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How well do doctors understand a scientific article in English when it is not their first language? A randomised trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-043444

Article Type: Original research

Date Submitted by the 07-Aug-2020 Author:

Complete List of Authors: Rostadmo, Martine; Journal of The Norwegian Medical Association, Strømme, Siri Lunde; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 , Nylenna, Magne; , Box 1171, Blindern, 0318 Oslo, Norway; The Norwegian Institute of Public Health, Box 222 Skøyen, 0213 Oslo, Norway Gulbrandsen, Pal; University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway, Institute of Clinical Medicine; HØKH, Akershus University Hospital, Box 1000, 1478 Lørenskog, Norway Hem, Erlend; University of Oslo, Box 1171 Blindern, 0318 Oslo, Norway, Department of Behavioural Sciences in Medicine; , Postboks 4956 Nydalen, 0424 Oslo, Norway, Division of Mental

Health and Addiction http://bmjopen.bmj.com/ Skovlund, E; Norwegian University of Science and Technology NTNU, Department of Public Health and Nursing Brean, Are; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway; The Norwegian Academy of Music, Box 5190 Majorstuen, 0302 Oslo, Norway Orstavik, Ragnhild; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway; The Norwegian Institute of Public health, Box 222 Skøyen, 0213 Oslo, Norway

Health economics < HEALTH SERVICES ADMINISTRATION & on October 1, 2021 by guest. Protected copyright. MANAGEMENT, MEDICAL JOURNALISM, HEALTH ECONOMICS, Human Keywords: resource management < HEALTH SERVICES ADMINISTRATION & MANAGEMENT

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1 2 3 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 1 2 3 How well do doctors understand a scientific article in English when it is not their first language? A 4 randomised trial BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 6 7 Authors' names: 8 9 Martine Rostadmo (0000-0003-3401-5203), Siri Lunde Strømme (0000-0002-9566-0954), Magne 10 Nylenna (0000-0002-5180-1225), Pål Gulbrandsen (0000-0001-7434-5392), Erlend Hem (0000-0002- 11 1845-1147), Eva Skovlund (0000-0002-2997-6141), Are Brean (0000-0001-5683-5099), Ragnhild 12 13 Ørstavik (0000-0003-2640-3273) 14 15 Authors' addresses and positions: 16 17 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 18 For peer review only 19 Martine Rostadmo 20 21 Editor 22 23 24 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 25 26 Siri Lunde Strømme 27 28 Scientific Editor 29 30 31 University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway 32 33 The Norwegian Institute of Public Health, Box 222 Skøyen, 0213 Oslo, Norway 34 35 Magne Nylenna 36

37 Professor http://bmjopen.bmj.com/ 38 39 40 Institute of Clinical Medicine, University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway 41 42 HØKH, Akershus University Hospital, Box 1000, 1478 Lørenskog, Norway 43 44 Pål Gulbrandsen

45 on October 1, 2021 by guest. Protected copyright. 46 Professor 47 48 49 Department of Behavioural Sciences in Medicine, University of Oslo, Box 1111 Blindern, NO-0317 50 Oslo, Norway 51 52 Division of Mental Health and Addiction, Oslo University Hospital, Box 4956 Nydalen, NO-0424 Oslo, 53 Norway 54 55 Erlend Hem 56 57 Professor 58 59 60

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2 1 2 3 Department of Public Health and Nursing, Norwegian University of Science and Technology, NTNU, 4

PO Box 8905, 7491 Trondheim, Norway BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 6 Eva Skovlund 7 8 Professor 9 10 11 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 12 13 The Norwegian Academy of Music, Box 5190 Majorstuen, 0302 Oslo, Norway 14 15 Are Brean 16 17 Editor in chief 18 For peer review only 19 20 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 21 22 The Norwegian Institute of Public health, Box 222 Skøyen, 0213 Oslo, Norway 23 24 Ragnhild Ørstavik 25 26 Deputy Editor 27 28 29 30 31 Corresponding author: 32 33 Martine Rostadmo: [email protected] 34 35 36 Licence: The lead author has the right to grant on behalf of all authors and does grant on behalf of all

37 http://bmjopen.bmj.com/ 38 authors, an exclusive licence on a worldwide basis to the BMJ Publishing Group Ltd to permit this 39 article (if accepted) to be published in BMJ editions and any other BMJPGL products and sublicences 40 such use and exploit all subsidiary rights, as set out in their licence. 41 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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3 1 2 3 How well do doctors understand a scientific article in English when it is not their first 4 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 language? A randomised trial 6 7 8 Abstract 9 Introduction 10 11 English is the lingua franca of science. How well doctors understand English is therefore crucial for 12 their understanding of scientific articles. However, only 5 % of the world's population have English as 13 their first language. 14 15 Methods 16 17 Objectives: To compare doctors' comprehension of a scientific article when read in their first 18 language (Norwegian)For versus their peer second language review (English). Ouronly hypothesis was that doctors 19 reading the article in Norwegian would comprehend the content better than those reading it in 20 English. 21 22 Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical 23 review article in either Norwegian or English, before completing a questionnaire about the content of 24 the article. 25 26 Setting: Conference in primary care medicine in Norway, 2018 27 28 Participants: 130 native Norwegian speaking doctors, 71 women and 59 men. One participant 29 withdrew before responding to the questionnaire and was excluded from the analyses. 30 31 Interventions: Participants were randomly assigned to read a review article in either Norwegian 32 (n=64) or English (n=66). Reading time was limited to seven minutes followed by seven minutes to 33 answer a questionnaire. 34 35 Main outcome measures: Total score on questions related to the article content (potential range -9 36 to 20).

37 http://bmjopen.bmj.com/ 38 Results 39 Doctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared to 40 41 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% 42 confidence interval 0.03 to 2.62; p=0.046). Age was independently associated with total score, with 43 decreased comprehension with increasing age. 44 Conclusion 45 on October 1, 2021 by guest. Protected copyright. 46 The difference in comprehension between the group who read in Norwegian and the group who read 47 48 in English was statistically significant but modest, suggesting that the language gap in academia is 49 possible to overcome. 50 51 52 53 Article summary 54 55 Strengths and limitations of this study 56  This study contributes to the sparse literature on the subject of science comprehension. 57 58  Participants were bilingual doctors; a presumably homogenous population regarding 59 language, level of education and socioeconomic class. 60  The authors were blinded to the outcome whilst analysing the data.

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4 1 2 3  The results are probably not generalizable to all non-anglophone scientific communities. 4  Further research is needed to ascertain how the language gap in academia most effectively BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 6 can be closed. 7 8 9 Introduction 10 English is considered the global lingua franca of scientific research and publication, but only about 5 11 12 % of the world's population has the privilege of having English as their native language.1 Equity in 13 14 global access to research is an important goal. Open access publishing and enabling low- and middle- 15 16 income countries access to collections of biomedical and health literature through the Hinari 17 program, are important steps in this direction.2 They do not, however, help readers overcome their 18 For peer review only 19 language barrier.3 Non-native English speaking scientists experience disadvantage as they read, do 20 21 research, publish and attend conferences in a different language than the one that is closest to their 22 culture, thoughts and feelings.4 23 24 25 To date, research on second language comprehension has primarily targeted children, adolescents 26 and immigrants to English-speaking countries,5 while little is known about professionals. Our 27 28 research group conducted a study in 2002, which concluded that Scandinavian doctors' ability to 29 30 retain information from a review article was better when they read the article in their mother tongue 31 than in English .6 To the best of our knowledge, no similar study has been conducted since. 32 33 34 Norwegian is the official language in Norway, and the spoken and written language of daily life, in 35 doctor's offices and hospitals. Children in Norway learn English as a second language in school from 36 7 37 age six, and Norway is ranked third in the world for non-native English proficiency. http://bmjopen.bmj.com/ 38 39 The aim of our study was to learn about comprehension of science when presented in first versus 40 41 second language. Our objective was to compare doctors’ ability to answer questions correctly about 42 43 the content in a scientific article after having read the article in either their first language 44 (Norwegian) or their second language (English). Our hypothesis was that doctors reading the article

45 on October 1, 2021 by guest. Protected copyright. 46 in Norwegian would comprehend the content better than doctors reading the article in English. 47 48 49 Methods 50 Study design 51 52 53 We performed a parallel group randomised controlled trial among doctors who attended a 54 conference in primary care medicine in Oslo 22nd- 26th October 2018. Participants were randomised 55 56 to read the same review article on paper in either Norwegian or English (appendix 1).8 57 58 Setting and participants 59 60

