Relevant bibliographies by topics / Randomized controlled trial/methods

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Randomized controlled trial/methods'

Author: Grafiati
Published: 4 June 2021
Last updated: 14 February 2022

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Journal articles on the topic "Randomized controlled trial/methods"

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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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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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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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Jackson, Margaret A., Margaret Kellett, Helen V. Worthington, and Valerie Clerehugh. "Comparison of Interdental Cleaning Methods: A Randomized Controlled Trial." Journal of Periodontology 77, no. 8 (August 2006): 1421–29. http://dx.doi.org/10.1902/jop.2006.050360.

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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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Kessels, Rob, Reagan Mozer, and Jos Bloemers. "Methods for assessing and controlling placebo effects." Statistical Methods in Medical Research 28, no. 4 (December 26, 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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Gany, Francesca, Jennifer Leng, Ephraim Shapiro, David Abramson, Ivette Motola, David C. Shield, and Jyotsna Changrani. "Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial." Journal of General Internal Medicine 22, S2 (October 24, 2007): 312–18. http://dx.doi.org/10.1007/s11606-007-0360-8.

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Kuroiwa, Erin, Rebecca L. Ragar, Crystal S. Langlais, Angelica Baker, Maria E. Linnaus, and David M. Notrica. "Car seat education: A randomized controlled trial of teaching methods." Injury 49, no. 7 (July 2018): 1272–77. http://dx.doi.org/10.1016/j.injury.2018.05.003.

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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 (January 31, 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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ŠAPOKA, Virginijus, Vytautas KASIULEVIČIUS, and Janina DIDŽIAPETRIENĖ. "How should a clinician interpret results of randomized controlled trials?" Acta medica Lituanica 17, no. 1-2 (January 1, 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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Dissertations / Theses on the topic "Randomized controlled trial/methods"

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Reichmann, William Michael. "Methods in subgroup analysis: estimation of risk and implications for randomized controlled trial design." Thesis, Boston University, 2012. https://hdl.handle.net/2144/32047.

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Thesis (Ph.D.)--Boston University
PLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you.
Estimation of exposure-specific risks (ESRs) using estimates of the overall risk and relative risk of disease given exposure has been performed in previous studies, but the performance of such an estimator has not been assessed nor has a variance for such an estimate been proposed. In this project I evaluated the performance of a simple product-based ESR and its variance derived using the delta method. I used the variance to estimate the 95% confidence interval. I found that this point estimate was biased and that the accompanying 95% confidence interval did not attain 95% coverage. I also proposed a revised product-based estimator and found that this estimator was unbiased. I used the delta method to derive a variance for this estimator and estimated the 95% confidence interval. The coverage of this interval attained 95% coverage in most situations. According to the CONSORT statement, subgroup analyses in randomized controlled trials (RCTs) should be pre-planned and accompanied with a formal test of interaction. I considered the interaction between treatment and a dichotomous prognostic factor with a continuous outcome. I examined the impact of misspecifying the distribution of the prognostic factor on power and sample size for interaction effects. I found that power for the interaction test was decreased when the misspecification of the distribution of the prognostic factor was away from a balanced design. I also proposed three methods for improving the power under misspecifications. Quota sampling maintained the power at 80%, but trial completion may be delayed under misspecifications. Modified quota sampling improved the power, but results were related to the proportion of trials switching to the quota sampling procedure. Sample size re-estimation improved the power, but did not always attain 80% power. All three methods maintained appropriate type I error. Lastly, I examined the impact of unplanned cross-over on power and sample size for interaction effects in RCTs. Unplanned cross-over is common in surgical trials and can diminish the magnitude of the interaction effect. Due to this, the sample size re-estimation procedure performed better than quota sampling and modified quota sampling in the presence of unplanned cross-over.
2031-01-02
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McNellis, Jennie L. "Meta-analysis of Weight Change in the Placebo Arm of RCT’s for Weight Loss: Methods and Pilot Study." The University of Arizona, 2008. http://hdl.handle.net/10150/624315.

