One of the key characteristics of family medicine is a long-term doctor-patient relationship (1). Research shows that most patients decide to stay with their personal physician, i.e. family medicine doctor, for at least eight years or even longer (2). A personal relationship thus develops between the patient and the physician, and the nature of this relationship has significant effects on prognosis and patient satisfaction (3).
1.1 The Long-Term Doctor-Patient Relationship
The long-term doctor-patient relationship can also be described by the concept of therapeutic alliance. The most commonly-cited definition of this was first articulated by Bordin (4) in 1979; he argued that the construct consists of three components: the bond between the therapist and the patient; therapist-patient agreement on the goals of treatment; and therapist-patient agreement on the tasks of treatment. Therapeutic alliance also involves an assessment of doctor-patient trust, communication, and patient cooperation (5). It thus exceeds the paternalistic doctor-patient relationship and implements a model of shared decision-making, where the relationship is based on mutual trust, understanding, and the doctor’s empathy. Scales for assessing therapeutic alliance were first developed and validated in psychotherapy (6), and proved to be a useful tool in assessing psychotherapeutic alliance when dealing with both in- and outpatients (7). The scales have not yet been specifically altered for use outside psychotherapy, but can nonetheless be helpful in the evaluation and improvement of the therapeutic relationship elsewhere (8). Several research studies show that therapeutic alliance is also associated with better treatment results in clinical medicine (9). A study evaluating patient outcomes in cardiac rehabilitation programmes showed that a strong therapeutic alliance could play an important role in achieving favourable results (10). Its use, therefore, also seems to be applicable to family medicine.
1.2 The Assessment of a Therapeutic Alliance
The importance of using validated assessment tools has been receiving growing attention, with researchers becoming more aware that tools and techniques with established validity and reliability produce more consistent and accurate results.
Internationally, several tools have been used to assess therapeutic alliance in previous research (8, 11, 12, 13, 14, 15). In Slovenia, different studies have been conducted assessing various doctor-patient relationship attributes, such as empathy (16) or patient satisfaction (2), but no study has validated or even used the therapeutic alliance scales. This survey is the Slovenian part of an international research study aiming to validate the WAI-SR scale for therapeutic alliance for patients and physicians throughout Europe (8).
1.3 Validation of the Slovenian WAI-SR Scale
A WAI-SR instrument that has been previously validated in one language is not automatically equivalent to the same instrument in another language and/or culture. The equivalence between translated versions of the questionnaire is important for its international comparison.
Slovene is a language spoken by only about two million people. However, scales from other languages still need to be translated and made equivalent to the original language in terms of concepts (the concept must exist in different cultures (17) and semantics, i.e. “equivalence in meaning between the source and the question wording” (18). International research also requires scales to be culturally equivalent, to enable understanding, interpretation and assessment of the subject, that is equal or similar across different cultures. However, cultural factors cannot be seen at the level of the form or meaning of language, and exist only in the background. Since cultural factors are those relating to value systems, geographical situation, traditions, religion, etc., it is important to consider any impact that a culture or way of life can have on wording. The procedure for testing cultural linguistic equivalence consists of the evaluation of the back-translated version, test-retest by bilingual respondents, adaptation of the translated version, and a final cultural check by a principal researcher in the target country (19).
The aim of this study was to obtain a culturally consistent translation of the two WAI-SR scales (one concerning physicians and one concerning patients) and their scoring key. The semantic and cultural equivalence process is also presented.
2.1 Design of the Study
An international group of researchers was formed under the umbrella of the European General Practice Research Network (EGPRN), led by the University of Brest, consisting of ten national research teams simultaneously working on a translation procedure following the same protocol, aiming to develop a tool available and equivalent in different languages and cultures. In this paper, we present the Slovenian part of the study.
With the aim of obtaining semantic, idiomatic, experiential and conceptual equivalence in translation, both scales and the scoring key were translated by an e-mail with a forward and back translation using a Delphi procedure. Afterward, a cultural equivalence was performed to adapt the translations within the national context, in order to ensure the homogeneity of the scales throughout Europe.
A small group of four experts was formed for the forward translation from English to Slovene.
A convenient sample of 30 practising and academic Family Medicine Doctors (FMDs) were invited to participate in the Delphi method to achieve consensus (20). All participants were provided with a written explanation of the aims and procedure of the study, and signed a statement on voluntary participation. Among those thirty invited experts, four did not accept the invitation, with one saying he was too busy, and three not replying.
Two independent English language translators undertook back translation.
