Textbooks for PRO and HRQoL Research Methods
Fairclough DL. Design and Analysis of Quality of Life Studies in Clinical Trials, 2nd edition. New York: Chapman & Hall/CRC Interdisciplinary Statistics Series, 2010.
Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical methods, such as mixed effect models, to their own studies. The author illustrates the implementation of the methods using the statistical software packages SAS, SPSS, and R.
Cappelleri JC, Zou KH, Bushmakin AG, et al. Patient-reported outcomes: measurement, implementation and interpretation. New York: Chapman & Hall/CRC Biostatistics Series, 2014.
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.
Fayers, P, Hays, R. Assessing quality of life in clinical trials: methods and practice, 2nd edition. New York: Oxford University Press, 2005.
Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. Assessment of Quality of Life in Clinical Trials: methods and practice explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It covers a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance.
Cleeland, CS, Fisch, MJ, Dunn, A. Cancer symptom science: measurement, mechanisms, and management. New York: Cambridge University Press, 2011.
Cancer Symptom Science is the first interdisciplinary compilation of research on the mechanisms underlying the expression of cancer-related symptoms. It presents innovations in clinical, animal and in vitro research, research methods in brain imaging, and statistical-descriptive approaches to understanding the mechanistic basis of symptom expression. This volume also provides perspectives from patients, government and industry. By collecting and synthesizing the developing threads of new approaches to understanding cancer-related symptoms, the book promotes a pioneering framework for merging behavioral and biological disciplines to clarify mechanisms of symptom evolution, incorporating new technologies, testing novel agents for symptom control, and improving patient functioning and quality of life both during and after cancer treatment. With an expert editorial team led by Charles S. Cleeland, an internationally-recognized leader in cancer pain assessment and treatment, this is essential reading for surgical, clinical and medical oncologists, academic researchers, and pharmaceutical companies developing new agents to control symptom expression.
de Vet, HCW, et al. Measurement in medicine: a practical guide. New York: Cambridge University Press, 2011.
The success of the Apgar score demonstrates the astounding power of an appropriate clinical instrument. This down-to-earth book provides practical advice, underpinned by theoretical principles, on developing and evaluating measurement instruments in all fields of medicine. It equips you to choose the most appropriate instrument for specific purposes. The book covers measurement theories, methods and criteria for evaluating and selecting instruments. It provides methods to assess measurement properties, such as reliability, validity and responsiveness, and interpret the results. Worked examples and end-of-chapter assignments use real data and well-known instruments to build your skills at implementation and interpretation through hands-on analysis of real-life cases. All data and solutions are available online. This is a perfect course book for students and a perfect companion for professionals/researchers in the medical and health sciences who care about the quality and meaning of the measurements they perform.
Bourgeault, I, Dingwall, R, De Vries, R. The SAGE handbook of qualitative methods in health research. Los Angeles: SAGE, 2010.
The Sage Handbook of Qualitative Methods in Health Research is a comprehensive and authoritative source on qualitative research methods.The Handbook compiles accessible yet vigorous academic contributions by respected academics from the fast-growing field of qualitative methods in health research and consists of:
- A series of case studies in the ways in which qualitative methods have contributed to the development of thinking in fields relevant to policy and practice in health care.
- A section examining the main theoretical sources drawn on by qualitative researchers.
- A section on specific techniques for the collection of data.
- A section exploring issues relevant to the strategic place of qualitative research in health care environments.
The Sage Handbook of Qualitative Methods in Health Research is an invaluable source of reference for all students, researchers and practitioners with a background in the health professions or health sciences.