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Class of 2008 Abstract
Objectives: 1) To determine if data on weight change in the placebo arm of RCT's for weight loss were available, and 2) to conduct a pilot meta-analysis to estimate the average weight change in the placebo arm. Methods: Four randomized placebo controlled trials of rimonabant for weight loss were retrieved. A draft data extraction form was developed to record weight loss and demographic data. Potential for bias was assessed on design issues related to withdrawals, blinding, allocation procedure, adherence, and manufacturer influence. Based on available data, a forest plot was constructed and heterogeneity was assessed. The a priori alpha level was 0.05. Results: The placebo groups from all studies were similar. The pooled data indicated that individuals in the placebo arm lost an average of 3.3 kg, p < 0.001. One study had a significantly greater completion rate than the other studies. Participants were prescribed a hypocaloric diet and were instructed to increase physical activity but no data were reported on calories consumed or amount of physical activity. Weight loss of 5% ranged from 15-20% of participants. There was potential for bias relating to reported adherence, allocation concealment process, and manufacturer funding. Conclusions: Participants in the placebo arm of rimonabant trials lost an average of 3.3 kg, which was statistically significant. Little can be learned about weight loss in the placebo arm because no data on calories consumed, amount of exercise, or hunger were reported. Information from other RCT's is needed to provide additional data and to confirm the findings.
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Gloster, Andrew T., Hans-Ulrich Wittchen, Franziska Einsle, Michael Höfler, Thomas Lang, Sylvia Helbig-Lang, Thomas Fydrich, et al. "Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia." Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2013. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-106614.

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Cognitive behavioral therapy (CBT) is efficacious for panic disorder with agoraphobia (PD/A). Nevertheless, the active ingredients of treatment and the mechanisms through which CBT achieves its effects remain largely unknown. The mechanisms of action in CBT (MAC) study was established to investigate these questions in 369 patients diagnosed with PD/A. The MAC study utilized a multi-center, randomized controlled design, with two active treatment conditions in which the administration of exposure was varied, and a wait-list control group. The special feature of MAC is the way in which imbedded experimental, psychophysiological, and neurobiological paradigms were included to elucidate therapeutic and psychopathological processes. This paper describes the aims and goals of the MAC study and the methods utilized to achieve them. All aspects of the research design (e.g., assessments, treatment, experimental procedures) were implemented so as to facilitate the detection of active therapeutic components, and the mediators and moderators of therapeutic change. To this end, clinical, behavioral, physiological, experimental, and genetic data were collected and will be integrated.
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Gloster, Andrew T., Hans-Ulrich Wittchen, Franziska Einsle, Michael Höfler, Thomas Lang, Sylvia Helbig-Lang, Thomas Fydrich, et al. "Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia." Technische Universität Dresden, 2009. https://tud.qucosa.de/id/qucosa%3A26684.

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Cognitive behavioral therapy (CBT) is efficacious for panic disorder with agoraphobia (PD/A). Nevertheless, the active ingredients of treatment and the mechanisms through which CBT achieves its effects remain largely unknown. The mechanisms of action in CBT (MAC) study was established to investigate these questions in 369 patients diagnosed with PD/A. The MAC study utilized a multi-center, randomized controlled design, with two active treatment conditions in which the administration of exposure was varied, and a wait-list control group. The special feature of MAC is the way in which imbedded experimental, psychophysiological, and neurobiological paradigms were included to elucidate therapeutic and psychopathological processes. This paper describes the aims and goals of the MAC study and the methods utilized to achieve them. All aspects of the research design (e.g., assessments, treatment, experimental procedures) were implemented so as to facilitate the detection of active therapeutic components, and the mediators and moderators of therapeutic change. To this end, clinical, behavioral, physiological, experimental, and genetic data were collected and will be integrated.
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Ward, Roxanne E. "Examining Methods and Practices of Source Data Verification in Canadian Critical Care Randomized Controlled Trials." Thèse, Université d'Ottawa / University of Ottawa, 2013. http://hdl.handle.net/10393/23974.

