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Ethics in oncology: principles and responsibilities declared in the Italian Ragusa statement

Abstract

Cancer care involves many ethical issues. The need for more patient-centered healthcare together with the improved empowerment of every person diagnosed with cancer have been transposed by the Italian Association of Medical Oncology (AIOM) and eventually translated in the Ragusa statement. This position paper describes the philosophy that lies beneath this document and its fundamental principles.

Tumori 2016; 102(6): e25 - e27

Article Type: SHORT COMMUNICATION

DOI:10.5301/tj.5000582

Authors

Stefania Gori, Carmine Pinto, Caterina Caminiti, Giuseppe Aprile, Paolo Marchetti, Francesco Perrone, Massimo Di Maio, Emanuela Omodeo Salè, Annamaria Mancuso, Maurizio De Cicco, Francesco Di Costanzo, Sergio Crispino, Rodolfo Passalacqua, Marco Merlano, Vittorina Zagonel, Luisa Fioretto, Giovanni Micallo, Roberto Labianca, Roberto Bordonaro, Alessandro Comandone, Sandro Spinsanti, Carmelo Iacono, Fabrizio Nicolis, On behalf of AIOM (Italian Medical Oncology Association) and AIOM Foundation

Article History

Disclosures

Financial support: None.
Conflict of interest: None.

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Introduction

The principle that cancer care should be person-centered is stressed by several healthcare organizations around the world, such as the British National Health Service Trust and the US Institute of Medicine (1). This means that the patient should be informed and involved in decision-making, with rights, privacy, and dignity respected at all times. Although these principles are recognized globally, much remains to be done in terms of their implementation (2). It is therefore crucial to integrate ethics in healthcare and clinical research.

Scientific associations play an important role in promoting the responsible and ethical conduction of research (3-4-5), by means of educational initiatives and subscription to codes or principles.

The awareness of this responsibility has led the Italian Association of Medical Oncology (AIOM) to take an active role in promoting the integration of ethical principles both in the organization of the healthcare system and in the conduct of clinicians throughout the continuum of care. As part of this strategy, in 2010 AIOM launched a consensus conference in Valderice (Sicily, Italy). During this event, oncologists and other experts (judges, philosophers, bioethicists) focused on informed consent, issues relating to patient preferences during the choice of therapy, and ethical issues of clinical research.

The debate during the fourth edition of the conference, “Oncology Ethics Days,” held in Ragusa in May 2015, was rich in contributions and proposals. Conference attendees who contributed to the discussion were Italian experts from all fields involved in the care of people with cancer: medical oncologists, psycho-oncologists, nurses, psychologists, pharmacists, legal experts, representatives of the Ministry of Health, and industry leaders. The event focused on the following crucial areas of the oncologist’s practice where ethics plays a predominant role: treatment choice, sustainability by the Italian healthcare system of effective but expensive therapies, and clinical research.

Treatment choice

The diagnosis of cancer represents the beginning of a new phase of life for the patient. The oncologist has to clearly communicate the diagnosis and impart correct information about therapeutic choices and prognosis. Moreover, the oncologist has to evaluate the best available therapeutic choices, taking into account the patent’s decisions and preferences. This ethical equilibrium becomes even more complex for end-of-life treatment decisions, when palliation and support become the most relevant aspects of the care pathway.

Sustainability by the public health service

Sustainability by the public health service of the effective but expensive therapies that are now available is an important issue. A strong ethical relationship exists between ensuring access to the most effective anticancer treatments for everyone and health care policies that may determine disparities to access to registered medicinal products between citizens of different regions of Italy.

Also, there is an ethical relationship among the right to receive the best treatment and cancer care value, the cost of a drug, and strategies of resource utilization in healthcare.

All stakeholders (institutions, the industry, universities, clinicians, and patients) must be involved in these evaluations and participate in this debate.

Clinical research

Clinical research is not only aimed at testing the most effective drugs, but should also respond to unmet medical needs, both in the prevention and treatment settings. The contribution of clinicians to research is essential, as they can recognize medical needs, facilitate patient recruitment, and ensure translation of significant research results into clinical practice. However, a minority of clinicians are engaged in research, mainly because of work overload and lack of acknowledgement for their commitment. Healthcare institutions should enhance clinicians’ efforts devoted to research and encourage their participation in clinical trials by supporting them with human resources (clinical study coordinators, statistics, research nurses) and by improving available informational technologies.

The outcome of this debate was summarized in the 2015 Ragusa statement, which aimed at providing a practical ethical guidance for scientists, clinicians, and healthcare institutions.

In this statement, 4 principles and 16 responsibilities were included, with a view to improving the integration of ethics in the organization of healthcare and clinician behavior.

The 4 principles regarded the following:

Sharing therapeutic choices

Empathy in the patient-oncologist relationship

Equity of access to innovative treatments

Value of commitment in research

The 16 responsibilities focused on the following topics:

Communication: Medical oncologists and the healthcare team should guarantee the involvement of any patient in the decision-making process, supplying information that is appropriate to individual needs and carrying out effective communication with patients and their families.

Autonomy: The medical oncologist and the healthcare team should supply information tools to the patient. That information regards the person’s state of health so as to ensure that he or she can make choices uninfluenced by external pressure.

