C M Todea

C Monz

Asbach

S Bau

R Payet

A Toussaint

O Witschger

A M Todea

C Asbach

Combining NSAM and CPC concentrations to

Keywords: count median diameter, lung-deposited surface area concentration, NSAM/CPC

published or not. The documents may come

INTRODUCTION

Due to the growing use of manufactured nanomaterials, it is likely that workers in research laboratories and industry are also increasingly being exposed to them at all points of their life cycle, from synthesis and production to downstream use, aging and disposal [START_REF] Savolainen | Nanotechnologies, engineered nanomaterials and occupational health and safety -A review[END_REF] .

Although the toxicological effects of inhaled airborne nanoparticles cannot be directly correlated with their physico-chemical properties, developing and testing robust methods to determine some of the key parameters of airborne nanoparticles remains necessary.

The parameters that should be assessed to characterize airborne nanomaterials are still being debated, thus, implementing a multi-metric approach has recently been suggested [START_REF] Shepard | An occupational exposure assessment for engineered nanoparticles used in semiconductor fabrication[END_REF][START_REF] O'shaughnessy | Occupational health risk to nanoparticulate exposure[END_REF][START_REF] Gordon | Workshop report: Strategies for setting occupational exposure limits for engineered nanomaterials[END_REF] . In addition to chemical composition and number concentration, particle size is among the parameters which play a role in the potential health effects of nanoparticles [START_REF] Wang | How can nanobiotechnology oversight science and industry: examples from environmental, health, and safety studies of nanoparticles (nano-EHS)[END_REF] . This is mainly due to the role of particle diameter in its deposition in the human respiratory tract [START_REF] Broday | Deposition of fractal-like soot aggregates in the human respiratory tract[END_REF][START_REF]Human respiratory tract model for radiological protection[END_REF] , where inhaled nanoparticles will potentially interact.

Measuring the size of airborne nanoparticles can be achieved by time-integrated techniques, e.g. (personal) cascade impactors or diffusion batteries with subsequent SEM analysis. Size can be measured in real-time with instruments such as electrical mobility analyzers (e.g. Scanning Mobility Particle Sizer -SMPS, Fast Mobility Particle Sizer -FMPS) or electrical low pressure cascade impactors (e.g. Electrical Low Pressure Impactor -ELPI, ELPI+). Their lack of field-portability, complexity of use and high cost make them not ideally suited to monitor aerosols in workplaces [START_REF] Leskinen | Comparison of nanoparticle measurement instruments for occupational health applications[END_REF] . Another option relies in the use of optical aerosol spectrometers. The latter are, however, limited to particle size approximately larger than 250 nm.

In the absence of size-resolving instruments, approaches based on the simultaneous measurement of size-integrated particle concentrations (number, surface area or mass) have been proposed by different authors (e.g. Woo et al [START_REF] Woo | Use of continuous measurements of integral aerosol parameters to estimate particle surface area[END_REF] , Maynard [START_REF] Maynard | Estimating aerosol surface-area from number and mass concentration measurements[END_REF] , Park et al [START_REF] Park | Comparison of two estimation methods for surface area concentration using number concentration and mass concentration of combustion-related ultrafine particles[END_REF] , Park et al [START_REF] Park | Estimation of surface area concentration of workplace incidental nanoparticles based on number and mass concentrations[END_REF] , Park et al [START_REF] Park | Real-time measurement of submicron aerosol particles having a lognormal size distribution by simultaneously using unipolar diffusion charger and unipolar field charger[END_REF] ), in particular to determine the number size distribution or airborne particles.

In a recent work, Pham & Jung [START_REF] Pham | Alternative metrics for spatially and temporally resolved ambient particle monitoring[END_REF] combined a Condensation Particle Counter (CPC) and an Electrical Aerosol Detector (EAD, TSI) to determine particle count median diameter based on the response function of the EAD over the range from 10 nm to 1 µm and the assumption of lognormally-distributed aerosols with a geometric standard deviation of 1.7. They tested their methodology during ambient aerosol monitoring by comparing their results to SMPS data, highlighting a good correlation (R 2 = 0.77) between both approaches.

We proposed and tested a methodology that relies on the simultaneous measurement of number and lung-deposited surface area (LDSA) concentrations of airborne nanoparticles to evaluate the count median diameter (CMD) of an aerosol in a previous work [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] . Polydisperse monomodal metal aerosols in a range of CMDs between 60 and 180 nm were used to evaluate the performance of the approach. The results highlighted that, the reference CMDs and the CMDs determined with the approach developed agree within 30%. In this methodology, the number concentration is measured by a CPC, while the LDSA concentration requires the use of a unipolar diffusion charging instrument, e.g. the Nanoparticle Surface Area Monitor (NSAM).

The NSAM (TSI, model 3550) was developed to provide the fractions of the geometric surface area concentrations of particles that would deposit in either the tracheobronchial or the alveolar region of the lung. A good agreement with the ICRP deposition model [START_REF]Human respiratory tract model for radiological protection[END_REF] has already been shown in several experimental and theoretical studies [START_REF] Asbach | Conceptual limitations and extensions of lung-deposited Nanoparticle Surface Area Monitor (NSAM)[END_REF][START_REF] Fissan | Rationale and principle of an instrument measuring lung deposited nanoparticle surface area[END_REF][START_REF] Shin | Calibration and numerical simulation of Nanoparticle Surface Area Monitor (TSI model 3550 NSAM)[END_REF][START_REF] Mokhtar | NSAM-derived total surface area versus SMPS-derived "mobility equivalent" surface area for different environmentally relevant aerosols[END_REF][START_REF] Leavey | Comparison of measured particle lungdeposited surface area concentrations by an AeroTrak 9000 using size distribution measurements for a range of combustion aerosols[END_REF][START_REF] Bau | Response of three instruments devoted to surface-area for monodisperse and polydisperse aerosols in molecular and transition regimes[END_REF][START_REF] Bau | Evaluating three direct-reading instruments based on diffusion charging to measure surface area concentrations in polydisperse nanoaerosols in molecular and transition regimes[END_REF][START_REF] Todea | Accuracy of electrical aerosol sensors measuring lung deposited surface area concentrations[END_REF] for various particles with sizes between 15 and 520 nm. Levin et al [START_REF] Levin | Can we trust real-time measurements of lung deposited surface area concentrations in dust from powder nanomaterials?[END_REF] investigated the behaviour of FMPS and ELPI compared to NSAM data for a set of aerosolized powder nanomaterials. They concluded that there is a need for increasing knowledge on the measurement of LDSA concentrations, in particular when regulatory issues are considered. In a recent study [START_REF] Cao | A novel weighted sum method to measure particle geometric surface area in real-time[END_REF] , NSAM's signal was modulated through the use of two optimized trap voltages to provide the geometric surface area concentration of airborne nanoparticles. This leads us to think that the NSAM is a robust instrument and suitable for many applications including exposure assessment. As shown in Table I, the NSAM has been implemented in different laboratory or field studies for different purposes.

It should be noted that other devices can be used to provide airborne LDSA concentration, such as the field-portable AeroTrak 9000 (TSI), as well as personal monitors [START_REF] Asbach | Review of measurement techniques and methods for assessing personal exposure to airborne nanomaterials in workplaces[END_REF] , like DiSCmini / miniDiSC [START_REF] Fierz | Design, calibration, and field performance of a Miniature Diffusion Size Classifier[END_REF] (Testo AG, Titisee-Neustadt, Germany), NanoTracer [START_REF] Marra | Monitor for detecting and assessing exposure to airborne nanoparticles[END_REF][START_REF] Marra | Using the Aerasense NanoTracer for simultaneously obtaining several ultrafine particle exposure metrics[END_REF] (oxility b.v., Eindhoven, The Netherlands) and Partector (naneos GmbH, Windisch, Switzerland) [START_REF] Fierz | Aerosol Measurement by Induced Currents[END_REF][START_REF] Fierz | Miniature nanoparticle sensors for exposure measurement and TEM sampling[END_REF] . It has been demonstrated that these devices behave similar to the NSAM (21-23, 32, 33) and that wearing them as personal monitors does not affect their response [START_REF] Asbach | On the effect of wearing personal nanoparticle monitors on the comparability of personal exposure measurements[END_REF] .

In this context and bringing new elements compared to our previous work [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] , the present study provides new results for estimating the count median diameter of airborne nanoparticles from the combined NSAM/CPC approach. In particular, this paper investigates the case of 40 polydisperse aerosols consisting of metal oxides, organic oil and salt particles. The CMDs obtained from the NSAM/CPC measurements in the laboratory were compared to SMPS data.

The reference CMDs range from 16 to 410 nm.

In addition, workplace measurement data were used to test the field applicability of the method. Because of limited SMPS transportation possibilities in France (due to legislation on radioactive sources), the data measured with an ELPI were used as reference. The workplace aerosols had CMDs in the range from 42 to 190 nm.

MATERIALS AND METHODS

Theoretical background: establishing a relationship between the count median diameter and airborne particle number and lung-deposited surface area concentrations

The mathematical basis of the approach was proposed and detailed elsewhere [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] , thus, only a short description of it is given in this section. The lung-deposited surface area (LDSA) concentration of an aerosol formed of spherical particles, noted , is given by:

(1)

This equation corresponds to the product of the geometric surface area concentration ( with the particle number concentration) and the probability ( ) of a particle to deposit in a given region of the respiratory apparatus. Solving equation ( 1) to determine the diameter of average geometric surface area ( ) is complex because the particle deposition probability is size-dependent. In particular, it relies on the response function of the instrument, which has been described in previous studies for various aerosols in a range from 15 to 520 nm [START_REF] Bau | Response of three instruments devoted to surface-area for monodisperse and polydisperse aerosols in molecular and transition regimes[END_REF][START_REF] Bau | Evaluating three direct-reading instruments based on diffusion charging to measure surface area concentrations in polydisperse nanoaerosols in molecular and transition regimes[END_REF] . From this diameter , the corresponding count median diameter (CMD) of an aerosol can be obtained, assuming a lognormal number size distribution, according to (35) :

(

) 2
where GSD is the geometric standard deviation of the distribution. Thus, by combining equations 1 and 2 the CMD of airborne particles can be determined.

A panel of theoretical curves, which provide the count median diameter of an aerosol based on the ratio and the GSD of the distribution, was published by Bau et al [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] in a range from 50 to 200 nm. When the GSD of the aerosol is unknown, a typical value of 1.8 can be considered according to different authors [START_REF] Maynard | Estimating aerosol surface-area from number and mass concentration measurements[END_REF][START_REF] Park | Comparison of two estimation methods for surface area concentration using number concentration and mass concentration of combustion-related ultrafine particles[END_REF][START_REF] Harris | Signature Size Distributions for Diesel and Gasoline Engine Exhaust Particulate Matter[END_REF] for submicron airborne particles.

Roughly, 30% variation in the calculated CMD can be observed between cases where the GSD is known or unknown (and thus fixed at 1.8).

Laboratory test aerosols

Various test aerosols were produced in two different laboratories at INRS and IGF to investigate the applicability of the combined NSAM/CPC approach and complement the data already published by Bau et al [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] . The generation set-up and the characteristics of the different test aerosols are gathered in Table II and described in the sections below. The GSD used in the NSAM/CPC approach to determine the CMD of the test aerosols are the ones included in Table II.

