometry in Cancer Research 27 3 Quantitative Proteomics 59 4 Proteomic Analysis of Posttranslational Modifications 87 5 Characterization of Protein Complexes 117 6 Global Phosphorylation Analysis 145 7 the Search for Biomarkers in Biofluids 171 8 Proteomic Patterns: a New Paradigm in Diagnostics And Therapeutics? 195 9 the Emergence of Protein Arrays 215 10 the Role of Proteomics in Personalized Medicine 241 11 the Critical Role of Bioinformatics 263 12 Future Prospects of Proteomics in Cancer Research 281 Index 305

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Book SynopsisTHE MOST PRACTICAL, UP-TO-DATE GUIDE TO MODELLING AND ANALYZING TIME-TO-EVENT DATANOW IN A VALUABLE NEW EDITION Since publication of the first edition nearly a decade ago, analyses using time-to-event methods have increase considerably in all areas of scientific inquiry mainly as a result of model-building methods available in modern statistical software packages. However, there has been minimal coverage in the available literature to9 guide researchers, practitioners, and students who wish to apply these methods to health-related areas of study. Applied Survival Analysis, Second Edition provides a comprehensive and up-to-date introduction to regression modeling for time-to-event data in medical, epidemiological, biostatistical, and other health-related research. This book places a unique emphasis on the practical and contemporary applications of regression modeling rather than the mathematical theory. It offers a clear and accessible presentation of modern modeling tTrade Review“This is a great book for anyone analyzing time-to-event data. Researchers interested in the underlying theory will have to go elsewhere..” (Stat Papers, 1 December 2012) "It is well suited for teaching a graduate-level course in medical statistics, and the data sets used in the book are available online." (Biometrical Journal, August 2009) "This is a superb resource - a practical guide with up-to-date applications. The authors are excellent teachers of the mathematics and application of survival data regression modeling." (Doodys, August 2009) "The extensive and detailed coverage of the process of survival model fitting, as well as the applied exercises, make this textbook an excellent choice for an applied survival analysis course." (Journal of Biopharmaceutical Statistics, Volume 18, Issue 6, 2008)Table of ContentsPreface xi 1. Introduction to Regression Modeling of Survival Data 1 2. Descriptive Methods for Survival Data 16 3. Regression Models for Survival Data 67 4. Interpretation of a Fitted Proportional Hazards Regression Model 92 5. Model Development 132 6. Assessment of Model Adequacy 169 7. Extensions of the Proportional Hazards Model 207 8. Parametric Regression Models 244 9. Other Models and Topics 286 Appendix 1: The Delta Method 355 Appendix 2: An Introduction to the Counting Process Approach to Survival Analysis 359 Appendix 3: Percentiles for Computation of the Hall and Wellner Confidence Band 364 References 365 Index 383

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Book SynopsisThe concepts of epidemiology, the science that uses statistical methods to investigate associations between risk factors and disease outcomes in human populations, are developed using examples involving real data from published studies.Table of ContentsEpidemiological Research. Statistical Methods I. Statistical Methods II. Mantel-Haenzel Methods. Logistic Regression. Logistic Regression II. Survival Analysis. Matching. Sample Size. Appendix. Index.

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Book SynopsisThe aim of this book is to suggest and exemplify a systematic methodology for analysing survival data which contains immune, or cured individuals, denoted generically as long-term survivors. Such data occurs in medical and epidemiological applications, where the intention may be to identify whether or not cured or immune individuals are present in a population, perhaps as a result of treatments given; in the analysis of recidivism data in criminology, where the intentions are similar with respect to prisoners released from and possibly returning to prison; and in many other areas where followup data is available on individuals, with the possibility that not all suffer the event under investigation. Both nonparametric and parametric methods are proposed and developed. The effects of covariate information can be assessed via a kind of generalised linear framework in the parametric analyses. The proposed methodologies are supported by asymptotic analyses and simulations of real situationsTrade Review"The book contains an admirable blend of theory and practice beingclearly explained and illustrated with realistic examples ofsurvival analyses from medical and criminological studies." "...an introduction to the analysis of survival data..." (Quarterlyof Applied Mathematics, Vol. LVIII, No. 4,December 2000)Table of ContentsFormulating Tests for the Presence of Immunes and SufficientFollow-up. Properties of the Kaplan-Meier Estimator. Nonparametric Estimation and Testing. Parametric Models for Single Samples. The Use of Concomitant Information. Large Sample Properties of Parametric Models: Single Samples. Large-Sample Properties of Parametric Models with Covariates. Further Topics. References. Statistical Tables. Index.

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Book SynopsisThis volume provides health care professionals with a comprehensive but readable guide to the design, conduct and interpretation of health services research. It strips the research process of its technical jargon, illuminating the methods of research by an extensive use of real examples.Table of ContentsIntroduction to Health Services Research. The Foundations of Research. Developing the Research Question. Reviewing the Literature. Case Reports and Case Series. Surveys. Cohort Studies. Clinical Trials. Case-Control Studies. Other Methods of Research. Selecting the Method. Related Disciplines. Issues in Data Collection. Practical Issues in the Design and Conduct of Studies. Introduction to Data Analysis and Interpretation. Communicating the Findings. Index.

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Book SynopsisThe twentieth century has been a great success for modern medicine, and has resulted in the generation of a plethora of drugs to treat most common illnesses. However, in the light of increasing regulatory demands, spiralling costs and diminishing commercial returns, the question of how, when, where and whether to conduct pharmaceutical R&D has profound implications, and not just for those within the pharmaceutical industry. In response to these and other dilemmas, the authors define the processes involved in drug research, and examine the advantages and disadvantages of collaborative methods of drug research, and examine the roles that academia, CROs, small biotechnology companies and research boutiques, and possibly even the virtual research company might play as contractors and collaborators.Table of ContentsThe Pharmaceutical Development Process. The Advantages of Contracts and Collaborations. The Disadvantages of Contracts and Collaborations. The Role of Academic Institutes. The Role of CROs and Small Research Companies. Towards the Virtual Research Company. References. Index.

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Book Synopsisexplains the ethos and principles of action research demonstrates how it may be used in health care practice helps practitioners participate in and/or plan, carry out and evaluate their own action research studies author of best-selling Mentoring, Preceptorship and Clinical Supervision with Anne Palmer.Trade Review"This book would be an excellent starting point for someone interested in undertaking research in practice who feels the reductionist or qualitative research method is not appropriate." Physiotherapy Journal "Action Research in Healthcare is a welcome addition to the literature on methods because it outlines an alternative problem-solving, collaborative approach to research. It is accessible and engages the reader..." Health Service Journal "Where the book really does triumph is in the provision of guidelines for critiquing action research, thus emphasizing the practical utility of the text. It is a book which should certainly be available in all nursing libraries." Journal of Advanced NursingTable of ContentsAcknowledgements; Introduction; Principles of action research design; Preparing a proposal; Managing action research; Writing a valid account; Appendix: Guidelines for critiquing action research; References; Further reading; Index

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Book Synopsisaeo An encyclopaedic reference text for all aspects of advanced medical statistics aeo Special regression problems have been added to the new edition aeo ". the standard text for professional medical statisticians. " -- Aslib Book Guide aeo new chapter on laboratory assays.Trade ReviewOn the fourth edition: '...this breakthrough revision of a classic...is truly excellent: comprehensive, informative, able to be read at a variety of levels by a variety of readers, modern and insightful.' Statistics in Medicine, Volume 22, 2003 '...this is a volume which could usefully, and perhaps should, be read from cover to cover by anyone embarking on the study of medical statistics. For those already working in the area, it should at least be on their bookshelves.' Short Book Reviews, Volume 22, Number 2, August 2002 '...each edition has improved and expanded considerably on the last, keeping pace with the ever-changing field of medical statistics...' eMJA Bookroom, 2002 On previous editions: '...this is an excellent book...I strongly recommend this book...' International Society for Clinical Biostatistics, December 1997 '...this classical beauty has aged well.' International Statistical Institute, April 1996 '...readers who...use statistical analysis...must buy this third edition' Australian-New Zealand Journal of Surgery, Spring 1995 '...the standard text for professional medical statisticians.' Aslib Book Guide, November 1994Table of ContentsPreface to the fourth edition. 1 The Scope of Statistics. 2 Describing Data. 3 Probability. 4 Analysing Means and Proportions. 5 Analysing Variances, Counts and Other Measures. 6 Bayesian Methods. 7 Regression and Correlation. 8 Comparison of Several Groups. 9 Experimental Design. 10 Analysing Non-Normal Data. 11 Modelling Continous Data. 12 Further Regresson Models for a Continuous Response. 13 Multivariate Methods. 14 Modelling Categorical Data. 15 Empirical Methods for Categrorical Data. 16 Further Bayesian Methods. 17 Survival Analysis. 18 Clinical Trials. 19 Statistical Methods in Epidemiology. 20 Laboratory Assays. Appendix tables. References. Author Index. Subject Index.

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Book SynopsisThis extremely important book is the comprehensive and authoritative independent consensus report of the British Nutrition Foundation''s Task Force on Obesity. The Task Force was invited by the Council of the British Nutrition Foundation to review the present state of knowledge of the causes, consequences, prevention and treatment of obesity, and to prepare a report and should it see fit, to draw conclusions, make recommendations and identify areas for future research. Obesity is an authoritative and definitive landmark publication covering all major aspects of this vitally important condition. Bringing together a huge wealth of research information from a wide variety of disciplines, in a well-presented, clear and carefully-edited format, Obesity is an indispensable guide for all personnel involved in the prevention and treatment of obesity, or for those studying and researching in this area. The book provides comprehensive coverage of the health risks of obesity, clinical assessmTable of ContentsTerms of reference. Obesity Task Force Membership. Acknowledgements. 1. Introduction (Dr Michele Sadler). 2. Health Risks of Obesity (Professor John Garrow). 3. Clinical Assessment of Obesity (Professor John Garrow). 4. Epidemiology of Obesity in the UK (Dr Ann Gehily). 5. Aetiology of Obesity I: Introduction (Dr Andrew Prentice). 6. Aetiology of Obesity II: Genetics (Professor Peter Kopelman). 7. Aetiology of Obesity III: Critical Periods for the Development of Obesity (Dr Mary Flynn, Ms Gail Goldberg, Dr Andrew Prentice, Dr Tim Cole). 8. Aetiology of Obesity IV: Metabolic Factors (Dr Andrew Prentice). 9. Aetiology of Obesity V; Macronutrient Balance (Dr Andrew Prentice). 10. Aetiology of Obesity VI: Appetite Control, Physiological Factors (Dr Andrew Prentice, Dr James Stubbs). 11. Aetiology of Obesity VII: Endocrine Causes (Dr Nick Finer, Dr Andrew Prentice). 12. Aetiology of Obesity VIII: Psychological Factors (Professor Jane Wardle). 13. Aetiology of Obesity IX: Dietary Factors. (Dr Andrew Prentice, Dr Susan Jebb). 14. Aetiology of Obesity X: Food Choice, Food Policy and Eating Patterns (Dr David Mela, Professor Christopher Ritson, Ms Sharon Kuznesof). 15. Aetiology of Obesity XI: Physical Inactivity (Professor Kenneth Fox). 16. Significance of within Person Weight Variation (Professor John Garrow). 17. Prevention of Obesity (Professor John Garrow). 18. Treatment of Obesity I: Introduction (Professor John Garrow, Ms Mary O'Kane). 19. Treatment of Obesity II: Dietary Treatment of Obesity (Professor John Garrow, Ms Mary O'Kane). 20. Treatment of Obesity III: Physical Activity and Exercise (Professor Kenneth Fox). 21. Treatment of Obesity IV: Behavioural Treatment (Professor Jane Wardle). 22. Treatment of Obesity V: Pharmacotherapy for Obesity (Professor Peter Kopelman). 23. Treatment of Obesity VI: Surgical Treatments (Professor John Garrow). 24. Treatment of Obesity VII: Resources and Evaluation (Professor John Garrow). 25. Suggestions of Further Reading. 26. Recommendations of the BNF Task Force on Obesity. Appendix : Answers to Questions from medical journalists. Glossary. References. Index.

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Book SynopsisNurses are faced with the need for practice grounded in research-based evidence. This book presents qualitative research methodologies creatively developed within nursing. It enables people to research critical issues for nursing practice and health care.Table of ContentsPreface. List of Contributors. 1. Introducing Fields, Selves, Stories, Texts and Materials. 2. Where Do We Stand in Relation to the Data? Being Reflexive About Reflexivity in Health Care Evaluation. 3. Moving Nursing Practice: Integrating Theory and Method. 4. Participative Observation: Using the Subject Body to Understand Nursing Practice. 5. Self and Others: The Rigour and Ethics of Insider Ethnography. 6. Researching Story and Narrative in Nursing: An Object-Relations Approach. 7. Rational Solutions and Unreliable Narrators: Content, Structure and Voice in Narrative Research. 8. Discourse Analysis, Ideology and Professional Practice. 9. Words Are Powerful Tools: Discourse Analytic Explanations of Nursing Practice. 10. Taking Things Seriously: Studying the Material Culture of Nursing. 11. A History of Small Things. 12. Studying The Women in White. Epilogue. Index

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Book SynopsisThere have been few credible studies of the risks and benefits of widely used medical treatments. Howard Frazier and Frederick Mosteller, leading figures in the field of medical technology assessment, attempt to distill the methods and knowledge base of their highly specialized discipline, with particular reference to medical innovations.Trade ReviewIn Medicine Worth Paying For, the editors…begin by asking ‘How is medicine doing?’ Many of the 14 case studies included suggest a qualified positive assessment… This book is far more than a round of applause for medical advances that have been proven to yield health benefits. The editors criticize the methods by which medical interventions are studied, or, not studied… The editors…[have] distinguished backgrounds in technology assessment…[and] the text itself is highly readable, and sufficiently accessible so that lay readers will find it readily comprehensible. -- Thomas H. Lee * Nature Medicine *[T]his book would be valuable for many audiences, especially for policymakers, because it identifies most of the serious deficiencies in the American health care delivery system and suggests remedial steps that are endorsed by virtually all serious scholars of the problems this nation faces on the scientific side of health care. Health professionals and medical and nursing students, as well as lay readers, should find this book very informative in helping them to understand the issues in present-day health care delivery in the United States. -- Seymour Perry, M.D. * Academic Medicine *This book is grounded in solid reviews of clinical studies, shows awareness of the economic consequences of alternative interventions, and is sensitive to the social and psychological factors that affect the well being of patients. It deserves a wide audience among physicians, other health professionals, and all those responsible for public and private health policy decisions. -- Victor R. Fuchs, Henry J. Kaiser, Jr., Professor, Emeritus, Stanford UniversityThis book is must reading for anyone interested in the role of new technologies in medicine. Two eminent scholars, Professors Frazier and Mosteller, and their colleagues discuss examples of specific new technologies—how they are evaluated, how they are accepted in the market place, and how their impact on the cost and the quality of medical care is evaluated. As the United States and most Western nations struggle with the challenges of containing the rise in the costs of care, while preserving and enhancing the quality of care, the lessons taught in this book will be instructive and sometimes sobering. -- Anthony L. Komaroff, M.D., Director, Division of General Medicine and Primary Care, Brigham and Women’s Hospital, BostonTable of ContentsPart 1 Background: the nature of inquiry, Howard S. Frazier and Frederick Mosteller; evaluating medical technologies, Frederick Mosteller and Howard S. Frazier. Part 2 Physician performance: laparoscopic cholecystectomy for gallstones, Leon D. Goldman; preserving vision in diabetic retinopathy - the impact of laser treatment, Michael R. Albert and Daniel M. Albert; the treatment of unipolar depression, Howard S. Frazier. Part 3 Perverse financial incentives: kidney transplantation, Miriam E. Adams; epoetin therapy for renal anemia - health policy and quality-of-life perspectives, Jennifer F. Taylor. Part 4 Patient empowerment: the control of postoperative pain, Jane C. Ballantyne et al. Part 5 Monitoring and delivering care: immunization against measles, Donald N. Medearis, Jr; treatment of hypertension, Sidney Klawansky. Part 6 The delivery of routine care - visual and dental health: the contributions of lenses to visual health, Georgianna Marks et al; dentistry, Alexia Antczak-Bouckoms and J.F.C. Tulloch. Part 7 Quality of life and cost-effectiveness: total joint replacement for the treatment of osteoarthritis, Jennifer F. Taylor and Elisabeth Burdick. Part 8 Unanticipated effects of treatment: peptic ulcer, Thomas C. Chalmers; oral contraceptives - post-marketing surveillance and rare, late complications of drugs, Howard S. Frazier and Graham A. Colditz. Part 9 Administrative innovations: surgery and anesthesiology, Debra R. Milamed and John Hedley-Whyte. Part 10 Conclusions and recommendations: improving the health care system, Frederick Mosteller and Howard S. Frazier; innovation-specific improvements, Frederick Mosteller and Howard S. Frazier; recommendations for change, Howard S. Frazier and Frederick Mosteller.

