1.      BACKGROUND AND CURRENT RESEARCH

1.1      Legal background

Clinical research involving human participants is regulated by international and national laws and declarations of principle, which form the basis for the ethical and scientific quality standards for the conduct of clinical trials. The background for these standards and regulations is formed by a history of medical research abuse, including medical experiments in Nazi-Germany and the Tuskegee study of syphilis (DeNeen, 2017).

The rights, safety and welfare of human subjects have been set out in regulations such as the Nuremberg Code (1947), the Declaration of Human Rights (1948), the Declaration of Helsinki by the World Medical Association (1964), the Belmont Report (1979), or the Guideline for Good Clinical Practice (GCP) (1997).

In the US, the requirement for drug safety tests was legally implemented as early as 1936, and national standards for clinical research have since been further developed by the Food and Drug Administration (FDA).  The overall set of ethical principles and regulations which US researchers are obliged to follow is referred to as the ‘Common Rule’ (Collins & Sather, 2002).

Germany has no general law regulating medical research in humans, but there are comprehensive regulations in special laws such as the Medical Products Law [Medizinproduktegesetz] from 2003 and the Medicines Act [Arzneimittelgesetz] from 2004 (Harnischmacher, Ihle, Berger, Goebel, & Scheller, 2006, p. 2).

A key element which is common to these standards and regulations is the requirement to obtain voluntary consent from trial participants. Appropriate information is considered essential to their ability to give that consent. Patients who are invited to take part in a clinical trial have the right to be informed about the content of the trial, in order to understand what such participation means for them, what they can expect as a result, and what potential harm could arise.

Laws governing the conduct of clinical trials include general explanations of the required nature and content of patient information accompanying clinical trials. For example, according to the Professional Code for Physicians in Germany [Musterberufsordnung für Ärzte], patient information should explain ‘the nature, significance and implications of the treatment, including alternative treatments and associated risks […] in a comprehensible and appropriate manner’ (Bundesärztekammer, 2018). In the US, requirements for informed consent are set out in the Code of Federal Regulations, article 46 (OFR, 2018): ‘The information that is given to the subject […] shall be in language understandable to the subject […]’.

It belongs to the responsibilities of Institutional Review Boards (US) or Ethical Review Committees (Germany) to review whether the patient information materials forming the basis for voluntary consent is complete and comprehensible (Bundesamt für Justiz, 2010, §5, section 4; OFR, 2018, §46.116).

1.2      Current research on the accessibility of ICFs

Comprehensibility

Numerous studies have shown inadequate comprehensibility of patient information materials for clinical studies (Reinert et al., 2014; Munley et al., 2018) or other patient information, e.g., leaflets (Haug, Box, Kohn, Streiftau & Haseloff, 2011). Knapp, Raynor, Silcock and Parkinson (2011, p. 2) conclude that the level of literacy required to understand patient information for a clinical trial is often too high for the general population. Surveys at the end of trials find that one in five participants does not know the name of the study medication or is not aware of the fact that they could withdraw at any time (Knapp et al., 2011, p. 2).

The length of patient information materials for study participants is generally acknowledged to continue to grow ever longer and more complex, thereby potentially becoming ever less understandable (Herschel, 2009, p. 177). As Bleiberg et. al (2017, p. 923) point out, many ethics committees do not seem willing to address this problem when reviewing research study applications. Moreover, a study by Paasche-Orlow, Taylor and Brancati (2003) showed that the sample texts for IFCs provided by Institutional Review Boards do not meet their own comprehensibility standards (Paasche-Orlow et al., 2003, p. 724).

Much of the information in ICFs, although important, is not essential for the decision-making process. Legal and formal aspects, e.g., insurance details, are also subjects contributing to the oversize of ICFs. Other commonly recognized problems with the comprehensibility of ICFs include abbreviations and unnecessary medical details, redundancy, and contradictions (Bleiberg et al., 2017, p. 923).

Suggested solutions frequently include shorter length. The focus for IFCs should generally shift more towards the relevance of information for patients, and away from strictly legal or formal aspects (Reinert et al., 2014, p. 156).

Ethical aspects

There has been little examination of the role of ethical language in ICFs.

Bleiberg (217, p. 927) argues that respect for patients participating in a clinical trial is a key factor in clinical research and is in the interest of sponsor, investigators, and the medical community.

A study on the effective collection of genetic and clinical data finds that the majority of prospective participants had a more positive view of the planned research when they were asked for their permission if researchers want to share participants´ data for additional purposes (Brown et al., 2012).

Cultural aspects

Understanding of medical terms can vary between English and German. As Stolze (2009, p. 126) has observed, technical terms contain cultural elements, since they can reflect different conceptual understandings. Related to the translation of ICFs, Penn (2018, p. 34) points out that patient information in English generally contains many medical terms without explanation. The English language has far fewer lay terms for medical concepts than German, and an English-speaking patient will more likely be familiar with the special term – as compared to a German-speaking patient. Medical terms can also vary conceptually: e.g., the common translation for the English ‘subject’, ‘Proband’, is used in German only for pre-clinical trials, while the English term can refer to trials of all phases (Penn, 2016, p. 79).

Apart from medical terminology, no research specific to cultural aspects of language in patient information has been found. General differences in norms for communication between English and German have been investigated and described from a viewpoint of cultural differences for example by House and Kasper (1981) and House (1996, 2002).

2.      DEFINITIONS OF ACCESSIBILITY IN PATIENT INFORMATION

Accessibility is ‘the quality of being easily understood or appreciated’ (Oxford English Dictionary). In this paper, accessibility is understood as an umbrella term covering aspects of comprehensibility, ethical language and communicative cross-cultural differences.

2.1      Comprehensibility

The following is a brief explanation for the most common terms relating to the comprehensibility of patient information.

Comprehensibility: General term, referring to ‘the ability to be understood, intelligibility’ (Oxford English Dictionary). The degree of comprehensibility of a text depends on its content and wording as well as on non-textual features such as text organisation, and on reader knowledge.

Readability: General term, referring to ‘the quality of being legible or decipherable’ (Oxford English Dictionary). The degree of readability can be measured by text tools (or readability formulas) based on quantitative text features (the number of syllables, and the lengths of words and sentences). In the context of critical remarks on readability formulas, Göpferich (2019, p. 282) points out that ‘readability’ should not be mistaken for ‘comprehensibility’, since the first represents only a sub-area of the latter. In this research, the term readability is only used when clearly referring to quantitative text features.

Plain language: General term, describing communication ‘if its wording, structure, and design are so clear that the intended readers can easily find what they need, understand what they find, and use that information’ (International Plain Language Association, 2018). The term summarizes text features including short sentences, simple syntax, and avoidance of specialized terminology. Plain language addresses the general population and does not implement a strict set of regulations, but rather follows general guidelines (Baumert, 2016, p. 94-95).

Easy Language: Primarily in use in Germany (‘leichte Sprache’), describing language intended for people with reading disabilities (Baumert, 2016, p. 5). Use of Easy Language is applied with a specific set of guidelines. The principles of easy language can provide a useful orientation for writing complex texts for a broader population (e.g., to include only one important piece of information in per sentence), and are as such useful for writers or translators of patient information.

Lay language: ‘Terminology that an average non-professional can understand’ (Online Community Dictionary). Widely used in the context of patient information, it does not describe the overall comprehensibility of the text, but includes only the use of lay terms in place of specialized terms (e.g., ‘cancer-causing’ instead of ‘carcinogenic’).