The laboratory aerosols under study consisted of:

 metal-based agglomerates made of C, Ag, Ti, Cu and Constantan and produced by spark discharge (PALAS GFG 1000 within the CAIMAN facility at INRS [START_REF] Jacoby | CAIMAN: a versatile facility to produce aerosols of nanoparticles[END_REF] and PALAS GFG3000 at IGF, NanoTestCenter, Dortmund, Germany);

 ZnO supplied by a prototype of the burner-type nanoparticle generator FG2 (MoTec Konzepte GmbH, Bochum, Germany, see Monsé et al [START_REF] Monsé | Development and evaluation of a nanoparticle generator for human inhalation studies with airborne zinc oxide[END_REF] ), where a constant solution [START_REF] Heim | Performance of a new commercial electrical mobility spectrometer[END_REF] or TSI model 3007, d 50 = 10.5 nm [START_REF] Mordas | On Operation of the Ultra-Fine Water-Based CPC TSI 3786 and Comparison with Other TSI Models (TSI 3776, TSI 3772, TSI 3025, TSI 3010, TSI 3007)[END_REF] )

and a Nanoparticle Surface Area Monitor (NSAM, TSI model 3550), as stated in Table III. In parallel, airborne particle number size distributions were measured by a SMPS (Table III) to provide the reference CMD and GSD values.

Workplace aerosols

In the framework of assessing occupational exposure to airborne nanoparticles, different workplaces were investigated, where both NSAM and CPC measurements were performed in parallel. The six different sets of experimental data stemming from workplace measurement campaigns are (Table IV):

 aerosols measured in a plant that produces both pigment grade TiO 2 and nano-TiO 2 as powders during bagging operations [START_REF] Witschger | Potential for exposure during bagging operations in a plant that produces both pigment grade TiO 2 and nano-TiO 2 as powders[END_REF] -workplace "A";

 aerosols emitted during discharging bags of nano-TiO 2 powder into an industrial funnel for further incorporation into cosmetic products -workplace "B";

 aerosols measured in a research laboratory during dry sandpapering of a reactor producing nanocomposite thin films embedded with silver nanoparticles [START_REF] Witschger | Potential for exposure during cleanout operations of a reactor producing nanocomposite thin films embedded with silver nanoparticles[END_REF] workplace "C";

 aerosols released during automated extrusion of a polymer containing Multi-Walled Carbon Nanotubes (MWCNT) [START_REF] Möhlmann | Characterization of aerosols released during handling or processing operations of MWCNTs[END_REF] -workplace "D";

 aerosols released in a workshop producing photocatalytic media made of amorphous silica fibers felt with titanium dioxide (data not published yet) -workplace "E".

Except for case "E", the CMD given in Table IV do not correspond to the size of the materials handled.

As stated earlier, the GSD of the workplace aerosols can be assumed to be 1.8 according to different authors. The CPC used in parallel of the NSAM was a Grimm model 5.403 for workplaces "A" and "E", a TSI model 3007 for workplaces "B" and "D", and a TSI P-Trak for workplace "C". Although these counters have different size ranges, the aim of this paper is to experience the field-feasibility of the approach, whatever the CPC used to provide particle number concentration.

Considerations regarding the reference CMD

For the case of laboratory test aerosols, the reference CMDs considered are determined from the adjusted lognormal law based on number size distribution measured by a SMPS, all of them being monomodal. Indeed, the count median diameter of a lognormal size distribution can be derived from the modal diameter and the geometric standard deviation of the distribution according to [START_REF] Hinds | Aerosol Technology. Properties, behavior and measurement of airborne particles (2nd Edition)[END_REF] :

(3) Thus, the reference CMD is an electrical mobility equivalent diameter. Although NSAM is not based on electrical migration of charged particles in an electric field, it was demonstrated that the charging efficiency, and thus the response of the instrument, scales with the electrical mobility diameter [START_REF] Todea | Accuracy of electrical sensors measuring lung deposited surface area concentrations[END_REF][START_REF] Fissan | Total Surface Area Concentration Measurements of Nanoparticles in Gases with an Electrical Sensor[END_REF] .

Defining the reference count median diameter for the case of workplace aerosols is The reader's attention shall be drawn to the operation investigated for case "B", where aerosol sampling was performed directly in the plume, contrary to other situations considered in this paper in which aerosols were sampled in the surrounding area of the workers. Thus, it can be considered that the aerosol of workplace "B" only consists of TiO 2 , which allows a particle density of ~ 4 g/cm³ to be used for the conversion of the modal aerodynamic diameter into mobility equivalent diameter.

It is also worth mentioning that data from ELPI were not further specifically treated (e.g. lognormal optimization, data inversion, etc). Although particle density influences the number concentration in each channel of the ELPI (e.g. the number size distribution as well as the total number concentration), data published by Charvet et al [START_REF] Charvet | On the importance of density in ELPI data post-treatment[END_REF] for thermal metal spraying aerosols show that the modal diameter is almost constant (roughly ± 20 %), whatever the particle density considered in ELPI data post-treatment (calculation of the number size distribution based on the currents measured). In addition, some of the workplace aerosols defined in Table IV presented a second mode in their number size distribution in the micron size range (aerosols "A1", "A2"). The latter populations, when present according to the ELPI data, were not considered since (1) the NSAM is equipped with an inlet cyclone (d 50 = 1 µm aerodynamic), (2) they are probably not efficiently taken into account in the CPC number concentration, and (3) their contribution to the overall number concentration as measured by the ELPI is below 10%.

NSAM calibration

To ensure the reliability of LDSA measurements, experimental data stemming from NSAM were compared to theoretical LDSA concentrations calculated according to:

(4)
where is the number size distribution based on SMPS-fitted data. Three cases covering the range of LDSA concentrations are reported in Table V.

According to Table V, it can be considered that with the given assumptions, NSAM and SMPS data are in good agreement. The biases, even below ±10%, can be partly explained by the use of a lognormal fit of SMPS data to compute the corresponding LDSA concentration and the calibration factor of the NSAM.

RESULTS AND DISCUSSION

Although both alveolar ('alv') and tracheobronchial ('tb') regions of the respiratory tract can be considered, only the 'alv' configuration of the NSAM was used in the experiments carried out in this study. In previous work it was noticed that equivalent results are observed for both configurations [START_REF] Bau | Determining the count median diameter of nanoaerosols by simultaneously measuring their number and lung deposited surface area concentrations[END_REF] . Due to potential biases in the response of the NSAM for larger particles, it is worth mentioning that the combined NSAM/CPC approach is considered to be applicable for particles up to roughly 500 nm in diameter.

Laboratory test aerosols

Figure 1 presents the results obtained when sampling the polydisperse aerosols (n = 40, see Table II) generated in the laboratory, with reference CMDs ranging from 16 to 411 nm.

NSAM/CPC-based and reference CMDs are highly correlated. More precisely, Figure 1 shows that CMD based on the NSAM/CPC approach tend to be lower than the corresponding reference CMD by a nearly constant relative deviation between -30% and -40%. No systematic effect of airborne particle composition, morphology or CMD can be noticed.

To further interpret the data displayed in Figure 1, the ratio R is defined as:

(5)

The closer to unity the ratio is, the better the agreement between the CMD based on the NSAM/CPC approach and the CMD based on SMPS data (equation 3). The median ratio is found to be R 50 = 0.66, with a narrow 50%-confidence interval in the range 0.61-0.69 and a 95%-confidence interval in the range 0.54-0.74, which attests the good fidelity of the NSAM/CPC approach. This systematic bias remains unexplained yet. Therefore, this step highlights the need for prior verification of the combined NSAM/CPC approach by comparison to SMPS reference data. This step being carried out, users are able to determine the correction factor (1/R 50 ) of their own specimen combination to further implement the approach proposed.

Based on our experimental results, considered as representative for a variety of aerosols, a correction factor of 1/R 50 = 1/0.66 = 1.52 can be introduced to make the NSAM/CPC-based CMD fit to the reference CMD. Applying this correction factor yields a 50%-confidence interval in the range 0.93-1.04 and a 95%-confidence interval in the range 0.81-1.12. Thus, it can be considered that the CMD of airborne particles can be determined from the combined NSAM/CPC approach within ± 20%.

Workplace aerosols

To experience the feasibility of the approach in workplace situations, a series of occupational environments has been considered, as stated in Table IV. The average particle number size distributions measured by the ELPI are presented in Figure 2.

Figure 2 highlights the variability in workplace aerosol number size distribution; each of them being quite singular compared to each other. It can be noticed that workplace aerosols

were not found to be lognormal. Thus, this can lead to biases because the method relies on the assumption of a lognormal size distribution with GSD of 1.8. Based on the distributions measured by the ELPI, the modal aerodynamic diameters considered were the ones corresponding to the geometric aerodynamic diameter of the modal impaction stage. The latter is then converted into mobility equivalent modal diameter, and further into CMD according to equation 3.

Accounting for the presence of the cyclone upstream the NSAM, it is reminded that only the submicron mode of the ELPI number size distribution is considered. The CMDs derived from the NSAM/CPC combination are compared to the reference CMD based on ELPI measurements in Figure 3.

In general, Figure 3 shows a correlation between the CMDs based on the NSAM/CPC ratio and the ELPI-based ones. Out of the 6 cases considered, the relative discrepancies between the CMDs based on the NSAM/CPC approach ('raw') and the reference are -42%.

This corroborates previous observations for laboratory test aerosols (Figure 1), where the median relative discrepancy was found to be -34%. When the correction factor of 1.52 derived from laboratory data is applied to NSAM/CPC-based CMDs ('corrected'), the relative discrepancies range from -23% to +9%, with an average deviation of -11%.

More particularly, the aerosols measured in workplace "A", where nano-TiO 2 powder is filled into big bags, are highly polydisperse, as can be seen in Figure 2. The relative discrepancies between the two CMDthe one stemming from the NSAM/CPC approach and the modal diameter based on ELPI dataare -18% and -6% for cases "A1" and "A2", respectively, which is satisfactory.

The case of the aerosol measured in workplace "B", which involves discharging a 10 kgbag of powder of nano-TiO 2 , corresponds to a relative deviation of -11% in terms of CMD.

This aerosol is monomodal, not necessarily lognormal (tail due to smaller particles), with a GSD likely larger than 1.8.

Dry sandpapering of a reactor producing nanocomposite thin films embedded with silver nanoparticles, noted "C", produced monomodal aerosols with a quite low GSD. The latter GSD is found to be near 1.8, which corresponds to the assumption in the NSAM/CPC approach. In this case, the CMD derived from the NSAM/CPC combination underestimates particle modal diameter by -23% compared to the reference.

The aerosol measured in workplace "D" during the automated extrusion of a polymer containing MWCNT presents a number size distribution below 400 nm aerodynamic. Based on ELPI data (Figure 2), it is likely that the modal aerodynamic diameter is below the lowest stage cutpoint, i.e. below 30 nm aerodynamic. We hypothesized the modal aerodynamic diameter is equal to 30 nm (corresponding CMD of 42 nm). Although this might lead to an overestimation of the true modal diameter of the aerosol, the CMD based on the NSAM/CPC combination is found to be 46 nm (relative discrepancy of +9%), which is in line with the abovementioned assumption.

Aerosols observed in workplace "E" mainly consisted of amorphous silica aggregates with a fractal-like morphology. As for workplace "C", the aerosol from workplace "E" is quite well described by a lognormal aerosol with a GSD of 1.8, as depicted in Figure 2. The CMD stemming from the NSAM/CPC approach tends to underestimate the reference modal diameter by about -20%, which is considered to be satisfactory.