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Book SynopsisSince 1972, the Robert Wood Johnson Foundation (RWJF) has supported research efforts that touch on a broad range of public health care issues. In this volume, leading health care researchers, who are funded by the RWJF, report on their most current investigative efforts.Table of ContentsForeword by Steven A. Schroeder. Introduction by Stephen L. Isaacs and James R. KnickmanAcknowledgments. Inside the Foundation. 1. Expanding the Focus of The Robert Wood Johnson Foundation: Health as an Equal Partner to Health Care by J. Michael McGinnis and Steven A. Schroeder. 2. 'Getting the Word Out': A Foundation Memoir and Personal Journey by Frank Karel. Programs. 3. Children's Health Initiatives by Sharon Begley and Ruby Hearn. 4. The Changing Approach to Managed Care by Janet Firshein and Lewis Sandy. 5. Integrating Acute and Long-term Care for the Elderly by Joseph Alper and Rosemary Gibson. 6. The Workers' Compensation Health Initiative by Allard Dembe and Jay Himmelstein. 7. Sound Partners for Community Health by Digby Diehl. A Look Back. 8. The Regionalized Perinatal Care Program by Marguerite Holloway. 9. Improving Dental Care by Paul Brodeur. Collaboration with other Philanthropies. 10. Partnership Among National Foundations: Between Rhetoric and Reality by Stephen Isaacs and John Rodgers.

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Book SynopsisProvides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a range of topics, such as consent, confidentiality, subject recruitment and selection, and Institutional Review Board, this book offers useful strategies for achieving regulatory compliance while reducing liability.Trade Review"Ideal for anyone who wants a comprehensive understanding of clinical research…" (Journal of Clinical Research Best Practices)

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Book SynopsisThis invaluable guide shows students and professionals how measurements and data can be used to balance quality services and financial viability and how measures can help to evaluate and improve organizational, clinical, and financial processes. The book explains the various performance measurement methods used in health care and shows their practical impact on clinical patient outcomes.Table of ContentsFigures and Tables. Preface. The Author. Introduction. 1 Overview: What Measures Measure. Measures and the Medical Staff. Measures and Patients. Measures and Health Care Leaders. Measures and Money. Measures and Evaluating Care. Summary. Things to Think About. 2 Fundamentals of Data. Quality and Finance: A Perfect Fit. Quality and Accountability. Let the Walls Come Tumbling Down. Finding Answers. Objectifying the Delivery of Care. Case Example: Cardiac Mortality. Case Example: Intensive Care Units. Defining Goals. Nothing New Under the Sun. Case Example: Falls. Communicating Information from Quality Measures. Leadership Defines the Level of Quality. Finding Questions. Summary. Things to Think About. 3 Using Data to Improve Organizational Processes. Satisfying the Demanding Consumer. Offering Value. Showing the Numbers. Measures Are Good Business. Managing with Measures. The Value of Measures. Measures and Organizational Processes. Case Example: Nutrition. Case Example: Housekeeping. Monitoring Performance. Measures Promote Knowledge. Lack of Measures Leads to Poor Resource Management. Measures and Evaluating Services. Summary. Things to Think About. 4 What to Measure—and Why. Leadership Determines What to Measure. Measures Define Quality Care. Measures Inform Financial Decisions. Measures and Purchasing Decisions. Measures and Patient Safety. Quality Methodology for Performance Improvement. Developing a Performance Improvement Plan. Case Example: Plan Do Check Act for Bariatric Surgery. Monitoring Variation from the Standard. Case Example: Moving Between Levels of Care. Understanding Patient Flow. Summary. Things to Think About. 5 Promoting Accountability Through Measurements. Measures and Organizational Goals. Justifying Expenses. Case Example: Self-Extubations. Getting the Doctors on Board. Case Example: Wrong-Site Surgery. Analyzing Errors. Changing the Culture. Asking Questions. Evaluating Information and Communicating Results. Summary. Things to Think About. 6 The Rationale for External Drivers of Quality. The Government Takes the Lead. Monitoring Quality for Changed Practices. The Media Carry the Message. Public Pressure Forces Change. Quality and Community Relations. Truth or Consequences. Quality Data Force Change. Case Example: Coronary Artery Bypass Graft. Make the Regulations Work for You. Summary. Things to Think About. 7 Integrating Data for Operational Success. Different Data Tell Different Stories About Care. Working with Administrative Data. Working with Primary Data. Case Example: Stroke. Operational Decisions and Quality Data. Quality and Risk. Case Example: FMEA and Blood Transfusions. Communicating Quality Data. Case Example: Decubiti. Measures Tell the Truth. Summary. Things to Think About. 8 Internal Drivers of Quality. Using Guidelines to Drive Quality. Ensuring That the Standard of Care Is Met. CareMaps Promote Standardized Care. Variance Data Help Drive Quality. Dealing with Resistance to CareMaps. Implementing Guidelines to Drive Quality Care. Everyone Benefits from CareMaps. Documenting the Delivery of Care. Case Example: Detoxification Guidelines. Summary. Things to Think About. 9 Using Data for Performance Improvement. Aggregated Data Offer a Different Perspective. Case Example: Using Quality Methods to Ensure Consistency of Care. Case Example: Increasing Access to Care. Case Example: Improving Sterilization Across the System. Collaboration Works. Summary. Things to Think About. Conclusion. Bibliography. Index.

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Book SynopsisCrane reveals how Africa went from being a continent largely excluded from advancements in HIV medicine to an area of central concern and knowledge production within the increasingly popular field of global health science.Trade ReviewAnthropologist Crane (Univ. of Washington-Bothell) presents a solidly documented and well-reasoned discussion of AIDS and its far-reaching effects. An excellent overview deals with resistance to treatment.. Recommended. Graduate students, faculty, professionals. * Choice *Table of ContentsIntroduction1. Resistant to Treatment2. The Molecular Politics of HIV3. The Turn Towards Africa4. Research and Development5. Doing Global HealthConclusionReferences Index

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Book SynopsisIn this text the author provides a history of biomedical research on human subjects in the US from 1890 to 1940. She offers accounts of experiments conducted on both healthy and unhealthy adults and children including the yellow fever experiments and "dental drill" experiments on insane patient.Trade ReviewLederer's writing is crisp and clear, her historical documentation is exhaustive, and her social commentary persuasive. This book is an important addition to the growing literature on the history of human experimentation and medical research. New England Journal of Medicine Essential reading for anyone concerned with clinical research public policy and attitudes. -- Norman M. Goldfarb Journal of Clinical Research Best Practices 2006Table of ContentsList of IllustrationsAcknowledgments IntroductionChapter 1. "The Sacred Cord": Doctors, Patients, and Medical ResearchChapter 2. The Charge of Human VivisectionChapter 3. The American Medical Association and the Defense of ResearchChapter 4. Rules for Research: Human Experimentation and the AMA Code of EthicsChapter 5. "Your Dog and Your Baby": The Continuing Campaign Against Human VivisectionChapter 6. Heroes and Martyrs: Human Experimentation in an Age of Medical ProgressEpilogueAppendixNotesBibliographic EssayIndex

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Book SynopsisProfessionals in need of such training and bioethicists will be interested.Trade ReviewProvides excellent material on a broad variety of ethical topics in clinical research. The editors are commended for the wise and diverse selection of articles and the broad range of sources of literature included. A lot of information is made available at a very affordable price. Quality Assurance Journal 2005 Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics. -- Leonardo D. de Castro Bulletin of the World Health Organization 2004 One word will suffice to describe the book-outstanding. -- Sanjay A. Pai Current Science 2004Table of ContentsContents:Part I. Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and TuskegeePart II. Ethical and Regulatory Guidance for Research with HumansPart III. The Ethics of Clinical Trial DesignPart IV. The Ethics of Research Participant RecruitmentPart V. Informed Consent in ResearchPart VI. Clinical Research with Special PopulationsPart VII. Special Topics in Research EthicsPart VIII. The Behavior of Clinical Investigators: Conflicts of InterestPart IX. Scientific MisconductPart X. Challenges to the Institutional Review Board System

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Book SynopsisContaining helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.Trade ReviewA well-written and informative narrative of the inner workings of IRBs. It is a must-read for those who are (or will be) members of an IRB and for those who need to submit a proposal. -- Maura Pilotti, Ph.D. Metapsychology 2007 An indispensable guide for both experienced and inexperienced IRB members... I would recommend it to any IRB member. Doody's Review Service 2007 Mazur's book provides IRB members with essential questions they should ask when reviewing proposed and ongoing studies. -- Karen J. Maschke New England Journal of Medicine 2007 The book contains an interesting perspective and a wealth of knowledge. It contains quite a lot of information for any single audience, but those who serve on IRBs can benefit greatly from reading and referring to Mazur's work. -- Alice Z. Frohna JAMA 2007 College-level holdings strong in medical and research issues or medical ethics will want this review. Midwest Book Review 2007 There is much to like about Evaluating the Science and Ethics of Research on Humans; its depth and sophistication... Not just Mazur's experience but the overall evolution of research administration is reflected in this volume. -- Kenneth A. DeVille Journal of Legal Medicine 2007 Every IRB member must read this book so that the participants of clinical trials benefit from it. -- Sanjay A. Pai Indian Journal of Medical Ethics 2008 The author applies extensive experience to illustrate the depth of ethical reflection that research proposals can generate and provides guidance on how reflection can be directed to decision making... Checklists in the text and appendices afford IRB members and officers the comfort of knowing that little, if anything, has been overlooked in discharging ethics review. -- Bernard M. Dickens, PhD Annals of Internal Medicine 2008 The analysis of a study's risk-benefit ratio is especially good. U.S. Dept. of Energy, Office of Biological and Environmental Research 2007 Contains helpful summaries and checklists throughout based on the author's thirty years of research experience. Issues in Law and Medicine 2008Table of ContentsPrefaceIntroduction: What Can the New IRB Member Expect?Part I: The IRB, Its Work, and Its Challenges1. What Is an IRB, and What Does It Do?2. Basic Terms and Concepts Used in IRB Work3. What Is Risk?Part II: The Scientific Protocol and the Informed Consent Form4. Prescreening of Proposals5. The Scientific Protocol6. The Informed Consent Form7. Recruitment, Selection, and Compensation of Study Participants8. Research involving Questionnaires and Surveys9. Protection of Participants' Privacy in Research Dataand SpecimensPart III: The Continuing Work of the IRB10. The Ethical Issues of Informed Consent11. Continuing Review, Communication, and Feedback12. Where Are IRBs Making Mistakes, and How Can We Minimize Mistakes?13. Strategies for Managing the IRB Workload and Supporting IRB Decision Making14. Decision-Making Capacity and Accountability in ResearchSummary: The IRB's Key RoleAppendix 1: A Check List for Reviewing a Scientific ProtocolAppendix 2: A Check List for Reviewing an Informed Consent FormNotesWebsite References for Cited DocumentsIndex

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Book SynopsisThis volume details methods and protocols covering multiple aspects of Medulloblastoma. Divided into four parts, chapters guide readers through nucleic acids detection and analysis, cell-based analysis methodologies, and applications of patient-information on designing better experimental strategies for future drug development efforts in Medulloblastoma. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Medulloblastoma: Methods and Protocols aims to deliver a clear-cut and standardized set of protocols to a broad scientific community.Table of Contents 1. Childhood Medulloblastoma: An Overview Yujin Suk, William D Gwynne, Ian Burns, Chitra Venugopal and Sheila K Singh Part I: Molecular Assay-based Methods 2. Real-time PCR assays on formalin-fixed paraffin embedded medulloblastomas Ratika Kunder and Neelam Vishwanath Shirsat 3. Validation of microRNA target genes using luciferase reporter assay and western blot analysis Pooja Panwalkar, Atul Khire and Neelam Shirsat 4. Chromatin Immunoprecipitation Assays on Medulloblastoma Cell Line DAOY Tara Dobson and Jyothishmathi Swaminathan 5. Quantification of microRNAs in cells and tissues using stem-loop RT PCR and qPCR Pooja Panwalkar, Atul Khire and Neelam Shirsat 6. Analysis of Microarray Data from Medulloblastoma tissue samples Debojyoti Dhar and Gopala Kallapura 7. Advancement of single- cell sequencing in Medulloblastoma Deepanshu Verma, Namyashree Nayak, Ashuthosh Singh, Ashutosh Kumar Singh, Neha Garg Part II: Cellular Assays and Inhibitors for Medulloblastoma 8. Flow cytometry approaches to obtain medulloblastoma stem cells from bulk cultures Praveen Kumar and Neha Garg 9. Drug Screening assays on Medulloblastoma Stem Cells using compound libraries Ashutosh Singh and Neha Garg 10. 3D-on-2D: A physiologically-relevant and gel-free in vitro co-culture method to assay anti-metastatic agents Abhinav Dey, Samuel Eisenberg, Rayna Birnbaum and David J Sharp 11. In vitro screening assay for activators of T- cell migration to solid tumors Abhinav Dey and David Sharp 12. Impact of Nano preparation of phytoconstituents in Medulloblastoma Priyanka Mishra and Y.B. Tripathi 13. Challenges and Recent Advances of novel chemical inhibitors in Medulloblastoma Therapy Anand Maurya, Upendra Kumar Patel, Jitendra Kumar Yadav, Virender Pratap Singh, Alka Agarwal 14. Role of ayurvedic plants as anti-cancer agents Nikhil Pandey and Y.B. Tripathi Part III: Animal Models in Medulloblastoma 15. In vivo tumorigenicity assays using subcutaneous and orthotopic xenografts in immunodeficient mice Kedar Yogi, Rahul Thorat and Neelam Shirsat 16. Manufacture of an Oncolytic Measles Virus-Sensitive Immune-Competent Mouse Model of Medulloblastoma. Sangeet Lal and Corey Raffel Part IV: Patient data based approaches for Biomedical Research in Medulloblastoma 17. Preclinical Research Strategy Development for RNAi-based therapies in Oncology using patient-centred information from public databases of Human Protein Atlas and R2Genomics Platform Abhinav Dey, Isabelle Balachandran, Ava Solis and David J Sharp 18. Magnetic resonance imaging in the contemporary management of medulloblastoma: current and emerging applications Archya Dasgupta, Madan Maitre, Sona Pungavkar and Tejpal Gupta 19. Multidisciplinary Management of Medulloblastoma: Consensus, Challenges and Controversies Abhishek Chatterjee, Madan Maitre, Archya Dasgupta, Epari Sridhar and Tejpal Gupta

