Vincent Aurélie

Lydia Fanny

Yassine Et Marie

Julie Océane

Anne Marie

Marine Lisa Charlotte

Camille Laura Thomas

Sophie

Pauline Laetizia

Anne Sophie

Anne Julien

Rachel Hugo

Gerhard

A Monsieur le Professeur Jean-Yves LE RESTE :

Merci pour ce sujet de thèse, pour ta réactivité incomparable, pour ton implication dans les groupes de thèse et auprès des étudiants. Je te remercie infiniment, j'ai passé un SASPAS, une fin d'internat et un début d'activité professionnelle qui n'aurait pas été les mêmes sans tes conseils personnalisés et tes mises en perspectives originales. En me faisant me remettre en question dans ma façon de penser, réagir et interagir avec les autres, et pas seulement sur le plan professionnel, grâce à toi, j'ai grandi. Sois assuré de tout mon respect et de ma profonde reconnaissance.

A Monsieur le Docteur Patrice NABBE :

Pour votre travail et votre investissement auprès des étudiants et au sein du département de Médecine Générale. Pour me faire l'honneur de juger mon travail de thèse. Soyez assuré de tout

INTRODUCTION

General context

Therapeutic alliance (TA), also called working alliance, refers to the quality of care between a physician and his patient, and is defined as an agreement on goals, an assignment of tasks and the development of bonds [START_REF] Bordin | The Generalizability of the Psychoanalytic Concept of the Working Alliance[END_REF]. It is a partnership, a mutual collaboration, between the patient and the therapist, in order to achieve shared goals. It requires active negotiation and participation between patient and therapist [START_REF] Bioy | L'alliance thérapeutique : historique, recherches et perspectives cliniques[END_REF].

TA concept was first initialized by Freud in 1912 in his book named « The Dynamics of Transference », where he introduced the importance of communication in therapist-patient relationship. For him it was a necessary factor in an analytic therapy process, and he pointed out the interest of a comprehensive and positive attitude of the therapist for his patient, which can enhance the other therapeutic techniques used in the analytic therapy [START_REF] Elvins | The conceptualization and measurement of therapeutic alliance: An empirical review[END_REF][START_REF] Lindgren | Therapeutic Alliance; Exploration of the construct validity of the concept[END_REF].

The pan theorical model that Bordin developped in 1979, introduced three dimensions of TA, Bond, Task and Goal, which served as a common base for the construction of several important tools that evaluated TA [START_REF] Bordin | The Generalizability of the Psychoanalytic Concept of the Working Alliance[END_REF].

Since the 1960s more than 30 quality assessment tools for TA have been developed [START_REF] Noël | Revue systématique de la littérature sur les moyens d'évaluation de l'alliance thérapeutique par des outils de mesure fiables et reproductibles[END_REF]. The working alliance has been one of the most investigated psychometric factors of patient care in the psychotherapeutic field. A considerable number of studies have demonstrated a positive link between an effective working alliance, the adherence to treatment and the outcome of the therapy [START_REF] Barber | Therapeutic Alliance as a Predictor of Outcome and Retention in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study[END_REF][START_REF] Martin | Relation of the therapeutic alliance with outcome and other variables: a meta-analytic review[END_REF].

In psychotherapeutic field, therapeutic alliance is already very studied in Spain and Spanish psychotherapy studies have been carried out using translations of the WAI and the WAI Short patient and therapist versions [START_REF] Tracey | Factor Structure of the Working Alliance Inventory. Psychological Assessment[END_REF][START_REF] Corbella | La alianza terapéutica: historia, investigación y evaluación[END_REF][START_REF] Corbella | Alianza terapeutica evaluada por el paciente y mejora sintomatica a lo largo del proceso terapeutico[END_REF][START_REF] Gonzalez | La Alianza Terapeutica[END_REF]. In one of the studies, the author concluded the need to improve the study of patient and therapist perceptions of the working alliance and to increase the convergence between them. In another the results suggested that therapeutic alliance may be a more unified construct than it is usually accepted.

Justification of the study

In Europe, with an ageing population, primary cares face an increase in prevalence of multimorbidity and chronic diseases. New therapy models have to be found to help these patients [START_REF] Esandi | Atención centrada en la familia: un modelo para abordar los cuidados de la demencia en la comunidad[END_REF]. As quality of care enhancement has become an important medical research issue in the last years, one of the ways to improve it that appears among the most effective in primary care is patient-centered medicine. That means cares that are respectful and responsive to individual patient preferences and needs, and that ensure that the patient's values guide all clinical decisions [START_REF] Barry | Shared decision making--pinnacle of patient-centered care[END_REF].

This involves using new models of interaction between the physician and the patient during medical consultation, such as shared-decision making, that is an intermediate model between the old paternalistic hierarchical model, characterized by physician dominance of the medical decision, and the informed decision making model, where the physician only informs the patient who takes the responsibility of the choice [START_REF] Charles | Shared decision-making in the medical encounter: What does it mean? (or it takes at least two to tango)[END_REF][START_REF] Metz | Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial[END_REF][START_REF] Loh | The Effects of a Shared Decision-Making Intervention in Primary Care of Depression: A Cluster-Randomized Controlled Trial[END_REF].

The adoption of a more shared decision model appears necessary in Spain, the involvement of the patient being desired to adapt to the new stakes of the current medicine [START_REF] Jovell-Fernández | El paciente existe, luego no lo ignores[END_REF]. The "National conference for the care of patients with chronic diseases" which occurred in 2011 in Seville [START_REF] Orozco-Beltrán | Conferencia nacional para la atención al paciente con enfermedades crónicas[END_REF] generated a consensus that promotes the development of comprehensive plans for the care of patients with chronic diseases in which a system of care is based on integrally, continuity of care, and also promotes an informed and involved patient managing his disease [START_REF] Badia | Decidiendo juntos ganaremos efectividad[END_REF]. The long-term care of patients with chronic diseases leads to more frequent consultations with their general practitioners [START_REF] Escarrabill | Competencias transversales de los profesionales que facilitan atención domiciliaria a pacientes crónicos[END_REF][START_REF] Díaz | Tiempos durante la visita médica en atención primaria[END_REF]. It appears important for the clinician and patient to work together to produce the best outcomes possible as continuity of care is based on the stability and quality of the doctor-patient relationship [START_REF] Barry | Shared decision making--pinnacle of patient-centered care[END_REF].

Understanding the psychological aspects of a general medical consultation becomes essential because of their importance for patient follow-up [START_REF] Moujmid-Ferdjaoui | La relation médecin-patient, l'information et la participation des patients à la décision médicale : les enseignements de la littérature internationale[END_REF]. An effective doctor-patient communication is a central clinical function in building a therapeutic doctor-patient relationship [START_REF] Ha | Doctor-Patient Communication: A Review[END_REF]. It is known to have a positive influence on the patients' satisfaction which is known to enhance direct compliance and support to therapy [START_REF] Sylvia | Association between therapeutic alliance, care satisfaction, and pharmacological adherence in bipolar disorder[END_REF].

Today, the physician's technical skills are no longer considered sufficient to achieve successful therapy or to get patient satisfaction [START_REF] Jovell-Fernández | El paciente existe, luego no lo ignores[END_REF][START_REF] Badia | Decidiendo juntos ganaremos efectividad[END_REF]. Because of its constant utility in daily practice, communication is now considered as one of the fundamental competences of the general practitioner [START_REF] Allen | La définition européenne de la médecine générale-médecine de famille[END_REF]. Many physicians tend to overestimate their ability in communication [START_REF] Ha | Doctor-Patient Communication: A Review[END_REF][START_REF] Moore | Comunicación médico-paciente: una de las competencias básicas pero diferente[END_REF]. In order to acquire a more efficient practice model, an involvement of their communication skills is needed. The objective of a study carried out in 2004 in Minorca, was to determine the mean time per meeting visit and per problem attended to in the doctor´s office and their distribution according to the care procedure during the visit. They concluded that the short time spent on the explanation of the patient's problem suggests that the period for active listening should be extended [START_REF] Díaz | Tiempos durante la visita médica en atención primaria[END_REF].

Communication is an essential aspect of the day-to-day work of the general practitioner, which unfortunately is not sufficiently discussed in the curriculum of medical studies of trainees. In 2006 in Barcelona, a seminar was carried out at the Health Study Institute for Medicine teachers. They realized medical schools in Spain lack the tradition to consider communication as a core professional skill. They enlightened the need to identify difficulties about the implementation of the communicational dimension and to integrate communication skills in undergraduate medical education [START_REF] Clèries | Formar en comunicación a los estudiantes de medicina: A propósito de un seminario para profesores universitarios[END_REF].

