Beyond evidence supremacy: Reclaiming the Clinician’s role through the integration of structural and existential approaches in daily practice

Clinical medicine has advanced substantially with the introduction of evidence-based medicine (EBM) [1]. I have been deeply involved in this process, contributing to randomized controlled trials (RCTs) and to the development of clinical practice guidelines, and I have personally experienced the benefits that EBM has brought to patient care. At the same time, through continuous engagement in daily clinical practice, I have long sensed a persistent discomfort – one that EBM alone cannot fully address. This discomfort did not arise from theoretical considerations, but from the realities of caring for individual patients in routine clinical settings. In this editorial, I offer reflections and proposals from the perspective of a clinician who has worked within the EBM framework and has now completed one phase of professional responsibility. My focus is on the future direction of clinical research based on daily clinical practice and on how clinicians’ responsibility can be meaningfully sustained and strengthened for the next generation. Since the concept of EBM was introduced more than three decades ago, clinical medicine has undergone a profound transformation. Clinical practice guidelines based on EBM have been developed across a wide range of medical disciplines, enabling clinicians to propose treatment strategies with greater confidence. As a result, patient outcomes have improved, and more standardized medical care has become accessible worldwide. Clinical decision-making, which had previously relied heavily on individual physicians’ experience and judgement, has shifted towards structured recommendations derived from established evidence. Importantly, this transformation has also reduced the psychological burden on clinicians. Compared with earlier eras in which physicians bore full individual responsibility for therapeutic decisions, EBM represented a substantial reduction in professional stress – an aspect of its contribution that should not be overlooked. Despite its many achievements, EBM also has important limitations. Within the hierarchy of evidence, the highest level is generally assigned to RCTs. By design, RCTs enrol only patients who meet predefined inclusion criteria and do not meet exclusion criteria, and they evaluate specific interventions over a limited period of time. Consequently, participants in RCTs do not necessarily represent the full spectrum of patients encountered in daily clinical practice. Clinical guidelines developed primarily on the basis of RCT evidence may therefore be appropriate for patients who resemble those enrolled in trials, but they do not automatically justify treatment decisions for patients who fall outside those narrowly defined populations. Moreover, while RCT evidence is highly valued despite relatively small sample sizes, evidence derived from daily clinical practice – often involving far larger numbers of patients – tends to be undervalued [2, 3]. A useful analogy is that RCTs resemble model houses in a housing exhibition. They are constructed under ideal conditions: no leaks, optimal furniture placement, and no signs of daily living. Such houses effectively demonstrate architectural concepts, but no one actually lives in them. In contrast, daily clinical practice resembles real homes in which people live – diverse in age, medical history, comorbidities, socioeconomic circumstances, and personality. These environments are imperfect, continuously modified, and often unpredictable, yet they are where clinical decisions must ultimately be made in daily clinical practice [4]. Another important concern is the diminishing engagement of clinicians. As EBM has functioned as a powerful system of implicit exemption from individual responsibility, the locus of clinical judgement has become increasingly ambiguous. This shift risks undermining clinicians’ motivation and professional growth, even among highly capable practitioners. Questioning an evidence framework predominantly built on RCTs that enrol only selected patient populations, I initiated a prospective observational cohort study – the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) – in 2000. The primary aim of IORRA was to capture the realities of daily clinical practice that were largely invisible within RCT-based evidence. Over a period of 25 years, IORRA accumulated data corresponding to more than 110,000 patient-years. The database integrates patient-reported outcomes, physician assessments, and clinical and laboratory data. Using this comprehensive dataset, IORRA has generated a substantial body of real-world evidence (RWE), with particular emphasis on longitudinal patient-reported outcomes. To date, more than 180 peer-reviewed English-language publications have been produced based on IORRA data. These studies have provided quantitative, time-dependent insights into clinical phenomena that many clinicians intuitively recognize in daily clinical practice but that are difficult to capture through RCTs alone. In this sense, IORRA has served as a