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Book SynopsisThis detailed book provides an exhaustive picture of current methods to detect, isolate, and analyze extracellular vesicles (EVs) from diverse sources, now seen as potential disease biomarkers as well as tools for the development of new therapies.Table of ContentsPart I: Extracellular Vesicles Detection and Isolation 1. Aptasensors for Cancerous Exosome Detection Jin Li, Sitao Xie, Fengli Qu, and Weihong Tan 2. Detection of Cancer-Derived Exosomes Using a Sensitive Colorimetric Aptasensor Lizhou Xu and Khuloud T. Al-Jamal 3. Isolation of Circulating Extracellular Vesicles by High-Performance Size-Exclusion Chromatography Kaloyan Takov, I-Jou Teng, and Manuel Mayr 4. Isolation and Proteomic Analysis of Mouse Serum Small Extracellular Vesicles for Individual Subject Analysis Federica Anastasi, Marialaura Dilillo, Davide Pellegrini, and Liam A. McDonnell 5. Protocol for Measuring Concentrations of Extracellular Vesicles in Human Blood Plasma with Flow Cytometry Najat Hajji, Chi M. Hau, Rienk Nieuwland, and Edwin van der Pol Part II: Isolation and Characterization of Tissue and Biofluid-Specific EVs 6. Targeted Mass Spectrometry-Based Proteomics Method to Quantify Placental Extracellular Vesicles Andrew Lai, Carlos Palma, Alexis Salas, Flavio Carrion, and Carlos Salomon 7. Isolation and Characterization of Extracellular Vesicles Secreted from Human Pluripotent Stem Cell-Derived Cardiovascular Progenitor Cells Qiang Wu, Min-Xia Ke, and Huang-Tian Yang 8. Isolation and Characterization of Salivary Exosomes for Cancer Biomarker Discovery Lucas Trevisan França de Lima, Juliana Müller Bark, Mohammad Rasheduzzaman, Chameera Ekanayake Weeramange, and Chamindie Punyadeera 9. Isolation and Characterization of Urinary Extracellular Vesicles for MicroRNA Biomarker Signature Development with Reference to MISEV Compliance Marlene Reithmair, Anja Lindemann, Veronika Mussack, and Michael W. Pfaffl Part III: Analysis of EV Components 10. Direct Detection of Extracellular Vesicle miRNAs Using a Single-Step RT-qPCR Assay Ayyanar Sivanantham, Heedoo Lee, and Yang Jin 11. Purification and Phosphoproteomic Analysis of Plasma-Derived Extracellular Vesicles Anton B. Iliuk 12. Lipidomic Analysis of Extracellular Vesicles Isolated from Human Plasma and Serum Yuchen Sun, Kosuke Saito, and Yoshiro Saito Part IV: EV Engineering 13. Extracellular Vesicles and their Use as Vehicles of Immunogens Chiara Chiozzini, Barbara Ridolfi, and Maurizio Federico 14. Isolation and Fluorescent Labeling of Extracellular Vesicles from Cultured Tumor Cells Noelle Leary, Sarina Walser, and Lothar C. Dieterich 15. Generation, Characterization, and Count of Fluorescent Extracellular Vesicles Flavia Ferrantelli, Valentina Tirelli, Valeria Barreca, and Francesco Manfredi 16. Optimized Protocol for Plasma-Derived Extracellular Vesicles Loading with Synthetic miRNA Mimic Using Electroporation Margherita A.C. Pomatto, Federica Negro, and Giovanni Camussi 17. Extracellular Vesicle Loading via pH-Gradient Modification Stephanie M. Kronstadt, Steven M. Jay, and Anjana Jeyaram

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Book SynopsisThis volume discusses the latest approaches used to investigate molecular biology and physiology in the peripheral and central olfactory system.Table of ContentsPreface…Table of Contents…Contributing Authors…1. Visualizing and Manipulating Olfactory Cilia through Viral Delivery Coupled with En Face Imaging of Intact OEJulien C. Habif, Chao Xie, and Jeffrey R. Martens2. Genome-Wide RNA Tomography in the Mouse Whole Olfactory MucosaEman Abou Moussa, Melanie Makhlouf, Lisa S. Mathew, and Luis R. Saraiva3. Optical Activation of Photoswitchable TRPC Ligands in the Mammalian Olfactory System Using Laser Scanning Confocal MicroscopyNavin K. Ojha, Frank Zufall, and Trese Leinders-Zufall4. Intranasal Pressure Recording for Monitoring Mouse RespirationEmma Janke, Janardhan P. Bhattarai, and Minghong Ma5. Identification of Immune Cells in Murine Olfactory MucosaSebastian A. Wellford and E. Ashley Moseman6. Chromatin Immunoprecipitation from Formaldehyde Cross-Linked Olfactory Sensory NeuronsJerome Kahiapo and Kevin Monahan7. Activity-Dependent Labeling of Olfactory Sensory Neurons using RNA Fluorescence In Situ Hybridization followed by Phospho-S6 ImmunofluorescenceMaira Harume Nagai and Hiroaki Matsunami8. Measuring Cell Surface Expression of Odorant Receptors Via Flow Cytometry Jeevan Tewari and Hiroaki Matsunami9. Dissociation of Mouse Olfactory Mucosae for Fluorescence-Activated Cell Sorting of Olfactory Sensory NeuronsQiang Wang, Tomoko Sengoku, William B. Titlow, Jennifer L. Strange, and Timothy S. McClintock10. Preparation of Human Olfactory Epithelial Biopsies for Downstream AnalysisRhea Choi, Tiffany Ko, John B. Finlay, Ralph Abi Hachem, David Jang, and Bradley J. Goldstein11. Cranial Window for Acute and Chronic Optical Access to Record Neuronal Network Dynamics in the Olfactory BulbMarco Brondi and Claudia Lodovichi12. Target-Captured mRNA from Murine Olfactory BulbKevin W. Zhu and Hiroaki Matsunami13. Identification and Localization of Cell Types in the Mouse Olfactory Bulb using Slide-SeqV2Ai Fang, Kaitlyn Petentler, Andrew Price, Seth Malloy, Cindy Maddera, Jonathan Russel, McKenzie Treese, Hua Li, Yongfu Wang, Sean McKinney, Anoja Perera, and C. Ron Yu14. Dense and Sparse Labelling of Mitral Cells by Oral and Intraperitoneal Routes of Tamoxifen AdministrationXiaochen Fu, Yu-Pei Huang, Sander Lindeman, Adam Mago, and Izumi Fukunaga15. Techniques in Staining of Rodent and Human Olfactory TissueHironobu Nishijima and Eric H. Holbrook16. Electrophysiological Recordings from Identified Cell-Types in the Olfactory Cortex of Awake MiceKevin A. Bolding and Kevin M. FranksSubject Index List…

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Book SynopsisThe bestselling textbook to understanding health research, updated and expanded Research Methods in Health Promotion provides students and practitioners with essential knowledge and skills regarding the design, implementation, analysis, and interpretation of research in the field of health promotion. Now in its second edition, this bestselling textbook has been updated with more recent research methodologies and additional information on sampling, participatory and survey research, and qualitative data analysis. The entire research process is covered, with specific points relating to both qualitative and quantitative research. By breaking the daunting process of research into simple and well-defined steps, this user-friendly text encourages students to think about research as a sequential process and provides explanations that facilitate better understanding of each step in the research process. A separate set of chapters cover the more quantitative methodological areTable of ContentsFigures, Tables, and Boxes vii Preface xv Acknowledgments xix The Authors xxi The Contributors xxiii Foreword xxv Part One: Foundations of Health Promotion Research 1 Chapter 1 Key Steps in the Research Process 3 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Chapter 2 Philosophy of Science and Theory Construction 23 Laura F. Salazar, Ralph J. DiClemente, and Richard A. Crosby Chapter 3 Ethical Issues in Health Promotion Research 45 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Part Two: Fundamentals of Health Promotion Research 79 Chapter 4 Observational Research Designs 81 Laura F. Salazar, Richard A. Crosby, and Ralph J. DiClemente Chapter 5 Experimental Research Designs 115 Laura F. Salazar, Richard A. Crosby, and Ralph J. DiClemente Chapter 6 Principles of Sampling 147 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Chapter 7 Measurement in Health Promotion 177 Richard A. Crosby, Laura F. Salazar, Richard R. Clayton, and Ralph J. DiClemente Chapter 8 Qualitative Research Strategies and Methods for Health Promotion 209 Laura F. Salazar, Alejandra Mijares, Richard A. Crosby, and Ralph J. DiClemente Part Three: Applications of Health Promotion Research 257 Chapter 9 Conducting Observational Research 259 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Chapter 10 Methodological Considerations in the Design, Implementation, and Reporting of Randomized Controlled Trials in Health Promotion Research 285 Ralph J. DiClemente, Laura F. Salazar, and Richard A. Crosby Chapter 11 Community-Based Participatory Research in the Context of Health Promotion 313 Ralph J. DiClemente, Laura F. Salazar, and Richard A. Crosby Chapter 12 Program Evaluation 337 Nancy J. Thompson and Michelle C. Kegler Chapter 13 Survey Research for Health Promotion 367 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Part Four: Data Analysis 395 Chapter 14 Statistical Techniques for Analyzing Observational Research in Health Promotion 397 Richard A. Crosby, Laura F. Salazar, and Ralph J. DiClemente Chapter 15 Principles of Statistical Analysis for Randomized Controlled Trials in Health Promotion Research 429 Ralph J. DiClemente, Laura F. Salazar, and Richard A. Crosby Chapter 16 Methods and Procedures for Analyzing Qualitative Data in Health Promotion 455 Laura F. Salazar, Alejandra Mijares, Richard A. Crosby, and Ralph J. DiClemente Part Five: Core Skills Related to Health Promotion Research 491 Chapter 17 Introduction to Scientific Writing 493 Richard A. Crosby, Ralph J. DiClemente, and Laura F. Salazar Chapter 18 Understanding the Grant Process and Developing an Effective Research Grant Application 525 Ralph J. DiClemente, Laura F. Salazar, and Richard A. Crosby Name Index 560 Subject Index 565

