Relevant bibliographies by topics / Randomised controlled trials (RCTs)

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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 'Randomised controlled trials (RCTs)'

Author: Grafiati
Published: 4 June 2021
Last updated: 30 January 2023

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Journal articles on the topic "Randomised controlled trials (RCTs)"

1

Shields, Linda, and Alison Twycross. "How randomised controlled trials (RCTs) work." Paediatric Nursing 17, no. 7 (September 2005): 24. http://dx.doi.org/10.7748/paed.17.7.24.s20.

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Shields, Linda, and Alison Twycross. "How randomised controlled trials (RCTs) work." Paediatric Care 17, no. 7 (September 2005): 24. http://dx.doi.org/10.7748/paed2005.09.17.7.24.c1000.

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Hotopf, Matthew, Rachel Churchill, and Glyn Lewis. "Pragmatic randomised controlled trials in psychiatry." British Journal of Psychiatry 175, no. 3 (September 1999): 217–23. http://dx.doi.org/10.1192/bjp.175.3.217.

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BackgroundRandomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry.AimsTo explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry.MethodA narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities.ResultsObstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions.ConclusionsResearchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.
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Li, Wentao, Sophie Suke, Dagmar Wertaschnigg, Sarah Lensen, Rui Wang, Lyle Gurrin, and Ben W. Mol. "Randomised controlled trials evaluating endometrial scratching: assessment of methodological issues." Human Reproduction 34, no. 12 (December 1, 2019): 2372–80. http://dx.doi.org/10.1093/humrep/dez207.

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Abstract STUDY QUESTION Do randomised controlled trials (RCTs) evaluating endometrial scratching suffer from methodological issues including insufficient trial registration, statistical errors or irreproducibility, randomisation errors or miscellaneous issues? SUMMARY ANSWER The majority of RCTs investigating endometrial scratching have methodological issues. WHAT IS KNOWN ALREADY A large number of small RCTs investigating the effectiveness of endometrial scratching prior to in vitro fertilisation (IVF) and intrauterine insemination (IUI)/intercourse have reported favourable findings. Subsequently, systematic reviews incorporating these RCTs yielded meta-analyses in favour of endometrial scratching. Endometrial scratching has been widely adopted by infertility specialists around the world. Recently, an international RCT including 1364 women reported no benefit from endometrial scratching before IVF. STUDY DESIGN, SIZE, DURATION We evaluated several methodological issues of RCTs investigating the effectiveness of endometrial scratching prior to IVF and IUI/intercourse. We identified 25 RCTs for IVF and 12 RCTs for IUI/intercourse with full-text publication. PARTICIPANTS/MATERIALS, SETTING, METHODS We assessed the RCTs on the following criteria: adequacy of trial registration, statistical issues (description of statistical methods and reproducibility of univariable statistical analysis), excessive similarity or difference in baseline characteristics that is not compatible with chance (Monte Carlo simulations and Kolmogorov–Smirnov test) and miscellaneous methodological issues. MAIN RESULTS AND THE ROLE OF CHANCE Of 25 RCTs evaluating endometrial scratching prior to IVF, only eight (32%) had adequate trial registration. In total, 10 (40%) RCTs had issues regarding statistical methods. Nine (69%, 13 applicable) RCTs had at least one inconsistency between reported and reproduced univariable statistical analysis for categorical baseline/intermediate characteristics. Statistical results of at least one outcome were not reproducible in 14 (74%, 19 applicable) RCTs. Only two (8%) RCTs had none of the above issues. Suggested by the simulations, these RCTs did not significantly violate the null hypothesis that the baseline characteristics were the results of a properly conducted randomisation process (P = 0.4395). Of 12 IUI/intercourse RCTs, only 2 (17%) had adequate trial registration. In total, five (42%) studies had issues of statistical methods. Inconsistency between reported and reproduced univariable analysis for baseline/intermediate categorical variable(s) was found in four (57%, 7 applicable) RCTs. Statistical analysis was not reproducible for at least one outcome in eight (80%, 10 applicable) studies. All RCTs had at least one of the above issues. These RCTs were inconsistent with the null hypothesis that their baseline characteristics were the results of proper randomised allocation (P = 1.659*10−7). LIMITATIONS, REASONS FOR CAUTION We were unable to assess RCTs which were not published as full-text papers. We could not analyse individual participant data to investigate possible reasons for statistical inconsistencies. The method to infer the likelihood of proper random sampling rests on assumptions including independent baseline characteristics, simple randomisation and no publication bias. WIDER IMPLICATIONS OF THE FINDINGS The methodological issues common to RCTs evaluating endometrial scratching may have biased the results of the trials. Further development and validation of these novel methods may be helpful for the critical appraisal of RCTs. STUDY FUNDING/COMPETING INTEREST(S) No external funding was sought to support this work. B.W.M. is supported by a National Health Medical Research Council (NHMRC) Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck and Guerbet. D.W. is supported by a grant from the Paracelsus Medical University Salzburg, Austria (PMU Research Fund—PMU FFF Number: L-18/02/006-WET) and by Drs Haackert Foundation, Germany. S.L. is an author of a trial included in this study, an author of an included systematic review and a Cochrane editor. All other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER N/A
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Mathie, Robert T., Michel Van Wassenhoven, Jennifer Jacobs, Menachem Oberbaum, Helmut Roniger, Joyce Frye, Raj K. Manchanda, et al. "Model validity of randomised placebo-controlled trials of individualised homeopathic treatment." Homeopathy 104, no. 03 (July 2015): 164–69. http://dx.doi.org/10.1016/j.homp.2015.02.004.

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Background: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated. Objective: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment. Methods: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary. Results: Nineteen trials were judged overall as ‘acceptable’ MVHT, nine as ‘uncertain’ MVHT, and four as ‘inadequate’ MVHT. Conclusions: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with ‘uncertain’ or ‘inadequate’ MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.
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Brown, Thomas, Thomas Jones, Kerry Gove, Clair Barber, Scott Elliott, Anoop Chauhan, and Peter Howarth. "Randomised controlled trials in severe asthma: selection by phenotype or stereotype." European Respiratory Journal 52, no. 6 (October 25, 2018): 1801444. http://dx.doi.org/10.1183/13993003.01444-2018.

