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1

Matthews, J. N. S. An introduction to randomized controlled clinical trials. Arnold, 2000.

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2

Machin, David. Randomized clinical trials: Design, practice, and reporting. John Wiley & Sons, 2010.

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3

Machin, David. Randomized clinical trials: Design, practice and reporting. Wiley-Blackwell, 2010.

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4

M, Cavanaugh Mary, and Draine Jeffrey, eds. Randomized controlled trials: Design and implementation for community-based psychosocial interventions. Oxford University Press, 2009.

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5

Randomized clinical trials of nonpharmacologic treatments. Chapman and Hall/CRC, 2012.

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6

Modern adaptive randomized clinical trials: Statistical and practical aspects. Taylor & Francis, 2015.

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7

Neil, Klar, ed. Design and analysis of cluster randomization trials in health research. Arnold, 2000.

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8

Campbell, Michael J. How to design, analyse and report cluster randomised trials in medicine and health related research. John Wiley & Sons, 2014.

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9

Randomised controlled clinical trials. 2nd ed. Kluwer Academic Publishers, 1996.

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10

Everitt, Brian. Clinical trials in psychiatry. Oxford University Press, 2004.

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11

Simon, Wessely, ed. Clinical trials in psychiatry. 2nd ed. John Wiley & Sons, 2008.

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12

National Research Council (U.S.). Committee on National Statistics and National Academies Press (U.S.), eds. The prevention and treatment of missing data in clinical trials. National Academies Press, 2010.

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13

Kmet, Leanne Marie. Standard quality assessment criteria for evaluating primary research papers from a variety of fields. Alberta Heritage Foundation for Medical Research, 2004.

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14

Torgerson, David J. Designing and running randomised trials in health, education, and the social sciences. Palgrave Macmillan, 2008.

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15

Walters, Stephen John. Quality of life outcomes in clinical trials and health-care evaluation: A practical guide to analysis and interpretation. John Wiley & Sons, 2009.

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16

Quality of life outcomes in clinical trials and health-care evaluation: A practical guide to analysis and interpretation. John Wiley & Sons, 2009.

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17

Brymer, Christopher David. A randomized, double-blind, placebo-controlled crossover trial of nimodipine for geriatric urge incontinence. National Library of Canada = Bibliothèque nationale du Canada, 1999.

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18

Coulter, Harris L. The controlled clinical trial: An analysis. Center for Empirical Medicine : Project Cure, 1991.

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19

Coulter, Harris L. The controlled clinical trial: An analysis. Center for Empirical Medicine, 1991.

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20

Davies, Allyson Ross. Consumer acceptance of prepaid and fee-for-service medical care : results from a randomized controlled trial. Rand, 1986.

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21

Glazerman, Steven. Impacts of comprehensive teacher induction: Final results from a randomized controlled study. National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences, U.S. Dept. of Education, 2010.

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22

Travis, Heather E. Evaluating three self-help smoking cessation interventions for post-secondary smokers: A randomized controlled trial on six Ontario campuses. Brock University, Dept. of Community Health Sciences, 2003.

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23

Akoury, Hani. A randomized controlled trial to evaluate the use of misoprostol for second trimester pregnancy temination associated with fetal malformation. National Library of Canada, 2002.

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24

Finkel, Angela M. Childbirth satisfaction of participants in a randomized controlled trial of the treatment of postterm pregnancy induction of labour versus serial antenatal monitoring. National Library of Canada, 1990.

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25

Coalition Against Malaria in Ethiopia. Effect of a combined use of mosquito repellent and insecticide treated net on malaria prevalence in southern Ethiopia: A cluster randomized controlled trial. Malaria Consortium Ethiopia, 2009.

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26

Peacock, Janet L., Sally M. Kerry, and Raymond R. Balise. Presenting a randomized controlled trial. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198779100.003.0012.

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Chapter 12 covers all aspects of reporting a randomized controlled trial, and illustrates the use of the CONSORT statement and its checklist to report a trial. It discusses what is meant by intention-to-treat analysis. It considers the presentation of trials with other designs, particularly cluster randomized trials.
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27

Robb, Sheri L., and Debra S. Burns. Randomized Controlled Trials in Music Therapy. Edited by Jane Edwards. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199639755.013.14.