2.2      Ethics

Ethics, according to the Oxford English Dictionary, are ‘moral principles that govern a person´s behaviour or the conducting of an activity’.

Lehtonen (2011, p. 200) points out that it is ‘appropriate, even necessary, to morally evaluate language’. The goal of ICFs is to enable patients to decide to participate and to follow the requirements for participation in a trial. It is clear that readers should be addressed in a way that instils confidence and increases the willingness to invest time in the decision-making process and to actively contribute to the treatment or procedure. To provide a text which is comprehensible is of course a key step in achieving this goal. However, comprehensibility is not alone sufficient. One feature of language is that it is ‘a means of social inclusion and exclusion’ (Lehtonen, 2011, p. 207). Hart (2015, p. 191) emphasizes the importance of patient education being ‘factual and empathetic’, concluding that ‘a judgmental or patronizing tone can […] negatively affect the patient’.

Reducing potential research participants to passive ‘subjects’ of procedures and treatments, making statements about their feelings (‘suffer’ from a disease) or judging their ‘eligibility’ for a treatment (instead of judging the eligibility of a treatment for the patient) are examples for language which can have an impact on the confidence of patients in the proposed treatment or procedure and their willingness to participate.

2.3      Culture

Culture in the context of translation has been defined by Goodenough (1964, p. 36) as: ‘not a material phenomenon […]. It is the forms of things that people have in mind, their model of perceiving, relating, and otherwise interpreting them.’ It is ultimately the task of the translator to be aware of differences in these perceptions between two language communities. House (2002, p. 100) suggests the application of a ‘cultural filter’ to identify differences in communicative preferences, but taking into consideration existing empirical research on socio-cultural norms, and not based solely on personal experience or attitudes (House, 2002, p. 101).

Cross-cultural communication differences are related to underlying ‘cultural value dimensions’ which have been defined and studied by Hofstede (2003). He observed a much higher ‘Uncertainty Avoidance Index’ (UAI) for Germany than for English-speaking countries (Hofstede, 2003, p. 243), i.e. the tolerance for uncertainties tends to be low and strategies to avoid risks are prominent – for example, gathering as much information as possible before making a decision. Research in this paper will focus on the application of communicative preferences (see 3.3 and 5.2.2) in the sample translations, without adding information.

3.                REQUIREMENTS ON ACCESSIBILITY IN PATIENT INFORMATION

3.1      Comprehensibility

The guidelines and recommendations mentioned in this chapter originate from related literature in the field of clinical research and healthcare as well as from general sources.

3.1.2    General guidelines and recommendations

For the source language, the Plain Language Action and Information Network (PLAIN, 2011) has published comprehensive guidelines for written materials published by federal agencies which include elements of text organisation, terminology, consistency, and style, such as:

·         Direct address of the reader

·         Logical order of information, with the most important information first

·         Usage of familiar, concrete, short, non-technical words

·         Minimisation of abbreviations and definitions        

·         Consistent usage of terms

·         Avoidance of noun strings, preference for verbs.

For the target language, a noteworthy and successful concept has been the ‘Hamburger Verständlichkeitsmodell’ [Hamburg Comprehensiblity Model] (Lutz, 2017, pp. 285-286). The Model contains the four characteristics of simplicity, structure, brevity, and inspiring text additions (to make a text lively). Specific recommendations include:

·         Usage of common, specific, descriptive words

·         Explanation of unknown words

·         Short sentences

·         Placement of subordinate clauses before or after (not in the middle) of main clauses

·         Logical order of information

·         Usage of headings, paragraphs, etc.

In her article on ‘comprehensible writing’ Salchert (2012, p. 6) summarizes ‘rules for clear language’, such as:

·         Placement of important information at the beginning

·         Omission of redundant information

·         Specific wording instead of general wording

·         Short main clauses, few subordinate clauses

·         Active instead of passive style

·         Little usage of loanwords and abbreviations.

3.1.2    Medically-related guidelines and recommendations

Guidelines and recommendations on the comprehensibility of patient information for clinical trials have been published by Institutional Review Boards (IRB) or Ethical Review Committees.

An ‘Informed Consent Guidance’ by the John Hopkins Medicine, IRB (2016) entails recommendations such as:

·         No higher than 8^th grade level, checked by tools to assess reading level

·         Lay terms, words with 3 syllables or fewer

·         Short paragraphs, limited to one idea; short, simple sentences

·         Active verbs, second person (you)

·         Font size at least 12 points

·         Highlighting of important points

·         Avoidance of repetitions, avoidance of large blocks of text

Recommendations from other sources (referring to medication leaflets) can be applied to ICFs in addition to the criteria mentioned above. The ‘Guideline on the readability of the labelling and package leaflet of medicinal products for human use’ by the European Commission (2009, pp. 7-10) contains a set of recommendations, such as:

·         Use of headings, with bold type face or different colour

·         Bullet points to structure information

·         Verbs instead of noun strings

Similar recommendations are to be found in the Patient Counselling Information – Guidance for Industry by the US Food and Drug Administration (FDA) (2014, p. 9) or in the FDA´s Guidance on Useful Written Consumer Medication Information (CMI) (2006, pp. 10, 11). The latter has been published as ‘nonbinding recommendations’ and also contains the suggestion that CMI be provided at sixth to eighth grade reading level.

For the target language, the German ‘Arbeitskreis Medizinischer Ethik-Kommissionen’ [Working Group of Medical Ethics Commissions] has published a handout which contains recommendations for language used in informed consent forms:

·         easily understandable language

·         clear design

·         sentence length limited to a maximum of 20 words

Sänger et al. (2016, p. 23-24) in their ‘Manual of Patient Information’ also include linguistic features, such as:

·         simple, short sentences

·         commonly known words

·         clarification of specialised terms

·         structured text, logical order of information

No equivalent recommendations regarding the reading grade level for patient information in Germany has been found in the literature review.

3.1.3 Identifying possible gaps

Several very specific recommendations do exist, but none of these are commonly accepted and binding with regard to ICFs, either on a national or international level. Existing binding regulations on comprehensibility refer to other health care contexts (i.e., package leaflets).

While it might seem a straightforward task to create standards for text structure and presentation, given the many specific recommendations already published, developing a standard describing linguistic features would be a bigger challenge, and would need to be based on results of future focussed research.

Examples of open questions include:

·         What does a ‘simple sentence’ look like?

·         How long should ICFs be, as a maximum?

·         What information is really essential for the decision-making process?

·         Which abbreviations require explanation in all cases; which can be assumed to be generally understood (e.g., AIDS)?

·         Should there be a list of accepted terms, similar to the concept of controlled language?

·         Should tools be used to assess readability? If so, which tools should be used?

·         On what reading level should assessment of readability be based?

3.2      Ethical aspects

Aspects of ethical language in ICFs have been addressed by ethics commissions and authors. The Health Research Ethics Board of Alberta, for example, has published a standard consent form with mandatory requirements for any study protocol to contain the use of the 2^nd person address and phrasing ‘in a tone that is respectful to participants’ (HREBA, Clinical Trials Committee, n.d.).

Life science editor O´Moore-Klopf (2019) includes recommendations such as the avoidance of addressing patients as ‘cases’, equating patients with their disease (e.g., ‘person with diabetes’ instead of ‘diabetic’), use of inclusive pronouns (‘they’ instead of ‘he’ or ‘she’), addressing study participants as participants, not as ‘subjects’. The British Medical Journal announced a ban on the use of ‘subject’ for study participants altogether, since it has been found to be demeaning and conceals the fact that researchers are in debt to study participants and should therefore treat them with the ‘highest standards of consideration and respect’ (Chalmers, 1999).

