Abstract

Introduction

The iatrogenic potential of clinical and health/preventive interventions have grown with the technological development of biomedicine, drawing more and more attention to it¹1 Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016; 353:i2139. Doi: https://doi.org/10.1136/bmj.i2139.
https://doi.org/10.1136/bmj.i2139... . This concerning phenomenon has prompted European family physicians and general practitioners to propose a new concept and practice aiming to prevent medical harms, called ‘quaternary prevention’ (P4)²2 Bentzen N. Wonca dictionary of general / Family practice [Internet]. Copenhagen: Manedsskrift for Praktisk Lægergerning; 2003 [cited 2020 Nov 12]. Available from: http://www.ph3c.org/PH3C/docs/27/000092/0000052.pdf
http://www.ph3c.org/PH3C/docs/27/000092/... . The World Organisation of Family Physicians (WONCA) defines P4 as an action

Built in P4 is the concept of overmedicalisation, which is

Such issues have gained progressive relevance in recent years, especially overdiagnosis, considered a problem both for public health⁴4 Bulliard JL, Chiolero A. Screening and overdiagnosis: public health implications. Public Health Rev. 2015; 36(1):1-5. and primary health care (PHC)⁵5 Kale MS, Korenstein D. Overdiagnosis in primary care: framing the problem and finding solutions. BMJ. 2018; 362:k2820.^,66 Singh H, Dickinson JA, Thériault G, Grad R, Groulx S, Wilson BJ, et al. Overdiagnosis: causes and consequences in primary health care. Can Fam Physician. 2018; 64(9):654-9..

Although the reduction of iatrogeny is not explicitly in WONCA’s definition, there is a consensus that this is inherent in P4 definition. This adds an ethical concern to preventive and clinical care within the doctor-patient relationship. The P4 is “aimed more at the doctor than the patient [...] is a new term for an old concept: first, do not harm”⁷7 Jamoulle M. Quaternary prevention: first, do not harm. Rev Bras Med Fam Comunidade. 2015; 10(35):1-3. Doi: https://doi.org/10.5712/rbmfc10(35)1064.
https://doi.org/10.5712/rbmfc10(35)1064... (p. 1).

In recent years, European authors have proposed a new definition of P4 that excludes the concept of medicalisation⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278...

9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^-1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... , which might have implications to P4’s scope in the daily practice of health professionals.

This article revisits the proposed new definition of P4. Firstly, we present the conceptual ideas that underpin the medicalisation and its relationship with overmedicalisation. Secondly, we organise the critics made by European authors to the current P4 definition, as well as to the proposed changes to it. Thirdly, we address each of the criticisms directed towards WONCA’s P4 concept, which in turn highlight that the proposed “new” P4 definition is weaker than the original one. Finally, we argue that clarity about the meaning and relevance of the elements, concepts, and phenomena involved in P4 definition is necessary and relevant to its practice in PHC.

Medicalisation and overmedicalisation

Social medicalisation, or simply medicalisation, is academically recognised since the 1970s. It consists in expanding the jurisdiction of biomedical knowledge and technologies to issues that were traditionally interpreted and managed outside the remit of health services¹¹11 Conrad P. The medicalization of society. Baltimore: Johns Hopkins University Press; 2007.. Medicalisation carries a great potential of adverse effects and iatrogenesis. Thus, it is intrinsically related to the concept of P4.

The idea of medicalisation, although not mentioned in P4 definition, is clearly implicit in it and is inherent to overmedicalisation such as in overdiagnosis, overtreatment, etc. “All these terms refer to ‘clinical issues’ of the medicalisation phenomenon, and the daily challenges faced by family doctors”³3 Cardoso RV. Quaternary prevention: a gaze on medicalization in the practice of Family doctors. Rev Bras Med Fam Comunidade. 2015; 10(35):1-10. Doi: https://doi.org/10.5712/rbmfc10(35)1117.
https://doi.org/10.5712/rbmfc10(35)1117... (p. 4). Overmedicalisation is a particular case of medicalisation and has high prevalence in clinical care. It could be understood as an excessive medicalisation that is more harmful than beneficial. Overdiagnosis is the most famous example of overmedicalisation in the literature.