Improving management of chronic diseases involves optimizing patient adherence to their treatment. According to the WHO, promoting drug adherence would be more effective than finding new treatments [START_REF] Baudrant | Thinking differently the patient medication compliance: From an injunctive posture to a working alliance between the patient and the healthcare provider -Concepts and determinants[END_REF]. The quality of therapeutic alliance is correlated positively with the adherence to the treatment [START_REF] Fuertes | The physician-patient working alliance[END_REF][START_REF] Fuertes | Behavioral Indices in Medical Care Outcome: The Working Alliance, Adherence, and Related Factors[END_REF]. A Spanish study carried out in 2006, aimed to find the determinants of the adherence to therapeutic plan in elderly Spaniards. It found that the use of the monthly consultation for women patients showed that they had a greater therapeutic compliance. The reasons for this were that they reinforced the medical indications during the visit and a better interaction between the doctor and the patient, which promoted the therapeutic alliance [START_REF] Tuesca-Molina | Determinantes del cumplimiento terapéutico en personas mayores de 60 años en España[END_REF].

Due to the interest of the Spanish-speaking countries in the subject, it is necessary to develop an assessment scale for TA practical, simple to use and adapted to the common language in Spanish, usable in primary cares.

TATA

In 2012, in coordination with the European General Practice Research Network (EGPRN), a European project was initiated by the Medicine Faculty of Brest named TATA (Tool Assessment for Therapeutic Alliance Study). Its objective was to find available quality tools to assess TA for Family Physicians medicine faculties and trainees. Several European research teams are involved, all over Europe. First phase of the project has been the selection of validated assessment tools for TA, with a systematic literature review which found 6 reliable and reproducible tools for TA evaluation [START_REF] Noël | Revue systématique de la littérature sur les moyens d'évaluation de l'alliance thérapeutique par des outils de mesure fiables et reproductibles[END_REF].

Second phase was to determinate which one in these assessment tools was the most appropriate for primary care in Europe. Using a RAND/UCLA AM method consensus the WAI SR (Working Alliance Inventory Short Revised) scale was selected for its reliability, reproducibility and ergonomics to assess TA by a panel of European experts in General Practice [START_REF] Borgne | Selection of a reproductible and reliable tool assessment for therapeutic alliance in general practice, by a RAND/UCLA consensus method[END_REF][START_REF] Hatcher | Development and validation of a revised short version of the working alliance inventory[END_REF].

This study occurred during the third phase, its aim was to translate the selected assessment tool, the WAI SR, in vernacular language of each European country. It took part of the TATA project. It used a cultural check to verify an appropriate adaptation of each translation to their national context, to insure their homogeneity, and comparability of the measures.

Before the study no validated translation of the WAI Short Revised existed in Spanish.

The objective of this study was to translate the WAI SR from English into Spanish. The Spanish translation used a forward-backward translation, including a Delphi consensus process, with the help of experts with a sufficient English level.

MATERIAL AND METHODS

Methodology

As with the other European countries participating in the study, with the Spanish team a forwardbackward translation English-Spanish was chosen to ensure a strong linguistic equivalence and maintain the validity of the tool, with a cultural control to the national context, in order to ensure the homogeneity and the comparability of measures across Europe.

Among available methods of consensus, using a multistep procedure enabled to make a valid and consistent translation [START_REF] Sousa | Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline:Validation of instruments or scales[END_REF][START_REF]Process of translation and adaptation of instruments[END_REF][START_REF] Acquadro | European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials[END_REF][START_REF] Beaton | Guidelines for the process of cross-cultural adaptation of self-report measures[END_REF]. Delphi procedure was the most appropriate consensus method for the study. It allows obtaining a final opinion, unique and convergent of an expert group [START_REF] Hasson | Research guidelines for the Delphi survey technique[END_REF][START_REF] Okoli | The Delphi method as a research tool: an example, design considerations and applications[END_REF][START_REF] Powell | The Delphi technique: myths and realities[END_REF][START_REF] Fitch | The RAND/UCLA Appropriateness Method User's Manual[END_REF]. The experts were selected and contacted separately, anonymously, which made it possible to avoid a dominant opinion.

The entire methodology is summarized in Figure 1.

Ethics statement

The study was approved by the Université de Bretagne Occidentale Ethics Committee in October 2014.

Each participant in the study was asked to fill out a consent form after reading the informations about the study. The Ethics Committee approved the consent procedure.

A Spanish Gallego Ethics Committee, named Comité de Etica de la Investigaciòn de Pontevedra-Vigo-Ourense, approved the study in July 2016, the document is presented in appendices.

Research team and forward translation

A first research, named the Research team, was composed of 5 experts. In July 2016 they carried out a first translation of the WAI SR from English to Spanish. The team was composed by 1 preventive medicine specialist, 2 general practitioners, 1 psychologist, and 1 linguist. They were all fluent in English. They took into account the cultural context and adapted their translation to the possible future uses of the scale [START_REF] Sousa | Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline:Validation of instruments or scales[END_REF].

Participant selection for consensual validation and eventually changes in forward translation

24 Spanish general practitioners were recruited in Galicia and in other places of Spain to participate in the study as experts during the first round of the Delphi procedure.

They were contacted separately by email, according to what the Delphi method recommends, without mailing list, to avoid contamination [START_REF] Novakowski | Using the Delphi Technique in Normative Planning Research: Methodological Design Considerations[END_REF].

Information about all the experts, age, gender, type of activity, student coaching and research activity, numbers of publications in English and other languages, and level of English was collected. These datas were collected to ensure their quality as experts both for Spanish GP and for English level. Their consent forms were collected by e-mail.

Data collection and first Delphi round

In October 2016, the 24 experts received by separated email an individual form, where each item of the English version of the WAI SR was associated with its Spanish translation.

The experts were asked to evaluate the equivalence of translations using a Likert scale. The scale ranged from 1 (total disagreement) to 9 (full agreement). For each rating under 7, they had to explain it with a short commentary.

Consensus was reached when at least 70% of the participants rated the items 7 or above.

If an item was considered as consensual, it was validated and no further work was needed on it. If an item was not consensual, the first team of 5 experts had to collect the comments and the other proposed versions and had to design a new item proposal to be submitted to the group of 24 experts. The process was continued until a final consensus was reached [START_REF] Hasson | Research guidelines for the Delphi survey technique[END_REF][START_REF] Okoli | The Delphi method as a research tool: an example, design considerations and applications[END_REF][START_REF] Powell | The Delphi technique: myths and realities[END_REF][START_REF] Fitch | The RAND/UCLA Appropriateness Method User's Manual[END_REF].

The first team met at the reception of the forms in December 2016 and took into account the remarks to make changes on the Spanish version: they created a second Spanish version with the contributions of the participants.

The scoring sheet was not included in the form sent to the experts, the research team decided to send it after, in August 2017, with 4 questions to rank.

Backward translation

The consensual translation in Spanish was then submitted to a professional translator for a backward translation into English. The translator was not aware of the original version and was not trained on the subject of the study. His native language was English.

RESULTS

Forward translation and research team

The Research team finalised a first Spanish translation of the WAI SR in July 2016. It was not a literal translation, as cultural adaptations had to be made for the framework of general practice and the Spanish sociocultural context. It is presented in table 4.

This research team was composed of 5 women: 1 preventive medicine specialist, 2 general practitioners, 1 psychologist and 1 linguist; their average age was 47.6 years old. On average they had practiced for 22 years. 60% were involved in teaching and 80% in research activities. They all worked in group, on an urban environment. 40% were fluent in English, 20% had an intermediate level and 20% had a basic level. The 5 experts signed a written consent form.

BASIC INTERMED FLUENT 1 0 0 1 1 0 1 0 10 1 0 0 1 2 1 0 0 0 1 0 1 0 5 1 0 0 3 0 0 1 0 1 0 1 3 5 0 0 1 4 1 0 0 1 0 1 0 0 1 0 1 0 5 0 0 1 1 0 1 0 0 12 1 0 0 6 0 0 1 1 0 0 1 0 0 0 1 0 7 0 1 0 1 0 1 0 0 0 0 1 0 8 0 0 1 1 0 1 0 0 0 1 0 0 9 0 0 1 1 0 0 1 0 2 0 0 1 10 0 0 1 1 0 0 1 0 0 0 0 1 11 0 0 1 1 0 0 1 0 4 0 1 0 12 0 0 1 1 0 1 0 0 5 0 1 0 13 1 0 0 0 1 1 0 1 6 1 0 0 14 0 0 1 1 0 1 0 0 3 0 1 0 15 0 0 1 1 0 1 0 0 5 1 0 0 16 0 0 1 0 1 1 0 2 6 0 0 1 17 0 1 0 0 1 0 1 0 10 1 0 0 18 0 0 1 1 0 1 0 1 0 0 1 0 19 0 0 1 1 0 1 0 0 15 0 0 1 20 0 0 1 1 0 1 0 5 2 0 1 0 21 0 1 0 0 1 1 0 2 24 0 1 0 22 0 0 1 0 1 0 1 0 4 0 1 0 23 0 0 1 1 0 1 0 3 50 1 0 0 24 1 0 0 1 0 0 1 0 3 0 1 0 24

In the WAI SR Patient:

In the instructions, and in the 2 nd , 4 th and 10 th questions the first Spanish translation used the word "terapia" to translate "therapy", as it was more connected with a psychotherapeutic context, and too far from the terms used in general medicine, it was modified into "tratamiento".

