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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 often managed in groups, the ‘unit of concern’ used in a vaccine trial becomes of great importance. Whether the trial should be carried out at the individual or group level will depend on the objectives of the trial and the extent of concern about ‘group effects’ affecting the trial. Sample sizes will also be influenced heavily by the choice of unit of concern and the nature of the primary outcome being assessed. Finally, while there is no easy solution (except to conduct group-level trials, which may be logistically impossible), the potential for group effects to influence the trial outcome must be considered.

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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 intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.

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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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10

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 evolution of their methods using a new bibliometric tool developed at the National Institutes of Health. We then discuss the questions to be considered when selecting from among these designs or selecting the traditional randomized controlled trial. We close with a review of current methods for the analysis of data from these designs, a case study to illustrate each design, and a brief summary.

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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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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 medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo-controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes. Key words: Randomized controlled trial (RCT), placebo-controlled trial, pragmatic controlled trial, randomization, allocation concealment, sample size, blinding, consolidated standards of reporting trials (CONSORT) statement, minimal clinically important change (MCIC), minimal clinical important difference (MCID)

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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 dropping poorly performing agents as well as incorporating new candidate agents. When compared to sequentially conducted randomized two-arm trials, screening platform designs have the potential to yield considerable reductions in cost, alleviate the bottleneck between phase I and II, eliminate bias stemming from inter-trial heterogeneity, and control for multiplicity over a sequence of a priori planned studies. When screening five experimental agents, our results suggest that platform designs have the potential to reduce the mean total sample size by as much as 40% and boost the mean overall response rate by as much as 15%. We explain how to design and conduct platform designs to achieve the aforementioned aims and preserve desirable frequentist properties for the treatment comparisons. In addition, we demonstrate how to conduct a platform design using look-up tables that can be generated in advance of the study. The gains in efficiency facilitated by platform design could prove to be consequential in oncologic settings, wherein trials often lack a proper control, and drug development suffers from low enrollment, long inter-trial latency periods, and an unacceptably high rate of failure in phase III.

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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 questions be answered in different stages of trials by choosing the appropriate control or comparator. This concept is adapted from classical drug trials developed by the Food and Drug Administration (FDA) of USA in which trials are staged in four phages in order to address different research questions. From the points listed above, this guideline offers the specific recommendations in an acupuncture RCT.

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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 North Carolina. All children eligible for intervention services between 2008 and 2011 underwent random assignment. Effects were tested with an intent-to-treat design. Outcome data were obtained for all subjects from child welfare administrative data. Additional outcome data for a subset of older youth came from in-person interviews. Subjects: Subjects included 568 children who were in foster care, were 10–17 years old (at time of referral), had no identified permanent placement resource, and had no plan for reunification. Measures: The confirmatory outcome was moves to more family-like placements, whether through a step-down in foster care placement or discharge from foster care to legal permanency. Results: No impact on the confirmatory outcome was observed. Findings regarding exploratory impacts are also described; these must be interpreted with caution, given the large number of outcomes compared. Conclusions: The evaluation failed to find evidence that family finding improves the outcomes of older youth at risk of emancipation from foster care.

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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 the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.

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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 studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research. (J Am Podiatr Med Assoc 94(3): 221–228, 2004)

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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 to support this methodological extension. Operating characteristics can now be calculated for a design with binding or nonbinding stopping rules for lack of benefit and with efficacy stopping boundaries. An additional option searches for a design that strongly controls the familywise error rate at the desired level. We illustrate how the new features can be used to design a trial with the drop-down menu, using the original comparisons from the MAMS trial STAMPEDE as an example. The new functionality of the command will serve a broader range of trial objectives and increase efficiency of the design and thus increase uptake of the MAMS design in practice.

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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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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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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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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 more likely to be answered by a pragmatic approach to trials.

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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 its inference by taking steps to exclude any such differences.This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.