Medicalisation refers to a historical, intricate, complex, and expanding phenomenon initially conceptualised in Europe, but today it has been recognised globally with several social agents involved in it. In theory, medicalisation can be harmful or beneficial, constructed and deconstructed, as in de-pathologising homosexuality. Conrad¹¹11 Conrad P. The medicalization of society. Baltimore: Johns Hopkins University Press; 2007. describes three dimensions of medicalisation: conceptual, institutional, and interactional. In the latter, doctors tend to be protagonists. For example, without realising that the patient’s main problem is lack of food (hunger not reported), the physician treats a person complaining of stomach pain with proton pump inhibitor³3 Cardoso RV. Quaternary prevention: a gaze on medicalization in the practice of Family doctors. Rev Bras Med Fam Comunidade. 2015; 10(35):1-10. Doi: https://doi.org/10.5712/rbmfc10(35)1117.
https://doi.org/10.5712/rbmfc10(35)1117... .

The diagnoses and treatments produced by the biomedical approach tend to be reductionists. This approach usually disconnect patients’ complaints and symptoms from the social, existential, moral, spiritual, economic, cultural, familial, and psychological context, interpreting them in accordance to a biological body-disease framework (i.e., pathologies, syndromes, dysfunctions, and disorders).

In addition to clinical iatrogenesis, Ivan Illich¹²12 Illich I. Limits to medicine. Medical nemesis: the expropriation of health. Harmondsworth: Penguin Books; 1976. warned the scientific community that medicalisation comprises iatrogenic effects at cultural and social levels, i.e, reducing individuals’ competence to deal autonomously with most of the pains, sufferings, and life’s crises. These generate and increase the demand for professional care, which tend to stimulate passive behaviours by patients in face of such sufferings. The cultural and social medicalisation process contributes, therefore, to an imbalance between autonomous and heteronomous care. Unfortunately, the pendulum tends to swing biasedly towards the latter end, transferring the management of many life’s problems and situations to health professional interventions. This reflects, in part, the increasing and growing demand by patients for medical care in PHC. If these health demands are medicalised, they feedback a counterproductive vicious circle in the whole system. Hence, it is justifiable and appropriate that health professionals should be aware about their role in demedicalising each patient encounter as much as possible.

In addition, other health professions and other knowledge/practices about health-disease dyad coexist with biomedicine. The concept of medicalisation has been expanded to embrace different branches of health knowledge, including complementary and alternative medicine¹³13 Tesser CD, Dallegrave D. Práticas integrativas e complementares e medicalização social: indefinições, riscos e potências na atenção primária à saúde. Cad Saude Publica. 2020; 36(9):e00231519. Doi: https://doi.org/10.1590/0102-311x00231519.
https://doi.org/10.1590/0102-311x0023151... , regardless of their political and scientific status¹⁴14 Correia T. Revisiting medicalisation: a critique of the assumptions of what counts as medical knowledge. Front Sociol. 2017; 2:14. Doi: https://doi.org/10.3389/fsoc.2017.00014.
https://doi.org/10.3389/fsoc.2017.00014... .