Whatever the situation considered, Figure 3 suggests that the approach based on the combination of a NSAM and a CPC leads to a satisfying estimation of particle CMD (roughly ± 20%). Although few in number, the occupational environments investigated covered a wide range of modal aerodynamic diameters, ranging roughly from 30 to 300 nm, i.e. CMD ranging from 40 to 190 nm. In addition, it should be kept in mind the assumptions required to apply the approach: (1) lognormal size distribution, (2) GSD of 1.8 used for both the calculation of the reference CMD and the NSAM/CPC-based one, and (3) particle density taken equal to 1 g/cm 3 (or the one of the raw material when for sure different than 1 g/cm 3 ) to convert ELPI-based aerodynamic into mobility equivalent diameter.

CONCLUSION

This study focused on testing the performance of the NSAM/CPC combination to estimate the count median diameter of aerosols over the particle size range from 15 to 410 nm. Given that the NSAM (1) has been thoroughly investigated and characterized, (2) is a robust instrument, and

(3) is suitable for many applications such as occupational and environmental monitoring, it has been involved in many laboratory or field studies for different purposes. Since it is likely that many researcher teams own a NSAM worldwide, proposing an approach allowing the CMD of airborne particles to be determined based on NSAM measurement is relevant. Indeed, in the absence of any data with regards to particle size (distribution), this approach can be used as a screening tool to detect the presence of nanoparticles.

In a first step, our work was carried out using test aerosols generated in the laboratory.

The polydisperse test aerosols covered a wide range of CMDs (from 16 to 410 nm), chemical natures (mineral, organic), and morphologies (cubic, spherical, fractal-like). Experimental results highlight that the approach based on the NSAM/CPC tends to underestimate the CMD by a constant factor of 0.66. This led to the introduction of a correction factor of ~1.5 to improve the comparability of NSAM/CPC-based and reference CMDs. A setup involving SMPS and NSAM/CPC laboratory data can be carried out by the users to determine the constant factor of a given specimen combination prior to the implementation of the approach proposed.

In a second step, the feasibility of the method was investigated in workplace situations.

Six sets of experimental data stemming from workplace measurement campaigns (TiO 2 , SiO 2 , Ag, MWCNT) were considered; the corresponding modal aerodynamic diameters ranged between 30 and 300 nm. Assuming the GSD of the aerosols to be 1.8, the CMDs stemming from 'corrected' NSAM/CPC combination were found to in reasonable agreement (± 20%) as the CMDs obtained from the conversion of ELPI-based reference data into electrical mobility CMD; this finding suggests the possible field-applicability of the approach.

Overall, results between the NSAM/CPC combination and reference instrument indicated a strong positive correlation, independent of the type of aerosol.

Although not tested here, we can speculate that this approach is also valid for other diffusion charging devices that do not provide particle size, such as the AeroTrak 9000 or the Electrical Aerosol Detector. Thus, further experiments involving such devices are required to validate the applicability of the approach to them. Buonanno et al [START_REF] Buonanno | Exposure to welding particles in automotive plants[END_REF] automobile plants

Cheng et al [START_REF] Cheng | Measurements of ultrafine particle concentrations and size distributions in an iron foundry[END_REF] iron foundry

McGarry et al [START_REF] Mcgarry | Application of multimetric approach to characterization of particle emissions from nanotechnology and non-nanotechnology processes[END_REF] laser printers operation, extruder process, clay process, MWCNT decanting, SWCNT synthesis Gomes et al [START_REF] Gomes | Comparison of deposited surface area of airborne ultrafine particles generated from two welding processes[END_REF] , Avino et al [START_REF] Avino | Submicron particles during macro-and micro-weldings procedures in industrial indoor environments and health implications for welding operators[END_REF] welding processes

Wang et al [START_REF] Wang | Using a modified electrical aerosol detector to predict nanoparticle exposures to different regions of the respiratory tract for workers in a carbon black manufacturing industry[END_REF] black carbon manufacturing Sillanpää et al [START_REF] Sillanpää | High collection efficiency electrostatic precipitator for in vitro cell exposure to concentrated ambient particulate matter (PM)[END_REF] , Westerdahl et al [START_REF] Westerdahl | Characterization of on-road vehicle emission factors and microenvironmental air quality in Beijing, China[END_REF] , Buonanno et al [START_REF] Buonanno | Exposure to particle number, surface area and PM concentrations in pizzerias[END_REF] , Okuda et al [START_REF] Okuda | Factors controlling the variation of aerosol surface area concentrations measured by a diffusion charger in Fukuoka, Japan[END_REF] , Reche et al [START_REF] Reche | Determinants of aerosol lung-deposited surface area variation in an urban environment[END_REF] , Kuuluvainen et al [START_REF] Kuuluvainen | Lung deposited surface area size distributions of particulate matter in different urban areas[END_REF] atmospheric aerosol monitoring Li et al [START_REF] Li | Evaluation of filter media for particle number, surface area and mass penetrations[END_REF] , Koivisto et al [START_REF] Koivisto | Workplace performance of a loose-fitting powered air purifying respirator during nanoparticle synthesis[END_REF] filtration performance evaluation Geiss et al [START_REF] Geiss | Lujng-deposited surface area concentration measurements in selected occupational and non-occupational environments[END_REF] occupational (welding, car journey, etc.) and nonoccupational (3D-printer, incense, candle etc.) environments [START_REF] Jacoby | CAIMAN: a versatile facility to produce aerosols of nanoparticles[END_REF] instruments placed in a 23 m 3 chamber with homogenously distributed aerosol [START_REF] Asbach | Comparison of four mobility particle sizers with different time resolution for stationary exposure measurements[END_REF][START_REF] Dahmann | Intercomparison of mobility particle sizers (MPS)[END_REF]



  flowrate is introduced into a flame by means of an automated syringe (40 mL/h for zinc acetate solution to produce ZnO particles, 15 mL/h for a 5 g/L NaCl solution) and vaporized. A sheath and dilution air flow allows particle concentration to be controlled; Diethyl-hexyl sebacate (DEHS) and CsCl generated by atomization (home-built atomizer) under different solution concentrations (pure DEHS and diluted with isopropanol, CsCl concentrations of 1.25 g/L and 80 g/L) and atomizer inlet pressures (IGF);  TiO 2 P25 produced by a Rotating Brush Generator (PALAS RBG 1000) operating at 1200 rpm under 1 bar inlet pressure and constant elevation speed of 3 mm/h (INRS). Airborne particles were simultaneously measured by means of a Condensation Particle Counter (CPC, Grimm model 5.403, d 50 = 7.5 nm

  different. Due to their measurement principle based on Boltzmann electrical state-of-charge equilibrium, SMPS are commonly equipped with radioactive sources (except recent models using a soft X-ray charger). In France, the regulation relating to holding and transport of radioactive sources makes it difficult to perform SMPS measurements in workplaces. Instead, data stemming from an Electrical Low Pressure Impactor (ELPI, Dekati) were considered to provide the reference modal aerodynamic diameter. The latter modal aerodynamic diameters (as defined by the geometric diameter of the modal impaction stage) were then converted into mobility equivalent modal diameter considering spherical particles with unit density, and further converted into CMD by applying equation 3 to ensure comparability with the NSAM/CPC-based CMD with GSD = 1.8.

Figure 1 .Figure 2 .

 12 Figure 1. Comparison between the CMDs determined with the NSAM/CPC approach and the reference CMDs for various polydisperse test aerosols generated in the laboratory. The solid line corresponds to the 1:1 line, the dashed lines represent  30% deviation and the dotted lines display  50% deviation.

Figure 3 .

 3 Figure 3. Comparison between the CMD based on the NSAM/CPC approach and the reference CMD based on ELPI number size distribution for various workplace aerosols. The asterix (*) corresponds to a modal aerodynamic diameter likely below 30 nm, i.e. reference CMD likely below 42 nm.

Table 1 .

 1 Examples of NSAM's Use (Non-Exhaustive List)

	investigators	situation

Table 2 .

 2 Characteristics of the 40 Test Aerosols Generated in the Laboratory

	aerosol generator (test center)	material	range of reference CMD (nm)	range of GSD (-)	n
	spark discharge (INRS)	C	16 -411	1.50 -1.58	4
		Ag	32	1.41	1
		Ti	57 -335	1.46 -1.81	13
		Cu	28 -136	1.45 -1.58	9
		Constantan	236 -281	1.62 -1.69	3
	spark discharge (IGF)	C	62 -125	1.62 -1.80	3
	atomizer (IGF)	CsCl	58 -120	1.84 -2.13	3
		DEHS	118 -126	1.64 -1.75	2
	rotating brush generator (INRS)	TiO 2	206	2.09	1
	burner (IGF)	ZnO	98	1.48	1

Table 3 .

 3 Instruments Used in the Different Setups for the Measurement of Particle Reference CMD, Number and Lung-Deposited Surface Area Concentrations of Test Aerosols

			INRS	IGF
	Number	DMA	Grimm Vienna Type	TSI model 3081
	size
	distribution
		CPC	Grimm 5.403	TSI model 3772
		Size	11 -1000 nm	9 -800 nm
		range
	Number concentration	Grimm 5.403	TSI model 3007
	LDSA concentration	NSAM TSI model 3550
	Comments		instruments connected to a
			2L homogenization
			volume

Table 4 .

 4 Characteristics of the Different Workplace Aerosols

	Workplace	Task	Duration (min)	Modal aerodynamic	diameter (nm)	Reference CMD (nm)	C N (10 3 cm -3 )	C S,LD (µm 2 /cm 3 )
	A A1 Big bag filling with pigmentary TiO 2	1		40	57	17	31
	A2 Closing big bag of nano-TiO 2	0.5		74	104	25	118
	B	Discharging bags of powder of nano-TiO 2	1	319	190	1.7	29
	C	Dry sandpapering of a reactor	50		74	104	5.0	43
	D	Extrusion of polymer containing MWCNT	30	< 30	42	154	619
	E	Fabrication of photocatalytic media	5	123	173	355	2603

Table 5 .

 5 Comparison of Theoretical (SMPS-based) and Experimental (NSAM) LDSA

	Concentrations
	Material	CsCl	DEHS	C
	Modal diameter (nm)	40	118	151
	GSD (-)	1.84	1.75	1.57
	Number concentration C N (10 3 cm -3 )	9.7	14.2	132
	SMPS-based theoretical C S,LD (µm 2 /cm 3 )	25.5	92	1581
	Experimental C S,LD (µm 2 /cm 3 )	26	97	1606
	Bias (%)	+1.6	+5.4	+2.0

ACKNOWLEDGEMENTS

Part of the experimental results presented in this paper were obtained within the framework of the European Mandate M/461.


Alexandra Anaëlle

Ewen, Ludivine Eva Benjamin

REMERCIEMENTS

Aux membres du jury :

A Monsieur le Professeur Jean-Yves LE RESTE, pour m'avoir proposé ce travail de recherche, pour tes conseils et ta disponibilité tout au long de son élaboration. Merci pour tout ce que j'ai appris en stage à ton contact et pour avoir partagé ta passion de la médecine générale. Sois assuré de toute ma reconnaissance et de mon respect.

A Monsieur le Professeur Bernard LE FLOCH, merci pour votre implication dans l'enseignement de la médecine générale à Brest. Vous me faites l'honneur de juger mon travail.

Soyez assuré de toute ma reconnaissance et de mon respect.

