Background: Mental health conditions affect aspects of people’s lives that are often not captured in common health-related outcome measures. The OxCAP-MH self-reported, quality of life questionnaire based on Sen’s capability approach was developed in the UK to overcome these limitations. The aim of this study was to develop a linguistically and culturally valid German version of the questionnaire. Methods: Following forward and back translations, the wording underwent cultural and linguistic validation with input from a sample of 12 native German speaking mental health patients in Austria in 2015. Qualitative feedback from patients and carers was obtained via interviews and focus group meetings. Feedback from mental health researchers from Germany was incorporated to account for cross-country differences. Results: No significant item modifications were necessary. However, changes due to ambiguous wordings, possibilities for differential interpretations, politically unacceptable expressions, cross-country language differences and differences in political and social systems, were needed. The study confirmed that all questions are relevant and understandable for people with mental health conditions in a German speaking setting and transferability of the questionnaire from English to German speaking countries is feasible. Conclusions: Professional translation is necessary for the linguistic accuracy of different language versions of patient-reported outcome measures but does not guarantee linguistic and cultural validity and cross-country transferability. Additional context-specific piloting is essential. The time and resources needed to achieve valid multi-lingual versions should not be underestimated. Further research is ongoing to confirm the psychometric properties of the German version. Keywords: Mental health, Quality of life, Capabilities, PROM, Translation, Validation * Correspondence: email@example.com Department of Health Economics, Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15/1, 1090 Vienna, Austria Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Simon et al. BMC Psychiatry (2018) 18:173 Page 2 of 8 Background expression; appreciation of nature; respecting and valu- Mental health conditions can have a substantial effect ing people; friendship and support; self-determination; on quality of life, well-being and physical and social imagination and creativity and access to interesting functioning [1, 2]. People suffering from mental health activities. problems often face social stigma and experience The capability approach has been increasingly applied discrimination or social isolation. Connel et al. (2014) in general outcome measurement in health economics. found that aspects perceived by mentally ill people as Instruments including ICECAP (ICEpop CAPability) [14, the most important concerning their quality of life 15] and ASCOT (Adult Social Care Outcome Toolkit) include quality of relationships, sense of belonging and  have been developed to use in the health and social acceptance, self-perception, autonomy and freedom of care sectors . The application of the OxCAP-MH choice and feeling of hope . These important aspects currently remains in the area of mental health research. of well-being are often overlooked in the currently exist- The instrument was used for the first time and validated ing generic patient self-reported quality of life outcome in a randomised controlled trial in which study measures (PROMs) [4, 5]. For example, the focus of the participants suffered from severe mental health condi- most commonly used preference-based measure in eco- tions [9, 18]. The analysis showed that the instrument nomic evaluations, the EuroQoL EQ-5D, lies mostly on significantly correlated with social functioning (Global different dimensions of physical health. It covers five Assessment of Functioning, GAF) and health-related dimensions of quality of life: mobility, self-care, usual ac- quality of life (EQ-5D VAS and EQ-5D-3L). A response tivities, pain/discomfort and anxiety/depression which rate above 70% and positive patient feedback indicated are expressed in three or five levels of severity [6, 7]. In good feasibility of the instrument [9, 18]. These results recent years, concerns have been raised whether the suggest that the OxCAP-MH could be a suitable alterna- EQ-5D is an accurate outcome measure in mental health tive for quality of life/well-being measurement in mental research . The EQ-5D does not always detect the health research. However, more research is needed to change in quality of life in cases of severe mental health examine its cross-cultural application and inter-country problems such as bipolar disorder . Saarni and col- transferability to different linguistic and cultural settings leagues (2010) found that existing self-reported quality since, until now, the instrument has been available only of life questionnaires, EQ-5D in particular, are not sensi- in English. The main objective of this study was to de- tive enough and do not always correlate with the clinical velop a linguistically and culturally valid German version outcomes or socio-economic situation of patients . of the OxCAP-MH to facilitate its use in German speak- In light of the ongoing discussion on the appropriate- ing countries and international research. We describe ness of the existing outcome measures in psychiatric the complete translation and linguistic and cultural val- care, a new concept of measuring the quality of life/ idation processes of the questionnaire and discuss any well-being in mental health research