In their Manual of Patient Information (2006, p. 21), Sänger et al. recommend avoiding the use of any ‘fear-inducing wording’ that may push the reader into a certain direction. Almost all German Ethical Review Committees require the use of a personal form of address, and according to the Ethical Review Committee of the University of Luebeck, the choice of words should also be based on aspects of ‘discretion and benevolence’ (Harnischmacher et al., 2006, p. 28).

3.2.1 Identifying possible gaps

A common standard for ethical language in ICFs, which would go beyond individual recommendations of ethics commissions or authors in this field, is missing.

Examples of open questions include:

·         What constitutes ethical language in patient information materials for clinical trials?

·         Are there terms and phrases which should be avoided?

·         Are there currently commonly used expressions which should be replaced?

·         Which terms or phrases should be considered inappropriate or even offensive?

3.3      Cultural aspects

The different usage of medical terms in English and German requires particular consideration for the translation. The translator has to decide whether an unexplained medical term in the source text can be translated into a lay term in German, must be explained, or can remain as a medical term in the target text. Anglicisms are to be avoided in patient information (Penn, 2016, p. 35).

The existing body of research on differences in communication between English and German provides potential further guidance for the wording of ICFs. House (1996, p. 347) has identified five key dimensions of German vs. English cross-cultural differences to be considered in translation (German is listed first):

·         directness vs. indirectness

·         orientation towards content vs. orientation towards addressees

·         explicitness vs. implicitness

·         orientation towards self vs. orientation towards others

·         ad-hoc formulation vs. verbal routines.

Only the first three dimensions will be taken into consideration for the translation analysis as the last two are elements more specific to spoken language.

3.3.1 Identifying possible gaps

The avoidance of anglicisms and the translation or explanation of technical terms has been addressed in the guidelines of ethical committees. A possible open question to identify other cultural aspects in the context of ICFs, or patient information in general, is:

·         Is there a difference in the perception of information, when cross-cultural communicative preferences are considered?

For all three aspects, more research is required to answer these questions and should include the experience of real-life study participants.

4.      METHODOLOGY OF TRANSLATION AND TRANSLATION ANALYSIS

4.1      Translation model and concepts

This research aims to define criteria for comprehensibility, ethics and culture in ICFs and to assess three sample texts based on the pre-set criteria. The concepts providing these definitions and potential guidelines for the translation of the sample texts are related to text-structural, linguistic and contrastive norms.

After outlining which particular features shall be included in a comprehensibility assessment and how other aspects (ethical, cultural) of patient information are to be assessed, the research focuses on the following questions:

·         How do the sample texts perform based on the pre-set criteria for the assessment?

·         How does the goal of improving accessibility influence translation decisions?

These questions seek to understand causal relationships (Williams & Chestermann, 2002, p. 87), e.g., between the wording of a text and its assumed impact on readers´ understanding of the text. In order to find answers to these questions a causal translation model has been chosen for this research, considering mainly descriptive concepts which help to explain which norms guide the comprehensibility and the wording for ethical and cultural aspects in these texts. In a normative approach to translation research, general principles and their practical application are discussed and related to linguistic norms (i.e., rules derived from linguistic regularities in source and target languages) and text-linguistic norms.

Toury (2012, pp. 172-174) defines three major sets of translation norms:

1. Preliminary norms apply before the actual translation of a text and are related to the source text type and textual genre. In the context of patient information for clinical trials, this includes regulations governing the layout and wording of such information. For the purposes of this research, a general set of norms for comprehensibility, ethical and cultural aspects will be derived from existing, general norms or recommendations to improve accessibility and facilitate the decision-making process for patients.
2. Operational norms apply to the translation process itself and are related to decisions on translation content and text structure. For the purpose of this research, key parts of the source ICF have been chosen and it is assumed that changes to the original textual structure, without compromising on the content, are allowed.

3.      Textual-linguistic norms apply to the selection of linguistic material, the stylistic choices for the translation into the target text. Text-linguistics considers the communicative function of the whole text as the base for translation decisions. By introducing concepts of linguistic norms beyond the sentence level, text-typological conventions are brought into focus, which are ‘culture-specific and can change over time’ (Schäffner, 1999, p. 4).  In this paper, textual-linguistic norms (rules, guidance) for the translation process will be applied by analysing quantitative and qualitative features of comprehensibility as well as wording rules related to ethical language and the language pair (contrastive stylistics).

4.2      Methodology and tools

The nature of this research is primarily empirical (Williams & Chestermann, 2002, pp. 96, 97), i.e., the goal is to derive information from primary sources (three representative ICFs) and to generalise aspects of comprehensibility, culture and ethics in patient information for clinical trials by analysis of these translations, in order to outline important implications for translators of such texts. The questions in this research are intended to lead to conclusions for practical problems and to have a meaning for day-to-day translation processes (Saldanha, 2014, p. 15). References to existing research (Chapter 1), the definition of key terms (Chapter 2), and the criteria for analysis (Chapter 4) derived from secondary sources provide the conceptual framework for the research. The analysis criteria are not, and do not aim to be, solely objective, but are also based on personal experience and preference (Williams & Chestermann, 2002, p. 95).

Choice of Texts

The ICFs to be translated have been chosen from a publicly available website (clinicaltrials.gov), which is a service of the U.S. National Library of Medicine. To ensure that the chosen ICFs are representative, the project search included only studies conducted by well-known organisations, included a typical research design and study documentation reviewed by an Institutional Review Board.

The analysis of the source texts and the translations is based on quantitative as well as qualitative approaches.

Quantitative Analysis

The quantitative analysis of readability includes formulas which are available online and which provide a formal assessment of readability, considering features such as the average sentence length and the average number of syllables per word. These tools calculate the classification of the given text according to the grade level needed to understand it, or according to a score between 0 and 100 to reflect the readability level (from ‘very difficult’ to ‘very easy’). Readability formulas have become widely accepted and used in research on comprehensibility, including in the context of patient information. However, these tools only measure quantitative features (Göpferich, 2019, p. 282), which inevitably leads to shortcomings of such an analysis. The tools do not reflect the text structure, an important feature of readability. They do not take into account that long words do not necessarily have to be difficult to understand, or that short special terms can be incomprehensible if not explained. There are also significant differences in the outcome depending on which readability formula has been used (AHRQ, n.d.). Readability formulas can therefore not provide a comprehensive analysis of a text, but must be complemented by qualitative analysis.

Qualitative Analysis

The qualitative analysis includes an assessment of comprehensibility not captured by quantitative readability tools (e.g., term usage, overall structure of the text, use of active vs. passive structures, etc.). The qualitative assessment also focuses on the assumed effect on the reader for other criteria of accessibility, based on research from the secondary literature outlining aspects of ethics and culture (as described in chapter 2). This section will include an analysis of previously defined criteria related to ethical and cultural aspects (e.g., politeness, respect, or cross-cultural dimensions of explicitness vs. implicitness, etc.) and their application to the given texts.

5.                CRITERIA FOR THE TRANSLATION ANALYSIS

The analysis includes

-          a quantitative assessment of source and target texts utilizing readability formulas

-          a qualitative assessment of source and target texts.