The WAI-SR scales are a 12-item questionnaire for the patient and a 10-item questionnaire for the physician, assessing the three main features of the therapeutic alliance between them: goal, tasks, and bond (8). In this scale, the patient or physician rates each item on a 5-point Likert scale from “1 – rarely or never” and “5 – always”. The higher the score, the better the therapeutic alliance. The scoring key provides instructions for the evaluation of the scales.
2.4.1 Forward Translation
The group of four experts made a forward translation from English to Slovene of both WAI-SR scales. All the differences in translation were reconciled between them until they reached a consensus.
2.4.2 Validation of the Forward Translation by the Delphi Method
To verify semantic equivalence, both scales were sent to the participants in the Delphi method, which allows a group to elicit judgments through an iterative process, interspersed with controlled feedback of opinions (20). The group evaluated the translation for clarity, common language, and conceptual adequacy. The experts were contacted separately by email to ensure the anonymity and independence of each opinion. Each participant was asked to validate or reject the translation by rating each statement on a scale from 1 to 9, where 1 meant “no agreement” and 9 meant “full agreement”. If they rated a translation with less than 7, they were asked to explain their disagreement and possibly propose a more suitable translation. The principal researcher evaluated the answers.
A successful validation for each statement was obtained when at least 70% of the participants rated it 7 or above. If a statement did not meet this criterion, the principal researcher proposed a new translation taking into account the participants’ suggestions. The new translation was again sent to the group for a second Delphi round. The process was repeated until all the statements were successfully validated.
2.4.3 Back Translation
Two licensed translators with no knowledge of the original English version of the WAI-SR scales independently translated the validated items back from Slovene into English. After the independent translation, they were asked to reach a consensus on the translated items. In the event of disagreement, the leader of the Slovenian research team led the consensus procedure until it was achieved for all statements.
2.4.4 Cultural Adaptation
Translation issues were discussed by the research group, which met twice a year for two years. The international collaborative group compared the back-translation to the original English version at a workshop during an EGPRN meeting in Dublin 2017. The team leaders of five countries and an international committee with the principal investigator of the TATA group carried out a cultural check by comparing a back-translation of five languages, including Slovenian, with the original version. The main task was to identify those translated items, whose meaning might have been lost or inappropriately altered in translation. If the problem could not be solved, it was submitted to the local research team to propose a solution.
3.1 The Sample
The group of four translators who did the forward translation consisted of two FMDs, one linguist, and one psychologist; three women and one man, with a mean age of 53 years (range 43–60). All were fluent in English.
26 experts (FMDs) participated in the Delphi part of the study. Among them, 3/26 were male and 23/26 female; their mean age was 40.7 years (range 27–60) and the mean number of years of working in the practice was 12.3 years (range 1–34). 18/26 experts were involved in teaching, and 19/26 were researchers. Of the whole group, 7/26 participants worked in a solo practice and 17/26 in a group practice, while 2/26 were still trainees; 13/26 worked in a rural or semirural environment.
3.2 WAI-SR Patient Scale
For validation, each item had to be rated at 7 or more by at least 17 participants. The first Delphi round for the WAI-SR patient scale showed acceptable agreement in all but one statement (Q8), where only 12/26 (46%) of the participants rated the translation with 7 or above (Table 1).
In the second Delphi round concerning Q8, the participants proposed 18 alternative translations. We present some of the suggestions in Supplementary material – Table 1. Agreement was reached on a revised translation.
WAI-SR patient scale Likert scores, mean and median – Round 1 (N=26).
3.3 WAI-SR Physician Scale
The first Delphi round for the WAI-SR Family physician scale showed agreement in all but two statements (Q2, Q10). Q2 was rated as adequate by 15/26 (58%) of participants, but Q10 by only 10/26 (38%) participants (Table 2).
WAI-SR physician scale Likert scores, mean and median – Round 1 (N=26).
Numerous alternative translations were again proposed in the second Delphi round – 6 for Q2 and 5 for Q10. Some of these are presented in Supplementary material – Tables 2 and 3. Again, agreement was reached on a revised translation.
Mean and median: Patient scale Q8 and Physician scale Q2, Q10 – Round 2.
|patient scale||physician scale||physician scale|
Consensus was achieved in two rounds of the agreement process between the two professional translators for both WAI SR scales. Consensus on the back-translation of the scoring key was achieved in four rounds.
3.5 International Cultural Equivalence Evaluation
The work on cultural equivalence highlighted three potential problems with translation: In Q10 of the patient scale, “treatment” was translated as “consultation”. We concluded that, considering its original use in psychotherapy, the word “treatment” did not relate solely to medical treatment but to the entire process of doctor-patient consultation. For this reason, the translation relates to the entire process of consultation and not only to treatment actions.