has been developed difficulties and queries that arose throughout this [9, 10]. The Oxford CAPabilities questionnaire-Mental process and can serve as a guide to other similar adapta- Health (OxCAP-MH) is a novel 16-item index measure. tion processes. Its theoretical background lies in Sen’s capability approach  and its later interpretation by Nussbaum Methods . According to Sen’s theory, the term “capabilities” The professional translation and linguistic validation refers to the “alternative combinations of things a person process was coordinated by the Clinical Outcomes team is able to do or be – the various ‘functionings’ he or she at Oxford University Innovation (previously Isis can achieve” . The capability approach focuses on a Innovation Ltd.), University of Oxford, UK and was person’s freedom to choose to do things that they value carried out by PharmaQuest Ltd., a company specialising in their life. It can refer to very basic aspects, such as in the translation and linguistic validation of being well nourished or sheltered, and to more complex patient-reported outcome measures (PROMs). The qual- concepts such as social integration or self-respect . ity of this process was ensured by complying with inter- The scope of the OxCAP-MH to capture quality of life national principles of good practice for PROMs’ is broad and multi-faceted and includes complex aspects translation according to the International Society for of individuals’ well-being such as social integration, ex- Pharmacoeconomics and Outcomes Research’s (ISPOR) posure to discrimination and social stigma. In particular, standards  and following relevant guidelines . the OxCAP-MH refers to capability domains including: The process of German translation and linguistic valid- daily activities; social networks; losing sleep over worry; ation of the OxCAP-MH is outlined in Fig. 1.To enjoying social and recreational activities; having suitable strengthen the conceptual equivalence of the target accommodation; feeling safe; likelihood of discrimination questionnaire to the original English version, instrument and assault; influencing local decisions; freedom of developers and an in-country investigator based in Simon et al. BMC Psychiatry (2018) 18:173 Page 3 of 8 back translations. In addition, two mental health special- ists from Hamburg University of Applied Sciences, Germany provided further feedback and information on this preliminary version of the German OxCAP-MH questionnaire. The complete back translation review process allowed exploration and finding of equivalent translations to all questionable items. The amended ver- sion (Version 2) of the German questionnaire could then be pilot tested on a sample of patients with mental health conditions. Cognitive debriefing (pilot testing) The aim of the pilot testing was to confirm whether the translations were accurately understood against the intended meaning of the original (English) OxCAP-MH questionnaire. The pilot test drew on a sample of 12 study participants who were the patients of “pro mente Kärnten GmbH”. Pro mente is an organisation that pro- vides care and support for patients with mental health conditions in their everyday life in different organisa- tional settings including crisis services, mobile care and assistance, psychosocial counselling, day centres and housing. It is located in the Austrian province Carinthia. The study participants were approached by the carers in the respective institutionalised settings. The relevant selection and inclusion criteria for the patients were as follows: being able and willing to give written consent, aged between 18 and 65 years old, native German speaker, and not in an active phase of their mental Fig. 1 Translation process of OxCAP-MH according to PharmaQuest’s standard translation and ISPOR guideline condition. All participants received an oral and written information on the study and were asked to give an informed written consent prior to the face-to-face Austria were involved in the translation process. Com- interview. munication between them and project investigators and The carers were trained by the in-country investigator qualified translators was maintained throughout the to carry out the interviews in accordance with the guide- whole project period (March 2015–August 2015). line provided by Oxford University Innovation . Firstly, the patients were asked to complete the trans- Forward translation lated questionnaire alone. Secondly, the questionnaire The forward translation from English to German lan- was read aloud by the carers while the patients could guage was carried out by two independent qualified follow it by having the questionnaire in front of them. translators, native German speakers, who were proficient Thirdly, the study participants were asked to comment in English, specialised in medical translations and had a on any wording that was difficult for them to understand minimum of three years of experience. Two independent and if applicable, suggest alternative wording. Patients German versions of the questionnaire were produced, were asked to describe in their own words what the on which a reconciled single version was created wording meant to them. All interviews were recorded, (Version 1). transcribed and translated into English and analysed qualitatively using a content analysis approach . Back translation and back translation review In addition, four care workers and interviewers within The reconciled version of the German language instru- pro mente Kärnten provided further feedback and ment (Version 1) was back translated