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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 research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

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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 can help identify when treatment effects are affected by erroneous beliefs and inappropriate effort expenditure.(JEL C90, D82)

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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 randomized trials. In this article, we discuss the problematic areas that can affect the outcome of a trial, such as blinding, sample size calculation, randomization; concealment allocation; intention of treating the analysis; selection of end points; selection of traditional versus equivalence testing, early stopped trials, selective publications. Keywords: randomized controlled trials, sample size, outcomes, type of analyses

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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 outcome measures: blood pressure, lipid profile, nutrients intake, hunger/satiety, quality of life. Analysis. Generalized linear models with time as repeated measure were used to analyze these data. Results. Daily consumption of NBSB for 12 weeks, as compared to daily consumption of conventional snacks, significantly reduced percentage body fat (−1.7% ± 10.8% vs. 6.2% ± 9.3%; p = .04) and visceral fat (−1.3 ± 5.9 vs. 2.7 ± 4.0; p = .03). There were no between-group differences (p > .05) for blood pressure, lipid panel, satiety, or quality of life measures. Conclusion. Our data suggest that daily consumption of NBSB for 12 weeks reduced body fat and had no adverse effects on weight, blood pressure, lipid profile, satiety, or quality of life in this small sample of overweight adults.

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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 controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>

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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 carried out by searching PubMed, Ovid Medline and the Cochrane Register of Controlled Trials. The placebo ARRs were modelled by negative binomial regression. Computer simulations were conducted to assess the utility of BSSR in RRMS. Results: Data from 26 placebo-controlled randomized trials were included in this analysis. The placebo ARR decreased by 6.2% per year ( p < 0.0001; 95% CI (4.2%; 8.1%)) resulting in substantial uncertainty in the planning of future trials. BSSR was shown to be feasible and to maintain power at a prespecified level also if the ARR was misspecified in the planning phase. Conclusions: Our investigations confirmed previously reported trends in ARR. In this context adaptive strategies such as BSSR designs are recommended for consideration in the planning of future trials in RRMS.

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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 first approach considers designs that represent alternatives to the classical placebo-controlled randomized trial design. Separately, the second approach considers adopting new methods for the statistical analysis of placebo and treatment effects to be implemented after the data have been collected using a classical randomized trial design.

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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 health is needed. Objective This systematic review aimed to (1) identify and describe RCTs investigating the effect of smartphone-based treatment in adult patients with a psychiatric diagnosis, (2) discuss methodological challenges in designing and conducting individual trials, and (3) suggest recommendations for future trials. Methods A systematic search in English was conducted in PubMed, PsycINFO, and EMBASE up to August 12, 2019. The search terms were (1) psychiatric disorders in broad term and for specific disorders AND (2) smartphone or app AND (3) RCT. The Consolidated Standards of Reporting Trials electronic health guidelines were used as a template for data extraction. The focus was on trial design, method, and reporting. Only trials having sufficient information on diagnosis and acceptable diagnostic procedures, having a smartphone as a central part of treatment, and using an RCT design were included. Results A total of 27 trials comprising 3312 patients within a range of psychiatric diagnoses were included. Among them, 2 trials were concerning drug or alcohol abuse, 3 psychosis, 10 affective disorders, 9 anxiety and posttraumatic stress disorder, 1 eating disorder, and 1 attention-deficit/hyperactivity disorder. In addition, 1 trial used a cross-diagnostic design, 7 trials included patients with a clinical diagnosis that was subsequently assessed and validated by the researchers, and 11 trials had a sample size above 100. Generally, large between-trial heterogeneity and multiple approaches to patient recruitment, diagnostic procedures, trial design, comparator, outcome measures, and analyses were identified. Only 5 trials published a trial protocol. Furthermore, 1 trial provided information regarding technological updates, and only 18 trials reported on the conflicts of interest. No trial addressed the ethical aspects of using smartphones in treatment. Conclusions This first systematic review of the methodological challenges in designing and conducting RCTs investigating smartphone-based treatment in psychiatric patients suggests an increasing number of trials but with a lower quality compared with classic medical RCTs. Heterogeneity and methodological issues in individual trials limit the evidence. Methodological recommendations are presented.

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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 information. Purpose: To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial. Methods: An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared. Results: Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%. Limitations: Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated. Conclusion: The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials.

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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 terms of concomitant diseases and treatments. Main outcome measures: Foot volume, ankle circumference and venous re-fill time, using light reflex rheo-graphy, served as objective variables, while a number of typical symptoms were recorded as subjective parameters. Results: A more pronounced improvement in all objective signs in group A compared to B was observed. Four out of seven subjective symptoms improved more frequently in group A than in B. Conclusions: Hydrotherapy is effective in treating primary varicose veins. It can be considered as an adjunct measure to compression therapy and other conservative treatments.

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