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Previous publications have highlighted the disparity between research trial populations and those in clinical practice, but it has not been established how this relates to randomised controlled trials (RCTs) of phenotype-targeted biological therapies in severe asthma.Detailed characterisation data for 342 severe asthma patients within the Wessex Severe Asthma Cohort (WSAC) was compared against comprehensive trial eligibility criteria for published phase IIB and phase III RCTs evaluating biological therapies in severe asthma since 2000.37 RCTs evaluating 20 biological therapies were identified. Only a median of 9.8% (range 3.5–17.5%) of severe asthma patients were found to be eligible for enrolment in the phase III trials. Stipulations for airflow obstruction, bronchodilator reversibility and smoking history excluded significant numbers of patients. A median of 78.9% (range 73.2–86.6%) of patients with severe eosinophilic asthma would have been excluded from participation in the phase III licensing trials of interleukin (IL)-5/IL-5R targeted therapies.Despite including only well characterised and optimally treated severe asthmatics under specialist care within the WSAC study, the vast majority were excluded from trial participation by criteria designed to re-confirm diagnostic labels rather than by biomarker criteria that predict the characteristic addressed by the treatment.
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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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Howard, Louise, and Graham Thornicroft. "Patient preference randomised controlled trials in mental health research." British Journal of Psychiatry 188, no. 4 (April 2006): 303–4. http://dx.doi.org/10.1192/bjp.188.4.303.

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SummaryThe relationship between psychiatric patients' preferences for different treatments and the outcome of interventions is unclear, as the few relevant trials have tended to be underpowered. Strong patient preferences result in patients refusing to enter a trial. This leads to bias and limits generalisability, and the patient preference randomised controlled trial (RCT) design has been proposed as an alternative. Limitations and advantages of patient preference RCTs are discussed.
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White, P. V. "Issues in finding and keeping randomised controlled trials (RCTs)." Schizophrenia Research 18, no. 2-3 (February 1996): 137. http://dx.doi.org/10.1016/0920-9964(96)85457-0.

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Johnson, Danielle, Dyfrig Hughes, Sir Munir Pirmohamed, and Andrea Jorgensen. "Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials." Journal of Personalized Medicine 9, no. 3 (September 1, 2019): 42. http://dx.doi.org/10.3390/jpm9030042.

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Pharmacogenetics and biomarkers are becoming normalised as important technologies to improve drug efficacy rates, reduce the incidence of adverse drug reactions, and make informed choices for targeted therapies. However, their wider clinical implementation has been limited by a lack of robust evidence. Suitable evidence is required before a biomarker’s clinical use, and also before its use in a clinical trial. We have undertaken a review of five pharmacogenetic biomarker-guided randomised controlled trials (RCTs) and evaluated the evidence used by these trials to justify biomarker inclusion. We assessed and quantified the evidence cited in published rationale papers, or where these were not available, obtained protocols from trial authors. Very different levels of evidence were provided by the trials. We used these observations to write recommendations for future justifications of biomarker use in RCTs and encourage regulatory authorities to write clear guidelines.
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Dissertations / Theses on the topic "Randomised controlled trials (RCTs)"

1

Ferrante, di Ruffano Lavinia. "Using randomised controlled trials to evaluate the clinical effectiveness of diagnostic tests : how useful are test-treatment RCTs?" Thesis, University of Birmingham, 2013. http://etheses.bham.ac.uk//id/eprint/4269/.

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Background: Decisions on which tests to use should be informed by evidence that they do more good than harm. Test-treatment RCTs are recommended as the ‘gold–standard’ approach, but have attracted criticism that question whether they are fit for purpose. Confronting this question, the thesis investigates four key challenges by finding and analysing all identifiable test-treatment RCTs (2004–2007). Methods: Capture–recapture analysis estimated the total population of trials; descriptive analysis characterised the diagnostic questions evaluated by RCT; reviews of reporting and methodological quality investigated how informative and valid trials are; analytic induction was used to develop a theoretical framework linking tests to health outcomes, from which a tool was designed. Results: Published trials were poor quality, and found to be highly complex studies that will be challenging to evaluate reliably: interventions are difficult to capture and translate into protocols; several methods traditionally used to eliminate bias are more difficult to implement; test-treatment strategies impact on patient health in numerous and highly complicated ways. Conclusion: Test-treatment trials have the potential to be very useful instruments, and though highly challenging they could be both reliable and informative. However, it must be acknowledged that trials will not be suited to all comparisons.
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Watson, Hunna J. "Clinical and research developments in the treatment of paediatric obsessive-compulsive disorder." Thesis, Curtin University, 2007. http://hdl.handle.net/20.500.11937/2374.