into English by information on Version 2 of the German OxCAP-MH two independently working translators who were English questionnaire in a focused group discussion setting. The native speakers with proficiency in German. The group indicated some additional difficult or odd word- in-country investigator commented on any queries re- ings and gave suggestions of alternative wording of the garding wording and terminology that arose from the items. Simon et al. BMC Psychiatry (2018) 18:173 Page 4 of 8 The pilot study was approved by the Ethics Committee Overall, 14 out of the 17 suggested changes were ac- of the Medical University of Vienna (EK-No.: 1900/2014 cepted (82%) resulting in a total of 12 changed phrases Votum 27.03.2015). out of the 29 originally translated phrases (41%) in the final German version of the OxCAP-MH instrument Results (Table 1). The majority of the proposed changes (12 out Translation of 17; 71%) referred to ambiguous wording and the pos- Twenty-nine phrases were translated from the English sibility of different interpretations. One suggested source questionnaire to German, of which sixteen phrases change (6%) was due to a politically unacceptable corresponded to the questions comprising the final expression, and one due to differences in political and OxCAP-MH instrument. Two phrases were additional social systems (6%). Three changes were suggested and questions not included in the final score, four were implemented due to need for harmonisation for instructions (e.g. “Please tick one”), six were different cross-country language differences between Austria and response options, and one was an explanatory sentence Germany (18%) (Table 1). included at the beginning of the questionnaire, i.e. “This While professional translators were able to discuss questionnaire asks about your overall quality of life.” changes that referred to pure linguistic issues, feedback Following the formal steps of the translation process from the in-country investigator, mental health special- (Fig. 1), three German versions of the questionnaire were ists, and patients and carers resulted in modifications in developed with the third version being the final wording mostly due to cultural and political differences approved translation of the OxCAP-MH. First, two inde- between the countries (UK and Austria/Germany) as pendent forward translations were conducted and well as cross-country differences between Austria and Version 1 of the German questionnaire was created. Germany (Table 1). Response option 5 (R8a in Table 1) After conducting two independent back translations of serves as an example of a change necessary due to the Version 1 and carrying out the back translation review, politically and culturally differential meaning of a word nine out of 29 phrases (31%) were changed (seven based in the German language. The direct translation of “race” on the suggestions of the professional translators and to “Rasse” had to be removed from the final German two based on feedback from the in-country investigator version, as “Rasse” is a term considered politically incor- in Austria and mental health specialists from Germany) rect in the German language due to historical reasons. and Version 2 was developed (Table 1). Changes to Question 9a were necessary due to relevant terminology differences between Austria and Germany. Cognitive debriefing The word “local area” was initially translated as Eight women and four men participated in the pilot test- “Ortsgebiet” which was expected to be difficult to inter- ing of the German OxCAP-MH questionnaire (Version pret for psychiatric patients according to the feedback 2). The mean age of study participants was 37 years from the in-country investigator and the mental health (range 24–62 years). The most common diagnosis was specialists from Germany. Consequently, the wording depression (n = 5). The average duration of the inter- “Wohngebiet” (living area) was adopted in the final views including both the times for completion and cog- version of the questionnaire (Additional file 1). nitive debriefing was 16 min (range 5–40 min) (Table 2). Differences in cultural and political concepts between As the cognitive debriefing sessions revealed, neither the UK and Germany/Austria were also reflected in the patients nor carers experienced any major difficulties translation of Question 9a which asks about the ability with understanding the individual item concepts or an- to influence decisions affecting the local area, i.e. if swering them. For patients, nine (56%) out of the 16 patients have a ‘voice’ in their local area. At first glance questions were entirely clear and six questions were easy this question seemed to be unclear to most participants to understand. Only one item referring to “influencing in the pilot study (Table 3). Qualitative analysis revealed decisions in the local area” proved problematic to inter- that this is likely to be due to the fact that the concept pret (Table 3). Carers considered potential difficulties of participation in decision making at the community with six questions (Table 3). level seems more relevant in the Anglo-Saxon culture. Based on the qualitative analysis of the cognitive Nevertheless, as many study participants were able to debriefing sessions, another six change suggestions were come up with accurate exemplifications, the question brought forward by the in-country investigator and three was left unchanged to protect the instrument’s integrity by the patients and/or carers (Table 1). Following careful (Additional file 1). linguistic and construct considerations