Abstracts

A combined qualitative/quantitative survey assessment of publication steering committee usage patterns and operationalization

Brian Scheckner^a, Kenneth Pomerantz^b, Gina D’Angelo^a and Christopher Rains^c

^aShire, Wayne, PA, USA

^bBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA

^cShire, Eysins, Switzerland

Objective: A survey was developed to assess and gain insight into the International Society for Medical Publication Professionals (ISMPP) membership’s level of experience related to the implementation of publication steering committees (PSCs).

Research design and methods: A 19-question online survey was distributed to ISMPP members and conducted from October 11–25, 2013. Questions included demographics, PSC composition/logistics, and success factors.

Results: Summary statistics are presented from 146 (11.4%) of survey respondents from 1284 members. Participants reported present/prior employment at agencies (43.8%, n = 63), pharmaceutical companies (25.7%, n = 37), or both (30.6%, n = 44). Over half (51.0%, n = 74) of participants had ≥10 years of publications experience. More than half of participants reported limited PSC experience (no PSC experience, 24.3% [n = 35] or attended PSCs in a supportive role only, 27.8% [n = 40]). Of those having PSC experience, the majority (56.6%, n = 47) reported experience with ≤3 PSCs. Most PSCs were co-led by company and external staff (40.0%, n = 32) or by company publication leads alone (31.3%, n = 25). The most common company representatives on PSCs were the publication lead (84.5%, n = 71), medical affairs physician (76.2%, n = 64), statistician (66.7%, n = 56), and clinical development physician lead (63.1%, n = 53). The use of a publication charter alone (13.4%, n = 11), an agreement alone (32.9%, n = 27), both (17.1%, n = 14), or neither (36.6%, n = 30) was reported.

Conclusions: In this combined qualitative/quantitative survey, a large proportion of respondents reported limited PSC experience. Information provided by those with PSC experience yielded valuable benchmarking standards.

An analysis of Twitter activity of pharmaceutical companies and tweets relating to publication activity

Sarah Feeny^a, Ray Magee^a and Elaine Wilson^b

^aComplete Medical Communications, Macclesfield, Cheshire, UK

^bMcCann Complete Medical, Macclesfield, Cheshire, UK

Objective: The purpose of this ongoing quantitative and qualitative analysis was to characterize the monthly Twitter activity of the top 20 pharmaceutical companies (based on revenue) every three months (June, September, December 2013; March, June 2014), and to determine whether content of tweets related to publications activity.

Research design and methods: Every three months, the monthly twitter feeds of the top 20 pharmaceutical companies will be downloaded and characterized in terms of number of tweets, use of hashtags, links to websites, and content. The results presented here are for the twitter feeds of the top 10 pharmaceutical companies (@Pfizer_news, @Novartis, @SanofiUS, @Merck, @GSK, @AstraZeneca, @JNJNews, @LillyPad, @AbbottNews, @bmsnews) in June 2013.

Results: The average number of tweets per day ranged from 0.7 (@AstraZeneca) to 8.9 (@SanofiUS); mean 4.1 tweets/day. Overall, the mean number of hashtags per tweet was 0.8 (range 0.1 [@GSK] to 2.2 [@Novartis]) and half of all tweets contained a link (range 14.5% [@Merck] to 72.2% [@AbbottNews]). Across all 1224 June tweets, 101 were considered related to manuscripts or abstract presentations; over half of these were from @Novartis. Data from all 20 pharmaceutical companies from June 2013 until December 2014 will be presented.

Conclusions: Twitter activity varies greatly across the top pharmaceutical companies. This analysis provides useful information for individual pharmaceutical companies to benchmark their own Twitter activities against those of their competitors, and adapt their own activity should they so wish.

Are industry-sponsored clinical trials cited more than trials sponsored by government, not-for-profit or academia? A review of oncology journals at Nature Publishing Group

Neil Adams^a, Jamie Feigenbaum^a, Kathleen Lyons^a, Pooja Aggarwal^b and Martin Delahunty^b

^aNature Publishing Group, New York, NY, USA

^bNature Publishing Group, London, UK

Objective: It is widely accepted that clinical trials sponsored by the pharmaceutical industry are cited more in the scientific literature than non-industry trials. One study showed that industry-sponsored trials published in major general medical journals were cited 1½–2 times more than non-industry trials¹. The authors state that their findings might not be generalizable to other journals, however, because they did not examine specialty journals. Our objective is to build on these findings by investigating citations in a selection of oncology journals published by the Nature Publishing Group (NPG).

Research design and methods: We analyzed clinical trials published in the British Journal of Cancer, Leukemia, Bone Marrow Transplantation, and Prostate Cancer and Prostatic Diseases from 2004–2011. Sponsors were identified from acknowledgement sections and citation information was provided by the Web of Science. We excluded studies with mixed sponsorship and used a Mann–Whitney U test for statistical significance.

Results: An analysis of 1426 papers revealed that citations from industry-sponsored trials were higher than non-industry trials in all groups (1st quartile [8, 7]; median [18, 15]; 3rd quartile [35.25, 29]; maximum [406, 187]) except minimum (0, 0). The p-value (two-tailed) was approximately 0.066084.

Conclusions: Industry-sponsored clinical trials were cited more than non-industry trials for these specialized journals. However, citation results varied greatly within and across titles.

Reference

• Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC. Conflicts of interest at medical journals. PLOS Medicine 2010;7(10). doi: 10:1371/journal.pmed.1000354
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Assessment of publication metrics: Google Scholar vs. PubMed Central

Kathleen Covino^a, Michele Patton^a, Melanie Blanchard^b, Piyali Dhar Chowdhury^c and Gina Fusaro^c

^aNucleus Global, Hamilton, NJ, USA

^bNucleus Global, Atlanta, GA, USA

^cCelgene Corporation, Summit, NJ, USA

Objective: Publication metrics are integral for assessing the impact of a publication in the peer-reviewed literature. We sought to compare the utility of two commonly used search engines, Google Scholar (GS) and PubMed Central (PM), for retrieval of citations in the peer-reviewed literature.

Research design and methods: The citation of two phase 3 trials in metastatic breast cancer (MBCpub1 and MBCpub2) published in highly cited journals (Journal of Clinical Oncology and New England Journal of Medicine, respectively) was followed for 5 years from the time of publication using the ‘cited by’ tools in PM and GS for the specific citation. The recall rate (i.e., total number of clinical articles/total number of citations available), uniqueness of returns, and types of citations returned were assessed.

Results: For MBCpub1, GS and PM retrieved 321 and 46 items, respectively, of which 38 items appeared in both databases. Sixty-seven GS items (21%) were non-peer-reviewed publications, including patents, theses, and continuing education materials. Of the 254 peer-reviewed publications retrieved, GS had a higher number of clinical trial publications (n = 46 vs. n = 9), leading to a higher recall rate (18% vs. 4%). Similar results were observed for MBCpub2, with 1250 GS and 243 PM items retrieved.

Conclusions: GS retrieved a higher overall number of items and proportion of peer-reviewed clinical articles compared with PM. Thus, GS may be a better option for determining publication reach. The use of both databases may provide the most accurate publication metrics.

Author guidance on self-plagiarism: a review of top-tier journal guidelines

Joshua Fink^a, Elizabeth Harvey^a and Diane Hoffman^b

^aEngage Scientific Solutions, London, UK

^bEngage Scientific Solutions, Southport, CT, USA

Objective: Self-plagiarism, the unattributed reuse of one’s own work (encompassing text-recycling and duplicate or redundant publication), can have serious ethical and legal implications and is recognized as scientific misconduct. The number of publications discussing and characterizing self-plagiarism have increased in recent years (based on a search of PubMed and Web of Knowledge), but authors may remain unaware of the issue. We reviewed author guidelines from top-tier journals to assess current guidance on self-plagiarism.

Research design and methods: Author guidelines for the top 100 (by impact factor) biomedical journals were reviewed for explicit guidance on self-plagiarism, identified by the key words ‘self-plagiarism’, ‘text-recycling’, ‘redundant’, or ‘[author’s/one’s] own’, in the context of reuse of work. Guidelines were also reviewed for stated use of search tools (e.g., CrossCheck/iThenticate) to identify plagiarism/self-plagiarism in submitted manuscripts.

Results: Across the top 100 journals, 44 unique author guidelines (accounting for shared guidelines among journals with the same publisher) were identified and reviewed. Of these, 16/44 (36.4%) had explicit guidance on an aspect of self-plagiarism (56/100 individual journals). However, only 3/44 (6.8%) guidelines mentioned ‘self-plagiarism’ by name (28/100 individual journals). Fifteen of 44 (34.1%) stated they use search tools such as CrossCheck/iThenticate (41/100 individual journals).

Conclusions: Many top-tier journals do not have explicit guidance for authors on self-plagiarism. Given the ethical and legal implications of self-plagiarism, more comprehensive guidance from journals could be beneficial to increase author awareness and understanding of the issue.

Author perceptions: impact of the Physician Payment Sunshine Act (PPSA) on publications

Shawn J. Boyle and Colleen Hedge

Synchrony Medical Communications LLC, West Chester, PA, USA

Objective: The Physician Payment Sunshine Act (PPSA) requires full transparency regarding industry–physician financial relationships. However, communication to authors about direct payments and transfers of value (TOV) concerning publications can vary significantly among companies. A survey was conducted to assess author awareness of the PPSA, the communications they have received on manufacturers’ policies, and the potential impact on authors’ future participation in publications.

Research design and methods: An eight-question online survey was distributed to 156 authors who received writing support from a single medical communications company from 2009–2013. Responses were solicited over a 2-week period in December 2013.

Results: Twenty-six individuals (16.7%) responded to the survey. Leading author specialities included pain medicine, primary care, and psychiatry. While all respondents reported being aware of the PPSA, 46% said that none of the manufacturers they work with have shared their policies. The majority of respondents (62%) stated that none of the manufacturers they work with consider medical writing to be a TOV, with just 13% of respondents reporting that manufacturers have shared their specific approach to reporting writing support. One-third of participants said that their participation as manuscript authors has changed or will change.

Conclusions: In this sample, all of the physicians were aware of the PPSA. Yet, many of the specifics concerning PPSA reporting and TOV have not been readily communicated to authors. Additionally, the PPSA has had some immediate impact on author participation in publications.