bridge between daily clinical practice and RCT-based evidence [5]. In recent years, clinical medicine has begun to move beyond an evidence framework centred exclusively on RCTs towards greater recognition of evidence derived from observational studies conducted in real-world settings. Cohort studies based on routine clinical practice constitute a core source of real-world data (RWD) and RWE [6]. The presence of various biases and confounding factors is an inherent limitation of RWD, and these influences can never be completely eliminated. However, advances in statistical methodology have made it increasingly feasible to utilize RWD as a meaningful source of evidence. When IORRA was established, the terms RWD and RWE were not yet in common use. Nevertheless, evidence derived from daily clinical practice through IORRA made it possible to quantitatively describe phenomena that clinicians recognize in everyday practice but that are not systematically captured by RCT-based evidence. Similar shifts can be observed across other medical disciplines, including psychiatry and nursing science, where increasing attention is being paid to lived experience alongside formal evidence. Together, these trends indicate that RWE should not be regarded as a secondary or inferior form of RCT-based evidence, but rather as a complementary framework that captures dimensions of clinical reality inherently inaccessible to RCTs. In philosophy, structuralism and existentialism have long been discussed as distinct, though not inherently opposing, modes of understanding human experience. I suggest that the relationship between EBM and RWE can be meaningfully interpreted through a similar conceptual lens. Here, ‘structuralism’ is used in a pragmatic sense: an approach that prioritizes standardized frameworks, reproducibility, and generalizability over individual context. Viewed in this way, EBM closely resembles a structuralist system in which clinical decisions are primarily guided by standardized guidelines rather than by individual physicians’ experience, and uniform rules are applied to comparable conditions while individual differences are deliberately abstracted [7]. In contrast, daily clinical practice can be understood through what may be described as an existentialist mode of clinical practice. Patients encountered in routine care are never ‘average.’ Clinical decisions are irreversible, clinicians must actively bear uncertainty, and the appropriateness of a decision often becomes clear only retrospectively. These characteristics closely align with core themes of existentialist thought [8]. Readers familiar with intellectual history may recognize a broader parallel. Similar transitions can be observed across society, where emphasis has shifted from object-centred systems towards renewed recognition of human experience and contribution. Clinical medicine appears to be undergoing a comparable oscillation. Importantly, this return does not represent regression, but rather a more mature integration of structured evidence with clinical responsibility. I am, at my core, a clinician. Over many years, I have been deeply engaged in the care of patients with rheumatoid arthritis while also participating extensively in RCTs and in the development of clinical practice guidelines. Through these experiences, I have contributed from within to the advancement of EBM. At the same time, I have consistently felt discomfort with an overly uniform, guideline-centred view of clinical medicine. This discomfort motivated my efforts to bridge daily clinical practice and evidence generation through IORRA. I emphasize this background to clarify my position: my concerns do not arise from opposition to EBM, but from long-term engagement within it. From this perspective, I offer two proposals. First, guideline development should incorporate evidence derived from observational studies and real-world settings more substantially, rather than treating such evidence as merely supplementary. Second, clinicians should not apply guideline recommendations mechanically. Instead, they must consciously assume responsibility for adapting recommendations to the individual circumstances of each patient. This may require systems that support clinical judgement, rather than replace it. Such changes may represent a shift in perspective – from excessive reliance on abstract structures towards renewed recognition of clinical responsibility. Although this shift inevitably increases the burden borne by clinicians, it also restores the dignity and responsibility inherent in everyday clinical practice. In particular, I hope that this perspective will encourage clinicians engaged in everyday practice – especially those working in busy real-world settings – to recognize the value of their clinical judgement and experience as an essential component of evidence generation. The author conceived and wrote this manuscript. Artificial intelligence (ChatGPT, OpenAI) was used solely for linguistic refinement and editorial assistance. The author reviewed and approved the final version and takes full responsibility for the content of the manuscript. None declared. None declared.