Translation decisions will be based on the criteria defined in this chapter.

5.1      Criteria for the quantitative assessment of readability

The quantitative assessment is based on an analysis of source and target texts using two readability formulas: the Flesch-Index test and the Flesch-Kincaid test for the source texts, and the Flesch-Index test (German formula) and the Wiener Sachtextformel [Vienna formula for non-fictional texts] (WSTF) test for the target texts.

The Flesch-Index test measures the readability of a text based on the average sentence length and the average number of syllables per word. The test is scored from 0 to 100, with higher scores indicating better readability (Scott, n.d.). The Flesch-Index formula has been adapted to the German language, taking into consideration the generally greater length of German words.

The Flesch-Kincaid test uses the same core measures as the Flesch-Index, but is calculated using a different formula. Scores are reported as the grade level required to understand the text; that is, a lower score indicates better readability. Equivalent to the Flesch-Kincaid text, the ‘Wiener Sachtextformel’, or WSTF, calculates the reading grade level of a text. The test was developed specifically for German and measures sentence length, number of polysyllables, and word length. It is considered to provide reliable results, especially for higher readability grades (Schmidt, Alilovic, Klärs, 2011, p. 97).

The questions to be answered by the quantitative analysis are:

·         Does the source text meet the required reading level of 8^th grade or below?

·         Does the target text meet a reading level of 8^th grade or below, or at least a better reading level compared to the source text?

For the calculation of the Flesch-Index score  and the grade level according to the Flesch-Kincaid score the following online tool was used (https://www.online-utility.org/english/readability_test_and_improve.jsp).

The Flesch-Index test (German) and WSTF for the target texts were analysed using http://www.schreiblabor.com/textanalyse/.

5.2      Criteria for the qualitative assessment

5.2.1    Aspects of comprehensibility

Given the lack of an existing common standard for comprehensibility of ICFs as well as of a commonly recognized version of plain German language (Baumert, 2016, p. 94), the following criteria have been combined based on the recommendations and guidelines reviewed in chapter 2.1:

Text organisation

·         Use of headings to structure the entire text

·         Use of bullet points to structure series of associated information

·         Important information at the beginning of paragraphs and sentences.

·         New paragraphs and/or headings for new topics

·         Omission of redundant information

Syntax

• Maximum sentence length of 20 words with only 1 new piece of information per sentence; average sentence limited to 12 words
• Use of simple versus convoluted sentences (avoidance of subordinate clauses and parentheses)

Terminology

• Use of lay language for medical terms or clear explanation of medical terms
• Rephrasing or separation of long words by hyphenation

Style

• Active instead of passive wording
• Specific instead of general wording
• Verbs instead of nouns

5.2.2    Aspects of ethics and cultural differences

The following criteria have been derived from recommendations reviewed in chapter 2.4.

Ethical aspects

·         Acknowledgment of patients´ active role: avoidance of terms like ‘subjects’ or ‘cases’; judgement of patients´ eligibility or performance

·         Differentiating patients from their disease

·         Avoidance of fear-inducing wording

·         Avoidance of statements of patients´ feelings

Cultural aspects for the translation

·         Application of an appropriate level of directness (e.g., use of raw imperative) to reduce ambiguities

·         Application of an appropriate level of explicitness to reduce ambiguities

·         Focus on content-oriented versus interactional style

The questions to be answered by the qualitative analysis are:

·         Is comprehensibility in the source text reduced as measured by these qualitative criteria?

·         If so, how can this reduced comprehensibility be improved in the translation?

·         Are there elements in the source text which could potentially carry over as deficiencies in the comprehensibility of the target text, without representing a comprehensibility problem in the original?

6.                TRANSLATION AND ANALYSIS OF 3 INFORMED CONSENT FORMS

For each ICF, the source texts (with the original text organisation) and translations are shown in the attachments I, II, and III, respectively.

The criteria for the quantitative and qualitative assessment have been applied to the translations. The attachments include comments for all text adaptations compared to the source text (such as additional explanations, usage of uncommon translations, rewording, etc.), as well as changes in text organisation. Aspects of comprehensibility, ethics and culture identified in the source and target texts are described in the quantitative and qualitative assessments for each ICF (below), with reference to related lines in the attachment.

In some cases, there are suggestions for a simplified translation which would require direct discussion with the client. (These suggestions are not noted in every case).

The titles of the studies have not been included in the quantitative analyses. Study titles are legally required to be included in ICFs and can remain unexplained in the beginning of the document, if the terminology is explained later in the text (Harnischmacher et al., 2006, p. 27).

6.1      ICF 1, Melanoma study

6.1.1    Analysis

6.1.1.1 Quantitative analysis

Source text (number of words: 1,991)

Flesch-Index: 51.72. This corresponds to a ‘fairly difficult’ reading level.

Flesch-Kincaid grade level: 11.00. This rating does not meet the required reading level of 8th grade or below.

The average number of words per sentence is 19.94; the average number of syllables per word is 1.6.

Target text

Flesch-Index: 54. This score is slightly better than for the source text and nonetheless corresponds to a ‘fairly difficult’ reading level.

WSTF grade level: 9. This is 2 grade levels below the score for the source text, but does not meet a reading level of 8th grade or below.

The average number of words per sentence is 11.55; the average number of syllables per word is 1.95.

With both tools, the target text scores better than the source text. Some long words could not be changed as they are standard terms (e.g., ‘Einwilligungserklärung’ [informed consent]). Other long words have been separated by hyphenation, but have been marked by the readability tool as too long.

6.1.1.2 Qualitative analysis

Text organisation:

The source text contains headings and bullet points to structure the text. These have been applied at the corresponding positions in the target text. Initially, the source text includes a substantial amount of information without headings (‘Background’, see line 39). The first paragraph of this section has been deleted, as the information is repeated later in the text. The most important information of this section has been converted into a heading and moved to the beginning (see line 13). Further on the source text contains a section (‘Treatment period’, see line 154) which includes long passages of running text without simplifying structure, making finding information difficult (Knapp et al., 2011, p. 2). For these passages, new headings and subheadings, as well as new bullet points, have been inserted into the target text. Following the example of Knapp et al. (2011, pp. 7-8), the wording of headings has been changed in some cases in order to clarify the subject of the following section.

In some cases, the structure of sentences has been simplified by shortening and changing the order of information (lines 52, 55, 65, 183, 224, 348, 349).

Syntax:

The source text contains very long, at times very convoluted, sentences. A translation without shortening and/or structural changes would lead to even longer German sentences, thereby further reducing readability. Long sentences have been broken down in order to limit sentence length to a maximum of 20 words (and an average of about 12 words or below) and were edited to include only one new item of information (number of adaptations: 31, lines 17, 52, 55, 66, 72, 78, 88, 97, 101, 105, 121, 147, 166, 174, 202, 213, 230, 236, 244, 261, 266, 277, 280, 292, 299, 326, 340, 348, 353, 361, 368).

Terminology

There are many technical terms in the source text which may not be understandable to lay persons. This terminology has been translated into lay language, explained, or deleted, if redundant (number of adaptations: 12, lines 42, 45, 49, 66, 88, 132, 172, 178, 181, 228, 261, 305).

There are several terms in the source text which do not impair comprehensibility, but which could potentially lead to reduced comprehensibility and understanding if translated literally in the target text. This applies to ‘screening’ (lines 123, 127), which must not be translated as ‘Screening’ in patient information for clinical trials, since this term is known to German lay people only in the context of preventive examination (which is not the meaning here).