including pre- As a result of cognitive debriefing, Question 9e was serving the integrity of the instrument and focusing on also modified. Originally phrased, the question asked if common concerns, five of the suggested changes were patients “find it easy to enjoy the love, care and support implemented at this stage (Table 1). of [their] family and friends”. It was easy to understand Simon et al. BMC Psychiatry (2018) 18:173 Page 5 of 8 Table 1 Change analysis Back translation review Cognitive debriefing Overall change (Yes/No) Phrase Content Reason Source Accepted Reason Source Accepted I0 Explanation L 2 + L 2 + N Q1 Daily activities I 3 + Y I1 Instruction 1 R1–4 Response option 1 I 1 + Y Q2 Social networks Q3 Losing sleep I 1 + Y Q4 Enjoying recreation Q5 Suitable accommodation R5 Response option 2 Q6 Neighbourhood safety R6 Response option 3 Q7 Potential for assault I 2 – N R7–8 Response option 4 Q8 Discrimination I2 Instruction 2 I 1 + Y Q8a Additional question I 1 + Y I3 Instruction 3 R8a Response option 5 P 2, 3 + Y Q9 Additional question I4 Instruction 4 I 2 + Y R9 Response option 6 I 1 + Y Q9a Influencing local decisions L 2 + S 2 – Y Q9b Freedom of expression Q9c Appreciating nature Q9d Respect and appreciation I 1 + Y Q9e Love and support I 3 + Y Q9f Planning one’s life Q9g Imagination and creativity Q9h Access I 1 + I 2 – Y Number of accepted changes (%) 9 (31%) 5 (17%) 12 (41%) Phrase: I = instruction, Q = question, R = response option Reason: S = differences in political and social systems, L = cross-country language differences, I = possibilities for differential interpretation, P = politically unacceptable expressions Source: 1 = professional translators; 2 = in-country investigator and/or mental health specialists; 3 = patients and/or carers Overall change: + = suggested change accepted; − = suggested change rejected but considered problematic by both carers and some life in the context of mental disorders. In the final trans- patients, since the expression implies that someone has lation the linking word “and” was therefore replaced a supporting family to begin with. “Family? In the old with “and/or” (“Mir fällt es leicht, die Liebe, Fürsorge days, yes …” (ID 007), “If I actually got [support] from und Unterstützung meiner Familie und/oder Freunde my family, I would gratefully accept it …” (ID 008) and anzunehmen und zu genießen.”). “Sure, but to this end [support] would actually need to Contrary to the English language, the use of masculine exist to begin with” (ID 009) were three of the (trans- and feminine forms is inherent in the German language, lated) comments hinting a potential deficit experienced especially in written communication. The text of the by people with mental health conditions in this respect questionnaire, however, only contained one word where and showing a very important dimension of quality of this issue was relevant, i.e. ‘Freunde/Freundinnen’ Simon et al. BMC Psychiatry (2018) 18:173 Page 6 of 8 Table 2 Cognitive debriefing (pilot study) sample characteristics Patient ID Age Sex Time (min.) Diagnosis 001 24 Male 7 Schizophrenia 002 28 Male 10 Paranoid schizophrenia 003 36 Female 9 Depression, panic disorder 004 34 Female 10 Depression, panic disorder 005 26 Female 11 Borderline personality disorder 006 27 Female 5 Depression, panic disorder 007 32 Male 6 Depression, mental and behavioural disorders due to use of alcohol 008 62 Female 26 Schizoaffective disorder 009 50 Male 30 Depression, anxiety disorder 010 31 Female 23 Posttraumatic stress disorder 011 50 Female 20 Bipolar disorder 012 41 Female 40 Schizoaffective disorder meaning ‘friends’. In order to keep the questionnaire Additional file 1 presents the full details of the transla- easy to read, only the male version was included in the tion process based on one sample item from the translation (‘Freunde’). Neither carers nor patients noted OxCAP-MH questionnaire. or brought this issue up at the piloting stage and there- fore no changes were deemed necessary. Discussion Another characteristic of the German language is the This study describes the development of the German use of “Du/Sie” forms. While the English “you” is used version of the OxCAP-MH well-being questionnaire that in both formal and informal communication, in German is both equivalent to the English source version and two variants are used for this personal pronoun: “Du” in culturally acceptable and feasible to comprehend by informal and “Sie” in formal language. In line with Ger- German speaking patients. The development of the man cultural standards, the “Sie” form was used German version consisted of forward and back transla- throughout the questionnaire. No relevant concerns tions valid both for Austria and Germany. This was were raised. followed by cultural and linguistic validation through Table 3 Results of the cognitive debriefing Item Content Concern by patients (Yes (n)/No) Concern by carers (Yes/No) Q1 Daily activities Y (1) Y Q2 Social networks Y (3) Y Q3 Losing sleep Y (3) Y Q4 Enjoying recreation N Y Q5 Suitable accommodation N Y Q6 Neighbourhood safety Y (1) N Q7 Potential for assault Y (1) N Q8 Discrimination N N Q9a Influencing local decisions Y (8) N Q9b Freedom of expression Y (1) N Q9c Appreciating nature N N Q9d Respect and appreciation N N Q9e Love and support N Y Q9f Planning one’s life N N Q9g Imagination and creativity N N Q9h Access N N Simon et al. BMC Psychiatry (2018) 18:173 Page 7 of 8 pilot testing with a sample of 12 German native speaking alternative for/addition to health-related quality of life patients with mental