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Statement of the Problem: Source data verification (SDV) is the process of comparing data collected at the source to data recorded on a Case Report Form, either paper or electronic (1) to ensure that the data are complete, accurate and verifiable. Good Clinical Practice (GCP) Guidelines are vague and lack evidence as to the degree of SDV and whether or not SDV affects study outcomes. Methods of Investigation: We performed systematic reviews to establish the published evidence-base for methods of SDV and to examine the effect of SDV on study outcomes. We then conducted a national survey of Canadian Critical Care investigators and research coordinators regarding their attitudes and beliefs regarding SDV. We followed by an audit of the completed and in-progress Randomized Controlled Trials (RCTs) of the Canadian Critical Care Trials Group (CCCTG). Results: Systematic Review of Methods of SDV: The most common reported or recommended frequency of source data verification (10/14 - 71%) was either based on level or risk, or that it be conducted early (i.e. after 1st patient enrolled). The amount of SDV recommended or reported, varied from 5-100%. Systematic Review of Impact of SDV on Study Outcomes: There was no difference in study outcomes for 1 trial and unable to assess in the other. National Survey of Critical Care Investigators and Research Coordinators: Data from the survey found that 95.8% (115/120) of respondents believed that SDV was an important part of Quality Assurance; 73.3% (88/120) felt that academic studies should do more SDV; and 62.5% (75/120) felt that there is insufficient funding available for SDV. Audit of Source Data Verification Practices in CCCTG RCTs: In the national audit of in-progress and completed CCCTG RCTs, 9/15 (60%) included a plan for SDV and 8/15 (53%) actually conducted SDV. Of the 9 completed published trials, 44% (4/9) conducted SDV. Conclusion: There is little evidence base for methods and effect of SDV on study outcomes. Based on the results of the systematic review, survey, and audit, more research is needed to support the evidence base for the methods and effect of SDV on study outcomes.
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Leichsenring, Falk, Jürgen Hoyer, Manfred Beutel, Sabine Herpertz, Wolfgang Hiller, Eva Irle, Peter Joraschky, et al. "The Social Phobia Psychotherapy Research Network: The First Multicenter Randomized Controlled Trial of Psychotherapy for Social Phobia: Rationale, Methods and Patient Characteristics." Karger, 2009. https://tud.qucosa.de/id/qucosa%3A27526.

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This paper presents the Social Phobia Psychotherapy Research Network. The research program encompasses a coordinated group of studies adopting a standard protocol and an agreed-on set of standardized measures for the assessment and treatment of social phobia (SP). In the central project (study A), a multicenter randomized controlled trial, refined models of manualized cognitive-behavioral therapy and manualized short-term psychodynamic psychotherapy are compared in the treatment of SP. A sample of 512 outpatients will be randomized to either cognitive-behavioral therapy, short-term psychodynamic psychotherapy or waiting list. Assessments will be made at baseline, at the end of treatment and 6 and 12 months after the end of treatment. For quality assurance and treatment integrity, a specific project using highly elaborated measures has been established (project Q). Study A is complemented by 4 interrelated add-on projects focusing on attachment style (study B1), on cost-effectiveness (study B2), on variation in the serotonin transporter gene in SP (study C1) and on structural and functional deviations of the hippocampus and amygdala (study C2). Thus, the Social Phobia Psychotherapy Research Network program enables a highly interdisciplinary research into SP. The unique sample size achieved by the multicenter approach allows for studies of subgroups (e.g. comorbid disorders, isolated vs. generalized SP), of responders and nonresponders of each treatment approach, for generalization of results and for a sufficient power to detect differences between treatments. Psychological and biological parameters will be related to treatment outcome, and variables for differential treatment indication will be gained. Thus, the results provided by the network may have an important impact on the treatment of SP and on the development of treatment guidelines for SP.
Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
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Mukaka, Mavuto. "Comparison of statistical methods of handling missing binary outcome data in randomized controlled trials of efficacy studies." Thesis, University of Liverpool, 2013. http://livrepository.liverpool.ac.uk/14593/.

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The presence of some missing outcomes in randomized studies often complicates the estimation of measures of effect, even in well designed randomized controlled trials. The process may be complicated further when the efficacy rates are close to 0% or 100% as the standard binomial model is susceptible to model non-convergence. The main objective of this study was to compare the performance of multiple imputation (MI) and Complete Case analysis for dealing with missing binary outcomes when modeling a risk difference. Firstly, however, the binomial regression COPY method and the Cheung’s modified Ordinary Least Squares (OLS) method were examined using simulation processes for their appropriateness in risk difference modeling. It was found that the number of copies (for the COPY method) required to minimize non-convergence coincided with the number of copies that gave the most biased estimates of the true efficacy difference while increasing the number of copies made the problems of non-convergence and bias worse; using Cheung’s method, however, there was 100% convergence with unbiased estimates of effect size. Simulation methods were used to compare the performance of complete case (CC) analysis and several multiple imputation (MI) models for handling missing outcome data over a wide range of efficacy environments and missing value assumptions. When outcomes were missing at random (MAR) or completely at random (MCAR), MI analyses that included treatment group membership in the imputation calculations yielded unbiased estimates of efficacy differences. The CC method was found to be as good, and often better, than MI methods when outcomes were MAR or MCAR, with coverage close to 95% in many situations – but neither CC nor MI produced unbiased estimates of effect difference when outcomes were missing not at random (MNAR). It was concluded that CC and MI methods are equally good in terms of producing unbiased estimates of effect difference in most missing outcome situations, but applying the intention to treat principle (ITT) which requires all randomized patients to be included in the primary analysis of a RCT, MI should be adopted as the analysis method of first choice, accompanied by a secondary CC analysis for sensitivity purposes (i.e. to investigate the extent of any likely bias).
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Compton, Dickinson Stella J. "A feasibility trial of group cognitive analytic music therapy in secure hospital settings." Thesis, Anglia Ruskin University, 2014. http://arro.anglia.ac.uk/581523/.