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5 1 2 3 Approximately 1200 doctors working within primary care or public health attended the conference. 4 5 Participants were consecutively recruited in the conference exhibition area. They were informed that BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 we wanted to test whether different presentations of a scientific article affected reading 8 comprehension and the ability to retain information. Before finally agreeing to participate, attendees 9 10 were given written information about the study (appendix 2), including that only doctors with 11 12 Norwegian as first language were eligible for participation. 13 14 Randomisation 15 16 We randomised participants by letting them pick an envelope from a box. The envelope contained 17 18 the article in either NorwegianFor peeror English. Each review participant would only open their envelope and start 19 20 reading the article, as an assistant set a digital alarm clock at seven minutes. After seven minutes, or 21 earlier if the participant had finished reading, the assistant collected the article, handed the 22 23 questionnaire to the participant and reset the alarm. 24 25 Data and variables 26 27 8 28 The topic of the article was the use of medication in pregnancy, thought to be a relevant issue for 29 GPs. The article had been accepted for publication in the Journal of the Norwegian Medical 30 31 Association but was not yet published at the time of the study. The English version was provided by 32 33 the professional translation agency that is used routinely by the Journal of the Norwegian Medical 34 Association.9 35 36

37 The article was 2300 words long. Reading time and the questionnaire had been separately piloted. http://bmjopen.bmj.com/ 38 Median reading time among pilot readers was 7.49 minutes for those reading in Norwegian and 8.35 39 40 minutes for those reading in English. We set the reading time to 7 minutes as we figured that time 41 42 pressure would highlight possible differences between the two groups, and because we wanted to 43 reflect the time pressure often met in clinical practice. We made minor modifications in the 44

45 questionnaire based on feedback from the piloting. on October 1, 2021 by guest. Protected copyright. 46 47 Both groups filled in the questionnaire in Norwegian, which covered four components: a) consent to 48 49 participate, b) demographic information on the participant, c) background knowledge on the topic of 50 51 the article and d) questions related to the content of the article (appendix 3). Demographic 52 information included gender and age group (<34, 35-44, 45-54, > 55 years). We tested background 53 54 knowledge on medication in pregnancy with a single multiple choice question with several correct 55 56 answers (potential range -5 to 5). Questions related to the article content included five multiple 57 58 choice questions (final scores potentially ranging from -9 to 12), and three open questions (range 0 to 59 8), adding up to a total potential score range from -9 to 20. Two of the authors (MR and SLS) 60

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6 1 2 3 independently scored the answers to the open questions based on pre-specified guidance and 4 5 blinded for language of the study article. They agreed in 83-94% of cases dependent on variable. In BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 cases of disagreement, consensus was reached by discussion (MR, SLS and RØ). 8 9 10 11 Power analysis 12 13 14 With random assignment to groups, independent samples of equal size, an alpha-level of 0.05, and 15 power (1-beta) of 0.80 a sample of n=128 would be necessary to detect an effect size of d=0.5 (two- 16 17 sided test). 18 For peer review only 19 Statistical analysis 20 21 22 Data were processed and primary analyses performed blinded for language of the study article. 23 The primary outcome of our study was the total score on questions related to the article content. 24 25 Groups were compared by two sample t-tests. Additional exploratory analyses were performed by 26 27 simple and multiple linear regression, with total score on questions related to the article content as 28 dependent variable and the following as independent variables: language, gender, age, and 29 30 background knowledge score. We tested for interaction between language and the following 31 32 variables respectively: gender, age, and background knowledge. Finally, we performed two 33 multivariate analyses: one limited to independent variables that were statistically significant in 34 35 univariate analyses and one including all independent variables. Statistical significance was defined 36

37 by an alpha level of 0.05. All analyses were performed in IBM SPSS Statistics 25. http://bmjopen.bmj.com/ 38 39 40 Patient and public involvement 41 42 This study did not include or directly relate to patients, and was therefore done without patient 43 44 involvement. Our research subjects are doctors, and the study was designed by doctors and doctors

45 on October 1, 2021 by guest. Protected copyright. 46 were involved at all stages of the process. The findings will be disseminated to the research subjects 47 and to the general public through The Journal of The Norwegian Medical Association. 48 49 50 Results 51 130 participants were recruited, of whom 64 read the article in Norwegian and 66 in English. One 52 53 participant in the first group withdrew before responding to the questionnaire and was excluded 54 55 from the analyses. This resulted in a final sample of 129 (63 vs 66) (fig. 1). 56 57 Table 1 presents demographic data and scores on background knowledge for each group. 58 59 Participants who read the article in Norwegian had a mean total score on questions related to the 60

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7 1 2 3 article content of 10.40 (SD 3.96) compared to 9.08 (SD 3.47) among participants who read the 4 5 article in English, giving a mean difference of 1.32 (95% confidence interval 0.03 to 2.62; p=0.046). BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 The results from the linear regression analyses are shown in table 2. Participants > 55 years had a 8 9 mean total score of 8.29 (SD 2.87) compared with 10.41 (SD 4.35) among participants < 34 years 10 11 (Unstandardized B -2.13 95% confidence interval -3.81 to -0.44; p=0.014). The effects of language 12 and age on total score were also statistically significant in both multivariate analyses (table 2). We 13 14 found no statistically significant interactions (data not shown). 15 16 17 18 For peer review only 19 Table 1. Characteristics of study population and scores on background knowledge. Values are 20 numbers (percentages) unless stated otherwise. 21 22 23 Variable Norwegian English 24 text text 25 (n=63) (n=66) 26 Gender 27 Female 35 (55.6) 35 (53.0) 28 Male 28 (44.4) 31 (47.0) 29 Age (years) 30 < 34 17 (27.0) 22 (33.3) 31 35-44 17 (27.0) 16 (24.2) 32 45-54 12 (19.0) 10 (15.2) 33 > 55 17 (27.0) 18 (27.3) 34 Score on background 1.33 (1.32) 1.06 (1.12) 35 knowledge, mean (SD)* 36

37 *Range -5 to 5 http://bmjopen.bmj.com/ 38 39 40 Table 2. Linear regression with total score related to the article content as the dependent variable. 41 Univariate and multivariate analyses (model 1 and model 2). 42 43 44

45 Univariate analysis Model 1* Model 2† on October 1, 2021 by guest. Protected copyright. 46 Variables Unstandardized B p- Unstandardized B p- Unstandardized B p- 47 (95% KI) value (95% KI) value (95% KI) value 48Language 49 Norwegian Reference Reference Reference 50 English -1.32 (-2.62 to -0.03) 0.046 -1.36 (-2.62 to -0.11) 0.034 -1.29 (-2.55 to -0.03) 0.046 51Gender 52 Female Reference - Reference 53 Male 0.11 (-1.21 to 1.43) 0.871 0.83 (-0.51 to 2.16) 0.222 54Age 55 < 34 Reference Reference Reference 56 57 35-44 0.47 (-1.24 to 2.18) 0.588 0.36 (-1.33 to 2.05) 0.673 0.61 (-0.11 to 2.32) 0.486 58 45-54 -1.37 (-3.29 to 0.56) 0.163 -1.51 (-3.42 to 0.39) 0.118 -1.46 (-3.37 to 0.44) 0.131 59 > 55 -2.13 (-3.81 to -0.44) 0.014 -2.19 (-3.85 to -0.53) 0.010 -2.21 (-3.91 to -0.51) 0.011 60

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8 1 2 3 Background 0.40 (-0.13 to 0.94) 0.140 - - 0.31 (-0.22 to 0.84) 0.243 4 ††

knowledge BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 *Adjusted for variables statistically significant in univariate analyses 6 7 †Adjusted for all independent variables ††Range -5 to 5 8 Discussion 9 10 We investigated whether reading comprehension of a scientific article was best in the subjects' first 11 12 or second language by randomising 130 native Norwegian doctors to read the same article in either 13 14 Norwegian or English, and then answer questions about the article content. Doctors who read the 15 article in their first language had more correct answers than the doctors who read the article in 16 17 English. The difference in score was small, but statistically significant. 18 For peer review only 19 Some of us performed a similar study in 2002 among Norwegian, Swedish and Danish doctors. All 20 21 three groups retained information from a given article better when read in their mother tongue 22 6 23 versus English, with a median (IQR) of 4 (3-6) versus 3(2-4) respectively (p=0.01). The two studies are 24 not directly comparable, but our results indicate that the difference might have diminished over the 25 26 past two decades. Our finding is also in line with previous research in the field of bilingualism.10 27 28 Comprehension is a complex process that is hard to define and even harder to test. It is the ability to 29 30 process text, decode its meaning, and to integrate that with what the reader already knows about 31 32 the subject. We tested comprehension in the same manner as at exams in many medical schools, 33 with a mix of multiple choice and open questions. We tested all participants in Norwegian, a choice 34 35 we made based on the presumption that true comprehension should be more than simple 36