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It is of crucial importance to identify and disseminate effective treatments for paediatric obsessive-compulsive disorder (OCD). OCD is time-consuming and distressing, and can substantially disable functioning at school, at home, and with peers (Piacentini, 2003). Children who do not receive treatment are at risk of psychological difficulties in adulthood, including continued OCD, clinical anxiety and depression, personality disorders, and social maladjustment (Wewetzer et al., 2001). Two-thirds of adult cases of OCD develop in childhood, and adults with OCD have lower employment, poorer academic achievement, and lower marital rates compared to non-OCD adults (Hollander et al., 1996; Koran, 2000; Lensi et al., 1996; Steketee, 1993). The distressing nature of OCD in childhood, accompanying psychosocial impairment and risk of future psychopathology, underscore the need to identify effective treatments. The primary aim of this thesis was to expand knowledge of evidence-based treatments for paediatric OCD. A mixed-methodology approach was employed to examine key issues in this area. The first study used meta-analytic methodology to determine the evidence supporting available treatments for paediatric OCD. An extensive literature search revealed over 100 published reports of treatments, encompassing a broad array of theoretical approaches and treatment strategies. Examples of treatments used for paediatric OCD included psychodynamic therapy, pharmacotherapy, cognitive-behavioural therapy (CBT), hypnosis, family therapy, immunotherapy, and homeopathy.Study 1 comprised the first known meta-analysis of randomised, controlled treatment trials (RCTs) for paediatric OCD. Included studies were limited to RCTs as they are the most scientifically valid means for determining treatment efficacy and provide a more accurate estimate of treatment effect by removing error variance associated with confounding variables. The literature search identified 13 RCTs containing 10 pharmacotherapy to control comparisons (N = 1016) and 5 CBT to control comparisons (N = 161). Random effects modelling yielded statistically significant pooled effect size (ES) estimates for pharmacotherapy (ES = 0.48, 95% CI = 0.36 to 0.61, p < .00001) and CBT (ES = 1.45, 95% CI = 0.68 to 2.22, p =.002). The results support the efficacy of CBT and pharmacotherapy, and confirm these approaches as the only two evidence-based treatments for paediatric OCD. Implications and suggestions for future research are discussed. The effectiveness of CBT provided impetus to further examine this treatment. Group CBT is an understudied treatment modality among children with OCD. It was hypothesised that group CBT would possess efficacy because of the effectiveness of individual CBT for children with OCD, the demonstrated effectiveness of group CBT among adults with OCD, the practical and therapeutic advantages afforded by a group treatment approach, and the embeddedness of the approach in robust psychological theory. The aim of the second study was to evaluate the efficacy of group CBT. The study comprised the largest known conducted randomised, placebo-controlled trial of group CBT for paediatric OCD.Twenty-two children and adolescents with a primary diagnosis of OCD were randomly assigned to a 12-week program of group CBT or a credible psychological placebo. Children were assessed at baseline, end of treatment, and at 1 month follow-up. Outcome measures included the Children’s Yale-Brown Obsessive-Compulsive Scale, global measures of OCD severity, Children’s Depression Inventory, and parent- and child-rated measures of psychosocial functioning. An intention-to-treat analysis revealed that children in the group CBT condition had statistically significantly lower levels of symptomatology at posttreatment and follow-up compared to children in the placebo condition. Analysis of clinical significance showed that 91% of children that received CBT were ‘recovered’ or ‘improved’ at follow-up, whereas 73% of children in the placebo condition were ‘unchanged’. Effect size analysis using Cohen’s d derived an effect of 1.14 and 1.20 at posttreatment and follow-up, respectively. These effects are comparable to results from studies of individual CBT. This study supported group CBT as an effective treatment modality for paediatric OCD and demonstrated that the effect extends beyond placebo and nonspecific treatment factors. In addition to treatment efficacy, the inherent worth of a treatment lies in its adoption by the relevant clinical population. Children with OCD are known to be secretive and embarrassed about symptoms, and there is often a long delay between onset of symptoms and treatment-seeking (Simonds & Elliot, 2001). An important observation during the course of conducting the RCT was that a high rate (39%) of eligible families declined participation.This led to the question, "What barriers prevent participation in group CBT for paediatric OCD?" Qualitative methodology was employed to address this research question. Eligible families that had declined participation in the RCT were contacted and invited to participate in semi-structured interviews that explored reasons for non-participation and positive and negative perceptions of group CBT. The average time between non-participation and interview was 1.33 years (SD = 3 months). Data were collected from nine families and thematic analysis methodology was utilised to identify emergent themes. Failure to participate was predicted by practical and attitudinal barriers. Practical barriers included a lack of time, distance, severity of OCD symptoms, financial, and child physical health. Attitudinal barriers included child embarrassment about OCD symptoms, child belief that therapy would be ineffective, fear of the social aspect of the group, lack of previous success with psychology, lack of trust in strangers, parental concern about the structure of the group, denial of a problem, and ‘not being ready for it’. Attitudinal barriers more frequently predicted treatment non-participation. Positive and negative perceptions of this treatment modality were informative. Parents showed no differences in preference for individual or group CBT. An important finding was that 56% of the children had not received treatment since parental expression of interest in the group CBT program. Application of the findings to methods that promote service utilisation is discussed.
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3

Watson, Hunna J. "Clinical and research developments in the treatment of paediatric obsessive-compulsive disorder." Curtin University of Technology, School of Psychology, Division of Health Sciences, 2007. http://espace.library.curtin.edu.au:80/R/?func=dbin-jump-full&object_id=115091.

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It is of crucial importance to identify and disseminate effective treatments for paediatric obsessive-compulsive disorder (OCD). OCD is time-consuming and distressing, and can substantially disable functioning at school, at home, and with peers (Piacentini, 2003). Children who do not receive treatment are at risk of psychological difficulties in adulthood, including continued OCD, clinical anxiety and depression, personality disorders, and social maladjustment (Wewetzer et al., 2001). Two-thirds of adult cases of OCD develop in childhood, and adults with OCD have lower employment, poorer academic achievement, and lower marital rates compared to non-OCD adults (Hollander et al., 1996; Koran, 2000; Lensi et al., 1996; Steketee, 1993). The distressing nature of OCD in childhood, accompanying psychosocial impairment and risk of future psychopathology, underscore the need to identify effective treatments. The primary aim of this thesis was to expand knowledge of evidence-based treatments for paediatric OCD. A mixed-methodology approach was employed to examine key issues in this area. The first study used meta-analytic methodology to determine the evidence supporting available treatments for paediatric OCD. An extensive literature search revealed over 100 published reports of treatments, encompassing a broad array of theoretical approaches and treatment strategies. Examples of treatments used for paediatric OCD included psychodynamic therapy, pharmacotherapy, cognitive-behavioural therapy (CBT), hypnosis, family therapy, immunotherapy, and homeopathy.
Study 1 comprised the first known meta-analysis of randomised, controlled treatment trials (RCTs) for paediatric OCD. Included studies were limited to RCTs as they are the most scientifically valid means for determining treatment efficacy and provide a more accurate estimate of treatment effect by removing error variance associated with confounding variables. The literature search identified 13 RCTs containing 10 pharmacotherapy to control comparisons (N = 1016) and 5 CBT to control comparisons (N = 161). Random effects modelling yielded statistically significant pooled effect size (ES) estimates for pharmacotherapy (ES = 0.48, 95% CI = 0.36 to 0.61, p < .00001) and CBT (ES = 1.45, 95% CI = 0.68 to 2.22, p =.002). The results support the efficacy of CBT and pharmacotherapy, and confirm these approaches as the only two evidence-based treatments for paediatric OCD. Implications and suggestions for future research are discussed. The effectiveness of CBT provided impetus to further examine this treatment. Group CBT is an understudied treatment modality among children with OCD. It was hypothesised that group CBT would possess efficacy because of the effectiveness of individual CBT for children with OCD, the demonstrated effectiveness of group CBT among adults with OCD, the practical and therapeutic advantages afforded by a group treatment approach, and the embeddedness of the approach in robust psychological theory. The aim of the second study was to evaluate the efficacy of group CBT. The study comprised the largest known conducted randomised, placebo-controlled trial of group CBT for paediatric OCD.
Twenty-two children and adolescents with a primary diagnosis of OCD were randomly assigned to a 12-week program of group CBT or a credible psychological placebo. Children were assessed at baseline, end of treatment, and at 1 month follow-up. Outcome measures included the Children’s Yale-Brown Obsessive-Compulsive Scale, global measures of OCD severity, Children’s Depression Inventory, and parent- and child-rated measures of psychosocial functioning. An intention-to-treat analysis revealed that children in the group CBT condition had statistically significantly lower levels of symptomatology at posttreatment and follow-up compared to children in the placebo condition. Analysis of clinical significance showed that 91% of children that received CBT were ‘recovered’ or ‘improved’ at follow-up, whereas 73% of children in the placebo condition were ‘unchanged’. Effect size analysis using Cohen’s d derived an effect of 1.14 and 1.20 at posttreatment and follow-up, respectively. These effects are comparable to results from studies of individual CBT. This study supported group CBT as an effective treatment modality for paediatric OCD and demonstrated that the effect extends beyond placebo and nonspecific treatment factors. In addition to treatment efficacy, the inherent worth of a treatment lies in its adoption by the relevant clinical population. Children with OCD are known to be secretive and embarrassed about symptoms, and there is often a long delay between onset of symptoms and treatment-seeking (Simonds & Elliot, 2001). An important observation during the course of conducting the RCT was that a high rate (39%) of eligible families declined participation.
This led to the question, "What barriers prevent participation in group CBT for paediatric OCD?" Qualitative methodology was employed to address this research question. Eligible families that had declined participation in the RCT were contacted and invited to participate in semi-structured interviews that explored reasons for non-participation and positive and negative perceptions of group CBT. The average time between non-participation and interview was 1.33 years (SD = 3 months). Data were collected from nine families and thematic analysis methodology was utilised to identify emergent themes. Failure to participate was predicted by practical and attitudinal barriers. Practical barriers included a lack of time, distance, severity of OCD symptoms, financial, and child physical health. Attitudinal barriers included child embarrassment about OCD symptoms, child belief that therapy would be ineffective, fear of the social aspect of the group, lack of previous success with psychology, lack of trust in strangers, parental concern about the structure of the group, denial of a problem, and ‘not being ready for it’. Attitudinal barriers more frequently predicted treatment non-participation. Positive and negative perceptions of this treatment modality were informative. Parents showed no differences in preference for individual or group CBT. An important finding was that 56% of the children had not received treatment since parental expression of interest in the group CBT program. Application of the findings to methods that promote service utilisation is discussed.
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4

