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Journal articles on the topic 'Randomized Controlled Trial Design'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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1

Dohoo, Ian R. "The design of randomized controlled trials of veterinary vaccines." Animal Health Research Reviews 5, no. 2 (2004): 235–38. http://dx.doi.org/10.1079/ahr200474.

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AbstractRandomized controlled trials of veterinary vaccines are essential if we are to have a reasonable understanding of how those vaccines can be expected to perform when used in the field. This manuscript reviews a few (but certainly not all) of the key elements that need to be considered in the design of veterinary vaccine trials. The first step in the design of such a trial is to have a clear statement of the objective of the trial that reflects what is expected of the vaccine (e.g. should it minimize clinical disease or does it need to prevent infection?). Because domestic animals are of

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van der Baan, Frederieke H., Olaf H. Klungel, Antoine CG Egberts, et al. "Pharmacogenetics in randomized controlled trials: considerations for trial design." Pharmacogenomics 12, no. 10 (2011): 1485–92. http://dx.doi.org/10.2217/pgs.11.95.

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NAVANEETHAN, SANKAR D., SUETONIA C. PALMER, ALICIA SMITH, DAVID W. JOHNSON, and GIOVANNI FM STRIPPOLI. "How to design a randomized controlled trial." Nephrology 15, no. 8 (2010): 732–39. http://dx.doi.org/10.1111/j.1440-1797.2010.01428.x.

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Badian, Reza A., Brendan McCormack, and Vibeke Sundling. "Person-Centered Research: A novel approach to Randomized Controlled Trials." European Journal for Person Centered Healthcare 6, no. 2 (2018): 209. http://dx.doi.org/10.5750/ejpch.v6i2.1435.

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Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we i

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Hannon, Peggy A., Kristen Hammerback, Claire L. Allen, et al. "HealthLinks randomized controlled trial: Design and baseline results." Contemporary Clinical Trials 48 (May 2016): 1–11. http://dx.doi.org/10.1016/j.cct.2016.02.011.

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Bailey, Julia V., Menelaos Pavlou, Andrew Copas, et al. "The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials." Journal of Medical Internet Research 15, no. 12 (2013): e278. http://dx.doi.org/10.2196/jmir.2668.

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Uveges, Melissa Kurtz, Dina George Lansey, Olive Mbah, Tamryn Gray, Lisa Sherden, and Jennifer Wenzel. "Patient navigation and clinical trial participation: A randomized controlled trial design." Contemporary Clinical Trials Communications 12 (December 2018): 98–102. http://dx.doi.org/10.1016/j.conctc.2018.09.003.

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Purgato, Marianna, Corrado Barbui, and Andrea Cipriani. "Assessing risk of bias in randomized controlled trials." Epidemiology and Psychiatric Sciences 19, no. 4 (2010): 296–97. http://dx.doi.org/10.1017/s1121189x00000622.

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AbstractEven though randomised controlled trials are the design of choice for evaluating the efficacy of health care interventions, they are not immune to bias that may affect research process and validity of results. In the present paper we discussed how trial quality may be appraised considering both whether a clinical trial is reported in a comprehensive and complete way (consistently with what had been declared in the study protocol), and whether the characteristics of the trial itself are associated with risk of bias.

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Jones, Mark, Val Gebski, Mark Onslow, and Ann Packman. "Design of randomized controlled trials." Journal of Fluency Disorders 26, no. 4 (2001): 247–67. http://dx.doi.org/10.1016/s0094-730x(01)00108-5.

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Stanley, Kenneth. "Design of Randomized Controlled Trials." Circulation 115, no. 9 (2007): 1164–69. http://dx.doi.org/10.1161/circulationaha.105.594945.

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Murray, David M., Monica Taljaard, Elizabeth L. Turner, and Stephanie M. George. "Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials." Annual Review of Public Health 41, no. 1 (2020): 1–19. http://dx.doi.org/10.1146/annurev-publhealth-040119-094027.