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There are no large-scale outcome studies of music therapy in secure hospital settings for people who have committed serious offences. These patients have a right to expect evidence-based multi-disciplinary treatment (Duggan et al. 2006); NICE (2010). Music therapy therefore should take a form which can be integrated into the treatment pathway. A single site implementation of a mixed-methods patient preference randomised controlled trial investigated the clinical effectiveness of a manualised music therapy model called Group Cognitive Analytic Music Therapy (G-CAMT). This context-specific, time limited intervention incorporates theories from Group Analysis (Foulkes 1964) and Cognitive Analytic Therapy (Ryle and Kerr 2003). The central research question was ‘Is G-CAMT feasible and effective for offenders in a secure multi-disciplinary treatment setting?’ The research process followed the Medical Research Council framework for developing and evaluating complex interventions (Campbell et al. 2000, 2007). Twenty patients were recruited; those expressing no preference were randomised to treatment or control arms. The two music therapists and the principal investigator were masked to their allocation status. Those in the treatment arm were allocated to one of two treatment groups of five, each run individually by one of the music therapists. Each group had sixteen ninety minute weekly sessions with followup at eight weeks. Treatment and control groups received standard care. The primary measure was the Person’s Relating to Others Questionnaire (Birtchnell and Evans 2004) Secondary measures were the Basic Empathy Scale (Jolliffe and Farrington 2006a), The Multi-Scale Dissociation Inventory (Briere, 2002) and an observational measure, the Chart of Interpersonal Reactions in Closed Living Environments (Blackburn and Glasgow, 1993). Quantitative data from these measures were examined for associations with qualitative data from semi-structured interviews administered to the music therapists and analyzed using Interpretative Phenomenological Analysis (Smith et.al. 2009) Findings from the results of the primary measure demonstrated statistically significant (Mann Whitney U: p<.05) reductions in favour of the treatment group compared to the control, in intrusive, restrictive and possessive behaviors and helpless or self-denigrating behaviours. There were improvements over time within the treatment group in the domains of sociability and hostility (Friedman Test :p<.04). The use of a manual was shown to help the music therapists manage the risk of violence without constraining their creativity. Two years after the end of the treatment 78% of treatment participants had moved to conditions of lower security over a mean period of 19 months compared with 66% of control subjects over a mean period of 25.5 months. The thesis concludes by situating G-CAMT amongst contemporary music therapy models.
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Rebele, Stephan F. [Verfasser], and Markus [Akademischer Betreuer] Hürzeler. "Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage : a randomized controlled clinical trial using 3D digital measuring methods." Freiburg : Universität, 2015. http://d-nb.info/1119805813/34.

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Hodgson, Nicole Christina Fink. "The search for the ideal method of abdominal fascial closure, a meta-analysis, a provincial survey and a randomized controlled trial proposal." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape8/PQDD_0003/MQ42158.pdf.

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Books on the topic "Randomized controlled trial/methods"

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

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Kim, KyungMann, Frank Bretz, Ying Kuen K. Cheung, and Lisa V. Hampson. Handbook of Statistical Methods for Randomized Controlled Trials. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694.

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

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Machin, David. Randomized clinical trials: Design, practice, and reporting. Chichester, West Sussex: John Wiley & Sons, 2010.

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Randomized clinical trials of nonpharmacologic treatments. Boca Raton: Chapman and Hall/CRC, 2012.

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Machin, David. Randomized clinical trials: Design, practice and reporting. Chichester, West Sussex, UK: Wiley-Blackwell, 2010.

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Modern adaptive randomized clinical trials: Statistical and practical aspects. Boca Raton: Taylor & Francis, 2015.

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Binary data analysis of randomized clinical trials with noncompliance. Chichester, West Sussex, United Kingdom: John Wiley & Sons Inc., 2011.

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Neil, Klar, ed. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.

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The use of restricted significance tests in clinical trials. New York: Springer-Verlag, 1992.