Bad news travels furthest: the social media impact of publications around trial disclosure and medical writing

Tom Rees^a, Euan Adie^b and and Sheelah Smith^a

^aPAREXEL International, Worthing, UK

^bAltmetric LLP, London, UK

Objective: Issues around disclosure of clinical trial results and provision of medical writing support have gained significant traction in the social and conventional media, as well as among industry professionals and academics. We sought to understand the social media response to articles concerning these topics.

Research design and methods: We assessed the social media reach of seven representative peer-reviewed commentaries published in 2012–2014 with positive and negative perspectives. We also undertook a temporal and sentiment analysis of tweets containing the #alltrials hashtag.

Results: An analysis of ‘non-publication’ of randomized trials achieved the greatest impact with an Altmetric score of 600. In comparison, an analysis of trial publications emphasizing high publication rates for industry trials achieved a score of 46. Other negative perspectives scored 287 (a commentary criticizing trial non-publication) and 99 (calling for authors of ghostwritten articles to be prosecuted). Three articles with more positive perspectives scored 48 (addressing inaccessible research), 27 (recommendations to close the credibility gap in reporting industry-sponsored clinical research) and 14 (a call to ‘Promote Ethical Authorship and Other Good Publication Practices’). However, tweets featuring the #alltrials hashtag were primarily driven by non-publication events.

Conclusions: The social media impact of this small sample of articles on trial disclosure and medical writing is substantially lower for articles carrying a positive message. However, the direct impact of publication events on social media interactions is small compared with non-publication events.

Best practices for sharing clinical trial results with participants: insights from China

Karen L. Woolley^a,b,c, Janelle R. Keys^a and and Julie A. Monk^a

^aProScribe Medical Communications, Noosa Heads, QLD, Australia

^bUniversity of the Sunshine Coast, Maroochydore DC, QLD, Australia

^cUniversity of Queensland, Brisbane, QLD, Australia

Objective: New international guidelines reinforce the ethical imperative of providing results summaries to clinical trial participants. Publication professionals have a unique opportunity to demonstrate leadership and enhance the healthcare industry’s reputation by ensuring compliance with these guidelines. However, evidence is needed to guide best practice, especially for international trials. We investigated patient preferences for results summaries in China, a country where industry trials are surging and compliance concerns are intensifying.

Research design and methods: A brief questionnaire was distributed to a well-established consumer panel of prescreened Shanghai-based residents (November 14–19, 2013). Respondents were defined as the first 100 people meeting target demographic criteria and completing the questionnaire.

Results: Of the 100 respondents (344 panelists accessed the questionnaire, response rate 29%), 50% were female, 61% were 36–65 years, and 91% were university educated; 22% had participated in a clinical trial. Almost all respondents thought trial participants should receive a results summary if they wanted one (97%) and should be warned if they were unlikely to receive one (98%). Most respondents (95%) thought it was important/very important for summaries to be prepared by specifically trained professionals. Preferred delivery methods were a trial website (69%) or letter (67%), available in Chinese and English (75%).

Conclusions: This original research provides evidence to guide best practice. Given industry’s intense focus on China, publication professionals can demonstrate leadership, collaboration with patients, and compliance by ensuring results summaries are available to Chinese participants.

Challenges in identifying published registration studies for FDA-approved pharmaceuticals

Kim Pepitone^a and and Sandeep Kamat^b

^aCactus Communications, Trevose, PA, USA

^bCactus Communications, Mumbai, India

Objective: Identifying published registration studies for use as primary references presents a challenge. Product approvals are based on results of registration studies. We tested an approach to identify registration studies using clinical trial data in prescribing information (PI).

Research design and methods: PIs were reviewed for a sampling of products granted Food and Drug Administration (FDA) approval during 2011–2013. Registration study data were assessed in the clinical trial sections of PIs, and PubMed was searched using the generic drug name and ‘phase 3’, the latter as a surrogate for registration.

Results: A total of 32 products were identified. Some discrete trial or aggregate-only information was provided in 32% of PIs; 68% provided details by trial, the latter mostly with single registration trials. No PI included ClinicalTrials.gov identifiers or published data citations. Results of cross-matching a random sampling (n = 9) of PIs showed no correlation between numbers of studies included in PIs, number of PubMed hits from the above search, and number of papers with phase 3 in the title. More detailed searching, e.g., with patient numbers and drug regimens, yielded better, yet still inconsistent results, and caused a large increase in time spent to identify publications.

Conclusions: Identifying published registration studies appears to be an exercise in back-guessing based on various parameters. A standardized system is needed whereby registration study data can be easily tied to published studies.

Clinical trials – commitment to publish

LaVerne A. Mooney, Amy Nathan, Stephanie Ring and Lorna Fay

Pfizer Inc., New York, NY, USA

Objective: Publishing clinical research is important for enhancing public health and advancing research. In 2010, key pharmaceutical associations issued a joint statement that recommended that results from all phase 3 clinical trials and any results of significant medical importance should be submitted for publication regardless of outcome¹. Our company’s goal was to develop and implement a policy for publishing clinical trials results.

Research design and methods: A multi-functional group was formed to develop the policy. The following questions were considered. Should the policy include trials in healthy subjects? Should trials in investigational products adhere to the same policy? What guidance should be given for terminated studies and discontinued development programs? What is a reasonable timeframe from study completion to submission? Should Consumer Health Studies follow the same guidelines? From an operational aspect, we considered such topics as volume of studies, how many attempts should be made to publish, internal tracking and reporting processes, training, and roles and responsibilities.

Results: In January 2013 the following policy was implemented: all company-sponsored interventional clinical studies in patients involving a company product (approved and investigational) must have a primary manuscript submitted within 18 months of study completion. Clinical teams have been trained and a reporting and compliance monitoring/escalation process has been put in place.

Conclusions: Implementation of a new policy was the first step towards ensuring that trial results are made available to patients, clinicians and researchers. The next step is to measure the success of the implementation.

Reference

• Joint position on the publication of clinical trial results in the scientific literature. 2010. Available at: http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/20100610_Joint_Position_Publication_10Jun2010.pdf [Last accessed 8 January 2014]
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Collaboration, cooperation and compliant scientific communications: identifying local market needs*

Julie Newman^a and Alan Hempel^b

^aBristol-Myers Squibb, Melbourne, VIC, Australia

^bBristol-Myers Squibb, Plainsboro, NJ, USA

Objective: Successful publication planning requires an in-depth understanding of internationally accepted good publication practice (GPP). However, publication tools geared toward global planning may not consider the specific needs or nuances of local markets. Our objective is to understand knowledge and process gaps in local markets to further develop a regional publication toolkit that facilitates effective and compliant communication of scientific data.

Research design and methods: As regional leads, we collaborated with local publications planners across Asia-Pacific, Latin America, Canada, the Middle East and Africa to understand local approaches and challenges to developing effective scientific communications for those markets. We then identified potential gaps as a basis from which to address common issues and develop solutions.

Results: We discovered that questions related to practical aspects of local publication development were remarkably similar across regional geographies. Queries included development of encore publications and their strategic value, particularly since local encores may postdate the original publication by ≥12 months. Other examples include copyright requirements and considerations arising from local language translation of published material. Local publication planners also inquired how to respond to requests from healthcare providers (HCPs) for editorial support. The majority of these requests relate to publications based on independent sponsored research and real world data compiled by HCPs.

Conclusions: Regardless of geography, knowledge gaps are similar across local markets and require a bidirectional approach to GPP training, process development, and global-to-market collaboration to ensure best publication practices.

Commercial and health economics and outcomes research (HEOR) group involvement in publication strategies and plans: a benchmark assessment

Cherie Whitmore^a, Yeshi Mikyas^b and Tricia L. Gooljarsingh^b

^aKnowledgepoint360 Group, Lyndhurst, NJ, USA

^bBaxter Healthcare Corporation, Westlake Village, CA, USA

Objective: A benchmark survey was designed by Baxter Healthcare and KnowledgePoint360 (KP360) to understand the involvement of commercial and health economics and outcomes research (HEOR) organizations in publication strategies and plans in pharmaceutical/biotechnology companies.

Research design and methods: MyVHow™ members (a KP360-facilitated community with >60 medical publications professionals from 11 pharmaceutical and biotechnology companies) were invited to respond to a 14-question survey to assess how the commercial and HEOR organizations in their respective companies were involved in developing publication strategies and plans.

Results: A total of 16 US and European respondents representing eight pharmaceutical companies (one large, six mid-size, and one small) completed the survey. Table 1 on the next page summarizes 13/14 responses.

Conclusions: This survey was limited by a small sample size. However, among the eight companies surveyed, commercial teams attended publication team meetings and ensured publication strategies were aligned to brand goals. Most HEOR teams in this survey develop publications and were members of the publication team.

Table 1.  Participant responses to the benchmark survey assessing how commercial and HEOR organizations are involved in developing publication strategies and plans.

Question	Response (only highest scoring responses shown)
1. Are there internal policies that define the role(s) of the commercial organization on the publication team, i.e., are there formal company guidelines or SOPs defining the scope of contributions from the commercial organization?	88% – Yes
2. Have your publication policies regarding the role of the commercial organization participation changed in the last 12 months?	63% – No
3. What does the commercial team provide to the publication team for the publication strategy?	75% – Assures alignment between brand goals and the publication plan
4. To what extent is the commercial organization involved in the tactical aspects of publication planning?	69% – Attends publication team meetings
5. What is the exact role of the commercial organization (whether a member of the publication team or not) in contributing to scientific objectives/messages developed by the publication team?	50% – The commercial team uses scientific objectives as a reference for brand plan messages
6. What is the role of the commercial organization in publication steering committees (PSCs)?	94% – No involvement
7. What is the nature of the interaction between the commercial organization and external authors?	50% – No interaction
8. During the author proposal process, does the team (or PSCs) vet the suggested author for prior commercial activities (e.g., speaking engagement)?	69% – No
9. What is the most challenging aspect associated with the commercial organization contributions to the publication plan?	38% – Assuring the strategy is focused on medical needs 25% – Maintaining fair balance and assuring the dissemination of medically accurate information 19% – Assuring alignment between brand goals and the publication plan, in addition to scientific objectives/messaging 19% – Managing differences between medical and commercial priorities
10. In terms of publication activities, how do the HEOR and medical publication teams interact?	69% – HEOR colleagues are members of our publication teams and develop manuscripts/abstracts through a regular plan
11. If HEOR works through the publication team, do HEOR manuscripts undergo the same review process as manuscripts based exclusively on clinical data?	100% – Yes
12. Which functions contribute to the internal review of HEOR-focused manuscript/abstracts?	≥63% – HEOR, medical affairs, publication team leader, regulatory/legal, medical director, biostatistics, and clinical
13. What strategies guide HEOR publication content?	75% – Global HEOR function strategic goals
(One question was a free text field and the responses are not included in this table)

Comparison of the publication policies and guidelines of major medical journals and professional associations

Frank J. Rodino^a, Philip Thoman^b, Nick Tobenkin^c and Al Weigel^d

^aChurchill Communications, Maplewood, NJ, USA

^bSpringer Healthcare, St. Louis, MO, USA

^cAdvocacy Associates, Washington, DC, USA

^dInternational Society for Medical Publication Professionals (ISMPP), Tarrytown, NY, USA

Objective: Complying with new guidelines governing the publication of medical information has become a challenge for authors and professional medical writers. This study compares, contrasts, and summarizes the reporting requirements of influential medical journals and professional associations.

