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1 Translation of the Working Alliance Inventory Short Revised (WAI-SR) from English into Spanish, using a forward backward translation and a Delphi consensus method Soline Delaigue Baechler To cite this : Soline Delaigue Baechler. Translation of the Working Alliance Inventory Short Revised (WAI-SR) from English into Spanish, using a forward backward translation and a Delphi consensus method. Life Sciences [q-bio] dumas HAL Id: dumas Submitted on 13 Oct 2017 HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d enseignement et de recherche français ou étrangers, des laboratoires publics ou privés. Distributed under a Creative Commons Attribution - NonCommercial - NoDerivatives 4.0 International License

2 UNIVERSITÉ DE BREST - BRETAGNE OCCIDENTALE Faculté de Médecine & des Sciences de la Santé ***** Année 2017 N THÈSE D'EXERCICE DE DOCTORAT EN MÉDECINE SPÉCIALITÉ MÉDECINE GÉNÉRALE Par Madame DELAIGUE BAECHLER Soline Née le 16 octobre 1986 à Toulouse (31) Présentée et soutenue publiquement le 12 octobre 2017 Translation of the Working Alliance Inventory Short Revised (WAI-SR) from English into Spanish, using a forward backward translation and a Delphi consensus method Président Membres du Jury Monsieur le Professeur Jean-Yves LE RESTE Madame le Docteur Marie BARAIS Monsieur le Docteur Patrice NABBE Monsieur le Docteur Damien CLUS 1

3 UNIVERSITE DE BRETAGNE OCCIDENTALE FACULTE DE MEDECINE ET DES SCIENCES DE LA SANTE DE BREST DOYENS HONORAIRES : DOYEN : Professeur H. FLOCH Professeur G. LE MENN ( ) Professeur B. SENECAIL Professeur J. M. BOLES Professeur Y. BIZAIS ( ) Professeur M. DE BRAEKELEER Professeur C. BERTHOU PROFESSEURS ÉMÉRITES CENAC Arnaud LEHN Pierre YOUINOU Pierre Médecine interne Biologie Cellulaire Immunologie PROFESSEURS DES UNIVERSITÉS EN SURNOMBRE COLLET Michel MOTTIER Dominique RICHE Christian SENECAIL Bernard Gynécologie - Obstétrique Thérapeutique Pharmacologie fondamentale Anatomie PROFESSEURS DES UNIVERSITÉS - PRATICIENS HOSPITALIERS DE CLASSE EXCEPTIONNELLE BOLES Jean-Michel COCHENER - LAMARD Béatrice DEWITTE Jean-Dominique FEREC Claude JOUQUAN Jean LEFEVRE Christian Réanimation Médicale Ophtalmologie Médecine & Santé au Travail Génétique Médecine Interne Anatomie 2

4 OZIER Yves ROBASZKIEWICZ Michel Anesthésiologie et Réanimation Chirurgicale Gastroentérologie Hépatologie PROFESSEURS DES UNIVERSITÉS - PRATICIENS HOSPITALIERS DE 1ÈRE CLASSE BAIL Jean-Pierre BERTHOU Christian BLONDEL Marc BRESSOLLETTE Luc DE PARSCAU DU PLESSIX Loïc DE BRAEKELEER Marc DELARUE Jacques DUBRANA Frédéric FENOLL Bertrand FOURNIER Georges GILARD Martine GOUNY Pierre HU Weiguo KERLAN Véronique LACUT Karine LEROYER Christophe LE MEUR Yannick LE NEN Dominique LOZAC H Patrick MANSOURATI Jacques MARIANOWSKI Rémi MISERY Laurent MERVIEL Philippe NEVEZ Gilles NONENT Michel PAYAN Christopher Chirurgie Digestive Hématologie Transfusion Biologie cellulaire Médecine Vasculaire Pédiatrie Génétique Nutrition Chirurgie Orthopédique et Traumatologique Chirurgie Infantile Urologie Cardiologie Chirurgie Vasculaire Chirurgie plastique, reconstructrice & esthétique ; brûlologie Endocrinologie, Diabète & maladies métaboliques Thérapeutique Pneumologie Néphrologie Chirurgie Orthopédique et Traumatologique Chirurgie Digestive Cardiologie Oto. Rhino. Laryngologie Dermatologie Vénérologie Gynécologie médicale : option gynécologie obstétrique Parasitologie et Mycologie Radiologie & Imagerie médicale Bactériologie Virologie; Hygiène 3

