scholarly journals 'It is not a pill'

2019 ◽  
Vol 7 (2) ◽  
pp. 4-14
Author(s):  
Doris Lydahl

Person-centered care seeks to improve health care by recognizing the individual patient’s unique experience and by acknowledging the patient as an active and responsible participant in their own care. It is also conceptualized as a reaction to evidence-based medicine, opposing its alleged reductionist and exclusionary tendencies. Therefore, person-centered care is often conceived as different from evidence-based medicine, taking into account the combined biological, psychological and social identity of the patient which evidence-based medicine reduces to a set of signs and symptoms. In this article, I analyze a paradoxical case in which a randomized controlled trial was used to evaluate person-centered care. Drawing on five interviews with researchers involved in this trial and on research documents and articles, I examine the entanglement of person-centered-care and evidence-based medicine from an STS perspective of standardization, uncertainties and promises. I first discuss the uncertainties and promises that emerge when trying to follow a research protocol. Second, the article illustrates the uncertainties and possibilities in knowing exactly what one measures. Finally, the article discuss the creation of a standard person. The article concludes that while the relation between person-centered care and evidence-based medicine is more complex than we might assume, the randomized controlled trial also transformed person-centered care in the process of evaluating it.

2018 ◽  
Vol 6 (2) ◽  
pp. 209
Author(s):  
Reza A Badian ◽  
Brendan McCormack ◽  
Vibeke Sundling

Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.


2015 ◽  
Vol 22 (3) ◽  
pp. 707-717 ◽  
Author(s):  
Aaron M Cohen ◽  
Neil R Smalheiser ◽  
Marian S McDonagh ◽  
Clement Yu ◽  
Clive E Adams ◽  
...  

ABSTRACT Objective: For many literature review tasks, including systematic review (SR) and other aspects of evidence-based medicine, it is important to know whether an article describes a randomized controlled trial (RCT). Current manual annotation is not complete or flexible enough for the SR process. In this work, highly accurate machine learning predictive models were built that include confidence predictions of whether an article is an RCT. Materials and Methods: The LibSVM classifier was used with forward selection of potential feature sets on a large human-related subset of MEDLINE to create a classification model requiring only the citation, abstract, and MeSH terms for each article. Results: The model achieved an area under the receiver operating characteristic curve of 0.973 and mean squared error of 0.013 on the held out year 2011 data. Accurate confidence estimates were confirmed on a manually reviewed set of test articles. A second model not requiring MeSH terms was also created, and performs almost as well. Discussion: Both models accurately rank and predict article RCT confidence. Using the model and the manually reviewed samples, it is estimated that about 8000 (3%) additional RCTs can be identified in MEDLINE, and that 5% of articles tagged as RCTs in Medline may not be identified. Conclusion: Retagging human-related studies with a continuously valued RCT confidence is potentially more useful for article ranking and review than a simple yes/no prediction. The automated RCT tagging tool should offer significant savings of time and effort during the process of writing SRs, and is a key component of a multistep text mining pipeline that we are building to streamline SR workflow. In addition, the model may be useful for identifying errors in MEDLINE publication types. The RCT confidence predictions described here have been made available to users as a web service with a user query form front end at: http://arrowsmith.psych.uic.edu/cgi-bin/arrowsmith_uic/RCT_Tagger.cgi.


The pursuit of tests for therapeutic interventions has been a characteristic of Western medicine since ancient times. Historical accounts of the clinical trial are usually expressed through the lens of presentism: how the various components of the first modern randomized controlled trial-the comparison, blinding, and randomization-culminated in Austin Bradford Hill’s 1946 trial of streptomycin for tuberculosis. The factual context of the development of the randomized controlled trial is important if only to emphasize the historicity of contemporary research methodology. However, the adoption of the various components of the trial at any one time has as much to do with changing the socio-political and ethical contexts as the ‘objective’ scientific standards of evidence. Evidence is not just scientific data floating in some ethereal medium, but is also linked to facts and beliefs of the various members of diverse medical communities who interpret evidence and deploy it to legitimize various strategies. This introductory chapter aims to present the background and context through which evidence-based medicine has emerged.


Author(s):  
Louis R. Caplan

Proponents of evidence-based medicine (EBM) have established a clear, unambiguous requirement for what they consider credible evidence, the randomized controlled trial (RCT), and especially the systematic review of several RCTs. They propose that clinical practice should be dominated by adherence to the ‘evidence’ as they define it....


2010 ◽  
Vol 10 (1) ◽  
Author(s):  
David A Feldstein ◽  
Matthew J Maenner ◽  
Rachaya Srisurichan ◽  
Mary A Roach ◽  
Bennett S Vogelman

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