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Much of the last 2 centuries of modern medicine has been spent on eliminating subjectivity in medicine. This concerted effort to minimise clinician and patient subjectivity (and thereby bias) has led to one of the most remarkable breakthroughs of modern medicine—the randomised controlled trials (RCTs). While RCTs are highly effective in evaluating objective findings and ‘hard’ end-points, a similar adjudication of the more subjective endpoints, such as quality of life (QoL), is particularly difficult. This is especially true when testing medical interventions, where placebo effects are difficult to control. Significant efforts have been put in developing techniques and designing trials to reduce these placebo effects.
An erosion of the importance given to patient ‘well being’ and subjective improvement is an unfortunate consequence of this effort, even if an unintended one. However, in the 21st century, this is changing. All across medicine, focus is gradually reshifting towards patient-reported outcomes (PROs) and QoL. This is partly driven by a push from the Institute of Medicine in the early 2000s to incorporate the patient back into the focus of care and partly by market forces as the business of medicine becomes more patient and payer-centric.1 QoL has been defined by the WHO as ‘individuals’ perception of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectations, standards and concerns’.2 In a sense, this encompasses the definition of being human and everything that we value.
Since atrial fibrillation (AF) ablations were introduced in late 1990s, there have been multiple trials evaluating the outcomes of catheter ablation of AF in comparison to medical therapy (online supplemental table 1). These trials have traditionally evaluated various hard endpoints including mortality, stroke, heart failure, hospitalisations, bleeding, recurrent …
Contributors AS: concept, manuscript preparation, critical editing. RC: manuscript preparation.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
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