37 recollection, i.e. if you read in a second language you should be able to answer questions about it in http://bmjopen.bmj.com/ 38 your first language. A possible pitfall with this design is that the participants asked to read the article 39 40 in English in a Norwegian context and then answer questions in Norwegian are subject to what is 41 42 known as linguistic switch costs.11 Switch costs refer to the cognitive burden of switching languages, 43 which results in longer processing times or higher error rates. This could explain the difference in 44

45 scores between the groups. on October 1, 2021 by guest. Protected copyright. 46 47 A strength of this study is that research subjects were recruited from a presumably homogenous 48 49 population regarding language, level of education and socioeconomic class, and then randomised. In 50 51 the field of bilingualism this is quite rare, as most studies on second language comprehension test

52 12 53 bilinguals with a monolingual control group ; often the bilingual group consists of a minority 54 population and the monolingual group consists of the cultural majority. This comes with a set of 55 56 systematic differences between the groups regarding culture, education and socioeconomic class. 57 58 Furthermore, testing bilinguals versus monolinguals is problematic in itself as it is well documented 59 that bilingualism per se offers a cognitive advantage in some tasks related to executive function.13 60

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9 1 2 3 One participant in the group who read in Norwegian withdrew before responding to the 4 5 questionnaire and was excluded from the analyses. Depending on the reason for non-response, the BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 estimated difference between groups might be slightly biased in this complete case analysis. 8 9 Our findings are probably not generalizable to all non-anglophone scientific communities for many 10 11 reasons. For one, English and Norwegian are both Germanic languages which means they have more 12 linguistic features in common than do for instance English and Russian or Hindi. Further, proficiency 13 14 in English is high in Norway compared to most other countries.7 Norwegian doctors do also have 15 16 better access to the Internet and to research articles both in English and in their first language than 17 do many colleagues in low- and middle-income countries. Hence, our results might be a best-case 18 For peer review only 19 scenario for comprehension of science in a second language. Similar studies in other countries would 20 21 yield additional insight. 22 23 Implications 24 25 In order to level the playing field in global academia, we must acknowledge that language is 26 27 intrinsically linked to power and privilege1. If the goal is to leave no-one behind,14 funding of 28 29 education in English and academic English in low-income countries is essential. In this mindset, 30 reaching those furthest behind would mean reaching the 6 billion people who do not speak English at 31 32 all. English as a common language in science offer unprecedented possibilities for cooperation, 33 34 mutual understanding and dissemination of research, and it can also be a democratising institution if 35 extended to all. 36

37 http://bmjopen.bmj.com/ 38 39 40 What is already known on this topic 41 42 95 % of the world's population does not have English as their first language 43 44 First and second languages are processed slightly differently in the brain

45 on October 1, 2021 by guest. Protected copyright. 46 Little is known about comprehension of science in a second language 47 48 What this study adds 49 Comprehension of a scientific article was almost as good in English as in Norwegian among the 50 51 doctors studied 52 53 Comprehension decreased with increasing age 54 The results of this study suggest that the language gap in academia is possible to overcome 55 56 57 Acknowledgments 58 59 We thank the participating doctors for their time and patience. 60

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10 1 2 3 Footnotes 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 Contributors: SLS, AB, RØ, PG, MN, EH and MR designed the study and collected the data. SLS, 7 AB, RØ, ES and MR analysed the data. SLS, AB, RØ and MR wrote the first draft of the manuscript. 8 All authors revised the manuscript and approved the final version of the submitted manuscript. The 9 corresponding author attests that all listed authors meet authorship criteria and that no others 10 meeting the criteria have been omitted. MR acts as the guarantor. 11 12 13 Transparency: MR affirms that the manuscript is an honest, accurate, and transparent account of the 14 study being reported; that no important aspects of the study have been omitted; and that any 15 discrepancies from the study as planned (and, if relevant, registered) have been explained. 16 17 Data sharing: Data is available upon request to the authors. 18 For peer review only 19 Funding: The study was funded by The Journal of The Norwegian Medical Association. 20 21 22 23 Competing interests: All authors have completed the ICMJE uniform disclosure form at 24 www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted 25 work; no financial relationships with any organisations that might have an interest in the submitted 26 work in the previous three years; and no other relationships or activities that could appear to have 27 influenced the submitted work. 28 29 30 Ethical approval: Participation was voluntary and based on informed consent. We included few 31 demographic variables to ensure anonymity in accordance with criteria from the Norwegian Centre 32 for Research Data. The Data Protection Officer at the Norwegian Medical Association approved the 33 plan for handling the data. The project confers to the standards for ethical research defined by The 34 35 Norwegian Research Ethics Committees. 36

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45 1. Crystal D. English as a Global Language. 2. ed: Cambridge University Press 2012. on October 1, 2021 by guest. Protected copyright. 46 2. WHO. Hinari Access to Research for Health programme 2019 [Available from: 47 https://www.who.int/hinari/en/ accessed 11.11. 2019. 48 3. The Lancet Global H. The true meaning of leaving no one behind. The Lancet Global health 49 50 2019;7(5):e533. doi: 10.1016/s2214-109x(19)30176-7 [published Online First: 2019/04/20] 51 4. Meyer P. The english language: a problem for the non-Anglo-Saxon scientific community. British 52 Medical Journal 1975;2(5970):553-54. doi: 10.1136/bmj.2.5970.553 53 5. Portocarrero JS, Burright RG, Donovick PJ. Vocabulary and verbal fluency of bilingual and 54 monolingual college students. Archives of Clinical Neuropsychology 2007;22(3):415-22. doi: 55 https://doi.org/10.1016/j.acn.2007.01.015 56 6. Gulbrandsen P, Schroeder TV, Milerad J, et al. Paper or screen, mother tongue or English: which is 57 better? A randomized trial. JAMA 2002;287(21):2851-3. 58 59 60

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11 1 2 3 7. EF English Proficiency Index 2019. A Ranking of 100 Countries and Regions by English Skills 2019 4

[Available from: https://www.ef-danmark.dk/__/~/media/centralefcom/epi/downloads/full- BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 reports/v9/ef-epi-2019-english.pdf. 6 7 8. Westin AA, Reimers A, Spigset O. Should pregnant women receive lower or higher medication 8 doses? Tidsskrift for den Norske laegeforening 2018;138(17) doi: 10.4045/tidsskr.18.0065 9 [published Online First: 2018/11/01] 10 9. Akasie. Akasie Who are we? [Available from: https://www.akasie.no/who-are-we. 11 10. Ardila A, Lopez-Recio A, Sakowitz A, et al. Verbal intelligence in bilinguals when measured in L1 12 and L2. Appl Neuropsychol Adult 2018:1-6. doi: 10.1080/23279095.2018.1448819 13 11. Peeters D, Runnqvist E, Bertrand D, et al. Asymmetrical Switch Costs in Bilingual Language 14 Production Induced by Reading Words. Journal of experimental psychology Learning, 15 memory, and cognition 2013;40 doi: 10.1037/a0034060 16 17 12. Poarch GJ, Krott A. A Bilingual Advantage? An Appeal for a Change in Perspective and 18 RecommendationsFor for Futurepeer Research. review Behavioral sciences only (Basel, Switzerland) 19 2019;9(9):95. doi: 10.3390/bs9090095 20 13. van den Noort M, Struys E, Bosch P, et al. Does the Bilingual Advantage in Cognitive Control Exist 21 and If So, What Are Its Modulating Factors? A Systematic Review. Behavioral sciences (Basel, 22 Switzerland) 2019;9(3):27. doi: 10.3390/bs9030027 23 14. What does it mean to leave no one behind? : United Nations Development Programme; 2018 24 [Available from: https://www.undp.org/content/undp/en/home/librarypage/poverty- 25 26 reduction/what-does-it-mean-to-leave-no-one-behind-.html. 27 28 29 30 31 32 33 34 35 36