A Monsieur le Docteur Benoit Chiron, merci pour votre implication dans l'enseignement de la médecine générale à Brest. Vous me faites l'honneur de juger mon travail. Soyez assuré de toute ma reconnaissance et de mon respect.

A Madame le Docteur Dominique Delavaud, merci pour ton accompagnement lors de mon stage de SASPAS. Toi qui connais si bien l'importance du relationnel dans notre travail, je suis honorée de t'avoir dans mon jury

INTRODUCTION

MATERIALS AND METHODS

ETHICS STATEMENT………………………………………………………………………………… RESEARCH TEAM……………………………………………………………………………………

PARTICIPANT SELECTION…………………………………………………………………………… DELPHI PROCEDURE………………………………………………………………………………… BACK TRANSLATION AND CULTURAL CHECK………………………………………………………..

RESULTS

CHARACTERISTICS

LIST OF TABLES

RESUME

Introduction : Les compétences relationnelles sont essentielles au médecin autant que les connaissances médicales et techniques. Dans le champ de la communication, le concept d'alliance thérapeutique (AT) est une notion intéressante qui peut être définie comme la collaboration active entre le patient et le médecin vers l'objectif visé. L'AT est fortement corrélée à la satisfaction du patient, à son observance et à ses résultats médicaux. Une revue systématique de la littérature puis une RAND/UCLA Appropriateness Method a retenu la Working Alliance Inventory Short Revised (WAI-SR) comme étant l'échelle la plus appropriée pour évaluer l'AT. L'objectif de l'étude était de traduire en allemand la WAI-SR suivant une méthode référencée et validée.

Méthode : Une traduction aller-retour de la WAI-SR en allemand via une procédure Delphi et un contrôle culturel a été réalisé. Une équipe de recherche composée de 2 médecins généralistes, 1 linguiste et 1 psychologue a été recrutée pour traduire la WAI-SR en allemand. Après validation par consensus auprès de médecins généralistes experts, la traduction en allemand de la WAI-SR a été traduite en anglais par 2 linguistes puis comparée à la version originale en anglais pour s'assurer de l'équivalence linguistique et culturelle.

Résultats : 18 médecins généralistes allemands ayant une bonne maîtrise de l'anglais ont été sélectionnés pour participer à la procédure Delphi. La traduction a été validée par consensus après 3 rondes Delphi. La traduction retour et le contrôle culturel ont conduit à des modifications de la traduction allemande.

Conclusion :

Une traduction de la WAI-SR en allemand selon une méthode validée est désormais disponible. Elle peut être utilisée dans la pratique des médecins généraliste germanophones, comme outil pédagogique dans la formation des étudiants en médecine germanophones et dans de futures recherches sur l'AT à travers l'Europe.

INTRODUCTION

Advances in medicine require the acquisition always bigger of technical and scientific skills. In order to take care of patients, technical knowledge is of course necessary, but not sufficient.

Communication is also a key element in medical care [START_REF] Simpson | Doctor-patient communication: the Toronto consensus statement[END_REF]. Moreover, an effective communicator is one of the qualities the most desired by patients [START_REF] Wensing | A systematic review of the literature on patient priorities for general practice care. Part 1: Description of the research domain[END_REF].

Many studies show the positive influence between an effective doctor-patient relationship and the patient's satisfaction and compliance and health outcomes, especially in chronic diseases (diabetes mellitus, hypertension, cancer, polyarthritis…)(3)(4) [START_REF] Tahri | Observance thérapeutique et maladies inflammatoires chroniques de l'intestin[END_REF]. In European societies whose ageing population is growing and with it, the increase of chronic illnesses, to enhance the communication between the patient and the doctor is interesting. It will increase health outcomes, patient's quality of life and could also be cost effective. Surprisingly, although communication appears like an essential tool in medical practice, communication skills are rarely taught formally during the medical curriculum in most European countries (6) [START_REF] Ishikawa | Can nonverbal communication skills be taught?[END_REF]. Medical students learn with their experiences with patients during their clinical internships and by seeing their chiefs physicians' behaviours. There is no academic basic education and no assessment of communication skills for students and for physicians throughout their careers.

It is just recently that medical schools in German-speaking countries started to integrate communication competencies in the regular curriculum [START_REF] Kiessling | Communication and social competencies in medical education in German-speaking countries: The Basel Consensus Statement.: Results of a Delphi Survey[END_REF].

In the wide field of communication, it is not possible to evaluate all the aspects. The therapeutic alliance (TA) seems to be an interesting notion useable in medical education and practice. It was initially developed to evaluate outcomes of psychotherapies and can be defined as a mutual collaboration, the partnership, between the patient and the therapist with the aim of achieving fixed objectives [START_REF] Bioy | L'alliance thérapeutique!: historique, recherches et perspectives cliniques[END_REF]. The notion of TA is now enlarging to somatic field and reflects the quality of the doctor-patient relationship [START_REF] Rodgers | Therapeutic alliance in psychotherapy: the contribution of empirical research[END_REF]. First, in the absence of a gold standard, a systematic literature review of tools assessment of the TA, according to the PRISMA guidelines, was performed and found 6 interesting tools [START_REF] Noel | Revue systématique de la littérature sur les moyens d'évaluation, de l'alliance thérapeutique par des outils de mesure fiables et reproductibles[END_REF]. Then a RAND/UCLA Appropriateness Method, leading at an European level, identified the Working Alliance Inventory Short Revised (WAI-SR) as the most appropriate scale to evaluate the TA for general practitioners (GPs), according to its reproducibility and reliability [START_REF] Borgne | Selection of a reproducible and reliable tool assessment for therapeutic alliance in general practice, by a RAND/UCLA consensus method[END_REF].

The aim of this study was to undertake a German forward-backward translation of the WAI-SR patient version, physician version and its scoring sheet using a Delphi consensus procedure.

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MATERIALS AND METHODS

In order to have a high quality of translation a step by step method was used [START_REF] Guillemin | Cross-cultural adaptation of health-related quality of ! 36! life measures: literature review and proposed guidelines[END_REF] [START_REF] Acquadro | European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate healthrelated quality of life questionnaires for use in multinational clinical trials[END_REF]. In Germany, as in the other participating countries in Europe, a forward and backward translation of WAI-SR using a Delphi consensus procedure and a control cultural check was performed. Translations were adapted to their national context to ensure their homogeneity throughout Europe.

The Delphi method was chosen because it was the most appropriate method, reliable and efficient, to reach consensus in defined clinical areas [START_REF] Letrilliart | A la recherche du consensus: quelle méthode utiliser? Seeking a consensus: which method should be used?[END_REF]. It is a systematic interactive method which involves a panel of experts using iterative procedures [START_REF] Skulmoski | The Delphi Method for Graduate Research[END_REF]. This process requires following four rules: anonymity of participants (ensures responses reliability and avoids dominance), iteration (allows participants to change their opinions in the light of the progress of the group's work), controlled feedback (under the responsibility of national investigator) and statistical group response to allow a quantitative and qualitative analysis of the data [START_REF] Jones | Consensus methods for medical and health services research[END_REF].

This study was led by a national investigator doubled of a French medical student who insured the all process follows the protocol. They did not take part in the translation phases or in Delphi rounds.

Ethics Statement

The study was approved by the ethics committee of the University de Bretagne Occidental in October 2014. The participants provided their written informed consent to participate in the study.

The ethics committee approved the consent procedure.

Participant selection 30 experts GPs should be selected in order to have at least 20 in the last Delphi round. A minimum of 15 experts GPs was required in order to have at least 10 in the last Delphi round. The experts GPs were selected on the basis of having a German nationality, being fluent in English (understanding/speaking/writing), being involved in clinical practice, in research, and/or in teaching activities, and having the willingness to dedicate the time to this method of discussion.

Information regarding age, gender, years of practice, practice type, setting type, teaching activities, research activities, number of English articles, number of native language articles and level of English was collected for all these experts. The research team wasn't a part of the participants group.

Delphi procedure

From January 2017 to December 2017 the panel of experts were individually contacted by email to receive the original WAI-SR and its translation into German. Each participant was contacted separately to avoid contamination which is the basic methodology for Delphi procedure.

! 18!

Participants ranked translation from 1 (absolutely no agreement) to 9 (fully agreement). The participant should explain each rank under 7 with a short commentary and a proposition for a new version. Consensus was defined as at least 70 % of the participants rating 7 or above the consensual items. If an item was consensual then it was validated and no further work was needed on it. If an item was not consensual all commentaries were collected and we proposed a new proposition taking into account the maximum of proposals. Then we designed a new form with only the nonconsensual items and sent it again to the group. This process was repeated until a consensual translation was found for each proposition.

If an expert did not answer, we sent a second email, then a third. After three recalls and no answer he was considered as lost.

Back translation and cultural check

The final phase involved the translation in German to English (backward blind translation). This was achieved by an official translator (native English speaker) and a non-official translator. They had no previous knowledge of the original English WAI-SR. Subsequently, the authors of the study compared the back-translated version with its original version for linguistic congruence and cultural relevancy. Then a final German translation of the WAI-SR patient version, client version and its scoring sheet was issued. The research team was constituted by 2 GPs, one linguist and one psychologist. There was a majority of 3 women for one man. The average age was 53 years old. They all had a good level of English and teaching activities. The average number of publications in English was 12 and 21 in German. The GPs and the psychologist worked in an urban environment and the linguist in a rural environment. The GP 2, the linguist and the psychologist had research activities.

RESULTS

Characteristics of the research team

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Characteristics of the panel of experts GPs table 2 : Characteristics of the panel of experts GPs

The panel of GPs experts was constituted by 18 GPs. Data from 8 experts are missing. The average age was 43 years old. They were as many women as men. They had 9 years of practice on average.

A majority worked in a group practice, was settled in an urban environment, had teaching and research activities and had a fluent level of English. They published in average 9 articles in English and 9 in German. The whole answers of the participants are listed in annex 2. At the end of the first Delphi round all items from the scoring sheet of the WAI-SR were consensual.

The non-consensual items after the first Delphi round, the comments of the experts GPs and the new proposal of translation are registered in annex 3. In the original English version instructions say: "insert the name of your therapist in place of ____". The German translation team chose to write "my GP" instead of the name of the GP. In Germany it is very common to have the same GP for a long period even for decades. It is more common to say "my GP" instead of using his name. In the same way, they say "my dentist" and "my gynaecologist". Nevertheless, some experts GPs noticed that this choice "ihrem/ihrer Hausartz/-ärtin" confuse the readability of the statements. After discussion it was concluded that the difference was due to cultural differences and the German translation which underlines the role of the therapist was accepted. In the original English version, the patient is the actor of the therapy. In backward translations the patient is passive. In the first German translation the patient was active: "Was ich in der Behandlung tue, eröffnet mir neue Sichtweisen auf mein Problem." This statement was not consensual after the first Delphi round. A lot of German experts GPs thought that during therapy or treatment the patient talk, report their problems but do not act too much. After discussion it was concluded that it was due to a different approach of the doctor patient relationship and the German translation was accepted. The German translation uses two verbs "handeln" = to act and "entscheiden"= to decide to translate

WAI-SR patient version

! 29!
"to do". This statement was not consensual after the first Delphi round. It was initially translated into "Ich habe das Gefühl, dass mein/e Hausarzt/-ärztin sich um mich sorgt, auch wenn ich etwas ohne seine/ihre Zustimmung tue." The translation team decided to use these two verbs to point out that patients can not only "do" things that their GP does not approve of but also "only decide" against their recommendations. The English verb "to do" has a wide range of meaning. In German there is a lot of different words for "to do". After discussion it was decided to accept the German translation. The German translation did not translate "both". There is no explanation for this choice. After discussion "beide" was added to the final German translation which underlines the bond between the patient and the physician.