Critiques to the original definition of P4

The WONCA’s P4 definition embraces three main domains: (a) risk of over-medicalisation; (b) patients’ protection; and (c) sound ethical alternatives. This definition is generally illustrated by Marc Jamoulle’s⁷7 Jamoulle M. Quaternary prevention: first, do not harm. Rev Bras Med Fam Comunidade. 2015; 10(35):1-3. Doi: https://doi.org/10.5712/rbmfc10(35)1064.
https://doi.org/10.5712/rbmfc10(35)1064... insightful 2x2 table figure, which visually reorganises Leavell and Clarke’s classic levels of prevention. These levels were originally based on disease evolution over time. However, Jamoulle proposes a new relational perspective to prevention. It focuses on doctor-patient relationship by crossing two perspectives: (1) Doctors’ knowledge (columns) and (2) Patients’ well-being (rows) (Figure 1). To the original Jamoulle’s⁷7 Jamoulle M. Quaternary prevention: first, do not harm. Rev Bras Med Fam Comunidade. 2015; 10(35):1-3. Doi: https://doi.org/10.5712/rbmfc10(35)1064.
https://doi.org/10.5712/rbmfc10(35)1064... 2x2 table, we have added a third column on the far right end of Figure 1. It facilitates the understanding of the differences between the bottom and top rows of the 2x2 table. There are distinctions in P4 strategies when dealing with patients who feel unwell and/or have a known disease (bottom row) than those situations where individuals are asymptomatic (top row). The former is the domain of clinical medicine, which requires individualised and crafted approaches to patients’ sufferings. The latter is the domain of Public Health, which entails population preventive initiatives such as vaccination campaigns and organised screening programmes. This is in line with Jamoulle’s P4 concept¹⁵15 Jamoulle M. Prevencion cuaternaria, evolución del concepto. NotasL@cas/M@dNotes serie [Internet]. 2020 [cited 2021 Feb 12]. Available from: https://drive.google.com/file/d/1rlcpVinrgGyS6rCMuNV8sNMhiGgdLvUK/view
https://drive.google.com/file/d/1rlcpVin... ^,1616 Norman AH, Tesser CD. Quaternary prevention: a balanced approach to demedicalisation. Br J Gen Pract. 2019; 69(678):28-9. Doi: https://doi.org/10.3399/bjgp19X700517.
https://doi.org/10.3399/bjgp19X700517... .

The proposed new P4 definition refers to “action taken to protect individuals (persons/ patients) from medical interventions that are likely to cause more harm than good”⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278...

9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^-1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... (p. 3, 108, 614). According to Martins et al.¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... the goal of P4 is to reduce overmedicalisation (overdiagnosis and overtreatment) and iatrogenic harms. This resulted in a new graphic representation within which P4 has been displaced from quadrant four to the centre of Jamoulle’s 2x2 table. (Figure 2).

Both definitions focus on clinical practice and patients’ safety/protection. However, there are important differences. The proposed new definition, for example, blurs Jamoulle’s P4 original emphasis on doctor-patient relationship, by highlighting the benefit/harm ratio via evidence-based medicine (EBM). Additionally, the new proposal eliminates from the definition the reference to overmedicalisation, which remains only as the main ‘goal’ of P4⁹9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^,1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... . This was crafted in three papers were the authors criticise WONCA’s P4 definition (Frame 1).

Discussion

Before addressing the critique to WONCA’s P4 definition, we briefly contextualise the articles used to elaborate Frame 1. In 2014, Brodersen et al.⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278... , while discussing the problem of overdiagnosis in cancer screening provide a relatively short paragraph criticising WONCA’s P4 concept and suggesting the need for a new P4 definition: statements (a) and (b) in Frame 1. In 2018, Martins et al.⁹9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... , in partnership with Brodersen, span a whole article on the proposed new definition of P4 on the European Journal of General Practice. In 2019, the same authors¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... published an article in response to a sentence in an article published in the British Journal of General Practice by Norman and Tesser¹⁶16 Norman AH, Tesser CD. Quaternary prevention: a balanced approach to demedicalisation. Br J Gen Pract. 2019; 69(678):28-9. Doi: https://doi.org/10.3399/bjgp19X700517.
https://doi.org/10.3399/bjgp19X700517... who have claimed that WONCA’s P4 definition “is more comprehensive than the recent initiative to redefine it in terms of the harm/benefit ratio” (p. 29).

Imaginary step

In the imagination of Brodersen et al.⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278... , the WONCA’s P4 definition creates a step within which physicians have to gauge who are at risk of overmedicalisation (critique [a] Frame 1). This stage seems more chimeric than operational, since all patients possess this risk. There is a strong trend in medical practice, especially in prevention, to overmedicalise. However, at no point in the discussions about P4 is there a proposal to create such a “step”. The original definition implies that professionals should assess the degree of medicalisation of each clinical encounter to avoid and/or reduce it, if applicable. This is not a “step”, but rather embedded in the elaboration of the diagnostic interpretation as an integral part of the shared therapeutic plan with the patient.

