Abstracts for Poster Presentation
P1 - The Use of Electronic Patient-Reported Outcome Measures in Different Languages - An Experience Report
Diarmuid De Faoite, Amir Kamali, Beate Hanson
Smith & Nephew, Clinical Scientific and Medical Affairs, Global Clinical Strategy
Traditional Patient-Reported Outcome Measures (PROMs) are burdensome. For example, the Knee Osteoarthritis Outcome Score comprises 42 questions. PROMIS® is a publicly available system that standardizes PROMs. PROMIS® Computer Adaptive Tests (CATs) are dynamically selected from an item (question) bank based upon the respondent’s previous answers and are typically just 5-7 questions long.
We designed a prospective cohort study to determine the usability, reliability and validity of PROMIS® CATs for patients undergoing total knee arthroplasty (TKA). TKA patients complete the following PROMIS® CATs pre-operatively and post-operatively:
- Pain Behaviour
- Pain Interference
- Physical Function
Our target languages are German, Spanish, Dutch, Japanese, Italian and French. The CAT translation process involves three steps: translation/cultural adaptation, calibration, and validation.1 Short forms are a fixed set of 4-10 items for one domain and precede CATs. Translation/validation work is carried out by a network of international researchers.2
English has the most available CATs. CAT translations are at differing stages of completion.
Translating, validating and calibrating CATs for international use is time-intensive and at different stages of development internationally. This impacts upon contemporary use of CATs outside of the Anglosphere. International multicentre studies are also affected by the limited availability of CATs.
2 PROMIS International. http://promis-international.org/. Accessed 22 September 2017.
P2 - Expanding medical Writing Across Borders: Daunting or Doable?
Jennifer Clemens, Catalina Gonzalez Rueda, Mary McKenna, Susan Sfarra, Merck
Expanding a medical writing department internationally is something many companies with mature medical writing departments contemplate. Merck’s “young” Medical Writing Department was entering only its second year of existence when we launched a remote medical writing team in Bogotá, Colombia. The results? We discovered the benefits far outweigh any challenges, with successes exceeding our expectations. Could it be right for you?
Three critical items influenced our success:
- Relationship Building
We achieved numerous rewards and successes at various levels.
Corporate level: Financial benefits were revealed, untapped resources discovered, and succession planning and development pathways created.
Department level: We knew the Colombia team would expand our resources. We believed that it could enhance rapport across the country team members. What we did not expect, however, was a newfound positive energy infused throughout the department. We leveraged this opportunity to re-evaluate, develop, and improve many of our process documents and training materials, benefiting the entire medical writing department.
Individual level: Career path opportunities resulted in renewed enthusiasm and motivation. Everyone obtained a global perspective and an appreciation for other cultures—a realisation that despite our differences, we share many similarities and are all working towards the same goal.
Establishing a remote operation in a different country can present challenges, but a prepared team that is aligned towards the same objectives, open to learning from a new culture, and strongly supported, can produce a highly successful start-up and yield unexpected benefits.
P3 - Using science news podcasts for introduction to discipline-specific English - Development of genre awareness envisaging medical research article writing
Motoko Asano, Osaka University
Miho Fujieda, Osaka Medical College
The prevalence of English as a lingua franca in academic discourse requires medical students to reach their literacy goal for writing up research articles on a global scale. However, in Japan, there is a significant gap between general English instruction at secondary schools and discipline-specific language instructions for research publication purposes at tertiary levels.
To try to bridge the gap, we used science news podcasts in Japanese first-year medical college student classes to develop the students’ awareness of disciplinary conventions regarding knowledge dissemination and between-genre relationships. The students participated in communicative activities such as listening to science news podcasts and performing recitations as well as in genre-based tasks including reading the transcripts of the podcasts and writing a summary of the research-related information provided in the podcasts. Questionnaires were administered to quantify the burdens of listening to science news and writing summaries and to qualitatively assess the students’ comments.
The questionnaires revealed that the degree of difficulty in listening to science news podcasts decreased at the end of the course. Some students commented that summary writing was a difficult task; however, the idea of Swales’ move framework tended to help students listen to and summarise the news.
The science news podcasts are considered appropriate to use as a guide to help medical students learn about discipline-specific conventions of communication in English.