5 REMY-NERIS Olivier SALAUN Pierre-Yves SARAUX Alain SIZUN Jacques TILLY - GENTRIC Armelle TIMSIT Serge VALERI Antoine WALTER Michel Médecine Physique et Réadaptation Biophysique et Médecine Nucléaire Rhumatologie Pédiatrie Gériatrie & biologie du vieillissement Neurologie Urologie Psychiatrie d'adultes PROFESSEURS DES UNIVERSITÉS - PRATICIENS HOSPITALIERS DE 2ÈME CLASSE ANSART Séverine AUBRON Cécile BEN SALEM Douraied BERNARD-MARCORELLES Pascale BEZON Eric BOTBOL Michel CARRE Jean-Luc COUTURAUD Francis DAM HIEU Phong DEVAUCHELLE-PENSEC Valérie GIROUX-METGES Marie-Agnès HUET Olivier LIPPERT Éric LE GAL Grégoire LE MARECHAL Cédric L HER Erwan MONTIER Tristan NOUSBAUM Jean-Baptiste PRADIER Olivier RENAUDINEAU Yves SEIZEUR Romuald STINDEL Éric Maladies infectieuses, maladies tropicales Réanimation ; médecine d urgence Radiologie & Imagerie médicale Anatomie et cytologie pathologiques Chirurgie thoracique et cardiovasculaire Psychiatrie Infantile Biochimie et Biologie moléculaire Pneumologie Neurochirurgie Rhumatologie Physiologie Anesthésiologie - Réanimation Chirurgicale/Médecine d urgences Hématologie ; transfusion : option hématologie Médecine interne Génétique Réanimation Médicale Biologie Cellulaire Gastroentérologie - Hépatologie Cancérologie - Radiothérapie Immunologie Anatomie-Neurochirurgie Biostatistiques, Informatique Médicale & 4

6 Technologies de communication PROFESSEUR DES UNIVERSITÉS - PRATICIEN LIBÉRAL LE RESTE Jean Yves LE FLOCH Bernard Médecine Générale Médecine Générale PROFESSEUR DES UNIVERSITÉS ASSOCIÉS À MI-TEMPS BARRAINE Pierre Médecine Générale PROFESSEUR DES UNIVERSITÉS LRU BORDRON Anne Biochimie et Biologie moléculaire MAÎTRES DE CONFÉRENCES DES UNIVERSITÉS PRATICIENS HOSPITALIERS DE HORS CLASSE LE MEVEL Jean Claude PERSON Hervé Physiologie Anatomie MAÎTRES DE CONFÉRENCES DES UNIVERSITÉS PRATICIENS HOSPITALIERS DE 1ÈRE CLASSE ABGRAL Ronan CORNEC Divi DE VRIES Philine DOUET-GUILBERT Nathalie HERY-ARNAUD Geneviève HILLION Sophie JAMIN Christophe LE BERRE Rozenn Biophysique et Médecine nucléaire Rhumatologie Chirurgie infantile Génétique Bactériologie Virologie; Hygiène Immunologie Immunologie Maladies infectieuses-maladies tropicales 5

7 LE GAC Gérald LE ROUX Pierre-Yves LODDE Brice MIALON Philippe MOREL Frédéric PLEE-GAUTIER Emmanuelle QUERELLOU Solène VALLET Sophie Génétique Biophysique et Médecine nucléaire Médecine et santé au travail Physiologie Médecine & biologie du développement et de la reproduction Biochimie et Biologie Moléculaire Biophysique et Médecine nucléaire Bactériologie Virologie ; Hygiène MAÎTRES DE CONFÉRENCES DES UNIVERSITÉS PRATICIENS HOSPITALIERS DE 2ÈME CLASSE LE GAL Solène LE VEN Florent PERRIN Aurore TALAGAS Matthieu Parasitologie et Mycologie Cardiologie Biologie et médecine du développement & de la reproduction Cytologie et histologie MAÎTRES DE CONFÉRENCES PRATICIENS HOSPITALIERS STAGIAIRES UGUEN Arnaud Anatomie et Cytologie Pathologique MAITRE DE CONFÉRENCES - PRATICIEN LIBERAL NABBE Patrice Médecine Générale MAÎTRES DE CONFÉRENCES ASSOCIÉS DES UNIVERSITÉ MI-TEMPS BARAIS Marie CHIRON Benoît Médecine Générale Médecine Générale MAÎTRES DE CONFÉRENCES DES UNIVERSITÉS 6