Also, in the patient scale, Q12 was originally in the active voice, but was translated to the passive voice in the validated Slovene translation. After the cultural check was carried out, the national team agreed that the use of the active voice was more suitable, since it emphasized the patient’s active role in the consultation and corresponded to the “shared decision-making” model (Supplementary material – Table 5).
In Q8 of the physician scale, the discussion on cultural equivalence revealed that there was a difference between ‘the common perception of a goal’ (as in the original version) and ‘common agreement on the goal’ (as translated). We consulted the linguist and appropriately altered the validated translation so that the original meaning of the statement was retained (Supplementary material – Table 6).
The final version of the WAI-SR Slovene translation was accepted after the second Delphi round, including these cultural adaptations.
3.6 Validation of the Scoring Key
The scoring key contains instructions concerning the evaluation of the scale. The same procedure was used for the translation of the scoring key as for the WAI-SR items. It was validated in the first Delphi round with Q1, Q2, and Q3 each having one evaluation of <7, and all the others (except the last item) >7. Item 11 was adapted after consulting the author of the scale, AO Horvath, who gave additional instructions.
4.1 Main Findings
Only two rounds of the Delphi method were needed to achieve a consensus on the translations of all the items. Cultural equivalence of the back-translation was obtained after some minor adaptations were made. The process showed that a simple literal translation was inappropriate, and rigorous efforts must be made to ensure the meaning and intent of the original items are maintained so the scale remains relevant.
4.2 Validation Process and Comparison to other Countries
The equivalence procedure in the translation of the two scales assessing therapeutic alliance was complex and time-consuming, but it served well for the purpose of semantic validation. The same procedure was used to validate and achieve equivalence in the translation of the definition of multi-morbidity (21, 22) and to validate the WAI-SR questionnaire in other countries (23). The translation into Polish showed the feasibility of the procedure, taking only one Delphi round to achieve consensus (23). The advantage of this procedure also lies in the fact that it was simultaneously taking place in several European countries with different linguistic bases, which provided the opportunity to discuss the difficulties national and local research groups met with while translating the original WAI-SR scales.
The Delphi method was used to validate the agreed forward translation and has been shown to be suitable for exploring areas where controversy, debate or a lack of clarity exist. Within this process, translations of WAI-SR scales were actively tested in representatives of the target population or language group to determine whether the respondents understood the questionnaire in the same way as the original. We feel that the use of this method for translation was legitimate, since it provided an accurate consensus technique (24).
Ideally, every questionnaire translation should undergo a cultural equivalence to identify and resolve any inadequate expressions in the translation, as well as to sort out any other discrepancies between the original items and the back-translated ones. The first steps in the process were inspired by the work of Streiner et al. (25). The standardized approach for the cultural adaptation of patient-measured outcomes was confirmed in recent guidelines (26, 27). In this study, we followed the recommendations at all stages: in the first part of cultural adaptation by using the Delphi method, because we recognized this as the best option given the specifics of our language, social and cultural context, and then by the supervision of the researchers led by the University of Brest, who oversaw the adaptation of the questionnaire and the cultural adaptation based on the back-translation. This was to ensure that the items were translated considering their structure as well as the suitability of their content.
Given that translation is the most common method for preparing instruments for cross-cultural research, we must be alert to the pitfalls that threaten validity.
Firstly, when translating scales such as the WAI-SR, it would be best if the forward translation was carried out by professionals who fit these criteria: familiar with the terminology used in the questionnaire; knowledgeable about the subjects covered; experienced in translating scales from (as here) English; and have Slovene as their native language. The content of the WAI-SR covers the fields of psychology and medicine, and its translation must be understandable by both physicians and patients. In Slovenia, we were unlikely to find a professional translator who would meet all these criteria. Creating a group of two family medicine doctors, a psychologist and a linguist to carry out the forward translation solved this problem.
Secondly, we stated that the experts carrying out the consensus procedure consisted of individuals who were fluent in English. However, the method of evaluating fluency in the language is debatable. Proficiency in English was assessed in two ways: one was self-evaluation, and the other was the number of English publications of each of the participants. The latter, in particular, may not be a powerful tool for showing language fluency; however, it was a pragmatic and feasible solution.
Thirdly, the Delphi group was not representative of the community of Slovenian family medicine doctors (FMDs) – men were underrepresented and the percentage of the academic FMDs involved was higher than the Slovenian average. But considering that the Delphi method is a qualitative one, population representativeness is not necessary. It is more important that all the characteristics of the participants that can influence decisions regarding validation are represented, such as different ages, location of practice, years of experience and involvement in the academic side of family medicine.