! WAI-SR physician version

! 31!

DISCUSSION

Main result

The main result of this study was a culturally controlled translation of the WAI-SR from the original English into German using a cautious and rigorous consensus method. This scale is in annex 4.

Strengths and limitations of the study

The Delphi procedure for translation has its own strengths and weaknesses. Nevertheless, it is considered as an accurate consensus technique in health research (18) [START_REF] Hasson | Research guidelines for the Delphi survey technique[END_REF].

In this study there was no information bias as all data were sent separately by mail to all participants. Anonymity among the panel of experts avoids dominance effect, group pressure and limits conflicts of interest.

The study followed the recommendations of proper methodology for the Delphi technique according to the literature [START_REF] Waggoner | Is There a Consensus on Consensus Methodology? Descriptions and Recommendations for Future Consensus Research[END_REF]. The panel size was appropriate with 18 participants at the beginning of the study and 12 participants at the end of the second Delphi round which is enough to have significant results. Only 7 participants answered the third Delphi round, which is insufficient to validate question 8 from the WAI-SR patient version. Lots of commentaries were collected which signs the interest of the participants for the study.

There was no selected bias. The sampling data showed that most of the participants were working in a group practice (80%), were settled in an urban environment (78%) and had teaching (78%) and research activities (78%). The diversity of their gender was adapted because there were as many women as men. This study was a qualitative one. As a consequence, the sample did not need to be

! 32!
representative of a group but heterogeneous, which is the case. Experts were selected for their knowledge: they all were German GPs with a good level of English (70%).

Before this study, a German version of the WAI-SR existed [START_REF] Wilmers | Die deutschsprachige Version des Working Alliance Inventory -short revised (WAI-SR) -Ein schulenübergreifendes, ökonomisches und empirisch validiertes Instrument zur Erfassung der therapeutischen Allianz[END_REF]. Several points are different: the use of a validated consensus method and a cultural check to ensure the semantic and conceptual homogeneity and the use of a WAI-SR physician version with 10 items.

Key points

Many studies showed that TA is fundamental in medical treatment [START_REF] Fuertes | The physicianpatient working alliance[END_REF]. It is strongly associated with patients' adherence and satisfaction. Physicians have to use these interpersonal dimension to improve health care outcomes [START_REF] Fuertes | Behavioral indices in medical care outcome: the working alliance, adherence, and related factors[END_REF]. To have an European scale to measure TA and to translate this scale into all European languages, like German is of importance. Thereby, German speaking countries can be compared to other European countries in terms of quality of TA in clinical practice, throughout medical curriculum and for further multinational studies.

Implications for practice, medical training and further research

The WAI-SR translation in German could be useful for clinical practice in many fields and especially in medical treatment of chronic diseases like hypertension, diabetes mellitus or obesity.

An American study showed that primary care consultations with higher levels of patient-reported physician-patient concordance were associated with one-third greater medication compliance. An emphasis on understanding and facilitating agreement between physician and patient may benefit outcomes in primary care [START_REF] Kerse | Physician-Patient Relationship and Medication Compliance: A Primary Care Investigation[END_REF]. Using the German version of WAI-SR could improve the interpersonal contact between the GP and patients with chronic diseases in order to improve their medication compliance. The German version of the WAI-SR could also be useful in day-to-day clinical activities like treatment of depression. A French study [START_REF] Frémont | The therapeutic alliance in the initial stages of the management of depression by the general practitioner[END_REF] showed that 95% of patients who are suffering from depression considered that the quality of the doctor patient relationship is significant in the success of treatment. This study also showed that 60% of patients think of their care as a partnership with their Doctor, where they work together towards a positive outcome. The use of the German WAI-SR could be beneficial to enhance the treatment of depression in primary care.

Medical schools in German-speaking countries started to integrate communication competencies in the regular curriculum [START_REF] Kiessling | Communication and social competencies in medical education in German-speaking countries: The Basel Consensus Statement.: Results of a Delphi Survey[END_REF]. Some of them use simulated patients for doctor-patient communication training (27). The German version of the WAI-SR could be used in complement of this kind of didactic method to assess the quality of TA that medical students try to establish with simulated patients.

The implications of a standardized and reproducible questionnaire like the WAI-SR is of great value for further research. Its translation into many European languages will make it possible to undertake multination studies on the TA.

WAI-SR Patient Version

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 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.

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

!

WAI-SR Therapist Version

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.

1. ___ and I agree about the steps to be taken to improve his/her situation.

!

SCORING KEY FOR THE HATCHER GILLASPY SHORT FORM OF THE WAI

Patient and Family Physician version

WAI SR Item Punktzahl der Patientenversion

Punktzahl der Arztversion

Art der Skala

ANNEX 1 :

 1 OF THE RESEARCH TEAM………………………………………………………... CHARACTERISTICS OF THE PANEL OF EXPERTS GPS…………………………………………………. FIRST DELPHI ROUND………………………………………………………………………………. SECOND DELPHI ROUND……………………………………………………………………………. THIRD DELPHI ROUND……………………………………………………………………………… BACKWARD TRANSLATIONS AND CULTURAL CHECK……………………………………………….. DISCUSSION MAIN RESULT………………………………………………………………………………………. STRENGTHS AND LIMITATIONS OF THE STUDY……………………………………………………… KEY POINTS………………………………………………………………………………………… IMPLICATIONS FOR PRACTICE, MEDICAL TRAINING AND FURTHER RESEARCH………………………. WAI-SR ORIGINAL ENGLISH VERSION…………………………………………………... ANNEX 2: DETAILS OF CHARACTERISTICS OF THE PARTICIPANTS……………………………………43 ANNEX 3: NON-CONSENSUAL ITEMS DURING THE FIRST DELPHI ROUND, COMMENTS AND NEW TRANSLATION………………………………………………………………………………………. ANNEX 4: NON-CONSENSUAL ITEMS DURING THE SECOND DELPHI ROUND, COMMENTS AND NEW TRANSLATION………………………………………………………………………………………. ANNEX 5: BACKWARD TRANSLATIONS AND CULTURAL CHECK…………………………………….. ANNEX 4: WAI-SR FINAL GERMAN VERSION………………………………………………………

! 15 !

 15 From this fact is born the TATA Study (Tool Assessment for Therapeutic Alliance) within the European General Practice Research Network (EGPRN) to improve the medical academic communication training through Europe.

table 8 :

 8 Results of the third Delphi round of the WAI-SR patient versionAt the end of the third Delphi round, question 8 was consensual with 7 evaluations.Backward translations and cultural checkBackward translations and the cultural check point out several discrepancies in terms of linguistic congruence and cultural relevancy. Every difference between the original WAI-SR and the two backward translations were discussed. All results of backward translations and cultural check are in annex 5.

  In another field, the general practitioner has a key role in prevention of cardiovascular diseases. As shows a German study: the incidence of cardiovascular diseases can be reduced by the early detection and targeted treatment of risk factors and subclinical forms of the disease. In addition to a drug-based therapy, especially lifestyle modifying measures, such as physical activity, normalization of body weight, consistent nicotine abstinence and the consideration of psychosocial aspects represent core components of prevention programs[START_REF] Prochaska | Prevention of cardiovascular diseases[END_REF]. The WAI-SR German version could help German GPs in the care of overweight and obesity or when patients want to give up smocking.

CONCLUSIONAnnex 1 :

 1 This study has finalized, through a careful forward backward translation, including a Delphi consensus process and a cultural check, a German translation of the WAI-SR patient version, physician version and its scoring sheet. This study is a part of a larger project called "Tool Assessment for Therapeutic Alliance study" (TATA study) which aims to improve the medical academic communication training across Europe. After selection of the most appropriate tool to assess therapeutic alliance, the original WAI-SR was translated in all European languages. The German version of the WAI-SR and the other validated translations can be used in clinical practice, in medical training and for further research. The next step would be to test this tool in clinical practice and medical training to evaluate the consequences on medical care. Holzinger A, Wagner-Menghin M. Doctor-Patient Communication Training in Simulated Situations: Emotions and Perceptions of Simulated Patients during Patient-Centered Conversations. Psychother Psychosom Med Psychol. 2018; WAI-SR (Original English version)

Annex 2 :

 2 Details of characteristics of the participants

  Les compétences relationnelles sont essentielles au médecin autant que les connaissances médicales et techniques. Dans le champ de la communication, le concept d'alliance thérapeutique est une notion intéressante qui peut être définie comme la collaboration active entre le patient et le médecin vers l'objectif visé. L'AT est fortement corrélée à la satisfaction du patient, à son observance et à ses résultats médicaux. Une revue systématique de la littérature puis une RAND/UCLA Appropriateness Method a retenu la Working Alliance Inventory Short Revised (WAI-SR) comme étant l'échelle la plus appropriée pour évaluer l'AT. L'objectif de l'étude était de traduire en allemand la WAI-SR suivant une méthode référencée et validée.Méthode : Une traduction aller-retour de la WAI-SR en allemand via une procédure Delphi et un contrôle culturel a été réalisé. Une équipe de recherche composée de 2 médecins généralistes, 1 linguiste et 1 psychologue a été recrutée pour traduire la WAI-SR en allemand. Après validation par consensus auprès de médecins généralistes experts, la traduction en allemand de la WAI-SR a été rétro traduite en anglais par 2 linguistes puis comparée à la version originale en anglais pour s'assurer de l'équivalence linguistique et culturelle.Résultats : 18 médecins généralistes allemands ayant une bonne maîtrise de l'anglais ont été sélectionnés pour participer à la procédure Delphi. La traduction a été validée par consensus après 3 rondes Delphi. La traduction retour et le contrôle culturel ont conduit à des modifications de la traduction allemande.Conclusion :Une traduction de la WAI-SR en allemand selon une méthode validée est désormais disponible. Elle peut être utilisée dans la pratique des médecins généraliste germanophones, comme outil pédagogique dans la formation des étudiants en médecine germanophones et dans de futures recherches sur l'AT à travers l'Europe.MOTS CLES: ALLIANCE THERAPEUTIQUE -WORKING ALLIANCE INVENTORY SHORT REVISED (WAI-SR) -TRADUCTION -ALLEMAND -METHODE DELPHI JURY : Président : Monsieur le Professeur Jean-Yves LE RESTE Membres : Monsieur le Professeur Bernard LE FLOCH Monsieur le Docteur Benoît CHIRON Madame le Docteur Dominique DELAVAUD DATE DE SOUTENANCE : 28 juin 2018

table 1 : Characteristics of the research team………………………………………………………………………...19 table 2 : Characteristics of the panel of experts GPs………………………………………………………………... 20table 3 : Results of the first Delphi round of the WAI-SR patient version…………………………………………. 21table 4 : Results of the first Delphi round of the WAI-SR physician version………………………………………. 22table 5 : Results of the first Delphi round of the WAI-SR scoring sheet…………………………………………….23 table 5: Equivalencies………………………………………………………………………………………………….. 23table 6 : Results of the second Delphi round of the WAI-SR patient version………………………………………. 24table 7 : Results of the second Delphi round of the WAI-SR physician version…………………………………….24 table 8: Results of the third Delphi round of the WAI-SR patient version………………………………………… 25table 9 : Backward translations and cultural check of WAI-SR patient version Instructions……………………. 26 table 10: Backward translations and cultural check of WAI-SR patient version Recommendations…………….27 table 11: Backward translations and cultural check of WAI-SR patient version Question 2…………………….. 27 table 12: Backward translations and cultural check of WAI-SR patient version Question 8…………………….. 28 table 13: Backward translations and cultural check of WAI-SR patient version Question 9…………………….. 28 table 14: Backward translations and cultural check of WAI-SR physician version Recommendations………… 29 table 15: Backward translations and cultural check of WAI-SR physician version Question 4…………………..29 table 16 : WAI-SR scoring sheet……………………………………………………………………………………… 42 table 17 : Details of characteristics of the panel of experts GPs……………………………………………………. 43 table 18: Question 1 WAI-SR patient version………………………………………………………………………...44 table 19: Question 2 WAI-SR patient version………………………………………………………………………...45 table 20: Question 8 WAI-SR patient version………………………………………………………………………...46 table 21: Question 9 WAI-SR patient version………………………………………………………………………...47 table 22: Question 11 WAI-SR patient version……………………………………………………………………….48 table 23: Question 6 WAI-SR physician version…………………………………………………………………….. 49 table 24: Question 8 WAI-SR patient version………………………………………………………………………...50 table 25: WAI-SR patient version_ backward translation and cultural check……………………………………. 51 table 26: WAI-SR physician version_ backward translation and cultural check………………………………… 54 table 27 : WAI-SR scoring sheet_ backward translation and cultural check……………………………………… 57 table 28 : WAI-SR Auswertungsschlüssel…………………………………………………………………………….62