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Book chapters on the topic "Randomized controlled trial/methods"

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Armour, Mike, Carolyn Ee, and Genevieve Z. Steiner. "Randomized Controlled Trials." In Handbook of Research Methods in Health Social Sciences, 645–62. Singapore: Springer Singapore, 2019. http://dx.doi.org/10.1007/978-981-10-5251-4_94.

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Armour, Mike, Carolyn Ee, and Genevieve Z. Steiner. "Randomized Controlled Trials." In Handbook of Research Methods in Health Social Sciences, 1–18. Singapore: Springer Singapore, 2018. http://dx.doi.org/10.1007/978-981-10-2779-6_94-1.

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Foley, Robert N. "Randomized Controlled Trials 2: Analysis." In Methods in Molecular Biology, 177–90. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2428-8_10.

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Curtis, Bryan M., Brendan J. Barrett, and Patrick S. Parfrey. "Randomized Controlled Trials 1: Design." In Methods in Molecular Biology, 159–75. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2428-8_9.

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Curtis, Bryan M., Brendan J. Barrett, and Patrick S. Parfrey. "Randomized Controlled Trials 1: Design." In Methods in Molecular Biology, 193–211. New York, NY: Springer US, 2021. http://dx.doi.org/10.1007/978-1-0716-1138-8_11.

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Foley, Robert N., and Patrick S. Parfrey. "Randomized Controlled Trials 2: Analysis." In Methods in Molecular Biology, 213–27. New York, NY: Springer US, 2021. http://dx.doi.org/10.1007/978-1-0716-1138-8_12.

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Bland, Martin, and Mona Kanaan. "Cluster Randomized Designs." In Handbook of Statistical Methods for Randomized Controlled Trials, 191–214. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694-10.

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Hatfield, Elizabeth, Elizabeth Dicks, and Patrick S. Parfrey. "Randomized Controlled Trials: Planning, Monitoring, and Execution." In Methods in Molecular Biology, 273–86. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2428-8_16.

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Proschan, Michael. "Group Sequential Methods." In Handbook of Statistical Methods for Randomized Controlled Trials, 317–38. Boca Raton: Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781315119694-15.

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Rigatto, Claudio, and Brendan J. Barrett. "Randomized Controlled Trials 4: Biomarkers and Surrogate Outcomes." In Methods in Molecular Biology, 207–24. New York, NY: Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2428-8_12.

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Conference papers on the topic "Randomized controlled trial/methods"

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Nikolaychyk, T. "Multicenter Randomized Controlled Trial Of Methods For Removing Polyps Of The Colon Up To 10 MM." In ESGE Days 2021. Georg Thieme Verlag KG, 2021. http://dx.doi.org/10.1055/s-0041-1724480.

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Hyun, JJ, JW Choe, D. Kim, SY Kim, SW Jung, YK Jung, JS Koo, HJ Yim, and SW Lee. "ONE-MAN METHOD VS. TWO-MAN METHOD FOR COLONOSCOPE INSERTION: A RANDOMIZED CONTROLLED TRIAL." In ESGE Days. © Georg Thieme Verlag KG, 2020. http://dx.doi.org/10.1055/s-0040-1704431.

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Giassi, Karina, Renato Gorga Bandeira de Mello, Bruna Cambrussi de Lima, Gabriela Stahl, Raquel Almeida de Oliveira, and Marina Siqueira Flores. "RANDOMIZED CONTROLLED TRIAL COMPARING MORNING VERSUS NIGHT ADMINISTRATION OF LEVOTHYROXINE IN OLDER PERSONS." In XXII Congresso Brasileiro de Geriatria e Gerontologia. Zeppelini Publishers, 2021. http://dx.doi.org/10.5327/z2447-21232021res04.