In the 2 nd question, the sentence "me da nuevas formas de ver mi problema" were not said in an usual way of speaking in Spanish, therefore it was changed into "me proporciona otros puntos de vista sobre mi problema"

In the 8 th question, the phrase "importante para mi para continuar trabajando" brought a heavy formulation of the sentence; it was modified into "importante que trabaje".

In the WAI SR Family Physician:

In the instructions, the words "que va leyendo" used a time no much used in usual Spanish language, it was changed into "que lea".

Backward translation and Cultural check

The backward translation was carried out by a professional translator, an Irish person who lived in Spain for 7 years, graduated in Spanish anthropology. In the 7 th , 9 th and 10 th question, the original English version used the expression "I Feel" whereas the backward translation used the expression "I think". The sense was different, so the Spanish version was modified into "Siento que".

The Research team considered that the discrepancies between "Seldom" and "Rarely" and "Fairly often" and "Often" came from the fact that there are many English terms to describe the frequency and that they were less numerous, or not used in Spanish. This did not change the Spanish version.

In the WAI SR Family Physician:

In the 2 nd question, the original English version said "I am genuinely concerned for ___'s welfare." Whereas the backward translation was "I am really worried about ___'s wellbeing.". The sense was different, so the Spanish version was changed.

In the 4 th question, the original English version said " ___ and I collaborate on setting goals for my therapy." While the backward translation said " ___ and I trust that our present therapeutical activities are worthwhile." The sense was not exactly the same, the Spanish version was changed.

Scoring Sheet:

In the scoring sheet, the original English Version used the word "Bond" while the backward translation said "Relationship". The sense was different, the Spanish word was changed.

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version 5. ___ and I respect each other.

5. ___ y yo nos respetamos mutuamente.

5. ___ y yo nos respetamos mutuamente.

5. ___ and I respect each other.

5. ___ y yo nos respetamos mutuamente.

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version 12. I believe the way we are working with my problem is correct.

12. Creo que la forma en que estamos trabajando con mi problema es correcta.

12. Creo que la forma en que estamos trabajando con mi problema es correcta.

12. I think the way we are dealing with my problem is correct.

12. Creo que la forma en que estamos trabajando con mi problema es correcta.

WAI SR FAMILY PHYSICIAN

English original version

Spanish version Spanish second version

Backward translation

Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version 3. We are working towards mutually agreed upon goals.

3. Estamos trabajando en los objetivos que hemos acordado juntos/as.

3. Estamos trabajando en los objetivos que hemos acordado juntos/as.

3. We are working towards the goals we have set together.

Estamos trabajando en los objetivos que hemos acordado juntos/as.

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version 5. I appreciate ___ as a person.

5. Aprecio a ___ como persona.

5. Aprecio a ___ como persona.

5. I appreciate ___ as a person.

Aprecio a ___ como persona.

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version

English original version

Spanish version Spanish second version

Backward translation Spanish final version 9. I respect ___ even when he/she does things that I do not approve of. 9. Respeto a ___ incluso cuando hace cosas con las que no estoy de acuerdo.

9. Respeto a ___ incluso cuando hace cosas con las que no estoy de acuerdo.

9. I respect ___ even when he/she does things I do not agree with. 9. Respeto a ___ incluso cuando hace cosas con las que no estoy de acuerdo.

English original version

Spanish version Spanish second version

Backward translation Spanish final version

SCORING SHEET

English original version

Spanish version Spanish second version

Backward translation Spanish final version

G=Goal T=Task B=Bond

G=Objetivo T=Tarea B=Relación G=Objetivo T=Tarea B=Relación G=Goal T=Task B=Relationship

G=Objetivo T=Tarea B=Vínculo

English original version

Spanish version Spanish second version

Backward translation Spanish final version

To derive a scale or total score, simply sum or take the mean of the items.

Para calcular la puntación de la subescala o del total, solamente realice la suma o la media de los ítems.

Para calcular la puntación de la subescala o del total, solamente realice la suma o la media de los ítems.

To work out the subscale score or total score just add the items or calculate the average.

Para calcular la puntación de la subescala o del total, solamente realice la suma o la media de los ítems.

DISCUSSION

Main results

A valid Spanish translation of the WAI SR was carried out. There was no translation of the WAI in its Short Revised form in Spanish before this one. The quality of the translation is important in order to be validated during field studies. It has been adapted for its use with general practitioners and in medical students training.

The Forward-Backward translation and the Delphi round methods were respected, homogeneity was assured by the backward translation and the modifications made after.

The characteristics of the expert panel show a fairly sufficient exhaustivity of Spanish general practitioners.

The persistent differences between the original English version and the backward translation were related to the cultural adaptations necessary for the use of the scale in Spanish-language.

Limitations and bias

Information and investigation biases were avoided by using separate emails for data collection, no mailing list and no exchange between the 24 Delphi experts. There was no confusion or interpretation bias.

The Scoring Sheet was only ranked by 9 experts of the Delphi group, which is the lower limit of the Delphi method.

A selection bias can be discussed: the Research team knew some of the experts of the Delphi group; the first team is composed only by women, as is the majority of the second group. Most of them worked in a group practice and in an urban environment. Also, there is probably a selection bias with the team selected for the scoring sheet, the research team having probably restricted the selection on the most suitable experts to respond quickly, which create a subpopulation effect.

The Delphi method itself has limitations: it does not allow a debate or the emergence of new ideas [START_REF] Powell | The Delphi technique: myths and realities[END_REF][START_REF] Fitch | The RAND/UCLA Appropriateness Method User's Manual[END_REF].

In the replies received, expert number 22 had not fully understood the initial instructions for noting the quality of the translation, his remarks being all oriented towards the change of the English version of the scale. His notations did not prevent consensus, and they were kept in the final table. The experts' remarks for the first round are presented in the appendix.

Key points

The WAI SR has advantages compared to other scales as it has clear theoretical conceptualization, it is economic, it has effective psychometric properties, and is standardized and reproducible [START_REF] Borgne | Selection of a reproductible and reliable tool assessment for therapeutic alliance in general practice, by a RAND/UCLA consensus method[END_REF]. Nevertheless, it was developed for the psychiatric and psychotherapeutic field. A new quantitative research study and validation of applied psychometric properties in the general practice field will be undertaken in Spain, as in the other European countries that participated in the study. The aim of those surveys will be to assess the level of effective TA found in each country and to permit a comparison between countries.

From now on, Spain has at its disposal an assessment tool for therapeutic alliance, which makes possible to carry out national evaluation studies. Spain will now be able to be compared with the other countries in European multicentre qualitative studies that will deal with this subject. Also the comparability of the data collected will be valid internationally. A consistent tool between all involved countries is enough to undertake comparative surveys. Even if a numerical ratio of what an effective TA is between countries could be achieved, comparison are possible with the achieved translations using the same method.

Implications for practice, further research, medical training:

The improvement of the communication techniques of the European general practitioners, with the aim of increasing patients' adherence to treatment and more generally quality of care, depends in part on the improvement of their therapeutic alliance. Having a tool available to evaluate this working alliance on a daily practice will allow professionals to focus on their strengths and work on their shortcomings [START_REF] Fuertes | The physician-patient working alliance[END_REF][START_REF] Fuertes | Behavioral Indices in Medical Care Outcome: The Working Alliance, Adherence, and Related Factors[END_REF].

In the Barcelona Declaration of Patient Associations in 2003 [START_REF]Declaración de Barcelona de las asociaciones de pacientes[END_REF], was proposed, among the main findings, a greater involvement of patients in clinical decision-making, improving the patient doctor relationship with mutual trust, more appropriate information, a longer time of attention to the patient and a better active listening of the physician. Methods of improvement and evaluation of the therapeutic alliance can be a part of a solution to these issues.

Using WAI SR will also improve the training of medical students in communication techniques with feedback on their evolution, with a view to enhance their future practice. It appears necessary to incorporate the communicational and relational competence in the training of the future doctors.

In a book for the training of Spanish medical students published in 2007, the author notes that communication skills can and should be learned because although some professionals are naturally skilled in the domain of such skills, it is not the same with everyone. She provides a guide to communication techniques to improve patient doctor relationship in order to establish an adequate therapeutic alliance [START_REF] Del | Acerca de la Buena comunicacion en Medicina[END_REF]. WAI SR can be a good tool for improving communication skills of students.

The effectiveness of the training will also be assessable. Comparative studies of patient satisfaction before and after the training of professionals and students throughout Europe may be useful.