Ethically acceptable alternatives

In a multitude of undifferentiated clinical scenarios (or possible diagnosis) intertwined with preventive activities, it seems that reducing P4 definition to ‘harm/benefit ratio’ is a narrower approach than to ethically span different potential therapeutic interventions. According to Starfield et al.¹⁷17 Starfield B, Hyde J, Gérvas J, Heath I. The concept of prevention: a good idea gone astray? J Epidemiol Community Health. 2008; 62(7):580-3. Doi: http://dx.doi.org/10.1136/jech.2007.071027.
https://doi.org/10.1136/jech.2007.071027... , 40% of clinical encounters in the USA are due to check-ups. In patient centred medicine, family doctors need more than ‘harm/benefit ratio’ of an intervention to ponder with patients’ real concerns about disease screening. Patients are not just worried about probabilities, statistics, and numbers. They have personal experiences leading to anxieties and fear about certain diseases, or even concern about their future health. Some of these are realistic and other not. In addition, those individuals without disease who feel ill (fourth quadrant - Figure 1) are a common event in PHC. This context, which inspired the concept of P4, highlights one of the facets of general practice. Family doctors need to adjust constantly their lens to be less iatrogenic and less medicalising while interpreting patients’ complaints and symptoms. It is possible to criticise the original P4 definition due to its excessive generality, as this ethical requirement exists in every clinical decision, not only in P4. Nevertheless, this does not diminish the WONCA’s P4 definition. On the contrary, in the face of a general culture and socio-institutional environment that favours biomedical interventions, it seems particularly appropriate to emphasise the ethical dimension in P4 definition.

Scope of the definition

The intersection of patients’ illness perspective with physician’s no disease gaze (fourth quadrant – Figure 1) was just the starting and insightful fact that gave rise to P4 definition. However, Martins et al.¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... take this point of intersection to build their critique to WONCA’s P4 definition:

It seems that placing emphasis on the balance between harms and benefits of an intervention would “make the [P4] impact stronger”⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278... (p. 3). Martins et al. are mistaken since P4 definition is not confined to its graphic representation. The origin of P4 definition might help us clarify this issue. Marc Jamoulle’s 1986¹⁸18 Jamoulle M. Information et informatisation en médecine générale [Internet]. In: Berleur J, Labet-Maris CL, Poswick RF, Valenduc G, Van Bastelaer P, editors. Les informagiciens. Namur: Presses Universitaires de Namur; 1986 [cited 2020 Nov 26]. p. 193-209. Available from: http://www.ph3c.org/ph3c/docs/27/000103/0000405.pdf
http://www.ph3c.org/ph3c/docs/27/000103/... and 1994¹⁹19 Jamoulle M, Roland M. Mental health inside the primary care; a different mental health? [Internet]. Washington: National Institute of Mental Health; 1994 [cited 2020 Nov 19]. Available from: https://orbi.uliege.be/bitstream/2268/175035/1/washington.pdf
https://orbi.uliege.be/bitstream/2268/17... first writings do not provide a formal P4 definition. He introduced the current P4 definition to the Hong Kong WONCA Classification Committee in 1995. Since its inception, P4 definition was broad in its scope to accommodate all levels of preventions and clinical activities. It is an umbrella definition. The authors confuse a specific aspect of P4 practice with depth in P4 definition. The former entails balancing the harm/benefit ratio of biomedical interventions. The latter refers to the wide-ranging scope of WONCA’s P4 definition that encompasses the cultural, social, relational, and ethical aspects of medicalisation. This implies a profound ethical change of professionals’ stance in regards to doctor-patient relationship. Therefore, instead of expanding the scope of P4, the proposed new definition restricts it, making its impact less robust by eliminating the reference to overmedicalisation. The concern with excessive medicalisation is an inherent feature of P4 definition and one of its scientific foundations (further discussed), as acknowledged in almost all P4 scientific literature.