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OBJECTIVE: To evaluate the effectiveness of levothyroxine administration strategies in the treatment of hypothyroidism in older persons in a tertiary outpatient clinic. METHODS: A randomized controlled trial of older persons with a diagnosis of primary hypothyroidism who had been receiving levothyroxine for at least 6 months with a stable dose in the last 3 months. Patients were randomly assigned to one of two administration strategies: morning (1 hour before breakfast) or night (1 hour after the last meal). In a period ≥ 12 weeks, patients were instructed to cross over between strategies. Laboratory tests for thyroid-stimulating hormone (TSH) and free thyroxine (FT4) were performed at visit 0 (baseline), visit 1 (period ≥ 12 weeks), and visit 2 (completion — period ≥ 24 weeks); a standardized questionnaire was also applied. Preliminary analyses of the period before crossover are presented. RESULTS: The preliminary sample consisted of 98 patients, with a mean age of 71.26 (SD 7.12) years; 83.67% were women. Fifty-three patients started with the morning strategy and 45 with the night strategy, and one patient did not return for reassessment. Median TSH levels ranged from 2.74 (IQR 1.06–4.19) at baseline to 2.77 (IQR 0.75–4.41) after a 12-week follow-up in the morning group, and from 2.36 (IQR 1.48–4.85) to 2.28 (IQR 1.69–3.56) in the night group. Mean FT4 levels ranged from 1.44 (SD 0.39) to 1.42 (SD 0.36) in the morning group, and from 1.35 (SD 0.27) to 1.37 (SD 0.32) in the night group. CONCLUSIONS: The administration of levothyroxine at night was as effective as morning administration at controlling primary hypothyroidism in older persons. Therefore, this can be considered an alternative dosage strategy for the treatment of this condition.
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Novitasari, Elisa, RB Soemanto, and Hanung Prasetya. "Acupuncture Therapy in Reducing Pain in Patients with Low Back Pain: Meta Analysis." In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.05.43.

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ABSTRACT Background: With growing evidence of high prevalence in developing countries, LBP is no longer recognized as a disorder confined to high-income nations but is a major health problem globally. The functional limitations and consequent disability create a heavy economic burden on individuals and society. This study aimed to acupuncture therapy in reducing pain in patients with low back pain. Subjects and Method: A meta-analysis and systematic review was conducted by search published articles from PubMed, Google Schoolar, Mendeley, Hindawi, and Clinical key databases. Keywords used “acupuncture low back pain” OR “acupuncture chronic pain” AND “efficacy acupuncture” AND “chronic low back pain” AND “effect acupuncture for low back pain” AND “randomized controlled trial” AND “visual analogue scale”. The inclusion criteria were full text and using randomized controlled trial (RCT) study design. The articles were selected by PRISMA flow chart and the quantitative data were analyzed by Revman 5.3. Results: 7 studies were met criteria. This study showed that acupuncture therapy reduced pain in patients with low back pain (Mean Difference= -0.40; 95% CI= -0.80 to 0.01; p= 0.05) with heterogeneity I2= 83%. Conclusion: Acupuncture therapy reduces pain in patients with low back pain. Keywords: low back pain, acupuncture chronic low back pain, randomized controlled trial. Correspondence: Elisa Novitasari. Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: elisanovita58@gmail.com. Mobile: 085727851938. DOI: https://doi.org/10.26911/the7thicph.05.43
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Sandelowsky, Hanna, Ingvar Krakau, Sonja Modin, Björn Ställberg, Sven-Erik Johansson, and Anna Nager. "Effectiveness of 2x2-hour lectures and case methods in Swedish general practitioners’ continuing medical education about COPD: a cluster randomized controlled trial." In ERS International Congress 2018 abstracts. European Respiratory Society, 2018. http://dx.doi.org/10.1183/13993003.congress-2018.oa291.

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Mohajeryami, Saeed, and Valentina Cecchi. "An investigation of the Randomized Controlled Trial (RCT) method as a Customer Baseline Load (CBL) calculation for residential customers." In 2017 IEEE Power & Energy Society General Meeting (PESGM). IEEE, 2017. http://dx.doi.org/10.1109/pesgm.2017.8274073.

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El Hajj, Maguy, Ahmed Awaisu, Nadir Kheir, Mohamad Haniki, Rula Shami, Rana Saleh, Noora AlHamad, Ahmad Almulla, and Ziyad Mahfoud. "Evaluation of an Intensive Education Program on the Treatment of Tobacco-use Disorder for Pharmacists: A Randomized Controlled Trial." In Qatar University Annual Research Forum & Exhibition. Qatar University Press, 2020. http://dx.doi.org/10.29117/quarfe.2020.0112.