8 BERNARD Delphine FAYAD Hadi HAXAIRE Claudie KARCHER Brigitte LANCIEN Frédéric LE CORRE Rozenn MIGNEN Olivier MORIN Vincent Biochimie et biologie moléculaire Génie Informatique, automatique et traitement du signal Sociologie - Démographie Psychologie clinique Physiologie Biologie cellulaire Physiologie Électronique et Informatique MAÎTRES DE CONFÉRENCES ASSOCIÉS DES UNIVERSITÉS A TEMPS COMPLET MERCADIE Lolita Rhumatologie MAÎTRES DE CONFÉRENCES ASSOCIÉS DES UNIVERSITÉS A MI - TEMPS SCHICK Ulrike Cancérologie, radiothérapie : option radiothérapie AGRÉGÉS / CERTIFIÉS DU SECOND DEGRÉ MONOT Alain RIOU Morgan Français Anglais 7

9 UNIVERSITE DE BREST - BRETAGNE OCCIDENTALE Faculté de Médecine & des Sciences de la Santé ***** AUTORISATION D IMPRIMER **** Présentée par Monsieur le Professeur Jean-Yves LE RESTE Translation of the Working Alliance Inventory Short Revised (WAI-SR) from english into spanish, using a forward backward translation and a Delphi consensus method ACCORD DU PRESIDENT DU JURY DE THESE SUR L IMPRESSION DE LA THESE OUI En foi de quoi la présente autorisation d imprimer sa thèse est délivrée à DELAIGUE BAECHLER Soline Née le 16 octobre 1986 à Toulouse (31) Fait à BREST, le VISA du Doyen de la faculté Le Président du Jury de Thèse A BREST, le Professeur C. BERTHOU 8

10 SERMENT D HIPPOCRATE Au moment d'être admise à exercer la médecine, je promets et je jure d'être fidèle aux lois de l'honneur et de la probité. Mon premier souci sera de rétablir, de préserver ou de promouvoir la santé dans tous ses éléments, physiques et mentaux, individuels et sociaux. Je respecterai toutes les personnes, leur autonomie et leur volonté, sans aucune discrimination selon leur état ou leurs convictions. J'interviendrai pour les protéger si elles sont affaiblies, vulnérables ou menacées dans leur intégrité ou leur dignité. Même sous la contrainte, je ne ferai pas usage de mes connaissances contre les lois de l'humanité. J'informerai les patients des décisions envisagées, de leurs raisons et de leurs conséquences. Je ne tromperai jamais leur confiance et n'exploiterai pas le pouvoir hérité des circonstances pour forcer les consciences. Je donnerai mes soins à l'indigent et à quiconque me le demandera. Je ne me laisserai pas influencer par la soif du gain ou la recherche de la gloire. Admise dans l'intimité des personnes, je tairai les secrets qui me seront confiés. Reçue à l'intérieur des maisons, je respecterai les secrets des foyers et ma conduite ne servira pas à corrompre les mœurs. Je ferai tout pour soulager les souffrances. Je ne prolongerai pas abusivement les agonies. Je ne provoquerai jamais la mort délibérément. Je préserverai l'indépendance nécessaire à l'accomplissement de ma mission. Je n'entreprendrai rien qui dépasse mes compétences. Je les entretiendrai et les perfectionnerai pour assurer au mieux les services qui me seront demandés. J'apporterai mon aide à mes confrères ainsi qu'à leurs familles dans l'adversité. Que les hommes et mes confrères m'accordent leur estime si je suis fidèle à mes promesses ; que je sois déshonorée et méprisée si j'y manque. 9

11 REMERCIEMENTS 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 mon respect et de ma reconnaissance. A Madame le Docteur Marie BARAIS : Je vous remercie pour les cours que vous avez donnés à la faculté auxquels j ai eu la chance de participer, votre bonne humeur et votre fulgurance ne les ont rendus que plus attrayants et enrichissants. Vous me faites l honneur de juger mon travail. Soyez assuré de tout mon respect et de ma reconnaissance. A Monsieur le Docteur Damien CLUS : Merci pour ta patience et ta capacité d écoute sans pareil. Que de chemin parcouru depuis le début de l internat! Je suis heureuse d avoir assisté à ta réussite dans tous les domaines. J espère entendre encore longtemps ton accent chantant qui me réchauffe le cœur. Pour me faire le privilège et l honneur de juger mon travail de thèse. Sois assuré de toute mon amitié, de mon respect et de ma reconnaissance. 10