Research design and methods: Included in this analysis are four influential journals with international readership (BMJ, New England Journal of Medicine [NEJM], JAMA, and Lancet), one open access journal (PLOS ONE), one online publisher (BioMed Central), and one evidence-based medicine library (Cochrane Collaboration). Also evaluated were the ethical publication policies of the Committee on Publication Ethics, International Committee of Medical Journal Editors (ICMJE), World Association of Medical Editors, Council of Science Editors, American Medical Writers Association, and International Society for Medical Publication Professionals. We compared policies relating to authorship, contributorship, guarantorship, editorial support, funding sources, clinical trial registration, needs assessments, and conflict of interest declarations.

Results: Author instructions varied within the group of journals evaluated. With regards to conflict of interest declarations, JAMA, NEJM, and BMJ link directly to the PDF version of the ICMJE declaration form. Lancet and PLOS ONE have their own unique declaration forms. Declarations for BioMedCentral varied within their portfolio of open access journals, and Cochrane declarations depended upon the individual review groups. Separate summary tables for journals and associations have been created to permit ‘at-a-glance’ comparison of guidelines that impact medical publications.

Conclusions: The end goals of any policy affecting medical publications should be to assure that accurate and unbiased clinical trial data are made available in a timely, accessible, and consistent manner, regardless of authorship or funding source. Given the variability of current medical publishing guidelines, the authors conclude that a comprehensive, universal set of guidelines are needed.

Delegate interactions with congress posters: current preferences and future opportunities

Paul Farrow^a, Fran Young^b, Annabelle Ballsdon^a, Michael Molloy-Bland^a and Chris Rains^c

^aOxford PharmaGenesis Ltd, Oxford, UK

^bShire Development LLC, Wayne, PA, USA

^cShire AG, Eysins, Switzerland

Objective: We developed a platform to offer digital posters as an alternative to paper handouts. Usage has grown, supported by increased availability of smart devices and Wi-Fi. We conducted a pilot survey to assess preferences around traditional and digital platforms.

Research design and methods: A questionnaire was administered at the Annual International Psychiatric Pharmacy Conference of the College of Mental Health Pharmacy (UK, 2013).

Results: Of ∼150 delegates, 69 completed the survey. When asked about the last poster visited, 29% of respondents had attended the live presentation and 35% had read the poster in detail. However, over 75% said they regularly collect handouts for future reference. More than 80% of respondents said they used smart devices, but most (86%, 49/57) had not used a quick response (QR) code to obtain a digital poster. Of these, 35% (17/49) would use QR codes. Of those who were less likely to use QR codes, over half (55%, 12/22) demonstrated limited knowledge about these codes. The most attractive features that may be available via QR codes were the ability to obtain a poster PDF (75%), links to reference materials (54%) and a facility to engage with authors (33%).

Conclusions: Delegates may prefer to engage with the content of posters away from the live presentation. Many now use smart devices, but few understand and use QR codes. Our results will inform the development of awareness campaigns and additional functionality to support use of digital posters.

Development of an authorship algorithm for industry-sponsored clinical trials

Gina Fusaro^a, Robert Matheis^a and Al Weigel^b

^aCelgene Corporation, Summit, NJ, USA

^bInternational Society for Medical Publication Professionals (ISMPP), Tarrytown, NY, USA

Objective: While the International Committee of Medical Journal Editors (ICMJE) states that an author is generally considered to be someone who has made substantive intellectual contributions to a published study, they leave unresolved the question of the quantity and quality of contributions that qualify for authorship. As such, determining potential author candidates for primary publications within large clinical trial programs is a common industry challenge. To meet this challenge, publication steering committees are often implemented to direct authorship decisions. Patient enrollment is often utilized as a common metric for candidate determination for investigators not involved in trial design or direct data analysis. We endeavored to develop an objective methodology for determining whether investigators potentially qualify for participation (and ultimately authorship) and order of authorship using a more comprehensive approach.

Research design and methods: We developed an authorship algorithm that will be assessed qualitatively in ongoing clinical trial programs.

Results: The algorithm developed encompasses three key factors for assessing author qualification: (1) recruitment effort, (2) data quality, and (3) steering committee participation. Our methodology modifies baseline patient recruitment by weighting the quality of data obtained, as well as the level of participation in a steering committee. Specifically, a point-based system is utilized to award investigators with credit for patient recruitment, detract points for poor data quality, and/or award points for active participation in a clinical trial steering committee.

Conclusions: We conclude that the algorithm developed provides a fair and objective mechanism for determining whether investigators might participate in primary manuscript development, thereby addressing the ‘quantity and quality’ ICMJE dilemma, which is a common industry challenge in selecting potential author candidates from a large investigator pool.

Digital evolution of medical journals in 2013

Samantha Collings^a, Lucinda Huxley^a, David Haworth^a, Wasim Rashid^a, Angela Cairns^a and Gregory Thompson^b

^aKnowledgePoint360 Group, Macclesfield, Cheshire, UK

^bKnowledgePoint360 Group, Lyndhurst, NJ, USA

Objective: The use of digital platforms by healthcare practitioners (HCPs) has dramatically increased in the last year. As such, peer-reviewed medical journals are adapting how they provide relevant and engaging healthcare information. Here, we evaluate how journals have evolved over the last year to effectively compete and provide enriched sources of publication content to users.

Research design and methods: The digital characteristics and electronic impact factor (eIF) score of 49 medical journal websites were measured in 2012 and 2013 using the proprietary eIF tool (developed by KnowledgePoint360), which assesses independently-evaluated metrics, including use of social media, traffic, search engine optimization and scientific credibility. Their online impact in 2012 and 2013 was compared in order to identify changes in how journals deliver their digital content.

Results: Of the 49 journal websites assessed, 94% showed an increase in eIF score in 2013, with a median increase of 11% (range 0.1–42%). An increased use of social media channels by the journal websites heavily contributed to the increased eIF scores. In fact, of 18 journals not utilizing social media in 2012, 10 had active social media channels in 2013, such as Facebook, Twitter and YouTube. In general, most journals are investing more time and resources into their websites and have evolved to include more digitally enriched opportunities.

Conclusions: There is a trend for peer-reviewed medical journals to evolve rapidly to meet the needs of HCPs in accessing healthcare information through mobile and online resources, particularly social media channels.

Experiences with open access journals: a survey of publication professionals

Kim Coleman Healy^a, Aruna Seth^b, Thomas Gegeny^a and Diane Hoffman^c

^aEnvision Scientific Solutions, Southport, CT, USA

^bExcel Scientific Solutions, Southport, CT, USA

^cEngage Scientific Solutions, Southport, CT, USA

Objective: This survey explored publication professionals’ experiences with open access (OA) and traditional journals, including encounters with publishers on Beall’s List, which identifies those with questionable practices (Beall, 2013¹), although debate exists about their characterization as predatory (Butler, 2014²).

Research design and methods: In an agency-based online survey, five questions prioritized journal attributes and collected OA perceptions. Ten OA-related questions evaluated OA-only journal submissions; compared OA with non-OA peer review, costs, and submission–decision/acceptance–publication speeds; reported potentially predatory OA encounters (e.g., undisclosed fees); and rated peer, client, and author awareness of Beall’s List. Non-OA respondents answered nine questions about traditional journals.

Results: Of 166 recipients, 58 responded, including 51 professional medical writers (36 with OA experience and 15 without). Twenty-eight of 36 OA respondents answered peer-review and journal-interaction questions; 3/28 reported multiple billings, 4/28 reported payment disputes (versus 0/14 and 0/14 non-OA respondents), and 2/28 reported previously undisclosed post-acceptance fees. OA and non-OA peer reviews were rated similar by 15/28, less thorough in OA by 11/28, and more thorough by 4/28 respondents (multiple responses allowed). Of 43 OA-submission examples, four publishers were on Beall’s List. Most OA respondents perceived authors as unaware of Beall’s List (17/28) and clients (12/28) and peers (11/28) slightly aware.

Conclusions: Surveyed publication professionals encountered potentially predatory behaviors from <10% of select OA submissions. Respondents perceived greater Beall’s List awareness among publication professionals or clients than authors. These results suggest further education in recognizing quality OA journals is warranted.

References

• Beall J. Beall’s list of predatory publishers. 2013. Available at: http://scholarlyoa.com/2012/12/06/bealls-list-of-predatory-publishers-2013/ [Last accessed 11 December 2013]
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• Butler D. Investigating journals: the dark side of publishing. Nature 2013;495:433-5
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Factors influencing manuscript development time

Joelle Suchy^a, Suzanne Van de Water^b, Catherine Martin^b, Roger McCarter^a and Beth Burke^a

^aNucleus Global, Hamilton, NJ, USA

^bNucleus Global, Atlanta, GA, USA

Objective: We aimed to determine factors affecting manuscript development time to maximize efficiency and minimize cost.

Research design and methods: Data were collected from 27 manuscripts developed by Nucleus Global in conjunction with external clients for publication in peer-reviewed journals. The mean number of hours was calculated, and predictors were examined. Two-tailed t-tests were used to determine the relationship between key predictors and development time. For continuous predictors, a median split was performed prior to conducting the t-test.

Results: Results are presented in Table 1.

Conclusions: Consistent with our previous findings, having a kickoff call was associated with shorter development time, as was having more internal (client) authors. Resubmitting to multiple journals resulted in longer development time, as did producing a more detailed outline. Most factors had a bigger impact on project management time vs. content development.

Table 1.  Factors impacting manuscript development time.