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1 2 3 TEXT FOR THE ACCOMPANYING LETTER: 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 Dear colleague, 7 8 The Journal of the Norwegian Medical Association is undertaking a study in which we 9 investigate whether varying presentations of a scientific article affect the amount of 10 information that a reader retains. The results are foreseen to be published in a scientific journal. 11 12 Participation is voluntary. If you choose to participate, you will receive a printout of an article 13 that you will be asked to read. You will have limited time to read it (7 minutes), which is 14 assumed to correspond to real conditions in a busy everyday schedule. You will then be 15 16 provided with a questionnaire that contains some background questions as well as questions 17 about the topic and content of the article. You will have 7 minutes to answer the questions. 18 Your response will be Foranonymous peer and cannot bereview traced back to you. only 19 20 You can withdraw from the study at any time until your response has been submitted. 21 22 We wish to emphasise that this is not a knowledge test. The questions have been designed in 23 such a way that only very few will be able to answer all questions correctly. 24 25 Having Norwegian as your first language is a precondition for participating. If Norwegian is 26 not your first language, please let us know. 27 28 As a token of our appreciation for your help, you will receive a small consideration from us. 29 30 31 Yours sincerely, 32 33 34 Are Brean 35 Editor-in-Chief 36 Journal of the Norwegian Medical Association 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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1 2 3 TEXT FOR THE QUESTIONNAIRE: 4

BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 INSTRUCTIONS: 6 Tick the answer that you think is the correct one. Where it is indicated that you should tick all that apply, incorrect 7 responses will cause points to be deducted from your total score. Questions 8, 9 and 10 are open-ended, and you are 8 kindly asked to write your answer on the dotted line. You have 7 minutes to answer all the questions. Your response 9 will be treated anonymously, and the questions are designed in such a manner that hardly anybody will be able to 10 answer them all correctly. 11 12 INFORMATION ABOUT YOU: 13 1. I have read the information leaflet and consent to participate in the study. 14 □ Yes 15 □ No 16 17 18 2. Gender For peer review only 19 □ Female 20 □ Male 21 22 3. Age 23 24 □ 34 years or younger 25 □ 35–44 years 26 □ 45–54 years 27 □ 55 years or older 28 29 QUESTIONS UNRELATED TO THE ARTICLE 30 31 32 4. Which of these drugs are normally contraindicated for all or parts of a pregnancy? 33 (Tick all that apply) 34 □ Omeprazole 35 □ Cephalexin 36 □ Valproate

37 http://bmjopen.bmj.com/ 38 □ Salbutamol 39 □ Loratadine 40 □ Atorvastatin 41 □ Enalapril 42 □ Misoprostol 43 □ Metoclopramide 44 □ Ibuprofen 45 on October 1, 2021 by guest. Protected copyright. 46 47 QUESTIONS RELATED TO THE ARTICLE 48 49 5. How soon after delivery will the pharmacokinetic changes that occur during 50 pregnancy be normalised? (Tick one only) 51 □ 1–2 days 52 □ 3–4 days 53 54 □ 1–2 weeks 55 □ 3–4 weeks 56 57 58 59 60

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1 2 3 6. What are the practical consequences of the pharmacokinetic changes that 4 occur during pregnancy? (Tick all that apply) BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 6 □ All those who are on regular medication require a baseline test at the earliest possible stage 7 of pregnancy. 8 9 □ Close clinical follow-up, including regularly measurement of blood pressure, is sufficient. 10 □ For drugs that we know to be affected by pregnancy, a baseline test must be taken, with 11 monthly follow-up tests. 12 13 □ For drugs that we know to be affected by pregnancy, measurement of serum concentration 14 may be necessary. 15 16 17 7. Which of these physiological changes occur during pregnancy and may 18 affect the concentrationFor ofpeer drugs? (Tick review all that apply) only 19 20 □ Increased gastric pH 21 □ Increased gastrointestinal motility 22 23 □ Increased plasma volume 24 □ Reduced concentration of α1-acid glycoprotein 25 26 □ Reduced glomerular filtration rate 27 28 29 8. According to the article, what is the most important thing to know about a 30 drug in order to estimate how a pregnancy will affect the drug 31 concentration in the mother? 32 33 ...... 34 35 36 9. What does it mean that a fetus may be doubly exposed?

37 ...... http://bmjopen.bmj.com/ 38 39 ...... 40 41 42 10. The article lists three issues that may cause therapeutic failure during 43 pregnancy. Which are they? 44

45 on October 1, 2021 by guest. Protected copyright. 46 A...... 47 48 B...... 49 C...... 50 51 52 53 54 11. Which of the statements below are true according to the article? (Tick all 55 that apply) 56 □ Methadone doses should be gradually reduced during pregnancy 57 58 □ Methadone is metabolised via CYP3A4 in the liver 59 □ Caffeine metabolism is reduced during pregnancy 60

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1 2 3 □ Doses of escitalopram should as a rule be increased during pregnancy 4 5 □ Serum concentration of lamotrigine should be measured regularly during BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 pregnancy 7 □ The dose requirement of methadone may increase during pregnancy 8 9 □ Serum concentration of lamotrigine increases during pregnancy 10 □ The dose requirement of lithium may increase during pregnancy 11 12 □ The clinical effect of methadone should be monitored during pregnancy 13 □ A fall in the concentration of escitalopram may cause therapeutic failure during 14 15 pregnancy 16 17 18 12. What proportionFor of pregnant peer women review in Norway have only used pharmaceutical 19 drugs during their pregnancy (Tick one only) 20 □ Nearly 50% 21 22 □ Nearly 30% 23 □ Nearly 80% 24 25 26 27 28 29 30 31 32 33 34 35 36

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1 CONSORT 2010 checklist of information to include when reporting a randomised trial* 2

3 4 Item Reported 5 Section/Topic No Checklist item on page No 6 7 Title and abstract 8 1a Identification as a randomised trial in the title 1 9 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 3 10 11 Introduction 12 Background and 2a Scientific backgroundFor and peerexplanation of rationale review only 3 13 objectives 2b Specific objectives or hypotheses 4 14 15 Methods 16 17 Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio http://bmjopen.bmj.com/ 4 18 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons - 19 Participants 4a Eligibility criteria for participants 4 20 4b Settings and locations where the data were collected 4 21 22 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were 4 23 actually administered 24

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including on October 1, 2021 by guest. Protected copyright. how and when they 5 25 26 were assessed 27 6b Any changes to trial outcomes after the trial commenced, with reasons - 28 Sample size 7a How sample size was determined 5 29 7b When applicable, explanation of any interim analyses and stopping guidelines - 30 31 Randomisation: 32 Sequence 8a Method used to generate the random allocation sequence 4 33 generation 8b Type of randomisation; details of any restriction (such as blocking and block size) 4 34 35 Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), - 36 concealment describing any steps taken to conceal the sequence until interventions were assigned 37 mechanism 38 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 4 39 40 interventions 41 Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those 5 42 43 CONSORT 2010 checklist For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from

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assessing outcomes) and how 1 2 11b If relevant, description of the similarity of interventions - 3 Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 5 4 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 5 5 6 Results 7 Participant flow (a 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and 6 8 diagram is strongly were analysed for the primary outcome 9 10 recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 6 11 Recruitment 14a Dates defining the periods of recruitment and follow-up 4 12 14b Why the trial endedFor or was peer stopped review only - 13 14 Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 7 15 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was 7 16 by original assigned groups http://bmjopen.bmj.com/ 17 Outcomes and 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its 7 18 19 estimation precision (such as 95% confidence interval) 20 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended - 21 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing 7 22 pre-specified from exploratory 23 24 Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) - on October 1, 2021 by guest. Protected copyright. 25 Discussion 26 27 Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 9 28 Generalisability 21 Generalisability (external validity, applicability) of the trial findings 9 29 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 9 30

31 Other information 32 Registration 23 Registration number and name of trial registry - 33 Protocol 24 Where the full trial protocol can be accessed, if available - 34 35 Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 10

36 37 *We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also 38 recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. 39 40 Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. 41 42 43 CONSORT 2010 checklist For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 2 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from

How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-043444.R1

Article Type: Original research

Date Submitted by the 02-Jan-2021 Author:

Complete List of Authors: Rostadmo, Martine; The Norwegian Medical Association Strømme, Siri Lunde; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway Nylenna, Magne; University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway; The Norwegian Institute of Public Health, Box 222 Skøyen, 0213 Oslo, Norway Gulbrandsen, Pal; University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway, Institute of Clinical Medicine; HØKH, Akershus University Hospital, Box 1000, 1478 Lørenskog, Norway Hem, Erlend; University of Oslo, Box 1171 Blindern, 0318 Oslo, Norway, Department of Behavioural Sciences in Medicine; Institute for Studies of the Medical Profession, Box 1152 Sentrum, NO-0107

Skovlund, Eva; Norwegian University of Science and Technology NTNU, http://bmjopen.bmj.com/ Department of Public Health and Nursing Brean, Are; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway; The Norwegian Academy of Music, Box 5190 Majorstuen, 0302 Oslo, Norway Orstavik, Ragnhild; The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway; The Norwegian Institute of Public health, Box 222 Skøyen, 0213 Oslo, Norway

Primary Subject Communication on October 1, 2021 by guest. Protected copyright. Heading:

Secondary Subject Heading: Communication

MEDICAL JOURNALISM, HEALTH ECONOMICS, MEDICAL EDUCATION & Keywords: TRAINING

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1 2 3 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36

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1 1 2 3 How well do doctors understand a scientific article in English when it is not their first language? A 4 5 randomised controlled trial BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 8 9 Authors' names: 10 11 Martine Rostadmo (0000-0003-3401-5203), Siri Lunde Strømme (0000-0002-9566-0954), Magne 12 13 Nylenna (0000-0002-5180-1225), Pål Gulbrandsen (0000-0001-7434-5392), Erlend Hem (0000-0002- 14 15 1845-1147), Eva Skovlund (0000-0002-2997-6141), Are Brean (0000-0001-5683-5099), Ragnhild 16 Ørstavik (0000-0003-2640-3273) 17 18 For peer review only 19 20 Authors' addresses and positions: 21 22 23 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 24 25 Martine Rostadmo 26 27 Publishing Editor 28 29 30 31 32 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 33 34 35 Siri Lunde Strømme 36

37 Scientific Editor http://bmjopen.bmj.com/ 38 39 40 41 42 University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway 43 44 The Norwegian Institute of Public Health, Box 222 Skøyen, 0213 Oslo, Norway

45 on October 1, 2021 by guest. Protected copyright. 46 Magne Nylenna 47 48 49 Professor 50 51 52 53 Institute of Clinical Medicine, University of Oslo, Box 1171, Blindern, 0318 Oslo, Norway 54 55 56 HØKH, Akershus University Hospital, Box 1000, 1478 Lørenskog, Norway 57 58 Pål Gulbrandsen 59 60 Professor

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2 1 2 3 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 Department of Behavioural Medicine, University of Oslo, Box 1111 Blindern, NO-0317 Oslo, Norway 7 8 Institute for Studies of the Medical Profession, Box 1152 Sentrum, NO-0107 Oslo, Norway 9 10 Erlend Hem 11 12 13 Professor 14 15 16 17 Department of Public Health and Nursing, Norwegian University of Science and Technology, NTNU, 18 For peer review only 19 PO Box 8905, 7491 Trondheim, Norway 20 21 Eva Skovlund 22 23 24 Professor 25 26 27 28 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 29 30 31 The Norwegian Academy of Music, Box 5190 Majorstuen, 0302 Oslo, Norway 32 33 Are Brean 34 35 Editor in chief 36

37 http://bmjopen.bmj.com/ 38 39 40 The Journal of The Norwegian Medical Association, Box 1152 Sentrum, 0107 Oslo, Norway 41 42 The Norwegian Institute of Public health, Box 222 Skøyen, 0213 Oslo, Norway 43 44

45 Ragnhild Ørstavik on October 1, 2021 by guest. Protected copyright. 46 47 Deputy Editor 48 49 50 51 52 53 54 Corresponding author: 55 56 Martine Rostadmo: [email protected] 57 58 59 60

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3 1 2 3 Licence: The lead author has the right to grant on behalf of all authors and does grant on behalf of all 4 5 authors, an exclusive licence on a worldwide basis to the BMJ Publishing Group Ltd to permit this BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 article (if accepted) to be published in BMJ editions and any other BMJPGL products and sublicences 8 such use and exploit all subsidiary rights, as set out in their licence. 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

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4 1 2 3 How well do doctors understand a scientific article in English when it is not their first 4 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 language? A randomised controlled trial 6 7 8 Abstract 9 Introduction 10 11 12 English is the lingua franca of science. How well doctors understand English is therefore crucial for 13 their understanding of scientific articles. However, only 5 % of the world's population have English as 14 15 their first language. 16 17 Methods 18 For peer review only 19 20 Objectives: To compare doctors' comprehension of a scientific article when read in their first 21 language (Norwegian) versus their second language (English). Our hypothesis was that doctors 22 23 reading the article in Norwegian would comprehend the content better than those reading it in 24 25 English. 26 27 Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical 28 29 review article in either Norwegian or English, before completing a questionnaire about the content of 30 the article. 31 32 33 Setting: Conference in primary care medicine in Norway, 2018 34 35 Participants: 130 native Norwegian speaking doctors, 71 women and 59 men. One participant 36

37 withdrew before responding to the questionnaire and was excluded from the analyses. http://bmjopen.bmj.com/ 38 39 Interventions: Participants were randomly assigned to read a review article in either Norwegian 40 41 (n=64) or English (n=66). Reading time was limited to seven minutes followed by seven minutes to 42 answer a questionnaire. 43 44

45 Main outcome measures: Total score on questions related to the article content (potential range -9 on October 1, 2021 by guest. Protected copyright. 46 47 to 20). 48 49 Results 50 51 Doctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared to 52 53 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% 54 55 confidence interval 0.03 to 2.62; p=0.046). Age was independently associated with total score, with 56 decreased comprehension with increasing age. 57 58 59 Conclusion 60

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5 1 2 3 The difference in comprehension between the group who read in Norwegian and the group who read 4 5 in English was statistically significant but modest, suggesting that the language gap in academia is BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 possible to overcome. 8 9 10 11 Strengths and limitations of this study 12 13 14  We applied a randomised control design. 15  The authors were blinded to group randomisation whilst analysing the data. 16 17  Participants were a presumably homogenous population regarding language, level of 18 For peer review only 19 education and socioeconomic class. 20  We studied Norwegian doctors, who might not be representative for doctors in all other non- 21 22 anglophone communities. 23 24  The questionnaire was in Norwegian (first language) for both groups, which could have 25 26 introduced a linguistic switch cost for the group that read the article in English (second 27 language). 28 29 30 31 Introduction 32 33 English is considered the global lingua franca of scientific research and publication, but only about 5 34 35 % of the world's population has the privilege of having English as their native language.1 Equity in 36 global access to research is an important goal. Open access publishing and enabling low- and middle- 37 http://bmjopen.bmj.com/ 38 income countries access to collections of biomedical and health literature through the Hinari 39 40 program, are important steps in this direction.2 They do not, however, help readers overcome their 41 3 42 language barrier. Non-native English speaking scientists experience disadvantage as they read, do 43 research, publish and attend conferences in a different language than the one that is closest to their 44 4 5 45 culture, thoughts and feelings. on October 1, 2021 by guest. Protected copyright. 46 47 To date, research on second language comprehension has primarily targeted children, adolescents 48 49 and immigrants to English-speaking countries,6 while little is known about professionals. Our 50 51 research group publisheda study in 2002, which concluded that Scandinavian doctors' ability to 52 retain information from a review article was better when they read the article in their mother tongue 53 54 than in English .7 To the best of our knowledge, no similar study has been conducted since. 55 56 Norwegian is the main official language in Norway, and the spoken and written language of daily life, 57 58 in doctor's offices and hospitals. Norwegian is also the tuition language of all medical schools in 59 60

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6 1 2 3 Norway. Children in Norway learn English as a second language in school from age six, and Norway is 4 5 ranked third in the world for non-native English proficiency.8 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 The aim of our study was to learn about comprehension of science when presented in first versus 8 9 second language. Our objective was to compare doctors’ ability to answer questions correctly about 10 11 the content in a scientific article after having read the article in either their first language 12 (Norwegian) or their second language (English). Our hypothesis was that doctors reading the article 13 14 in Norwegian would comprehend the content better than doctors reading the article in English. 15 16 Methods 17 18 Study design For peer review only 19 20 21 We performed a parallel group randomised controlled trial among doctors who attended a 22 conference in primary care medicine in Oslo 22nd- 26th October 2018. Participants were randomised 23 24 to read the same review article on paper in either Norwegian or English.9 25 26 Setting and participants 27 28 29 Approximately 1200 doctors working within primary care or public health attended the conference. 30 Participants were consecutively recruited in the conference exhibition area. They were informed that 31 32 we wanted to test whether different presentations of a scientific article affected reading 33 34 comprehension and the ability to retain information. Before finally agreeing to participate, attendees 35 were given written information about the study (appendix 1), including that only doctors with 36