12 Je remercie également : Le groupe de recherche espagnol sans qui ce travail n aurait pas été possible, pour leur gentillesse, et qu elles n ai pas été offensées de mon niveau d espagnol. Un abrazo a todas. Le groupe de thèse de la faculté de médecine Générale pour son aide dans l élaboration de la thèse et pour tous ces échanges intéressants et constructifs. Adrien pour ta science d Excel qui m impressionne à chaque fois que je regarde les formules bigarrées qui apparaissent dans les cellules. Tu nous a tous sauvé. Le Docteur Jean Jerome LE COQ pour son travail, sa vienveillance et son aide en tant que tuteur. Tous les médecins, co-internes et soignants que j ai pu rencontrer au cours de mes études et qui m ont apporté leur savoir, leur expérience, leurs conseils, leur temps et ont contribué à ma formation. Un merci tout particulier: A mes parents, mes sœurs et frère, neveux et nièce, beaux frères, pour les repas de famille avec des recettes suivies scrupuleusement, les parties de times up et carcassonne enflammées, les maisons qui se construisent selon les plans, des chasses aux œufs épiques, la passion des moules marinières pas cuites, les plus gentils des animaux et pour être toujours là pour moi malgré la distance, vous me manquez tous les jours. A mes grands-parents et à toute ma famille, pour leur présence et leur soutien. A ma meilleure amie Laura, pour ton amitié depuis toutes ces années, j espère le meilleur pour toi et les tiens, et je te remercie infiniment pour ta disponibilité pour améliorer la qualité de cette thèse! A mes amis de longue date, Aurélie, Vincent, Lydia, Fanny, Yassine et Marie, Julie, Océane, Etienne, Anne Marie, Charlotte, Lisa, Marine, c est toujours un réel bonheur de vous retrouver quand je descends, comme quoi la distance n a jamais altéré la véritable amitié! A mes amis rencontrés lors de cet internat breton, Laura et Thomas, Camille, Sophie, Laetizia, Pauline, Laurianne, Olivier et Anne Sophie, Julien, Anne, Caroline, Margot, Rachel, Hugo, Gerhard, pour les moments géniaux passés ensemble, grâce à vous j ai découvert une famille de cœur. Vous avez souvent plus cru en moi que moi. A ma Louzou d amour (fallait bien qu elle apparaisse ici aussi). 11

13 TABLE OF CONTENTS Abstract Introduction Material and Methods Methodology Ethics statement Research team and Forward translation Participant selection Data collection and First Delphi round Backward translation Results Forward translation and research team Group of 24 experts Backward translation and cultural check Discussion Main results Limitation and bias of the study Key points Implications for practice, further research Conclusion Bibliography Appendixces

14 ABSTRACT Background : The improvement of Therapeutic Alliance (TA) in medicine is an important lever to promote adherence to treatment and the quality of care. A research group at the Faculty of Medicine of Brest has been working on a TA assessment tool that can be used in everyday General Practice and for the training of medical students. A systematic literature review and a RAND/UCLA Appropriateness Method identified the Working Alliance Inventory Short Revised (WAI SR) as the most appropriate scale, according to its reliability and reproducibility, to evaluate TA. The purpose of this study was to translate into Spanish the WAI SR. Method: A forward and backward translation with a Delphi consensus method was used to ensure the transferability of the scale s properties. A research team of 5 Spanish experts produced a forward translation of the WAI SR into Spanish. For this translation they took into account the cultural context and the possible future uses of the scale. Only one Delphi round was necessary to achieve a first translation. The experts of the Delphi round were Spanish general practitioners who had a good level in English. After achieving a consensus, a professional translator finalized a backward-translation, to assess the linguistic equivalence. Results: An adapted forward translation was achieved. 24 experts took part in the Delphi round. A final consensus was reached with one Delphi round. The backward translation was carried out by a professional translator who has lived in Spain for 7 years. Conclusion: A Spanish translation of the WAI SR is now available for medical research, daily practice of general practitioners and for medical students training. This translation is consistent with the original scale. A validation of its applied psychometric properties in General Practice field in Spain could strengthen the validation process in future research. 13