 1345679

! 12!

table 1 : Characteristics of the research team Formation Gender Age English level Number of publications Practice type Setting type Teaching activities Research activities In English In German

 1

	General practitioner 1	F	55 intermediate	0	6	group	urban	yes	no
	General practitioner 2	M	48	fluent	30	70	group	urban	yes	yes
	Linguist	F	57	fluent	12	NA	other	rural	yes	yes
	Psychologist	F	50	fluent	4	8	other	urban	yes	yes
	NA: not available

Value Number of participants Number of Incomplete answers Analysis 43

	First Delphi round
	Characteristic
	Average age		10	8	10
	Gender
	% Male	50%	5	8	10
	% Female	50%	5
	Average years of practice	9,2	5	13	5
	Practice type
	% Solo	0%	0	8	10
	% Group	80%	8
	% Other	20%	2
	Setting type
	% Rural	0%	0	9	9
	% Semi rural	22%	2
	% Urban	78%	7
	Teaching	78%	9	9	9
	Research	78%	9	9	9
	Number of publications
	In English	9,4	10	8	10
	Other	9,2	10	8	10
	English level !				21!
	% Basic	10%	1	10	10
	% Intermediate 20%	2
	% Fluent	70%	7

table 3 : Results of the first Delphi round of the WAI-SR patient version ! !

 3 At the end of the first Delphi round questions 2, 8, 9 and 11 from the WAI-SR patient version were not consensual.

	Participant Instructions Anwers	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	Q11	Q12
	N°1	8	9	4	4	9	9	9	9	9	8	3	7	9	9
	N°2	8	9	9	9	6	9	9	8	9	6	9	9	9	9
	N°3	9	9	8	9	9	9	9	9	8	7	9	8	9	9
	N°4	7	8	5	8	7	8	8	7	7	6	5	8	5	7
	N°5	6	9	9	8	6	8	6	6	7	6	1	6	7	5
	N°6	7	9	8	6	9	8	9	7	5	4	9	7	3	9
	N°7	7	9	6	8	9	9	9	8	9	7	6	8	6	8
	N°8	4	5	4	5	9	9	9	3	6	3	5	8	5	8
	N°9	8	9	7	6	7	8	9	8	7	6	7	5	7	6
	N°10	5	9	8	4	9	9	9	9	9	5	9	8	4	7
	N°11	8	9	8	8	7	8	8	9	8	7	7	6	5	7
	N°12	7	9	6	5	9	9	9	7	6	6	7	9	7	9
	N°13	7	9	7	8	9	9	9	7	7	6	8	8	6	9
	N°14	5	9	7	8	9	9	9	8	7	5	5	8	9	9
	N°15	8	9	6	6	9	8	9	8	8	7	6	7	9	7
	N°16	7	9	9	8	9	7	9	9	9	7	7	9	8	9
	N°17	7	9	9	6	8	9	9	8	9	6	7	7	8	6
	N°18	7	8	7	5	9	7	9	7	7	7	6	8	7	8
	< 7	4	1	6	9	2	0	0	2	3	11	8	3	7	3
	≥7	14	17	12	9	16	18	18	16	15	7	10	15	11	15
	CHECK	18	18	18	18	18	18	18	18	18	18	18	18	18	18
	TOTAL	77,78%	94,44%	66,67%	50,00%	88,89%	100,00%	100,00%	88,89%	83,33%	38,89%	55,56%	83,33%	61,11%	83,33%

table 4 : Results of the first Delphi round of the WAI-SR physician version

 4

	!
	!

table 6 : Results of the second Delphi round of the WAI-SR patient version

 6

													table 5: Equivalencies
	Participant	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	Q11	Q1	SCORING KEY
	N°1	8	9	9	9	9	9	8	7	9	9	7	Q2	PATIENT SCALE MEAN
	N°2 N°3 N°4 N°5 N°6	8 8 9 8 8	9 9 8 9 8	9 9 8 9 8	9 9 9 9 8	9 9 9 9 7	9 9 9 9 7	9 9 7 1 7	8 7 8 5 7	9 9 8 9 8	9 9 6 7 8	8 7 7 6 6	Q3 Q4 Q5 Q6	FAMILY PHYSICIAN SCALE MEAN SCALE TYPE GOAL TASK
	N°7	9	9	9	7	9	9	7	7	7	7	8	Q7	BOND
	N°8	8	9	9	7	9	8	7	6	8	8	5	Q8	WAI SR ITEM
	N°9	7	8	8	8	8	8	8	7	8	8	6	Q9	SCORE PATIENT VERSION
	N°10	8	8	8	8	9	9	8	7	8	8	7	Q10	SCORE FAMILY PHYSICIAN
	N°11	8	8	8	8	8	8	8	6	8	8	7	Q11	VERSION INSTRUCTIONS
	N°12	8	9	9	8	9	9	8	7	8	8	7
	N°13	7	8	8	8	8	8	8	7	8	8	7
	N°14	7	8	8	8	8	8	8	7	8	8	7
	N°15	6	7	7	7	8	8	8	6	8	8	6
	N°16	8	9	9	8	9	9	8	7	8	8	7
	N°17	7	9	9	8	8	8	6	8	9	9	7
	N°18	8	9	9	8	8	8	8	8	9	6	7
	<7	1	0	0	0	0	0	2	4	0	2	5
	≥7	17	18	18	18	18	18	16	14	18	16	13
	CHECK	18	18	18	18	18	18	18	18	18	18	18
	TOTAL	94,44%	100,00%	100,00%	100,00%	100,00%	100,00%	88,89%	77,78%	100,00%	88,89%	72,22%

! !

At the end of the second Delphi round question 8 wasn't consensual. All comments of the experts GPs and the new proposal of translation for question 8 are registered in annex 4.

table 7 : Results of the second Delphi round of the WAI-SR physician version

 7

	Participant	Q1	Q2	Q8	Q9	Q11
	N°1		8	7	7	8
	N°2		8	7	8	8
	N°3		9	6	8	7
	N°4		9	8	6	9
	N°5		9	4	7	9
	N°6		9	5	6	7
	N°7		8	5	5	8
	N°8		8	6	8	8
	N°9		9	3	9	7
	N°10		7	8	8	7
	N°11		9	7	9	9
	N°12		9	8	8	9
	< 7		0	6	3	0
	≥7	10	12	6	9	12
	check	12	12	12	12	12
	TOTAL	83%	100%	50%	75%	100%

!

At the end of the second Delphi round all items of the WAI-SR physician version were consensual.

table 9 : Backward translations and cultural check of WAI-SR patient version Instructions

 9

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	Instructions:	Anleitung: Im	Introduction:	Instructions:	Anleitung: Im
	Below is a list of	Folgenden finden	Below, you will	Below is a list of	Folgenden
	statements and	Sie eine Reihe	find a range of	statements	finden Sie eine
	questions about	von Aussagen,	statements that	concerning	Reihe von
	experiences	die sich auf	relate to the	people's	Aussagen, die
	people might	Erfahrungen	experiences that	experiences	sich auf
	have with their	beziehen, die	people can have	during their	Erfahrungen
	therapy or	Menschen	during their	treatment or with	beziehen, die
	therapist. Some	während ihrer	treatment or with	their GPs. For	Menschen
	items refer	Behandlung oder	their family	each statement,	während ihrer
	directly to your	mit ihrem/ihrer	doctor. Please	please decide	Behandlung oder
	therapist with an	Hausartz/-ärtin	decide for each	how well it	mit ihrem/ihrer
	underlined space	machen können.	statement to what	matches your	Hausarzt/-ärztin
	--as you read the	Bitte entscheiden	extent it applies	treatment	machen können.
	sentences,	Sie bei jeder	to your treatment.	experience.	Bitte entscheiden
	mentally insert	Aussage,			Sie bei jeder
	the name of your	inwieweit sie auf			Aussage,
	therapist in place	Ihre Behandlung			inwieweit sie auf
	of ____ in the	zutrifft.			Ihre Behandlung
	text. Think about				zutrifft.
	your experience
	in therapy, and
	decide which
	category best
	describes your
	own experience.

! 27!

table 10 : Backward translations and cultural check of WAI-SR patient version Recommendations

 10

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	IMPORTANT!!!				Wichtig! Bitte
	Please take your				nehmen Sie sich
	time to consider	NA	NA	NA	Zeit, um jede
	each question				Frage sorgfältig
	carefully.				zu bedenken.

NA: not available

The research team forgot to translate this recommendation. A German translation was added. It was not validated by the experts GPs.

table 11 : Backward translations and cultural check of WAI-SR patient version Question 2

 11

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	What I am doing	Die Behandlung	The treatment is	The treatment	Die Behandlung
	in therapy gives	eröffnet mir neue	opening for me a	gave me new	eröffnet mir neue
	me new ways of	Sichtweisen auf	new perception	perspectives on	Sichtweisen auf
	looking at my	mein Problem.	of my problem.	my problem.	mein Problem.
	problem.

! 28!

table 12 : Backward translations and cultural check of WAI-SR patient version Question 8

 12

	ORIGINAL WAI-SR	GERMAN TRANSLATION	BACK TRANSLATION N°1	BACK TRANSLATION N°2	FINAL GERMAN TRANSLATION
	_____ and I agree	Mein/e
	on what is	Hausarzt/-ärztin
	important for me to work on.	und ich stimmen miteinander ab,	NA	NA	NA
		woran es für
		mich wichtig ist
		zu arbeiten.

