Beware of the difference between randomized controlled trials and daily clinical practice (in reply to “Surgery or antibiotics for acute appendicitis? Take care about study’s design and methodology!”, by Ceresoli M, et al.)

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.

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Which Randomized Controlled Trials Are Relevant to Clinical Practice?

Obstetrics and Gynecology ◽

10.1097/01.aog.0000173316.14537.7d ◽

2005 ◽

Vol 106 (2) ◽

pp. 216-218 ◽

Cited By ~ 5

Author(s):

John Collins

Keyword(s):

Clinical Practice ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Randomized Controlled

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Leveraging Data Science for a Personalized Haemodialysis

Kidney Diseases ◽

10.1159/000507291 ◽

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

Background: 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. Summary: 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. Key messages: 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.

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

Clinical Rehabilitation ◽

10.1177/0269215519847253 ◽

2019 ◽

Vol 33 (10) ◽

pp. 1586-1595 ◽

Cited By ~ 7

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.

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Placebo interventions, placebo effects and clinical practice

Philosophical Transactions of the Royal Society B Biological Sciences ◽

10.1098/rstb.2010.0383 ◽

2011 ◽

Vol 366 (1572) ◽

pp. 1905-1912 ◽

Cited By ~ 49

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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