Person-Centred Research: A novel approach to Randomized Controlled Trials
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McCormack, B., Sundling, V. & Badian, R. (2017) Person-Centred Research: A novel approach to Randomized Controlled Trials, European journal for person centered healthcare, vol. 6, , ,
Introduction Integrating person-centred values with randomized controlled trials methodology is a novel idea. Person-centredness 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-centred 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-centred care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design that is personcentred randomized controlled trial (PC-RCT). 2 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 the paper we will explain what the concept of person-centred 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 the person-centred values into a randomized controlled trial in a novel study design that is both person-centred 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-centred 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-centred 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 filling 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-centred values in the same study design.