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1

Jason, Payne, and Australian Institute of Criminology, eds. Criminal trial delays in Australia: Trial listing outcomes. Australian Institute of Criminology, 2007.

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2

Great Britain. Department of Health. and University of Bristol. School of Applied Social Studies., eds. Assessing outcomes in child care: Trial pack. HMSO, 1991.

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3

E, Loges William, ed. Free press vs. fair trials: Examining publicity's role in trial outcomes. Lawrence Erlbaum Associates, 2004.

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4

Su, Min. Factors affecting adverse fetal, neonatal, and maternal outcomes in the Term Breech Trial. National Library of Canada, 2003.

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5

Whyte, Kathryn J. Investigating Associations between Consumption of Unprocessed and Ultra Processed Foods and Maternal and Neonatal Health Outcomes—Secondary Outcomes of LIFT Trial. [publisher not identified], 2019.

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6

Valdez, Robert Otto Burciaga, 1956-, Rand Corporation, and United States. Dept. of Health and Human Services, eds. Prepaid group practice effects on the utilization of medical services and health outcomes for children: Results from a controlled trial. Rand, 1990.

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7

G, Manning Willard, and Valdez, Robert Otto Burciaga, 1956-, eds. The effects of a prepaid group practice on mental health outcomes of a general population: Results from a randomized trial. Rand, 1989.

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8

Drug and Therapeutics Bulletin. Symposium. From trial outcomes to clinical practice: Proceedings of thefourth Drug and therapeutics bulletin symposium held at the Royal College of Physicians, London, March 1996. Which? Ltd, 1996.

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9

V, Kovalev Ė. Bulgarian connection: CIA & Co. on the outcome of the Antonov trial. Novosti Press Agency Pub. House, 1986.

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10

Walters, Stephen J. Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation. John Wiley & Sons, Ltd, 2009. http://dx.doi.org/10.1002/9780470840481.

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11

Carole, Torgerson, and National Research and Development Centre for Adult Literacy and Numeracy., eds. Adult literacy and numeracy interventions and outcomes: a review of controlled trials. NRDC, 2004.

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12

Ray, Fitzpatrick, Health Technology Assessment Programme, National Co-ordinating Centre for HTA (Great Britain), Great Britain. Standing Group on Health Technology., and HTA Commissioning Board, eds. Evaluating patient-based outcome measures for use in clinical trials. Core Research, on behalf of the NCCHTA, 1998.

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13

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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14

J, Staquet Maurice, Hays Ron D, and Fayers Peter M, eds. Quality of life assessment in clinical trials: Methods and practice. Oxford University Press, 1998.

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15

National Cancer Institute (U.S.) and Community Clinical Oncology Program (National Cancer Institute (U.S.)), eds. Quality of life assessment in symptom management trials. Oxford University Press, 2007.

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16

Bruschke, Jon, and William Earl Loges. Free Press vs. Fair Trials: Examining Publicity's Role in Trial Outcomes. Taylor & Francis Group, 2003.

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17

Free Press vs. Fair Trials: Examining Publicity's Role in Trial Outcomes. Routledge, 2003.

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18

Bruschke, Jon, and William Earl Loges. Free Press vs. Fair Trials: Examining Publicity's Role in Trial Outcomes. Taylor & Francis Group, 2003.

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19

Bruschke, Jon, and William Earl Loges. Free Press vs. Fair Trials: Examining Publicity's Role in Trial Outcomes. Taylor & Francis Group, 2003.

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20

Bolton, Paul, and Judith Bass. Defining relevant outcomes. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199680467.003.0005.

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Defining relevant outcomes for mental health and related intervention trials requires consultation with a range of experts and stakeholders and the population for whom the services are being provided. The latter is not often consulted systematically, but doing so is necessary to ensure that their priorities are addressed within the study objectives and outcomes, and that instruments measure the outcomes accurately. Doing so will increase the likelihood that the services being tested, if found effective, will be sustained after the trial is completed. Changes in the types of outcomes assessed i
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21

Trial designs and outcomes in dementia therapeutic research. Taylor & Francis, 2006.

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22

Rockwood, Kenneth, and Serge Gauthier. Trial Designs and Outcomes in Dementia Therapeutic Research. Taylor & Francis Group, 2005.

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23

Rockwood, Kenneth, and Serge Gauthier. Trial Designs and Outcomes in Dementia Therapeutic Research. Taylor & Francis Group, 2005.

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24

Rockwood, Kenneth, and Serge Gauthier. Trial Designs and Outcomes in Dementia Therapeutic Research. Taylor & Francis Group, 2005.

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25

Rockwood, Kenneth, and Serge Gauthier. Trial Designs and Outcomes in Dementia Therapeutic Research. Taylor & Francis Group, 2005.

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26

Rockwood, Kenneth, and Serge Gauthier. Trial Designs and Outcomes in Dementia Therapeutic Research. Taylor & Francis Group, 2005.

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27

Trial Designs and Outcomes in Dementia Therapeutic Research. Informa Healthcare, 2005.