The fourth quadrant that gave birth to P4 also illustrates Jamoulle’s generalist thinking. As explained in the previous subsection, general practitioners’ clinical activities involve a myriad of undifferentiated presentations within which preventive activities have been blended with clinical care. Thus, P4 concept has always been comprehensive and this has even been acknowledged by Martins et al.⁹9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... (p. 109) themselves.

P4 graphic representation

In Jamoulle’s original graphic representation⁷7 Jamoulle M. Quaternary prevention: first, do not harm. Rev Bras Med Fam Comunidade. 2015; 10(35):1-3. Doi: https://doi.org/10.5712/rbmfc10(35)1064.
https://doi.org/10.5712/rbmfc10(35)1064... there is a circular arrow that starts on P4 and crosses the other quadrants (P1, P2 and P3), indicating that P4 encompasses all preventive and curative activities. Martins et al.¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... criticise this arrow since

On the contrary, the circular arrow is an attempt to show that P4 is not “confined to the quadrant with patients that feel ill and do not have a disease”¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... (p. 614) as have been interpreted by Martins et al.⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278...

9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^-1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... .

We agree that other forms of illustration might have solved P4 inclusiveness to other preventive and clinical activities in a better way. For instance, the static circular arrow in Jamoulle’s original graphic representation has been replaced by the “ripple effect” in Figure 1. This is an effort to better illustrate that P4 includes other preventive and curative activities in a non-sequential fashion. Regardless of the quality of the new visual representation proposed by Brodersen et al.⁸8 Brodersen J, Schwartz LM, Woloshin S. Overdiagnosis: how cancer screening can turn indolent pathology into illness. APMIS. 2014; 122(8):683-9. Doi: https://doi.org/10.1111/apm.12278.
https://doi.org/10.1111/apm.12278... and Martins et al.⁹9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^,1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... , the limits of the original figure are not an argument or a reason for a new P4 definition. In addition, Figure 2 has also problems. For example, it leaves a void in P4’s insightful origin (fourth quadrant), which was used to indicate a special concern for those people who feel unwell, but have no disease. The fourth quadrant works as a sort of “red-flag” of unnecessary medicalisation and iatrogenesis in these clinical situations. We acknowledge that every clinical encounter poses some risk of medicalisation and iatrogenic effects. Nonetheless, the fourth quadrant highlights those individuals who are particularly susceptible to overmedicalisation and iatrogenesis. This includes those individuals presenting with mental health problems.

Furthermore, the new graphic representation of P4 (Figure 2) obscures differences in the top and bottom rows of the original P4 framework (Figure 1). The top row situations (P1 and P2) are more involved with the public health tradition and generally concern large-scale iatrogenic harm, although they are also important in individual care. For instance, organised screening programmes carry the potential of overdiagnosis and overtreatment to large number of healthy individuals. The bottom row is the illness context, which requires the art of clinical and patient-centred care¹⁶16 Norman AH, Tesser CD. Quaternary prevention: a balanced approach to demedicalisation. Br J Gen Pract. 2019; 69(678):28-9. Doi: https://doi.org/10.3399/bjgp19X700517.
https://doi.org/10.3399/bjgp19X700517... . There are important bioethical requirements and differences between preventive initiatives and clinical care. Clinicians’ attitudes should change when dealing with people who are well (P1 and P2) and those who feel ill or have a known disease (P4 and P3). The former requires evidence of great net benefit and minimal harms of the preventive intervention via EBM paradigm. In this context, the bioethics of non-maleficence is of paramount importance; the latter needs individualised and crafted use of the available biomedical evidence, clinical reasoning, and the art of care to alleviate patients’ suffering. In this case, the bioethics of beneficence should prevail²⁰20 Tesser CD, Norman AH. Differentiating clinical care from disease prevention: a prerequisite for practicing quaternary prevention. Cad Saude Publica. 2016; 32(10):e00012316. Doi: http://dx.doi.org/s10.1590/0102-311X00012316.
https://doi.org/10.1590/0102-311X0001231... . Therefore, the rigour to which EBM paradigm is applied can vary greatly depending on the quadrants of Jamoulle’s 2x2 table and the clinical context. The original P4 definition makes it easier to recognise these differences and to develop clinical management strategies, as well as specific research agendas for them. According to the original definition of P4, such nuances in clinical situations require specific knowledge and techniques to minimise harms and de-medicalise as much as possible. These potentials of the original graphic representation of P4 are strengths that should not be overlooked.