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Randomized controlled trials (RCTs) are experiments that compare two or more groups of participants, and participants are assigned to groups based on chance. Groups include an experimental intervention group that is being compared to a treatment as usual, a low dose or attention control condition, and/or a comparative treatment group. The purpose of randomization is to equalize groups on both known and unknown characteristics that may influence the outcome and the effectiveness of the intervention. This chapter describes how music therapists have used RCTs to demonstrate the effectiveness of music therapy interventions and services. Key strategies for implementing RCT designs are presented, and studies in music therapy that have used this design are reviewed.
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28

Matthews, J. N. S. An Introduction to Randomised Controlled Clinical Trials. A Hodder Arnold Publication, 2000.

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29

Tango, Toshiro. Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials. Chapman and Hall/CRC, 2017. http://dx.doi.org/10.1201/9781315152097.

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30

Weiss, Helen. Design issues in global mental health trials in low-resource settings. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199680467.003.0004.

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In this chapter we outline the key principles in design and analysis of trials for mental health. The chapter focuses on randomized controlled trials as these are the gold-standard trial design, which minimizes confounding due to other factors and enables us to draw conclusions about the effectiveness of the intervention. Other key principles of trial design discussed in the chapter include methods to develop a clearly stated, testable research hypothesis, definition of well-defined outcomes, appropriate choice of the control condition, masking of providers and participants where possible, realistic sample size estimates, and appropriate data monitoring and statistical analysis plans. The chapter also outlines alternatives to the parallel arm superiority trial design, such as equivalence and non-inferiority trials, cross-over, stepped wedge, fixed adaptive, and patient preference trial designs.
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31

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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32

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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33

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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34

Fayers, Peter M. Clinical Trials: Design Application and Reporting. John Wiley & Sons, 2008.

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35

Clinical Trials: Design Application and Reporting. John Wiley & Sons, 2008.

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36

Sklar, Marisa, Joanna C. Moullin, and Gregory A. Aarons. Study Design, Data Collection, and Analysis in Implementation Science. Edited by David A. Chambers, Wynne E. Norton, and Cynthia A. Vinson. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190647421.003.0006.

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This chapter provides an introduction to study design, data collection, and analysis in implementation science. Although the randomized controlled trial is frequently employed in implementation science, a number of alternatives are relied on for addressing the unique challenges present. Alternatives include the cluster randomized control trial, roll-out designs such as the stepped wedge, cumulative trial, and effectiveness–implementation hybrid designs. Data collection and data analytic techniques must also address the unique challenges present in implementation science. Often, implementation occurs over time, often, across complex, multilevel contexts. Implementation scientists frequently utilize mixed, qualitative, and quantitative methodologies for collecting, analyzing, and interpreting data. Data represent the outer context of service systems and the inner context of organizations such that the data are often nested and hierarchical in nature. This chapter highlights the previously mentioned topics, particularly as they relate to currently funded implementation studies focused on the cancer control continuum.
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37

Miksza, Peter, and Kenneth Elpus. Design and Analysis of Experimental Research I. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780199391905.003.0008.

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This chapter builds on the previous chapter by elaborating from theories of causal knowledge presented earlier to practical considerations for the design, execution, and analysis of randomized experiments and randomized controlled trials in music education research. The straightforward statistical analysis of the two-group experimental designs is explained through the t test. The analysis of variance technique is explained for the analysis of experimental and quasi-experimental data involving more than two groups. The chapter closes with a discussion of the analysis of data arising from experiments where additional data, beyond group membership and the score on an outcome measure, is known about the participants (i.e., analysis of covariance).
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38

Peacock, Janet L., and Sally M. Kerry. Presenting a randomised controlled trial. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780198599661.003.0012.

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39

Hughes, Thomas. Foundations of clinical practice. Oxford University Press, 2011. http://dx.doi.org/10.1093/med/9780199550647.003.0001.

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♦ Conscious and unconscious competency♦ Clinical research and the placebo effect♦ Trial design and the randomized controlled trial♦ Critical review of the literature♦ Clinical governance and audit♦ Capacity and consent♦ Principles of teaching and learning.
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40

Campbell, Michael J., and Stephen J. Walters. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. Wiley & Sons, Incorporated, John, 2014.