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This article reviews the essential ingredients and innovations in the design and analysis of group-randomized trials. The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments. We review, in addition to the group-randomized trial, methods for two closely related designs, the individually randomized group treatment trial and the stepped-wedge group-randomized trial. After describing the essential ingredients for these designs, we review the most important developments in the e

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H Hassanein, Aladdin, Fernando A Herrera, and Omar Hassanein. "Challenges of Randomized Controlled Trial Design in Plastic Surgery." Canadian Journal of Plastic Surgery 19, no. 3 (2011): 28–29. http://dx.doi.org/10.1177/229255031101900302.

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13

Manchikanti, Laxmaiah. "Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials." December 2008 6;11, no. 12;6 (2008): 717–73. http://dx.doi.org/10.36076/ppj.2008/11/717.

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Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement me

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Hobbs, Brian P., Nan Chen, and J. Jack Lee. "Controlled multi-arm platform design using predictive probability." Statistical Methods in Medical Research 27, no. 1 (2016): 65–78. http://dx.doi.org/10.1177/0962280215620696.

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The process of screening agents one-at-a-time under the current clinical trials system suffers from several deficiencies that could be addressed in order to extend financial and patient resources. In this article, we introduce a statistical framework for designing and conducting randomized multi-arm screening platforms with binary endpoints using Bayesian modeling. In essence, the proposed platform design consolidates inter-study control arms, enables investigators to assign more new patients to novel therapies, and accommodates mid-trial modifications to the study arms that allow both droppin

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Chen, Haiyong, Mingxiao Yang, Zhipeng Ning, et al. "A Guideline for Randomized Controlled Trials of Acupuncture." American Journal of Chinese Medicine 47, no. 01 (2019): 1–18. http://dx.doi.org/10.1142/s0192415x19500010.

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Guidelines for clinical trials of acupuncture are scarce, particularly in their guidance on choosing an adequate control in an acupuncture trial. This guideline was developed to address the research methodology for clinical research in acupuncture which contains the essential elements to be considered in the design, preparation and reporting of an acupuncture RCT. Particularly, investigators focused on the control design because of the unique feature of acupuncture. As one size does not fit all, one single design cannot answer all research questions. Therefore, we recommend that the clinical q

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Vandivere, Sharon, Karin E. Malm, Tiffany J. Allen, Sarah Catherine Williams, and Amy McKlindon. "A Randomized Controlled Trial of Family Finding." Evaluation Review 41, no. 6 (2017): 542–67. http://dx.doi.org/10.1177/0193841x17689971.

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Background: Youth who have experienced foster care are at risk of negative outcomes in adulthood. The family finding model aims to promote more positive outcomes by finding and engaging relatives of children in foster care in order to provide options for legal and emotional permanency. Objectives: The present study tested whether family finding, as implemented in North Carolina from 2008 through 2011, improved child welfare outcomes for youth at risk of emancipating foster care without permanency. Research Design: A randomized controlled trial evaluation was carried out in nine counties in Nor

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Willan, Andrew R., and Lehana Thabane. "Bayesian methods for pilot studies." Clinical Trials 17, no. 4 (2020): 414–19. http://dx.doi.org/10.1177/1740774520914306.

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Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining th

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Porthouse, Jill, and David J. Torgerson. "The Need for Randomized Controlled Trials in Podiatric Medical Research." Journal of the American Podiatric Medical Association 94, no. 3 (2004): 221–28. http://dx.doi.org/10.7547/0940221.

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The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These stud

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Blenkinsop, Alexandra, and Babak Choodari-Oskooei. "Multiarm, multistage randomized controlled trials with stopping boundaries for efficacy and lack of benefit: An update to nstage." Stata Journal: Promoting communications on statistics and Stata 19, no. 4 (2019): 782–802. http://dx.doi.org/10.1177/1536867x19893616.

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Royston et al.’s (2011, Trials 12: 81) multiarm, multistage (MAMS) framework for the design of randomized clinical trials uses intermediate outcomes to drop research arms early for lack of benefit at interim stages, increasing efficiency in multiarm designs. However, additionally permitting interim evaluation of efficacy on the primary outcome measure could increase adoption of the design and result in practical benefits, such as savings in patient numbers and cost, should any efficacious arm be identified early. The nstage command, which aids the design of MAMS trial designs, has been updated

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Reiertsen, O., S. Larsen, E. Trondsen, B. Edwin, A. E. Faerden, and A. R. Rosseland. "Randomized controlled trial with sequential design of laparoscopicversus conventional appendicectomy." British Journal of Surgery 84, no. 6 (1997): 842–47. http://dx.doi.org/10.1002/bjs.1800840632.