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Book SynopsisStem Cells: A Short Course is a comprehensive text for students delving into the rapidly evolving discipline of stem cell research. Comprised of eight chapters, the text addresses all of the major facets and disciplines related to stem cell biology and research. A brief history of stem cell research serves as an introduction, followed by coverage of stem cell fundamentals; chapters then explore embryonic and fetal amniotic stem cells, adult stem cells, nuclear reprogramming, and cancer stem cells. The book concludes with chapters on stem cell applications, including the role of stem cells in drug discovery and therapeutic applications in spinal cord injury, brain damage, neurological and autoimmune disorders, among others. Written by a leader in the field, Stem Cells: A Short Course appeals to both students and instructors alike, appealing to academic enthusiasm for stem cell research and applications.Table of ContentsPreface to the Professor xvii Preface to the Student xxi Acknowledgments xxiii List of Figures xxv List of Tables xxxvii List of Case Studies xxxix List of Focus Boxes xli 1 A HISTORY OF STEM CELL RESEARCH 1 Early Studies 1 Hematopoietic Stem Cell Discovery 4 Mouse Embryonic Stem Cell Discovery 6 Successful Neural Stem Cell Culture 7 The Discovery of Cancer Stem Cells 8 Human Embryonic Stem Cell Discovery 9 Stem Cells And Cloning 11 Cord Blood Embryonic]Like Stem Cells—An Alternative to Es and Adult Stem Cells 14 Breakthrough In Spinal Cord Injury Repair 15 The Generation of ips Cells 16 iPS Cells Derived from Keratinocytes 20 iPS Induction Without the Use of Viruses 20 Transposon]Mediated iPS 21 Protein]Based iPS 22 The Discovery of Human Amniotic Stem Cells 24 Human Embryonic Stem Cells Generated Without Embryo Destruction 25 Human Cloning 25 Mesenchymal Stem Cell]Derived Human Knee Cartilage 27 The First Clinical Trial Using Human Embryonic Stem Cells 28 Mitochondrial DNA: A Barrier To Autologous Cell Therapeutics 29 Induced Pluripotency And The Potential To Save Endangered Species 30 Chapter Summary 33 Key Terms 37 Review Questions 39 Thought Question 40 Suggested Readings 40 2 FUNDAMENTALS OF STEM CELLS 43 Basic in Vitro Cell Culture—A Historical Perspective 43 Stem Cell Culture—Optimal Conditions and Techniques 48 Embryonic Stem Cell Culture 49 Hematopoietic Stem Cell Culture 52 Notch Regulation of HSC Proliferation 52 Other Drivers of HSC Proliferation 53 Adipose]Derived Stem Cell Culture 54 The Study of Embryonic Development 56 Embryonic Development and the Origin of Stem Cells 56 Early Events in Embryogenesis 56 Germ Cell Development 61 Basic Properties of Stem Cells 63 Long]Term Self]Renewal 63 Different Potency Capabilities 63 Totipotency 64 Pluripotency 65 Multipotency 68 Oligopotency 68 Unipotency 69 Types of Stem Cells 70 Embryonic Stem Cells 70 Fetal Stem Cells 70 Amniotic Stem Cells 71 Adult Stem Cells 71 Induced Pluripotency (iPS) Cells 71 Cancer Stem Cells 71 The Potential of Stem Cells in Medicine and Medical Research 71 Therapeutics 71 Tissue Engineering 71 Cell Therapy 73 Cell]Based Drug Screening 75 Chapter Summary 77 Key Terms 80 Review Questions 83 Thought Question 84 Suggested Readings 85 3 EMBRYONIC STEM, FETAL, AND AMNIOTIC STEM CELLS 87 ES Cells 87 Basic Properties 87 Pluripotency 87 Indefinite Replicative Capacity 89 Signaling and Transcriptional Control of ES Cell Replication 90 Examples of ES Cells 92 Mouse ES Cells 92 Rat ES Cells 95 Nonhuman Primate ES Cells 97 Human ES Cells 100 EC Cells 103 Embryonal Germ Cells 105 EG Cell Growth Factor Signaling 105 Comparing Embryonically Derived Cells 106 Fetal Stem Cells 108 Basic Properties 108 Amniotic Fluid Stem Cells 108 Wharton’s Jelly Stem Cells 109 Amniotic Membrane Stem Cells 110 Placental Stem Cells 110 Chapter Summary 112 Key Terms 114 Review Questions 115 Thought Question 116 Suggested Reading 116 4 ADULT STEM CELLS 118 Discovery and Origin of ASCs 118 Basic Properties of ASCs 118 Self]Renewal 119 Multipotency 119 Examples of ASCs 120 Hematopoietic Stem Cells 122 Morphology and Marker Expression 123 Sources 123 Signaling and Multipotency 123 Muscle]Derived Stem Cells 127 Myosatellite Cell Morphology and Marker Expression 129 Sources 129 Signaling, Transcriptional Control, and Multipotency 129 Adipose]Derived Stem Cells 130 Morphology and Marker Expression 130 Sources 131 Signaling and Multipotency 132 Mesenchymal Stem Cells 134 Morphology and Marker Expression 134 Sources 136 Signaling and Multipotency 136 Neural Stem Cells 140 Morphology and Marker Expression 141 Sources and Origins 143 Signaling and Multipotency 146 Endothelial Stem Cells 150 Morphology and Marker Expression 150 Sources and Origins 152 Signaling and Multipotency 153 Chapter Summary 156 Key Terms 158 Review Questions 161 Thought Question 162 Suggested Readings 162 5 NUCLEAR REPROGRAMMING 164 Examples of Nuclear Reprogramming in Nature 166 Cell Fusion 166 Cell Fusion for the Generation of Hybridomas 169 Mechanisms of Cell Fusion 172 Comparison of Cell Fusion Techniques 173 Electrofusion 173 Pegylation 173 Viral Induction 173 Mechanism of Nuclear Reprogramming in Cell Fusion 175 Somatic Cell Nuclear Transfer 176 Method for the Production of SCNT]Derived Cells 177 Somatic Cell Nuclear Transfer for the Creation of Stem Cells 178 Basic Properties of SCNT]Derived Stem Cells 180 Examples of SCNT]Derived Stem Cells 181 A Note Regarding Genomic Abnormalities in SCNT]Derived Clones 182 Telomeric Length 182 DNA Methylation and Epigenetics 183 X]Chromosome Inactivation 185 Induced Pluripotency 185 Breakthrough in the Production of iPS Cells 187 Methods for the Production of iPS Cells 191 Retroviral and Lentiviral Gene Delivery 192 Adenoviral Gene Delivery 195 Sendai Viral Gene Delivery 196 Plasmid]Based Gene Delivery 196 mRNA Delivery 198 MicroRNA Induction 199 Transposon Delivery 200 Direct Protein Delivery 200 Basic Properties of iPS Cells 201 A General Comparison of iPS Cells and Embryonic Stem Cells 203 Examples of Derived iPS Cells 205 Mouse Embryonic Fibroblast]Derived iPS Cells 206 Human Adult Skin]Derived iPS Cells 209 Advantages of ips Cells Over Other Cell Types 210 Origin and Bioethics 211 Patient Specificity 211 Broad Lineage Differentiation Potential 211 “Unlimited” Supply 211 Ease of Generation 212 Chapter Summary 212 Key Terms 214 Review Questions 217 Thought Question 218 Suggested Readings 218 6 CANCER STEM CELLS 220 Background on The Origins of Cancer 220 Discovery and Origin of Cancer Stem Cells 221 Basic Properties of Cancer Stem Cells 225 A Comparison of Cancer Stem Cells and Normal Stem Cells 226 Signaling Pathways Involved in Cancer Stem Cell Transformation 228 Examples of Cancer Stem Cells 229 Breast 229 Central Nervous System 229 Colon 231 Ovary 233 Pancreas 233 Prostate 234 Melanoma 235 Multiple Myeloma 237 Strategies for Treatment Targeting Cancer Stem Cells 238 Melanoma Treatment Targeting Chimeric Antigen Receptor 238 Multiple Myeloma Treatment Targeting CD20 239 Chapter Summary 240 Key Terms 241 Review Questions 243 Thought Question 244 Suggested Readings 244 7 STEM CELLS AS DRUG DISCOVERY PLATFORMS 245 Embryonic Stem Cells and Mouse Models of Gene Function 245 Stem Cell]Based Screening Assays 250 Stem Cells as Lineage Resources for HTS 250 Embryonic Stem Cells as a Resource 251 Adult Stem Cells as a Resource 253 iPS Cells as a Resource 254 Cancer Stem Cell Screens 256 Reprogramming Screens 258 Analysis of Disease Pathways 261 Stem Cells As A Toxicity]Testing Platform 267 Stem Cells as a Resource for Developmental Toxicity Testing 267 Stem Cells as a Source for Post]Natal Environmental Toxicity Testing 268 Cardiotoxicity 269 Hepatotoxicity 272 Chapter Summary 273 Key Terms 274 Review Questions 276 Thought Question 277 Suggested Readings 277 8 THERAPEUTIC APPLICATIONS OF STEM CELLS 279 History of Stem Cells as Therapeutics 279 History of Tissue Engineering 279 Disease]Specific Treatment and Patient Trials 282 Stem Cell]Based Patient Trials: An Overview 282 Cardiomyopathy and Cardiovascular Disease (CV) 284 Neuropathies and Neurodegenerative Diseases 286 Spinal Cord Injury 286 Brain Damage 288 Parkinson’s Disease 292 Autoimmune Disorders 292 Corneal Defects 296 Hematopoietic Disorders 297 Sickle Cell Disease 297 Wiskott–Aldrich Syndrome 299 Cancer 300 Muscular Dystrophy 301 Liver Disorders 303 Veterinary Applications 306 Equine 307 Canine 309 Osteoarthritis (OA) 309 Myocardial Infarction 311 Spinal Cord Injury 313 Stem Cells as an Emerging Industry 314 Seminal Discoveries Driving the Growth of a New Industry 317 Regulation and Reimbursement of Stem Cell Commercialization 320 A Word about Induced Pluripotency and Commercialization 320 Chapter Summary 321 Key Terms 324 Review Questions 326 Thought Question 327 Suggested Readings 328 About the Author 330 Index 331

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Book SynopsisStem Cell Nanoengineeringreviews theapplications ofnanotechnology in the fields of stem cells, tissue engineering, and regenerative medicine. Topics addressed include various types of stem cells, underlying principles of nanobiotechnology, the making of nano-scaffolds, nano tissue engineering, applications of nanotechnology in stem cell tracking and molecular imaging, nano-devices, as well asstem cell nano-engineering from bench to bedside. Written by renowned experts in their respective fields, chapters describe and explore a wide variety of topics in stem cellnanoengineering, making the book a valuable resource for both researchers and clinicians in biomedical and bioengineering fields.Table of ContentsAbout the Editors ix Contributors xi Preface xvii Part 1 An Introduction to Stem Cells 1 1 Adult Stem Cells 3 Andreas Nussler and Sahar Olsadat Sajadian 2 Pluripotent Stem Cells 25 Hossein Azizi, Akbar Hajizadeh Moghaddam, and Thomas Skutella 3 Interactions of Stem Cells and Components of the Extracellular Matrix 35 Anna K. Blakney, Julie J. Antetomaso, Winnie W. Leung, and Deok-Ho Kim 4 Regenerative Medicine and Cell Therapy: Past, Present, and Future 47 Hooman Sadri-Ardekani and Anthony Atala Part 2 An Introduction to Nanotechnology 67 5 Principles of Nanotechnology 69 Jerzy Leszczynski 6 Stem-Cell Nanoengineering: Explorations in a Rapidly Moving Field 87 Abhalaxmi Singh and Sanjeeb K. Sahoo Part 3 Nanostructures for Stem-Cell Engineering – Engineering Approach 97 7 Nanopatterned Surfaces for Stem-Cell Engineering 99 Waleed Ahmed El-Said, Tae-Hyung Kim, Ki-Bum Lee, and Jeong-Woo Choi 8 Biomimetic Nanostructures by Electrospinning and Electrospraying 123 Elham Vatankhah, Molamma P. Prabhakaran, and Seeram Ramakrishna 9 Nanoparticles for Stem-Cell Engineering 143 Esmaiel Jabbari 10 Toxicology of Nanobiomaterials 171 Shahin Bonakdar and Omid Mashinchian Part 4 Control of Stem-Cell Fate by Engineering of Microenvironment 185 11 Stem-Cell Responses to Surface Nanotopographies 187 Peng-Yuan Wang and Wei-Bor Tsai 12 Control of Mesenchymal Stem-Cell Fate by Engineering the Nanoenvironment 205 Habib Nikukar, Stuart Reid, Mathis O. Riehle, Adam S.G. Curtis, and Matthew J. Dalby 13 Delivery of Molecules and Genes/Small Interfering RNA into Stem Cells by Nanoengineering 223 Mohsen Ashjari Part 5 Nanotissue Engineering – Biological Approach along with Differentiation 243 14 Expansion of Stem Cells by Nanotissue Engineering 245 Amir Mellati and Hu Zhang 15 Nanotissue Engineering of Neural Cells 265 Sasan Jalili-Firoozinezhad, Fahimeh Mirakhori, and Hossein Baharvand 16 Nanotechnology and Cardiovascular Tissue Engineering 285 Savneet Kaur and Upasana Rishiraj 17 Nanotissue Engineering of Musculoskeletal Cells 299 Mohamadreza Baghaban Eslaminejad, Leila Taghiyar, and Fatemeh Safari 18 Nanotissue Engineering of Skin Cells 315 Daisy M. Ramos, Aditi Subramanian, Aja Aravamudhan, Matthew Harmon, Roshan James, Namdev B. Shelke, and Sangamesh G. Kumbar 19 High-Throughput Screening of Stem Cell Self-Renewal and Differentiation on Nanomaterials 327 Perry T. Yin, Tae-Hyung Kim, Jeong-Woo Choi, and Ki-Bum Lee Part 6 Nanotechnology in Stem-Cell Imaging 345 20 Nanotechnology for Cellular Imaging 347 Miroslaw Janowski, P. Walczak, and J.W.M. Bulte Part 7 Nanotissue Engineering and Clinical Applications 363 21 Advancing Translational Nanotechnology to Clinical Application 365 Michelle Griffin, Shima Salmasi, Naghmeh Naderi, Peter E. Butler, and Alexander M. Seifalian 22 Stem-Cell Nanoengineering from Bench to Bed 381 Omid Mashinchian, Shahin Bonakdar, Shahriar Sharifi, and Morteza Mahmoudi Index 397

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Book SynopsisTissue Engineering and Regeneration in Dentistry: Current Strategies presents a thorough update on the current advances, methods and understanding in tissue engineering in dentistry.Table of ContentsList of contributors, vi Preface, viii 1 Induced pluripotent stem cell technologies for tissue engineering, 1George T.‐J. Huang, Ikbale El Ayachi, and Xiao‐Ying Zou 2 Immunomodulation by adult stem cells: Mechanisms of action and clinical applications, 20Lindsay C. Davies and Katarina Le Blanc 3 Research advances in tissue regeneration by dental pulp stem cells, 50Rachel J. Waddington and Alastair J. Sloan 4 Assessing the potential of mesenchymal stem cells in craniofacial bone repair and regeneration, 69Rachel J. Waddington, S. Quentin Jones, and Ryan Moseley 5 Tissue culture models and approaches for dental tissue regeneration, 96Alastair J. Sloan, John Colombo, Jessica Roberts, Rachel J. Waddington, and Wayne Nishio Ayre 6 Industrial translation requirements for manufacture of stem cell–derived and tissue‐engineered products, 110Ivan Wall, David de Silva Thompson, Carlotta Peticone, and Roman Perez 7 Periodontal tissue engineering, 124Saso Ivanovski, P. Mark Bartold, Stan Gronthos, and Dietmar W. Hutmacher 8 Clinical strategies for dental and periodontal disease management: A way forward, 145Anibal Diogenes, Vanessa Chrepa, and Nikita B. Ruparel Index, 169