37 Norwegian as first language were eligible for participation. Participants were given a small token of http://bmjopen.bmj.com/ 38 39 appreciation (an umbrella, value < 10 £). 40 41 Randomisation 42 43 We randomised participants by letting them pick an envelope from a box. The envelope contained 44

45 the article in either Norwegian or English. Each participant would open their envelope and start on October 1, 2021 by guest. Protected copyright. 46 47 reading the article, as an assistant set a digital alarm clock at seven minutes. After seven minutes, or 48 earlier if the participant had finished reading, the assistant collected the article, handed the 49 50 questionnaire to the participant and reset the alarm. 51 52 Data and variables 53 54 55 The topic of the article was the use of medication in pregnancy,9 thought to be a relevant issue for 56 GPs. The article had been accepted for publication in the Journal of the Norwegian Medical 57 58 Association but was not yet published at the time of the study. The English version was provided by 59 60

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7 1 2 3 the professional translation agency that is used routinely by the Journal of the Norwegian Medical 4 5 Association.10 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 The article was 2300 words long. Reading time and the questionnaire had been separately piloted. 8 9 Median reading time among pilot readers was 7.49 minutes for those reading in Norwegian and 8.35 10 11 minutes for those reading in English. We set the reading time to 7 minutes as we figured that time 12 pressure would highlight possible differences between the two groups, and because we wanted to 13 14 reflect the time pressure often met in clinical practice. We made minor modifications in the 15 16 questionnaire based on feedback from the piloting. 17 18 Both groups filled in theFor questionnaire peer in Norwegian, review which covered only four components: a) consent to 19 20 participate, b) demographic information on the participant, c) background knowledge on the topic of 21 the article and d) questions related to the content of the article (appendix 2). Demographic 22 23 information included gender and age group (<34, 35-44, 45-54, > 55 years). We tested background 24 25 knowledge on medication in pregnancy with a single multiple choice question with several correct 26 answers (potential range -5 to 5). Questions related to the article content included five multiple 27 28 choice questions (final scores potentially ranging from -9 to 12), and three open questions (range 0 to 29 30 8), adding up to a total potential score range from -9 to 20. Two of the authors (MR and SLS) 31 independently scored the answers to the open questions based on pre-specified guidance and 32 33 blinded for language of the study article. They agreed in 83-94% of cases dependent on variable. In 34 35 cases of disagreement, consensus was reached by discussion (MR, SLS, and RØ). 36

37 http://bmjopen.bmj.com/ 38 39 Power analysis 40 41 42 With random assignment to groups, independent samples of equal size, an alpha-level of 0.05, and 43 power (1-beta) of 0.80 a sample of n=128 would be necessary to detect an effect size of d=0.5, which 44

45 would correspond approximately to a mean difference of 2 assuming SD=4 (two-sided test). on October 1, 2021 by guest. Protected copyright. 46 47 48 49 Statistical analysis 50 51 Data were processed and primary analyses performed blinded for language of the study article. 52 53 The primary outcome of our study was the total score on questions related to the article content. 54 55 Groups were compared by two sample t-tests. Additional exploratory analyses were performed by 56 57 simple and multiple linear regression, with total score on questions related to the article content as 58 dependent variable and the following as independent variables: language, gender, age, and 59 60 background knowledge score. We tested for interaction between language and the following

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8 1 2 3 variables respectively: gender, age, and background knowledge. Finally, we performed two 4 5 multivariate analyses: one limited to independent variables that were statistically significant in BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 univariate analyses and one including all independent variables. Statistical significance was defined 8 by an alpha level of 0.05. All analyses were performed in IBM SPSS Statistics 25. 9 10 11 12 Patient and public involvement 13 14 This study did not include or directly relate to patients, and was therefore done without patient 15 16 involvement. Our research subjects are doctors, and the study was designed by doctors and doctors 17 were involved at all stages of the process. The findings will be disseminated to the research subjects 18 For peer review only 19 and to the general public through The Journal of The Norwegian Medical Association. 20 21 22 23 Results 24 25 130 participants were recruited, of whom 64 read the article in Norwegian and 66 in English. One 26 27 participant in the first group withdrew before responding to the questionnaire and was excluded 28 from the analyses. All remaining questionnaires were complete, and this resulted in a final sample of 29 30 129 (63 vs 66) (fig. 1). 31 32 Table 1 presents demographic data and scores on background knowledge for each group. 33 34 Participants who read the article in Norwegian had a mean total score on questions related to the 35 36 article content of 10.40 (SD 3.96) compared to 9.08 (SD 3.47) among participants who read the

37 article in English, giving a mean difference of 1.32 (95% confidence interval 0.03 to 2.62; p=0.046). http://bmjopen.bmj.com/ 38 39 40 The results from the linear regression analyses are shown in table 2. Participants > 55 years had a 41 mean total score of 8.29 (SD 2.87) compared with 10.41 (SD 4.35) among participants < 34 years 42 43 (Unstandardized B -2.13 95% confidence interval -3.81 to -0.44; p=0.014). The effects of language 44

45 and age on total score were also statistically significant in both multivariate analyses (table 2). We on October 1, 2021 by guest. Protected copyright. 46 found no statistically significant interactions (data not shown). The assumption of normally 47 48 distributed observations was confirmed by visual inspection of histograms and QQ-plots. 49 50 51 52 53 54 Table 1. Characteristics of study population and scores on background knowledge. Values are 55 56 numbers (percentages) unless stated otherwise. 57 58 Variable Norwegian English 59 text text 60

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9 1 2 3 (n=63) (n=66) 4

Gender BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 Female 35 (55.6) 35 (53.0) 6 Male 28 (44.4) 31 (47.0) 7 Age (years) 8 < 34 17 (27.0) 22 (33.3) 9 35-44 17 (27.0) 16 (24.2) 10 11 45-54 12 (19.0) 10 (15.2) 12 > 55 17 (27.0) 18 (27.3) 13 Score on background 1.33 (1.32) 1.06 (1.12) * 14 knowledge, mean (SD) 15 16 *Range -5 to 5 17 18 For peer review only 19 Table 2. Linear regression with total score related to the article content as the dependent variable. 20 Univariate and multivariate analyses (model 1 and model 2). 21 22 23 Univariate analysis Model 1* Model 2† 24 Variables Unstandardized B p- Unstandardized B p- Unstandardized B p- 25 (95% CI) value (95% CI) value (95% CI) value 26 27Language 28 Norwegian Reference Reference Reference 29 English -1.32 (-2.62 to -0.03) 0.046 -1.36 (-2.62 to -0.11) 0.034 -1.29 (-2.55 to -0.03) 0.046 30Gender 31 Female Reference - Reference 32 Male 0.11 (-1.21 to 1.43) 0.871 0.83 (-0.51 to 2.16) 0.222 33Age 34 < 34 Reference Reference Reference 35 35-44 0.47 (-1.24 to 2.18) 0.588 0.36 (-1.33 to 2.05) 0.673 0.61 (-0.11 to 2.32) 0.486 36 45-54 -1.37 (-3.29 to 0.56) 0.163 -1.51 (-3.42 to 0.39) 0.118 -1.46 (-3.37 to 0.44) 0.131

37 > 55 -2.13 (-3.81 to -0.44) 0.014 -2.19 (-3.85 to -0.53) 0.010 -2.21 (-3.91 to -0.51) 0.011 http://bmjopen.bmj.com/ 38Background 0.40 (-0.13 to 0.94) 0.140 - - 0.31 (-0.22 to 0.84) 0.243 39knowledge†† 40 *Adjusted for variables statistically significant in univariate analyses 41 42 †Adjusted for all independent variables ††Range -5 to 5 43 Discussion 44