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21

Connolly, Dean J., and Ben D. Young. "The Case for Thinking Beyond Classic Randomized Controlled Trial Design." Regional Anesthesia and Pain Medicine 42, no. 5 (2017): 680–81. http://dx.doi.org/10.1097/aap.0000000000000630.

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22

Van Der Meersch, Hans, Dirk De Bacquer, Stefaan J. Vandecasteele, et al. "Hemodialysis Catheter Design and Catheter Performance: A Randomized Controlled Trial." American Journal of Kidney Diseases 64, no. 6 (2014): 902–8. http://dx.doi.org/10.1053/j.ajkd.2014.02.017.

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23

Strand, Vibeke, and Jeremy Sokolove. "Randomized controlled trial design in rheumatoid arthritis: the past decade." Arthritis Research & Therapy 11, no. 1 (2009): 205. http://dx.doi.org/10.1186/ar2555.

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Purgato, M., C. Barbui, S. Stroup, and C. Adams. "Pragmatic design in randomized controlled trials." Psychological Medicine 45, no. 2 (2014): 225–30. http://dx.doi.org/10.1017/s0033291714001275.

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At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but ‘local’ and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are

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25

Deane, Katherine H. O. "Randomised Controlled Trials: Part 1, Design." British Journal of Occupational Therapy 69, no. 5 (2006): 217–23. http://dx.doi.org/10.1177/030802260606900504.

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Occupational therapists need to be able to evaluate the profession's interventions critically: to stop the ineffective, to reduce the hazardous and to promote the effective. Randomised controlled trials are a research tool for testing the efficacy of interventions with small to moderate effects. This review aims to cover the issues to be considered when designing a randomised controlled trial of complex interventions, such as occupational therapy.

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McPeek, Bucknam, Frederick Mosteller, and Martin McKneally. "Randomized Clinical Trials in Surgery." International Journal of Technology Assessment in Health Care 5, no. 3 (1989): 317–32. http://dx.doi.org/10.1017/s026646230000739x.

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When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen i

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Relton, C., D. Torgerson, A. O'Cathain, and J. Nicholl. "Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design." BMJ 340, mar19 1 (2010): c1066. http://dx.doi.org/10.1136/bmj.c1066.

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Blencowe, Natalie S., Jonathan A. Cook, Thomas Pinkney, Chris Rogers, Barnaby C. Reeves, and Jane M. Blazeby. "Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design." Clinical Trials 14, no. 2 (2017): 211–18. http://dx.doi.org/10.1177/1740774516687272.

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Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological resear

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Magnusson, Peter, Leo Wennström, Robert Kastberg, and Per Liv. "Placement of Cardiac PacemaKEr Trial (POCKET) – Rationale and Design: A Randomized Controlled Trial." Heart International 12, no. 1 (2017): heartint.500023. http://dx.doi.org/10.5301/heartint.5000235.

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Wong, George K. C., Ronald Boet, W. S. Poon, and Matthew T. V. Chan. "Trial Design in “Magnesium Sulphate in Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial”." Stroke 36, no. 12 (2005): 2530–32. http://dx.doi.org/10.1161/01.str.0000190091.36915.84.

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Harvin, John A., Jeanette Podbielski, Laura E. Vincent, et al. "Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial." Trauma Surgery & Acute Care Open 2, no. 1 (2017): e000083. http://dx.doi.org/10.1136/tsaco-2017-000083.

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Chassang, Sylvain, Gerard Padró i Miquel, and Erik Snowberg. "Selective Trials: A Principal-Agent Approach to Randomized Controlled Experiments." American Economic Review 102, no. 4 (2012): 1279–309. http://dx.doi.org/10.1257/aer.102.4.1279.