Berrisford, Isabelle C. "Dual Agency of Physician-Researchers: The Role of Equipoise in RCTs in Preserving the Integrity of the Physician-Researcher Role During Public Health Crises." The Ohio State University, 2021. http://rave.ohiolink.edu/etdc/view?acc_num=osu1619164005499914.

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5

Relton, Clare. "A new design for pragmatic randomised controlled trials : a 'Patient Cohort' RCT of treatment by a homeopath for menopausal hot flushes." Thesis, University of Sheffield, 2009. http://etheses.whiterose.ac.uk/6644/.

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There is debate regarding the effectiveness of homeopathy and its continuing provision in the NHS, and despite 150+ clinical trials there are conflicting opinions as to what can be concluded from these trials. This thesis addresses the question: “What type of clinical trial design can provide the information needed to make decisions about the provision of homeopathy in a publicly funded healthcare system?” A critique of the methods used in existing clinical trial designs was undertaken which identified twelve key criteria for appropriate clinical trial design; methods from existing standard and alternative clinical trial designs were adapted in order to derive a new clinical trial design that has the potential to meet all twelve key criteria (the ‘Patient Cohort’ RCT design). A current clinical question was identified: ‘What is the clinical & cost effectiveness of treatment by a homeopath for women with menopausal hot flushes?” and a population based survey confirmed the importance of this question. The ‘Patient Cohort’ RCT design was piloted in an NHS setting in order to address this current clinical question. Seventy ‘with need’ women were recruited to the Hot Flush Cohort of whom forty-eight were eligible for the treatment, a proportion of whom were randomly selected to be offered the treatment. 70.8% of those offered treatment accepted the offer and completion of outcome measures was high (93.7%). The results indicate that a full trial of this treatment for this condition may be worthwhile conducting. A full RCT using this design would be an appropriate clinical trial design to provide answers as to the provision of homeopathy and other clinician delivered interventions in publicly funded healthcare system such as the NHS. The ‘Patient Cohort’ RCT design can be usefully applied to clinical questions that require very pragmatic approaches yet need the scientific rigour of randomisation.
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Ford, Shane Alwyn. "Delivering Acceptance and Commitment Therapy (ACT) for mental health disorders across group and guided self-help formats : a meta-analysis and randomised controlled trial." Thesis, University of Edinburgh, 2017. http://hdl.handle.net/1842/25924.

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Background: Acceptance and Commitment Therapy (ACT) has shown promise as an effective intervention in the treatment of mental health disorders. In the last decade, the delivery of ACT has expanded to include various formats (e.g. groups, self-help, online and phone apps). Further research is needed to evaluate whether such delivery formats are a viable extension of ACT. Furthermore, the existing evidence base of certain alternative delivery formats have yet to be reviewed. This thesis portfolio sought to contribute to this area of research. Methods: A systematic review of the literature was conducted to investigate the efficacy of group-based interventions for mental health disorders using ACT. Five databases were systematically searched, manual searches were conducted and corresponding authors were contacted. Studies which used a randomised-controlled design, with adult samples and investigated group-based ACT interventions for mental health disorders were included. A meta-analysis of the included studies was conducted for post-intervention and follow-up data. In the empirical study, an ACT manual was trialled using a randomised-controlled design to investigate the efficacy of using ACT in a guided self-help context. Participants with anxiety/depression were randomly assigned to receive either the ACT intervention or treatment as usual (TAU). Those in the ACT group were posted an ACT manual and received two telephone calls. Outcome measures were analysed after the six-week intervention. Results: From the meta-analysis, 18 randomised-controlled trials were identified, 14 of which focussed on anxiety and depression. The findings suggest that ACT-based groups have a large effect on symptom reduction when compared to non-active comparisons at post-treatment and a moderate effect when compared to non-active comparisons at follow-up. Additionally, there was a small effect in favour of ACT when compared to active treatment controls at post-treatment and equivalent effects when comparing ACT to active treatment controls at follow-up. Similar effects were found when separately comparing the 14 studies which focussed primarily on anxiety and depression. The empirical study revealed that guided self-help was found to be no more effective in improving quality of life or reducing psychological distress than the TAU group. However, such results should be interpreted with caution as the small sample size and high attrition rate indicates that further research with larger samples and follow-up are needed before strong conclusions can be made. Conclusions: The findings of this research indicate that group-based ACT interventions may be a suitable alternative delivery format for service providers in the provision of common mental health disorders, particularly anxiety and depression. Further research is needed before any strong conclusions can be made regarding the efficacy of guided self-help for anxiety/depression.
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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn, and Timo Siepmann. "Randomized controlled trials - a matter of design." Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2017. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-215848.

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Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.
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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn, and Timo Siepmann. "Randomized controlled trials - a matter of design." Dove Medical Press, 2016. https://tud.qucosa.de/id/qucosa%3A29007.

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Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.
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Ulucanlar, Selda. "Randomised controlled trials and equipoise." Thesis, University of Bristol, 2010. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.535188.