45 We investigated whether reading comprehension of a scientific article was best in the subjects' first on October 1, 2021 by guest. Protected copyright. 46 47 or second language by randomising 130 native Norwegian doctors to read the same article in either 48 49 Norwegian or English, and then answer questions about the article content. Doctors who read the 50 article in their first language had more correct answers than the doctors who read the article in 51 52 English. The difference in score was small, but statistically significant. 53 54 Some of us published a similar study in 2002 among Norwegian, Swedish, and Danish doctors. All 55 56 three groups retained information from a given article better when read in their mother tongue 57 7 58 versus English, with a median (IQR) of 4 (3-6) versus 3(2-4) respectively (p=0.01). The two studies are 59 60

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10 1 2 3 not directly comparable, but our results indicate that the difference might have diminished over the 4 5 past two decades. Our finding is also in line with previous research in the field of bilingualism.11 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 Comprehension is a complex process that is hard to define and even harder to test. It is the ability to 8 9 process text, decode its meaning, and to integrate that with what the reader already knows about 10 11 the subject. We tested comprehension in the same manner as at exams in many medical schools, 12 with a mix of multiple choice and open questions. We tested all participants in Norwegian, a choice 13 14 we made based on the presumption that true comprehension should be more than simple 15 16 recollection, i.e. if you read in a second language you should be able to answer questions about it in 17 your first language. A possible pitfall with this design is that the participants asked to read the article 18 For peer review only 19 in English in a Norwegian context and then answer questions in Norwegian are subject to what is 20 12 21 known as linguistic switch costs. Switch costs refer to the cognitive burden of switching languages, 22 which results in longer processing times or higher error rates. This could explain the difference in 23 24 scores between the groups. 25 26 A strength of this study is that research subjects were recruited from a presumably homogenous 27 28 population regarding language, level of education and socioeconomic class, and then randomised. In 29 30 the field of bilingualism this is quite rare, as most studies on second language comprehension test 31 bilinguals with a monolingual control group13; often the bilingual group consists of a minority 32 33 population and the monolingual group consists of the cultural majority. This comes with a set of 34 35 systematic differences between the groups regarding culture, education and socioeconomic class. 36 Furthermore, testing bilinguals versus monolinguals is problematic in itself as it is well documented

37 http://bmjopen.bmj.com/ 38 that bilingualism per se offers a cognitive advantage in some tasks related to executive function.14 39 40 One participant in the group who read in Norwegian withdrew before responding to the 41 42 questionnaire and was excluded from the analyses. Depending on the reason for non-response, the 43 44 estimated difference between groups might be slightly biased in this complete case analysis.

45 on October 1, 2021 by guest. Protected copyright. 46 Our findings are probably not generalizable to all non-anglophone scientific communities for many 47 48 reasons. For one, English and Norwegian are both Germanic languages which means they have more 49 linguistic features in common than do for instance English and Russian or Hindi. Further, proficiency 50 51 in English is high in Norway compared to most other countries.8 Norwegian doctors do also have 52 53 better access to the Internet and to research articles both in English and in their first language than 54 55 do many colleagues in low- and middle-income countries. Hence, our results might be a best-case 56 scenario for comprehension of science in a second language. Similar studies in other countries would 57 58 yield additional insight. 59 60 Implications

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11 1 2 3 In order to level the playing field in global academia, we must acknowledge that language is 4 5 intrinsically linked to power and privilege1. If the goal is to leave no-one behind,15 funding of BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 education in English and academic English in low-income countries is essential. In this mindset, 8 reaching those furthest behind would mean reaching the 6 billion people who do not speak English at 9 10 all. English as a common language in science offer unprecedented possibilities for cooperation, 11 12 mutual understanding and dissemination of research, and it can also be a democratising institution if 13 extended to all. 14 15 16 17 18 AcknowledgmentsFor peer review only 19 20 We thank the participating doctors for their time and patience. 21 22 Footnotes 23 24 25 Contributors: SLS, AB, RØ, PG, MN, EH and MR designed the study and collected the data. SLS, 26 27 AB, RØ, ES and MR analysed the data. SLS, AB, RØ and MR wrote the first draft of the manuscript. 28 29 All authors revised the manuscript and approved the final version of the submitted manuscript. The 30 corresponding author attests that all listed authors meet authorship criteria and that no others 31 32 meeting the criteria have been omitted. MR acts as the guarantor. 33 34 35 Transparency: MR affirms that the manuscript is an honest, accurate, and transparent account of the 36 study being reported; that no important aspects of the study have been omitted; and that any 37 http://bmjopen.bmj.com/ 38 discrepancies from the study as planned (and, if relevant, registered) have been explained. 39 40 41 Data sharing: Data is available upon request to the authors. 42 43 44 Funding: The study was funded by The Journal of The Norwegian Medical Association.

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 Competing interests: All authors have completed the ICMJE uniform disclosure form at 50 www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted 51 52 work; no financial relationships with any organisations that might have an interest in the submitted 53 54 work in the previous three years; and no other relationships or activities that could appear to have 55 influenced the submitted work. 56 57 58 59 60

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12 1 2 3 Ethical approval: Participation was voluntary and based on informed consent. We included few 4 5 demographic variables to ensure anonymity in accordance with criteria from the Norwegian Centre BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 7 for Research Data. The Data Protection Officer at the Norwegian Medical Association approved the 8 plan for handling the data. The project confers to the standards for ethical research defined by The 9 10 Norwegian Research Ethics Committees. References 11 12 1. Crystal D. English as a Global Language. 2. ed: Cambridge University Press 2012. 13 2. WHO. Hinari Access to Research for Health programme 2019 [Available from: 14 https://www.who.int/hinari/en/ accessed 11.11. 2019. 15 16 3. The Lancet Global H. The true meaning of leaving no one behind. The Lancet Global health 17 2019;7(5):e533. doi: 10.1016/s2214-109x(19)30176-7 [published Online First: 2019/04/20] 18 4. Meyer P. The englishFor language: peer a problem review for the non-Anglo-Saxon only scientific community. British 19 Medical Journal 1975;2(5970):553-54. doi: 10.1136/bmj.2.5970.553 20 5. Hyland K. Academic publishing and the myth of linguistic injustice. Journal of Second Language 21 Writing 2016;31:58-69. doi: https://doi.org/10.1016/j.jslw.2016.01.005 22 6. Portocarrero JS, Burright RG, Donovick PJ. Vocabulary and verbal fluency of bilingual and 23 monolingual college students. Archives of Clinical Neuropsychology 2007;22(3):415-22. doi: 24 25 https://doi.org/10.1016/j.acn.2007.01.015 26 7. Gulbrandsen P, Schroeder TV, Milerad J, et al. Paper or screen, mother tongue or English: which is 27 better? A randomized trial. JAMA 2002;287(21):2851-3. 28 8. EF English Proficiency Index 2019. A Ranking of 100 Countries and Regions by English Skills 2019 29 [Available from: https://www.ef-danmark.dk/__/~/media/centralefcom/epi/downloads/full- 30 reports/v9/ef-epi-2019-english.pdf. 31 9. Westin AA, Reimers A, Spigset O. Should pregnant women receive lower or higher medication 32 doses? Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke 33 2018;138(17) doi: 10.4045/tidsskr.18.0065 [published Online First: 2018/11/01] 34 35 10. Akasie. Akasie Who are we? [Available from: https://www.akasie.no/who-are-we. 36 11. Ardila A, Lopez-Recio A, Sakowitz A, et al. Verbal intelligence in bilinguals when measured in L1

37 and L2. Appl Neuropsychol Adult 2018:1-6. doi: 10.1080/23279095.2018.1448819 http://bmjopen.bmj.com/ 38 12. Peeters D, Runnqvist E, Bertrand D, et al. Asymmetrical Switch Costs in Bilingual Language 39 Production Induced by Reading Words. Journal of experimental psychology Learning, 40 memory, and cognition 2013;40 doi: 10.1037/a0034060 41 13. Poarch GJ, Krott A. A Bilingual Advantage? An Appeal for a Change in Perspective and 42 Recommendations for Future Research. Behavioral sciences (Basel, Switzerland) 43 44 2019;9(9):95. doi: 10.3390/bs9090095 14. van den Noort M, Struys E, Bosch P, et al. Does the Bilingual Advantage in Cognitive Control Exist 45 on October 1, 2021 by guest. Protected copyright. 46 and If So, What Are Its Modulating Factors? A Systematic Review. Behavioral sciences (Basel, 47 Switzerland) 2019;9(3):27. doi: 10.3390/bs9030027 48 15. What does it mean to leave no one behind? : United Nations Development Programme; 2018 49 [Available from: https://www.undp.org/content/undp/en/home/librarypage/poverty- 50 reduction/what-does-it-mean-to-leave-no-one-behind-.html. 51 52 Figure Legend 53 54 1. Figure 1. Flow of participants. 55 56 57 58 59 60