P4 - Anonymisation: a New Challenge for Medical Writers
Anna Ramirez-Soriano, PhD, PPD, Barcelona
Montserrat Cuadrado Lafoz, PhD, PPD, Barcelona
Sarah Richardson, RGN, BEd Hons, PPD, Cambridge, UK
The European Medicines Agency (EMA) implemented Policy/0043 and Policy/0070 to make data accessible, raising the need for protecting personal data. Applicants/Marketing Authorization Holders are to submit clinical reports rendered anonymous, i.e. with data written in a form that does not identify individuals. This includes anonymising direct identifiers (permit direct recognition, e.g. name, phone number) and quasi-identifiers (indirectly permis recognition, e.g. geographical location, dates).
We searched https://clinicaldata.ema.europa.eu/web/cdp/home for anonymisation reports submitted between October 2016 (EMA started publishing clinical data) and 04 December 2017. Duplicated reports (e.g. initial and resubmission) were only accounted once. We reviewed the reports to find the anonymisation techniques used.
Reports are available on 56 medicines. Anonymisation techniques used for direct identifiers were redaction (80%) and pseudonymisation (7%). For quasi-identifiers, techniques were redaction (80%), generalisation (9%), and randomisation (5%). Pseudonymisation, generalization, and randomisation were used for redaction, the technique used on each identifier in the document depended on the risk of re-identification. Twenty percent of reports were not anonymised because only the clinical overview was published.
Despite the additional effort required to anonymise clinical reports after submission, the more frequent anonymisation approach is redaction of the original document. The challenge for medical writers is to get involved in the anonymisation strategy, focusing on the balance between scientific value of risk of re identification, and reducing the anonymisation effort by avoiding unnecessary identifiers and applying anonymisation techniques in the initial versions of the document, e.g. avoiding gender related words or presenting relative days rather than actual dates.
P5 - Rare versus Common Diseases: Implications for Regulatory Medical Writing
Katie Brooks, PPD
Rare diseases account for an increasing proportion of pharmaceutical and biotechnological research. Regulatory medical writing evolved in an era dominated by research into common diseases; it is therefore worth considering whether adaptations are needed for rare disease studies.
The requirements of regulatory writing for common and rare disease studies were investigated through a qualitative comparison of characteristics and practices in the two study types. This investigation was enriched by review of published information, particularly in online resources dedicated to rare disease research.
Special features associated with rare disease studies include low subject numbers; data privacy implications in terms of potential identification of subjects; additional specific document types and a different balance of standard document types; and timeline challenges caused by factors such as later decisions on endpoints during study design, and recruitment challenges resulting from a small and often geographically diverse patient population.
Rare disease studies have specific characteristics that influence regulatory writing. Best practice can be informed by a variety of online resources.
P6 - Experience of non-native English medical writer in publishing phase IV clinical trials in interventional cardiology in the NEJM and Lancet
Dejan Danilovic, Erlangen, Germany
The New England Journal of Medicine (NEJM) and Lancet are the most prominent journals in general medicine. I provided key contribution to the publication of papers presenting phase IV clinical trials of implantable cardiac defibrillators (Lancet) and catheter ablation of cardiac arrhythmia (NEJM). The revision process in these journals is more challenging and time-consuming than in the European Heart Journal and other cardiology journals.
I intend to describe challenges of the revision process in the NEJM and Lancet.
First, high relevance of clinical findings is needed. In both studies, we had a significant reduction of a composite primary endpoint which was mainly driven by mortality reduction. Second, highly relevant findings necessitate expedited publication, with high time pressure imposed by the journal during several rounds of revisions (double working hours for months, no vacations). Third, the medical writing quality of initial submission was appreciated in Lancet, but not much in NEJM whose editors may massively edit text to be most accurate and optimal for the reader. Fourth, during revisions, many questions and requirements for additional clinical data and analyses are made by reviewers and editors. Our point-by-point reply to NEJM extended over 40 single-spaced pages. The online supplementary appendix, accommodating additionally required material, exceeded the size of the manuscript.
For publications in NEJM and Lancet, medical writing skills are less pivotal than medical expertise, logical reasoning, physical endurance, and concentration to handle extraordinary number of details addressed by the reviewers and editors.