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We study the design of randomized controlled experiments when outcomes are significantly affected by experimental subjects' unobserved effort expenditure. While standard randomized controlled trials (RCTs) are internally consistent, the unobservability of effort compromises external validity. We approach trial design as a principal-agent problem and show that natural extensions of RCTs—which we call selective trials—can help improve external validity. In particular, selective trials can disentangle the effects of treatment, effort, and the interaction of treatment and effort. Moreover, they ca

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ŠAPOKA, Virginijus, Vytautas KASIULEVIČIUS, and Janina DIDŽIAPETRIENĖ. "How should a clinician interpret results of randomized controlled trials?" Acta medica Lituanica 17, no. 1-2 (2010): 30–34. http://dx.doi.org/10.15388/amed.2010.21689.

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Randomized controlled trials (RCTs) and systematic reviews are the most reliable methods of determining the effects of treatment. The randomization procedure gives a randomized controlled trial its strength. Random allocation means that all participants have the same chance of being assigned to each of the study groups. The choice of which end point(s) to select is critical to any study design. Intention-to-treat is the preferred approach to the analysis of clinical trials. Sample size calculations and data analyses have an important impact on the planning, interpretation, and conclusions of r

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Njike, Valentine Yanchou, Yasemin Kavak, Judith A. Treu, Kimberly Doughty, and David L. Katz. "Snacking, Satiety, and Weight: A Randomized, Controlled Trial." American Journal of Health Promotion 31, no. 4 (2015): 296–301. http://dx.doi.org/10.4278/ajhp.150120-quan-676.

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Purpose. To compare the effects of nut-based snack bars (NBSB) vs. prepackaged 200-kcal portions of typical conventional snack foods, when consumed over a 12-week period by a group of overweight adults. Design. Randomized, single-blind parallel design with two treatment groups. Setting. Clinical trial. Subjects. Thirty-four overweight participants were enrolled. Intervention. Commercially available NBSB or conventional snack foods as part of an ad libitum diet for 12 weeks. Measures. Primary outcome measures: body mass index, body weight, body composition, waist circumference. Secondary outcom

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Elrggal, Mahmood E., Morooj Al-Muwallad, Areej Al-Otaibi, Jomanah Alsiddik, Alaa Shahbar, and Ejaz Cheema. "Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals." International Journal of Clinical Trials 5, no. 1 (2018): 21. http://dx.doi.org/10.18203/2349-3259.ijct20180127.

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<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controll

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Nicholas, Richard, Sebastian Straube, Heinz Schmidli, Simon Schneider, and Tim Friede. "Trends in annualized relapse rates in relapsing–remitting multiple sclerosis and consequences for clinical trial design." Multiple Sclerosis Journal 17, no. 10 (2011): 1211–17. http://dx.doi.org/10.1177/1352458511406309.

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Background: Sample size calculation is a key aspect in the planning of any trial. Planning a randomized placebo-controlled trial in relapsing–remitting multiple sclerosis (RRMS) requires knowledge of the annualized relapse rate (ARR) in the placebo group. Objectives: This paper aims (i) to characterize the uncertainty in ARR by conducting a systematic review of placebo-controlled, randomized trials in RRMS and by modelling the ARR over time; and (ii) to assess the feasibility and utility of blinded sample size re-estimation (BSSR) procedures in RRMS. Methods: A systematic literature review was

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Kessels, Rob, Reagan Mozer, and Jos Bloemers. "Methods for assessing and controlling placebo effects." Statistical Methods in Medical Research 28, no. 4 (2017): 1141–56. http://dx.doi.org/10.1177/0962280217748339.

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The placebo serves as an indispensable control in many randomized trials. When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect. Various alternative methods have been proposed for analyzing placebo and treatment effects in studies where large placebo effects are expected or have already occurred. This paper presents an overview of methodological work that has been proposed for assessing and/or controlling for placebo effects in randomized trials. Throughout this paper, two main approaches are discussed. The

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Tønning, Morten Lindbjerg, Lars Vedel Kessing, Jakob Eivind Bardram, and Maria Faurholt-Jepsen. "Methodological Challenges in Randomized Controlled Trials on Smartphone-Based Treatment in Psychiatry: Systematic Review." Journal of Medical Internet Research 21, no. 10 (2019): e15362. http://dx.doi.org/10.2196/15362.