15 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 (1). 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 (2). 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 (3,4 ). 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 (1). Since the 1960s more than 30 quality assessment tools for TA have been developed (5). 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 (6,7). 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 s (8,9,10,11). 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 (12). 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 (13). 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 (14,15,16). 14

16 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 (17). The National conference for the care of patients with chronic diseases which occurred in 2011 in Seville (18) 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 (19). The long-term care of patients with chronic diseases leads to more frequent consultations with their general practitioners (20,21). 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 (13). Understanding the psychological aspects of a general medical consultation becomes essential because of their importance for patient follow-up (22). An effective doctor-patient communication is a central clinical function in building a therapeutic doctor-patient relationship (23). It is known to have a positive influence on the patients satisfaction which is known to enhance direct compliance and support to therapy (24). Today, the physician's technical skills are no longer considered sufficient to achieve successful therapy or to get patient satisfaction (17,19). Because of its constant utility in daily practice, communication is now considered as one of the fundamental competences of the general practitioner (25). Many physicians tend to overestimate their ability in communication (23,26). 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 (21). 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 (27). 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 (28). The quality of therapeutic alliance is correlated positively with the adherence to the treatment (29,30). 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 (31). 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. 15

17 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 (5). 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 (32,33). 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. 16

18 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 (34,35,36,37). Delphi procedure was the most appropriate consensus method for the study. It allows obtaining a final opinion, unique and convergent of an expert group (38,39,40,41). 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 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 (34). 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 , according to what the Delphi method recommends, without mailing list, to avoid contamination (42). 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 . 17

19 Data collection and first Delphi round In October 2016, the 24 experts received by separated an individual form, where each item of the English 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 s 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 (38,39,40,41). 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 : they created a second Spanish 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 and was not trained on the subject of the study. His native language was English. 18

20 Figure 1 : Methodology summary of the study Previous studies 2013 Noel P.M: Systematic literature review Found 6 reliable and reproductible tools to assess TA 2016 Le Borgne E: RAND UCLA consensus method Selection of the most reproductible and reliable tool assessment for TA in general practice 19

21 RESULTS Forward translation and research team The Research team finalised a first Spanish translation of the WAI SR in July 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. Table 1: Research team characteristics GENDER YEARS OF PRACTICE PRACTICE TYPE SETTING TYPE MALE FEMALE SOLO GROUP OTHER RURAL SEMI RURAL URBAN dez an a Hernandez Gomez z ibas De Eguibar TEACHING RESEARCH NUMBER PUBLICATIONS LEVEL ENGLISH YES NO YES NO ENGLISH OTHER BASIC INTERMED FLUENT Group of 24 experts 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 years old. On average they had practiced for 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 % had a basic level in English, 45.83% had an intermediate level, and 25% were fluent. 20

22 Table 2 : 24 Experts group characteristics CODE BIRTHDAY AGE GENDER YEARS OF PRACTICE PRACTICE TYPE (years) MALE FEMALE SOLO GROUP OTHER 1 08/07/ /04/ /08/ /11/ /12/ /12/ /05/ /12/ /01/ /06/ /02/ /01/ /09/ /01/ /08/ /04/ /03/ /07/ /10/ /10/ /06/ /09/ /10/ /12/ NUMBER OF PARTICIPANTS INCOMPLETE ANSWER 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 PUBLICATIONLEVEL ENGLISH CONSENT RURAL SEMI RURAURBAN YES NO YES NO ENGLISH OTHER BASIC INTERMED FLUENT ,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% First Delphi Round The 24 experts received in October 2016 by individualized the form to fill. The answers with the filled forms including the experts specifications and ratings were received between October and November Each participant was assigned a numeric code. The answers are shown on table 3. 21

23 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. Table 3: Expert notes, first Delphi round WAI SR Patient CODE INSTRUCT IMPORT ANSWER Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q < >= CHECK TOTAL 87,50% 100,00% 95,83% 87,50% 87,50% 91,67% 87,50% 91,67% 91,67% 87,50% 87,50% 91,67% 91,67% 95,83% 87,50% WAI SR Family Physician CODE INSTR IMPORT ANSWER Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q < >= CHECK TOTAL 79,17% 100,00% 95,83% 87,50% 95,83% 83,33% 91,67% 95,83% 95,83% 100,00% 87,50% 91,67% 95,83% 22