The role of Evidence-Based Medicine

Martins et al.⁹9 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept. Eur J Gen Pract. 2018; 24(1):106-11. Doi: https://doi.org/10.1080/13814788.2017.1422177.
https://doi.org/10.1080/13814788.2017.14... ^,1010 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... believe that the proposed new definition is superior because it depicts the relationship between P4 and evidence-based practice movement. However, the EBM paradigm adds nothing to what P4 entails, as all health interventions should be based on the best available evidence. Reducing P4 to harm/benefit ratio via EBM seems too simplistic. It sounds as an appeal to apply EBM more often, which may be justifiable, given that not all health services are grounded on the EBM best practice model. We agree that EBM is a powerful tool for clinical decision-making; however, this does not lead to a change in P4 definition. In contrast, WONCA’s P4 definition surpasses EBM model by adding the complexity of social and cultural iatrogenic harm derived from an increased medicalised social context, largely unattainable by EBM paradigm. The growing and problematic use of psychotropic drugs in contemporary societies epitomises this fact²¹21 Whitaker R. Anatomy of an epidemic: magic bullets, psychiatric drugs, and the astonishing rise of mental illness in America. New York: Crown; 2010..

Additionally, EBM is not a neutral phenomenon, but also a socially constructed approach to authority over medical knowledge²²22 Lambert H. Accounting for EBM: notions of evidence in medicine. Soc Sci Med. 2006; 62(11):2633-45. Doi: https://doi.org/10.1016/j.socscimed.2005.11.023.
https://doi.org/10.1016/j.socscimed.2005... . EBM has transferred a substantial part of clinicians’ power to experts on EBM such as reviewers, focal specialists, and epidemiologists linked to institutions, task forces, expert committees, and scientific journals. These groups are susceptible to political and economic influences. Unfortunately, there are vested interests in biomedical research and its agenda is loaded with values²³23 Kelly MP, Heath I, Howick J, Greenhalgh T. The importance of values in evidence-based medicine. BMC Med Ethics. 2015; 16(1):69. Doi: https://doi.org/10.1186/s12910-015-0063-3.
https://doi.org/10.1186/s12910-015-0063-... . This has generated crises in the EBM movement²⁴24 Greenhalgh T, Howick J, Maskrey N. Evidence based medicine: a movement in crisis? BMJ. 2014; 348:g3725. Doi: https://doi.org/10.1136/bmj.g3725.
https://doi.org/10.1136/bmj.g3725... . Moreover, the artificial single-disease scenarios created by randomised controlled trials usually exclude the complex and multimorbid patients, as well as the elderly. In complex cases, chronic diseases, and medically unexplained symptoms, polypharmacy tends to be the norm. They need a careful and individualised assessment, in which EBM is necessary but insufficient. The fact that there are situations in which the benefit of the intervention outweighs the potential harms (clinical, social, and cultural iatrogeny) does not diminish the relevance of maintaining overmedicalisation as one of the reference points of P4 definition. EBM is just one more tool. Even Ivan Ilich¹²12 Illich I. Limits to medicine. Medical nemesis: the expropriation of health. Harmondsworth: Penguin Books; 1976. critically applied the available scientific evidence at his time to discuss benefits and harms of medical interventions. The author has used this approach in the first part of his classic book on medicalisation, focused on clinical iatrogenesis, to support his ideas. Thus, the proponents of P4 new definition are misleading to state that P4 is more than demedicalisation. As we have already said, the proposed change to P4 concept reduces its scope by eliminating the meaning of overmedicalisation from WONCA’s P4 definition.