The wording ‘alternative treatment’ in the source text (line 361) could be misunderstood if translated literally into German as related to alternative (non-orthodox) medicine and has been replaced by an equivalent.

Style:

Passive wording in the source text has been changed to the active form once (line 13). The usage of ‘we’, which is found on one occasion in the source text (line 354), appears questionable since it leaves open who ‘we’ refers to (Penn, 2016, p. 119). For the translation, ‘we’ has been replaced by a more specific wording (‘the study site’).

One noun string in the source text has been replaced by verbal phrasing (line 200).

In three instances, ambiguous general wording in the source text has been replaced by specific wording (lines 128, 235, 387) in the target text.

Ethical aspects

No ethical aspects have been identified according to the criteria outlined above.

Cultural aspects

A higher level of explicitness has been used in the translation in comparison to the source text (number of adaptations: 10, lines 27, 51, 62, 142, 202, 249, 263, 275, 299, 315) which was found to be necessary to reduce ambiguities. One sentence contains interactional style (repeated later in the text) which has been avoided in the translation and replaced by a content-oriented standard term (lines 138, 242). No other cultural aspects were identified according to the criteria outlined above.

6.2             ICF 2, Bladder cancer study

6.2.1        Analysis

6.2.1.1  Quantitative analysis

Source text (number of words: 2,015)

Flesch-Index: 54.18. This corresponds to a ‘fairly difficult’ reading level.

Flesch-Kincaid grade level: 10.16. This rating does not meet the required reading level of 8th grade or below.

The average number of words per sentence is 17.95; the average number of syllables per word is 1.6.

Target text

Flesch-Index: 54. This score is the same as for the source text and likewise corresponds to a ‘fairly difficult’ reading level.

WSTF grade level: 9. This is 2 grade levels below the score for the source text, but does not meet a reading level of 8th grade or below.

The average number of words per sentence is 11.90; the average number of syllables per word is 1.96.

The target text scores at the same readability level measured by Flesch-Index, and better than the source text measured by grade level. (In this text, many long words could not be changed as they are standard or common terms (e.g., ‘Nebenwirkungen’ [side effects], ‘Kopfschmerzen’ [headaches]).

6.2.1.2  Qualitative analysis

Text organisation:

Headings, paragraphs and bullet points from the source text have been applied to the translation. There are several long sections in the source text which contain unstructured running text. These sections have been structured with headings, subheadings, and bullet points in the translation. In some instances, information from the corresponding paragraph has been included in the heading (see lines 10, 43, 300, 335, 378). The order of information in the section ‘Why is this study being done’ is not coherent in the source text, making it difficult to find and understand information. This has been resolved in the translation by changing the order of information and adding three subheadings (see lines 69, 99, 116). The order of information in paragraph ‘cystoscopy’ (line 186) has also been changed to improve the logical structure.

The source text also contains paragraphs with redundant information (information without value for the decision-making process, see lines 20, 123). These text parts have been deleted.

Syntax:

The source text contains very long sentences (average length: 18 words). As for the first document, the most adaptations in the translation were shortenings of sentences relative to the source text (number of adaptations: 23, lines 12, 34, 38, 51, 80, 84, 87, 89, 121, 145, 154, 157, 186, 205, 216, 224, 261, 379, 429, 436, 460, 469, 491). One sentence has been shortened by simplifying the wording (line 436).

Terminology

The source text contains unexplained special terminology and technical jargon like ‘[side effect] has been reported’ (line 330) as well as unclear wording which has been marked for client consultation (lines 225, 269, 434). These text parts have been adapted by deletion, if redundant, or by rewording, explanation, or replacement with lay terms (number of adaptations: 9, lines 47 [2 times], 93, 120, 193, 217, 247, 255, 258, 262, 328, 345).  One technical term has not been adapted as this would have required a very long explanation (line 45).

For the title of the document, ‘Patient informed consent (…)’ (line 1), the most common translation in German has been chosen (‘Patienteninformation und Einwilligungserklärung’), as recommended by Harnischmacher et al. (2006, p. 20).

The source text contains a few terms (‘healthcare team’ ‘consenting professional’), which could cause problems of understanding if translated literally, due to differences in the health care systems between the countries of the source and target texts. These terms have been adapted (lines 27, 285, 491). Some terms have been simplified or shortened (lines 157, 198, 329, as well as repeatedly ‘study’ instead of ‘research study’).

Style:

Passive wording in the source text has been changed to the active form twice (line 10, 241). The source text contains general, ambiguous wording which has been replaced by more specific phrases (lines 11, 117, 201, 491). On one occasion, direct speech has been inserted to create consistency with wording in other headings (line 400).

The pronoun ‘we’ (line 405) has been adapted in the translation (using a preposition), since it is not known, who ‘we’ refers to.

Ethical aspects:

The source text contains the wording ‘Patients […] fail [a treatment]’ (lines 119, 122), a common phrase in medical communication. O´Moore-Klopf (2019) comments: ‘Treatments fail, patients do not fail treatments’. An adaptation for the target text was not necessary because a literal translation of this term is not possible, and the German equivalent (back-translated: ‘[the treatment] works for the patient’) has no connotation of ‘failure’.

The statement in the source text, ‘There is also a risk of death’, has been found to be frightening and therefore has been reworded (the positive statement has been converted into a negative statement, (‘The risk of death cannot be excluded’) (line 293).

Cultural aspects:

As in the first translation, a higher level of explicitness has been used relative to the source text (number of adaptations: 9, lines 39, 87, 125, 162, 198, 251, 402, 456, 469). A more direct wording has been chosen on several occasions (lines 38, 231, 241, 296). In one sentence, the interactional style in the source text has been converted into a formal, content-oriented style (line 168).

6.3.     ICF 3, Ocular melanoma study

6.3.1        Analysis

6.3.1.1 Quantitative analysis

Source text (number of words: 2,030)

Flesch-Index: 47.62. This corresponds to a ‘difficult’ reading level.

Flesch-Kincaid grade level: 11.99. This rating does not meet the required reading level of 8th grade or below.

The average number of words per sentence is 21.62; the average number of syllables per word is 1.62.

Target text

Flesch-Index: 52. This score is better than for the source text and corresponds to a ‘fairly difficult’ reading level.

WSTF grade level: 10 (according the WSTF formulas 1, and 2), or 9 (according to WSTF formulas 3 and 4). This is two to three grade levels below the score for the source text, but does not meet a reading level of 8th grade or below.

The average number of words per sentence is 12.01; the average number of syllables per word is 1.99.

6.3.1.2. Qualitative analysis

Text organisation:

The source text contains headings and subheadings, bold print and underlining to arrange information. This structure has been applied to the translation. Two subheadings have been added to better classify information (lines 12, 32).  The large amount of running text in the source text has been addressed by adding bullet points throughout the document.

In one section (‘cell harvest and growth’, line 70) information in the source text was poorly organized. This has been addressed by splitting the heading and re-structuring the information in this section.

A relatively large amount of redundant information in the source text has been deleted in the target text (lines 42, 75, 80, 123, 132, 146).

Syntax

The average length of sentences in this source text is particularly long (21). Most adaptations in the translation were shortenings and/or simplifications of sentences to limit length and to include only one piece of information per sentence (number of adaptations: 33, lines 16, 20, 72, 117, 138, 151, 160, 177, 187, 192, 196, 199, 206, 212, 224, 236, 243, 253, 265, 277, 284, 295, 302, 320, 331, 340, 348, 355, 360, 365, 397, 410, 417). Redundant words and filling words have been deleted.