CONCLUSION

TA is an essential element of the everyday work of physicians. The transmission of appropriate information, shared medical decision-making, patient-centered care, all imply effective communication skills. TA appears to be an important skill for physicians to acquire, and incorporates the core of fundamental competencies of General Practice as defined by WONCA. It is necessary to have access to a tool which assesses this capacity in the general medical curriculum and in the daily practice of general practitioners.

The creation of a positive relationship between the doctor and the patient plays a large part in the improvement of his symptoms, independently of the treatment followed [START_REF] Blasi | Influence of context effects on health outcomes: a systematic review[END_REF][START_REF] Stewart | Effective physician-patient communication and health outcomes: a review[END_REF].

The goal to achieve by improving the communication skills of general practitioners is to enhance the value of patient-centred medicine, to improve their clinical practice and therapeutic results, raise patient adherence to treatment, and ultimately improve the quality of care, and finally the patients quality of life.

To evaluate and improve communication and the quality of therapeutic alliance, in practice or in Continuing Medical Education, the use of WAI-SR opens up a wide field of possibilities. The WAI SR assess three essential elements of the alliance: agreement between patient and therapist on the goals of the treatment (Goal), agreement between patient and therapist about the tasks to achieve these goals (Task) and the quality of the bond between the patient and the therapist (Bond). Their separate evaluation will allow students and physicians to determine on which they will have to work on [START_REF] Horvath | The role of the therapeutic alliance in psychotherapy[END_REF].

Future health professionals are not sufficiently prepared for the importance of communication techniques that enable more effective therapeutic work and allow better results in their care [START_REF] Clèries | Formar en comunicación a los estudiantes de medicina: A propósito de un seminario para profesores universitarios[END_REF].

Today there is solid evidence to support the teaching of effective communication skills in all medical schools. All medical education programmes should include formal teaching on the doctor-patient relationship, but must take into consideration the aspects of communication teaching that make it different from teaching other aspects of medicine [START_REF] Moore | Comunicación médico-paciente: una de las competencias básicas pero diferente[END_REF]. Disposing of the WAI SR evaluation scale in medical school will raise awareness of students to communication and its importance in clinical practice, and will tend to preserve their empathy towards the patients throughout their studies [START_REF] Neumann | Empathy Decline and Its Reasons: A Systematic Review of Studies With Medical Students and Residents[END_REF]. They have to learn not to be automats that prescribe drugs but humans who interact with their patients. The need for training in TA Spanish and European medicine students appears essential. WAI SR is a tool that can be usefull for communication instruction, for each professional who works in direct contact with patient, in medical education of trainees, and continuing education for physicians.

The aim of TATA project will make available to all the European countries who took part in this study an assessment tool to evaluate therapeutic alliance in their language, elaborated with a validated method which insures the linguistic equivalence of the scale and comparability of measures between all the countries (even if some corrections should be needed with more quantitative surveys). This translation into all European languages will allow to undertake large-scale studies.

Some research carried out in the somatic field on the efficacy of treatments, will be able to take into account the therapist-patient interaction and the part of the therapeutic alliance in relation to the outcomes obtained [START_REF] Gonzalez | La Alianza Terapeutica[END_REF].

The WAI SR can be used in the training of all health professionals in connection with patients, such as nurses or physiotherapists, who also have a great interest in this tool [START_REF] Paap | Working Alliance Inventory-Short Form Revised[END_REF][START_REF]Efectividad de programas educativo-terapéuticos en Fisioterapia[END_REF].

As the translation of the WAI SR in Spanish is in Castilian, it can serve as a basis for other translations into the vernacular languages of the Spanish autonomies, for example Catalan, in order to use the everyday language used by patients and doctors.

APPENDICES Annex A WAI SR (English version) WAI SR Patient

Instructions: Below is a list of statements and questions about experiences people might have with their therapy or Family Physician. Some items refer directly to your Family Physician with an underlined space --as you read the sentences, mentally insert the name of your Family Physician in place of ______ in the text. Think about your experience in therapy, and decide which category best describes your own experience.

IMPORTANT!!! Please take your time to consider each question carefully.

WAI SR Family Physician

Instructions: Below is a list of statements about experiences people might have with their client. Some items refer directly to your client with an underlined space --as you read the sentences, mentally insert the name of your client in place of ___ in the text.

IMPORTANT!!! Please take your time to consider each question carefully.

WAI SR scoring sheet SCORING KEY FOR THE HATCHER GILLASPY SHORT FORM OF THE WAI patient and Family Physician version

ANNEX B WAI SR (Spanish finale Version) WAI SR Patient

Instrucciones: A continuación se presenta una lista de afirmaciones y preguntas sobre las experiencias que las personas podrían tener con su tratamiento o terapeuta. Algunos ítems se refieren a su terapeuta con un espacio subrayado cuando lea las frases, incluya el nombre del/la terapeuta en lugar del ____ en el texto. Piense en su experiencia en el tratamiento, y decida qué categoría describe mejor su propia experiencia.

IMPORTANTE:

Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente.

WAI SR Family Physician

Instrucciones: A continuación se presenta una lista de frases sobre la experiencia que los profesionales podrían tener con sus pacientes. Algunos ítems se refieren al paciente con un espacio subrayado_ , a medida que lea las frases, incluya el nombre del paciente en lugar del ___ en el texto.

Expert number 18

instrucciones: "en lugar del ______ del texto" creo sería mejor "en lugar del ______ en el texto" 8: yo pondría " qué es importante para mi seguir trabajando"

Expert number 19

General: al tratar de reproducir el espacio vacío para incluir el nombre del terapeuta al principio como en la versión ingles da lugar a frasas no del todo cotidianas. Una expresión más natural llevaría a incluir el nombre en medio de la frase. (esto aplica también al previo) 1.-La palabra terapia salvo en los casos del psicoanálisis me parace que se traduce mejor por tratamiento, incluso en terapias físicas como onda corta queda mejor tratamiento.

Expert number 20

Figure 1 :

 1 Figure 1 : Methodology summary of the study

IMPORTANTE: 2 . 3 . 4 . 6 . 9 . 10 .

 2346910 Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente 1. ___ y yo estamos de acuerdo en los pasos necesarios para mejorar su situación Me importa realmente el bienestar de esta persona. Estamos trabajando en los objetivos que hemos acordado juntos/as. ___ y yo estamos seguros de la utilidad de nuestras actividades terapéuticas actuales. Hemos llegado a comprender bien los tipos de cambios que serían buenos para ___. y yo tenemos una percepción común de sus objetivos. Respeto a ___ incluso cuando hace cosas con las que no estoy de acuerdo. Estamos de acuerdo en lo que es importante que ___ trabaje. THE HATCHER GILLASPY SHORT FORM OF THE WAI patient and Family Physician version Patient scale mean: G = Objetivo = T = Tarea = Family Physician scale mean: G = Objetivo = T = Tarea = Para calcular la puntación de la subescala o del

Table 1 : Research team characteristics Group of 24 experts

 1

	24 Spanish general practitioners have been recruited. They were living and working in Galicia,
	Andalusia, Asturias, Canary Island, Madrid, Extremadura and Corunna. They all signed a written
	consent form.
	Their average age was 48.04 years old. On average they had practiced for 19.42 years. There were
	62.5% of women, 37.5% of men. Most of them (75%) practiced in a medical group. The majority
	(70.83%) worked in an urban area, 12.5% semi rural area and 16.67% in rural environment. Most of
	them participated to research activities (62.5%) and 70.83% had teaching activities and supervised
	students. Their average number of publications in English was 1.13, and 6.79 in other languages.
	29.17% had a basic level in English, 45.83% had an intermediate level, and 25% were fluent.

Table 2 : 24 Experts group characteristics First Delphi Round The

 2 [START_REF] Sylvia | Association between therapeutic alliance, care satisfaction, and pharmacological adherence in bipolar disorder[END_REF] experts received in October 2016 by individualized email the form to fill. The answers with the filled forms including the experts' specifications and ratings were received between October and November 2016. Each participant was assigned a numeric code. The answers are shown on table 3.