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28

Bruschke, Jon, and William Earl Loges. Free Press Vs. Fair Trials: Examining Publicity's Role in Trial Outcomes (Lea's Communication Series). Lawrence Erlbaum, 2003.

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29

Bruschke, Jon, and William E. Loges. Free Press vs. Fair Trials: Examining Publicity's Role in Trial Outcomes (Lea's Communication Series). Lawrence Erlbaum Associates, 2005.

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30

Howell, Simon J. Clinical trial designs in anaesthesia. Edited by Jonathan G. Hardman. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199642045.003.0030.

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A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures select
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31

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial design. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0014.

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This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is identified Elimination of bias is critical to the study design and methods of eliminating bias are discussed, defining the population, randomisation and blinding. A summary of the elements to be considered when designing a study are presented including the types of control, placebo or active, and their uses, Non comparative and comparative designs are presented. In the comparative design both within and between pa
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32

Elwood, Mark. Critical appraisal of a randomized clinical trial. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0012.

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This chapter presents a randomised trial carried out in primary care in the UK, assessing the use of an antibiotic, chloramphenicol, for acute eye infections (conjunctivitis) in children. This study shows the challenges of conducting a high quality randomised trial in primary care, including issues of the appropriate assessment of outcome. The critical assessment follows the scheme set out in chapter 10: describing the study, assessing the non-causal explanations of observation bias, confounding, and chance variation; assessing time relationships, strength, dose-response, consistency and speci
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33

Springer, Matthew, John Pane, Vi-Nhuan Le, et al. No Evidence That Incentive Pay for Teacher Teams Improves Student Outcomes: Results from a Randomized Trial. RAND Corporation, 2012. http://dx.doi.org/10.7249/rb9649.

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34

Shlomo Agon, Sivan. International Adjudication on Trial. Oxford University Press, 2019. http://dx.doi.org/10.1093/oso/9780198788966.001.0001.

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Is the World Trade Organization (WTO) Dispute Settlement System (DSS) effective? How exactly is the effectiveness of this adjudicative system to be defined and measured? Is its effectiveness all about compliance? If not, what goals—beyond compliance—is the WTO DSS expected to achieve? Has it fulfilled these objectives so far, and how can their achievement and the system’s effectiveness be enhanced in the future? Building on a theoretical model borrowed from social science, this book lays down the analytical framework required to answer these questions, while crafting a revealing insider’s acco
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35

Strategy, Planning & Litigating to Win: Orchestrating Trial Outcomes with Systems Theory, Psychology, Military Science and Utility Theory. Telos Press, 2012.

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36

Kuy, SreyRam, Kai J. Yang, and Anahita Dua. Outcomes Following Endovascular versus Open Repair of Abdominal Aortic Aneurysm. Edited by SreyRam Kuy, Wayne Zhang, and Tze-Woei Tan. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199384075.003.0001.

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This chapter provides a summary of a landmark study in vascular surgery assessing whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared to traditional open repair. The OVER trial demonstrated comparable results at 2-year follow-up between the two groups. 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 r
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37

Stanev, Roger. Inductive Risk and Values in Composite Outcome Measures. Oxford University Press, 2017. http://dx.doi.org/10.1093/acprof:oso/9780190467715.003.0009.

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Composite outcomes are becoming widespread in clinical trials. By combining individual outcome measures (e.g., death, non-fatal heart attack, non-fatal stroke, re-hospitalization) as a single composite measure, composites can increase statistical precision and trial efficiency, consequently enabling researchers to answer questions that could not otherwise be answered and providing more patient-relevant information. Critics, however, argue that a composite threatens the scientific objectivity of the trial by introducing new risks. This chapter examines common use of composites in cardiovascular
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38

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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39

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, rea
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40

Jones, Lloyd M., Wayne W. Zhang, SreyRam Kuy, and Tze-Woei Tan. Endovascular Aneurysm Repair and Outcomes in Patients Unfit for Open Repair of Abdominal Aortic Aneurysm. Edited by SreyRam Kuy, Wayne Zhang, and Tze-Woei Tan. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199384075.003.0004.

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This randomized controlled trial, the endovascular aortic aneurysm repair (EVAR) trial 2, compared outcomes of EVAR and medical management of abdominal aortic aneurysm in patients who were deemed high risk and unfit for open repair. Three hundred thirty-eight patients were enrolled and randomized to undergo either EVAR or medical therapy alone. Endpoints were all-cause mortality, aneurysm-related mortality, quality of life, postoperative complications, and hospital costs. Although there was some cross-over between groups and this has been cited as a limitation of this study, there was no stati
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41

Kaasa, Stein, and Karen Forbes. Research in palliative care. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0191.

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Research in palliative care is essential for maintaining standards and advancing knowledge and improving practice. It is challenging, sometimes daunting, often frustrating, but always exciting and rewarding when a study is successfully completed, whether the outcome is positive or negative. This chapter discusses a wide range of topics that will help those who are new to research to get started, to proceed and complete it, and contribute to improving outcomes for patients with advanced disease. Topics include, among others, collaborative and translational research, research governance, control
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42

Swanson, James M., L. Eugene Arnold, Peter S. Jensen, et al. Long-term outcomes in the Multimodal Treatment study of Children with ADHD (the MTA). Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198739258.003.0034.