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Tobacco use is one of the main causes of premature deaths and preventable diseases in Qatar. The aim of this randomized controlled trial (RCT) is to design, implement, and evaluate an intensive education program on tobacco-use treatment for pharmacists in Qatar. The study objectives are to assess the effectiveness of the program on pharmacists’ knowledge, skills, attitudes and perceived self-efficacy toward tobacco cessation. Methods: Community pharmacists practicing in Qatar were eligible for participation in the study. Consenting participants were randomly allocated to intervention or control groups. Participants in the intervention group received an intensive education program on treatment of tobacco-use disorder. A short didactic session on a non-tobacco-related topic was delivered to pharmacists in the control group. Outcomes were assessed using survey instruments. Results: Participants in the intervention group (n=57) achieved significantly higher total tobacco-related knowledge scores (mean=33 points) than those in the control group (n=37) (mean=24.5 points) with a p-value of <0.001. Post-intervention total knowledge scores were significantly higher than the baseline scores for participants who received intensive tobacco education with a mean difference of 6.6 points (p-value <0.001). Overall attitudes toward tobacco cessation and self-efficacy in tobacco cessation interventions were better in the group of pharmacists who received tobacco education compared to those who did not. For instance, 43.4% of pharmacists in the intervention group “strongly agreed” that their counseling will increase a patient’s likelihood of quitting tobacco use compared to 14.7% in the control group (p-value=0.014). Furthermore, 20.4% of pharmacists in the intervention group reported that they are “extremely confident” to use appropriate questions to ask patients when providing tobacco cessation counseling versus 5.9% in the control group (p-value=0.005). Conclusion: The findings of this study suggest that provision of an intensive educational program on the treatment of tobacco use disorders results in improved tobacco-related knowledge and self-efficacy in tobacco cessation interventions.
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Fatati, Muhibbah, Setyo Sri Rahardjo, and Hanung Prasetya. "Lateral Wedge Insole Uptake in Reducing Pain in Patients with Knee Osteoarthritis: A Meta-Analysis Study." In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.05.45.

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ABSTRACT Background: The increase in rates of knee replacement for osteoarthritis has made the identification of effective nonsurgical treatments a high priority. One type of treatment for medial knee osteoarthritis involves reducing medial loading to ease the physical stress applied to that compartment of the joint. The wedge is placed under the sole of the foot and angulated so that it is thicker over the lateral than the medial edge, transferring loading during weight bearing from the medial to the lateral knee compartment. This study aimed to investigate the effect of lateral wedge insole uptake in reducing pain in patients with knee osteoarthritis. Subjects and Method: A meta-analysis and systematic review conducted by search published articles from PubMed, Science Direct, Google Scholar, Mendeley, and Clinical key databases. Keywords used “Lateral Wedge Insole” OR “Insole” AND “Foot Orthosis “AND “osteoarthritis” AND “patellofemoral osteoarthritis” AND “knee pain” AND “medial knee osteoarthritis “AND” effect lateral wedge insole for osteoarthritis” AND “randomized controlled trial”. The inclusion criteria were full text, using randomized controlled trial (RCT) study design, and reporting effect size (mean and standard deviation). The intervention was lateral wedge insole with comparison non lateral wedge insole. The study outcome was pain. The data were analyzed by Revman 5.3. Results: 6 studies were met the inclusion criteria. This study showed that the use of lateral wedge insole reduced pain in patients with knee osteoarthritis (Mean Difference= -0.17; 95% CI= -0.51 to 0.18; p= 0.340) with heterogeneity I2= 77%. Conclusion: Lateral wedge insole use reduced pain in patients with knee osteoarthritis. Keywords: knee osteoarthritis, lateral wedge insole, randomized control trial Correspondence: Muhibbah Fatati, Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: muhibbahfatati@gmail.com. Mobile: 089633466598. DOI: https://doi.org/10.26911/the7thicph.05.45
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Scherer, F., B. Lütkenhöner, F. Heitkötter, C. Rudack, and AG Beule. "Randomised, controlled trial on stimulation methods, frequencies and electrode positions to optimize oVEMP measurements in a clinical setting." In Abstract- und Posterband – 90. Jahresversammlung der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie e.V., Bonn – Digitalisierung in der HNO-Heilkunde. Georg Thieme Verlag KG, 2019. http://dx.doi.org/10.1055/s-0039-1686495.

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Reviana, Prita Alvina, Yulia Lanti Retno Dewi, and Vitri Widyaningsih. "The Effectiveness of Goat Milk to Increase the Quantity of Breast Milk Among Lactation Women: Randomized Controlled Trial Evidence." In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.05.38.