Implementation of standard, globally aligned publication development processes in the Asia-Pacific region (APAC)

Susan Nastasee^a, Julie Newman^b, Dan Henderson^c, Balaji Ganesan^b, Naomi Ishibashi^d, Jimmy Chiu^e, Wenlong Shao^e, Neil Baker^c, Ananya Bhattacharya^a and Brenda Connor^a

^aGlobal Medical Publications, Bristol-Myers Squibb, Princeton, NJ, USA

^bRegional Strategic Medical Communications, Bristol-Myers Squibb, Melbourne, VIC, Australia

^cEnvision Pharma Group, Horsham, West Sussex, UK

^dBristol-Myers K.K., Tokyo, Japan

^eRegional Strategic Medical Communications, Bristol-Myers Squibb, Shanghai, China

Objective: The key objective was to implement standard, globally aligned publication development processes in the Asia-Pacific (APAC) region that are compliant with industry-standard good publication practices (GPP).

Research design and methods: Concurrent face-to-face/virtual training was conducted on GPP, publication development processes, and a publication planning/management tool to document publication development compliance with GPP. Lessons learned from a local pilot of the tool supplemented the training. ‘Country champions’ were identified to be local trainers and provide support post-training.

Results: Over 120 APAC colleagues across eight countries from medical/clinical/statistics/health economics and outcomes research/legal/compliance departments were trained. Translation of reference guides and simultaneous translation of presentations ensured optimal comprehension. Sharing experience from the pilot program helped build confidence. Face-to-face training fostered long-term partnerships, demonstrated commitment, and enabled ongoing follow-up opportunities between global and local teams to understand local publication needs and extend publication capabilities. Topics generating discussion included author honoraria, encores, investigator-sponsored research, access to data, and translations. Post-training survey feedback indicated scope of topics and training materials were relevant and helpful to >90% of participants. Following implementation, ≥80 locally sponsored publications are being developed using the tool, thus enabling globally aligned, transparent publication development. Future training will focus on continued needs specific for the region. Quarterly measures of compliance will be reported.

Conclusions: Global alignment and transparency of GPP-compliant publication development was achieved in the APAC region through implementation of GPP training and a publication planning/management tool. Assessments of progress and compliance, emerging challenges, and additional training needs are ongoing.

Journal policies regarding medical writing assistance and industry sponsorship

Grace Lee, Emma Platt and Monica Dodge

Scientific Therapeutics Information Inc., Madison, NJ, USA

Objective: The objective was to determine whether select medical journals will consider manuscripts that were developed with medical writing assistance and/or pharmaceutical industry sponsorship, and to assess if there is an association between nonacceptance of such articles and impact factor, circulation, or professional society affiliation.

Research design and methods: UlrichsWeb was used to select infectious disease or general medicine journals. Then journal websites were reviewed to determine policies regarding medical writing assistance or industry sponsorship. If information was unavailable on the journal website, e-mails were sent to a journal contact. Impact factor, circulation, and professional society affiliations were compared for journals that do or do not consider such articles.

Results: A total of 180 journals were reviewed; 9 were excluded (e.g., ceased publication, newspaper/magazine format). The final analysis included 171 journals (52 general medicine, 31 infectious disease, and 88 other specialties [e.g., basic science, critical care]). More than a third of the journals did not specify their policies on their website and did not respond to two e-mails. Medical writing assistance is permitted by 90% of journals with available policies, and 86% allow industry-sponsored papers. No association was found between these policies and impact factor, circulation, and professional society affiliations.

Conclusions: These findings demonstrate that medical writing assistance and pharmaceutical industry sponsorship are acceptable to the majority of journals that disclose their policies or are responsive to e-mail inquiries. However, approximately one-third of journals do not clearly state policies on these matters.

Lack of consistency in use of value terminology in medical publications

Nathan White

NucleusX Market Access, Atlanta, GA, USA

Objective: The objectives for this research are as follows: (1) identify and determine frequency of use of specific terms that are used to convey health economic information and value in peer-reviewed medical journals, and (2) define specific meanings for terminology within the context of evolving healthcare forces and trends.

Research design and methods: A systematic search of PubMed was conducted analyzing the frequency of use of the following terms from 2006 to 2012: cost effectiveness, comparative effectiveness, quality adjusted life year, and reimbursement. Search terms were limited to all journals listed on PubMed, core clinical journals, and the following therapeutic categories: primary care, oncology, cardiology, and neurology. A limitation of the research design was that since only a quantitative search was conducted, titles with search terms were randomly selected to observe usage and contextual appropriateness. Search term definitions were obtained using primary (expert interviews) and secondary research sources.

Results: Of the four identified terms, cost effectiveness appeared most frequently in all journals and core clinical journals, and comparative effectiveness showed the most significant increase in core clinical journals (1500% increase from 2006 to 2012). Search terminology, particularly comparative effectiveness, was often observed to be used in a contextually inappropriate manner, especially in literature published prior to 2010.

Conclusions: There is an increased trend toward the use of health-economic and value terminology in all journals and core clinical journals, and an observed inconsistency in use in medical publications. Additional contextual research should be conducted to better define appropriate usage of value terminology.

Leveraging peer-reviewer comments*

Lorna Fay and LaVerne A. Mooney

Pfizer Inc., New York, NY, USA

Objective: Our company’s goal was to assess whether it is possible to leverage journals’ peer-reviewer comments to improve acceptance rates, speed the delivery of clinical trial results to the public, and increase efficiency.

Research design and methods: Thirty-seven journal rejection letters (RLs) from company-sponsored manuscripts were analyzed. All manuscripts described the primary end-point of a clinical trial on an approved product that completed in 2010. A scoring system was developed based upon the presence or absence of common issues encountered in RLs. Each RL was scored.

Results: Of 37 RLs, 18 included peer-reviewer comments (see Table 1), 17 did not, and 2 were missing. The median number of issues mentioned per RL was 3.5 (1–6).

Conclusions: This small descriptive study suggests that there are steps, e.g., focusing on issues 1, 4, and 6, that can be taken during manuscript development that may improve quality and acceptance rates.

Table 1. Frequency of issues cited in rejection letters.

Issue	# of RLs mentioning issue
1. Methods, e.g., the methods are not described in sufficient detail to allow an exact replication of the study	14
2. Study design limitations, e.g., open label, non-comparative, inappropriate comparator	11
3. Statistical analysis, e.g., multiple testing, statistical analyses need serious revision	9
4. Conclusions not supported by the data, e.g., overstates the data	8
5. Sample size, e.g., number of recruited subjects is below the number provided by the power calculation	7
6. Adverse event details, e.g., serious adverse events deserve more consideration than is given in the manuscript	6
7. Not novel, e.g., study addresses a question that has already been answered	5
8. Questionable rationale, e.g., rationale to explore lower doses is unclear, rationale in the introduction is borderline	4
9. Industry involvement, .e.g., there is a strong concern about the level of involvement of the company in design, execution and presentation of this study	2

Measuring influence of company-sponsored manuscripts

Angela Sykes^a and Mollie McKillop^a,b

^aPfizer Inc., New York, NY, USA

^bColumbia University, New York, NY, USA

Objective: Industry makes substantial efforts to publish results of clinical studies and develop comprehensive publication plans. Typically, these plans include primary and secondary publications, review articles and meta-analyses. Companies often track the number of publications, but data on the impact and ultimate influence of these publications are limited. The objective of this analysis was to evaluate the impact of 385 company-sponsored primary, secondary and review manuscripts published in 2010. Company-sponsored manuscripts are those for which the company provided some form of support (e.g., funding for editorial support, manuscript comes from a company-sponsored study). These manuscripts may or may not include company employees as authors (company authors).

Research design and methods: Impact factor (IF), number of citations, source normalized impact per paper, SCImago journal rank, article influence score, and Eigenfactor score were calculated for 385 company-sponsored primary, secondary and review manuscripts published in 2010. Effect of the type of manuscript, presence of company authors and number of resubmissions was assessed.

Results: Primary manuscripts were cited more than secondary and review manuscripts and had higher mean scores. Presence of company authors did not affect this result. In fact, presence of ≥1 company authors was associated with higher scores, probably due to the greater prevalence of company authors on primary/secondary manuscripts versus reviews. Interestingly, the number of resubmissions, 1–4, did not influence mean IF or other scores.

Conclusions: Primary manuscripts were published in journals of greater prestige than secondary manuscripts and review articles, suggesting that primary manuscripts have greater influence. The presence of company authors on a manuscript does not affect the quality of the journal in which it is published. Importantly, the number of times a manuscript was resubmitted to a new journal did not impact journal quality.

Measuring publication impact using article-level metrics (altmetrics)

Ted Huang^a, Janet Davies^b, Kate Weatherall^b, Sunil Joseph^b and Matthew Wadyka^c

^aNucleus Global, Hamilton, NJ, USA

^bNucleus Global, London, UK

^cGenentech Inc., San Francisco, CA, USA

Objective: Recent trends in social media and online access of publications have led to new ways of assessing publication impact, using altmetrics. This study is a semi-quantitative comparison of two commonly used altmetric tools.

Research design and methods: As part of a publications-gap analysis, altmetrics were assessed using Altmetric.com and ImpactStory.org. Here, we focus on publications for one drug in phase 3 development. Additionally, Twitter activity (tweet volume/sentiment) was assessed using Topsy.com.

Results: Results are presented in Table 1.

Conclusions: Altmetrics.com and ImpactStory.org report different aspects of publication impact. Further, traditional impact measures, such as JIF, did not equate to ImpactStory.com or Altmetric.com scores and calls into question their value as qualitative impact tools. Topsy analysis highlighted that Twitter activity focused around congress presentations and press releases rather than publications (data not shown). Further research is required to assess the utility of altmetrics in tracking publication impact.

Table 1. Comparison of ImpactStory.org and Altmetric.com scores.

Publication	Top ten primary research articles, 2009–2013						Altmetric.com
(year)	Journal impact factor (JIF)	ImpactStory.org scores*					score†
		PubMed citations	Scopus citations	Mendeley readers	Highly cited	Highly saved
1 (2010)	23.92	79	–	88	X	X	19
2 (2009)	8.31	80	–	97	X	X	9
3 (2012)	23.92	–	50	35	X	X	1
4 (2012)	7.11	4	–	28	X	X	–
5 (2011)	4.17	6	–	13	X	X	2
6 (2012)	7.58	14	42	–	X	–	21
7 (2012)	4.65	1	–	8	–	–	–
8 (2010)	4.17	17	–	27	–	–	–
9 (2013)	2.93	1	–	6	–	–	4
10 (2013)	14.48	1	–	6	–	–	1

*Impactstory.org focuses on academic metrics, including academic readers and citations. Highly saved = in the 75th–100th percentile of articles added to users’ Mendeley libraries vs. all articles published the same year. Highly cited = in the 75th–100th percentile of articles cited on PubMed Central or Scopus vs. all articles published the same year.