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Dakin, Helen A. "Economic evaluation of factorial randomised controlled trials." Thesis, University of Oxford, 2015. http://ora.ox.ac.uk/objects/uuid:77eda1f6-dd8c-439a-8871-75fd57a4c7f5.

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Factorial randomised controlled trials (RCTs) evaluate two or more interventions simultaneously, enabling assessment of interactions between treatments. This thesis presents literature reviews, methodological reviews, simulation studies and applied case studies that explore methods for assessing cost-effectiveness based on factorial RCTs. My systematic review suggests that factorial RCTs account for around 3% of trial-based economic evaluations, although there is currently no guidance or methodological work indicating the most appropriate methods. Around 40% of published studies assumed no interaction between treatments and many were poorly-reported. Various mechanisms are likely to produce large interactions within economic endpoints such as costs, quality-adjusted life-years (QALYs) and net benefits. Failing to take account of interactions can introduce bias and prevent efficient allocation of healthcare resources. I developed the opportunity cost of ignoring interactions as a measure of the implications of this bias. However, allowing for small, chance interactions is inefficient, potentially leading to over-investment in research if trial-based evaluations are used to inform decisions about subsequent research. Nonetheless, analyses on simulated trial data suggest that the opportunity cost of adopting a treatment that will not maximise health gains from the healthcare budget is minimised by including all interactions regardless of magnitude or statistical significance. Different approaches for conducting economic evaluations of factorial RCTs (including regression techniques, extrapolation using patient-level simulation, and considering different components of net benefit separately) are evaluated within three applied studies, including both full and partial factorials with 2x2 and 2x2x2 designs. I demonstrate that within both trial-based and model-based economic evaluation, efficient allocation of healthcare resources requires consideration of interactions between treatments, and joint decisions about interacting treatments based on incremental cost-effectiveness evaluated “inside-the-table” on a natural scale. I make recommendations for the design, analysis and reporting of factorial trial-based economic evaluations based on the results of this thesis.
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Books on the topic "Randomised controlled trials (RCTs)"

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Brass, Clinton T. Congress and program evaluation: An overview of randomized controlled trials (RCTs) and related issues. New York: Nova Science Publishers, 2008.

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Randomised controlled clinical trials. 2nd ed. Boston: Kluwer Academic Publishers, 1996.

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Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1.

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J, Hayes Richard, and Hayes Richard J. Cluster randomised trials. Boca Raton: Taylor & Francis, 2009.

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Song, F. Antimicrobial prophylaxis in colorectal surgery: A systematic review of randomised controlled trials. Alton: Core Research, on behalf of the NCCHTA, 1998.

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Eldridge, Sandra. A practical guide to cluster randomised trials in health services research. Chichester, West Sussex: John Wiley & Sons, 2011.

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Campbell, Michael J. How to design, analyse and report cluster randomised trials in medicine and health related research. Chichester, West Sussex: John Wiley & Sons, 2014.

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Torgerson, David J. Designing and running randomised trials in health, education, and the social sciences. New York: Palgrave Macmillan, 2008.

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Horsfall, Tessa Ann. What is the evidence to suggest that early supported discharge for patients following a stroke is a feasible alternative to usual care and rehabilitation of randomised controlled trials. Oxford: Oxford Brookes University, 2003.

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Robb, Sheri L., and Debra S. Burns. Randomized Controlled Trials in Music Therapy. Edited by Jane Edwards. Oxford University Press, 2015. http://dx.doi.org/10.1093/oxfordhb/9780199639755.013.14.

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Randomized controlled trials (RCTs) are experiments that compare two or more groups of participants, and participants are assigned to groups based on chance. Groups include an experimental intervention group that is being compared to a treatment as usual, a low dose or attention control condition, and/or a comparative treatment group. The purpose of randomization is to equalize groups on both known and unknown characteristics that may influence the outcome and the effectiveness of the intervention. This chapter describes how music therapists have used RCTs to demonstrate the effectiveness of music therapy interventions and services. Key strategies for implementing RCT designs are presented, and studies in music therapy that have used this design are reviewed.
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Book chapters on the topic "Randomised controlled trials (RCTs)"

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O’Flynn, Kieran. "Randomised Controlled Trials (RCTs)." In Imaging and Technology in Urology, 357–60. London: Springer London, 2012. http://dx.doi.org/10.1007/978-1-4471-2422-1_79.

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Suzuki, Aya, and Vu Hoang Nam. "Blue Revolution in Asia: The Rise of the Shrimp Sector in Vietnam and the Challenges of Disease Control." In Emerging-Economy State and International Policy Studies, 289–303. Singapore: Springer Nature Singapore, 2022. http://dx.doi.org/10.1007/978-981-19-5542-6_21.

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AbstractThe aquaculture sector has grown rapidly over the last two decades, particularly in Asia, providing a larger share of seafood for human consumption than capture fisheries. It has received attention for its contribution to poverty reduction and nutrition improvement for the poor. In this essay, we illustrate the brief history of the development of the aquaculture sector in Asia and present a case of the shrimp sector in Vietnam, one of the largest exporters in the global market in recent years. We show how the sector has developed, particularly in relation to rice production, using nationally-representative household-level data. We then examine a persistent challenge faced by the sector, the frequent occurrence of disease outbreaks, based on our analyses using primary data and randomized controlled trials (RCTs). Specifically, we consider the role of spillovers among farmers and the importance of quantifying unobserved qualities in promoting the adoption of good practices. The effectiveness of digital technology in this area is discussed.
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Michael, Mike, and Marsha Rosengarten. "A Brief and Partial History of Randomized Controlled Trials (RCTs) in the Context of HIV Prevention and Treatment." In Innovation and Biomedicine, 18–44. London: Palgrave Macmillan UK, 2013. http://dx.doi.org/10.1057/9781137316677_2.

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Shoff, William H., Catherine T. Shoff, Suzanne M. Shepherd, Jonathan L. Burstein, Calvin A. Brown, Ashita J. Tolwani, Bala Venkatesh, et al. "Randomized Controlled Trial (RCT)." In Encyclopedia of Intensive Care Medicine, 1951. Berlin, Heidelberg: Springer Berlin Heidelberg, 2012. http://dx.doi.org/10.1007/978-3-642-00418-6_3279.

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Stewart, Antony. "Randomised controlled trials." In Basic Statistics and Epidemiology, 125–27. 5th ed. London: CRC Press, 2022. http://dx.doi.org/10.1201/9781003148111-31.

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Abdulla, Adam. "Randomised controlled trials." In Coaching Students in Secondary Schools, 177–88. Abingdon, Oxon ; New York, NY : Routledge, 2018.: Routledge, 2017. http://dx.doi.org/10.4324/9781315113494-19.

