INTRODUCTION

Pain is a global health problem, underestimated for decades, and in Spain it affects 20 % of the adult population chronically. Despite the fact that about half of the patients receive some analgesic treatment, 64 % cannot control it ¹. In them, quality of life has become an indicator of the evolution of their health condition, as an expression of their vital functioning in relation to their goals, expectations, values and interests.

Pain medical practice raises ethical problems in the care for patients with a disease that causes impairment of functionality, with an uncertain prognosis for their reintegration into productive life, and with a large consumption of family and social resources. It is important that the patient can participate in decision-making in a rational way, and not under the influence of ignorance, irrational ideas, or fear ^2,3.

The decision of an adult and competent patient to refuse to be treated must be respected, in consistency with their values (principle of autonomy). This may be in conflict with values and duties of the professional, such as the duty to safeguard life and seek the good of the patient (principle of beneficence), not committing the crime of omission (duty to assist), the obligation of do no harm (principle of non-maleficence) ⁴, or the duty to guarantee equitable accessibility (principle of justice) . These and other problems interest and concern professionals.

The Spanish Pain Society ((Sociedad Española del Dolor, SED) has multidisciplinary active members (n = 1035), among which there is a majority group of anesthesiologists working in pain units (n = 365), in addition to pharmacologists, rehabilitationists, psychologists, internists, family doctors, physiotherapists, nurses, neurosurgeons and other professional profiles. This society has created an Interest Group and a Bioethics Working Group (GT BioSED). Its main objectives are to sensitize the scientific society and the whole society about the ethical aspects related to pain, promote training in bioethics and promote the development of scientific studies on bioethics and pain.

Following the scientific method, the first task of the group is to analyze the ethical questions and problems that the members perceive and are interested in. To investigate issues related to ethical attitudes, values and duties, the qualitative research approach is highly appropriate ⁵. In this way, the reflective interview allows to show emotions and thoughts related to situations that we live. It allows us to go deeper into the judgments we make about these situations and discard some prejudices. It facilitates a deeper knowledge of reality ⁶ and provides a deeper meaning ^7,8 to the experience, which can later be transformed during practice ^9,10. When the reflection is expressed in writing, it provides information about the workplaces from which it is written, and the character and values of the participants ¹¹. Ethical reflection should help to respond to the needs for transformation of work and professional processes.

Objectives: The main objective of this study is to understand the ethical problems related to pain management (in clinical practice, its settings, and the institutions where the professional members of the SED work and that interest or concern them). As a secondary objective, the present study aims to foster reflection on ethical problems in these professionals interested in pain management.

METHODOLOGY

A qualitative approach has been used, through a semi-structured interview, with open questions that invite reflective writing. All SED members (n = 1035) were invited to participate, through a link that leads them to the survey-interview. The invitation was accompanied by a short cover letter, and it was sent on September 9, 2016, by email from the SED technical secretariat. A deadline of 2 weeks was offered to answer it, and a reminder was sent 48 h before the deadline.

The interview consists of 4 open-ended questions, and there were no instructions that limited or closed the way to answer them. Open-ended questions make it possible to detect areas of interest for members in a broad way, although it requires subsequent synthesis work to establish priorities. For this synthesis, we now group the answers to the questions in 4 blocks, according to whether they refer to the indications (beneficence and non-maleficence), justice (equity), autonomy (information) or others.

RESULTS

A total of 6 % of professionals who received the interview participated (n = 62). No age, gender or profession was recorded. They present, under the aforementioned headings, the syntheses of the reflections on the ethical issues present in the reflections of the participants, which they perceive both in their daily practice and in their work environment, in the organizations in which they work, or in the suggestions to the research group. The concordance between researchers after the classification and consensus process was complete.

Table 1 summarizes the reflections that concern all bioethical principles. The synthesis of the 10 most relevant ethical questions (concordance, reliability, interpreting results among researchers) most mentioned in the reflections of the participants is presented in Table 2.

Table 1. Main ethical problems (controversial issue to be solved or explained) mentioned by the participants 

Table 2. Main ethical concerns (fear caused by a problem) mentioned by the participants 

DISCUSSION

The qualitative method used is a variant of an in-depth interview, using a reflective open survey, and its main drawbacks are that the analysis of the results is laborious for the researchers and that it does not facilitate mass participation. Still, it offers clear advantages for investigating not just perceived facts. It facilitates the expression of the professionals' reflections on their experience, and the expression of emotions and thoughts related to the situations experienced, helping to identify the conflicting values and the duties identified by the professionals, which are the fundamental content that studied by bioethics according to Professor Gracia ^12,13. This method facilitates the expression of the professio)nals' reflections on their experience, and the expression of emotions and thoughts related to the situations experienced, helping to deepen the ethical problems that these situations pose.

Despite the low number of responses, around 6 % of members, participation was sufficient to find saturation on issues and problems identified, repeated in numerous answers sent by experts and motivated professionals, which is shown by their answers to the questionnaire and in the content of their answers. Statistical representativeness is not intended.

This qualitative approach should be completed with a new study with a quantitative approach, through a closed survey of the contents detected in this first one, since the open-reflection interview explores understanding the beliefs and values of the interviewee, and a focus group methodology would provide more information, by grading the importance of the responses by virtue of their frequency, evidence and consistency. This would offer more rigor in the interpretation of the results.