			CODE	BIRTHDAY AGE		GENDER	YEARS OF PRACTICE PRACTICE TYPE
					(years)	MALE	FEMALE		SOLO	GROUP	OTHER
				1 08/07/1961	56	1	0	25	0	1
				2 03/04/1979	38	0	1	9	1	0
				3 05/08/1967	50	0	1	23	1	0
				4 10/11/1965	51	0	1	23	0	1
				5 16/12/1967	49	0	1	20	0	1
				6 26/12/1967	49	0	1	20	0	1
				7 04/05/1987	30	1	0	5	1	0
				8 17/12/1966	50	0	1	20	0	1
				9 01/01/1966	51	0	1	22	0	1
				10 18/06/1981	36	0	1	10	0	1
				11 26/02/1979	38	0	1	10	0	1
				12 18/01/1976	41	0	1	14	0	1
				13 03/09/1969	48	0	1	18	1	0
				14 09/01/1964	53	0	1	9	0	1
				15 16/08/1956	61	1	0	34	0	1
				16 13/04/1969	48	1	0	19	0	1
				17 10/03/1968	49	0	1	22	0	1
				18 01/07/1963	54	0	1	27	0	1
				19 01/10/1970	46	1	0	20	0	1
				20 18/10/1966	50	1	0	25	1	0
				21 24/06/1967	50	1	0	20	0	1
				22 20/09/1971	45	0	1	19	1	0
				23 28/10/1955	61	1	0	30	0	1
				24 27/12/1967	49	1	0	22	0	1
	NUMBER OF PARTICIPANTS	24		1153	9	15	466	6	18
	INCOMPLETE ANSWER	0				24
	ANALYSIS			24		48,04	37,50%	62,50%	19,42	25,00%	75,00%	0,00%
								100,00%		100,00%
					AVERAGE %MALE	%FEMALE AVERAGE YEARS	%SOLO	%GROUP %OTHER
					AGE			PRACTICE
	CODE	SETTING TYPE	TEACHING		RESEARCH	NUMBER PUBLICATIONS LEVEL ENGLISH	CONSENT
		RURAL	SEMI RURAL URBAN	YES	NO	YES	NO	ENGLISH OTHER

  Only 9 experts from the Delphi group took part in the translation of the scoring sheet, because the initial questionnaire sent in October 2016 did not include this part of the scale. The Scoring sheet was sent to them in August 2017, with 4 questions to rank.

	4	3	17	17	7	15	9	27	163	7	11	6
			24		24		24					24
	16,67%	12,50%	70,83%	70,83%	29,17%	62,50%	37,50%	1,13	6,79	29,17%	45,83%	25,00%
			100,00%		100,00%		100,00%					100,00% 100,00%

Table 3 :

 3 Expert notes, first Delphi round

	WAI SR Patient

SCORING SHEET

The consensus was reached after the first Delphi round.

Taking into account the remarks of the Delphi group, and the future use of the scale in general practice context, in December 2016 the Research group produced a second Spanish version, before its backward translation. It is shown in table 4.

  It is shown in the table 4.

	CODE	Q1	Q2	Q3	Q4
	1	9	9	9	9
	2	8	7	7	8
	7	8	9	7	8
	8	7	7	7	7
	9	9	9	9	8
	13	9	9	9	9
	14	9	9	9	9
	21	9	9	7	7
	22	9	9	7	3
	9
	<7	0	0	0	1
	>=7	9	9	9	8
	CHECK	9	9	9	9
	TOTAL	100,00%	100,00%	100,00%	88,89%

This English backward translation was compared with the original version of the WAI SR by the Research team. Discrepancies were sought and modifications were made if they varied too much from the original text. It led to a Spanish final version that is shown in the table 4.

In the WAI SR Patient:

Table 4 :

 4 Original

	English original	Spanish version	Spanish second	Backward	Spanish final
	version		version	translation	version
	Instructions:	Instrucciones:	Instrucciones:	Instructions:	Instrucciones:
	Below is a list of	A continuación se	A continuación se	A list of	A continuación se
	statements and	presenta una lista	presenta una lista	statements and	presenta una lista
	questions about	de afirmaciones y	de afirmaciones y	questions about	de afirmaciones y
	experiences	preguntas sobre	preguntas sobre	the experiences	preguntas sobre
	people	las	las	people could have	las
	might have with	experiencias que	experiencias que	with their	experiencias que
	their	las personas	las personas	treatment or their	las personas
	therapy or	podrían tener con	podrían tener con	therapist is shown	podrían tener con
	therapist.	su terapia o	su tratamiento o	below. Some	su tratamiento o
	Some items refer	terapeuta.	terapeuta.	items refer to the	terapeuta.
	directly to your	Algunos ítems se	Algunos ítems se	therapist with an	Algunos ítems se
	therapist with an	refieren a su	refieren a su	underlined space.	refieren a su
	underlined space	terapeuta con un	terapeuta con un	When you read	terapeuta con un
	--	espacio	espacio	the sentences fill	espacio
	as you read the	subrayado	subrayado	in the blank space	subrayado
	sentences,	cuando lea las	cuando lea las	____ with the	cuando lea las
	mentally	frases, incluya el	frases, incluya el	therapist's name.	frases, incluya el
	insert the name	nombre del/la	nombre del/la	Think about your	nombre del/la
	of	terapeuta en	terapeuta en	experience during	terapeuta en
	your therapist in	lugar del ____ en	lugar del ____ en	the treatment	lugar del ____ en
	place of ____ in	el texto. Piense	el texto. Piense	and decide which	el texto. Piense

version, Spanish first proposition of translation, Spanish second version, Backward translation and Spanish final version of the WAI SR

WAI SR PATIENT

English original version Spanish version Spanish second version Backward translation Spanish final version

	approve of.	no está de	no está de	with.	no está de
		acuerdo.	acuerdo.		acuerdo.
	English original	Spanish version	Spanish second	Backward translation Spanish final version
	version		version
	10. I feel that the	10. Creo que las	10. Creo que las	10. I think the	10. Siento que las
	things I do in	cosas que hago en	cosas que hago	things I do in the	cosas que hago en
	therapy	la terapia me	en el tratamiento	treatment will	el tratamiento me
	will help me to	ayudarán a	me ayudarán a	help me achieve	ayudarán a
	accomplish the	conseguir los	conseguir los	the changes I am	conseguir los
	changes that I	cambios que	cambios que	aiming at.	cambios que
	want.	quiero.	quiero.		quiero.
	English original	Spanish version	Spanish second	Backward translation Spanish final version
	version		version
	11. ___ and I have	11. ___ y yo	11. ___ y yo	11. ___ and I have	11. ___ y yo
	established a	hemos llegado a	hemos llegado a	reached an	hemos llegado a
	good	comprender bien	comprender bien	understanding	comprender bien
	understanding of	el tipo de cambios	el tipo de cambios	regarding the	el tipo de cambios
	the	que serían	que serían	changes that	que serían
	kind of changes	buenos para mí.	buenos para mí.	would be good for	buenos para mí.
	that			me.
	would be good for
	me.
	7. I feel that ___	7. Creo que ___	7. Creo que ___	7. I think ___	7. Siento que ___
	appreciates me.	me aprecia.	me aprecia.	appreciates me.	me aprecia.
	8. ___ and I agree	8. ___ y yo	8. ___ y yo	8. ___ and I agree	8. ___ y yo
	on what is	estamos de	estamos de	on what is	estamos de
	important	acuerdo en lo qué	acuerdo en lo qué	important for me	acuerdo en lo qué
	for me to work	es importante	es importante	to work on.	que es
	on.	para mi para	que trabaje.		importante que
		continuar			trabaje.
		trabajando.
	English original	Spanish version	Spanish second	Backward translation Spanish final version
	version		version
	9. I feel ___ cares	9. Creo que ___	9. Creo que ___	9. I think ___	9. Siento que ___
	about me even	se preocupa por	se preocupa por	cares about me;	se preocupa por
	when	mi; incluso	mi; incluso	even when I do	mi mí; incluso
	I do things that	cuando hago	cuando hago	things he/she	cuando hago
	he/she does not	cosas con las que	cosas con las que	does not agree	cosas con las que

English original version Spanish version Spanish second version Backward translation Spanish final version

	client	refieren al	refieren al	space), as you	refieren al
	with an	paciente con un	paciente con un	read the	paciente con un
	underlined	espacio	espacio	sentences write	espacio
	space --as you	subrayado_ , a	subrayado_ , a	the patient's	subrayado_ , a
	read	medida que va	medida que lea	name in the ___	medida que lea
	the sentences,	leyendo las	las frases, incluya	in the text.	las frases, incluya
	mentally insert	frases, incluya el	el nombre del		el nombre del
	the	nombre del	paciente en lugar		paciente en lugar
	name of your	paciente en lugar	del ___ en el		del ___ en el
	client	del ___ en el	texto.		texto.
	in place of ___ in	texto.
	the text.
	IMPORTANT!!!	IMPORTANTE:	IMPORTANTE:	IMPORTANT:	IMPORTANTE:
	Please take your	Por favor, tómese	Por favor, tómese	Please, take your	Por favor, tómese
	time	su tiempo para	su tiempo para	time to consider	su tiempo para
	to consider each	pensar cada	pensar cada	each question	pensar cada
	question	pregunta	pregunta	carefully.	pregunta
	carefully.	cuidadosamente	cuidadosamente		cuidadosamente
	English original	Spanish version	Spanish second	Backward translation Spanish final version
	version		version
	1. ___ and I agree	1. ___ y yo	1. ___ y yo	1. ___ and I agree	1. ___ y yo
	about the steps to	estamos de	estamos de	on the steps to	estamos de
	be	acuerdo en los	acuerdo en los	improve his/her	acuerdo en los
	taken to improve	pasos necesarios	pasos necesarios	situation.	pasos necesarios
	his/her situation.	para mejorar su	para mejorar su		para mejorar su
		situación	situación		situación
	2. I am genuinely	2. Estoy	2. Estoy	2. I am really	2. Me importa
	concerned for	realmente	realmente	worried about	realmente el
	___'s	preocupado/a por	preocupado/a por	___'s wellbeing.	bienestar de esta
	welfare.	el bienestar de	el bienestar de		persona.
		___.	___.
	Instructions:	Instrucciones:	Instrucciones:	Instructions:	Instrucciones:
	Below	A continuación	A continuación	A list of	A continuación
	is a list of	se presenta una	se presenta una	statements of the	se presenta una
	statements	lista de frases	lista de frases	experience	lista de frases
	about	sobre la	sobre la	therapists could	sobre la
	experiences	experiencia que	experiencia que	have with their	experiencia que
	people might	los	los	patients is shown	los
	have	profesionales	profesionales	below.	profesionales
	with their client.	podrían tener con	podrían tener con	Some items refer	podrían tener con
	Some items refer	sus pacientes.	sus pacientes.	to the patient as	sus pacientes.
	directly to your	Algunos ítems se	Algunos ítems se	__ (an underlined	Algunos ítems se

