Journal articles: 'Randomized controlled trial'

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G, Girish, and Ashok Deorari. "Randomized Controlled Trial." Journal of Neonatology 20, no. 1 (March 2006): 64–68. http://dx.doi.org/10.1177/0973217920060112.

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Castro, Fernando J., Baker Al-Khairi, Harjinder Singh, Mosaab Mohameden, Kanwarpreet Tandon, and Rocio Lopez. "Randomized Controlled Trial." Journal of Clinical Gastroenterology 53, no. 10 (2019): 724–30. http://dx.doi.org/10.1097/mcg.0000000000001213.

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Vautrin, M., G. Kaminski, B. Barimani, J. Elmers, V. Philippe, S. Cherix, E. Thein, O. Borens, and F. Vauclair. "Does candidate for plate fixation selection improve the functional outcome after midshaft clavicle fracture? A systematic review of 1348 patients." Shoulder & Elbow 11, no. 1 (June 4, 2018): 9–16. http://dx.doi.org/10.1177/1758573218777996.

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Introduction The hypothesis of this study was that patient selection for midshaft clavicle fracture (open reduction internal fixation with plate versus conservative) would give better functional outcome than random treatment allocation. Methods We performed a systematic literature search for primary studies providing functional score and non-union rate after conservative or surgical management of midshaft clavicle fractures. Six randomized controlled trial and 19 non-randomized controlled trial studies encompassing a total of 1348 patients were included. Results Patients treated with surgical management were found to have statistically superior Constant scores in non-randomized controlled trials than in randomized controlled trials (94.76 ± 6.4 versus 92.49 ± 6.2; p < 0.0001). For conservative treatment, randomized controlled trials were found to have significantly better functional outcome. The prevalence of non-union (6.1%) did not show significant statistical difference between non-randomized controlled trial and randomized controlled trial studies. The functional outcome after surgical management was significantly higher than after conservative management in both randomized controlled trial and non-randomized controlled trial groups. The non-union rate after surgery (1.1% for both non-randomized controlled trial and randomized controlled trial) was significantly lower than following conservative treatment (9.9% non-randomized controlled trial versus 15.1% randomized controlled trial). Discussion This review shows that patient selection for surgery may influence functional outcome after midshaft clavicle fracture. Our results also confirm that plate fixation provides better functional outcome and lower non-union rate.

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Takroni, Radwan, Sunjay Sharma, Kesava Reddy, Nirmeen Zagzoog, Majid Aljoghaiman, Mazen Alotaibi, and Forough Farrokhyar. "Randomized controlled trials in neurosurgery." Surgical Neurology International 13 (August 26, 2022): 379. http://dx.doi.org/10.25259/sni_1032_2021.

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Randomized controlled trials (RCTs) have become the standard method of evaluating new interventions (whether medical or surgical), and the best evidence used to inform the development of new practice guidelines. When we review the history of medical versus surgical trials, surgical RCTs usually face more challenges and difficulties when conducted. These challenges can be in blinding, recruiting, funding, and even in certain ethical issues. Moreover, to add to the complexity, the field of neurosurgery has its own unique challenges when it comes to conducting an RCT. This paper aims to provide a comprehensive review of the history of neurosurgical RCTs, focusing on some of the most critical challenges and obstacles that face investigators. The main domains this review will address are: (1) Trial design: equipoise, blinding, sham surgery, expertise-based trials, reporting of outcomes, and pilot trials, (2) trial implementation: funding, recruitment, and retention, and (3) trial analysis: intention-to-treat versus as-treated and learning curve effect.

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Al Abdukareem, Abdulmajeed. "Randomized, placebo-controlled trial." Annals of Saudi Medicine 24, no. 2 (March 2004): 145. http://dx.doi.org/10.5144/0256-4947.2004.145.

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Forster, Anne, John Young, Katie Chapman, Jane Nixon, Anita Patel, Ivana Holloway, Kirste Mellish, et al. "Cluster Randomized Controlled Trial." Stroke 46, no. 8 (August 2015): 2212–19. http://dx.doi.org/10.1161/strokeaha.115.008585.

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Healy, Ciaran, Aina V. H. Greig, Adrian D. Murphy, Christopher Powell, Richard J. Pinder, Samer Saour, Christopher Abela, William Knight, and Jenny L. C. Geh. "Prospective Randomized Controlled Trial." Plastic and Reconstructive Surgery 132, no. 1 (July 2013): 139e—146e. http://dx.doi.org/10.1097/prs.0b013e318299c6f4.