Scientificity of medicalisation

The statement that medicalisation (or demedicalisation) has no scientific basis (Frame 1) is empirically and academically refutable. Multiple aspects of medicalisation have been discussed for decades and investigated by authors such as Foucault²⁵25 Foucault M. Microfísica do poder. 18a ed. Rio De Janeiro: Graal; 1979., Zola²⁶26 Zola IK. Medicine as an institution of social control. Sociol Rev [Internet]. 1972 [cited 2020 Nov 13]; 20(4):487-504. Available from: https://www.jstor.org/stable/43618673
https://www.jstor.org/stable/43618673... , Szaz²⁷27 Szasz T. O mito da doença mental. São Paulo: Círculo do Livro S.A.; 1974., Illich¹²12 Illich I. Limits to medicine. Medical nemesis: the expropriation of health. Harmondsworth: Penguin Books; 1976., Skrabanek²⁸28 Skrabanek P. The death of humane medicine and the rise of coercive healthism. London: Social Affairs Unit; 1994., Rose²⁹29 Rose N. Beyond medicalisation. Lancet. 2007; 369(9562):700-2. Doi: https://doi.org/10.1016/S0140-6736(07)60319-5.
https://doi.org/10.1016/S0140-6736(07)60... , Conrad¹¹11 Conrad P. The medicalization of society. Baltimore: Johns Hopkins University Press; 2007. and Clarke et al.³⁰30 Clarke AE, Mamo L, Fosket JR, Fishman JR, Shim JK. Biomedicalisation: technoscience, health, and illness in the U.S. Durhan: Duke University Press; 2010.. Therefore, medicalisation is an important and scientifically well-established subject. Illich¹²12 Illich I. Limits to medicine. Medical nemesis: the expropriation of health. Harmondsworth: Penguin Books; 1976. pioneered the reasons why medicalisation should be avoided as much as possible. He analysed three types of iatrogenesis: clinical, cultural and social. Medicalisation and its three types of iatrogeny act as a disciplinary biotechnological dispositive. This can lead to a cultural and psychological impoverishment in people’s behaviour in managing their sufferings, pains, and life cycle’s normative crises. Thus, medicalisation creates a snowball effect of illusory expectations both in professionals and patients alike about medical interventions, overloading primary health care services with check-ups requests and, probably, unnecessary clinical visits.

Although researches on medicalisation may be more often found in other realms of scientific knowledge as in Sociology, Anthropology, History, Philosophy, and Ethics, this does not mean lack of scientific basis. Studies on medicalisation span from mental health, sexuality, risk factors, underuse of medical resources, manipulation and spurious interpretations of scientific evidence, creation of diseases, chronicity and catastrophisation of common problems (e.g. low back pain, etc.), as well as over-labelling of medically unexplained symptoms. Countless are the themes in which excessive medicalisation and iatrogenesis occur in the daily practice of family physicians.

Focus on demedicalisation

Martins et al.¹⁰10 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: an evidence-based concept aiming to protect patients from medical harm. Br J Gen Pract. 2019; 69(689):614-5. Doi: https://doi.org/10.3399/bjgp19X706913.
https://doi.org/10.3399/bjgp19X706913... attribute to Norman and Tesser¹⁶16 Norman AH, Tesser CD. Quaternary prevention: a balanced approach to demedicalisation. Br J Gen Pract. 2019; 69(678):28-9. Doi: https://doi.org/10.3399/bjgp19X700517.
https://doi.org/10.3399/bjgp19X700517... the idea that de-medicalisation would be the “main characteristic of P4” (p. 614). Decades ago, Ivan Illich discussed medicalisation in primary care at the Royal College of General Practitioners³¹31 Illich I. Medicalisation and primary care. J R Coll Gen Pract. 1982; 2(241):463-70.. Norman and Tesser just used Illich’s ideas to introduce the subject of P4 in the British Journal of General Practice as Illich held a paradoxical belief that family doctors could contribute to demedicalisation. These authors have not stated or implied that de-medicalisation is the main feature of P4.