English original version Spanish version Spanish second version Backward translation Spanish final version

	7. ___ and I	7. ___ y yo nos	7. ___ y yo nos	7. ___ and I	7. ___ y yo nos
	respect	respetamos	respetamos	respect each	respetamos
	each other.	mutuamente.	mutuamente.	other.	mutuamente.
	8. ___ and I have	8. ___ y yo	8. ___ y yo	8. ___ and I have	8. ___ y yo
	a	tenemos una	tenemos una	a common	tenemos una
	common	percepción	percepción	perception of	percepción
	perception	común de sus	común de sus	his/her goals.	común de sus
	of his/her goals.	objetivos.	objetivos.		objetivos.

  1. As a result of these sessions I am clearer as to how I might be able to change.

					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	8. _____ and I agree on what is important for me to work on.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	9. I feel _____ cares about me even when I do things that he/she does not approve of.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	10. I feel that the things I do in therapy will help me to accomplish the changes that I want.
					
	 Seldom	 Sometimes	 Fairly Often	 Very Often	 Always
	11. _____ and I have established a good understanding of the kind of changes that would be good for
	Seldom me.	Sometimes	Fairly Often	Very Often	Always
	2. What I am doing in therapy gives me new ways of looking at my problem.     
	 Seldom	 Sometimes	 Fairly Often	 Very Often	 Always
	Seldom 12. I believe the way we are working with my problem is correct. Sometimes Fairly Often Very Often	Always
	3. I believe ___ likes me.  			
	 Seldom	 Sometimes	 Fairly Often	 Very Often	 Always
	Seldom	Sometimes	Fairly Often	Very Often	Always
	4. ___ and I collaborate on setting goals for my therapy.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	5. ___ and I respect each other.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	6. ___ and I are working towards mutually agreed upon goals.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	7. I feel that ___ appreciates me.

  1. ___ and I agree about the steps to be taken to improve his/her situation. We have established a good understanding of the kind of changes that would be good for ___.

					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	3. We are working towards mutually agreed upon goals.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	4. ___ and I both feel confident about the usefulness of our current activity in therapy.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	5. I appreciate ___ as a person.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	6. 				
	Seldom	Sometimes	Fairly Often	Very Often	Always
	7. ___ and I respect each other.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	8. ___ and I have a common perception of his/her goals.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	9. I respect ___ even when he/she does things that I do not approve of.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	10. We agree on what is important for ___ to work on.
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
					
	Seldom	Sometimes	Fairly Often	Very Often	Always
	2. I am genuinely concerned for ___'s welfare.

  Lo que estoy haciendo en el tratamiento me proporciona otros puntos de vista sobre mi problema. Siento que ___ se preocupa por mi mí; incluso cuando hago cosas con las que no está de acuerdo. Siento que las cosas que hago en el tratamiento me ayudarán a conseguir los cambios que quiero. ___ y yo hemos llegado a comprender bien el tipo de cambios que serían buenos para mí. Creo que la forma en que estamos trabajando con mi problema es correcta.

	Rara vez	A veces	A menudo	Muy frecuentemente	Siempre
	10.  2.  Rara vez	  A veces	  A menudo	frecuentemente   Muy	  Siempre
	Rara vez	A veces	A menudo	Muy frecuentemente	Siempre
	3. Creo que a ___ le importo. 11.  		frecuentemente 		
	 Rara vez	 A veces	 A menudo	 Muy	 Siempre
	Rara vez	A veces	A menudo	Muy frecuentemente	Siempre
	frecuentemente 4. ___ y yo colaboramos en establecer los objetivos de mi tratamiento. 12.    	
	 Rara vez	 A veces	 A menudo	 Muy	 Siempre
	Rara vez	A veces	A menudo	Muy frecuentemente	Siempre
				frecuentemente
	5. ___ y yo nos respetamos mutuamente.
						
	Rara vez	A veces	A menudo	Muy	Siempre
				frecuentemente
	6. ___ y yo estamos trabajando hacia objetivos mutuamente acordados.
						
	Rara vez	A veces	A menudo	Muy	Siempre
				frecuentemente
	7. Siento que ___ me aprecia.
						
	Rara vez	A veces	A menudo	Muy	Siempre
				frecuentemente
	8. ___ y yo estamos de acuerdo en lo qué que es importante que trabaje.
						
	Rara vez	A veces	A menudo	Muy	Siempre
				frecuentemente
	9. 					
						
	Rara vez	A veces	A menudo	Muy	Siempre

1. Como resultado de estas sesiones tengo más claro cómo podría cambiar.

WAI SR Family Physician Expert number 10 2

  CLIENT: En nuestro caso es PACIENT ME en lugar de I: She or he and me. Frases 1,4,7,8 I´M REALLY WORRIED ABOUT, quizás se entienda mejor que I AM GENUINELY CONCERNED FOR sobre todo si va dirigido a profesionales que no tengan el inglés como lengua materna: Frase 2 WE ARE WORKING TOGETHER TO REACH AGREED UPON GOALS: Frase 3 CURRENT THERAPIES: Frase 4 PERCEPCION o POINT OF VIEW. Frase 8 . me proporciona otros puntos de vista sobre mi problema 7. Usaría me valora (en vez de aprecia) porque tiene una connotación menos sentimental y subjetiva. 8. en lo que es importante que trabaje Pregunta 1 , 4 y 5 -Se realiza una traducción literal a partir del español. Pregunta 7 -Me parece más indicado utilizar en presente continuo.

	Expert number 11

  feel that the things I do in therapy will help me to accomplish the changes that I want Hay un error o gazapo: dode dice "ma ayudarán" debe decir "me ayudarán". Y por otro lado creo que es mejor la traducción: "... me ayudarán llevar a cabo (o realizar) los cambios que quiero" que "me ayudarán a conseguir los cambios que quiero"NEW WAYS OF LOOKING AT MY PROBLEM o TO FACE MY PROBLEMS.Frase 2 LIKES HIM o HER (Le importo a ella o a él): Frase 3 HE o SHE and ME: Frase 4,5,6,8,11 I FEEL o I THINK SHE o HE LIKES ME: Frase 7 I THINK (creo) SHE o HE TAKES CARE OF ME: Frase 9 I FEEL THINGS THAT I DO IN THERAPY COULD CHANGE WHAT I WANT: Frase 10 IS ALL RIGHT más utilizado que correct: Frase 12

	Expert number 22

3, lo traduciría como creo que X me gusta

Expert number 21

I

ANNEX C: EXPERTS REMARKS WAI SR Patient

Expert number 10 :

1. Usaría mejor el presente simp: a medida que lea las frases ... En cuanto a la última parte... , sustituya (en vez de inserte) el___ en el texto por el nombre del paciente. 5. Usaría mejor: valoro a_ como persona.

Expert number 11 :

En la pregunta 1 y 6 creo que se ha realizado una traducción demasiado literal a partir de español sin tener en cuenta los modismos ingleses adecuados.

Expert number 18

en la pregunta 10 traduciría al español : "nosotros acordamos que es importante para ----trabajar en ello"

Expert number 22

Scoring Sheet

Expert number 22

La última cuestión parece una traducción literal que quizás pueda sonar raro. Yo creo que podría ser: "to calculate the result of the subscale you should only add up the items or make the average"

ANNEX D: Development of the concept of alliance ANNEX E: Theoretical genealogy of the therapeutic alliance concept

Therapeutic alliance concept has been predominantly developed in psychotherapy and psychiatric field.

 Freud (1913): he was the first one to suggest collaboration as a necessary factor in therapeutic process, motivation of patient being essential. He had also developed transfer concept, which infers a beneficial cooperation and attachment between patient and therapist.