^†Altmetrics.com focuses on ‘public’ social media, providing results including more investor-related blogs and posts. A weighted score is produced, factoring in relevant impact of each online forum. Articles with a score ≥3 are in the top 25% of all articles ranked by attention; a score ≥15 puts the article in the top 5% of all articles ranked by attention. Articles classified as highly cited/saved by ImpactStory.org could have no or low scores on Altmetrics.org and scores did not always correlate across the two tools.

Perception by medical communications professionals of online communal annotation of journal articles

Steven Tresker and Shruti Baijal

Cactus Communications, Mumbai, India

Objective: We assessed awareness of and interest in online communal annotation (OCA) of peer-reviewed medical journal articles among medical communications professionals.

Research design and methods: E-mails with a link to an eight-question anonymous online survey created with SurveyMonkey were sent to 506 members of the International Society for Medical Publication Professionals.

Results: The response rate was 7.5% (n = 38). Of these, 63.16% worked for medical communications or pharmaceutical (34.21%) companies; 44.74% were authors of peer-reviewed journal articles. Around one-third of respondents were unaware of OCA and only 5.26% had used it. To varying degrees, most respondents (71.05%) were interested in using OCA and 65.79% felt OCA could improve articles’ standards and the work of authors; yet, 76.31% reported a moderate to very high risk that OCA could diminish an article’s credibility. Main reasons for concern were inappropriateness/irrelevance of others’ annotations (84.21%), being able to view or make annotations without having to sign in or have a user profile (63.16%), and non-anonymity of OCA users (50%). Respondents also provided insightful free responses highlighting specific risks and benefits of OCA.

Conclusions: There is little awareness of OCA of medical journal articles among medical communications professionals. Although many respondents thought OCA carried risks to the credibility of journal articles, a majority of them were interested in using it and believed in its potential to benefit scholarly communication. Therefore, with some key considerations kept in mind, medical journals and the scholarly community could benefit from implementation and use of OCA.

Perceptions of CMPP certification among certified and noncertified ISMPP members

Elizabeth Bennett^a, Steven Palmisano^b, Ken Truman^c, Paula Farmer^b, Chris Lawrence^b and Jared Canady^c

^aClarity Consulting LLC, Raleigh, NC, USA

^bMedThink SciCom, Raleigh, NC, USA

^cMedThink Inc., Raleigh, NC, USA

Objective: The International Society for Medical Publication Professionals (ISMPP) Certified Medical Publication Professional (CMPP) credential certifies expertise in the medical publication profession. This study surveyed attitudes among ISMPP members regarding the perceived benefits of CMPP certification, the potential limitations or barriers to certification, and any unmet needs of certificants.

Research design and methods: Exploratory research involving 600 randomly selected ISMPP members, with equal distribution between CMPP certificants and noncertificants, was conducted via an online survey. Demographics, employment characteristics, and responses to statements regarding perceived benefits and limitations of certification were assessed using a 7-point Likert scale. Results included summed Likert scores (analyzed by Mann–Whitney U test) and rank order categorization of responses.

Results: A total of 141 ISMPP members (98 certificants, 43 noncertificants) participated in the survey (response rate, 23.5%). Benefits of CMPP certification were rated significantly more positively by certificants than by noncertificants (summed Likert scores: certificants, 105.9; noncertificants, 86.1; between-group difference, p < 0.001). Communication-agency certificants viewed the benefits significantly more highly than did pharmaceutical-industry certificants (p = 0.003). Conversely, pharmaceutical-industry noncertificants rated the benefits significantly more positively than did communication-agency noncertificants (p = 0.015). Summed scores associated with communication-agency management views and workplace culture were drivers of the positive perception of CMPP certification.

Conclusions: Among CMPP certificants, credibility was a recurrent theme in defining the value of the credential. Barriers to positive growth in the perception of CMPP certification can be addressed through better defining what the CMPP credential signifies, with communication efforts directed toward communication-agency management.

Preferences and practices of physicians in consumption of medical literature

Todd Parker^a, Angie Miller^a, Ken Truman^b, Chris Farlow^b, Jon Hudson^b and Susan Taylor^b

^aMedThink SciCom, Raleigh, NC, USA

^bMedThink Inc., Raleigh, NC, USA

Objective: Many practicing physicians have reported feeling overwhelmed by the deluge of medical literature. A survey was undertaken to improve the understanding of physician challenges with and preferences for consumption of medical literature.

Research design and methods: Exploratory research was conducted via a web-based Epocrates HCPView survey; 129 practicing physicians were invited.

Results: Twenty-six physicians across 13 specialties responded (20% response rate); 65% moderately to strongly agreed that keeping abreast of scientific information is challenging, with time constraints listed as the key contributing challenge (88%). Print/online journals and e-alerts from professional societies were selected as top sources for identifying articles of interest; 58% indicated they proactively search for new articles of interest; 42% rely upon trusted sources (e.g., peer recommendations). Respondents were as likely to identify a new article using a search engine (e.g., Google) as they were using PubMed (46% for each method). When identifying key findings, 40% watch/listen to article synopses, and 96% read the article. However, most do not review an article in its entirety (85%) but instead review the results/conclusions (31%) or the abstract only (23%). Interactive graphs, case studies, and procedural videos were perceived as providing the greatest value among interactive assets.

Conclusions: While the survey was small and results not generalizable, these physicians indicated time constraints significantly complicate their ability to keep up with medical literature. Physicians are coping by actively searching and consuming only the most relevant details, utilizing technology to supplement understanding.

Public disclosure of clinical trial results: is the glass 80% full or 20% empty?

Bill Kadish^a, Kate Bradford^b and Sheelah Smith^c

^aPAREXEL International, Hackensack, NJ, USA

^bPAREXEL International, Uxbridge, UK

^cPAREXEL International, Worthing, UK

Objective: We sought to evaluate disclosure of clinical trial results by the highest ranking pharmaceutical companies in light of claims that more than 30% of trials have undisclosed results.

Research design and methods: We identified all phase 3 or phase 2/3 trials completed between June 2010 and June 2011 conducted by 13 pharmaceutical companies. We determined the percentage of trials that had posted results on ClinicalTrials.gov, the percentage of the remaining trials that had at least one publication, and the time elapsed between trial completion and results disclosure. We searched ClinicalTrials.gov, PubMed, Trialtrove and Google to identify publications. Congress presentations, proprietary websites, and publication in a non-peer-reviewed journal were not considered public disclosures.

Results: From a sample of 401 pharmaceutical company–sponsored trials, 224 (55.9%) had results posted on ClinicalTrials.gov; mean/median time to first posting was 12/12 months. Of those trials that had no posted results (n = 177), 87 (49.2%) had a primary publication; mean/median time to publication was 21/21 months. In total, 90 studies (22.4%) had nondisclosure of results at least 2.5 years after completion. Among the 13 companies, there was substantial variability in rates of disclosure (median, 84.7%; range 51.4% to 100.0%).

Conclusions: Almost 80% of trials had either results posted on a registry or a publication, which is a higher percentage than what has been reported previously. There were large differences in rates of disclosure among the pharmaceutical companies investigated.

Social media activity for optimizing publication timing in accordance with drug approval

Ira Mills^a, Hajira B. Koeller^a, Nathaniel Hoover^a, Ken Youngren^a and Sheelah Smith^b

^aPAREXEL International, Hackensack, NJ, USA

^bPAREXEL International, Worthing, UK

Objective: Significant progress in prostate cancer drug development has led to recent New England Journal of Medicine (NEJM) publications and Food and Drug Administration (FDA) approvals. Notably, publication timing has varied in relation to approval. We sought to determine optimal publication timing relative to regulatory approval to maximize publication impact by measuring the association of social media activity of these events.

Research design and methods: We searched Twitter user activity by generic drug name for NEJM- and FDA-related tweets and determined the correlation of NEJM/FDA tweets versus NEJM publication timing in relation to FDA approval.

Results: There was some indication of diminishing publication impact post-approval, but the correlation was weak (Table 1).

Conclusions: Social media activity indicates that managing timing of publication in relation to FDA approval to potentially optimize publication impact may not be warranted.

Table 1. Twitter activity associated with NEJM publication and FDA approval of prostate cancer drugs in accordance with time between the two events.

Prostate Cancer Drug (Trial)	NEJM Publication Date [FDA Approval Date]	NEJM Date to FDA Date, Δ (days)	NEJM Tweets	FDA Tweets	NEJM Tweets/ FDA Tweets*
Enzalutamide	Aug 15, 2013	−16	254	279	0.91
(AFFIRM)	[Aug 31, 2013]
Abiraterone	Dec 12, 2013	0	85	62	1.37
(COU-AA-302)	[Dec 12, 2013]
Radium-223	Jul 18, 2013	+64	119	116	1.03
(ALSYMPCA)	[May 15, 2013]
Sipuleucel-T	Jul 29, 2010	+91	23	28	0.82
(IMPACT)	[Apr 29, 2010]

*FDA tweets (reference) = 1.0

The e-Compendium: an innovative cross-functional platform for scientific statements

Manon Boisclair^a, Nick Combates^a, Robert Matheis^a, Susan Pacconi^a, Debbie Wolinsky^b, Dan Sinsimer^b, Lisa Chang^b and Tina Huang^a

^aCelgene Corporation, Summit, NJ, USA

^bNucleus Global, Hamilton, NJ, USA

Objective: Evidence-based scientific statements provide the basis for educational initiatives and are used to ensure consistency across scientific publications and other medical projects. Ensuring that cross-functional teams have reliable, centralized access to current statements is often a challenge. The objective of this project was to develop a secure, web-based, searchable scientific statement repository with related supporting materials for use across the organization and cross-functional teams (e.g., clinical, medical, scientific communication, regulatory, health economics and outcomes research, etc.).

Research design and methods: The e-Compendium offers a web-based, repository solution that provides user search and source referencing as core capabilities. Publications, slides, abstracts, posters, and oral presentations are continuously updated to ensure that the scientific statements are supported with the most recent data. The platform was designed with an engaging user interface that requires minimal training.