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Book SynopsisThe book outlines first the importance of Extra Cellular Matrix (ECM), which is a natural surface for most of cells. In the following chapters the influence of biological, chemical, mechanical, and physical properties of surfaces in micro and nano-scale on stem cell behavior are discussed including the mechanotransduction. Biomimetic and bioinspired approaches are highlighted for developing microenvironment of several tissues, and surface engineering applications are discussed in tissue engineering, regenerative medicine and different type of biomaterials in various chapters of the book. This book brings together innovative methodologies and strategies adopted in the research and development of Advanced Surfaces in Stem Cell Research. Well-known worldwide researchers deliberate subjects including: Extracellular matrix proteins for stem cell fateThe superficial mechanical and physical properties of matrix microenvironment as stem cell fate regulatorEffects of mechanotransduction on sTable of ContentsPreface xv 1 Extracellular Matrix Proteins for Stem Cell Fate 1 Betül Çelebi-Saltik 1.1 Human Stem Cells, Sources, and Niches 2 1.2 Role of Extrinsic and Intrinsic Factors 5 1.2.1 Shape 5 1.2.2 Topography Regulates Cell Fate 6 1.2.3 Stiffness and Stress 6 1.2.4 Integrins 7 1.2.5 Signaling via Integrins 9 1.3 Extracellular Matrix of the Mesenchyme: Human Bone Marrow 11 1.4 Biomimetic Peptides as Extracellular Matrix Proteins 13 References 15 2 The Superficial Mechanical and Physical Properties of Matrix Microenvironment as Stem Cell Fate Regulator 23 Mohsen Shahrousvand, Gity Mir Mohamad Sadeghi and Ali Salimi 2.1 Introduction 24 2.2 Fabrication of the Microenvironments with Different Properties in Surfaces 25 2.3 Effects of Surface Topography on Stem Cell Behaviors 28 2.4 Role of Substrate Stiffness and Elasticity of Matrix on Cell Culture 31 2.5 Stem Cell Fate Induced by Matrix Stiffness and Its Mechanism 32 2.6 Competition/Compliance between Matrix Stiffness and Other Signals and Their Effect on Stem Cells Fate 33 2.7 Effects of Matrix Stiffness on Stem Cells in Two Dimensions versus Three Dimensions 34 2.8 Effects of External Mechanical Cues on Stem Cell Fate from Surface Interactions Perspective 34 2.9 Conclusions 35 Acknowledgments 36 References 36 3 Effects of Mechanotransduction on Stem Cell Behavior 43 Bahar Bilgen and Sedat Odabas 3.1 Introduction 43 3.2 The Concept of Mechanotransduction 45 3.3 The Mechanical Cues of Cell Differentiation and Tissue Formation on the Basis of Mechanotransduction 46 3.4 Mechanotransduction via External Forces 47 3.4.1 Mechanotransduction via Bioreactors 48 3.4.2 Mechanotransduction via Particle-based Systems 51 3.4.3 Mechanotransduction via Other External Forces 53 3.5 Mechanotransduction via Bioinspired Materials 54 3.6 Future Remarks and Conclusion 54 Declaration of Interest 55 References 55 4 Modulation of Stem Cells Behavior Through Bioactive Surfaces 65 Eduardo D. Gomes, Rita C. Assunção-Silva, Nuno Sousax, Nuno A. Silva and António J. Salgado 4.1 Lithography 66 4.2 Micro and Nanopatterning 70 4.3 Microfluidics 71 4.4 Electrospinning 71 4.5 Bottom-up/Top-down Approaches 74 4.6 Substrates Chemical Modifications 75 4.6.1 Biomolecules Coatings 76 4.6.2 Peptide Grafting 77 4.7 Conclusion 78 References 79 Contents vii 5 Influence of Controlled Micro- and Nanoengineered Environments on Stem Cell Fate 85 Anna Lagunas, David Caballero and Josep Samitier 5.1 Introduction to Engineered Environments for the Control of Stem Cell Differentiation 86 5.1.1 Stem Cells Niche In Vivo: A Highly Dynamic and Complex Environment 86 5.1.2 Mimicking the Stem Cells Niche In Vitro: Engineered Biomaterials 88 5.2 Mechanoregulation of Stem Cell Fate 89 5.2.1 From In Vivo to In Vitro: Influence of the Mechanical Environment on Stem Cell Fate 89 5.2.2 Regulation of Stem Cell Fate by Surface Roughness 90 5.2.3 Control of Stem Cell Differentiation by Micro- and Nanotopographic Surfaces 92 5.2.4 Physical Gradients for Regulating Stem Cell Fate 96 5.3 Controlled Surface Immobilization of Biochemical Stimuli for Stem Cell Differentiation 100 5.3.1 Micro- and Nanopatterned Surfaces: Effect of Geometrical Constraint and Ligand Presentation at the Nanoscale 100 5.3.2 Biochemical Gradients for Stem Cell Differentiation 107 5.4 Three-dimensional Micro- and Nanoengineered Environments for Stem Cell Differentiation 112 5.4.1 Three-dimensional Mechanoregulation of Stem Cell Fate 113 5.4.2 Three-dimensional Biochemical Patterns for Stem Cell Differentiation 119 5.5 Conclusions and Future Perspectives 122 References 122 6 Recent Advances in Nanostructured Polymeric Surface: Challenges and Frontiers in Stem Cells 141 Ilaria Armentano, Samantha Mattioli, Francesco Morena, Chiara Argentati, Sabata Martino, Luigi Torre and Josè Maria Kenny 6.1 Introduction 142 6.2 Nanostructured Surface 144 6.3 Stem Cell 146 6.4 Stem Cell/Surface Interaction 147 6.5 Microscopic Techniques Used in Estimating Stem Cell/Surface 148 6.5.1 Fluorescence Microscopy 148 6.5.2 Electron Microscopy 149 6.5.3 Atomic Force Microscopy 153 6.5.3.1 Instrument 154 6.5.3.2 Cell Nanomechanical Motion 156 6.5.3.3 Mechanical Properties 156 6.6 Conclusions and Future Perspectives 158 References 158 7 Laser Surface Modification Techniques and Stem Cells Applications 165 Çağrı Kaan Akkan 7.1 Introduction 166 7.2 Fundamental Laser Optics for Surface Structuring 166 7.2.1 Definitive Facts for Laser Surface Structuring 167 7.2.1.1 Absorptivity and Reflectivity of the Laser Beam by the Material Surface 167 7.2.1.2 Effect of the Incoming Laser Light Polarization 168 7.2.1.3 Operation Mode of the Laser 169 7.2.1.4 Beam Quality Factor 170 7.2.1.5 Laser Pulse Energy/Power 171 7.2.2 Ablation by Laser Pulses 172 7.2.2.1 Focusing the Laser Beam 172 7.2.2.2 Ablation Regime 173 7.3 Methods for Laser Surface Structuring 174 7.3.1 Physical Surface Modifications by Lasers 174 7.3.1.1 Direct Structuring 175 7.3.1.2 Beam Shaping Optics 177 7.3.1.3 Direct Laser Interference Patterning 180 7.3.2 Chemical Surface Modification by Lasers 181 7.3.2.1 Pulsed Laser Deposition 181 7.3.2.2 Laser Surface Alloying 184 7.3.2.3 Laser Surface Oxidation and Nitriding 186 7.4 Stem Cells and Laser-Modified Surfaces 187 7.5 Conclusions 191 References 192 8 Plasma Polymer Deposition: A Versatile Tool for Stem Cell Research 197 M. N. Macgregor-Ramiasa and K. Vasilev 8.1 Introduction 197 8.2 The Principle and Physics of Plasma Methods for Surface Modification 199 8.2.1 Plasma Sputtering, Etching an Implantation 200 8.2.2 Plasma Polymer Deposition 201 8.3 Surface Properties Influencing Stem Cell Fate 202 8.3.1 Plasma Methods for Tailored Surface Chemistry 203 8.3.1.1 Oxygen-rich Surfaces 204 8.3.1.2 Nitrogen-rich Surfaces 208 8.3.1.3 Systematic Studies and Copolymers 210 8.3.2 Plasma for Surface Topography 211 8.3.3 Plasma for Surface Stiffness 213 8.3.4 Plasma for Gradient Substrata 215 8.3.5 Plasma and 3D Scaffolds 218 8.4 New Trends and Outlook 219 8.5 Conclusions 219 References 220 9 Three-dimensional Printing Approaches for the Treatment of Critical-sized Bone Defects 231 Sara Salehi, Bilal A. Naved and Warren L. Grayson 9.1 Background 232 9.1.1 Treatment Approaches for Critical-sized Bone Defects 232 9.1.2 History of the Application of 3D Printing to Medicine and Biology 233 9.2 Overview of 3D Printing Technologies 234 9.2.1 Laser-based Technologies 235 9.2.1.1 Stereolithography 235 9.2.1.2 Selective Laser Sintering 236 9.2.1.3 Selective Laser Melting 236 9.2.1.4 Electron Beam Melting 237 9.2.1.5 Two-photon Polymerization 237 9.2.2 Extrusion-based Technologies 238 9.2.2.1 Fused Deposition Modeling 238 9.2.2.2 Material Jetting 238 9.2.3 Ink-based Technologies 239 9.2.3.1 Inkjet 3D Printing 239 9.2.3.2 Aerosol Jet Printing 239 9.3 Surgical Guides and Models for Bone Reconstruction 240 9.3.1 Laser-based Surgical Guides 240 9.3.2 Extrusion-based Surgical Guides 240 9.3.3 Ink-based Surgical Guides 241 9.4 Three-dimensionally Printed Implants for Bone Substitution 242 9.4.1 Laser-based Technologies for Metallic Bone Implants 244 9.4.2 Extrusion-based Technologies for Bone Implants 245 9.4.3 Ink-based Technologies for Bone Implants 246 9.5 Scaffolds for Bone Regeneration 246 9.5.1 Laser-based Printing for Regenerative Scaffolds 247 9.5.2 Extrusion-based Printing for Regenerative Scaffolds 247 9.5.3 Ink-based Printing for Regenerative Scaffolds 249 9.5.4 Pre- and Postprocessing Techniques 250 9.5.4.1 Preprocessing 250 9.5.4.2 Postprocessing: Sintering 256 9.5.4.3 Postprocessing: Functionalization 256 9.6 Bioprinting 257 9.7 Conclusion 262 List of Abbreviation 263 References 264 10 Application of Bioreactor Concept and Modeling Techniques to Bone Regeneration and Augmentation Treatments 277 Oscar A. Deccó and Jésica I. Zuchuat 10.1 Bone Tissue Regeneration 278 10.1.1 Proinflammatory Cytokines 279 10.1.2 Transforming Growth Factor Beta 279 10.1.3 Angiogenesis in Regeneration 280 10.2 Actual Therapeutic Strategies and Concepts to Obtain an Optimal Bone Quality and Quantity 281 10.2.1 Guided Bone Regeneration Based on Cells 282 10.2.1.1 Embryonic Stem Cells 282 10.2.1.2 Adult Stem Cells 282 10.2.1.3 Mesenchymal Stem Cells 283 10.2.2 Guided Bone Regeneration Based on PRP and Growth Factors 284 10.2.2.1 Bone Morphogenetic Proteins 287 10.2.3 Guided Bone Regeneration Based on Barrier Membranes 288 10.2.4 Guided Bone Regeneration Based on Scaffolds 290 10.3 Bioreactors Employed for Tissue Engineering in Guided Bone Regeneration 291 10.4 Bioreactor Concept in Guided Bone Regeneration and Tissue Engineering: In Vivo Application 294 10.5 New Multidisciplinary Approaches Intended to Improve and Accelerate the Treatment of Injured and/or Diseased Bone 303 10.5.1 Application of Bioreactor in Dentistry: Therapies for the Treatment of Maxillary Bone Defects 304 10.5.2 Application of Bioreactor in Cases of Osteoporosis 307 10.6 Computational Modeling: An Effective Tool to Predict Bone Ingrowth 310 References 311 11 Stem Cell-based Medicinal Products: Regulatory Perspectives 321 DenizOzdil and Halil Murat Aydin 11.1 Introduction 321 11.2 Defining Stem Cell-based Medicinal Products 323 11.3 Regional Regulatory Issues for Stem Cell Products 326 11.4 Regulatory Systems for Stem Cell-based Technologies 327 11.4.1 The US Regulatory System 328 11.5 Stem Cell Technologies: The European Regulatory System 336 References 340 12 Substrates and Surfaces for Control of Pluripotent Stem Cell Fate and Function 341 Akshaya Srinivasan, Yi-Chin Toh, Xian Jun Loh and Wei Seong Toh 12.1 Introduction 342 12.2 Pluripotent Stem Cells 342 12.3 Substrates for Maintenance of Self-renewal and Pluripotency of PSCs 344 12.3.1 Cellular Substrates 344 12.3.2 Acellular Substrates 345 12.3.2.1 Biological Matrices 345 12.3.2.2 ECM Components 348 12.3.2.3 Decellularized Matrices 350 12.3.2.4 Cell Adhesion Molecules 351 12.3.2.5 Synthetic Substrates 352 12.4 Substrates for Promoting Differentiation of PSCs 355 12.4.1 Cellular Substrates 355 12.4.2 Acellular Substrates 356 12.4.2.1 Biological Matrices 356 12.4.2.2 ECM Components 358 12.4.2.3 Decellularized Matrices 362 12.4.2.4 Cell Adhesion Molecules 363 12.4.2.5 Synthetic Substrates 363 12.5 Conclusions 366 Acknowledgments 367 References 367 13 Silk as a Natural Biopolymer for Tissue Engineering 379 Ayşe Ak Can and Gamze Bölükbaşi Ateş 13.1 Introduction 380 13.2 SF as a Biomaterial 383 13.2.1 Fibroin Hydrogels and Sponges 384 13.2.2 Fibroin Films and Membranes 386 13.2.3 Nonwoven and Woven Silk Scaffolds 386 13.2.4 Silk Fibroin as a Bioactive Molecule Delivery 386 13.3 Biomedical Applications of Silk-based Biomaterials 387 13.3.1 Bone Tissue Engineering 387 13.3.2 Cartilage Tissue Engineering 389 13.3.3 Ligament and Tendon Tissue Engineering 391 13.3.4 Cardiovascular Tissue Engineering 391 13.3.5 Skin Tissue Engineering 393 13.3.6 Other Applications of Silk Fibroin 393 13.4 Conclusion and Future Directions 393 References 394 14 Applications of Biopolymer-based, Surface-modified Devices in Transplant Medicine and Tissue Engineering 399 Ashim Malhotra, Gulnaz Javan and Shivani Soni 14.1 Introduction to Cardiovascular Disease 400 14.2 Need Assessment for Biopolymer-based Devices in Cardiovascular Therapeutics 400 14.3 Emergence of Surface Modification Applications in Cardiovascular Sciences: A Historical Perspective 401 14.4 Nitric Oxide Producing Biosurface Modification 403 14.5 Surface Modification by Extracellular Matrix Protein Adherence 404 14.6 The Role of Surface Modification in the Construction of Cardiac Prostheses 405 14.7 Biopolymer-based Surface Modification of Materials Used in Bone Reconstruction 406 14.8 The Use of Biopolymers in Nanotechnology 409 14.8.1 Protein Nanoparticles 410 14.8.1.1 Albumin-based Nanoparticles and Surface Modification 411 14.8.1.2 Collagen-based Nanoparticles and Surface Modification 412 14.8.1.3 Gelatin-based Nanoparticle Systems 413 14.8.2 Polysaccharide-based Nanoparticle Systems 413 14.8.2.1 The Use of Alginate for Surface Modifications 413 14.8.2.2 The Use of Chitosan-based Nanoparticles and Chitosan-based Surface Modification 414 14.8.2.3 The Use of Chitin-based Nanoparticles and Chitin-based Surface Modification 416 14.8.2.4 The Use of Cellulose-based Nanoparticles and Cellulose-based Surface Modification 417 References 418 15 Stem Cell Behavior on Microenvironment Mimicked Surfaces 423 M. Özgen Öztürk Öncel and Bora Garipcan 15.1 Introduction 424 15.2 Stem Cells 425 15.2.1 Definition and Types 425 15.2.1.1 Embryonic Stem Cells 426 15.2.1.2 Adult Stem Cells 426 15.2.1.3 Reprogramming and Induced Pluripotent Stem Cells 427 15.2.2 Stem Cell Niche 427 15.3 Stem Cells: Microenvironment Interactions 428 15.3.1 Extracellular Matrix 429 15.3.2 Signaling Factors 429 15.3.3 Physicochemical Composition 430 15.3.4 Mechanical Properties 430 15.3.5 Cell–Cell Interactions 431 15.4 Biomaterials as Stem Cell Microenvironments 431 15.4.1 Surface Chemistry 431 15.4.2 Surface Hydrophilicity and Hydrophobicity 434 15.4.3 Substrate Stiffness 435 15.4.4 Surface Topography 435 15.5 Biomimicked and Bioinspired Approaches 436 15.5.1 Bone Tissue Regeneration 439 15.5.2 Cartilage Tissue Regeneration 440 15.5.3 Cardiac Tissue Regeneration 441 15.6 Conclusion 442 References 442

