Randomized Controlled Trials in Psychiatry. Part II: Their Relationship to Clinical Practice

2003 ◽  
Vol 37 (3) ◽  
pp. 265-269 ◽  
Author(s):  
Roger T. Mulder ◽  
Chris Frampton ◽  
Peter R. Joyce ◽  
Richard Porter
Keyword(s):  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
External Validity ◽  
Internal Validity ◽  
Small Samples ◽  
Controlled Trials ◽  
Treatment Protocols ◽  
Randomized Controlled ◽  
Clinical Conditions ◽  
Internal And External Validity

Objective: To discuss the extent to which the results of randomized controlled trials (RCTs) in psychiatry can be generalized to clinical practice. Method: Threats to internal and external validity in psychiatric RCTs are reviewed. Results: Threats to internal validity increase the possibility of bias. Psychiatric RCTs have problems with small samples, arbitrary definitions of caseness, disparate definitions of outcome and high spontaneous recovery rates. Particular issues arise in psychotherapy RCTs. Threats to external validity reduce the extent to which the results of a RCT produce a correct basis for generalization to other circumstances. These include high rates of comorbidity and sub syndromal pathology in normal clinical practice, manual-based treatment protocols and varying definitions of successful treatment. Conclusions: Randomized controlled trials remain the most robust design to investigate the effectiveness of treatments. They should be applied to important clinical questions; and carried out, as far as possible, with typical patients in the clinical conditions in which the treatment is likely to be used.

scholarly journals Experimental and Non-Experimental Methods in Development Economics: A Porous Dialectic

2015 ◽  
Vol 6 (1) ◽  
Author(s):  
Rajeev Dehejia
Keyword(s):  
Randomized Controlled Trials ◽  
External Validity ◽  
Internal Validity ◽  
Experimental Methods ◽  
Controlled Trials ◽  
Data Sets ◽  
Randomized Controlled ◽  
Nationally Representative ◽  
High Degree ◽  
Internal And External Validity

AbstractThis paper surveys six widely-used non-experimental methods for estimating treatment effects (instrumental variables, regression discontinuity, direct matching, propensity score matching, linear regression and non-parametric methods, and difference-in-differences), and assesses their internal and external validity relative both to each other and to randomized controlled trials. While randomized controlled trials can achieve the highest degree of internal validity when cleanly implemented in the field, the availability of large, nationally representative data sets offers the opportunity for a high degree of external validity using non-experimental methods. We argue that each method has merits in some context and they are complements rather than substitutes.

scholarly journals External Validity and Worksite Wellness: Lessons From China and Illinois

2020 ◽  
Vol 35 (1) ◽  
pp. 9-12
Author(s):  
Paul E. Terry
Keyword(s):  
Best Practices ◽  
Randomized Controlled Trials ◽  
External Validity ◽  
Careful Consideration ◽  
Controlled Trials ◽  
Worksite Wellness ◽  
Randomized Controlled ◽  
Negative Findings ◽  
New Evidence ◽  
Internal And External Validity

This editorial describes recent randomized controlled trials of worksite wellness interventions and argues that fidelity to intervention designs should be contingent on careful consideration of internal and external validity. A China based hypertension management study which achieved impressive outcomes across 60 workplaces using a comprehensive approach is contrasted with the traditional wellness practices employed in other randomized controlled trials conducted in America. Why studies with negative findings receive more media and professional scrutiny than studies with positive findings is discussed. Three reasons are posited for why bad is stronger than good when it comes to capturing attention. Adoption of new evidence is discussed along with what health promotion professionals can do to advance best practices by considering adoption as an ongoing process.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

Tools to Assess the External Validity of Randomized Controlled Trials in Systematic Reviews: a Systematic Review of Measurement Properties

2021 ◽  
Author(s):  
Andres Jung ◽  
Julia Balzer ◽  
Tobias Braun ◽  
Kerstin Luedtke
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
External Validity ◽  
Measurement Properties ◽  
Controlled Trials ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Quality Of Evidence ◽  
Randomized Controlled

Abstract Background: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs in systematic reviews and to evaluate the quality of evidence regarding their measurement properties.Methods: A two-phase systematic literature search was performed in four databases: MEDLINE via PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies aiming to investigate the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.Results: 34 publications reporting on the development or validation of 26 included tools were included. For 62% of the included tools, there was no evidence of any measurement property. For the remaining tools, reliability was assessed most frequently. Reliability was judged as “sufficient” for three tools (very low quality of evidence). Content validity was rated as “sufficient” for one tool (moderate quality of evidence).Conclusions: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a new one. There is a need for more research for this purpose.Trial registration: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D

scholarly journals Leveraging Data Science for a Personalized Haemodialysis

2020 ◽  
Vol 6 (6) ◽  
pp. 385-394
Author(s):  
Miguel Hueso ◽  
Lluís de Haro ◽  
Jordi Calabia ◽  
Rafael Dal-Ré ◽  
Cristian Tebé ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Kidney Disease ◽  
Personalized Medicine ◽  
Data Collection ◽  
Randomized Controlled Trials ◽  
Data Science ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Use Of Data ◽  
The Right