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This chapter describes the long-term outcomes in the Multimodal Treatment study of ADHD (MTA), which began in 1994 and ended in 2014. First, we provide a short history of the origin of the MTA. Second, we review the design as a 14-month randomized clinical trial and the transition to a long-term follow-up. Third, we present findings from 12 key publications describing outcomes in four stages of the MTA from childhood to adulthood. Fourth, we discuss how the final adult assessments of the MTA address critical issues about symptomatic persistence of ADHD, functional outcomes outside the parental
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43

Elwood, Mark. Critical appraisal of a randomized trial of a preventive agent. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0013.

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This chapter presents an important, large, international randomised trial of prevention, the use of folic acid and multivitamins in preventing spina bifida and other neural tube defects. This shows the ethical and logistic issues involved, a factorial randomised design, a sequential analysis and early stopping example, and specificity of effect, and discusses the application to policy. The critical assessment follows the scheme set out in chapter 10: describing the study, assessing the non-causal explanations of observation bias, confounding, and chance variation; assessing time relationships,
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44

Gray, Nathan A., and Thomas W. LeBlanc. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) (DRAFT). Edited by Nathan A. Gray and Thomas W. LeBlanc. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190658618.003.0030.

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This chapter provides an overview and commentary on the SUPPORT trial main report, which began in 1989 and was published in 1995 and studied quality of care and communication in serious illness. It describes both the observational and interventional phases of this study, reviewing background and potential reasons for its negative findings. The chapter includes concise commentary on the study design and a brief review of relevant subsequent studies. Additionally, a short clinical case is included that highlights the impact of this study’s findings for similar interventions at the end-of-life an
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45

Krieger, Stephen, Ilana Katz Sand, Svenja Oynhausen, and Aaron Miller. Issues in the Design and Interpretation of Multiple Sclerosis Clinical Trials. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199341016.003.0031.

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This chapter covers important historical, scientific, and current issues in the development of modern clinical trials as well as therapeutic interventions for patients with multiple sclerosis. The chapter includes a review of terminology, methodology, and outcomes employed in clinical trials related to multiple sclerosis. A focus of the chapter is on the limitations of historical and current trial designs, particularly in regard to their application to clinical decision making. This second edition incorporates findings from clinical trials of oral agents and monoclonal antibodies developed for
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46

Haynes, Richard, Martin J. Landray, William G. Herrington, and Colin Baigent. Clinical trials. Edited by Christopher G. Winearls. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199592548.003.0019.

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Randomized trials are the best method for identifying and quantifying the benefits and risks of interventions in clinical practice. Nephrology lags behind most specialties in medicine in its evidence base. Many commonly used therapies are untested and may be ineffective or even cause harm. For trials to provide reliable answers to important clinical questions they must first avoid two sources of error. Firstly, systematic error (or bias) can only be removed by proper randomization. Secondly, random error (the play of chance) can only be removed by the randomization of large numbers of patients
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47

Kolb, Martin, and Claus F. Vogelmeier, eds. Outcomes in Clinical Trials. European Respiratory Society, 2013. http://dx.doi.org/10.1183/1025448x.erm6213.

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48

Lin, Eric, and Pochu Ho. Sequenced Treatment Alternatives to Relieve Depression. 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/9780190625085.003.0027.

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This chapter provides a summary of the landmark Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial on major depressive disorder. The STAR*D trial was designed to address some basic questions about depression treatment. What are the outcomes and the remission rates for depression? What are the long-term outcomes, especially the relapse rates, for patients receiving sequential depression therapies? Starting with these questions, this chapter describes the basics of the STAR*D trial, including funding, study location, study population, number of study participants, study design
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49

Lei, Peng, Scott Ayton, and Ashley I. Bush. Metal-Protein Attenuating Compounds in Neurodegenerative Diseases. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780190233563.003.0015.

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Neurodegenerative disorders including Alzheimer’s (AD), Parkinson’s disease (PD), Huntington’s disease (HD), and amyotrophic lateral sclerosis (ALS) are progressive diseases of the aging population with currently few therapeutic options. While aggregation and deposition of disease-specific proteins link the pathologies of these diseases, targeting these aggregating proteins with therapeutics has not yet been successful in clinical trial. This chapter profiles metals (copper, zinc, and iron) as alternative drug targets for neurodegeneration. Complex changes to metals occur in these neurodegener
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50

Rhodes, Jonathan K. J., and Peter J. D. Andrews. Intracranial pressure monitoring in the ICU. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0223.

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Intracranial pressure (ICP) measurement is an established monitoring modality in the ICU and can aid prognostication after acute brain injury. ICP monitoring is recommended in all patients with severe traumatic brain injury (TBI), and an abnormal cranial computed tomographic (CT) scan and the ability to control ICP is associated with improved outcome after TBI. The lessons from TBI studies can also be applied to other acute pathologies of the central nervous system where ICP can be increased. ICP measurement can warn of impending disaster and allow intervention. Furthermore, measurement of ICP
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