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Book SynopsisThe definitive guide to CBPR concepts and practice, updated and expanded Community-Based Participatory Research for Health: Advancing Health and Social Equity provides a comprehensive reference for this rapidly growing field in participatory and community-engaged research. Hailed as effective by the Centers for Disease Control and Prevention, CBPR and CEnR represent the link between researchers and community and lead to improved public health outcomes. This book provides practitioner-focused guidance on CBPR and CEnR to help public health professionals, students, and practitioners from multiple other clinical, planning, education, social work, and social science fields to successfully work towards social and health equity. With a majority of new chapters, the book provides a thorough overview of CBPR history, theories of action and participatory research, emerging trends of knowledge democracy, and promising practices. Drawn from a ten-year researcTable of ContentsThe Editors xiii The Contributors xv Preface xxxiiiCamara Phyllis Jones Acknowledgments xxxvii PART ONE: INTRODUCTION: HISTORY AND PRINCIPLES ONE: ON COMMUNITY-BASED PARTICIPATORY RESEARCH 3Nina Wallerstein, Bonnie Duran, John G. Oetzel, and Meredith Minkler TWO: THEORETICAL, HISTORICAL, AND PRACTICE ROOTS OF CBPR 17Nina Wallerstein and Bonnie Duran THREE: CRITICAL ISSUES IN DEVELOPING AND FOLLOWING CBPR PRINCIPLES 31Barbara A. Israel, Amy J. Schulz, Edith A. Parker, Adam B. Becker, Alex J. Allen, III, J. Ricardo Guzman, and Richard Lichtenstein PART TWO: POWER, TRUST, AND DIALOGUE: WORKING WITH DIVERSE COMMUNITIES FOUR: UNDERSTANDING CONTEMPORARY RACISM, POWER, AND PRIVILEGE AND THEIR IMPACTS ON CBPR 47Michael Muhammad, Catalina Garzón, Angela Reyes, and The West Oakland Environmental Indicators Project FIVE: TRUST DEVELOPMENT IN CBPR PARTNERSHIPS 61Julie E. Lucero, Kathrine E. Wright, and Abigail Reese PART THREE: CBPR CONCEPTUAL MODEL: CONTEXT AND PROMISING RELATIONSHIP PRACTICES SIX: SOCIO-ECOLOGIC FRAMEWORK FOR CBPR: DEVELOPMENT AND TESTING OF A MODEL 77Sarah L. Kastelic, Nina Wallerstein, Bonnie Duran, and John G. Oetzel SEVEN: YOUTH-LED PARTICIPATORY ACTION RESEARCH (YPAR): PRINCIPLES APPLIED TO THE US AND DIVERSE GLOBAL SETTINGS 95Emily J. Ozer and Amber Akemi Piatt EIGHT:PARTNERSHIP, TRANSPARENCY, AND ACCOUNTABILITY: CHANGING SYSTEMS TO ENHANCE RACIAL EQUITY IN CANCER CARE AND OUTCOMES 107Eugenia Eng, Jennifer Schaal, Stephanie Baker, Kristin Black, Samuel Cykert, Nora Jones, Alexandra Lightfoot, Linda Robertson, Cleo Samuel, Beth Smith, and Kari Thatcher NINE:SOUTH VALLEY PARTNERS FOR ENVIRONMENTAL JUSTICE: A STORY OF ALIGNMENT AND MISALIGNMENT 123Magdalena Avila, Shannon Sanchez-Youngman, Michael Muhammad, Lauro Silva, and Paula Domingo de Garcia PART FOUR: PROMISING PRACTICES: INTERVENTION DEVELOPMENT AND RESEARCH DESIGN TEN: CBPR IN HEALTH CARE SETTINGS 141Margarita Alegría, Chau Trinh-Shevrin, Bowen Chung, Andrea Ault, Alisa Lincoln, and Kenneth B. Wells ELEVEN: NATIONAL CENTER FOR DEAF HEALTH RESEARCH: CBPR WITH DEAF COMMUNITIES 157Steven Barnett, Jessica Cuculick, Lori Dewindt, Kelly Matthews, and Erika Sutter TWELVE: CBPR IN ASIAN AMERICAN COMMUNITIES 175Nadia Islam, Charlotte Yu-Ting Chang, Pam Tau Lee, and Chau Trinh-Shevrin THIRTEEN: ENGAGED FOR CHANGE: AN INNOVATIVE CBPR STRATEGY TO INTERVENTION DEVELOPMENT 189Scott D. Rhodes, Lilli Mann, Florence M. Simán, Jorge Alonzo, Aaron T. Vissman, Jennifer Nall, and Amanda E. Tanner PART FIVE: PROMISING PRACTICES: ETHICAL ISSUES FOURTEEN:CBPR PRINCIPLES AND RESEARCH ETHICS IN INDIAN COUNTRY 207Myra Parker FIFTEEN: DEMOCRATIZING ETHICAL OVERSIGHT OF RESEARCH THROUGH CBPR 215Rachel Morello-Frosch, Phil Brown, and Julia Green Brody SIXTEEN: EVERYDAY CHALLENGES IN THE LIFE CYCLE OF CBPR: BROADENING OUR BANDWIDTH ON ETHICS 227Sarah Flicker, Adrian Guta, and Robb Travers PART SIX: PROMISING PRACTICES TO OUTCOMES: CBPR CAPACITY AND HEALTH SEVENTEEN: EVALUATION OF CBPR PARTNERSHIPS AND OUTCOMES: LESSONS AND TOOLS FROM THE RESEARCH FOR IMPROVED HEALTH STUDY 237John G. Oetzel, Bonnie Duran, Andrew Sussman, Cynthia Pearson, Maya Magarati, Dmitry Khodyakov, and Nina Wallerstein EIGHTEEN:PARTICIPATORY EVALUATION AS A PROCESS OF EMPOWERMENT: EXPERIENCES WITH COMMUNITY HEALTH WORKERS IN THE UNITED STATES AND LATIN AMERICA 251Noelle Wiggins, Laura Chanchien Parajón, Chris M. Coombe, Aileen Alfonso Duldulao, Leticia Rodriguez Garcia, and Pei-Ru Wang NINETEEN: ACADEMIC POSITIONS FOR FACULTY OF COLOR: COMBINING LIFE CALLING, COMMUNITY SERVICE, AND RESEARCH 265Lorenda Belone, Derek M. Griffith, and Barbara Baquero PART SEVEN: PROMISING PRACTICES TO OUTCOMES: HEALTHY PUBLIC POLICY TWENTY: COMMUNITY-BASED PARTICIPATORY RESEARCH FOR HEALTH EQUITY POLICY MAKING 277Lisa Cacari-Stone, Meredith Minkler, Nicholas Freudenberg, and Makani N. Themba TWENTY ONE: IMPROVING FOOD SECURITY AND TOBACCO CONTROL THROUGH POLICY-FOCUSED CBPR: A CASE STUDY OF HEALTHY RETAIL IN SAN FRANCISCO 293Meredith Minkler, Jennifer Falbe, Susana Hennessey Lavery, Jessica Estrada, and Ryan Thayer TWENTY TWO: CRIMINAL JUSTICE REFORM THROUGH PARTICIPATORY ACTION RESEARCH 305Saneta deVuono-Powell, Meredith Minkler, Evan Bissell, Tamisha Walker, LaVern Vaughn, Eli Moore, and The Morris Justice Project TWENTY THREE: GLOBAL HEALTH POLICY: SLUM SETTLEMENT MAPPING IN NAIROBI AND RIO DE JANEIRO 321Jason Corburn, Ives Rocha, Alexei Dunaway, and Jack Makau APPENDIX 1: CHALLENGING OURSELVES: CRITICAL SELF-REFLECTION ON POWER AND PRIVILEGE 337Cheryl Hyde APPENDIX 2: GUIDING CBPR PRINCIPLES: FOSTERING EQUITABLE HEALTH CARE FOR LGBTQ+ PEOPLE 345Miria Kano, Kelley P. Sawyer, and Cathleen E. Willging APPENDIX 3: QUALITY CRITERIA OF THE INTERNATIONAL COLLABORATION FOR PARTICIPATORY HEALTH RESEARCH (ICPHR) 351Michael T. Wright APPENDIX 4: CULTURAL HUMILITY: REFLECTIONS AND RELEVANCE FOR CBPR 357Vivian Chávez APPENDIX 5: FUNDING IN CBPR IN US GOVERNMENT AND PHILANTHROPY 363Laura C. Leviton and Lawrence W. Green APPENDIX 6: REALIST EVALUATION AND REVIEW FOR COMMUNITY-BASED PARTICIPATORY RESEARCH: WHAT WORKS, FOR WHOM, UNDER WHAT CIRCUMSTANCES, AND HOW? 369Justin Jagosh APPENDIX 7: PARTNERSHIP RIVER OF LIFE: CREATING A HISTORICAL TIME LINE 375Shannon Sanchez-Youngman and Nina Wallerstein APPENDIX 8: PURPOSING A COMMUNITY-GROUNDED RESEARCH ETHICS TRAINING INITIATIVE 379Cynthia Pearson and Victoria Sánchez APPENDIX 9: PARTNERSHIP AGREEMENTS: A PRACTICAL GUIDE TO DEVELOPING DATA SHARING, OWNERSHIP, AND PUBLISHING AGREEMENTS 385Patricia Rodríguez Espinosa and Al Richmond APPENDIX 10: INSTRUMENTS AND MEASURES FOR EVALUATING COMMUNITY ENGAGEMENT AND PARTNERSHIPS 393Nina Wallerstein APPENDIX 11: PARTICIPATORY MONITORING AND EVALUATION OF COMMUNITY HEALTH INITIATIVES USING THE COMMUNITY CHECK BOX EVALUATION SYSTEM 399Stephen Fawcett, Jerry Schultz, Vicki Collie-Akers, Christina Holt, Jomella Watson-Thompson, and Vincent Francisco APPENDIX 12: POWER MAPPING: A USEFUL TOOL FOR UNDERSTANDING THE POLICY ENVIRONMENT AND ITS APPLICATION TO A LOCAL SODA TAX INITIATIVE 405Jennifer Falbe, Meredith Minkler, Robin Dean, and Jana Cordeiero APPENDIX 13: CBPR INTERACTIVE ROLE-PLAYS: THREE SCENARIOS 411Michele Polacsek and Gail Dana-Sacco AFTERWORD 417Budd Hall and Rajesh Tandon INDEX 419

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Book SynopsisThe authoritative guide for Data Monitoring Committeesfully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive fouTable of ContentsPreface to the Second Edition xiii Preface to the First Edition xv 1 Introduction 1 1.1 Motivation 1 1.2 History of data monitoring committees in government-sponsored trials 8 1.3 Data monitoring committees in trials sponsored by the pharmaceutical industry 15 1.4 Statistical methods for interim monitoring 18 1.5 When are data monitoring committees needed? 21 1.6 Models for data monitoring committees 22 1.7 Where we are today 24 1.8 Fundamental principles of data monitoring 25 References 27 2 Responsibilities of the Data Monitoring Committee and Motivating Illustrations 35 2.1 Fundamental charges 36 2.2 Specific tasks of the data monitoring committee 39 2.2.1 Initial review 40 2.2.1.1 Review of the study protocol 40 2.2.1.2 Review of procedures to ensure quality of study conduct 45 2.2.2 Evaluating the quality of ongoing study conduct 47 2.2.3 Assessing safety and efficacy data 56 2.2.3.1 Termination due to favorable benefit-to-risk 58 2.2.3.2 Termination due to unfavorable benefit-to-risk 63 2.2.3.3 Termination due to inability to answer trial questions 65 2.2.3.4 Continuation of ongoing clinical trials 68 2.2.3.5 Consideration of the overall picture: primary and secondary analyses 72 2.2.3.6 Modifying sample sizes based on ongoing assessment of event rates 76 2.2.4 Reviewing the final results 80 2.3 The data monitoring committee charter 83 References 84 3 Composition of a Data Monitoring Committee 89 3.1 Introduction 89 3.2 Required areas of expertise 90 3.3 Other relevant characteristics of committee members 96 3.4 Committee size 98 3.5 Selecting the committee chair 102 3.6 Responsibility for appointing committee members 102 3.7 Representation of other study components on the committee 104 3.8 Preparation for service on a committee 106 References 109 4 Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest 113 4.1 Introduction 113 4.2 Rationale for independence 114 4.3 Financial independence 116 4.3.1 Commercial sponsors 117 4.3.2 Government sponsors 118 4.3.3 Academic investigators 118 4.4 Intellectual independence 125 4.5 Emotional conflicts 131 4.6 Best practices to address challenges to the DMC’s independence 132 4.6.1 Adequate training/experience in the DMC process 133 4.6.2 Indemnification of DMC members 135 4.6.3 Maintaining confidentiality of interim data 136 4.6.4 Flexibility of procedures 138 4.6.5 DMC meeting format 139 4.6.6 Creating independent relationships and reducing conflicts of interest 141 4.6.7 Adequately informative DMC reports 142 4.7 Summary 143 References 144 5 Confidentiality Issues Relating to the Data Monitoring Committee 147 5.1 Rationale 147 5.2 Limits of confidentiality 159 5.2.1 Interim analysis reports 159 5.2.2 Access to aggregate data on efficacy and safety outcomes 161 5.2.3 Providing access to interim data on a “need-to-know” basis 164 5.2.4 Settings and procedures allowing broader unblinding of safety data 166 5.2.5 Consequences of unblinding interim data for regulatory review in ongoing trials 168 5.2.6 Some illustrations of broader unblinding 175 5.2.7 The steering committee and maintaining confidentiality 187 5.2.8 Indirect challenges to confidentiality 189 5.3 The need for the DMC to review unblended data 190 5.4 Conclusions: consensus regarding confidentiality 195 References 198 6 Data Monitoring Committee Meetings 203 6.1 Introduction 203 6.2 Specific objectives and timing of meetings 204 6.2.1 Organizational meeting 205 6.2.2 Early safety/trial integrity reviews 208 6.2.3 Formal interim efficacy analyses 212 6.2.4 End-of-trial debriefing 213 6.3 Preparation of meeting reports 214 6.3.1 Currentness of data in the report 217 6.3.2 Inclusion of unadjudicated data 220 6.4 Format for meetings 221 6.4.1 The initial closed session 223 6.4.2 The open session 224 6.4.3 The final closed session 227 6.4.4 Various formats for holding the open and closed sessions 227 6.4.5 Meeting duration and venue 229 6.5 DMC meeting minutes and the DMC recommendations 230 6.5.1 The DMC recommendations, the open minutes, and the closed minutes 230 6.5.2 The level of detail 232 6.5.3 The authorship of the minutes and the sign-off by committee members 233 References 235 7 Data Monitoring Committee Interactions with Other Trial Components or Related Groups 237 7.1 Introduction 238 7.2 Study sponsors 238 7.2.1 Industry sponsors 239 7.2.2 Government sponsors 241 7.3 Study steering committee/principal investigator 243 7.4 Study investigators 247 7.5 Trial statisticians and statistical centers 247 7.5.1 The independent statistical center 248 7.5.2 Ensuring optimal data presentations 253 7.6 Institutional review boards 253 7.7 Regulatory agencies 256 7.8 Study participants and/or advocacy groups 257 7.9 Other data monitoring committees 259 References 262 8 Statistical, Philosophical, and Ethical Issues in Data Monitoring 265 8.1 The need for statistical approaches to monitoring accumulating data 266 8.2 Overview of statistical methods 270 8.2.1 Group sequential methods 271 8.2.1.1 Some group sequential boundaries for establishing benefit 273 8.2.1.2 Group sequential alpha spending functions 277 8.2.1.3 Some group sequential boundaries when early results are unfavorable 280 8.2.2 Triangular boundaries 284 8.2.3 Stochastic curtailment/conditional power 286 8.2.4 Bayesian monitoring 290 8.2.5 The general approach to sequential stopping boundaries 293 8.2.6 Software packages for sequential clinical trial designs 294 8.2.7 Adaptive clinical trial designs 294 8.3 Protocol specification of the monitoring plan 299 8.4 Other statistical considerations in monitoring trial data 300 8.4.1 Primary versus secondary endpoints 300 8.4.2 Short-term versus long-term treatment effects 302 8.4.3 Results in subgroups 303 8.4.4 Taking external information into account 307 8.4.5 Evaluating safety in the context of evidence about efficacy: role of boundaries 309 8.4.6 Ensuring proper robustness when defining boundaries for establishing benefit 311 8.5 Ethical considerations 313 8.5.1 Early termination philosophies 313 8.5.1.1 Responding to early beneficial trends 314 8.5.1.2 Responding to early unfavorable trends 318 8.5.1.3 Responding to unexpected safety concerns 324 8.5.2 Other ethical considerations 325 References 326 9 Determining When a Data Monitoring Committee is Needed 335 9.1 Introduction 336 9.2 Typical settings for an independent data monitoring committee 336 9.3 Other settings in which an independent data monitoring committee may be valuable 339 9.3.1 Early trials of high-risk treatments 339 9.3.2 Trials in vulnerable populations 340 9.3.3 Trials with potentially large public health impact 341 9.4 An alternative monitoring approach: the internal monitoring committee 342 9.5 A decision model assessing need for an independent DMC or an internal monitoring committee 346 9.6 Settings with little need for an independent or internal monitoring committee 351 9.7 Summary 352 References 353 10 Regulatory Considerations for the Operation of Data Monitoring Committees 355 10.1 Introduction 356 10.2 Data monitoring committees in government regulations 356 10.3 Regulatory guidance 357 10.3.1 US Food and Drug Administration 357 10.3.2 International regulatory guidance 360 10.3.2.1 European Union 360 10.3.2.2 International Conference on Harmonization 361 10.3.2.3 The World Health Organization 363 10.4 Regulatory approaches relevant to data monitoring committee operation: the US FDA 364 10.5 Policies of funding agencies regarding DMC operations 367 10.5.1 National Institutes of Health 367 10.5.2 Other federal agencies 369 10.5.3 Funding agencies outside the US 369 10.6 Involvement of FDA staff in data monitoring committee deliberations 370 10.7 Examples of regulatory authority interaction with data monitoring committees 372 References 379 11 Legal Considerations for DMCs 383 11.1 DMC indemnification 383 11.1.1 Motivating examples 385 11.1.2 Emergence of DMCs and heightened awareness of their existence 388 11.1.3 Further motivation for indemnification to protect the DMC 390 11.1.4 Some specific concerns from current experiences with indemnification 392 11.1.5 Potential solutions to indemnification issues 394 11.1.6 Confidential disclosure agreement (CDA) 397 11.1.7 Summary of indemnification, liability, and contracting issues 399 11.2 Balancing legal and ethical responsibilities: a need for a mediator? 400 11.2.1 A case study: the setting of Actimmune in patients with idiopathic pulmonary fibrosis 402 11.2.2 IMMUNE response AIDS clinical trial 405 References 406 Appendix A The Data Monitoring Committee Charter 411 Appendix B Performance Standards Document 431 Statistics in Practice 451 Index 455