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Olsen, Jørn, Kaare Christensen, Jeff Murray, and Anders Ekbom. "The Randomized Controlled Trial (RCT)." In An Introduction to Epidemiology for Health Professionals, 81–84. New York, NY: Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-1497-2_12.

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Torgerson, David J., and Carole J. Torgerson. "Factorial Randomised Controlled Trials." In Designing Randomised Trials in Health, Education and the Social Sciences, 114–18. London: Palgrave Macmillan UK, 2008. http://dx.doi.org/10.1057/9780230583993_11.

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Torgerson, David J., and Carole J. Torgerson. "Pilot Randomised Controlled Trials." In Designing Randomised Trials in Health, Education and the Social Sciences, 119–26. London: Palgrave Macmillan UK, 2008. http://dx.doi.org/10.1057/9780230583993_12.

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Torgerson, David J., and Carole J. Torgerson. "Cluster Randomised Controlled Trials." In Designing Randomised Trials in Health, Education and the Social Sciences, 99–107. London: Palgrave Macmillan UK, 2008. http://dx.doi.org/10.1057/9780230583993_9.

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Conference papers on the topic "Randomised controlled trials (RCTs)"

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Meeraus, Wilhelmine, Hana Mullerova, Maggie Tabberer, William A. Fahy, and Victoria S. Benson. "Systematic review of COPD re-exacerbation and exacerbation treatment failure definitions used in randomised controlled trials (RCTs)." In ERS International Congress 2018 abstracts. European Respiratory Society, 2018. http://dx.doi.org/10.1183/13993003.congress-2018.pa1171.

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Pahus, Laurie, Pierre-Régis Burgel, Jean-Louis Paillasseur, Nicolas Roche, and Pascal Chanez. "Applicability of randomized controlled trials (RCTs) results to real-life patients in COPD." In ERS International Congress 2017 abstracts. European Respiratory Society, 2017. http://dx.doi.org/10.1183/1393003.congress-2017.pa3245.

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Koroleva, Anna, and Patrick Paroubek. "Extracting relations between outcomes and significance levels in Randomized Controlled Trials (RCTs) publications." In Proceedings of the 18th BioNLP Workshop and Shared Task. Stroudsburg, PA, USA: Association for Computational Linguistics, 2019. http://dx.doi.org/10.18653/v1/w19-5038.

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Aboelbaha, Shimaa, Monica Zolezzi, and Hazem Elewa. "Effect of Pharmacogenetic-Based Decision Support Tools in Improving Depression Outcomes: A Systematic Review." In Qatar University Annual Research Forum & Exhibition. Qatar University Press, 2021. http://dx.doi.org/10.29117/quarfe.2021.0104.

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Introduction: Evidence supporting pharmacogenetic (PGX) tests utility in depression is scarce. The main objectives of this study were to summarize, update, and assess the quality of the available evidence regarding PGX testing in depression as well as estimating the impact of using PGX testing tools in depression outcomes in the MENA region. Methodology: Scientific databases were systematically searched from inception to March 20, 2020 for systematic reviews (SRs) and randomized controlled trials (RCTs) assessing clinical utility of PGX tests in treatment of depression. Meta-analysis only and RCTs that that were included in eligible SRs were excluded. Quality of the eligible studies were assessed using Crowe Critical Appraisal Tool (CCAT). Results: Six SRs and three RCTs met the inclusion criteria and were included in this study. Results of the SRs have provided weak evidence on the efficacy of PGX testing especially in patients with moderate-severe depression at eight weeks. In addition, there was a lack of evidence regarding safety outcomes. Newer RCTs with better qualities showed clinical promise regarding efficacy outcomes especially in patients with gene-drug interactions. No evidence was found regarding PGX testing impact in the MENA region. Conclusion: This SR summarizes findings, provides an update, and assesses the quality of available SRs on this topic. Findings of this study have demonstrated that PGX testing prior to treatment initiation might improve efficacy outcomes. Further studies are warranted to assess PGX testing impact on safety outcomes.
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Gomes Vieira Carvalho, Thainá, Joyce Mothé de Souza, Elisa Haddad Pessanha Rangel, Caio Gomes Muniz, Julia Maria Maia de Azevedo, and Luciano Matos Chicayban. "Bronchial hygiene technique in patients with cystic fibrosis." In 7th International Congress on Scientific Knowledge. Biológicas & Saúde, 2021. http://dx.doi.org/10.25242/8868113820212402.

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Cystic Fibrosis is characterized by excess pulmonary secretions that cause recurrent respiratory infections, with consequent deterioration of gas exchange. Bronchial hygiene techniques aim to mobilize secretions from the peripheral airways so that they can be eliminated by coughing or tracheal aspiration. To identify the effects of different bronchial hygiene techniques on improving lung function in patients with Cystic Fibrosis. Through a systematic review of the literature, randomized controlled trials (RCTs) published between 2007 and 2021 were selected, according to the highest score in the PEDro score. The search involved the PEDro and PubMed databases, using the following keywords: bronchial hygiene. Six ECR`s were included. One study performedthe techniques during anesthesia and observed increased resistance and reduced compliance. Regarding FEV1, 3 RCTs with hospitalized patients showed improvement in lung function, regardless of the technique used. In outpatients, there was no improvement. Regarding secretion weight, the cough machine produced more secretion than autogenous drainage, as well as a drop in saturation after the 2-min walk test, and increased FEV1. Bronchial hygiene techniques in patients with cystic fibrosis have been shown to be effective in removing mucus, with consequent improvement in lung function and aerobic fitness.
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Ongenda, Inès, and Léa Leufflen. "2022-RA-156-ESGO Minimally invasive versus open abdominal approaches for early-stage cervical and endometrial cancer: a meta-analysis of prospective randomised controlled trials (RCTs)." In ESGO 2022 Congress. BMJ Publishing Group Ltd, 2022. http://dx.doi.org/10.1136/ijgc-2022-esgo.393.

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Leung, Janice M., Junfeng Sun, Yan Li, Judith Welsh, Charles Natanson, and Peter Q. Eichacker. "Academic Centers Investigating ARDS/ALI Therapies From 2000-2007: Tidal Volume (TV) Practices Differ Outside Vs. Within Randomized Controlled Trials (RCTs)." In American Thoracic Society 2012 International Conference, May 18-23, 2012 • San Francisco, California. American Thoracic Society, 2012. http://dx.doi.org/10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a3182.