Finally, it would have been preferable if the back-translation had been made by an independent translator fluent in Slovene but whose native language was English. Since no such translators were available, we settled for two independent licensed Slovenian translators who had no previous knowledge of the WAI-SR scale.
At this stage, the WAI-SR and its use in family medicine generally lacks a theoretical background that needs to be discussed and agreed upon in the broader field of family medicine. Given the complexities of patient care in family medicine, the question arises as to whether therapeutic alliance is relatively stable over the course of a relationship between a family doctor and a patient. In addition, if assessing the alliance at one or several points in time, alliance ratings are expected to be associated with morbidity changes over the course of a patient’s life, which may fail to capture the short-term impact of alliance on a specific symptom or improvement in their condition. Therefore, the future accuracy of ratings provided by this instrument can be affected by many methodological factors, including the quality of the instrument in terms of validity, reliability, and sensitivity to change. We only described the first phase, where the scale’s semantic and cultural equivalence were verified. Further studies will provide results of reliability and item validity analyses. Exploratory principal component analyses are to be conducted to compare response patterns with the hypothesized scale constructs. Four major issues need to be considered in the future: the psychometric properties of the Slovene WAI-SR scale; the appropriateness of the scale for FMDs; practical aspects of scale administration; and the theoretical foundation of scale interpretation within the field of family medicine.
Q8 patient scale translation examples.
|Q8 patient scale – original statement||Q8 patient scale – forward translation||Q8 patient scale – alternatives|
|_______ and I agree on what is important for me to work on.||Z _______ se skupaj dogovarjava o tem, kaj je zame pomembno, da počnem.||Z _______ se strinjava, na čem moram delati|
|Z _______ se strinjava/soglašava o tem, kaj je zame pomembno, da počnem.|
|Z _________ se strinjava, kaj je zame pomembno, da izboljšam.|
Q2 physician scale translation examples.
|Q2 patient scale – original statement||Q2 patient scale – forward translation||Q2 patient scale – alternatives|
|I am genuinely concerned for _______’s welfare.||Blagostanje _______ je moja osrednja skrb.||Skrbi me pacientovo dobro.|
|Dobrobit _______ je moja osrednja skrb.|
|Moja pristna skrb je dobro počutje _______.|
Q10 physician scale translation examples.
|Q10 patient scale – original statement||Q10 patient scale – forward translation||Q10 patient scale – alternatives|
|We agree on what is important for _______ to work on.||Z _________ se skupaj dogovarjava, kaj je zanj(o) pomembno, da počne.||Z _______ se strinjava, na čem mora delati.|
|Z_______ se strinjava o tem, kakšni ukrepi so pomembni.|
|Z _______ se strinjava, kaj je zanj(o) pomembno, da izboljša.|
validated translations: Q8 patient scale and Q2, Q10 physician scale – Round 2.
|Q8 patient scale – successfully validated translation||Q2 physician scale – successfully validated translation||Q10 physician scale – successfully validated translation|
|Z _________ se strinjava, kaj je zame pomembno, da izboljšam.||Dobrobit _________ je moja osrednja skrb.||Z _________ se strinjava, kaj je zanj(o) pomembno, da izboljša.|
Q12 patient scale cultural equivalence.
|Q12 patient scale – original statemet||Q12 patient scale – validated translation||Q12 patient scale – after cultural adaptation|
|I believe the way we are working with my problem is correct.||Verjamem, da je način obravnave moje težave pravilen.||Verjamem, da mojo težavo obravnavava na ustrezen način.|
Q8 physician scale cultural equivalence.
|Q8 patient scale – original statemet||Q8 patient scale – validated translation||Q8 patient scale – after cultural adaptation|
|_____ and I have a common perception of his/her goals||Z ___________ se strinjava glede njegovih/njenih ciljev.||Z ___________ enako dojemava njegove/njene cilje.|
We thank all the physicians who participated in the study and Ms. Justi Carey for the language editing.
We thank to TATA group researchers, who participated in the international translations and are non-author collaborators: Nicola Buono (National Society of Medical Education in General Practice, Caserta, Italy), Radost Assenova (University of Plovdiv, Bulgaria), Krzysztof Buczkowski (Nicolaus Copernicus University in Torun, Poland), Ana Claveria (Universidad de Vigo, Spain); Robert Hoffman (Tel Aviv University, Israel), Djurdjica Lazic (University of Zagreb, Croatia), Heidrun Linger (Hannover Medical School, Germany), Hans Thulesius (Lund University, Sweden).
the Working Alliance Inventory – Short Revised scale
Family medicine doctors
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