In the ethical questions explored, problems such as uncertainty in therapeutic decision-making, the limitation of therapeutic effort, the conditions of the health system that include, the search for excellence, or relationships with the pharmaceutical industry are appreciated. These emerging problems are similar to those found by other authors ^14,15. In the future, they will be categorized by type of pain (for example, acute, postoperative, chronic, oncologic or not), because perhaps the management of ethical issues may differ for each type, especially in potentially more preventable cases, such as acute postoperative pain.

Regarding the principle of autonomy, many comments refer to problems related to information and capacity and informed consent. The autonomy of the patient is not respected if it is considered a priori that he does not possess it or is diminished because of his illness, his opinions and wishes are not taken into account, and the details of his condition are hidden from him, forgetting that his preferences and values are paramount.

Regarding the indications (principles of beneficence and non-maleficence), the variability in the indications of invasive techniques raises a conflict of justice (inequity), which is mentioned in various ways. Uncertainty about the effectiveness of a technique is increased by insufficient evidence, and it is reflected in the problems of the environment rather than in clinical practice itself, motivating reflection on the need for protocols to avoid doing harm ("primum non nocere"). There is also a conflict between beneficence and justice, due to the obligation to be efficient in the interest of sustainability. The ambition for professional excellence and the search for patient safety lead to the need for expert help and supervision to perform the techniques. Concern about when to stop ineffective treatments is accompanied by comments about the duty not to abandon the patient when the therapeutic arsenal is depleted.

Regarding drug indications, the concern about opioids was highlighted (opioid use in general), the possibility of addiction and aberrant use, and prescriptions not indicated in the data sheet, especially in new ultrafast-acting opioids, which have a larger addictive potential and its indication in the technical sheet is only for patients with opioid-controlled base pain. This concern about opioids has been reported in some studies ¹⁶, but others seem to deny this topic. In clinical practice, it is recommended to assess the predictive factors of addictive behavior such as the positive Cage test ¹⁷.

Controlled studies on potential indications other than those included in the data sheet will be needed, as well as promoting training activities that favor dialogue and consensus, and eliminate prejudice. It is not possible to be beneficent if pain cannot be alleviated due to lack of rigorous and up-to-date theoretical-practical training, and maleficence occurs when someone, instead of refraining from doing harmful actions, refrains from alleviating pain by not providing the most suitable treatment. Pain relief is implicitly linked to the quality of patient care, and the professional has an ethical duty to try to do so, with the available resources and adequate knowledge, and for this, good communication with the patient is needed ¹⁸.

Regarding indications for advanced and terminal diseases, the main ethical questions arise regarding palliative sedation and the limitation or adaptation of therapeutic effort (in a broad sense, which includes not only life support measures, but also other treatments). There is a relationship between the two, since the limitation of invasive techniques can lead to considering pain as a refractory symptom, which is a criterion for palliative sedation. These will be questions on which to deepen training activities, and several comments raise the need to sensitize organizations and services about them, as well as the need for empathy and respect.

Regarding the principle of justice (equity), waiting lists and healthcare pressure are the most frequently mentioned problems, both with regard to the clinical practice of the participants, as well as in their environment and in organizations. There is concern about setting priorities in appointments, especially in cancer patients, and there are complaints about the saturation that comes from citing extra patients, after hours, during guards, etc. with the consequent risk of burnout. The pressure of care is related to insufficient time to perform a comprehensive assessment and provide psychological support. The conflict regarding the indication of drugs or techniques other than those recommended by the health system, generally with criteria of efficiency and sustainability, which may require justified exceptions, is also of concern.

Numerous comments on the need for training that favors the accessibility of the patients to the best treatments refer to justice. Programs for the study of pain during the training of health professionals are insufficient. It is not fear to consider that there is nothing left to do in patients with difficult pain and the necessary resources to alleviate their suffering are not available, in the same way that it would be performed with other types of diseases. Several thoughts deal with the influence of the pharmaceutical industry, which may condition the indication of new and more expensive treatments, and conflicts of interest. The costs of treatments pose ethical conflicts in private medicine and also in public health (sustainability / beneficence).

Thoughts pointing to the need for coordination at the regional and local levels also allude to equity, which is also raised in other studies on pain18 and in other fields of medicine between different services and primary and specialized care. The main suggestion in this regard was the thought on the saturation of the health system, with the need to adapt and make profitable material and human resources, act according to protocols and guidelines based on evidence, and evaluate its efficiency and quality.

Regarding research, there was concern about how to propose cancer patients to be included in trials, and the guarantee that control groups receive at least standardized treatment. They propose creating information sheets on frequently asked ethical questions when designing studies, developing a minimum plan of ethical requirements for a study, a new technique, or a change in clinical practice. They propose to complete this study with a quantitative descriptive study using a survey with closed questions, and to elaborate a bioethics guide of the SED.

CONCLUSIONS

Professionals dedicated to pain management in Spain are concerned about ethical problems related to uncertainty in the indications, especially regarding invasive and expensive techniques, and the risk/benefit of the use of certain drugs, especially opioids and for indications not included in the data sheet.

They are interested in problems related to information and the capacity for informed consent.

Regarding advanced and terminal diseases, they are challenged by the conspiracy of silence and decisions to limit therapeutic effort, refusal of treatments and palliative sedation.

They express their concern for equity and to avoid variability and discrimination, the pursuit of professional excellence, and constraints due to restrictions imposed by healthcare organizations, waiting lists, and the influence of the industry.

This first approach was qualitative, and it should be completed with a descriptive study using a questionnaire. It will be useful to take these results into account for drafting the questionnaire. The training and awareness activities on bioethics for SED members should consider these results in the design of their teaching objectives, content and methodologies.