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Oliveira, Diogo Abrantes de, Enzo Tibiriçá de Rezende, Larissa Rodrigues Sotto Maior, Nathália Vieira Caires, Vanessa Teixeira Miquelito, Alexandre Jahara Moreira Gomes Teixeira, Arthur Neves Egídio, Carolina Mendonça Cyranka, Guilherme Rufino Marques Pellegrin, and Leandro de Souza Cruz. "Therapeutic impact of hypothermia in traumatic brain injury management: systematic review." In XIII Congresso Paulista de Neurologia. Zeppelini Editorial e Comunicação, 2021. http://dx.doi.org/10.5327/1516-3180.208.

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Background: Traumatic brain injury(TBI) is an important component of mortality rate(MR) among young adults. Hypothermia(HT) is a treatment with questionable efficacy, given existing discordant views. Objective: investigate the performance of HT in TBI. Methods: Randomized controlled trials(RCT) from PUBMED, over the last five years, were analysed through the descriptors “Traumatic brain injury”; “Therapeutic hypothermia” and its MeSH variations. RCTs in individuals over 19 were included. After criteria were applied, four were selected for this review. This systematic review was submitted for registration on the PROSPERO plataform(ID: 253817). Results: Eurotherm3235 segregated n=387 to a group subjected to HP and another to standard treatment, evaluating them through the Glasgow Scale. The RCT was interrupted due potential damage to the participants, and showed greater MR(p <0.05) in the experimental group (EG). The POST-HOC of the B-HYPO sorted n=129 into a control group on fever management, and another group subjected to HT, separating them according to the injury. The patients with minor severity from the EG showed higher MR(p <0.05). The RCT from Chunhai T et al.(n=60) subjected to decompressive hemicraniectomy, which were divided into those who received HT, and a control group, displaying an inferior MR in the EG (p<0.05). Feng JZ et al. with n=14 subjected the EG to HT, and analysed the participants through the magnetic resonance metabolomics, showing lesser MR and better recovery in the EG(p<0.05). Conclusion: The studies indicated disparate results. However, those with larger samples indicated worse prognosis between patients subjected to HT.
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Boissel, J. P., J. C. Peyrieux, J. M. Destors, M. Lievre, and P. Moleur. "PREVENTION OF SYSTEMIC THROMBO-EMBOLISM IN PATIENTS WITH ATHEROSCLEROTIC INTERMITTENT CLAUDICATION." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1643461.

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Ticlopidine (TI), an anti-aggregating agent which inhibits the ADP-pathway has been tested in patients with intermittent claudication (IC) in 11 randomized clinical trials (RTCs).As expected, a significant reduction of cardio-vascular events (CVE) due to systemic thrombo-embolism was observed in the 2 larger. Reduction in the number of CVE due to systemic thromboembolism in any arterial bed was observed. This prompted us to confirm the hypothesis that TI was beneficial in preventing systemic thrombo-embolism in patients with IC. Four RCTs from the 11 were blindly selected on the basis on pre-set selection criteria : placebo controlled, more than 1 month duration, , less than 5 % lost-to-follow-up (index of quality), parallel groups, proven atherosclerotic disease. Meta-analysis was performed with 5 statistical methods which gave consistent findings : as compared to 311 patients on placebo, the 301 patients on TI have had a 66 % reduction in the number of CVE during the 6 months of follow-up (9.0 % to 3 % , p = 0.002). Walking distance, a secondary objective of meta-analysis, doubled in 42 % of the patients on TI as against 27 % (p = 0.0005).It was concluded that TI 250 mg b.i.d. prevents CVE in patients with atherosclerotic IC.
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Relton, Clare. "Randomised Controlled Trials." In HRI London 2019—Cutting Edge Research in Homeopathy: Presentation Abstracts. The Faculty of Homeopathy, 2020. http://dx.doi.org/10.1055/s-0040-1702078.

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Reports on the topic "Randomised controlled trials (RCTs)"

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Landon, Tess, and Harald Hochreiter. Randomised controlled trials and other experimental approaches in the Austrian Research Promotion Agency. Fteval - Austrian Platform for Research and Technology Policy Evaluation, April 2022. http://dx.doi.org/10.22163/fteval.2022.554.

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The objective of this paper/presentation is to highlight how experimental approaches, specifically Randomised Controlled Trials (RCTs), can be leveraged to evaluate and measure the impact of new programmes, support programme development and test new services in funding and innovation agencies. RCTs are seen in many facets of public policy, however RCTs as a method for innovation agencies to evaluate new initiatives is relatively new. We present three RCTs implemented in the Austrian Research Promotion Agency (FFG) that have received funding from the European Union’s Horizon 2020 research and innovation programme. The trials are implemented to evaluate the effectiveness of new measures intended to help strengthen R&I in start-ups and SMEs. Through these three examples, we aim to demonstrate the advantages in which RCTs can augment the evaluation of new services as well as challenges that come with implementing RCTs. For one RCT, we will present final results. Two RCTs are ongoing, and we will present the trial design. We also discuss the operational aspects of incorporating experimentation in an innovation agency.
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Villa, Michele, Massimo Le Pera, and Michela Bottega. Quality of Abstracts in Randomized Controlled Trials Published in Leading Critical Care Nursing Journals. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, June 2022. http://dx.doi.org/10.37766/inplasy2022.6.0039.

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Review question / Objective: This review aims to evaluate the methodological quality of RCT-abstracts in leading critical care nursing journals. A methodological quality review with the Consolidated Standards of Reporting Trials (CONSORT) criteria will be performed in RCT-abstracts published between 2011-2021 in the first Scopus-ranking (2021) nursing journals. Eligibility criteria: Abstracts of scientific articles will be included if they fulfil the following inclusion criteria: 1) they report the results of parallel and/or cross-over group RCTs, 2) they are written in English, 3) they refer to the care of adult patients with acute/critical illness or conducted in adult ICUs.Manuscripts reporting results of pilot or feasibility studies, cluster trials, observational or cohort studies, interim analyses, economic analyses of RCTs, post-trial follow-up studies, subgroup and secondary analyses of previously published RCTs, editorials and RCTs without an abstract such as RCTs published as letters to the editor, single-subject clinical trials will be excluded.
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Yan, Miao, Shuang Xia, and Yichang Zhao. Risk of sepsis in cancer patients treated with immune checkpoint inhibitors: a safety meta-analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, April 2022. http://dx.doi.org/10.37766/inplasy2022.4.0174.

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Review question / Objective: The aim of this meta-analysis is to estimate the risk of sepsis in cancer patients treated with immune checkpoint inhibitors in randomized controlled trials (RCTs). Condition being studied: Sepsis-related toxicities in cancer patients received immune checkpoint inhibitors. Information sources: Electronic databases:Medline; Embase; Central; Trial registers: ClinicalTrails.gov. EU Clinical Trials Register. International Clinical Trials Registry Platform. Regarding RCTs for which we had neither available adverse events on ClinicalTrials.gov nor available adverse events in publications, corresponding authors or sponsors of the study were contacted by e-mail to provide the required information.
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Yang, Xiangfeng, Yunlong Li, Yuanzhe Li, Qing Guo, and Xiangyu zhong. Effectiveness of Machine Perfusion Used in Liver Transplantation: A Meta-analysis of Randomized Controlled Trials (RCTs). INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, November 2022. http://dx.doi.org/10.37766/inplasy2022.11.0018.