24 SCORING SHEET CODE Q1 Q2 Q3 Q < >= CHECK TOTAL 100,00% 100,00% 100,00% 88,89% 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, before its backward translation. It is shown in table 4. 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. It is shown in the table 4. This English backward translation was compared with the original 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 that is shown in the table 4. In the WAI SR Patient: 23

25 In the 7 th, 9 th and 10 th question, the original English used the expression I Feel whereas the backward translation used the expression I think. The sense was different, so the Spanish 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. In the WAI SR Family Physician: In the 2 nd question, the original English 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 was changed. In the 4 th question, the original English 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 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. Table 4: Original, Spanish first proposition of translation,, Backward translation and Spanish final of the WAI SR WAI SR PATIENT Instructions: Below is a list of statements and questions about experiences people might have with their therapy or therapist. Some items refer directly to your therapist with an underlined space -- as you read the sentences, mentally insert the name of your therapist in place of in Spanish Instrucciones: A continuación se presenta una lista de afirmaciones y preguntas sobre las experiencias que las personas podrían tener con su terapia 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 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 Backward translation Instructions: A list of statements and questions about the experiences people could have with their treatment or their therapist is shown below. Some items refer to the therapist with an underlined space. When you read the sentences fill in the blank space with the therapist's name. Think about your experience during the treatment and decide which Spanish final 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 24

26 the text. Think about your experience in therapy, and decide which category best describes your own experience. en su experiencia en la terapia, y decida qué categoría describe mejor su propia experiencia. en su experiencia en el tratamiento, y decida qué categoría describe mejor su propia experiencia. category best defines it. en su experiencia en el tratamiento, y decida qué categoría describe mejor su propia experiencia. IMPORTANT!!! Please take your time to consider each question carefully. IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente. IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente. IMPORTANT: Please, take your time to consider every question carefully. IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente. Seldom Sometimes Fairly Often Very Often Always Spanish Rara vez A veces A menudo Muy frecuentemente Siempre Rara vez A veces A menudo Muy frecuentemente Siempre Backward translation Rarely Sometimes Often Very often Always Spanish final Rara vez A veces A menudo Muy frecuentemente Siempre 1. As a result of these sessions I am clearer as to how I might be able to change. Spanish 1. Como resultado de estas sesiones tengo más claro cómo podría cambiar. 1. Como resultado de estas sesiones tengo más claro cómo podría cambiar. Backward translation 1. As a result of these sessions I have a better understanding of how I could change. Spanish final 1. Como resultado de estas sesiones tengo más claro cómo podría cambiar. 2. What I am doing in therapy gives me new ways of looking at my problem. Spanish 2. Lo que estoy haciendo en la terapia me da nuevas formas de ver mi problema. 2. Lo que estoy haciendo en el tratamiento me proporciona otros puntos de vista sobre mi problema. Backward translation 2. What I am doing in the treatment gives me other perspectives of my problem. Spanish final 2. Lo que estoy haciendo en el tratamiento me proporciona otros puntos de vista sobre mi problema. Spanish Backward translation Spanish final 25

27 3. I believe likes me. 3. Creo que a le importo. 3. Creo que a le importo. 3. I think cares about me. 3. Creo que a le importo. 4. and I collaborate on setting goals for my therapy. Spanish 4. y yo colaboramos en establecer los objetivos de mi terapia. 4. y yo colaboramos en establecer los objetivos de mi tratamiento. Backward translation 4. and I cooperate in setting the goals for my treatment. Spanish final 4. y yo colaboramos en establecer los objetivos de mi tratamiento. 5. and I respect each other. Spanish 5. y yo nos respetamos mutuamente. 5. y yo nos respetamos mutuamente. Backward translation 5. and I respect each other. Spanish final 5. y yo nos respetamos mutuamente. 6. and I are working towards mutually agreed upon goals. Spanish 6. y yo estamos trabajando hacia objetivos mutuamente acordados. 6. y yo estamos trabajando hacia objetivos mutuamente acordados. Backward translation 6. and I are working towards the goals we agreed on. Spanish final 6. y yo estamos trabajando hacia objetivos mutuamente acordados. 7. I feel that appreciates me. Spanish 7. Creo que me aprecia. 7. Creo que me aprecia. Backward translation 7. I think appreciates me. Spanish final 7. Siento que me aprecia. 8. and I agree on what is important for me to work on. Spanish 8. y yo estamos de acuerdo en lo qué es importante para mi para continuar trabajando. 8. y yo estamos de acuerdo en lo qué es importante que trabaje. Backward translation 8. and I agree on what is important for me to work on. Spanish final 8. y yo estamos de acuerdo en lo qué que es importante que trabaje. 9. I feel cares about me even when I do things that he/she does not Spanish 9. Creo que se preocupa por mi; incluso cuando hago cosas con las que 9. Creo que se preocupa por mi; incluso cuando hago cosas con las que Backward translation 9. I think cares about me; even when I do things he/she does not agree Spanish final 9. Siento que se preocupa por mi mí; incluso cuando hago cosas con las que 26