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ABSTRACT Background: Goat milk has some potential nutrition than cow milk. Studies suggested that goat milk is better digested and absorbed than cow milk. It also has less allergen protein and lower lactose. Previous studies examined the benefit of goat milk as infant feeding to increase infant growth compared with cow milk-based formula. However, the studies that analyze the effect of goat milk in increasing breast milk production are scarce. This study aimed to examine the effectiveness of goat milk to increase breast milk volume in lactating mothers. Subjects and Method: This was a randomized controlled trial (RCT). The study was conducted in Madiun, East Java, in October 2019. A sample of 100 lactating mothers with children aged 1 to 3 months was selected purposively. The dependent variable was volume of breast milk. The independent variable was the effectiveness of goat milk. The data were collected by food recall 24 hours and observational sheet. The data were analyzed by t test. Results: Breast milk production after giving goat milk in the intervention group (Mean= 121.5; SD= 12.81) was higher than control group (Mean= 97.06; SD= 13.59), and it was statistically significant (p<0.001). Conclusion: Goat milk is effective to increase quantity of breast milk in lactating mothers. Keywords: breast milk production, goat milk Correspondence: Prita Alvina Reviana. Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java, Indonesia. Email: pritasessy@gmail.com. Mobile: +6282334673976 DOI: https://doi.org/10.26911/the7thicph.05.38
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Reports on the topic "Randomized controlled trial/methods"

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Patton, Amy, Kylie Dunavan, Kyla Key, Steffani Takahashi, Kathryn Tenner, and Megan Wilson. Reducing Stress, Anxiety, and Depression for NICU Parents. University of Tennessee Health Science Center, May 2021. http://dx.doi.org/10.21007/chp.mot2.2021.0012.

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This project aims to appraise evidence of the effectiveness of various practices on reducing stress, anxiety, and depression among parents of infants in the neonatal intensive care unit (NICU). The project contains six research articles from both national and international journals. Study designs include one meta-analysis, one randomized controlled trial, one small scale randomized controlled trial, one prospective phase lag cohort study, on pretest-posttest study, and one mixed-methods pretest-posttest study. Recommendations for effective interventions were based on best evidence discovered through quality appraisal and study outcomes. All interventions, except for educational programs and Kangaroo Care, resulted in a statistically significant reduction of either stress, anxiety, and/ or depression. Family centered care and mindfulness-based intervention reduced all barriers of interest. There is strong and high-quality evidence for the effect of Cognitive Behavioral Therapy on depression, moderate evidence for the effect of activity-based group therapy on anxiety, and promising evidence for the effect of HUG Your Baby on stress.
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Masset, Edoardo. Combining economic modelling and randomised controlled trials: An unexploited synergyCombining economic modelling and randomised controlled trials: An unexploited synergy. Edited by Radhika Menon. Centre of Excellence for Development Impact and Learning (CEDIL), 2021. http://dx.doi.org/10.51744/cmb3.

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Over the last decade, many researchers have conducted randomised trials alongside economic models. The work of these researchers has shown that both approaches are strengthened by their combined use and the conclusions they lead to are full of policy implications. In the latest CEDIL Methods Brief, Edoardo Masset, Research Director, CEDIL Programme, uses three examples to offer tips on the application of modelling to evaluate development interventions and explore various policy questions. The brief shows that models and experiments should be seen as complementary, rather than as alternative approaches. This brief is based on the CEDIL Inception Paper No. 9, Structural Modelling in Policy Making, by Orazio Attanasio and Debbie Blair. This paper is available on the CEDIL website.
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Ruzek, Josef. Randomized, Controlled Trial of CBT Training for PTSD Providers. Fort Belvoir, VA: Defense Technical Information Center, October 2013. http://dx.doi.org/10.21236/ada593743.

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Moss, David, Paul Crawford, Heather Pickett, and Eric Abbott. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, September 2014. http://dx.doi.org/10.21236/ada610454.

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Luxton, David D., Nigel Bush, Gregory Gahm, Mark Reger, Nancy Skopp, Janet Kemp, Tina Lee, Robert McLay, Joan Chipps, and Daphne Brown. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, February 2015. http://dx.doi.org/10.21236/ada614508.

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Luxton, David, Nigel Bush, Gregory Gahm, Mark Reger, Nancy Skopp, Janet Kemp, Jennifer Hoblyn, Robert McLay, Helenna Nakama, and Joan Chipps. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, February 2012. http://dx.doi.org/10.21236/ada574923.

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Luxton, David. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial. Fort Belvoir, VA: Defense Technical Information Center, February 2014. http://dx.doi.org/10.21236/ada596676.

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Roy, Michael J. Randomized, Controlled Trial of Combination Treatment With Pyridostigmine, DEET, and Teremethrin. Fort Belvoir, VA: Defense Technical Information Center, July 2005. http://dx.doi.org/10.21236/ada446574.

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Erickson, Jay. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches. Fort Belvoir, VA: Defense Technical Information Center, May 2009. http://dx.doi.org/10.21236/ada503819.

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Erickson, Jay. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches. Fort Belvoir, VA: Defense Technical Information Center, December 2011. http://dx.doi.org/10.21236/ada562926.

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