NA: not available

There is no backward translation for question 8 of the WAI-SR patient version.

table 13 : Backward translations and cultural check of WAI-SR patient version Question 9

 13

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	I feel _____ cares	Ich fühle, dass	I feel that my	I feel that my GP	Ich fühle, dass
	about me even	mein/e Hausarzt/-	family doctor is	cares about me,	mein/e Hausarzt/-
	when I do things	ärztin sich um	concerned for me	even when I act	ärztin sich um
	that he/she does	mich sorgt, auch	even if I act	or decide against	mich sorgt, auch
	not approve of.	wenn ich gegen	against his	his/her	wenn ich gegen
		seine/ihre	recommendation	recommendations.	seine/ihre
		Empfehlung	or decision.		Empfehlung
		handle oder			handle oder
		entscheide.			entscheide.

table 14 : Backward translations and cultural check of WAI-SR physician version Recommendations

 14

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	IMPORTANT!!!				Wichtig! Bitte
	Please take your				nehmen Sie sich
	time to consider	NA	NA	NA	Zeit, um jede
	each question				Frage sorgfältig
	carefully.				zu bedenken.

NA: not available

The research team forgot to translate this recommendation. A German translation was added. It was not validated by the experts GPs.

table 15 : Backward translations and cultural check of WAI-SR physician version Question 4

 15

	ORIGINAL	GERMAN	BACK	BACK	FINAL GERMAN
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	TRANSLATION
			N°1	N°2
	___ and I both	____ und ich sind	_____ and I are	___ and I are	_____ und ich sind
	feel confident	zuversichtlich	confident about	confident that the	beide
	about the	bezüglich des	the benefits of	content of our	zuversichtlich
	usefulness of	Nutzens unserer	the current	current treatment	bezüglich des
	our current	aktuellen	treatment.	is useful.	Nutzens unserer
	activity in therapy.	Behandlungsinhalte			aktuellen Behandlungsinhalte

table 16 : WAI-SR scoring sheet

 16

		"	#	$	%
	Seldom	Sometimes Fairly Often Very Often	Always
	2. I am genuinely concerned for ___'s welfare.
	%	$	#	"	!
	Always	Very Often Fairly Often Sometimes	Seldom
	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.
	%	$	#	"	!
	Always	Very Often Fairly Often Sometimes	Seldom
	6. We have established a good understanding of the kind of changes that would be
	good for ___.
	%	$	#	"	!
	Always	Very Often Fairly Often Sometimes	Seldom
	7. ___ and I respect each other.
	!	"	#	$	%
	Seldom	Sometimes Fairly Often Very Often	Always

table 17 : Details of characteristics of the panel of experts GPs

 17 Annex 3: Non-consensual items during the first Delphi round, comments and new translation

	Participant	Birthday	Male Gender	Female	Years of practice	Solo Practice type Group Other	Rural Semi rural Urban Yes No Setting type Teaching	Yes No Research	In English Other Number of publications	Basic English level Intermediate Fluent
	N°1	11/04/1970	0	1	NA	0	1	0	0	0	1	0	1	0	1	0	0	0	0	1
	N°2	28/04/1969	1	0	14	0	1	0	0	0	1	0	1	0	1	0	0	1	0	0
	N°3	NA	0	1	NA	0	1	0	0	0	1	NA NA NA NA	0	0	0	1	0
	N°4	13/06/1987	1	0	3	0	1	0	0	0	1	1	0	1	0	2	1	0	0	1
	N°5	01/01/1975	0	1	NA	0	0	1	NA	NA	NA	1	0	1	0	2	2	0	0	1
	N°6	27/10/1968	0	1	NA	0	1	0	0	1	0	1	0	1	0	26	20	0	0	1
	N°7	NA	1	0	NA	0	1	0	0	1	0	1	0	1	0	60	60	0	0	1
	N°8	21/04/1982	1	0	2	0	0	1	0	0	1	1	0	1	0	1	2	0	0	1
	N°9	01/01/1962	1	0	25	0	1	0	0	0	1	1	0	1	0	0	3	0	1	0
	N°10	07/03/1984	0	1	2	0	1	0	0	0	1	1	0	1	0	3	4	0	0	1
	N°11	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°12	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°13	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°14	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°15	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°16	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°17	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA
	N°18	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA	NA NA NA NA	NA	NA	NA	NA	NA

table 18 : Question 1 WAI-SR patient version

 18

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Aufgrund der	Ein Ergebnis der	Diese Termine haben dazu
	Behandlungstermine ist mir	Behandlungstermine ist das	geführt, dass ich besser weiß,
	deutlich geworden, wie ich	mir klarer ist wie ich etwas	wie ich mich ändern könnte.
	mich verändern kann.	verändern kann
		Nur teilweise einverstanden.
		Anstelle von "termine" würde
		ich "-sitzungen" bevorzugen.
		Das kommt dem Wort
		"sessions" näher und ist auch
		inhaltlich passender. Den
		Nebensatz würde ich
		zumindest im Konjunktiv
		formulieren. Vorschlag: "…,
		auf welche Weise ich mich
		verändern könnte."
		…, wie ich mich verändern
		könnte.
		…, wie ich mich verändern
		könnte
		Wie ich mein Verhalten ändern
		kann
		Aufgrund der Besuche
		in der Sprechstunde…

table 19 : Question 2 WAI-SR patient version

 19

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Was ich in der Behandlung	Was ich in der Behandlung	Die Behandlung eröffnet mir
	tue, eröffnet mir neue	erfahre,…	neue Sichtweisen auf mein
	Sichtweisen auf mein Problem.	problem wird zwar mit	Problem.
		Problem übersetzt, in der
		Praxis wird aber wohl eher
		Erkrankung gesagt
		Patienten "tun" während der
		Behandlung in der HA-Praxis
		eher nicht viel
		Vorschlag: Die Behandlung
		eröffnet mir….
		Besser: Was ich in der
		Behandlung "mache"
		Das was ich in den Sitzungen
		erfahre, gibt mir neue
		Sichtweisen auf mein Problem.
		Besser "erfahre",
		Hausarztpatient "tut" in der
		Behandlung selten etwas
		Tue →erfahre
		Durch die durchgeführte
		Behandlung, werden mir neue
		Sichtweisen auf mein Problem
		eröffnet.

table 20 : Question 8 WAI-SR patient version

 20

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Mein/e Hausarzt/-ärztin und	______ und ich verständigen	Mein/e Hausarzt/-ärztin und
	ich stimmen miteinander ab,	uns an welche wichtigen	ich stimmen miteinander ab,
	was für mich wichtig zu	Punkte ich arbeiten will.	was ich (aufgrund seiner
	bearbeiten ist.	Mein/e Hausarzt/-ärztin und	Wichtigkeit) bearbeiten soll.
		ich stimmen überein, was für
		mich wichtig zu bearbeiten ist.
		Nur teilweise einverstanden,
		da "work on" für mich in
		diesem Kontext eher mit "an
		etwas arbeiten" übersetzt
		werden sollte. Vorschlag:
		"Mein/e Hausarzt/-ärztin und
		ich vereinbaren, woran es
		wichtig für mich ist zu
		arbeiten."
		…, woran ich arbeiten sollte.
		Stimmen miteinander ab
		→stimmen überein in dem,
		Was für mich wichtig zu
		bearbeiten ist→woran es für
		mich wichtig ist zu arbeiten
		Besser: stimmen miteinander
		ab, woran ich arbeiten sollte.
		…"woran ich arbeiten sollte"
		Außerdem sehr lang zu lesen,
		auch wegen der
		Gendergerechten Sprache
		Stimmen überein, woran ich
		arbeiten sollte
		Stimmen darin überein
		Was ich für mich tun kann

table 21 : Question 9 WAI-SR patient version

 21

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Ich habe das Gefühl, dass	das Wort care heißt hier	Ich fühle, dass mein/e
	mein/e Hausarzt/-ärztin sich	unbedingt nicht sorgen, aber	Hausarzt/-ärztin sich um mich
	um mich sorgt, auch wenn ich	bedeutet eher, dass ich	sorgt, auch wenn ich gegen
	etwas ohne seine/ihre	demjenigen nicht gleichgültig	seine/ihre Empfehlung handle
	Zustimmung tue.	bin. Um mich sorgt wäre eher	oder entscheide.
		"care for".
		Approve heißt hier auf jeden
		Fall nicht zustimmen, weil es
		sich um einen autonomen
		Menschen handelt. Es heißt in
		diesem Kontext sowas wie
		"Dinge die er nicht für gut
		hält" oder "Sachen die er nicht
		befürwortet", z.B. Rauchen.
		Vorschlag: Ich habe das
		Gefühl, dass __________ sich
		sogar dann für mein Wohl
		interessiert, wenn ich etwas
		mache, das er nicht für gut
		hält.
		Ich habe das Gefühl, dass
		mein/e Hausarzt/-ärztin sich
		um mich sorgt, auch wenn ich
		etwas tue womit er / sie nicht
		ein Einverstanden ist.
		Nur teilweise einverstanden:
		"sich um jemanden sorgen" ist
		für mich eher "to worry about
		so."Vorschlag: "Ich habe das
		Gefühl, dass mein/e Hausarzt/-
		ärztin mir zugeneigt ist
		(alternativ: sich für mich
		interessiert), auch wenn ich
		etwas tue, dass er/sie nicht
		gutheißt."
		Klingt bevormundend. Besser:
		gegen Empfehlung tue
		Statt ohne Zustimmung würde
		ich hier nicht befürwortet
		schreiben
		Vorschlag: auch wenn ich
		etwas gegen seine/ihre
		Empfehlung tue
		Klingt sehr bevormundend,
		evtl. "gegen meine
		Empfehlung handelt"

table 22 : Question 11 WAI-SR patient version

 22

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Mein/e Hausarzt/-ärztin und	____________ und ich haben.	Mein/e Hausarzt/-ärztin und
	ich haben uns ausgetauscht	verhindert schwierigen	ich haben ein gutes
	und uns darauf geeinigt,	Gender-Hausarzt/-ärztin	Verständnis davon entwickelt,
	welche Veränderungen gut für		welche Veränderungen gut für
	mich wären.	Mein/e Hausarzt/-ärztin und	mich wären.
		ich haben uns abgestimmt
		welche Veränderungen gut für
		mich wären. Geeinigt ist nicht
		teil der Frage
		Nur teilweise einverstanden:
		Übersetzung von "establish a
		good understanding" nicht
		optimal gelungen. Vorschlag:
		"Mein/e Hausarzt/-ärztin und
		ich haben ein gutes
		Verständnis davon entwickelt,
		welche Veränderungen gut für
		mich wären."
		…. Und ich haben ein gutes
		Verständnis erreicht, welche…
		Mein/e Hausarzt/-ärztin und
		ich sind uns darüber einig
		ODER stimmen überein,
		welche Veränderungen gut für
		mich wären.
		Mein HA und ich haben ein
		gutes/gemeinsames
		Verständnis davon entwickelt,
		welche…
		ausgetauscht" steht im
		Englischen nicht
		…haben uns besprochen und
		darauf geeinigt,…

table 23 : Question 6 WAI-SR physician version

 23 Non-consensual items during the second Delphi round, comments and new translation

	FIRST TRANSLATION	COMMENTS	NEW TRANSLATION
	Wir haben uns ausgetauscht	Geeinigt seht im Englischen	Wir haben ein gutes
	und darauf geeinigt, welche	nicht.	Verständnis davon entwickelt,
	Veränderungen gut für _______ wären.	Nur teilweise einverstanden: Übersetzung von "establish a	welche Veränderungen gut für _______ wären.
		good understanding" nicht
		optimal gelungen. Vorschlag:
		"Wir haben ein gutes
		Verständnis davon entwickelt,
		welche Veränderungen für
		___gut wären."
		Ausgetauscht weglassen
		Wir haben ein gutes
		Verständnis erreicht, s.o.
		Wir stimmen in den
		wesentlichen Punkten überein,
		welche Veränderungen gut für
		_______ wären.
		Mein HA und ich haben ein
		gutes/gemeinsames
		Verständnis davon entwickelt,
		welche…
		"ein gutes Verständnis
		entwickelt" Wir haben uns
		besprochen…
		Wir haben ein gutes
		Verständnis davon entwickelt,
		welche…