28 approve of. no está de acuerdo. no está de acuerdo. with. no está de acuerdo. 10. I feel that the things I do in therapy will help me to accomplish the changes that I want. Spanish 10. Creo que las cosas que hago en la terapia me ayudarán a conseguir los cambios que quiero. 10. Creo que las cosas que hago en el tratamiento me ayudarán a conseguir los cambios que quiero. Backward translation 10. I think the things I do in the treatment will help me achieve the changes I am aiming at. Spanish final 10. Siento que las cosas que hago en el tratamiento me ayudarán a conseguir los cambios que quiero. 11. and I have established a good understanding of the kind of changes that would be good for me. Spanish 11. y yo hemos llegado a comprender bien el tipo de cambios que serían buenos para mí. 11. y yo hemos llegado a comprender bien el tipo de cambios que serían buenos para mí. Backward translation 11. and I have reached an understanding regarding the changes that would be good for me. Spanish final 11. y yo hemos llegado a comprender bien el tipo de cambios que serían buenos para mí. 12. I believe the way we are working with my problem is correct. Spanish 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. Backward translation 12. I think the way we are dealing with my problem is correct. Spanish final 12. Creo que la forma en que estamos trabajando con mi problema es correcta. 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 Spanish Instrucciones: A continuación se presenta una lista de frases sobre la experiencia que los profesionales podrían tener con sus pacientes. Algunos ítems se Instrucciones: A continuación se presenta una lista de frases sobre la experiencia que los profesionales podrían tener con sus pacientes. Algunos ítems se Backward translation Instructions: A list of statements of the experience therapists could have with their patients is shown below. Some items refer to the patient as (an underlined Spanish final Instrucciones: A continuación se presenta una lista de frases sobre la experiencia que los profesionales podrían tener con sus pacientes. Algunos ítems se 27

29 client with an underlined space -- as you read the sentences, mentally insert the name of your client in place of in the text. refieren al paciente con un espacio subrayado_, a medida que va leyendo las frases, incluya el nombre del paciente en lugar del en el texto. refieren al paciente con un espacio subrayado_, a medida que lea las frases, incluya el nombre del paciente en lugar del en el texto. space), as you read the sentences write the patient's name in the in the text. refieren al paciente con un espacio subrayado_, a medida que lea las frases, incluya el nombre del paciente en lugar del en el texto. IMPORTANT!!! Please take your time to consider each question carefully. IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente IMPORTANT: Please, take your time to consider each question carefully. IMPORTANTE: Por favor, tómese su tiempo para pensar cada pregunta cuidadosamente 1. and I agree about the steps to be taken to improve his/her situation. Spanish 1. y yo estamos de acuerdo en los pasos necesarios para mejorar su situación 1. y yo estamos de acuerdo en los pasos necesarios para mejorar su situación Backward translation 1. and I agree on the steps to improve his/her situation. Spanish final 1. y yo estamos de acuerdo en los pasos necesarios para mejorar su situación 2. I am genuinely concerned for s welfare. Spanish 2. Estoy realmente preocupado/a por el bienestar de. 2. Estoy realmente preocupado/a por el bienestar de. Backward translation 2. I am really worried about 's wellbeing. Spanish final 2. Me importa realmente el bienestar de esta persona. 3. We are working towards mutually agreed upon goals. Spanish 3. Estamos trabajando en los objetivos que hemos acordado juntos/as. 3. Estamos trabajando en los objetivos que hemos acordado juntos/as. Backward translation 3. We are working towards the goals we have set together. Spanish final 3. Estamos trabajando en los objetivos que hemos acordado juntos/as. Spanish Backward translation Spanish final 4. and I both 4. y yo 4. y yo 4. and I trust 4. y yo 28