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Field, David, and Diana Elbourne. "The randomized controlled trial." Current Paediatrics 13, no. 1 (February 2003): 53–57. http://dx.doi.org/10.1054/cupe.2003.0409.

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Murphy, Adrian D., Aina V. H. Greig, Chris A. Powell, Richard J. Pinder, Samer Saour, Jenny L. C. Geh, and Ciaran M. Healy. "Prospective Randomized Controlled Trial." Plastic and Reconstructive Surgery 130 (November 2012): 50–51. http://dx.doi.org/10.1097/01.prs.0000421755.15147.58.

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Montgomery, Michelle O., Jessica J. Kram, Marie M. Forgie, Ana C. Perez Moreno, and Taylor Romdenne. "A Randomized Controlled Trial." Obstetrics & Gynecology 135 (May 2020): 167S. http://dx.doi.org/10.1097/01.aog.0000663980.54152.fb.

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DUFFY, MARY E. "The Randomized Controlled Trial." Clinical Nurse Specialist 20, no. 2 (March 2006): 62–64. http://dx.doi.org/10.1097/00002800-200603000-00004.

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Stel, Vianda S., Carmine Zoccali, Friedo W. Dekker, and Kitty J. Jager. "The Randomized Controlled Trial." Nephron Clinical Practice 113, no. 4 (September 11, 2009): c337—c342. http://dx.doi.org/10.1159/000237143.

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Field, David, and Diana Elbourne. "The randomized controlled trial." Current Paediatrics 14, no. 6 (November 2004): 519–24. http://dx.doi.org/10.1016/j.cupe.2004.07.005.

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Likosky, Donald S. "A Primer on Randomized Controlled Trials." Journal of ExtraCorporeal Technology 38, no. 1 (March 2006): 10–13. http://dx.doi.org/10.1051/ject/200638010.

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Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.

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Khan, Erum Behroz, Mairah Shah, S. M. Tariq Rafi, Sadia Rizwan, and Zuhair Ahmed. "Oral Hygiene Maintenance Via Teledentistry in Orthodontic Patients: A Randomized Controlled Trial." Journal of the Pakistan Dental Association 30, no. 1 (February 16, 2021): 34–38. http://dx.doi.org/10.25301/jpda.301.34.

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OBJECTIVES: To determine the extent of improvement in oral hygiene via text message reminder in patients undergoing fixed orthodontic treatment. METHODOLOGY: The participants were from 13 to 30 years of age recruited from Department of Orthodontics, Sindh Institute of Oral Health Sciences, Jinnah Sindh Medical University, Karachi, Pakistan. The sample comprised of 70 patients (59 female and 11 male) about to have fixed orthodontic treatment, 35 in text message group and 35 in control group. Patient's plaque index was evaluated at baseline and after 30 days. RESULTS: Text message group had highly significant (P < .05) plaque index score (PostPI) than control group. CONCLUSIONS: Orthodontic patients frequently reminded to brush have better oral hygiene. KEYWORDS: Plaque index, Text message, Oral hygiene, Orthodontics. HOW TO CITE: Khan EB, Shah M, Rafi S.M.T, Rizwan S, Ahmed Z, Fatima S. Oral hygiene maintenance via teledentistry in orthodontic patients: A randomized controlled trial. J Pak Dent Assoc 2021;30(1):34-38.

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Sarker, Jyotirmoy. "Ethical issues of randomized controlled trials." Bangladesh Journal of Bioethics 5, no. 1 (March 26, 2014): 1–4. http://dx.doi.org/10.3329/bioethics.v5i1.18441.

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Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must meet all ethics issues. The institutional review board (IRB) must check whether all ethical demands are met or not before permitting the research. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18441 Bangladesh Journal of Bioethics 2014 Vol.5(1): 1-4

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John, Joseph, and Naveen Kumar I. "Blinding Induced Risk of Bias in Randomized Controlled Trials of Physiotherapy Interventions — A Retrospective Study." JOURNAL OF CLINICAL AND BIOMEDICAL SCIENCES 13, no. 4 (December 28, 2023): 108–14. http://dx.doi.org/10.58739/jcbs/v13i4.23.2.