Results: The e-Compendium was demonstrated to have wide utilization during a pilot program designed to assess utility. Notably, users have experienced ready access to current scientific statements and references, thereby ensuring consistency and improving efficiency in the development of medical as well as educational initiatives.

Conclusions: The e-Compendium provides easy access for cross-functional teams, ensuring that the latest scientific statements and supporting materials are readily available. This centralized and dynamic platform may be used broadly across the organization to improve access and consistency in scientific statements that support medical communication and the delivery of appropriate patient care.

The potential use of alternative article metrics to predict long-term scientific impact*

Kevin Ryder^a, Tracy Johnson^a, Ross Ruriani^b and Neil Adams^c

^aCHC Group, Chadds Ford, PA, USA

^bDove Medical Press, Princeton, NJ, USA

^cNature Publishing Group, New York, NY, USA

Objective: The objective of this study was to determine whether alternative journal article metrics (page views/visits or PDF downloads) are significantly correlated with an accepted measure of scientific impact (citation frequency).

Research design and methods: Articles published in 2010 in a subscription fee–based model or in an open-access model were analyzed with a citation database to determine the frequency of citation over a 2-year period following publication. The number of page visits, page views, and/or PDF downloads were retrieved for each article. Pearson’s correlation coefficients were derived and standard tables used to examine possible relationships between frequency of citation and each alternative metric.

Results: Correlation coefficients were 0.36 (views) and 0.53 (downloads) for original research articles, and 0.49 (views) and 0.34 (downloads) for review articles published in the open-access model (p < 0.01 for original articles). For the subscription fee–based model, the results were 0.36 (views) and 0.37 (visits) for original research articles, and approached linearity (0.97 and 0.98 for views and visits) for review articles (p < 0.01 for all).

Conclusions: Alternative metrics such as page views/visits or PDF downloads are significantly correlated with a traditional measure of scientific impact such as frequency of citation following publication. In contrast to citations, which can only be measured in the years following publication, the majority of page views/visits occur soon after publication. These results suggest that alternative metrics gathered within the first few weeks following publication may predict an article’s longer-term scientific impact.

Trends in new drug approvals and clinical trial publications over a 2-decade interval

Charlene Rivera^a, Ken Truman^b, Todd Parker^a and Steven Palmisano^a

^aMedThink SciCom, Raleigh, NC, USA

^bMedThink Inc., Raleigh, NC, USA

Objective: The volume of new data can affect the ability of healthcare practitioners to keep abreast of medical literature pertaining to their specialty. This study aimed to ascertain historical trends in new drug approvals and publication of clinical trials.

Research design and methods: A search of the US Food and Drug Administration’s Drug Approval Report database was conducted to identify original New Drug Applications (NDAs) and Biologic License Applications (BLAs) approved between January 1993 and December 2012. An advanced search of the US National Library of Medicine’s PubMed database was conducted to identify clinical publications in the therapeutic areas of cancer, HIV, diabetes, and cardiovascular disease during this same period.

Results: Most NDAs and BLAs were approved during the fourth quarter of the year, followed by the second, third, and first quarters. The total number of NDA and BLA approvals remained fairly constant. However, the number of cancer, HIV, diabetes, and cardiovascular disease clinical trial publications increased steadily from 1993 through 2012. Collectively, these publications increased by 200% in 2012 compared with 1993.

Conclusions: Although the number of drug approvals has not varied substantially over recent years, the number of clinical publications in major therapeutic areas has continued to rise every year after the release of guidelines from the International Committee of Medical Journal Editors and Good Publication Practice (GPP/GPP2), and enactment of the Food and Drug Administration Amendments Act/Food and Drug Administration Modernization Act laws. Future analyses should explore the reasons for this continued increase and its potential effects on how clinicians maintain awareness of the literature.

Trends in the acknowledgement of professional medical writers for publication of clinical trial data

Disha Dayal, Ruchika Agrawal and Yoganand Duppalapudi

CACTUS Communications Ltd, Mumbai, India

Objective: This study analyzed the trends in the acknowledgement of professional medical writers (MWs) in clinical trial-based publications.

Research design and methods: A PubMed search was performed using ‘lymphoma’ as a representative example. Results were filtered using ‘clinical trial’, ‘free full-text’, ‘10-years’, and ‘English language’ as limits. The acknowledgements section of all the articles was analyzed. Trends in MW acknowledgement across different geographies and journal impact factors were also studied.

Results: Overall, of the 1360 articles, 151 (11.1%) acknowledged MWs; of these, 46 (30.46%) MWs were employed by professional agencies. An approximate 3-fold increase in MW acknowledgement was observed over the last 10 years (2004, 7.14%; 2013, 20.37%). Interestingly, a substantial increase in the acknowledgement of agency-based MWs was observed (2004, 0%; 2013, 45.45%) as opposed to in-house writers. A majority (97.35%) of the MWs were acknowledged by name. Acknowledgement of MWs’ contribution was higher in papers published in US-based (11.47%) and Europe-based (11.51%) journals compared to those based in Asia, Australia, North America (except USA), and South America (0% each). There was no relationship between journal impact factors and MW acknowledgement. Corresponding authors affiliated to institutions in Asia (5.41%) and Africa (0%) acknowledged MWs less frequently compared to those from the USA (13.01%) and Europe (10.62%). In our search, the five most frequently appearing journals had a similar instance of MW acknowledgement.

Conclusions: Acknowledgement of MWs, particularly professional agency-based writers, has increased substantially over the last 10 years.

Trends in the perception of professional medical writing in the popular press and biomedical journals*

Joanna Bloom

Envision Pharma Group, Southport, CT, USA

Objective: This study evaluated attitudes toward the medical writing profession in the popular press and biomedical journals from 2007 to 2013.

Research design and methods: Five US newspapers with the widest daily circulation as of March 2013 (The Wall Street Journal, The New York Times, USA Today, Los Angeles Times, and NY Daily News) and PubMed were searched for the terms ‘medical writing’ OR ‘medical writer’ OR ‘ghostwriting’ OR ‘ghostwriter’ (2007–2013). Articles discussing medical writers in conjunction with the pharmaceutical industry were categorized as positive, neutral, or negative based on tone and content.

Results: The analysis included 38 newspaper and 62 PubMed articles. The number of newspaper articles peaked in 2008 (n = 20), with no articles published in the popular press in 2011 or thereafter. The number of PubMed articles peaked in 2010 (n = 13). Overall, the proportion of negative articles was higher in the popular press vs. PubMed (92% vs. 56%); the proportion of positive (5% vs. 24%) or neutral (3% vs. 19%) articles was lower. The percentage of negative newspaper articles was relatively stable over time; greater fluctuation was observed in negative PubMed articles, with the highest percentages in 2011 (92%) and 2012 (75%).

Conclusions: The dearth of recent newspaper articles indicates medical writing is no longer considered newsworthy by the popular press. Continued criticism of medical writing in biomedical journals suggests further demonstration of the legitimacy and value of this profession is needed.

Under-representation of Southeast Asian articles in top-tier journals

Catherine Rees^a, Nicola Ryan^a and Andrew Sporle^b

^aRata Communications Ltd, Auckland, New Zealand

^bUniversity of Auckland, Auckland, New Zealand

Objective: The aim of this study was to assess trends in the number of articles from Southeast Asia (SEA) published in PubMed-listed journals, focusing on top-tier journals, and to identify potential factors associated with publication success.

Research design and methods: Using PubMed, we investigated the number of articles listing Hong Kong, Taiwan, Singapore, Malaysia, Philippines, Thailand, Indonesia, Cambodia, Vietnam, Laos, or Myanmar in the Affiliation field each year from 2000 through 2012. The top five journals by impact factor across 18 therapeutic areas were identified and publication numbers in those journals analyzed as a percentage of total publications. Multivariate analysis was used to assess factors associated with publication success, with Australia as the referent.

Results: SEA publications represented 2.25% of total publications on PubMed between 2000 and 2012. The highest number of SEA publications were from Taiwan (47.1%), followed by Hong Kong (17.5%), Singapore (14.6%), Thailand (11.9%), and Malaysia (6.4%). Publications from each of the other SEA countries comprised <1.0%. In the top five journals, articles from SEA comprised between 0.29% (endocrinology) and 2.87% (ophthalmology); mean ± SD was 1.37% ± 0.19%. Total SEA citations have increased over time, but citations in the top five journals have declined. Results of the multivariate analysis will be presented.

Conclusions: Although publication activity from SEA has been increasing, articles from SEA are under-represented in top-tier journals. Qualitative research is needed to identify barriers to publication for SEA-authored articles.

Understanding industry practices for author selection, engagement and training

Tricia L. Gooljarsingh^a, Christopher Rabbat^a and Cherie Whitmore^b

^aBaxter Healthcare Corporation, Westlake Village, CA, USA

^bKnowledgepoint360 Group, Lyndhurst, NJ, USA

Objective: A 15-question benchmark survey was designed by Baxter Healthcare and KnowledgePoint360 to gain insights into authorship.

Research design and methods: We conducted an online benchmarking survey with an online community of medical publication professionals in the US and Europe in April 2013 (prior to the new International Committee of Medical Journal Editors [ICMJE] guidelines) to learn what criteria are used to qualify authors, policies for internal (company employee) authors and author training.

Results: Twenty-two members of the MyVHow community responded, representative of nine pharmaceutical/biotech companies. All respondents included internal authors on primary manuscripts, 73% included internal authors on reviews, and 77% included internal authors for editorials. About 27% agree that the predominant use of external versus internal authors lends more credibility to the publication, but 64% believe that the individual’s contributions and the type of data reported should be the governing criteria. About 59% try to balance the ratio of internal to external authors.

About 59% felt that ICMJE authorship criteria needed to be revised, and more specifically, in the areas of ‘substantial contribution’ of analysis and interpretation of data, acquisition of data, and conception and design of the study. Clearer definitions of authorship exclusion were desired by 55%, and 45% felt that ICMJE criteria for authors of a review paper were not appropriately defined.

Surprisingly, 82% do not provide training on good publication practice to external authors. Thirty-six percent of respondents require that every author approve every publication draft.

Conclusions: This survey sheds insights into current industry practices and contributes to high standards for professional working practices.