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Background Smartphone-based technology is developing at high speed, and many apps offer potential new ways of monitoring and treating a range of psychiatric disorders and symptoms. However, the effects of most available apps have not been scientifically investigated. Within medicine, randomized controlled trials (RCTs) are the standard method for providing the evidence of effects. However, their rigidity and long time frame may contrast with the field of information technology research. Therefore, a systematic review of methodological challenges in designing and conducting RCTs within mobile h

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Tuffaha, Haitham W., Heather Reynolds, Louisa G. Gordon, Claire M. Rickard, and Paul A. Scuffham. "Value of information analysis optimizing future trial design from a pilot study on catheter securement devices." Clinical Trials 11, no. 6 (2014): 648–56. http://dx.doi.org/10.1177/1740774514545634.

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Background: Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional

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Reiertsen, O., S. Larsen, E. Trondsen, B. Edwin, A. E. Faerden, and A. R. Rosseland. "Randomized controlled trial with sequential design of laparoscopic versus conventional appendicectomy." British Journal of Surgery 84, no. 6 (1997): 842–47. http://dx.doi.org/10.1046/j.1365-2168.1997.02694.x.

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Lacroix, Jacques, Paul Hébert, Dean Fergusson, et al. "The Age of Blood Evaluation (ABLE) Randomized Controlled Trial: Study Design." Transfusion Medicine Reviews 25, no. 3 (2011): 197–205. http://dx.doi.org/10.1016/j.tmrv.2011.03.001.

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Wallace, P. G., A. Haines, R. Harrison, et al. "Design and performance of a multicentre, randomized controlled trial of teleconsulting." Journal of Telemedicine and Telecare 8, no. 2 (2002): 94–95. http://dx.doi.org/10.1258/135763302320302208.

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Wallace, P. G., A. Haines, R. Harrison, et al. "Design and Performance of a Multicentre, Randomized Controlled Trial of Teleconsulting." Journal of Telemedicine and Telecare 8, no. 2_suppl (2002): 94–95. http://dx.doi.org/10.1177/1357633x020080s243.

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Gregorowitsch, M., D. Van den Bongard, D. Young-Afat, et al. "Promising alternative for classic randomized controlled trials: first experience with the cohort multiple randomized controlled trial design in the oncologic setting." European Journal of Cancer 72 (February 2017): S9. http://dx.doi.org/10.1016/s0959-8049(17)30109-0.

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Brocklehurst, P., and Z. Hoare. "How to design a randomised controlled trial." British Dental Journal 222, no. 9 (2017): 721–26. http://dx.doi.org/10.1038/sj.bdj.2017.411.

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Egbewale, BolajiEmmanuel. "Common design concepts in randomized controlled trials." Nigerian Medical Journal 61, no. 2 (2020): 51. http://dx.doi.org/10.4103/nmj.nmj_112_19.

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Richter, Felicitas, and Marc Dewey. "Zelen Design in Randomized Controlled Clinical Trials." Radiology 272, no. 3 (2014): 919. http://dx.doi.org/10.1148/radiol.14140834.

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Hayes, John L. "Design flaws in some randomized controlled trials." American Journal of Orthodontics and Dentofacial Orthopedics 134, no. 4 (2008): 466–67. http://dx.doi.org/10.1016/j.ajodo.2008.08.011.

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Trenouth, M. J. "Design flaws in some randomized controlled trials." American Journal of Orthodontics and Dentofacial Orthopedics 135, no. 2 (2009): 141. http://dx.doi.org/10.1016/j.ajodo.2008.12.010.

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Ernst, E., T. Saradeth, and K. L. Resch. "Hydrotherapy for Varicose Veins: A Randomized, Controlled Trial." Phlebology: The Journal of Venous Disease 7, no. 4 (1992): 154–57. http://dx.doi.org/10.1177/026835559200700407.

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Objective: To assess the effectiveness of regular hydrotherapy in primary varicose veins. Design: Randomized, single blind, prospective, controlled trial. Setting: Social security system related rehabilitation center for employees (nationwide assignment of inpatients). Patients: 122 patients with primary varicose veins. Interventions: Group A (n=60) received daily treatments during 24 days that consisted of external application of alternating cold and warm water to both lower extremities. Group B (n=62) served as controls and was not treated with hydrotherapy. Both groups were comparable in te

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