Sharing: The medical oncologist and the assisted person should exercise their legitimate role in treatment decisions, stating their preferences and the rationale for their choice, in the attempt to construct a consensus on the most appropriate treatment.

Adherence to evidence-based medicine: Both in the treatment choice and in the physician-patient relationship, all medical oncologists should always maintain an approach driven by rigorous scientific methodology.

Involvement of family members: Medical oncologists should take into account the preferences of the patient and his or her family members regarding the degree of involvement in the decision-making process, with particular attention to possible cultural differences.

Empathy: In the treatment relationship, medical oncologists must avoid demonstrating attitudes or behaviors that are incongruous with the suffering of the assisted person and that of family members. They should make every effort to establish a fruitful emotional alliance with the patient and family.

Taking care: The assisted person must be guaranteed continuity in the relationship with his or her own healthcare providers (doctors and nurses) at all stages of the illness and be monitored by the National Health Service beyond the acute phase.

Monitoring: Medical oncologists should ensure the shared participation in end-of-life choices, in particular in that of treatment discontinuation. Treatment interruptions should not be perceived as abandonment, but as part of assistance.

Dignity: The role of the caregiver is not only that of respecting the dignity of the sick person, but also that of asking which relationship best serves the dignity of the sick person.

Accessibility: The cost of treatments must be proportional to their efficacy and safety. To achieve this objective, new strategies of reimbursement are being explored. For example, a unique price negotiation, conducted at the same time as the European Medicines Agency efficacy and safety assessment, might reduce or even eliminate the disparity of access to novel drugs across different European countries or different Italian regions.

Treatment equity: In order to avoid individual economic concerns over the risk-benefit assessment of the possible treatment options, it is important that financial choices are undertaken at the highest decisional level, and in any case as far as possible from the individual doctor-patient relationship.

Health migration: It is necessary to reduce the phenomenon of regional migration to gain access to innovative drugs, which involves inconvenience for patients and their families and may disadvantage the weaker/poorer parts of the population.

Collaboration with voluntary workers: The promotion of relationships with patient associations is fundamental for an active presence at the times of planned choices and an assessment of the perceived quality of the advantages offered by the service.

Support: Spontaneous (independent) research should be supported and encouraged, aimed at testing therapeutic strategies useful for clinical practice.

Efficiency: It is hoped that there is organization with a Coordinator Ethics Committee (regional/macro-regional) for the centralized evaluation of clinical trials. In the hospital, the presence of a Clinical Trials Office to evaluate local feasibility and support the investigators is important.

Improvement: Participation in clinical research activity is of great value for the patient, for healthcare workers, and for participating centers. It should be properly recognized and appreciated as such by directors and senior management, who should create the necessary conditions and supply the needed resources.

These principles and responsibilities cover essential aspects of cancer patients’ care and address all actors involved: patients, oncologists, the healthcare team, ethics committees, and institutions. We suggest all stakeholders embrace the statement and contribute to compliance with its indications. For this reason, AIOM and AIOM Foundation have ensured wide dissemination of the document, both on their websites (http://www.aiom.it/professionisti/documenti-scientifici/position-paper/ragusa-statement-2015/1,764,1) and as a poster to be displayed in all Italian oncology departments.

Disclosures

Financial support: None.
Conflict of interest: None.
References
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Authors

Affiliations

  • U.O.C. Oncologia Medica, Ospedale Sacro Cuore-Don Calabria, Negrar (Verona) - Italy
  • Oncologia Medica, IRCCS-Arcispedale Maria Nuova, Reggio Emilia - Italy
  • UO Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Parma, Parma - Italy
  • SOC Oncologia, Azienda Ospedaliera, Vicenza - Italy
  • IV Divisione Oncologia, Ospedale I.D.I., Rome - Italy
  • Unità Sperimentazioni Cliniche, Istituto Tumori-Fondazione Pascale, Naples - Italy
  • Oncologia Medica, A.O. Ordine Mauriziano, Torino - Italy
  • Farmacia, Istituto Europeo di Oncologia, Milan - Italy
  • Presidenza Salute Donna, Milan - Italy
  • Farmindustria, Rome - Italy
  • S.C. di Oncologia Medica, A.O.U. Careggi, Florence - Italy
  • Dipartimento Oncologico, Usl 7-Centro Direzionale, Siena - Italy
  • U.O. Medicina e Oncologia Medica, Azienda Istituti Ospitalieri, Cremona - Italy
  • Oncologia Medica, A.O.S. Croce e Carle, Cuneo - Italy
  • Oncologia Medica 1, IRCCS, I.O.V., Padua - Italy
  • U.O.C. di Oncologia Medica, Azienda Sanitaria, Florence - Italy
  • Oncologia, Istituto Tumori - Fondazione Pascale, Naples - Italy
  • Dipartimento di Oncologia ed Ematologia, Ospedali Riuniti, Bergamo - Italy
  • S.C. Oncologia Medica, P.O. Garibaldi-Nesima, Catania - Italy
  • Servizio di Oncologia, Ospedale Gradenigo, Turin - Italy
  • Direzione Generale Istituto Giano, Riano (Rome) - Italy
  • Direzione Generale, Azienda Sanitaria Provinciale, Caltanissetta - Italy
  • Direzione Sanitaria Ospedale Sacro Cuore-Don Calabria, Negrar (Verona) - Italy

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