Terminology:

The text contains unexplained special terms which could not be adapted without major text changes as well as other unclear and inaccurate information which would require client consultation (see comments, lines 74, 134, 166, 167). Other unexplained special terminology in the source text has been reworded, deleted (where redundant), or explanation has been added; abbreviations have been replaced by full words or lay terms (number of adaptations: 17, lines 72, 79, 88, 109, 117, 135, 147, 186, 222, 226, 231, 252, 282, 370, 374, 375, 419).

The usage of the term ‘cells’ (throughout the source text) is ambiguous as it sometimes applies to cells in general, sometimes to TIL (tumour infiltrating cells). Therefore, ‘cells’ has been specified to ‘TIL cells’ throughout the text, where appropriate (lines 92, 183, 205, 328, 349).

Style:

The frequent usage of ‘we’ in the source text is not explained (Penn, 2016, p. 119). Therefore, ‘we’ has been either omitted or replaced by a more specific term, where possible (number of adaptations: 7, lines 27, 276, 326, 334, 357, 394, 403), passive/indirect wording, if necessary (number of adaptations: 8, lines 86, 89, 94, 151, 183, 203, 250, 253) or by direct speech (number of adaptations: 8, lines 10, 96, 98, 256, 273, 302, 332, 422).

In 2 cases, specific wording has been chosen to replace general wording in the source text (lines 10, 421).

Passive wording has been replaced by active wording in the target text several times (lines 120, 192, 219).

Ethical aspects:

A very commonly used term in patient information is ‘to undergo’ (e.g., a procedure), which translates as ‘sich unterziehen’ into German. While formally correct, this term can have a negative connotation since most of its synonyms imply sacrifice, submission, or affliction, thereby pointing to a passive and subordinate role of patients in these contexts. For this reason, the term ‘sich unterziehen’ has been paraphrased (lines 112, 178, 321).

Another ethical aspect was found to be the wording that a patient is ‘eligible’ (for the medicine, line 241). It appears to be more appreciative and respectful for the contribution of patients in this context to state the eligibility of a medicine for the patient instead (O´Moore-Klopf, 2019), which was reflected by an adaptation in the translation.

The wording ‘may cause your death’ (line 392) has been found to sound frightening. In this case, the possessive pronoun was replaced by the definite article in the translation (back-translated: ‘may lead to death’).

Cultural aspects:

A more explicit wording has been chosen in 9 instances (lines 16, 32, 40, 52, 172, 196, 231, 381, 404). The interactional style of the source text has been converted into more content-oriented wording on four occasions (lines 116, 259, 284, 360). A more direct wording to reduce ambiguities has been chose several times (lines 302, 334, 366, 405).

7.      CONCLUSIONS

7.1      Summary and discussion of results

Some of the steps to increase comprehensibility (in particular, text organisation, rewording of headings and deletion of text parts) would require a consultation with the client and may be more easily implemented within a well-established client relationship.

7.1.1    Quantitative analyses

The source texts scored with 3 (ICF 1), 2 (ICF 2), 4 levels (ICF 3) above the recommended grade level as measured by Flesch-Kincaid. The translated texts were scored as 2 grades below (ICF 1), 1 grade below (ICF 2), and 2-3 grades below (ICF 3) the level of the source texts by WSTF (Wiener Sachtextformel). The Flesch-Index showed a different picture: here the target texts scored similar or only slightly better than the source texts (3 points for ICF 1, 0 points for ICF 2, and 5 points for ICF 3), and the translations were assigned to the same readability category (‘fairly difficult’) as the originals, except for ICF 3, where a better readability category was achieved. This gives rise to the question which of these tools are best suited to compare readability in English and German texts – the Flesch-Index, originally developed for the English language and later adopted to a German formula, or the Wiener Sachtextformel, which was developed specifically for the German language. More research is needed to answer this.

Regarding the grade level, the improvements for all three translations were significant compared to the original text. This has been principally achieved by shortening and simplifying sentences and words – the criteria which form the base for the formulas.

As readability formulas measure only quantitative text characteristics, the results must be used with caution. How understandable a term is, how logical the structure of information or how comprehensible the presentation of information is not reflected by readability scores. For example, the tools marked many long words which are very common terms (such as ‘Nebenwirkungen’ [side effects]) and will probably rarely reduce readability. Readability formulas also disregard layout, an important feature to enable patients to find information in a text (Knapp et al., 2011, p. 2).

Nevertheless, as commonly used tools in readability research the formulas can be considered a valuable source to guide improvements in readability. Focusing on quantitative, next to qualitative, features of a text can help translators to achieve better results. To intensify knowledge about the usefulness of readability formulas for translations, systematic comparisons between ‘regular’ medical translations (without appliance of quantitative readability criteria) and translations under conscious consideration of these criteria might be an appropriate first step.

7.1.2    Qualitative analyses

The source texts often contained long running text, redundant text, and poorly ordered information. Text organisation led to improved clarity and logical structure in all three translations, making it easier to find information. However, further research would be required to provide an objective assessment of the role of text organization in improving comprehensibility, preferably involving test persons.

The most changes addressed syntax and terminology. The syntax was significantly simplified in many cases, especially by splitting sentences. This appears to be one of the most important steps to consider for translations from English into German. The generally shorter English words and the possibility of stringing together large amounts of information without using subordinate clauses can create very long, complex sentences – a common feature of English technical language, as Hüging (2011, p. 11) points out. Significant adaptations may be required to avoid producing even more convoluted sentences in German.

Another important adaptation, although apparent only for ICF 3, was the spelling in full of abbreviations. The frequent use of abbreviations is a common feature of technical language, which, however, decreases the comprehensibility of a text (Hüging, 2011, p. 191).

Each of the sample texts contained wording which did not represent a barrier to comprehensibility in the source language, but could be problematic for the target language if translated literally.

Providing specific in place of general wording provided the most opportunities for stylistic improvement in the three documents, while replacements of passive with active forms or nouns with verbs were required in very few instances. On the contrary, for the last document, ICF 3, the translation contained more passive wording than the original because, for reasons stated, the personal pronoun ‘we’ was replaced. As direct speech is a requirement of Ethical Review Committees in Germany (see chapter 5.1.1.2), such an adaptation should normally be avoided – and can be easily avoided, when the persons who represent ‘we’ are identified in the text.

The qualitative analysis identified some ethical concerns in ICFs 2 and 3. Although the number of identified issues does not appear to indicate this as a major topic, the text described in ICF 3 represents very common wording in patient information documents and refers to the acknowledgement of patients´ active role. This may therefore provide a basis for further discussion and research.

Contrastive cultural aspects, as per the pre-set criteria, were in most cases related to differences in the level of explicitness and directness, followed by replacements of interactional wording with content-oriented style.  Considerations of cross-cultural dimensions appear to have a potentially important role in the translation of patient information documents.

7.2      Implications for translators

The formal analyses of these three texts have shown that a careful consideration of defined criteria can improve the readability of the target text significantly, although less so according to the Flesch-Index test. The qualitative analysis that defined criteria for comprehensibility beyond quantitative assessments has revealed potential for improvement in many instances. Ethical and cultural aspects have shown to play an important role in the translation of these sample ICFs.