P4 demands a contextualised patient-centred medicine to enhance patients’ values and autonomy. If on the one hand, WONCA’s P4 definition does not prioritise demedicalisation, on the other hand by keeping overmedicalisation within its definition, broadens health professional’s gaze. This does not mean depriving patients of good medical interventions. The complexities in assessing the harm/benefit ratio of health interventions require a systematised knowledge via EBM. However, EBM is not enough for the realisation of P4, since it disregards much of the social and cultural iatrogeny resulting from the current excessive medicalisation in contemporary societies.

WONCA’s P4 definition seen as a process of de-medicalisation may sound as an unrealistic approach, as being medicalised is an essential aspect of what constitutes the contemporary urbanised human being in the Western world. Since the 18^th century, biomedicine has played a key role in the politics’ of life itself. Human beings have become objects of scientific research²⁹29 Rose N. Beyond medicalisation. Lancet. 2007; 369(9562):700-2. Doi: https://doi.org/10.1016/S0140-6736(07)60319-5.
https://doi.org/10.1016/S0140-6736(07)60... . From birth to grave, biomedicine has contributed to organising the way we live: modelling, supervising, controlling, disciplining and producing the “homo medicandus”¹²12 Illich I. Limits to medicine. Medical nemesis: the expropriation of health. Harmondsworth: Penguin Books; 1976.. Thus, it may seem logical to reduce P4 definition to a binary thought of net harm/benefit ratio for biomedical interventions. This would be more in line with the positivist tradition of biomedicine, which is the basis for structuring EBM³²32 Anjum RL, Copeland S, Rocca E. Rethinking causality, complexity and evidence for the unique patient: a causehealth resource for healthcare professionals and the clinical encounter. Cham: Springer; 2020. Doi: https://doi.org/10.1007/978-3-030-41239-5.
https://doi.org/10.1007/978-3-030-41239-... . However, the focus on individualised and contextualised type of practice in PHC makes EBM relevant, but insufficient for delivering increasingly necessary personalised medical care³²32 Anjum RL, Copeland S, Rocca E. Rethinking causality, complexity and evidence for the unique patient: a causehealth resource for healthcare professionals and the clinical encounter. Cham: Springer; 2020. Doi: https://doi.org/10.1007/978-3-030-41239-5.
https://doi.org/10.1007/978-3-030-41239-... . Thus, P4 involves avoiding overmedicalisation or excessive medicalisation, but it fundamentally points to the need for deep reflection on the doctor-patient relationship. This is essential to an improvement on physicians’ ethical and attitudinal standard.

Conclusion

The interest in P4 is gradually growing. In 2016, the “Special Interest Group: Quaternary Prevention & Overmedicalisation”³³33 WONCA. Special interest group: quaternary prevention & overmedicalization [Internet]. Brussels: WONCA; 2016 [cited 2020 Nov 12]. Available from: https://www.globalfamilydoctor.com/groups/specialinterestgroups/quaternaryprevention.aspx
https://www.globalfamilydoctor.com/group... was created within WONCA. The name of the group highlights that overmedicalisation is already in its title, thus, considering it as an essential aspect of P4 concept. To imagine P4 purified from the complex discussion of overmedicalisation and the ethical challenges of the doctor-patient relationship as an improvement of its definition seems to be a backfire, a remedy worse than the disease³⁴34 Norman AH, Tesser CD. Amending WONCA’s P4 definition: the cure has been worse than the disease. Br J Gen Pract. 2020; 70(692):109. Doi: https://doi.org/10.3399/bjgp20X708389.
https://doi.org/10.3399/bjgp20X708389... . If the assessment of the degree of medicalisation in each clinical encounter requires a tailored approach to patients’ context, this does not indicate a lack of scientific basis of medicalisation nor does it support its elimination from WONCA’s P4 definition. On the contrary, this indicates the need for critical thinking and deep ethics apprehension by health professionals with the doctor-patient relationship at the centre of P4. Improvements in P4 initiatives require studies that can contribute to its operationalisation in clinical practice. This might facilitate recognition and better management of situations and contexts within which there are great potential of iatrogenic harm and overmedicalisation.

Acknowledgments

We would like to thank Samuel Casal for creating the figures we envisage in a more artistic fashion and to Josane Norman for proofreading the final version of this article.

References

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