 Roger (1951): he described ideal facilitator conditions suggested by therapist (empathy, congruence, positive look), in an approach made for patient. He extended researches on therapeutic relation in humanist psychotherapy.

 Zetzel (1956): in his opinion, alliance is a conception which cannot be transfer; it depends on capacity to make stable trust relation (long-established in forming of early relations between young child and his parents).

 Greeson (1967): he defined working alliance or therapeutic alliance as an active collaboration between patient and therapist to expected objective.

 Strong (1968): he went further into interpersonal influence, advice relation, and ideal conditions proposed by therapist.

 Orlinsky & Howard (1975): they studied empathy concept with an empirical method and others factors predicting therapeutic conclusion/clinical improvement. After a synthesis of results, they proposed three dimensions of alliance: working alliance (involvement of patient and therapist in therapeutic process), empathic resonance, and mutual affirmation (near the "positive look" of Rogers).

 Bordin (1975): new alliance conceptualization with objective of an approach pan-theoretical. It was developed on Greeson's theory commending collaboration in therapy, and he rewrited the three Orlinsky and Howard's dimensions to three others conceptions:

-Agreement of patient and therapist on objectives of treatment (Goal).

-Agreement on the way to reach it (Task).

-Development of a link between them, whose quality permits to negotiate an agreement on tasks and objectives of therapy (Bond).

 Luborsky (1976): he relied on the Strong and Zetzel's definitions and described two dimensions of alliance:

-The first in which patient sees therapist as a potential helping and care source.

-

The second in which patient experiments therapeutic process in a partnership with therapist to the expected objectives.

 Gaston (1990): he identified in a more precise way four independent factors of alliance:

-Ability of patient to work deliberately in therapy.

-Affective link uniting patient and therapist.

-Comprehension and implication of therapist.

-Agreement shared by patient and therapist to aims of the follow-up.

 Kim (2001): added notion of empowerment of patient to the four Gaston's factors.

ANNEX F : Forms sent to the 24 experts

ANNEX G: CONSENT FORM FOR THE GALLEGO ETHICS COMITEE

ANNEX H: CONSENT FORM AND DATA FOR SAMPLING


S A Aouanouk

A Mouheb

R Zazoun

R Absi

The behavior of -lactoglobulin protein in plate heat exchanger's channel during milk heat treatment

Keywords: Milk fouling, Plate Heat Exchanger, Modelling, -lactoglobulin

A major problem related to heat treatment of milk is formation of deposits. This is due to chemical alteration of -lactoglobulin protein which will products deposits on the walls of the equipment. These deposits induce losses in the thermal performance of the heat exchanger. In order to provide an adequate prediction of these deposits, we present a two-dimensional (2D) modeling study of the channel of a plate heat exchanger. Instead of the former studies, where the domain is related to a single plate, our work is related to the area which is between two plates. This approach will allow a better understand and description of the evolution and the behavior of the -lactoglobulin protein. Equations for fluid flow, energy and fouling were resolved. Special boundary conditions had implemented to link the amount of deposits with thermal transfer. Predicted results for the amount of fouling deposit on the wall were validated by comparisons with experimental data available in literature. The behavior of -lactoglobulin protein was studied by analyze of its distribution in the channel.

The major problem encountered during milk heat treatment in plate heat exchangers is the deposit of unwanted materials on heat treatment surfaces, which induce performance loss of the equipment [START_REF] Belmarbeiny | The Effect of Reynolds-Number and Fluid Temperature in Whey-Protein Fouling[END_REF]. Consequently, regular cleaning steps of equipment must be scheduled generating losses in capital, energy and production time [START_REF] Visser | Fouling of heat exchangers in the dairy industry[END_REF]. Many authors studied the main parameters affecting milk fouling in plate heat exchangers [START_REF] Bansal | A Critical Review of Milk Fouling in Heat Exchangers[END_REF]). These parameters involve hydrodynamics of fluid flow and thermal process [START_REF] Belmarbeiny | The Effect of Reynolds-Number and Fluid Temperature in Whey-Protein Fouling[END_REF] [START_REF] Belmarbeiny | The Effect of Reynolds-Number and Fluid Temperature in Whey-Protein Fouling[END_REF], plate heat exchanger configuration and heat surface properties [START_REF] Huang | Influence of fluid milk product composition on fouling and cleaning of Ni-PTFE modified stainless steel heat exchanger surfaces[END_REF]. Proteins of milk, especially β-lactoglobulin, represent a key component in deposit formation.

Since several years ago, studying the milk fouling mechanism is a very attractive investigation field. LALANDE and co-workers (1985) reported that the formation of deposit on the heat exchange surface is attributed to the chemical alteration of -lactoglobulin protein. [START_REF] Toyoda | A computational model for reaction and mass transfer in fouling from whey protein solutions[END_REF], proposed a fouling model that takes into account the mass transfer between the fluid bulk and boundary layer. [START_REF] Georgiadis | Dynamic modelling and simulation of plate heat exchangers under milk fouling[END_REF] established a two-dimensional mathematical model using fluid flow to predict, with more accuracy, the temperature distribution. [START_REF] Jun | A 2D dynamic model for fouling performance of plate heat exchangers[END_REF] Few studies have attempt on kinetics of -lactoglobulin denaturation. The effect of calcium on -lactoglobulin denaturation have been discussed by PETIT andco-workers (2011) and[START_REF] Erabit | Effect of calcium chloride and moderate shear on β-lactoglobulin aggregation in processing-like conditions[END_REF]co-workers (2013), they conclude that high calcium concentrations catalyzes unfolding and aggregation reactions. KHALDI and co-workers (2015) carried out experiments in order to determine the relationship between the deposit mass distribution generated in plate heat exchanger and the ratio between the unfolding and aggregation rate constants. Recently, BOUVIER and co-workers (2014) used CFD (Computational Fluid Dynamics) as a tool to simulate -lactoglobulin heat induced denaturation and aggregation in plate heat exchanger.

They demonstrated that the unfolded -lactoglobulin is the main precursor generating a dry deposit on the heat transfer wall.

All these works are mainly axed on the amount of deposits on the plate heat exchangers surface and none have describe the behavior of -lactoglobulin protein during milk flow in the channels of plate heat exchangers. Therefore, the present work adapt milk fouling model of [START_REF] Jun | A 2D dynamic model for fouling performance of plate heat exchangers[END_REF] on a two-dimensional channel situated between two plates of the plate heat exchanger in order to study the transformations that undergone -lactoglobulin protein along the channel. In order to obtain accurate results, we present a two-dimensional (2D) modeling study. Governing equations of momentum, heat and mass transfer in the channel were resolved using the finite volume method for the discretization of the partial differential equations. In order to link heat and mass transfer, Biot number is used as a boundary condition at the walls. First, the simulation results were validated with experimental data of GEORGIADIS and co-workers (1998). Then, -lactoglobulin protein distribution in its three forms namely, native, unfolded and aggregated, was discussed in the first channel of plate heat exchanger during milk pasteurization.

Mathematical formulation

In order to predict the evolution of -lactoglobulin protein denaturation during milk flow in a channel of plate heat exchanger, we solve numerically the governing equations of fluid flow, heat and mass transfer which represent the model of milk fouling. Figure 1 describes the channel geometry used in this study. Milk, at uniform inlet temperature T in , rising between two smooth and parallel plates of 75 cm long (L) and 20 cm width (W) making a channel of 4 mm thick (e). The plates are held at constant temperature of 90 °C.

Fluid flow and energy equations

The equations of continuity (1) and momentum (2-3) according to axial and vertical directions for the two-dimensional laminar flow in the channel are given as :

  0 V      (1)     u x p u V t u 2                 (2)     v y p v V t v 2                 (3)
where u and v denote, respectively, axial and vertical component of velocity,  is the density of milk,  its dynamic viscosity, p represent the pressure and t time. Heat transfer in the channel is governed by:

    T T V t T          2  (4)
Where: T is the temperature and  the thermal diffusivity of milk.

Fouling model

Fouling model used in this work is drown on the model presented by [START_REF] Jun | A 2D dynamic model for fouling performance of plate heat exchangers[END_REF] which is mainly adapted from the work of [START_REF] Georgiadis | Dynamic modelling and simulation of plate heat exchangers under milk fouling[END_REF]. This model based on the chemical reactions those is subjected -lactoglobulin protein from 65 °C and mass transfer between the thermal boundary layer and the bulk of fluid. Indeed, when milk temperature reaches 65 °C, -lactoglobulin protein becomes thermally unstable, it is prone to chemical alteration producing molecules containing sulfhydryl groups (-SH) which polymerize irreversibly giving an insoluble aggregate. Aggregated protein adheres on the wall of the equipment. Figure 2 represent the reaction scheme of this fouling model [START_REF] Georgiadis | Dynamic modelling and simulation of plate heat exchangers under milk fouling[END_REF].