2013 European meeting of ISMPP abstracts

The following abstracts were accepted for oral or poster presentation at the 2014 European Meeting of ISMPP

A survey of current practices in encore abstract submissions from industry-sponsored study data*

Antonia Panayi^a, Jurgen Wiehn^a, Susan Wieting^a, Amina Elsner^a, Slavka Baronikova^b, Jackie Marchington^c and Christopher Rains^a

^aShire, Eysins, Switzerland

^bShire, Diegem, Belgium

^cCaudex Medical, Oxford, UK

Objective: We developed a survey to understand publication practices when submitting encore abstracts that report industry-funded study data to congresses.

Research design and methods: This was a 20-question online survey conducted from 07/19/2013–08/31/2013. The survey was forwarded to the International Society for Medical Publication Professionals members via e-mail and posted on the Publication Plan website. The survey was piloted by a small group of experienced publication professionals.

Results: Of 195 respondents, 98/192 (51%) were from pharmaceutical/biotechnology/medical device companies, 89 (46%) from agency and 8 (42%) from other. Most respondents had a global role (152/192, 79%) and were USA-based (120/182, 66%). In total, 175/184 (95%) respondents stated that the current company/sponsor followed the International Committee of Medical Journal Editors (ICMJE) guidelines for congress abstract development, and 162/181 (90%) believed that ICMJE uniform requirements for manuscripts apply to abstracts. With respect to the number of encores, most believed they were appropriate in moderation (129/182, 71%), particularly for different countries/audiences. There was no strong consensus on whether additional authors, such as investigators, could be included on encores; however, most agreed that original authors could be removed if requested (132/182, 73%). Most agreed that the same guidelines apply globally and locally (170/182, 93%) and, importantly, there should be more guidance on encore abstracts from the publication organizations (141/180, 78%).

Conclusions: In general, encores were considered appropriate for different countries/audiences. Respondents overwhelmingly indicated that they followed the ICMJE authorship criteria for development of congress abstracts, although authorship practices varied widely for encore abstract submissions.

Acknowledgements in journals from emerging markets^†

Gayle Nicholas Scott^a and Andrea G. Scott^b

^aEnvision Pharma Group, Southport, CT, USA

^bVirginia Commonwealth University – Medical College of Virginia, Richmond, VA, USA

Objective: The objective of this research was to examine the use of acknowledgements in publications from emerging markets.

Research design and methods: Emerging markets were identified^†. Journals with a clinical focus (Table 1) from emerging markets were searched on PubMed and selected for review on the basis of availability in English and free online accessibility of full text, with preference given to general medical journals over specialty journals. We obtained full texts of the 10 most recent articles describing clinical trials, randomized control trials, or reviews on PubMed and looked for acknowledgements.

Table 1. Journals surveyed for acknowledgements.

Country of publication	Journal surveyed
Argentina	Archivos Argentinos de Pediatría
Brazil	Sao Paulo Medical Journal
Bulgaria	Folia Medica
China	Journal of the Chinese Medical Association
Czech Republic	Acta Medica
Egypt	Arab Journal of Gastroenterology
India	Indian Journal of Medical Research
Indonesia	Acta Medica Indonesiana
Korea	Journal of Korean Medical Science
Lithuania	Medicina (Kaunas, Lithuania)
Malaysia	Medical Journal of Malaysia
Mexico	Annals of Hepatology
Nigeria	Annals of African Medicine
Pakistan	Journal of the Pakistan Medical Association
Puerto Rico	Puerto Rico Health Sciences Journal
Romania	Journal of Medicine and Life
Saudi Arabia	Saudi Medical Journal
South Africa	South African Medical Journal
Thailand	Asian Pacific Journal of Cancer Prevention
Turkey	Turkish Journal of Gastroenterology

Results: Twenty journals from emerging markets were selected on the basis of the above criteria. Of the 200 articles reviewed (10 per journal), 81 (40.5%) included acknowledgements. Funding sources were acknowledged in 54 (27.0%), medical writers/editors in 1 (0.5%), colleagues/reviewers in 48 (24%), and statisticians in 8 (4%).

Conclusions: Acknowledgements of medical writers/editors, statisticians, and colleagues/reviewers are infrequent in journals from emerging markets. Funding source was the most common acknowledgement.

Reference

• Looney W. Crunch time for emerging markets. Pharmaceutical Executive 2013. Available at: http://www.pharmexec.com/pharmexec/Top+Feature/Crunch-Time-for-Emerging-Markets/ArticleStandard/Article/detail/822703
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Adoption of social media channels in leading medical journals in different therapeutic areas^†

Paul Lane

Envision Pharma Group, Horsham, West Sussex, UK

Objective: Social media, most notably Twitter, is now a route of dissemination and exchange for medical information. This study assesses the levels of adoption, activity and reach for the top 10 journals in five Institute for Scientific Information (ISI) categories: general/internal medicine, endocrinology/metabolism, oncology, urology/nephrology, and pharmacology/pharmacy.

Research design and methods: The top 10 journals in each ISI category were ranked using Eigenfactor and the levels of adoption (channels being utilized), activity (Tweet volume) and reach (Twitter followers) were assessed. Only dedicated journal social-media accounts (not affiliated professional organizations or publishers) were assessed for correlation analyses. Data were collected on 5/12/13.

Results: Overall 20/50 journals assessed had a Twitter account. Numbers of Twitter followers ranged from 21 to 153,845 (New England Journal of Medicine) and correlated well with Eigenfactor (r = 0.67) and impact factor (r = 0.64), but more strongly with Twitter activity (r = 0.82). Journal-specific Twitter channels were being utilized by 9/10 general/internal medicine, 2/10 endocrinology/metabolism, 3/10 oncology, 3/10 urology/nephrology, and 4/10 pharmacology/pharmacy journals. However, in other therapeutic areas, journals were often associated with a professional organization’s Twitter account. The general/internal medicine journals were more active in the adoption of other social media channels and 7/10 displayed channel links on their home page; channels utilized were Facebook (9/10), YouTube (5/10), Google+ (5/10) and Pinterest (1/10).

Conclusions: The use of social media by journals is increasing and reach of these media correlates well with citation-based measures (e.g., Eigenfactor) but more strongly correlates with Twitter activity.

Are phase 1 trials registered and results reported?^†

Lakshmi Venkatraman^a, Tom Rees^b and Sheelah Smith^b

^aPAREXEL International, Hyderabad, India

^bPAREXEL International, Worthing, UK

Objective: In 2007, the International Committee of Medical Journal Editors (ICMJE) stipulated prospective registration of phase 1 trials commencing after July 2008 for publication in their member journals. We surveyed the trend for phase 1 trial registration and results reporting, and publication.

Research design and methods: We searched ClinicalTrials.gov, Trialtrove and PubMed for year-wise data from 2000–2012. The search criteria were: ‘all completed, phase 1, interventional, industry-sponsored studies’ (with and without results) on ClinicalTrials.gov; ‘all completed, phase 1, industry-sponsored studies’ on Trialtrove; and ‘clinical trial, phase 1’ (Publication Type) AND ‘English’ (Language) AND ‘(Date – Entrez [year-wise])’ on PubMed.

Results: Registration of phase 1 trials on ClinicalTrials.gov increased after 2008; however, less than 10% of the registered phase 1 trials overall had results reported. From 2000–2012, 8063 trials were registered on ClinicalTrials.gov, 8829 on Trialtrove and 9212 publications retrieved from PubMed. Although there is no direct correlation, comparison of year-wise data on ClinicalTrials.gov, Trialtrove and PubMed sites further confirmed the increase in public disclosure of phase 1 trials on ClinicalTrials.gov after 2008. The year-wise ClinicalTrials.gov/Trialtrove ratio increased from <25% before 2005 to >50% after 2005, and to >100% after 2008. Similarly, the year-wise ClinicalTrials.gov/PubMed ratio increased from <15% before 2005 to >50% after 2005, and to >100% after 2008.

Conclusions: Public disclosure of phase 1 trials on ClinicalTrials.gov has increased since registration was made mandatory for publication in ICMJE journals. Results disclosure for phase 1 trials has largely not improved, probably because it is not mandatory.

Authorship: how to decide the order of authors on the byline?

Evelin Kozma^a, Michele Burling^a, Yvonne von Coburg^b and Kordula Heinen^b

^aMundipharma Research Ltd, Cambridge, UK

^bMundipharma Research GmbH & Co. KG, Limburg, Germany

Objective: The International Committee of Medical Journal Editors (ICMJE) authorship criteria have strengthened the integrity and accountability associated with named authors. The objective of this analysis was to review recognized guidelines and literature on how the order of the authors on the byline should be determined.

Research design and methods: A review of recommendations on author order from 17 manuscripts, the ICMJE criteria, and three top-tier journals in clinical medicine was undertaken.

Results: Historical connotations associated with author position on the byline include first, second and last typically having more ‘weight’ regarding contribution, funding, and position of authority within the organization or research area. The ‘publish or perish’ phenomenon is a huge burden on all academics; links often forged with such experts means this also impacts pharmaceutical industry publications. There is no clear guidance on the number or order of authors. Contributorship criteria have been adopted by several journals to eliminate guest, ghost and honorary authorship. Guarantorship is typically defined, but not the corresponding author or the order of the authors. Listing authors alphabetically and quantifying contributions have been suggested, but neither has proved popular in clinical medicine.

Conclusions: There remains a lack of guidance on the order in which authors appear on the byline, an increasing concern since global collaborations, and thus the number of authors, are growing. We would therefore recommend formal guidance on the order of authors, for example, to weight by contribution, which may then be endorsed by all scientific journals.

Case study: using social media monitoring to measure qualitative impact and inform communication strategy^†‡

Andy Shepherd and Jackie Marchington

Caudex Medical, Oxford, UK

Objective: Medical communications are adapting to embrace new technologies, increasing the variety of communication channels that are available, and also facilitating the collection of feedback from a given target audience. Our aim was to monitor social media over time to assess the dissemination of information, the resulting topics and opinions, and the potential use of feedback from social media in publication planning.

Research design and methods: References in social media to one drug and two of its competitors were captured following regulatory approval and over the subsequent year. Qualitative information on the topics discussed was collected and compared to publication activity.

Results: We present a quantitative overview of social media activity for the drug and its competitors over the subsequent year with heuristic analysis and qualitative observations. We also discuss a selection of free online tools that were trialed and assessed for their utility with respect to both automating the monitoring process and visualizing the findings.

Conclusions: Social media has the potential to facilitate better engagement with a target audience and could help tailor future communications to meet their needs.

