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1

Introduction to randomized controlled clinical trials. 2nd ed. Boca Raton, FL: Chapman & Hall/CRC, 2006.

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2

Kim, KyungMann, Frank Bretz, Ying Kuen K. Cheung, and Lisa V. Hampson. Handbook of Statistical Methods for Randomized Controlled Trials. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694.

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3

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

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4

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

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5

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

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6

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

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7

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

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8

Binary data analysis of randomized clinical trials with noncompliance. Chichester, West Sussex, United Kingdom: John Wiley & Sons Inc., 2011.

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9

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

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10

The use of restricted significance tests in clinical trials. New York: Springer-Verlag, 1992.

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11

Salsburg, David. The use of restricted significance tests in clinical trials. New York: Springer-Verlag, 1992.

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12

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

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13

J, Hayes Richard, and Hayes Richard J. Cluster randomised trials. Boca Raton: Taylor & Francis, 2009.

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14

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

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15

Simon, Wessely, ed. Clinical trials in psychiatry. 2nd ed. Chichester, West Sussex, England: John Wiley & Sons, 2008.

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16

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. Washington, D.C: National Academies Press, 2010.

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17

Morash, Mark D. Surgery of the aorta and its body branches. Shelton, Conn: People's Medical Pub. House-USA, 2010.

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18

Shukla, Vijay K. Novel antipsychotics for patients with bipolar disorder: A systematic review. Ottawa, Ont: Canadian Coordinating Office for Health Technology Assessment, 2001.

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19

Shukla, Vijay K. Novel antipsychotics for patients with bipolar disorder: A systematic review. Ottawa, Ont: Canadian Coordinating Office for Health Technology Assessment, 2001.

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20

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

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21

A, Steinberg Benjamin, and Sharis Peter J, eds. Evidence-based cardiology. 3rd ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health, 2011.

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22

Markowitz, John C. Interpersonal psychotherapy for dysthymic disorder. Washington, DC: American Psychiatric Press, 1998.

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23

Selection bias and covariate imbalances in randomzied clinical trials. Hoboken, NJ: John Wiley & Sons, 2005.

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24

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

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25

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

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26

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

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27

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

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28

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. Ottawa: National Library of Canada, 1990.

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29

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. Addis Ababa, Ethiopia: Malaria Consortium Ethiopia, 2009.

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30

Greenbank, Janet. A randomized clinical trial to examine the efficacy of a cognitive coping strategy in reducing pain, anxiety and improving functional ability in an in-patient rheumatoid arthritic population. [Hamilton, Ont.]: McMaster University, 1988.

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31

Drabble, Sarah J., and Alicia O’Cathain. Moving From Randomized Controlled Trials to Mixed Methods Intervention Evaluations. Edited by Sharlene Nagy Hesse-Biber and R. Burke Johnson. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199933624.013.26.

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32

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

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33

Cluster Randomized Trials (Interdisciplinary Statistics). Chapman & Hall/CRC, 2008.

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34

O'Cathain, Alicia. A Practical Guide to Using Qualitative Research with Randomized Controlled Trials. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198802082.001.0001.

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A Practical Guide to Using Qualitative Research with Randomized Controlled Trials focuses on qualitative research, emphasizing subjectivity, flexibility, open data collection, depth, and context, and randomized controlled trials (RCTs), emphasizing objectivity, standardization, measurement, and a key goal of bias reduction. The differences between the two methodologies make their combination an interesting ‘extreme case’ of mixed methods research. The book is about how to use qualitative research when preparing for, undertaking, or implementing the results of an RCT. The focus is on a range of designs, including pilot and pragmatic RCTs. The book focuses on health research because the majority of RCTs are undertaken in this field. It is written for researchers who are undertaking or planning to undertake qualitative research with RCTs. The book may also be useful to researchers leading RCTs and graduate students. It does not explain how to do qualitative research or how to do RCTs. The book focuses on how to undertake qualitative research in the specific context of RCTs. The book is divided into three parts. Part 2 offers the practical guidance promised within the title of the book. Each chapter focuses on key steps when undertaking qualitative research in the context of RCTs: writing a proposal, selecting research questions, collecting data, analysing data, integrating qualitative and quantitative components, and publishing. Part 1 sets the scene for the practical aspects. Part 3 focuses on the human beings we work closely with during research and offers practical advice to ensure these interactions are positive and fruitful.
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35

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

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36

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

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37

M, Nezu Arthur, and Nezu Christine M, eds. Evidence-based outcome research: A practical guide to conducting randomized controlled trials for psychosocial interventions. Oxford: Oxford University Press, 2008.

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38

Evidence-based outcome research: A practical guide to conducting randomized controlled trials for psychosocial interventions. New York, NY: Oxford University Press, 2007.

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39

(Editor), Arthur M. Nezu, and Christine Maguth Nezu (Editor), eds. Evidence-Based Outcome Research: A Practical Guide to Conducting Randomized Controlled Trials for Psychosocial Interventions. Oxford University Press, USA, 2007.

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40

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Navigating research methods: critical appraisal. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0006.

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This chapter discusses the role of critical appraisal as an integral part of evidence based practice. There is no gold standard for conducting critical appraisal of medical literature. Standard check lists are presented for the specific study designs (randomized controlled trials, cohort studies, case control studies and cross-sectional studies). The check lists include questions which capture four main components of a scientific paper (introduction, methods, results and discussion), and are organized as screening questions (1. Does the research address a clearly focused question?, and 2. Was the type of study appropriate?) and detailed questions focusing on the different aspects of internal and external validity.
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41

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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42

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

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43

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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44

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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45

Treatment And Management Of Multiple Sclerosis. Nova Science Publishers, 2004.

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46

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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47

Postnatal Care: Evidence and Guidelines for Management. Churchill Livingstone, 2002.

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48

Bick, Debra, Christine MacArthur, Heather Winter, Kathy de Mott, and Gill Ritchie. Postnatal Care. Elsevier - Health Sciences Division, 2008.

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49

Bick, Debra, Sheena Byrom, and Grace Edwards. Postnatal Care. Wiley & Sons, Incorporated, John, 2009.

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50

Wheeler, Barbara L. Music Therapy Research. Edited by Jane Edwards. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199639755.013.11.

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Music therapy is a diverse field and music therapy research increasingly reflects that diversity. Many methods and approaches are used to examine the various facets of music therapy practice and theory. This chapter provides an overview of music therapy research, and provides basic information about how research is conducted in this field. Research methods in music therapy research are similar to those used in other healthcare disciplines. A range of methods are reviewed and presented including; experimental research and Randomized Controlled Trials, Participatory Action Research, Grounded Theory, and Phenomenological methods.
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