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Introduction: In randomized clinical trials, the methodological idea of preventing bias by withholding knowledge of the allocation status is known as blinding. Blinding refers back to the concealment of group allocation from one or extra individuals concerned in scientific studies, most commonly a randomized controlled trial (RCT). Even though randomization minimizes variations among treatment groups on the outset of the trial, it does nothing to prevent differential treatment of the groups later within the trial or the differential assessment of outcomes, either of which may also bring about biased estimates of treatment outcomes. The most beneficial strategy to limit the chance of differential remedy or assessments of results is to blind as many individuals as viable in a trial. Objective: To study the extent of blinding induced bias in RCT of physiotherapy interventions and to evaluate the extent of interpretative consideration it the trials are not blinded in the sample of RCT included. Methodology : We conducted a retrospective analysis to estimate the blinding bias in the randomized controlled trials published in physiotherapy interventions from 2016 to 2022. Results & Conclusion : We included 50 RCTs for blinding assessment. About 88% of included articles were not having participants blinding 90% has not done therapist blinding and nearly 50% of studies were conducted without assessors blinding. Based on the results of this study blinding of important participants were infrequently reported in the included studies. Keywords: Blinding, Risk of bias, Physiotherapy, Randomized controlled trials

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Milsom, K. M., A. S. Blinkhorn, T. Walsh, H. V. Worthington, P. Kearney-Mitchell, H. Whitehead, and M. Tickle. "A Cluster-randomized Controlled Trial." Journal of Dental Research 90, no. 11 (September 15, 2011): 1306–11. http://dx.doi.org/10.1177/0022034511422063.

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We conducted a school-based parallel cluster randomized controlled trial with 36-month follow-up of children aged 7 to 8 years. Primary schools were randomly assigned to 2 groups: 3 applications of fluoride varnish (22,600 ppm) each year or no intervention. The primary outcome was DFS increment in the first permanent molars, with the hypothesis that 9 applications of varnish over 3 years would result in a lower increment in the test group. Follow-up measurements were recorded by examiners blind to the allocation. Ninety-five schools were randomized to the test and 95 to the reference groups; 1473 (test) and 1494 (reference) children participated in the trial. An intention-to-treat analysis was carried out with random effects models. The DFS increment was 0.65 (SD 2.15) in the test and 0.67 (SD 2.10) in the reference groups, respectively. There was no statistically significant difference between the groups. We were unable to demonstrate an effect for fluoride varnish when it was used as a public health intervention to prevent caries in the first permanent molar teeth (Inter-national Standard Randomized Controlled Trial Registration: ISRCTN: #72589426)

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O’Neill, Linda M., Emer Guinan, Suzanne L. Doyle, Annemarie E. Bennett, Conor Murphy, Jessie A. Elliott, Jacintha OʼSullivan, John V. Reynolds, and Juliette Hussey. "The RESTORE Randomized Controlled Trial." Annals of Surgery 268, no. 5 (November 2018): 747–55. http://dx.doi.org/10.1097/sla.0000000000002895.

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Sippel, Rebecca S., Sarah E. Robbins, Jennifer L. Poehls, Susan C. Pitt, Herbert Chen, Glen Leverson, Kristin L. Long, David F. Schneider, and Nadine P. Connor. "A Randomized Controlled Clinical Trial." Annals of Surgery 272, no. 3 (September 2020): 496–503. http://dx.doi.org/10.1097/sla.0000000000004345.

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Sanz Rubiales, Álvaro, and María Luisa del Valle. "Placebo-Controlled Feasibility Randomized Trial?" Journal of Pain and Symptom Management 48, no. 1 (July 2014): e4-e5. http://dx.doi.org/10.1016/j.jpainsymman.2014.03.011.

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Diletti, Roberto, Patrick W. Serruys, Vasim Farooq, Krishnankutty Sudhir, Cecile Dorange, Karine Miquel-Hebert, Susan Veldhof, et al. "ABSORB II randomized controlled trial." American Heart Journal 164, no. 5 (November 2012): 654–63. http://dx.doi.org/10.1016/j.ahj.2012.08.010.

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Resteghini, Peter, Tamim A. Khanbhai, Shabaaz Mughal, and Ziali Sivardeen. "Double-Blind Randomized Controlled Trial." Clinical Journal of Sport Medicine 26, no. 1 (January 2016): 17–23. http://dx.doi.org/10.1097/jsm.0000000000000184.

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Chiarioni, Giuseppe, William E. Whitehead, and Gabrio Bassotti. "Randomized Controlled Trial of Biofeedback." Clinical Gastroenterology and Hepatology 5, no. 9 (September 2007): 1119. http://dx.doi.org/10.1016/j.cgh.2007.05.027.