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Book SynopsisTable of ContentsPreface xi List of Abbreviations xiii Notation xv 1 Introduction 1 1.1 Random Truncation 1 1.2 One-sided Truncation 2 1.2.1 Left-truncation 2 1.2.2 Right-truncation 2 1.2.3 Truncation vs. Censoring 3 1.3 Double Truncation 3 1.4 Real Data Examples 5 1.4.1 Childhood Cancer Data 5 1.4.2 AIDS Blood Transfusion Data 6 1.4.3 Equipment-S Rounded Failure Time Data 7 1.4.4 Quasar Data 7 1.4.5 Parkinson’s Disease Data 8 1.4.6 Acute Coronary Syndrome Data 9 References 10 2 One-Sample Problems 13 2.1 Nonparametric Estimation of a Distribution Function 13 2.1.1 The NPMLE 14 2.1.2 Numerical Algorithms for Computing the NPMLE 21 2.1.3 Theoretical Properties of the NPMLE 24 2.1.4 Standard Errors and Confidence Limits 36 2.2 Semiparametric and Parametric Approaches 43 2.2.1 Semiparametric Approach 44 2.2.2 Parametric Approach 52 2.3 R Code for the Examples 56 2.3.1 Code for Example 2.1.8 56 2.3.2 Code for Examples 2.1.11 and 2.1.13 56 2.3.3 Code for Example 2.1.14 58 2.3.4 Code for Example 2.1.15 59 2.3.5 Code for Example 2.1.22 60 2.3.6 Code for Example 2.2.6 61 2.3.7 Code for Example 2.2.8 62 References 65 3 Smoothing Methods 69 3.1 Some Background in Kernel Estimation 69 3.2 Estimating the Density Function 71 3.3 Asymptotic Properties 71 3.4 Data-driven Bandwidth Selection 77 3.4.1 Normal Reference Bandwidth Selection 78 3.4.2 Plug-in Bandwidth Selection 79 3.4.3 Least-squares Cross-validation Bandwidth Selection 80 3.4.4 Smoothed Bootstrap Bandwidth Selection 81 3.4.5 Bandwidth Selectors in Practice 82 3.5 Further Issues in Kernel Density Estimation 88 3.6 Estimating the Hazard Function 90 3.7 R Code for the Examples 98 3.7.1 Code for Example 3.2.1 98 3.7.2 Code for Examples 3.3.4 and 3.3.5 99 3.7.3 Code for Examples 3.4.2 and 3.4.3 100 3.7.4 Code for Example 3.5.1 102 3.7.5 Code for Example 3.6.4 104 3.7.6 Code for Example 3.6.5 105 References 106 4 Regression Analysis 109 4.1 Observational Bias in Regression 109 4.2 Proportional Hazards Regression 114 4.3 Accelerated Failure Time Regression 117 4.4 Nonparametric Regression 121 4.5 R Code for the Examples 126 4.5.1 Code for Example 4.1.1 126 4.5.2 Code for Example 4.1.4 126 4.5.3 Code for Example 4.2.4 127 4.5.4 Code for Example 4.3.2 127 4.5.5 Code for Example 4.4.2 128 References 129 5 Further Topics 131 5.1 Two-Sample Problems 132 5.2 Competing Risks 137 5.2.1 Cumulative Incidences 139 5.2.2 Regression Models for Competing Risks 142 5.3 Testing for Quasi-independence 146 5.4 Dependent Truncation 150 5.5 R Code for the Examples 157 5.5.1 Code for Example 5.1.3 157 5.5.2 Code for Example 5.2.4 159 5.5.3 Code for Example 5.2.6 160 5.5.4 Code for Example 5.3.1 161 5.5.5 Code for Example 5.4.3 161 References 162 A Packages and Functions in R 165 A.1 Computing the NPMLE and Standard Errors 166 A.2 Assessing the Existence and Uniqueness of the NPMLE 167 A.3 Semiparametric and Parametric Estimation 168 A.4 Kernel Estimation 168 A.5 Regression Analysis 169 A.6 Competing Risks 169 A.7 Simulating Data 170 A.8 Testing Quasi-independence 170 A.9 Dependent Truncation 170 References 171 Index 173

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Book SynopsisReviewing research evidence for nursing practice: systematic reviews highlights the key issues involved in conducting different types of systematic reviews - encompassing qualitative studies, quantitative studies and combining quantitative and qualitative studies. It enables nurses and researchers to understand the key principles involved in preparing systematic reviews and to critically appraise the reviews they read and evaluate their usefulness in developing their own practice. Each section starts with an overview of the methodology, followed by a selection of systematic reviews carried out in specialist areas of nursing practice. Part 1 explores systematic reviews and meta-analysis of quantitative research, part 2 explores meta-synthesis and meta-study of qualitative research and part 3 addresses integrative reviews that combine both qualitative and quantitative evidence. The final part explores the use of systematic reviews in service and practice developmeTable of ContentsIntroduction. Part 1 Systematic Reviews and Meta-Analysis of Quantitative Research. Chapter 1 Overview of methods. Chapter 2 Urinary continence – what the method does – Synopsis of systematic reviews on bladder training and voiding regimens. Chapter 3 Evidence-based practice for nursing and PAMS; also stroke care. Chapter 4 Pelvic floor exercise. Chapter 5 Faecal continence. Part 2 Metasynthesis and Metastudy of Qualitative Research. Chapter 6 Overview of methods. Chapter 7 Chronic illness. Chapter 8 HIV and childbirth. Chapter 9 Role development. Chapter 10 Integrative reviews – enhancing rigour. Part 3 Integrative Reviews of Quantitative and Qualitative Research Chapter 11 Overview of methods. Chapter 12 Toileting programmes for UI. Chapter 13 Domiciliary visiting and public health nursing. Chapter 14 Older people and respite care. Chapter 15 Several possible topics. Part 4 Applications and Uses of Reviews. Chapter 16 Using systematic reviews in service and practice development (to include evaluating evidence, critiquing). Chapter 17 Summary and future directions. Glossary

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Book SynopsisAddiction Research Methods is a comprehensive handbook forhealth professionals, policy-makers and researchers working andtraining in the field of addiction. The book provides a clear, comprehensive and practical guide toresearch design, methods and analysis within the context of thefield of alcohol and other drugs.Table of ContentsList of contributors ix Acknowledgements xiii 1 Introduction 1Peter G. Miller, John Strang and Peter M. Miller 1.1 Introduction 1 1.2 Where to start? 1 1.3 Does theory matter? 2 1.4 The literature review 3 1.5 Which method suits my question – is a screwdriver better than a saw? 4 1.6 Focus and structure of the book 5 1.7 Terminology 6 1.8 The need for a wider perspective and more careful selection of study design 8 Section I: Research Fundamentals 2 Reliability and validity 11Gerhard Bühringer and Monika Sassen 2.1 Introduction 11 2.2 Background: Reliability and validity in addiction research 11 2.3 Reliability and validity in addiction research 16 2.4 Strengthening the quality of your results and conclusions: A brief checklist to improve reliability and validity 19 2.5 Summary 24 3 Sampling strategies for addiction research 27Lisa Kakinami and Kenneth R. Conner 3.1 Introduction 27 3.2 Probability sampling 27 3.3 Non-probability sampling 32 3.4 Qualitative sampling 36 3.5 Selecting your sampling approach 37 3.6 Technical considerations 37 3.7 Conclusion 40 4 Experimental design issues in addiction research 43Robert West 4.1 Introduction 43 4.2 What constitutes an experiment? 43 4.3 Is an experiment appropriate? 44 4.4 What kind of experimental design? 44 4.5 What intervention and comparison conditions? 48 4.6 What target population and recruitment strategy? 50 4.7 What sample size? 52 4.8 What outcome measures? 53 4.9 What statistical analyses? 55 4.10 Conclusions 56 5 Qualitative methods and theory in addictions research 59Tim Rhodes and Ross Coomber 5.1 Introduction 59 5.2 Theory 59 5.3 A recurring debate 62 5.4 Principles for practice 63 5.5 Data generation 64 5.6 Analysis 70 5.7 Conclusions 73 6 Ethical issues in alcohol, other drugs and addiction-related research 79Peter G. Miller, Adrian Carter and Wayne Hall 6.1 Introduction 79 6.2 Key concepts 79 6.3 Major ethical frameworks 80 6.4 Addiction-specific ethical issues 83 6.5 Writing an ethics application 87 6.6 Ethical processes in different countries 87 6.7 Influence of funding body 88 6.8 Ethical dissemination 89 6.9 Conclusion 89 Section II: Basic Toolbox 7 Surveys and questionnaire design 97Lorraine T. Midanik and Krista Drescher-Burke 7.1 Introduction 97 7.2 Brief history 97 7.3 Survey research designs 98 7.4 Advantages and limitations of survey research designs 99 7.5 Modes of data collection 100 7.6 Questionnaire design 101 7.7 Piloting the questionnaire 104 7.8 Technological assistance 105 7.9 Common challenges 106 8 Interviews 109Barbara S. McCrady, Benjamin Ladd, Leah Vermont and Julie Steele 8.1 Introduction 109 8.2 Why interviews? 109 8.3 Reliability and validity of self-reported information 110 8.4 Interviewing skills 112 8.5 Types of interviews 116 8.6 Types of interview data 118 8.7 Technological resources 120 8.8 Summary 120 9 Scales for research in the addictions 127Shane Darke 9.1 Introduction 127 9.2 Screening instruments 128 9.3 Frequency of substance use 130 9.4 Multi-dimensional scales 133 9.5 Dependence 135 9.6 Psychopathology 139 9.7 Summary 143 10 Biomarkers of alcohol and other drug use 147Scott H. Stewart, Anton Goldmann, Tim Neumann and Claudia Spies 10.1 Introduction 147 10.2 Uses of state biomarkers in research 147 10.3 General principles when considering biomarkers 149 10.4 Summary 156 11 Quantitative data analysis 163Jim Lemon, Louisa Degenhardt, Tim Slade and Katherine Mills 11.1 Introduction 163 11.2 Imagining data – planning the study 163 11.3 Collecting data – gathering the measurements 165 11.4 Organising data – structuring the measurements 166 11.5 Describing data – what do the data look like? 167 11.6 Manipulating data 171 11.7 Relationships within the data 173 11.8 Interpreting relationships within the data 177 11.9 Conclusion and exercises 178 Section III: Real World Research Methods 12 Applied research methods 187David Best and Ed Day 12.1 Introduction 187 12.2 Auditing clinical activity in the city 189 12.3 Needs assessment 190 12.4 Qualitative research approaches 192 12.5 Evaluation research 193 12.6 The audit cycle 197 12.7 Measuring outcomes in applied settings 197 12.8 Overview and conclusions 198 13 Conducting clinical research 201Jalie A. Tucker and Cathy A. Simpson 13.1 Conducting clinical research 201 13.2 Discussion and conclusions: The role of the practitioner-researcher 211 Section IV: Biological Methods 14 Psychopharmacology 223Jason White and Nick Lintzeris 14.1 Introduction 223 14.2 Psychopharmacology: drugs, behaviour, physiology and the brain 223 14.3 Measuring drug effects 226 14.4 Human drug self-administration 229 14.5 Drug withdrawal and craving 231 14.6 Summary 232 15 Imaging 235Alastair Reid and David Nutt 15.1 Introduction 235 15.2 Introduction to neuroimaging 235 15.3 Imaging techniques 235 15.4 Image analysis 241 15.5 Some considerations when setting up an imaging study 244 16 Genes, genetics, genomics and epigenetics 249David Ball and Irene Guerrini 16.1 Introduction 249 16.2 Animal studies 252 16.3 Quantitative genetics 254 16.4 Molecular genetics 256 16.5 Why bother? 263 16.6 An addiction gene 263 16.7 Ethics 264 16.8 Concluding remarks 264 17 Animal models 269Leigh V. Panlilio, Charles W. Schindler and Steven R. Goldberg 17.1 Introduction 269 17.2 Basic principles of behaviour: Reinforcement 269 17.3 Basic principles of behaviour: Effects of environmental cues 270 17.4 Drug self-administration: Simple schedules 270 17.5 Drug self-administration: Using dose–effect curves to assess the effects of treatments 271 17.6 Drug self-administration: Measuring the reinforcing effects of drugs 271 17.7 Drug self-administration: Modelling the effects of environmental cues with second-order schedules 273 17.8 Drug self-administration: Reinstatement 275 17.9 Drug self-administration: Modelling the uncontrolled and compulsive nature of addiction 275 17.10 Intracranial drug self-administration and intracranial electrical self-stimulation 276 17.11 Drug self-administration: Advantages and disadvantages 278 17.12 Conditioned place preference 278 17.13 Drug discrimination 279 17.14 Locomotor activity 279 17.15 Adjunct procedures 281 17.16 Integration of behavioural and neuroscience techniques 281 Section V: Specialist Methods 18 Understanding contexts: Methods and analysis in ethnographic research on drugs 287Jeremy Northcote and David Moore 18.1 Introduction 287 18.2 Tracing the history of ethnographic drug research 288 18.3 Designing ethnographic research 289 18.4 Getting started 290 18.5 Collecting data 292 18.6 Analysing ethnographic data 293 18.7 Producing ethnographic texts 294 18.8 Conclusion 295 19 Epidemiology 299Mark Stoov´e and Paul Dietze 19.1 Introduction 299 19.2 Origins of epidemiology 299 19.3 Definitions and uses of epidemiology in alcohol and other drug research 299 19.4 Descriptive epidemiology 300 19.5 Epidemiological research designs 301 19.6 Analysis of case-control and cohort studies 308 19.7 Experimental study designs 310 19.8 Potential sources of error in epidemiology 311 19.9 Summary 314 20 Meta-analysis: Summarising findings on addiction intervention effects 319John W. Finney and Anne Moyer 20.1 Introduction 319 20.2 Overview of meta-analytic methods 319 20.3 Issues in meta-analyses of addiction interventions 327 20.4 Limitations 331 20.5 Conclusion 331 21 Drug trend monitoring 337Paul Griffiths and Jane Mounteney 21.1 Introduction 337 21.2 Point of departure – divergent policy perspectives, difficulties in definition and temporal relevance 337 21.3 International, national and local drug monitoring mechanisms 338 21.4 Challenges in monitoring illicit drug use 339 21.5 An overview of common information sources and some of their limitations 341 21.6 Issues for the interpretation and analysis of data 345 21.7 Mixed methods 347 21.8 Triangulation 347 21.9 Reliability and validity 348 21.10 Reflections in a broken mirror: Pragmatic and imperfect solutions to an intractable problem 349 22 Drug policy research 355Jonathan P. Caulkins and Rosalie Liccardo Pacula 22.1 Introduction 355 22.2 Methods for quantitatively comparing an intervention’s benefits and costs 356 22.3 Issues that arise in quantifying an intervention’s benefits and costs 360 22.4 Methods for estimating an intervention’s effects 362 22.5 Modelling methods 365 22.6 Summary 366 Section VI: Beyond Research 23 Concluding remarks 375Peter G. Miller, John Strang and Peter M. Miller 23.1 Publishing addiction science 375 23.2 Final thoughts 376 Index 377