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Tsai, I.-Chen, and Ke-Vin Chang. Effectiveness of Coenzyme Q10 for Reducing Fatigue: a Systematic Review and Meta-analysis of Randomized Controlled Trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, January 2022. http://dx.doi.org/10.37766/inplasy2022.1.0113.

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Review question / Objective: To investigate the treatment effect of CoQ10 on fatigue syndromes. Eligibility criteria: To generate a recruited study list, the following inclusion criteria will be used: (1) randomized controlled trials (RCTs) enrolling human participants, (2) RCTs investigating the quantitative evaluation of fatigue symptoms before and after CoQ10 supplement, (3) placebo-controlled trials (without limitation of age and treatment duration ) and (4) trials with available data of pre- and post-intervention fatigue assessment or changes in fatigue scores. In this meta-analysis, open-label studies were also included since recent studies found that the open-label placebo had similar efficacy as the double-blind one.
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Luo, Jing, Chen Zhang, Mengjie Xia, and Yuelian Chen. Acupoint catgut embedding reduces postoperative pain of mixed hemorrhoids: a meta-analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, February 2022. http://dx.doi.org/10.37766/inplasy2022.2.0021.

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Review question / Objective: Can acupoint catgut embedding alleviate postoperative pain of mixed hemorrhoids? Condition being studied: Mixed hemorrhoids. Information sources: Two authors (JL and CZ) will examine the publications independently and extract data according to predefined criteria. RCTs will be assessed for the methodology, study design, inclusion and exclusion criteria, and outcome measures. The methodological quality of each RCT will be recorded for method of randomization, blinding, protocol violation, and allocation concealment Any disagreement will be resolved by consensus discussions with the senior member of the review team (MJX and YLC). Data to collect includes intervention and control measures, measured outcomes and statistical significant difference with regards to chewing gum.
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Luo, Jing, Chen Zhang, Xiaoping Wu, and Rongrong Ren. The effect of acupoint catgut embedding and drug therapy on hyperlipidemia: a meta-analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, February 2022. http://dx.doi.org/10.37766/inplasy2022.2.0019.

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Review question / Objective: Acupoint catgut embedding and drug treatment of hyperlipidemia compared, which is better. Condition being studied: Hyperlipidemia. Information sources: Two authors (JL and CZ) will examine the publications independently and extract data according to predefined criteria. RCTs will be assessed for the methodology, study design, inclusion and exclusion criteria, and outcome measures. The methodological quality of each RCT will be recorded for method of randomization, blinding, protocol violation, and allocation concealment Any disagreement will be resolved by consensus discussions with the senior member of the review team (XP W). Data to collect includes intervention and control measures, measured outcomes and statistical significant difference with regards to chewing gum.
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Cao, Shudian, Soh Kim Geok, R. Samsilah, H. Sun, Soh Kim Lam, and J. Liu. Does Brief Mindfulness-Based Interventions Improve Sport-Related Performance? A Systematic Review. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, December 2022. http://dx.doi.org/10.37766/inplasy2022.12.0086.

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Review question / Objective: This review aims to know whether brief mindfulness-based interventions could Improve sport-related performance. Eligibility criteria: 1. Full-text article published in English or Chinese 2. Participants who reported mindfulness experience were no more than 5% of total sample size3. Study used the brief mindfulness-based intervention in experimental group4. Without mindfulness intervention in control group5. Outcome measures are sport-related performance6. randomized controlled trials (RCTs), non-randomized controlled trials (nRCTs) and non-randomized non-controlled trials (nRnCTs) with two or more groups and single-group trials.
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Liao, Jian-Qiang, Darrell Shih, Tzu-Yu Lin, Meng Lee, and Cheng-Wei Lu. Appropriate dosing of sugammadex for reversal of rocuronium-/vecuronium-induced muscle relaxation in morbidly obese patients: a meta-analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, April 2022. http://dx.doi.org/10.37766/inplasy2022.4.0130.

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Review question / Objective: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to compare the effect of lower-dose sugammadex using IBW or CBW as dosing scalars, with that of standard-dose sugammadex based on TBW, on reversal time, defined as time to recovery of train of four ratio (TOFR) ≥ 0.9, among morbidly obese people after moderate or deep NMB with either rocuronium or vecuronium. Eligibility criteria: We included only randomized controlled trials (RCTs) that compared TBW with other dosing scalars for sugammadex. Studies not published in full text articles or in languages other than English were excluded. Trials that included patients above 18 years of age and BMI more than or equal to 40 who underwent general anaesthesia with any degree of NMB induced by either rocuronium or vecuronium. Trials that evaluated TBW and other dosing scalars for sugammadex were included. We included trials that compared TBW with any other dosing scalars for sugammadex. Trials that did not include dosing based on TBW as one arm in the comparison were excluded.
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Wang, Jiajie, Wei Huang, Yanji Zhang, Zhengrong Zhao, and Zhongyu Zhou. Acupuncture and related interventions for the treatment of obesity: protocol for a scoping review of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, March 2022. http://dx.doi.org/10.37766/inplasy2022.3.0099.

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Review question / Objective: The purpose of this study is to summarize the characteristics of RCT in the treatment of obesity by acupuncture and other related intervention measures, so as to enhance evidence-based clinical practice about acupuncture for obesity. Condition being studied: Obesity is a chronic metabolic disease that is defined as a body's excessive accumulation or abnormal distribution of total or local fat content. Their complications such as Type II diabetes mellitus, hyperlipidemia, and cardiovascular diseases are strongly related to higher risks of mortality. In recent years, with the changes in diet structure and living habits, 1.9 billion adults were overweight and over 650 million were obese according to the report by the WHO in 2016. Acupuncture is a characteristic therapy of traditional Chinese medicine, which is effective and safe for the treatment of simple obesity. In recent years, many RCTs using acupuncture in simple obesity were carried out within and outside of China. But currently, acupuncture treatment has no uniform standard, and there are a number of problems with this current clinical application of modern Chinese Medicine. Unfortunately, there is an absence of high-quality data supporting their use. This scoping review aims to summarize the characteristics of RCT in the treatment of obesity by acupuncture and other related intervention measures, so as to enhance evidence-based clinical practice about acupuncture and moxibustion for obesity.
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