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Golden, Isaac. "Beyond Randomized Controlled Trials." Journal of Evidence-Based Complementary & Alternative Medicine 17, no. 1 (January 2012): 72–75. http://dx.doi.org/10.1177/2156587211429351.

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Complementary and alternative medicine is criticized by some as lacking evidence to support the effectiveness of its methods and medicines. Such critics typically point to mixed results from using randomized controlled trials to test complementary and alternative medicine. Randomized controlled trials have been held to be the “gold standard” in pharmaceutical research, but a growing body of evidence in orthodox journals has identified their limitations. Here, 5 fundamental flaws in the randomized controlled trial–based model are discussed as well as the impact on its relevance for testing complementary and alternative medicine therapies. A better way to evaluate complementary and alternative medicine therapies is also proposed. A 7-item checklist is suggested to quantify the strength of an area of complementary and alternative medicine research.

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Msaouel, Pavlos, Juhee Lee, and Peter F. Thall. "Interpreting Randomized Controlled Trials." Cancers 15, no. 19 (September 22, 2023): 4674. http://dx.doi.org/10.3390/cancers15194674.

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This article describes rationales and limitations for making inferences based on data from randomized controlled trials (RCTs). We argue that obtaining a representative random sample from a patient population is impossible for a clinical trial because patients are accrued sequentially over time and thus comprise a convenience sample, subject only to protocol entry criteria. Consequently, the trial’s sample is unlikely to represent a definable patient population. We use causal diagrams to illustrate the difference between random allocation of interventions within a clinical trial sample and true simple or stratified random sampling, as executed in surveys. We argue that group-specific statistics, such as a median survival time estimate for a treatment arm in an RCT, have limited meaning as estimates of larger patient population parameters. In contrast, random allocation between interventions facilitates comparative causal inferences about between-treatment effects, such as hazard ratios or differences between probabilities of response. Comparative inferences also require the assumption of transportability from a clinical trial’s convenience sample to a targeted patient population. We focus on the consequences and limitations of randomization procedures in order to clarify the distinctions between pairs of complementary concepts of fundamental importance to data science and RCT interpretation. These include internal and external validity, generalizability and transportability, uncertainty and variability, representativeness and inclusiveness, blocking and stratification, relevance and robustness, forward and reverse causal inference, intention to treat and per protocol analyses, and potential outcomes and counterfactuals.

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Dohoo, Ian R. "The design of randomized controlled trials of veterinary vaccines." Animal Health Research Reviews 5, no. 2 (December 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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Purgato, Marianna, Corrado Barbui, and Andrea Cipriani. "Assessing risk of bias in randomized controlled trials." Epidemiology and Psychiatric Sciences 19, no. 4 (December 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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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 (December 14, 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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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 (January 23, 2018): 21. http://dx.doi.org/10.18203/2349-3259.ijct20180127.

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Background: 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. 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 Helicobacter pylori associated infections by using the CONSORT 2010 checklist.Methods: 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 Helicobacter pylori associated infections were included in the review.Results: 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%). The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.Conclusions: 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.

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Willan, Andrew R., and Lehana Thabane. "Bayesian methods for pilot studies." Clinical Trials 17, no. 4 (April 16, 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 (May 1, 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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van der Baan, Frederieke H., Olaf H. Klungel, Antoine CG Egberts, Hubert G. Leufkens, Diederick E. Grobbee, Kit CB Roes, and Mirjam J. Knol. "Pharmacogenetics in randomized controlled trials: considerations for trial design." Pharmacogenomics 12, no. 10 (October 2011): 1485–92. http://dx.doi.org/10.2217/pgs.11.95.

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Lockshin, Michael D. "Clinical Trial Registration and Publication of Randomized Controlled Trials." JAMA 303, no. 6 (February 10, 2010): 517. http://dx.doi.org/10.1001/jama.2010.95.

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West, Stephen G., Naihua Duan, Willo Pequegnat, Paul Gaist, Don C. Des Jarlais, David Holtgrave, José Szapocznik, et al. "Alternatives to the Randomized Controlled Trial." American Journal of Public Health 98, no. 8 (August 2008): 1359–66. http://dx.doi.org/10.2105/ajph.2007.124446.

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Miller, Mary G., and Jessica Corner. "The ‘n = 1’ randomized controlled trial." Palliative Medicine 13, no. 3 (April 1999): 255–59. http://dx.doi.org/10.1191/026921699674890886.