The results show that the translated content can be made more accessible compared to the source text, when applying pre-defined quantitative and qualitative criteria derived from existing related norms. As mentioned above, further research is needed for more substantial and objective results, including studies with test persons such as (potential) clinical study participants and/or translators.

Future research will also need to reflect fact that rules related to comprehensibility, ethics and cultural differences may change over time. Snel Trampus (2002, pp. 47, 48) points to the ‘relativity of norms’ and their fluctuating nature. While it can be assumed that convoluted sentences and technical language will always be considered poorly comprehensible, it is not clear what may be assessed as unethical language in coming years, or if future generations of Germans will still expect more explicit information or prefer more direct communication in comparison with English speakers. Cultural norms tend to become more universal, or in fact, shift more towards Anglo-American norms (House, 2002, pp. 107, 108)

While the aspects of comprehensibility, ethics and culture which have been described in this research are related to practical problems, the solutions discussed in this paper are usually not applied in the translation process. This represents a significant limitation for real-life, day-to-day translations, where time, budget, and client requirement constraints have to be considered. The only part of this analysis which medical translators routinely deal with is special terminology, which requires different considerations depending on whether the target text is intended for medical experts or patients. Given these limitations, it appears to be a ‘nice-to-have’, if not, strictly speaking, expendable procedure for translators to include readability formulas and comprehensive qualitative accessibility criteria into their workflow.

On the other hand, translators, as the authors of the target text, take responsibility for its ‘performance’, which includes the accessibility for the given target audience. With the growing number of clinical studies and the corresponding increase in volume of patient information related to them, it is to be expected that related norms will be increasingly required and standardised. If and when such binding requirements and/or guidelines for comprehensibility, ethical language and cross-cultural differences have been established, translators will have to use the relevant standards to ensure good results.

With no clearly defined, legally binding requirements in effect, the knowledge and usage of quantitative and qualitative accessibility criteria may nonetheless represent a resource to improve translations. It can be also a ‘competitive advantage’ for translators, especially in well-established working relationships with agencies and direct clients that allow for time and opportunity to communicate such considerations. Ultimately, translators may be able develop new expertise to integrate writing/revising instead of ‘only’ translating patient information into their services. This would be a way to improve accessibility ‘at the source’ and to pursue one´s own writing skills, if desired. Translators often face strong competition and pressure on their reimbursement rates. To survive and flourish, and to maintain satisfaction with the art of translation, it is necessary for translators to specialize and refine their services in a creative way.

Bibliography

Agency for Healthcare Research and Quality of the U.S. Department for Health and Human Services (AHRQ) (n.d.). Tip 6. Use Caution With Readability Formulas for Quality Reports. Retrieved from https://www.ahrq.gov/talkingquality/resources/writing/tip6.html

Arbeitskreis Medizinischer Ethik-Kommissionen [Working Group of Medical Ethics Commissions] (2008). Merkblatt zur Verwendung der Mustertexte für die Patienten-/Probanden-information und -einwilligung. [Information Sheet on the Use of Sample Texts for the Information and Consent of Patients/Subjects]. Retrieved from:

https://www.ak-med-ethik-komm.de/docs/MerkblattSommertagung08endg.doc

Baumert, A. (2016). Leichte Sprache – Einfache Sprache. Literaturrecherche, Interpretation, Entwicklung [Simple Language – Plain Language. Literature Research, Interpretation, Development]. Retrieved from https://serwiss.bib.hs-hannover.de/frontdoor/deliver/index/docId/697/file/ES.pdf

Bleiberg, H., Decoster, G., de Gramont, A., Rougier, P., Sobrero, A., Benson, A. (…), Zalcberg, J. (2017). A need to simplify informed consent documents in cancer clinical trials. Annals of Oncology 28(5), 922-930.

Brown, S., Fullerton, S., Bares, J., Jarvik, G., Larson, E., Burke, W. (2012). Informed Consent in Genome-Scale Research: What Do Prospective Participants Think? AJOB Primary Research, 3(3), 3-11. doi: 10.1080/21507716.2012.662575

Bundesamt für Justiz (2010). Verordnung über klinische Prüfungen von Medizinprodukten [Ordinance on Clinical Trials with Medical Devices]. Retrieved from https://www.gesetze-im-internet.de/mpkpv/

Bundesärztekammer (2018). Musterberufsordnung-Ärzte. Retrieved from https://www.bundesaerztekammer.de/recht/berufsrecht/muster-berufsordnung-aerzte/

Chalmers, I. (1999). People are “participants” in research. BMJ, 318(7191): 1141. doi: 10.1136/bmj.318.7191.1141a

Collins, J., Sather, M. (2002). Regulatory Issues for Clinical Trials in Humans. Epidemiologic Reviews, 24(1). https://doi.org/10.1093/epirev/24.1.59

DeNeen, L. (2017). “You´ve got bad blood”: The horror of the Tuskegee syphilis experiment. The Washington Post. Retrieved from https://www.washingtonpost.com/news/retropolis/wp/2017/05/16/youve-got-bad-blood-the-horror-of-the-tuskegee-syphilis-experiment/?noredirect=on&utm_term=.187b7917f0fa

European Commission (2009). Guideline on the readability of the labelling and package leaflet of medicinal products. Retrieved from https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf

Food and Drug Administration (2006). Guidance on Useful Written Consumer Medication Information (CMI). Retrieved from https://www.fda.gov/downloads/drugs/guidances/ucm080602.pdf

Food and Drug Administration (2014). Patient Counseling Information, Section of Labeling for Human Prescription Drug and Biological Products – Content and Format. Retrieved from https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368602.pdf

Goodenough, W. (1964). Cultural anthropology and linguistics. In Hymes, D. (ed.), Language in Culture and Society (pp. 36-39). New York: Harper and Row.

Göpferich, S. (2019). Textverstehen und Textverständlichkeit [Text comprehension and comprehensibility of text]. In H. Janich (Ed.), Textlinguistik. 15 Einführungen und eine Diskussion [Textlinguistics. 15 introductions and one discussion] (pp. 281-302). Tübingen: Narr Franke Attempto Verlag + Co. KG.

Harnischmacher, U., Ihle, P., Berger, B., Goebel, J., Scheller, J. (2006). Checkliste und Leitfaden zur Patienteneinwilligung: Grundlagen und Anleitung für die klinische Forschung [Check list and guideline for patient informed consent: basis and instructions for clinical research]. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft.

Hart, S. (2015). Patient education accessibility. Medical Writing, 24(4), 190-194. Retrieved from file:///C:/Users/kdjon/Downloads/2047480615z2e000000000321.pdf

Haug, O., Box, G., Kohn, M., Streiftau, N., Haseloff, A. (2011). Prüfung der Verständlichkeit und Lesbarkeit von Arzneimittelinformationen anhand aktuell am Markt befindlicher Packungsbeilagen [Review of the comprehensibility and readability of drug information based on patient information inserts currently on the market]. Retrieved from https://www.langcor.de/PDF/Packungsbeilagen-Studie-OTC-2010.pdf

Herschel, M. (2009). Das KliFo-Buch: Praxisbuch Klinische Forschung. [Manual of Clinical Research]. Stuttgart: Schattauer.

Hofstede, G. (2003). Culture's Consequences: Comparing Values, Behaviors, Institutions and Organizations Across Nations. Thousand Oaks: Sage Publications.