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Book SynopsisThe Research Handbook for Health Care Professionals is the essential guide to the entire research process for students and practitioners alike.Table of ContentsPart 1: Getting started – planning your research. 1. Taking Stock. 2. Research Governance. 3. Formulating your research question. 4. Reviewing the literature. 5. Critically appraising papers. 6. Choosing the right research design. 7. Writing the initial research protocol. 8. Getting started with statistics. 9. Successful Grant Applications. 10. Obtaining approval for your research. 11. Participant consent. Part 2: Doing your analysis. 12. Collecting your data. 13. Recruiting Volunteers. 14. Data management and analysis. Part 3: Writing up and dissemination. 15. Disseminating your results. 16. Preparing for a conference presentation. 17. Writing a paper for a journal.

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Book SynopsisBy the time you've read this book, you'll be ready to design your own research project Not everyone in clinical research is a scientific investigator. In fact, a large proportion of health professionals undertaking a research project are working in clinical care, as junior doctors, nurses or allied health professionals.Trade Review"The purpose is to provide basic information for conducting a research project. This is a worthwhile objective, since many healthcare professionals who may not have a background in research have questions that need answers ... This will be a good guide as a starting point for conducting research." (Doody's, 20 January 2012) "This is a well-intentioned introduction to health research." (British Journal of Cardiology, 2011) "This book will appeal to students in all branches of the health profession and is warmly recommended." (Journal of Tropical Pediatrics, 2011) Table of ContentsPreface. PART I LIMBERING UP. 1 Turning Your General Aim Into a Specific Question. 2 Taking a Preliminary Look at What Has Already Been Done. PART II ON YOUR MARKS. 3 Coming Up With an Initial Plan of Action. 4 Carrying Out a Systematic Search. 5 Building a Team. PART III GET SET. 6 Choosing the Best Study Design. 7 Selecting Samples for Quantitative Research. 8 Selecting Samples for Qualitative Research. PART IV WAIT FOR IT. 9 Deciding What Information to Collect. 10 Tackling Confounders. 11 How Many People to Study? 12 Getting Ready for a Qualitative Analysis. 13 Getting Ready for a Quantitative Analysis. 14 Writing Your Final Protocol. 15 Arranging Funding. 16 Getting Permission to Go Ahead. PART V GO! 17 Recruiting the Participants. 18 Collecting and Recording the Data. 19 Living With (and Without) the Data. PART VI STAYING THE COURSE. 20 Taking Stock. 21 Making Sense of Your Results – the Quantitative Case. 22 Making Sense of Your Results – the Qualitative Case. PART VII THE FINISHING LINE. 23 Writing a Research Paper. 24 Setting Out Your Findings. 25 Writing Your Discussion. 26 Writing a Thesis or Other Report. 27 Dealing With Journals. Further Reading. Index.

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Book SynopsisAquaporins: A Family of Highly Regulated Multifunctional Channels.- Phylogeny of Major Intrinsic Proteins.- Metalloids, Soil Chemistry and the Environment.- Arsenic Transport in Prokaryotes and Eukaryotic Microbes.- Metalloid Transport by Aquaglyceroporins: Consequences in the Treatment of Human Diseases.- Roles of Vertebrate Aquaglyceroporins in Arsenic Transport and Detoxification.- Molecular Mechanisms of Boron Transport in Plants: Involvement of Arabidopsis NIP5;1 and NIP6;1.- Silicon Transporters in Higher Plants.- Major Intrinsic Proteins and Arsenic Transport in Plants: New Players and Their Potential Role.- Major Intrinsic Proteins in Biomimetic Membranes.Table of Contents1. Aquaporins: A Family of Highly Regulate d Multifunctional Channels Charles Hachez and François Chaumont Abstract Introduction—The Discovery of Aquaporins Topology of Aquaporins Selectivity of Aquaporins Measurement of Aquaporin Activity and Water Movement Aquaporin Inhibition Phenotype Analysis Reveals Involvement of Aquaporins in Key Physiological Processes Aquaporin Regulation: Gating and Localization Conclusion 2. Phylogeny of Major Intrinsic Proteins Jonas Å.H. Danielson and Urban Johanson Abstract Introduction A Historical Account of the MIP Phylogeny Plant MIPs Phylogenetic Analysis of NIPs Solute Transport NIP?Like Bacterial MIPs and Ancestral State of ar/R Filter Conclusion 3. Metalloids, Soil Chemistry and the Environment Enzo Lombi and Peter E. Holm Abstract Introduction Historical Perspective Environmental Relevance Factors Controlling Bioavailability Assessing Soil Bioavailability of Metalloids Conclusion 4. Arsenic Transport in Prokaryotes and Eukaryotic Microbes Barry P. Rosen and Markus J. Tamás Abstract Introduction Metalloid Transport in Prokaryotes Metalloid Transport in Eukaryotic Microbes Conclusion 5. Metalloid Transport by Aquaglyceroporins: Consequences in the Treatment of Human Diseases Rita Mukhopadhyay and Eric Beitz Abstract Introduction Metalloids and Cancer Uptake of Metalloids via Human Aquaglyceroporins Metalloids in Protozoan Parasitic Infections Parasite Aquaglyceroporins Facilitate Metalloid Transport Therapeutic Modulation of AQP Permeability Conclusion 6. Roles of Vertebrate Aquaglyceroporins in Arsenic Transport and Detoxification Zijuan Liu Abstract Introduction Expression of Vertebrate Aquaglyceroporins Arsenic Is Both an Environmental Toxin and Human Carcinogen Uptake of Organic and Inorganic Arsenic via Aquaglyceroporins Molecular Mechanisms for Arsenic Translocation by Aquaglyceroporins Arsenic Toxicity in Relation of Aquaglyceroporins Regulation Perspectives Conclusion 7. Molecular Mechanisms of Boron Transportin Plants: Involvement of Arabidopsis NIP5;1 and NIP6;1 Kyoko Miwa, Mayuki Tanaka, Takehiro Kamiya and Toru Fujiwara Abstract Physiological Function of Boron in Plants Physiological Analysis of B Transport Molecular Mechanisms of B Transport Improvement of Plant Growth Property through BOR and NIP Transporters Conclusion and Foresights 8. Silicon Transporters in Higher Plants Jian Feng Ma Abstract Introduction Silicon Transporters Influx Si Transporters Efflux Transporter of Silicon Difference in Si Uptake System between Paddy and Field Crops Silicon Transporters for Xylem Unloading Conclusion 9. Major Intrinsic Proteins and Arsenic Transport in Plants: New Players and Their Potential Roles Gerd P. Bienert and Thomas P. Jahn Abstract Introduction The Challenge of As Speciation in Plants Transport of As in Plants What Do the Different “Omics” Tell Us About NIP?Mediated As Transmembrane Transport? The Physiological Role of NIPs Plant NIPs Transport Trivalent Antimony Conclusion 10. Major Intrinsic Proteins in Biomimetic Membranes Claus Hélix Nielsen Abstract Introduction Biomimetic Membranes MIP Biomimetic Membranes and Osmotic Processes Conclusion Index

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Book SynopsisDo statistics-heavy research papers give you a headache? Are you baffled by bias, confused by correlation, or flummoxed by F-tests? A Guide for the Statistically Perplexed is here to help! This book is designed to assist students, clinicians, and researchers in becoming familiar with statistical and research techniques by covering the essentials of the topic and drawing attention to many common problem areas.Inspired to write on this topic in reaction to mistakes he encountered in actual papers, David L. Streiner uses his trademark sense of humour and light-hearted style to explain complex statistical concepts in lucid, jargon-free language. Streiner delves into topics such as presenting data (or, conversely, how not to), statistical techniques, and more advanced procedures. To help readers detect problems with research design and interpretation, he details important ‘CRAP’ (convoluted reasoning or anti-intellectual pomposity) detectors for whichTrade Review'An easy to read collection of excellent tutorials on selected areas of statistics, measurement, and to a lesser extent, research methods... I can recommend this volume without hesitation.' -- Ryan J. Van Lieshout Archives of Women's Mental Health - June 2013Table of ContentsIntroduction Acknowledgements PART 1: INTRODUCTORY STATISTICS 1. Do You See What I Mean? Indices of Central Tendency 2. Maintaining Standards: Differences Between the Standard Deviation and Standard Error, and When to Use Each 3. Breaking Up is Hard to Do: The Heartbreak of Dichotomizing Continuous Data 4. Pick a Number: Sample Size and Power in Psychiatric Research 5. Speaking Graphically: An Introduction to Some Newer Graphing Techniques 6. Let Me Count the Ways: Measuring Incidences, Prevalence, and Impact in Epidemiological Studies 7. Risky Business: Making Sense of Estimates of Risk PART 2: MORE ADVANCED STATISTICS 8. The Case of the Missing Data: Methods of Dealing with Dropouts and Other Research Vagaries 9. An Introduction to Multivariate Statistics 10. Figuring Out Factors: The Use and Misuse of Factor Analysis 11. Regression in the Service of the Superego: The Do's and Don'ts of Stepwise Multiple Regression 12. Regression Toward the Mean: Its Etiology, Diagnosis, and Treatment 13. Stayin' Alive: An Introduction to Survival Analysis 14. Life After Chi-Squared: An Introduction to Log-Linear Analysis 15. Confronting the Confounders: The Meaning, Detection, and Handling of Confounders in Research 16. Finding Our Way: An Introduction to Path Analysis 17. Building a Better Model: An Introduction to Structural Equation Modelling 18. Unicorns Do Exist: A Tutorial on "Proving" the Null Hypothesis PART 3: RESEARCH METHODS 19. Reconcilable Differences: The Marriage of Qualitative and Quantitative Methods 20. Thinking Small: Research Designs Appropriate for Clinical Practice 21. The Two "Es" of Research: Efficacy and Effectiveness Trials PART 4: MEASUREMENT 22. A Checklist for Evaluating the Usefulness of Rating Scales 23. Learning How to Differ: Agreement and Reliability Statistics 24. What's Under the ROC? An Introduction to Receiver Operating Characteristic Curves 25. Measure for Measure: New Developments in Measurement and Item Response Theory PART 5: MISCELLANEOUS 26. Putting it All Together: Using Meta-Analysis in Psychiatric Research 27. "While You're Up, Get Me a Grant": A Guide to Grant Writing 28. A Shortcut to Rejection: How Not to Write the Results Section of a Paper INDEX

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Book SynopsisDreams and Due Diligence vividly chronicles the work of two researchers who made medical history two men who possessed exactly the right complementary talents to achieve greatness and win nearly every award available in medical research.Table of ContentsContents Introduction Part I: Discovery 1. On a Sunday in 1960 2. After the A-Bomb, before the Beatles 3. The Impossible partnership Part II: Development 4. A bunch of kids having a good time 5. The progeny Part III: Today and Tomorrow 6. Ethics, hope and hype 7. The evil twin: the cancer stem cell 8. The beneficiary 9. The future 10. Little fame, no Nobel Conclusion

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Book SynopsisRegression Methods for Medical Research provides medical researchers with the skills they need to critically read and interpret research using more advanced statistical methods.Table of ContentsPreface viii 1 Introduction 1 2 Linear regression: practical issues 25 3 Multiple linear regression 43 4 Logistic Regression 64 5 P oisson Regression 98 6 Time-to-Event Regression 120 7 Model Building 146 8 Repeated Measures 176 9 Regression Trees 204 10 Further Time-to-Event Models 236 11 Further Topics 269 Statistical Tables 285 References 294 Index 298

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