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41

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Springer, 2012.

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42

Kendall, Philip C., Jonathan S. Comer, and Candice Chow. The Randomized Controlled Trial. Oxford University Press, 2013. http://dx.doi.org/10.1093/oxfordhb/9780199793549.013.0004.

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43

Everitt, Brian, and Simon Wessely. Clinical Trials in Psychiatry. 2nd ed. Wiley-Interscience, 2008.

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44

Karlan, Dean, and Jacob Appel. Failing in the Field. Princeton University Press, 2018. http://dx.doi.org/10.23943/princeton/9780691183138.001.0001.

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All across the social sciences, from development economics to political science departments, researchers are going into the field to collect data and learn about the world. While much has been gained from the successes of randomized controlled trials, stories of failed projects often do not get told. This book delves into the common causes of failure in field research, so that researchers might avoid similar pitfalls in future work. Drawing on the experiences of top social scientists working in developing countries, the book investigates failed projects and helps guide practitioners as they embark on their research. From experimental design and implementation to analysis and partnership agreements, the book shows that there are important lessons to be learned from failures at every stage. The book describes five common categories of failures, reviews six case studies in detail, and concludes with some reflections on best (and worst) practices for designing and running field projects, with an emphasis on randomized controlled trials. There is much to be gained from investigating what has previously not worked, from misunderstandings by staff to errors in data collection. Cracking open the taboo subject of the stumbles that can take place in the implementation of research studies, this is a valuable ‘how-not-to’ handbook for conducting fieldwork and running randomized controlled trials in development settings.
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45

Hui, David. Early Palliative Care for Patients with Advanced Cancer (DRAFT). Edited by Nathan A. Gray and Thomas W. LeBlanc. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190658618.003.0002.

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This chapter discusses the Zimmermann trial, a large partially blinded, cluster randomized controlled trial of routine oncology care with or without early routine referral to palliative care. This landmark study found that early palliative care involvement was associated with improved quality of life, symptom burden and satisfaction among patients with advanced cancer. This chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case to illustrate some key points around palliative care referral.
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46

Torgerson, David J., and Carole J. Torgerson. Designing and Running Randomised Trials in the Social Sciences. Palgrave Macmillan, 2008.

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47

Designing and Running Randomised Trials in the Social Sciences. Palgrave Macmillan, 2008.

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48

Taylor, Joseph J., and Robert Ostroff. National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program. Edited by Ish P. Bhalla, Rajesh R. Tampi, Vinod H. Srihari, and Michael E. Hochman. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190625085.003.0024.

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This chapter will summarize what is considered to be the first randomized controlled trial to directly compare psychotherapeutic and psychopharmacological interventions for unipolar nonpsychotic depression. More specifically, the authors were interested in the degree to which cognitive behavioral therapy, interpersonal therapy, imipramine and a placebo condition ameliorated symptoms of depression in patients from outpatient psychiatric clinics at three academic medical centers in the United States. The chapter will discuss the design and implementation of the study before focusing on the results and their implications. The last section of the chapter will list similar studies and present a hypothetical clinical case that requires the reader to apply basic concepts learned from the study.
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49

Patel, Chirag A. Reduction of Cancer-Related Fatigue with Dexamethasone (DRAFT). Edited by Nathan A. Gray and Thomas W. LeBlanc. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190658618.003.0019.

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“Reduction of Cancer-Related Fatigue with Dexamethasone: A Double-Blind, Randomized, Placebo-Controlled Trial in Patients with Advanced Cancer” reviews the study of the same name and outlines a clinical scenario in which the study may be applied. It begins by describing the study’s background, including location and participants. It then describes the study design and outcomes measured. The chapter reviews key study results, criticisms and limitations identified within the study, and other related literature on cancer-related fatigue (CRF). It then discusses the implications of the findings on the management of CRF in advanced cancer patients. The chapter concludes with a patient scenario that describes the use of dexamethasone in an outpatient palliative care clinic to reduce CRF.
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50

Ethical issues in the design and conduct of randomised controlled trials. Core Research, on behalf of the NCCHTA, 1998.

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