House, J., Kasper, G. (1981). Politeness Markers in English and German. In F. Coulmas (Ed.), Conversational Routine. Explorations in Standardized Communication Situations and Prepatterned Speech (pp. 160-184). The Hague: Mouton Publishers.

House, J. (1996). Contrastive Discourse analysis and misunderstanding: The case of German and English. In M. Hellinger and U. Ammon (Eds.), Contrastive Sociolinguistics (pp. 345-357), Berlin, New York: Mouton de Gruyter.

House, J. (2002). Universality versus culture specificity in translation. In: A. Riccardi (Ed.). Translation Studies. Perspectives of an Emerging Discipline (pp. 92-109). Cambridge: University Press.

HREBA (Health Research Ethics Board of Alberta): Clinical Trials Committee (n.d.). Standard Consent Form. Retrieved from https://hreba.ca/hreba-clinical-trials-committee/informed-consent-forms/

Hüging, A. (2011). Übersetzerisches Handeln im Kontext der medizinischen Fachkommunikation [Translational processes in the context of technical communication in medicine]. Trier: WVT Wissenschaftlicher Verlag Trier.

John Hopkins Medicine, Institutional Review Board (2016). Informed Consent Guidance – How to Prepare a Readable Consent Form. Retrieved from https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_ii.html

Knapp, P., Raynor, D., Silcock, J., Parkinson, B. (2011). Can user testing of a clinical trial patient information sheet make it fit-for-purpose? – a randomized controlled trial. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21777435

Lehtonen, T. (2011). Ethical Problems Related to Language and Linguistic Practices. VAKKI:n julkaisut 38(2011), 200-211. Retrieved from

www.vakki.net/publications/2011/VAKKI2011_Lehtonen.pdf

Lutz, B. (2017). Modelle für die verständliche Fachkommunikation [Models for Comprehensible Technical communication]. trans-kom 10(3), 282-314. Retrieved from http://www.trans-kom.eu/bd10nr03/trans-kom_10_03_02_Lutz_Verstaendlichkeit.20171221.pdf

Munley B., Buser A., Gaudreau S., Breault J., Bazzano L. (2018). An Analysis of Informed Consent Form Readability of Oncology Research Protocols. Journal of Empirical Research on Human Research Ethics, 13(4), 363-367. Retrieved from https://journals.sagepub.com/doi/abs/10.1177/1556264618795057?journalCode=jrea

Office of the Federal Register (OFR) (2018). Electronic Code of Federal Regulations. Retrieved from https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1116

O´Moore-Klopf, K. (2019, January 14). Tips for Using Patient-Friendly Language [Blog post]. Retrieved from https://aceseditors.org/news/2019/tips-for-using-patient-friendly-language

Paasche-Orlow, M., Taylor, H., Brancati, F. (2003). Readability Standards for Informed-Consent Forms as Compared with Actual Readability. The New England Journal of Medicine 348(8), 721-726. Retrieved from https://www.nejm.org/doi/pdf/10.1056/NEJMsa021212

Penn, D. (2016). Ein Überblick über klinische Studien und das Übersetzen von Studiendokumenten [An Overview of Clinical Studies and the Translation of Study-related Documents]. Berlin: BDÜ Weiterbildungs- und Fachverlagsgesellschaft mbH.

Plain Language Action and Information Network (2011). Federal plain language guidelines. Retrieved from https://www.plainlanguage.gov/guidelines/

Rammstedt, B., Maehler, D. (2013). Eine internationale Studie zur Untersuchung von Alltagsfertigkeiten Erwachsener [an international study to investigate daily life skills of adult persons]. Die Magazin Thema Forum III/2014, 26-29. Retrieved from https://www.die-bonn.de/zeitschrift/32014/kompetenz-05.pdf

Reinert, C., Kremmler, L., Burock, S., Bogdahn, U., Wick, W., Gleiter, C., Koller, M., Hau, P. (2014). Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials. European Journal of Cancer, 50(1), 150-158. Retrieved from https://doi.org/10.1016/j.ejca.2013.09.006

Salchert, M. (2012). Verständliches Schreiben – Mehr Erfolg durch gute Texte [Comprehensible Writing – More Success through Good Texts] (Materials for self-learning). Retrieved from the website of the Bundesakademie für öffentliche Verwaltung: https://www.bakoev.bund.de/SharedDocs/Publikationen/LG_2/Selbstlernheft_Verstaendliches_Schreiben.pdf?__blob=publicationFile

Saldanha, G. (2014). Research methodologies in translation studies. London: Routledge.

Sänger, S., Lang, B., Klemperer, D., Thomeczek, C., Dierks, M. (2006). Manual Patienteninformation: Empfehlungen zur Erstellung evidenzbasierter Patienteninformationen. [Manual of Patient Information: Recommendations for the creation of evidence-based Patient Information]. Berlin: Ärztliches Zentrum Qualit. Gesundheitsinformationen

Schäffner, C. (1999). The Concept of Norms in Translation Studies. Current Issues in Language & Society 5(1-2), 1-7. https://doi.org/10.1080/13520529809615500

Schmidt, H., Alilovic, I., Klärs, G. (2011). Evaluation schriftlicher Gesundheitsinformationen zu Brustkrebs [Evaluation of written health information on breast cancer]. In in Deutschland [Health information in Germany] (pp. 95-104). Köln: Gesellschaft für Versicherungswissenschaft und -gestaltung. Retrieved from http://gesundheitsziele.de/cms/medium/675/Band_67_f.pdf

Scott, B. (n.d.). The Flesch Reading Ease Readability Formula. Retrieved from http://www.readabilityformulas.com/flesch-reading-ease-readability-formula.php

Sharp, S. (2004). Consent documents for oncology trials: does anybody read these things? American Journal of Clinical Oncology 27(6), 570-5. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/15577434

Snel Trampus, R. D. (2002). Aspects of a theory of norms and some issues in teaching translation. In: A. Riccardi (Ed.). Translation Studies. Perspectives of an Emerging Discipline (pp. 38-55). Cambridge: University Press.

Stolze, R. (2009). Dealing with cultural elements in technical texts for translation. The Journal of Specialised Translation 11(1-1), 124-142. Retrieved from http://www.jostrans.org/issue11/art_stolze.pdf

Stossel, L, Segar, N., Gliatto, P., Fallar, R., Karani, R. (2012). Readability of Patient Education Materials Available at the Point of Care. Journal of General Internal Medicine 27(9), 1165-70. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/22528620

U.S. Department of Health and Human Services (2000). Healthy People 2010. Washington, DC: U.S. government Printing Office.

Toury, G. (2012). The Nature and Role of Norms in Translation. In L. Venuti (ed.), The Translation Studies Reader (3rd edition, pp. 168-181). London: Routledge

Viomedo. (2016). Herzstück medizinischen Fortschritts: Deutschland führender Standort für klinische Studien. [Core medical advancements: Germany a leading location for clinical studies]. Retrieved from https://www.viomedo.de/posts/klinische-studie-herzstueck-medizinischen-fortschritts

Williams, J., Chesterman, A. (2002). The map: a beginner´s guide to doing research in translation studies. Manchester: St. Jerome Pub.

World Medical Association (2018). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

Language Resources

International Plain Language Association (2019). Retrieved from http://www.iplfederation.org/

Online Community Dictionary (n.d.). Retrieved from https://www.definition-of.com/lay+language

Oxford English Dictionary (n.d.). Retrieved from https://en.oxforddictionaries.com/

Get a quote: katharina@pontesmedica.com

Return to Home