Distribution and impact of industry-authored articles in medical journals (2008–2012)

Iain Spray

Newmed Publishing Services, Chester, UK

Objective: The aim of this study was to observe trends in the publication of articles with top-10 pharmaceutical company authors.

Research design and methods: A Scopus search produced a set of all articles with ≥1 authors from top-10 pharmaceutical companies¹. The data were limited to subject area ‘medicine’, source type ‘journals’ and publication date 01/01/2008 to 12/31/2012.

Results: The number of articles published across all journals (n = 20,788) grew annually from 3807 in 2008 to 4406 in 2012 (+15.7%). Of the ‘big four’ journals, the New England Journal of Medicine (NEJM) published more articles (n = 135) than Lancet (n = 102), BMJ (n = 25) or JAMA (n = 17). The average number of citations received by NEJM articles (n = 232.30) was significantly greater than Lancet (n = 151.75), JAMA (n = 93.12) or BMJ (n = 18.24). NEJM published 36 of the top 100 most cited articles, followed by Lancet (n = 19), JAMA (n = 1) and BMJ (n = 0). PLOS ONE published more articles than any other journal (n = 577) and grew by 451.1%. Articles published in other gold open-access journals from PLOS and BioMed Central’s ‘BMC’ series (n = 48) grew from 88 to 114 (+29.6%). The number of articles published in journals with fee-based rapid publishing services peaked in 2009 at 169 and then steadily decreased to 100 in 2012.

Conclusions: The number of articles with top-10 pharmaceutical company authors is steadily increasing. The use of journals specializing in fee-based rapid publication is decreasing, while the use of gold open-access journals is increasing, with PLOS ONE accounting for the majority of that growth. NEJM publishes the highest impact articles by a considerable margin.

Reference

• Staton T. Top pharma companies by 2012 revenues. FiercePharma 2013. Available at: http://www.fiercepharma.com/special-reports/top-pharma-companies-2012-revenues
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Getting the word out: developing a multichannel social media strategy for publication-based initiatives

Doug Taylor, Cindy Busch, Nipa Patel, Gina Mushrock, Susan Martin and Philip Sjostedt

The Medicine Group, New Hope, PA, USA

Objective: Our objective was the development and implementation of a multifaceted social media strategy that incorporates a variety of outlets to promote publication awareness and evidence dissemination.

Research design and methods: Of 40 journals initially contacted, only three would approve the use of a banner advertisement to raise publication awareness, underscoring the need for a novel approach to enhance publication recognition. An evaluation of publication activities disseminated through multiple channels, including Facebook, Twitter, LinkedIn, and a variety of healthcare social media outlets was undertaken, utilizing a customized social media ‘listening’ platform.

Results: We developed a novel strategic approach for dissemination of medical publications across a spectrum of social media outlets. This approach employs both general and specific social networks and is supplemented by additional content, including video content, blog posts, and hyperlinking across multiple platforms to ensure the broad impact of a complete message. New controls and metrics are utilized to measure the impact of these social media tactics on medical publications reach and impact.

Conclusions: Increasing consumer dependence upon social media to learn about disease states, treatment options, and healthcare decisions requires industry stakeholders to adapt by collaborating and communicating through multiple social networks. This layered approach of disseminating information across social networks reveals a positive correlation between publication promotion through social media channels and relative awareness.

Going mobile: implementation of smartphone technology for internal congress attendees

Christina Gallagher^a, Kelly Hageman^a, Kiki Chandni Patel^a, Samantha R. Llanos^b and Angela M. Partisano^b

^aMassachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA

^bSanofi Oncology, Cambridge, MA, USA

Objective: Smartphone technology and mobile applications (apps) are gaining popularity among conference attendees. Sanofi Oncology piloted these technologies to create a company specific electronic congress roadmap to collate/prioritize relevant disease-, product-, and competitor-related scientific sessions.

Research design and methods: Pertinent posters, oral presentations, plenary sessions and symposia were identified using pre-specified keywords; corresponding details (abstract/poster number, date/time, and location) were included in the app. Logistical documents and internal events were also included. The app was configured for iOS, Android, Blackberry, and web browsers, with access limited to internal Sanofi employees. Usage data were collected and analyzed via QuickMobile Analytics.

Results: To date, three separate Sanofi Congress apps have been developed and released to 501 internal Sanofi staff. Collectively, the Sanofi Congress apps have been downloaded 319 times and attendee utilization increased with each subsequent conference (28% vs. 51% vs. 94% for ESMO 2012, ASH 2012, and ASCO 2013, respectively). Over 80% of usage occurred within 3 days of app release, regardless of congress length or release date; 69% of all information accessed by users was scientific in nature (i.e., posters, orals, educational sessions, symposia).

Conclusions: Mobile apps are an effective way to circulate relevant congress and logistical details to a large internal audience at national and international congresses. The aforementioned results suggest successful dissemination of relevant sessions via mobile app technology within Sanofi Oncology. Therefore, we will continue to utilize this technology instead of traditional printed, internal conference roadmaps.

Physicians’ attitudes to industry-sponsored review articles

Murray Edmunds^a, Cassie Partington^b, Tom Pugh^c, Sarah Thomas^a and Jodi Cusack^a

^aWatermeadow Medical, Witney, UK

^bInforMed Insight Ltd, Macclesfield, UK

^cAll Global, London, UK

Objective: This Internet survey tested end-readers’ attitudes to the value and integrity of pharmaceutical industry sponsored review articles, covering content and the writing/peer-review process.

Research design and methods: Responses were obtained from 484 healthcare providers (including 198 primary care and 229 specialist physicians) in the EU and USA to 12 specific questions comprising opposing negative/positive attitude descriptions. Responses were made on a 0–6 Likert scale, with mean values converted to %maximum. The proportion of 0 & 1 (skeptical) and 5 & 6 (enthusiastic) rankings were also recorded. Responses to an additional open invitation to comment were classed ‘negative’, ‘ambivalent’ or ‘positive’. Comparisons were made (t-test) between specialist and primary care physicians, and between those who had (n = 38) and had not authored such an article themselves.

Results: Mean %maximum scores for the specific questions were 54–65%, with ranges for skeptical and enthusiastic responses of 7.4–14.7% and 22.3–40.5%, respectively. Confidence was higher regarding the involvement of expert authors and peer-reviewers versus sponsors and professional writers. Specialists tended to give more positive responses than primary care physicians, as did authors versus non-authors. Primary care and specialist physicians, 22.2% and 27.5%, respectively, gave enthusiastic scores for a question concerning the likelihood of review articles influencing their prescribing. Overall, responses to the open question were: positive 31.1%, ambivalent 33.6% (often recognizing value but expressing a need for cautious interpretation), negative 11.6%, and no response 23.7%.

Conclusions: While opinion varies, the overall attitude of readers appears more positive than negative, with many considering these articles an important source of information.

When should medical writers be listed as authors?^†

Tamzin Gristwood^a, Paul Farrow^a, Catherine Hill^b, Gemma Carter^a, David Bennett^a and Christopher Winchester^a

^aOxford PharmaGenesis Ltd, Oxford, UK

^bPharmaGenesis London, London, UK

Objective: Good publication practice guidelines suggest that medical writers involved in producing peer-reviewed publications should be acknowledged or listed as authors, according to their contribution. This study sought opinions on medical writer authorship from clinicians, researchers and medical publication professionals.

Research design and methods: An electronic, anonymous, 10-question survey was circulated in August–September 2013 via e-mail to contacts of Oxford PharmaGenesis, and via Facebook and LinkedIn. Respondents were asked to answer questions according to their personal opinion rather than knowledge of the guidelines of the International Committee of Medical Journal Editors, which were updated during circulation of this survey.

Results: Of 155 respondents, 77% had worked with or as medical writers. Proportions of respondents believing that medical writers should always, frequently, occasionally or never be listed as authors were: systematic reviews, 34%, 31%, 22% and 6%; narrative reviews, 22%, 28%, 26% and 14%; and primary research manuscripts, 18%, 14%, 36% and 25%. Among respondents without experience of working with medical writers, 43–57% indicated that they should always be authors, compared with 11–29% of those with such experience. Most respondents (75%) agreed that medical writer authorship increases transparency, whereas only 25% thought that it reduces credibility. While 50% believed that medical writers usually contribute sufficiently to warrant authorship, only 38% believed they have sufficient control to take public responsibility for content.

Conclusions: There is good support for authorship by professional medical writers on all types of peer-reviewed publications, at least in certain circumstances.

Why do some manuscripts lag? An analysis of factors associated with delivery timelines*^†

Tom Rees^a, Bill Kadish^b and Sheelah Smith^a

^aPAREXEL International, Worthing, UK

^bPAREXEL International, Hackensack, NJ, USA

Objective: This study sought to understand the factors associated with variability in manuscript development time across multiple client accounts and therapy areas.

Research design and methods: Program Management was asked to provide the following data for manuscripts submitted from August 2011 through August 2013: therapeutic area, client account, manuscript type (primary, secondary, review), number of internal and external authors, initiation date, and date of first submission. Time from initiation to first submission (months) was evaluated using descriptive statistics and analysis of variance (ANOVA).

Results: After eliminating incomplete records, we obtained records for 175 manuscripts – 99 primary, 39 secondary, and 37 reviews – from 24 product teams spanning 10 major therapy areas. ANOVA demonstrated significant variation (p < 0.001) across accounts, therapy areas, article types, and author numbers. Time from initiation to submission ranged from 1–31 months (median, 10 months; mode, 9 months). Development time for primary manuscripts was significantly faster than for reviews (by 2.6 months, p < 0.05) and for secondary publications (by 3.3 months, p = 0.01). Outliers on development time were mostly linked to requirements for additional data analyses. Therapy area and the ratio of internal to external authors were also associated with variations in development times. Primary manuscript development times were consistent across major accounts, with one outlier that may be related to client procedures.

Conclusions: There was significant variability in manuscript development time that was largely a function of article type, with primary manuscripts having the shortest and secondary manuscripts the longest development times.

Notes

*Oral presentation.

*Oral presentation.

*Oral presentation.

*Oral presentation.

*Oral presentation.

^†Encored poster at the 10th Annual Meeting of ISMPP.

^†Encored poster at the 10th Annual Meeting of ISMPP.

^†Encored poster at the 10th Annual Meeting of ISMPP.

^‡Poster Winner, Best Original Research, 2014 European Meeting of ISMPP.

^†Encored poster at the 10th Annual Meeting of ISMPP.

*Oral presentation.

^†Encored poster at the 10th Annual Meeting of ISMPP.