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Olsson, Jesper, Darcey Terris, Matthias Elg, Jonas Lundberg, and Staffan Lindblad. "The One-Person Randomized Controlled Trial." Quality Management in Health Care 14, no. 4 (October 2005): 206–16. http://dx.doi.org/10.1097/00019514-200510000-00002.

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Goldstein, R. S., E. H. Gort, D. Stubbing, M. A. Avendano, and G. H. Guyatt. "Randomized Controlled Trial of Respiratory Rehabilitation." Journal of Cardiopulmonary Rehabilitation 15, no. 3 (May 1995): 235. http://dx.doi.org/10.1097/00008483-199505000-00013.

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Grimes, David A., and Kenneth F. Schulz. "A “randomized” controlled trial without randomization." American Journal of Obstetrics and Gynecology 175, no. 1 (July 1996): 240–41. http://dx.doi.org/10.1016/s0002-9378(96)70302-2.

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Vincent, Jean-Louis. "The randomized controlled trial turns pro." Intensive Care Medicine 28, no. 9 (July 30, 2002): 1200–1202. http://dx.doi.org/10.1007/s00134-002-1400-9.

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Laptook, A. R. "The neo.nEURO.network Hypothermia Randomized Controlled Trial." PEDIATRICS 126, no. 4 (September 20, 2010): e965-e966. http://dx.doi.org/10.1542/peds.2010-2075.

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Beckerman, Heleen, Jules G. Becher, and Gustaaf J. Lankhorst. "Definition of a randomized controlled trial." Clinical Rehabilitation 19, no. 3 (May 2005): 345–46. http://dx.doi.org/10.1191/0269215505cr872xx.

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Christie, Janice, Peter O'Halloran, and Mike Stevenson. "Planning a Cluster Randomized Controlled Trial." Nursing Research 58, no. 2 (March 2009): 128–34. http://dx.doi.org/10.1097/nnr.0b013e3181900cb5.

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Freeman, Brian J. C., Robert D. Fraser, Christopher M. J. Cain, David J. Hall, and David C. L. Chapple. "A Randomized, Double-Blind, Controlled Trial." Spine 30, no. 21 (November 2005): 2369–77. http://dx.doi.org/10.1097/01.brs.0000186587.43373.f2.

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Jain, Sumeet, and N. K. Arora. "Randomized controlled trial and economic evaluation." Indian Journal of Pediatrics 67, no. 5 (May 2000): 363–68. http://dx.doi.org/10.1007/bf02820689.

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Van der Does, W. "A Randomized, Controlled Trial of Prayer?" Archives of Internal Medicine 160, no. 12 (June 26, 2000): 1871–72. http://dx.doi.org/10.1001/archinte.160.12.1871.

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Petersen, Ronald C., Ronald G. Thomas, Paul S. Aisen, Richard C. Mohs, Maria C. Carrillo, and Marilyn S. Albert. "Randomized controlled trials in mild cognitive impairment." Neurology 88, no. 18 (April 5, 2017): 1751–58. http://dx.doi.org/10.1212/wnl.0000000000003907.

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Objective:To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI).Methods:Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects.Results:The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales.Conclusions:In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings.

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Chongwe, Gershom, Joseph Ali, Dan Kabonge Kaye, Charles Michelo, and Nancy E. Kass. "Ethics of Adaptive Designs for Randomized Controlled Trials." Ethics & Human Research 45, no. 5 (September 2023): 2–14. http://dx.doi.org/10.1002/eahr.500178.

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ABSTRACTOver recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in‐depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

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Pascoe, Elaine Mary, Serigne Lo, Anish Scaria, Sunil V. Badve, Elaine Mary Beller, Alan Cass, Carmel Mary Hawley, and David W. Johnson. "The Honeypot Randomized Controlled Trial Statistical Analysis Plan." Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis 33, no. 4 (July 2013): 426–35. http://dx.doi.org/10.3747/pdi.2012.00310.

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BackgroundThe HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients.ObjectiveTo make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial.MethodsStatisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes.ResultsA statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.ConclusionsMaking public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

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Tzedakis, Stylianos, and David Fuks. "A Japanese multi-institutional randomized controlled trial (ND-Trial)." Hepatobiliary Surgery and Nutrition 10, no. 2 (April 2021): 226–28. http://dx.doi.org/10.21037/hbsn-21-57.

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Journal articles on the topic 'Randomized controlled trial'

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