table 24 : Question 8 WAI-SR patient version

 24

	SECOND TRANSLATION	COMMENTS	NEW TRANSLATION
	Mein/e Hausarzt/-ärztin und	Lieber eine Lösung ohne	Mein/e Hausarzt/-ärztin und
	ich stimmen miteinander ab,	Klammern finden.	ich stimmen miteinander ab,
	was ich (aufgrund seiner Wichtigkeit) bearbeiten soll.	Das mit der Klammer ist nicht schön.	woran es für mich wichtig ist zu arbeiten.
		statt "was ich (aufgrund
		seiner Wichtigkeit)
		bearbeiten" besser "woran
		ich arbeiten soll"
		…, woran ich arbeiten sollte.
		"woran" es wichtig ist für mich
		zu arbeiten.
		Bearbeiten ist in der Arzt
		Patienten Beziehung ein eher
		ungewöhnliche Formulierung
		eher (ändern, verbessern, oder
		woran ich arbeiten soll)
		Die Klammer macht es
		umständlich zu lesen.
		Besser Konjunktiv statt "soll"
		Der Satz ist zu kompliziert

table 25 : WAI-SR patient version_ backward translation and cultural check

 25

	ORIGINAL	GERMAN	BACK	BACK	FINAL
	WAI-SR	TRANSLATION	TRANSLATION	TRANSLATION	GERMAN
			N°1	N°2	TRANSLATION
	Instructions:	Anleitung: Im	Introduction:	Instructions:	Anleitung: Im
	Below is a list of	Folgenden finden	Below, you will	below is a list of	Folgenden finden
	statements and	Sie eine Reihe von	find a range of	statements	Sie eine Reihe
	questions about	Aussagen, die sich	statements that	concerning	von Aussagen, die
	experiences	auf Erfahrungen	relate to the	people's	sich auf
	people might have with their therapy or therapist. Some items refer directly to your	beziehen, die Menschen während ihrer Behandlung oder mit ihrem/ihrer Hausartz/-ärtin	experiences that people can have during their treatment or with their family	experiences during their treatment or with their GPs. For each statement, please decide how	Erfahrungen beziehen, die Menschen während ihrer Behandlung oder mit ihrem/ihrer
	therapist with an underlined space --as you read the sentences, mentally insert the name of your	machen können. Bitte entscheiden Sie bei jeder Aussage, inwieweit sie auf Ihre Behandlung	doctor. Please decide for each statement to what extent it applies to your	well it matches your treatment experience.	Hausarzt/-ärztin machen können. Bitte entscheiden Sie bei jeder Aussage, inwieweit sie auf
	therapist in place	zutrifft.	treatment.		Ihre Behandlung
	of ____ in the				zutrifft
	text. Think
	about your
	experience in
	therapy, and
	decide which
	category best
	describes your
	own experience.
	IMPORTANT!!!				Wichtig! Bitte
	Please take your				nehmen Sie sich
	time to consider	NA	NA	NA	Zeit, um jede
	each question				Frage sorgfältig
	carefully.				zu bedenken.
	Seldom	Selten	Seldom	Rarely	Selten
	Sometimes	Manchmal	Sometimes	Sometimes	Manchmal
	Fairly often	Häufig	Frequently	Often	Häufig
	Very often	Sehr oft	Very often	Very often	Sehr oft
	Always	Immer	Always	Always	Immer

table 26 : WAI-SR physician version_ backward translation and cultural check

 26

	ORIGINAL	GERMAN	BACK	BACK	FINAL GERMAN
	WAI-SR	TRANSLATION	TRANSLATIO	TRANSLATIO	TRANSLATION
			N N°1	N N°2
	Instructions:	Anleitung: Im	Introduction:	Instructions:	Anleitung: Im
	Below is a list	Folgenden finden Sie	Below you will	below is a list	Folgenden finden
	of statements	eine Reihe von	find a series of	of statements	Sie eine Reihe von
	about	Aussagen über	statements	concerning	Aussagen über
	experiences	Erfahrungen, die man	about the	possible	Erfahrungen, die
	people might	mit seinen	experience that	experiences that	man mit seinen
	have with their	Patienten/Patientinne	one can have	you may have	Patienten/Patientinn
	client. Some	n machen kann.	with a patient.	with your	en machen kann.
	items refer	Einige Punkte	Some points	patients. Some	Einige Punkte
	directly to your	beziehen sich direkt	refer directly to	points are	beziehen sich direkt
	client with an	auf Ihre/n	your patient.	directly related	auf Ihre/n
	underlined	Patienten/Patientin.	They are	to your patients.	Patienten/Patientin.
	space --as you	Sie sind	marked with an	These are	Sie sind
	read the	gekennzeichnet	underlined	marked with an	gekennzeichnet
	sentences,	durch eine	space. Please	underlined	durch eine
	mentally insert	unterstrichene	put the name of	blank space.	unterstrichene
	the name of	Leerstelle. Setzen Sie	your patient in	When reading	Leerstelle. Setzen
	your client in	beim Lesen bitte in	this	these, please fill	Sie beim Lesen bitte
	place of ___ in	Gedanken den	space_____.	in the name of	in Gedanken den
	the text.	Namen Ihres/Ihrer		your patient in	Namen Ihres/Ihrer
		Patienten/Patientin in		the space in	Patienten/Patientin
		diese Leerstelle		your thoughts.	in diese Leerstelle
		_____ ein.			_____ ein.
	IMPORTANT!				Wichtig! Bitte
	!! Please take				nehmen Sie sich
	your time to consider each	NA	NA	NA	Zeit, um jede Frage sorgfältig zu
	question				bedenken.
	carefully.
	Seldom	Selten	Seldom	Rarely	Selten
	Sometimes	Manchmal	Sometimes	Sometimes	Manchmal
	Fairlyoften	Häufig	Frequently	Often	Häufig
	Very often	Sehr oft	Very often	Very often	Sehr oft
	Always	Immer	Always	Always	Immer

! 57!

table 27 : WAI-SR scoring sheet_ backward translation and cultural check

 27 Im Folgenden finden Sie eine Reihe von Aussagen, die sich auf Erfahrungen beziehen, die Menschen während ihrer Behandlung oder mit ihrem/ihrer Hausarzt/-ärztin machen können. Bitte entscheiden Sie bei jeder Aussage, inwieweit sie auf Ihre Behandlung zutrifft.Wichtig! Bitte nehmen Sie sich Zeit, um jede Frage sorgfältig zu bedenken.1. Diese Termine haben dazu geführt, dass ich besser weiß, wie ich mich ändern könnte. Mein/e Hausarzt/-ärztin und ich stimmen miteinander ab, woran es für mich wichtig ist zu arbeiten. Ich fühle, dass mein/e Hausarzt/-ärztin sich um mich sorgt, auch wenn ich gegen seine/ihre Empfehlung handle oder entscheide. Ich spüre, dass das, was ich während der Behandlung tue, mir helfen wird, die von mir gewünschten Veränderungen zu erreichen. Hausarzt/-ärztin und ich haben ein gutes Verständnis davon entwickelt, welche Veränderungen gut für mich wären. Ich glaube, die Art und Weise, wie wir mit meinem Problem umgehen, ist richtig. Im Folgenden finden Sie eine Reihe von Aussagen über Erfahrungen, die man mit seinen Patienten/Patientinnen machen kann. Einige Punkte beziehen sich direkt auf Ihre/n Patienten/Patientin. Sie sind gekennzeichnet durch eine unterstrichene Leerstelle. Setzen Sie beim Lesen bitte in Gedanken den Namen Ihres/Ihrer Patienten/Patientin in diese Leerstelle _____ ein.Wichtig! Bitte nehmen Sie sich Zeit, um jede Frage sorgfältig zu bedenken.1. _____ und ich sind einer Meinung bezüglich der notwendigen Maßnahmen zur Verbesserung seiner/ihrer Situation. Wir arbeiten auf Ziele hin, auf die wir uns gemeinsam verständigt haben. Wir haben ein gutes Verständnis davon entwickelt, welche Veränderungen gut für _______ wären. Ich respektiere _____ auch dann, wenn er/sie etwas tut, dem ich nicht zustimme. Wir stimmen miteinander ab, was für _____ wichtig zu bearbeiten ist.

	ORIGIN	GERMAN	BACK	BACK	FINAL GERMAN
	AL WAI-	TRANSLATION	TRANSLATION	TRANSLATION N°2	TRANSLATION
	SR		N°1
	Scoring	Auswertungsschlü	Evaluation key	Scoring key	Auswertungsschlü
	key	ssel			ssel
	Patient	Mittelwert der	Average for the	Average (mean) for the	Mittelwert der
	scale	Patientenskala	patient scale	patients' scale	Patientenskala
	mean
	Family	Mittelwert der	Average for the	Average (mean) for the	Mean/average
	Physician	Hausarztskala	family doctor	GPs' scale	have the same
	scale		scale		meaning
	mean
	Scale type Art der Skala	Type of scale	Type of scale	Art der Skala
	Goal	Ziel	Goal	Goal	Ziel
	Task	Aufgabe	Purpose	Task	Aufgabe
	Bond	Bindung	Connection	Connection	Bindung
	WAI SR	WAI SR	WAI SR	WAI SR	WAI SR Item
	Item	Item/Aussage/Beg	Item/Statement/P	Item/Statement/Expres
		riff	oint	sion
	Score	Punktzahl der	Patient version	Total score for the	Punktzahl der
	Patient	Patientenversion	total score	patients' version	Patientenversion
	version
	Score	Punktzahl der	Doctor version	Total score for the	Punktzahl der
	Family	Arztversion	total score	GPs' version	Arztversion
	Physician
	version
	To derive	Bitte zählen Sie	Please calculate	Please add the scores	Bitte zählen Sie
	a scale or	die Punktzahl	the score and	together and calculate	die Punktzahl
	total	zusammen und	form the mean of	the average (mean) for	zusammen und
	score,	bilden Sie den	the statements to	the statements in order	bilden Sie den
	simply	Mittelwert der	derive the	to derive the score for	Mittelwert der
	sum and take the mean of	Aussagen um den Score einer Skala oder den	score of a scale or the total score.	a scale or the total score.	Aussagen um den Score einer Skala oder den
	the items.	Gesamtscore			Gesamtscore
		abzuleiten.			abzuleiten.

Anleitung:

Anleitung:

table 28 : WAI-SR

 28

100,00% 100,00% 94,44% 77,78% 100,00% 50,00% 100,00% 94,44% 94,44% 77,78%

63!

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 intégrité́ 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.

Admis(e) dans l'intimité́ 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 moeurs.

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. ! 64! ! 65! KERVERN (Anne) -Traduction aller-retour en allemand de la Working Alliance Inventory Short Revised (WAI-SR) par une méthode de consensus Delphi.

First, a research team composed by 4 experts was asked to translate the original WAI-SR (annexe 1) from English to German (forward translation).