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1

Bothwell, Laura. The Emergence of the Randomized Controlled Trial: Origins to 1980. [New York, N.Y.?]: [publisher not identified], 2014.

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2

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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3

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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4

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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5

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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6

1941-, Lohr Kathleen N., United States. Dept. of Health and Human Services, and Rand Health Insurance Experiment, eds. Use of medical care in the Rand Health Insurance Experiment: Diagnosis- and service-specific analysis in a randomized controlled trial. Santa Monica, CA: Rand, 1986.

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7

A, Leibowitz Arleen, Rand Corporation, United States. Dept. of Health and Human Services., and Rand Health Insurance Experiment, eds. The Effect of cost-sharing on the use of medical services by children: Interim results from a randomized controlled trial. Santa Monica, CA: Rand, 1985.

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8

Jadad, Alejandro R., and Murray W. Enkin, eds. Randomized Controlled Trials. Oxford, UK: Blackwell Publishing Ltd, 2007. http://dx.doi.org/10.1002/9780470691922.

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9

Trained, Peer Mentorship and Veteran Support Organization Membership to Assist Transitioning Veterans: A Multi-arm, Parallel Randomized Controlled Trial (A Preliminary Investigation). [New York, N.Y.?]: [publisher not identified], 2018.

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10

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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11

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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12

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1.

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13

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

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14

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

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15

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

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16

Twisk, Jos W. R. Analysis of Data from Randomized Controlled Trials. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-81865-4.

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17

Jadad, Alejandro R. Randomized controlled trials: Questions, answers, and musings. 2nd ed. Malden, Mass: Blackwell Pub., 2007.

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18

Kohli, Richie, Harjit S. Sehgal, and Peter Milgrom, eds. Randomized Controlled Trials in Evidence-Based Dentistry. Cham: Springer International Publishing, 2024. http://dx.doi.org/10.1007/978-3-031-47651-8.

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19

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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20

Design and analysis of group-randomized trials. New York: Oxford University Press, 1998.

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21

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

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22

Brink, Wim van den. Medical co-prescription of heroin: Two randomized controlled trials. Utrecht: Central Committee on the Treatment of Heroin Addicts, 2002.

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23

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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24

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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25

Gupta, Rajesh. Randomized controlled trial evidence for gabapentin in post-herpetic neuralgia. Edited by Paul Farquhar-Smith, Pierre Beaulieu, and Sian Jagger. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198834359.003.0069.

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The landmark paper discussed in this chapter is ‘Gabapentin for the treatment of postherpetic neuralgia: A randomized controlled trial’, published by Rowbotham et al. in 1998. In the study, a 4-week initial period of titration of gabapentin (up to a maximum of 3,600 mg) or matching placebo was given, followed by a further 4-week period at the maximum tolerated dose. The primary efficacy measure was change in average daily pain score from start to finish of the treatment, and secondary measures observed were the average daily sleep score, a short-form McGill Pain Questionnaire, the subject’s global impression of change, the investigator-rated clinical global impression of change, the Short Form 36, a quality-of-life questionnaire, and a Profile of Mood States questionnaire. Subjects receiving gabapentin had significant reduction in daily pain scores as well as improvement in secondary measures of pain, although with an increased incidence of side effects.
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26

De Giorgi, Giacomo, and Aminur Rahman. SME Registration Evidence from a Randomized Controlled Trial in Bangladesh. The World Bank, 2013. http://dx.doi.org/10.1596/1813-9450-6382.

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27

Harvard University. Graduate School of Education, ed. Child-life services and preoperative anxiety trajectories: A randomized, controlled trial. 2010.

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28

Ozler, Berk, Lia C. H. Fernald, Patricia Kariger, Christin McConnell, Michelle Neuman, and Eduardo Fraga. Combining Preschool Teacher Training with Parenting Education: A Cluster-Randomized Controlled Trial. World Bank, Washington, DC, 2016. http://dx.doi.org/10.1596/1813-9450-7817.

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29

Rush, Janet Patricia Brown. A randomized controlled trial of the effects of the bath in labour. 1999.

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30

Green, T. A randomized controlled trial of a passive joint mobilization on acute ankle inversion sprains. 2001.

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31

Pfoh, Gabriele. Complicated Grief: Evaluating Individual Integrative Cognitive-Behavioral Therapy for Adults. A Randomized Controlled Trial. Logos Verlag, 2012.