health conditions in Austria. measurement in mental health research, to a German Incorporating this latter step allowed the development speaking setting . In the cognitive debriefing study, of a robust German translation of the OxCAP-MH with it was confirmed that the questions included in the full formal linguistic and cultural adaptations. instrument have personal relevance to the patients The study followed a robust methodological design and the capability questionnaire represents important reflecting the principles of good practice for translation aspects of quality of life of people with mental health of patient-reported outcome measures adopted by problems beside health. The study also demonstrates ISPOR . The aim was to create a valid German the necessity of conducting a formal, step-by-step translation which is as close as possible to the original translation and linguistic and cultural adaptation of a English source questionnaire. Feedback from the PROM instrument when developing different language in-country investigator, mental health specialists, carers versions. Pilot testing of the translation with patients and cognitive debriefing with patients were particularly and carers provided further valuable insights of the important to capture politically unacceptable expres- questionnaire’s content validity from their perspective. sions, cross-country language differences, and differ- A larger scale study is, however, needed to establish ences in cultural and political concepts. In total, 29 the psychometric properties and validity of the phrases comprising the OxCAP-MH instrument were German OxCAP-MH. translated from English into German. Changes in 31% of the phrases in the first translated version of the ques- Additional file tionnaire (Version 1) were made based on the back Additional file 1: Example of the translation process for one translation review which involved two professional questionnaire item. (DOCX 16 kb) translators, the in-country investigator and mental health specialists from Germany. Final changes to the Abbreviations second translation were made in 17% of the phrases OxCAP-MH: Oxford CAPabilities questionnaire-Mental Health; PROM: Patient- after obtaining feedback from patients and carers reported outcome measure through pilot cognitive debriefing interviews. Through Acknowledgements these linguistic and cultural adaptations, the final Ger- The authors wish to thank Tatiana Rivera and Anita Jerabek from pro mente man version of OxCAP-MH is deemed equivalent to the Kärnten for conducting most of the patient interviews. Many thanks to original English questionnaire. Professor Dieter Röh and Marcel Daum from Hamburg University of Applied Sciences for providing valuable feedback during the translation process. The pilot testing also allowed assessment of the The authors are grateful for Oxford University Innovation (previously Isis patients’ perception and conceptual understanding of Innovation Ltd.), University of Oxford, UK for providing the resources for and the German OxCAP-MH. The length of the full inter- coordinating the professional translation process. views ranged between 5 and 40 min. These differences Authors’ contributions in duration, however, were not linked to varying difficul- JS conceptualized, designed and supervised the study. DC supervised the ties in understanding the questions but were driven by translation process. GS and EL supervised the fieldwork and, in addition, EL interviewed some of the patients. AL obtained feedback from the focus the patients’ interest in and willingness to discuss the group and trained the interviewers. SM transcribed and translated the broader meaning and concept of the questionnaire. The interviews. SM and AL analysed the data. JS, AL and SM wrote the initial amount of time needed for going through all the manuscript. DC, GS and EL commented on the manuscript. JS prepared the final draft of the manuscript. All authors read and approved the final 16 questions was around five minutes for each patient, manuscript. indicating good feasibility of completion also for the German OxCAP-MH. Ethics approval and consent to participate The German OxCAP-MH is now available for use free The study was approved by the Ethics Committee of the Medical University of Vienna (EK-No.: 1900/2014 Votum 27.03.2015). All participants provided of charge for non-commercial use and is accessible via written informed consent. http://healtheconomics.meduniwien.ac.at/science-re- search/oxcap-mh/. Research on the full psychometric Competing interests The authors declare that they have no competing interests. validation of the German questionnaire is ongoing in a large sample of patients with mental health conditions in Austria. Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Conclusions This paper offers information about the linguistic and Author details Department of Health Economics, Center for Public Health, Medical cultural transferability of the OxCAP-MH instrument, University of Vienna, Kinderspitalgasse 15/1, 1090 Vienna, Austria. which measures broader well-being based on the cap- 2 Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford ability approach and is considered a promising OX3 7JX, UK. Health Economics Research Centre, Nuffield Department of Simon et al. BMC Psychiatry (2018) 18:173 Page 8 of 8 Population Health, University of Oxford, Richard Doll Building, Old Road 19. Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson Campus, Oxford OX3 7LF, UK. pro mente Kärnten, GmbH, Villacherstraße P. 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