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33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40

41 on October 1, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 19 BMJ Open

1 2 3 TEXT FOR THE ACCOMPANYING LETTER: 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 Dear colleague, 7 8 The Journal of the Norwegian Medical Association is undertaking a study in which we 9 investigate whether varying presentations of a scientific article affect the amount of 10 information that a reader retains. The results are foreseen to be published in a scientific journal. 11 12 Participation is voluntary. If you choose to participate, you will receive a printout of an article 13 that you will be asked to read. You will have limited time to read it (7 minutes), which is 14 assumed to correspond to real conditions in a busy everyday schedule. You will then be 15 16 provided with a questionnaire that contains some background questions as well as questions 17 about the topic and content of the article. You will have 7 minutes to answer the questions. 18 Your response will be Foranonymous peer and cannot bereview traced back to you. only 19 20 You can withdraw from the study at any time until your response has been submitted. 21 22 We wish to emphasise that this is not a knowledge test. The questions have been designed in 23 such a way that only very few will be able to answer all questions correctly. 24 25 Having Norwegian as your first language is a precondition for participating. If Norwegian is 26 not your first language, please let us know. 27 28 As a token of our appreciation for your help, you will receive a small consideration from us. 29 30 31 Yours sincerely, 32 33 34 Are Brean 35 Editor-in-Chief 36 Journal of the Norwegian Medical Association 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 2 3 TEXT FOR THE QUESTIONNAIRE: 4

BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 INSTRUCTIONS: 6 Tick the answer that you think is the correct one. Where it is indicated that you should tick all that apply, incorrect 7 responses will cause points to be deducted from your total score. Questions 8, 9 and 10 are open-ended, and you are 8 kindly asked to write your answer on the dotted line. You have 7 minutes to answer all the questions. Your response 9 will be treated anonymously, and the questions are designed in such a manner that hardly anybody will be able to 10 answer them all correctly. 11 12 INFORMATION ABOUT YOU: 13 1. I have read the information leaflet and consent to participate in the study. 14 □ Yes 15 □ No 16 17 18 2. Gender For peer review only 19 □ Female 20 □ Male 21 22 3. Age 23 24 □ 34 years or younger 25 □ 35–44 years 26 □ 45–54 years 27 □ 55 years or older 28 29 QUESTIONS UNRELATED TO THE ARTICLE 30 31 32 4. Which of these drugs are normally contraindicated for all or parts of a pregnancy? 33 (Tick all that apply) 34 □ Omeprazole 35 □ Cephalexin 36 □ Valproate

37 http://bmjopen.bmj.com/ 38 □ Salbutamol 39 □ Loratadine 40 □ Atorvastatin 41 □ Enalapril 42 □ Misoprostol 43 □ Metoclopramide 44 □ Ibuprofen 45 on October 1, 2021 by guest. Protected copyright. 46 47 QUESTIONS RELATED TO THE ARTICLE 48 49 5. How soon after delivery will the pharmacokinetic changes that occur during 50 pregnancy be normalised? (Tick one only) 51 □ 1–2 days 52 □ 3–4 days 53 54 □ 1–2 weeks 55 □ 3–4 weeks 56 57 58 59 60

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1 2 3 6. What are the practical consequences of the pharmacokinetic changes that 4 occur during pregnancy? (Tick all that apply) BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 5 6 □ All those who are on regular medication require a baseline test at the earliest possible stage 7 of pregnancy. 8 9 □ Close clinical follow-up, including regularly measurement of blood pressure, is sufficient. 10 □ For drugs that we know to be affected by pregnancy, a baseline test must be taken, with 11 monthly follow-up tests. 12 13 □ For drugs that we know to be affected by pregnancy, measurement of serum concentration 14 may be necessary. 15 16 17 7. Which of these physiological changes occur during pregnancy and may 18 affect the concentrationFor peerof drugs? (Tick review all that apply) only 19 20 □ Increased gastric pH 21 □ Increased gastrointestinal motility 22 23 □ Increased plasma volume 24 □ Reduced concentration of α1-acid glycoprotein 25 26 □ Reduced glomerular filtration rate 27 28 29 8. According to the article, what is the most important thing to know about a 30 drug in order to estimate how a pregnancy will affect the drug 31 concentration in the mother? 32 33 ...... 34 35 36 9. What does it mean that a fetus may be doubly exposed?

37 ...... http://bmjopen.bmj.com/ 38 39 ...... 40 41 42 10. The article lists three issues that may cause therapeutic failure during 43 pregnancy. Which are they? 44

45 on October 1, 2021 by guest. Protected copyright. 46 A...... 47 48 B...... 49 C...... 50 51 52 53 54 11. Which of the statements below are true according to the article? (Tick all 55 that apply) 56 □ Methadone doses should be gradually reduced during pregnancy 57 58 □ Methadone is metabolised via CYP3A4 in the liver 59 □ Caffeine metabolism is reduced during pregnancy 60

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1 2 3 □ Doses of escitalopram should as a rule be increased during pregnancy 4 5 □ Serum concentration of lamotrigine should be measured regularly during BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from 6 pregnancy 7 □ The dose requirement of methadone may increase during pregnancy 8 9 □ Serum concentration of lamotrigine increases during pregnancy 10 □ The dose requirement of lithium may increase during pregnancy 11 12 □ The clinical effect of methadone should be monitored during pregnancy 13 □ A fall in the concentration of escitalopram may cause therapeutic failure during 14 15 pregnancy 16 17 18 12. What proportionFor of pregnant peer women review in Norway have only used pharmaceutical 19 drugs during their pregnancy (Tick one only) 20 □ Nearly 50% 21 22 □ Nearly 30% 23 □ Nearly 80% 24 25 26 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 CONSORT 2010 checklist of information to include when reporting a randomised trial* 2

3 4 Item Reported 5 Section/Topic No Checklist item on page No 6 7 Title and abstract 8 1a Identification as a randomised trial in the title 1 9 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 3 10 11 Introduction 12 Background and 2a Scientific backgroundFor and peerexplanation of rationale review only 3 13 objectives 2b Specific objectives or hypotheses 4 14 15 Methods 16 17 Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio http://bmjopen.bmj.com/ 4 18 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons - 19 Participants 4a Eligibility criteria for participants 4 20 4b Settings and locations where the data were collected 4 21 22 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were 4 23 actually administered 24

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including on October 1, 2021 by guest. Protected copyright. how and when they 5 25 26 were assessed 27 6b Any changes to trial outcomes after the trial commenced, with reasons - 28 Sample size 7a How sample size was determined 5 29 7b When applicable, explanation of any interim analyses and stopping guidelines - 30 31 Randomisation: 32 Sequence 8a Method used to generate the random allocation sequence 4 33 generation 8b Type of randomisation; details of any restriction (such as blocking and block size) 4 34 35 Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), - 36 concealment describing any steps taken to conceal the sequence until interventions were assigned 37 mechanism 38 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 4 39 40 interventions 41 Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those 5 42 43 CONSORT 2010 checklist For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2020-043444 on 10 June 2021. Downloaded from

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assessing outcomes) and how 1 2 11b If relevant, description of the similarity of interventions - 3 Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 5 4 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 5 5 6 Results 7 Participant flow (a 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and 6 8 diagram is strongly were analysed for the primary outcome 9 10 recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 6 11 Recruitment 14a Dates defining the periods of recruitment and follow-up 4 12 14b Why the trial endedFor or was peer stopped review only - 13 14 Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 7 15 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was 7 16 by original assigned groups http://bmjopen.bmj.com/ 17 Outcomes and 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its 7 18 19 estimation precision (such as 95% confidence interval) 20 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended - 21 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing 7 22 pre-specified from exploratory 23 24 Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) - on October 1, 2021 by guest. Protected copyright. 25 Discussion 26 27 Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 9 28 Generalisability 21 Generalisability (external validity, applicability) of the trial findings 9 29 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 9 30

31 Other information 32 Registration 23 Registration number and name of trial registry - 33 Protocol 24 Where the full trial protocol can be accessed, if available - 34 35 Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 10

36 37 *We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also 38 recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. 39 40 Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. 41 42 43 CONSORT 2010 checklist For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 2 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60