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32

Tranmer, Joan Elizabeth. Nutritional support during labour: A randomized clinical trial of patient controlled oral intake during labour. 1999.

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33

Nyqvist, Martina Björkman, Lucia Corno, Damien de Walque, and Jakob Svensson. Using Lotteries to Incentivize Safer Sexual Behavior: Evidence from a Randomized Controlled Trial on HIV Prevention. The World Bank, 2015. http://dx.doi.org/10.1596/1813-9450-7215.

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34

Barrera-Osorio, Felipe, Pierre de Galbert, James Habyarimana, and Shwetlena Sabarwal. Impact of Public-Private Partnerships on Private School Performance: Evidence from a Randomized Controlled Trial in Uganda. World Bank, Washington, DC, 2016. http://dx.doi.org/10.1596/1813-9450-7905.

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35

Jamal, Abida S. The effects of isosorbide mononitrate on markers of bone turnover: A double-blind randomized placebo controlled trial. 2003.

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36

Stremler, Robyn. The labour position trial: A randomized, controlled trial of hands and knees positioning for women labouring with a fetus in occipitoposterior position. 2003.

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37

Soin, Herpreet Kaur. A randomized controlled trial of liposomal lidocaine versus placebo for intravenous cannulation of children in the emergency department. 2005.

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38

Zdravkovic, Vera. A randomized placebo-controlled trial of pioglitazone to improve metabolic control in adolescents with type 1 diabetes mellitus. 2005.

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39

Zdravkovic, Vera. A randomized placebo-controlled trial of pioglitazone to improve metabolic control in adolescents with type 1 diabetes mellitus. 2005.

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40

Soin, Herpreet Kaur. A randomized controlled trial of liposomal lidocaine versus placebo for intravenous cannulation of children in the emergency department. 2005.

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41

Young, Wendy I. The development, implementation and evaluation of a disease management program for post-myocardial infarction patients: A randomized controlled trial. 2002.

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42

Torok, Julie. A double-blind randomized controlled trial comparing nystatin cream with clotrimazole cream for the treatment of candida diaper dermatitis. 1996.

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43

Hancock, Rebecca Laura. Efficacy and safety of sucrose analgesia in reducing pain responses in infants undergoing repeated painful procedures: A randomized controlled trial. 2005.

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44

Stojanovski, Ognen, Mark C. Thurber, Frank A. Wolak, George Muwowo, and Kat Harrison. Assessing Opportunities for Solar Lanterns to Improve Educational Outcomes in Off-Grid Rural Areas: Results from a Randomized Controlled Trial. Published by Oxford University Press on behalf of the World Bank, 2021. http://dx.doi.org/10.1596/40839.

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45

Davies, Andrew N. Fast-acting fentanyl for breakthrough pain. Edited by Paul Farquhar-Smith, Pierre Beaulieu, and Sian Jagger. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198834359.003.0057.

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The landmark paper discussed in this chapter is ‘Oral transmucosal fentanyl citrate: Randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients’, published by Farrar et al. in 1998. It was the first description of a randomized controlled trial of a fast-acting fentanyl formulation for the management of breakthrough pain (i.e. oral transmucosal fentanyl citrate (OTFC)). Indeed, it was the first description of a randomized controlled trial of any of the so-called fast-acting fentanyl/rapid-onset opioid formulations for the management of breakthrough cancer pain. Moreover, the methodology employed in this study formed the basis for the methodology employed in many later studies (of other fast-acting fentanyl formulations).
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46

Winker, Margaret A., and Stephen J. Lurie. Randomized Controlled Trials. Oxford University Press, 2009. http://dx.doi.org/10.1093/jama/9780195176339.021.278.

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47

The effect of cost sharing on the use of antibiotics in ambulatory care: Results from a population-based randomized controlled trial. Santa Monica, CA: Rand, 1987.

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48

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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49

Laredo, Sheila E. Effect of exercise in women with polycystic ovary syndrome (PCOS): A randomized controlled trial of diet and exercise compared with diet alone. 2004.

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50

Aturupane, Harsha, Paul Glewwe, Tomoko Utsumi, Suzanne Wisniewski, and Mari Shojo. The Impact of Sri Lanka’s School-Based Management Program on Teachers’ Pedagogical Practices and Student Learning: Evidence from a Randomized Controlled Trial. Taylor and Francis, 2021. http://dx.doi.org/10.1596/40155.

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