This model is represented, mathematically, by mass transport of native, unfolded and aggregated form of -lactoglobulin protein as mentioned bellow by equations (5 -7), where C i denote the concentrations of different forms of the protein and D i their molecular diffusivity. R u and R a represent, respectively, the unfolding and aggregation reactions.

For modelling purpose, the variation of milk physical properties with temperature was neglected and the properties were taken as skimmed milk ones [START_REF] Georgiadis | Dynamic modelling and simulation of plate heat exchangers under milk fouling[END_REF].

    U N N N N C D C V t C           2  (5)     A U U U U U C D C V t C             2  (6)     A A A A A C D C V t C           2  (7)
R u and R a represent, respectively, the unfolding and aggregation reactions. Their kinetics depend on temperature by the Arrhenius equation as described below.

n N U U U C RT E exp k 0         (8) n A A A A C RT E exp k 0         (9)
The values of reaction order, n i , reaction rates constants, k i0 , and activation energies, E i , are summarized in table 1. Mass transfer takes place in the interface between the thermal boundary layer and the bulk of fluid. Its expression, according to x position inside or outside the thermal boundary layer, is as follows:

Inside boundary layer:

           i * i T m C C k i (10)
Outside boundary layer:

           * i i T m C C k i (11)
Where k mi represent mass transfer coefficient for each protein,  T the thermal boundary

    y , 0 C k t y Bi A w     (12)
Then, equation ( 13) gives the expression, in kg m -2 , of the mass deposits along the plates.

    0 d d U y Bi y , 0 m    (13)
with  d = 1030 kg m -3 is the density of deposit,  d = 0.5 W.m -1 .K -1 its thermal conductivity and U 0 the overall heat transfer coefficient at clean conditions. The average mass of deposit on the wall is defined by equation ( 14), where W is the plate width.

    L 0 dy y M W M ( 14
)
The mass of deposit on the right wall is the same as that deposited on the left one due to the symmetry prevailing in the channel.

Initial and boundary conditions

Milk come into the bottom of channel with constant temperature T in = 333 K and constant flow rate corresponding to Reynolds number of 2600. Concentration of native -lactoglobulin protein is 5 kg.m -3 . The diffusion flux in the direction normal to the outlet of channel is assumed to be zero for all variables.

The initial temperature of the walls is T 0 = 363 K. In order to take in account the effect of deposit on the thermal performance of plates, conditions imposed for energy and mass transfer are expressed by equations ( 15), e represents the channel thickness.

      y Bi 1 T y , e x T y , 0 x T 0      (15) 0 C C U N   (16) A T w e x A 0 x A C k x C x C          (17)

Numerical procedure

The equations presented in this model is a set of partial differential equations. In order to solve it, a computer code was carried out. It uses the finite volume method for spatial discretization with power law scheme. Establishment of pressure / velocity linkage is done with SIMPLE algorithm proposed by [START_REF] Patankar | Numerical Heat Transfer and Fluid Flow: Computational Methods in Mechanics and Thermal Science[END_REF]. The implicit scheme used for temporal discretization. The plate heat exchanger channel is assumed as a rectangular domain which consists of 80 x 160 nodes in staggered grid. The run of simulation has taken about 2 days of computing time on a Xeon server (2.53 GHz CPU, 6 Go RAM). Detailed procedure is described in Appendix A.

Results

Validation

The computational code was validated by comparing the amount of deposit on the wall obtained by sim corresponding of Re = 2600 and walls maintained at constant temperature of 363 K. Figure 3 illustrate the evolution of average mass of deposit with time for both experimental data and simulation results. We show that the simulation results are in good agreement with experimental values, where the maximal relative error does not exceed 0.66 %. We see that the amount of fouling increase linearly with time.

-lactoglobulin behavior

Figure 4 shows the distribution of -lactoglobulin concentration in its three forms native (a), unfolded (b) and aggregated (c) in half of the channel after 24000 seconds of milk treatment. The native protein concentrates in the bulk of fluid. The value of the concentration decreases, approaching towards the wall. As for aggregated protein, its concentration is higher near the wall. This is due to the fact that it adheres to the hot wall. Mass transfer between the thermal boundary layer and the bulk explains the concentration gradient of the native and aggregated forms of the protein in this zone of the channel. We show that the aggregated protein concentration is higher in top than at bottom of the channel. This is shown in the work of [START_REF] De Bonis | Conjugate flow and kinetics modeling for heat exchanger fouling simulation[END_REF] where the deposit of fouling is mainly created in the outlet section of the channel. The concentration of aggregated protein increase is predictable since milk becomes hotter approaching outlet of channel. This is in great accord with previews works of SIMMONS and co-workers (2007) and PETIT and co-workers (2013) saying that lactoglobulin denaturation increase at high temperature.

On the other hand, distribution of unfolded protein concentration is more complex because this protein is a deposited the aggregate. Unfolded protein concentrates mainly around the interface between bulk of channel and thermal boundary layer. It's generated by mass transfer which govern in this zone of the channel.

Conclusion

In this paper, we presented simulations of milk fouling in plate heat exchanger channel.

Fluid flow, heat and mass transfer have been considered during milk heat treatment in order to study the concentration distribution of -lactoglobulin over the channel.

The fouling model of Jun and Puri was used in this work and adapted to our calculation domain channel located between two plates of plate heat exchanger. The amount of deposit and heat transfer were coupled by using the Biot number in the expression of boundary condition. Numerical results of the amount of deposit were compared to experimental data in order to validate the model. Simulation results allow to validate the input data for the kinetic model of -lactoglobulin denaturation. The native protein is concentrated in the bulk fluid unlike the aggregated form of the protein which is present near hot walls and therefore adheres on it. However, unfolded form is focused around the interface between the thermal boundary layer and the bulk of fluid.

Finally, a three-dimensional study could allow a better understanding of the exact behavior of fouling mechanisms, since it allows to take into account corrugated form of the plates and also the plate port for the milk inlet and outlet. So far, the effects of turbulence neglected in this study, needs to be considered.

  developed the previous work into a dynamic 2D model to predict more precisely milk deposit patterns on the plate surface. DE BONIS and RUOCCO (2009) used commercial finite element solver in order to determine velocity profile, temperature distribution and protein distribution of the deposit in corrugated channel of plate heat exchanger. MAHDI and co-workers (2009) proposed a two-dimensional dynamic fouling model for milk fouling in a plate heat exchanger, which takes into account fouling caused by both -lactoglobulin protein and calcium phosphate.

  layer thickness and C i * the concentration of the protein in the first x position inside the thermal boundary layer. Calculation details of mass transfer coefficients and thermal boundary layer are presented in the work of JUN and PURI (2006). Deposition rate of fouling is represented by the dimensionless Biot number. It calculated by equation (12), where  = 129 m².kg -1 (GEORGIADIS & MACCHIETTO, 2000) represents an experimental coefficients which depends on the flow configuration of the plate heat exchanger and k w = 10 -7 m.s -1 is the mass transfer coefficient of the deposit on the wall.

Figure captions Figure 1 .

 captions1 Figure captions

Figure 2 .

 2 Figure 2. Reaction scheme of -lactoglobulin.

Figure 3 .

 3 Figure 3. Deposit profiles of simulation results (-) comparison with experimental data ( °).

Figure 4 .

 4 Figure 4. Distribution of (a) native, (b) unfolded and (c) aggregated -lactoglobulin protein

  Figure 1

Table 1 .

 1 Kinetics of -lactoglobulin denaturation reactions*.

	Reaction	Unfolding	1 Aggregation
	k i0 (kg 1-n m 3(n-1) s -1 )	3.42 x 10 40	3.25 x 10 9
	E i (kJ mol -1 )	276.3	79.7
	n	1.5	2

* BOUVIER, L., MOREAU, A., RONSE, G., SIX, T., PETIT, J. and DELAPLACE, G. (

2014

): A CFD model as a tool to simulate beta-lactoglobulin heat-induced denaturation and aggregation in a plate heat exchanger. Journal of Food

Engineering, 136,[56][57][58][59][60][61][62][63]

Appendix A. Numerical procedure

The differential equations described in previous sections are resolved numerically by a calculation code developed in Fortran 90 language by our research team. This code uses finite volume method with a power law scheme for the transformation of differential equations to systems of algebraic equations. A staggered grid and the SIMPLE algorithm provide the pressure / velocity coupling. Algorithm steps are presented as follows:

1. Initialize pressure field; 2. Resolve the momentum equations to obtain U and V fields; Coupling between temperature distribution and fouling amount on walls is accomplished by the boundary condition imposed for temperature by equation ( 15).

The systems of equations obtained by discretization are solved via the line-by-line method, which is a semi-iterative method combining between the direct method TDMA and the iterative one of Gauss Seidel.

Herein, steps of the calculation procedure performed using the calculation code.