<b><i>Background:</i></b> The 2019 Science for Dialysis Meeting at Bellvitge University Hospital was devoted to the challenges and opportunities posed by the use of data science to facilitate precision and personalized medicine in nephrology, and to describe new approaches and technologies. The meeting included separate sections for issues in data collection and data analysis. As part of data collection, we presented the institutional ARGOS e-health project, which provides a common model for the standardization of clinical practice. We also pay specific attention to the way in which randomized controlled trials offer data that may be critical to decision-making in the real world. The opportunities of open source software (OSS) for data science in clinical practice were also discussed. <b><i>Summary:</i></b> Precision medicine aims to provide the right treatment for the right patients at the right time and is deeply connected to data science. Dialysis patients are highly dependent on technology to live, and their treatment generates a huge volume of data that has to be analysed. Data science has emerged as a tool to provide an integrated approach to data collection, storage, cleaning, processing, analysis, and interpretation from potentially large volumes of information. This is meant to be a perspective article about data science based on the experience of the experts invited to the Science for Dialysis Meeting and provides an up-to-date perspective of the potential of data science in kidney disease and dialysis. <b><i>Key messages:</i></b> Healthcare is quickly becoming data-dependent, and data science is a discipline that holds the promise of contributing to the development of personalized medicine, although nephrology still lags behind in this process. The key idea is to ensure that data will guide medical decisions based on individual patient characteristics rather than on averages over a whole population usually based on randomized controlled trials that excluded kidney disease patients. Furthermore, there is increasing interest in obtaining data about the effectiveness of available treatments in current patient care based on pragmatic clinical trials. The use of data science in this context is becoming increasingly feasible in part thanks to the swift developments in OSS.

scholarly journals Moving stroke rehabilitation evidence into practice: a systematic review of randomized controlled trials

2019 ◽  
Vol 33 (10) ◽  
pp. 1586-1595 ◽  
Author(s):  
Marie-Louise Bird ◽  
Tiev Miller ◽  
Louise A Connell ◽  
Janice J Eng
Keyword(s):  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Stroke Rehabilitation ◽  
Educational Interventions ◽  
Risk Of Bias ◽  
Practice Change ◽  
Audit And Feedback ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Multicomponent Interventions

Objective: The aim of this study was to investigate the effectiveness of interventions aimed at moving research evidence into stroke rehabilitation practice through changing the practice of clinicians. Data sources: EMBASE, CINAHL, Cochrane and MEDLINE databases were searched from 1980 to April 2019. International trial registries and reference lists of included studies completed our search. Review methods: Randomized controlled trials that involved interventions aiming to change the practice of clinicians working in stroke rehabilitation were included. Bias was evaluated using RevMan to generate a risk of bias table. Evidence quality was evaluated using GRADE criteria. Results: A total of 16 trials were included (250 sites, 14,689 patients), evaluating a range of interventions including facilitation, audit and feedback, education and reminders. Of which, 11 studies included multicomponent interventions (using a combination of interventions). Four used educational interventions alone, and one used electronic reminders. Risk of bias was generally low. Overall, the GRADE criteria indicated that this body of literature was of low quality. This review found higher efficacy of trials which targeted fewer outcomes. Subgroup analysis indicated moderate-level GRADE evidence (103 sites, 10,877 patients) that trials which included both site facilitation and tailoring for local factors were effective in changing clinical practice. The effect size of these varied (odds ratio: 1.63–4.9). Education interventions alone were not effective. Conclusion: A large range of interventions are used to facilitate clinical practice change. Education is commonly used, but in isolation is not effective. Multicomponent interventions including facilitation and tailoring to local settings can change clinical practice and are more effective when targeting fewer changes.

scholarly journals Placebo interventions, placebo effects and clinical practice

2011 ◽  
Vol 366 (1572) ◽  
pp. 1905-1912 ◽  
Author(s):  
Klaus Linde ◽  
Margrit Fässler ◽  
Karin Meissner
Keyword(s):  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Context Effects ◽  
Clinical Investigation ◽  
Controlled Trials ◽  
Placebo Effects ◽  
Randomized Controlled ◽  
Placebo Intervention ◽  
Therapeutic Context

This article reviews the role of placebo interventions and placebo effects in clinical practice. We first describe the relevance of different perspectives among scientists, physicians and patients on what is considered a placebo intervention in clinical practice. We then summarize how placebo effects have been investigated in randomized controlled trials under the questionable premise that such effects are produced by placebo interventions. We further discuss why a shift of focus from the placebo intervention to the overall therapeutic context is necessary and what research methods can be used for the clinical investigation of the relevance of context effects. In the last part of the manuscript, we discuss why placebo or context effects are seen as positive in clinical practice when they are associated with active treatments, while placebo interventions pose major ethical and professional problems and have to be avoided.

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