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Objectives: A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy. Methods: A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation. Results: The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10). Conclusion: This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison. Refereed/Peer-reviewed

Introduction: People living with dementia may experience and express pain in different ways to people without dementia. People with dementia are typically prescribed fewer analgesics than people without dementia indicating a potential difference in how pain is identified and treated in these populations. The objectives of this study are to (1) investigate the prevalence of analgesic load, pain and daytime sedation in people with and without dementia in Australian residential aged care facilities (RACFs), and (2) investigate the clinical and diagnostic associations between analgesic load, pain and daytime sedation in people with and without dementia in Australian RACFs. Methods/analysis: This will be a cross-sectional study of 300 permanent residents of up to 10 low-level and high-level RACFs in South Australia with and without dementia. Trained study nurses will administer validated and dementia-specific assessments of self-reported and clinician-observed pain, sedation and other clinical and humanistic outcomes. Medicine-use data will be extracted directly from each resident's medication administration chart. Binary and multinominal logistic regression will be used to compute unadjusted and adjusted ORs and 95% CIs for factors associated with pain, analgesic load and daytime sedation. These factors will include dementia severity, behavioural and psychological symptoms, quality of life, resident satisfaction, attitudes towards medicines, activities of daily living and nutritional status. Ethics and dissemination: Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences and in peer-reviewed journal articles. The findings of this study will allow for a better understanding of the prevalence and factors associated with analgesic use, pain and other outcomes in residential care. The findings of this study will be used to inform the development and implementation of strategies to improve the quality of life of people with dementia Refereed/Peer-reviewed

Elsevier, publisher of The Lancet, is reviewing its publishing practice after court disclosure that it colluded with Merck to produce a fake journal, the Australasian Journal of Bone and Joint Medicine (AJBJM) to promote rofecoxib and other Merck products. Elsevier has called the incident an “isolated practice led by former employees in a local pharmaceutical services division”. This statement refers to the publication in Australia of nine fake journals, and the registration of another 13. Although Elsevier acknowledged that all the fakes “carried the name ‘journal of’ but lacked proper sponsor disclosures and were not in fact journals and should not have been titled as such”, it further defended its practice on the grounds that the AJBJM was the only one of the fakes bought by a single company. The others, it says, were “published with ads from multiple advertisers and therefore did not call for additional disclosure”. But neither the publication of faked journals nor the setting up of journals for a single advertiser turn out to be isolated to Australia, as revealed by an examination of the website of Excerpta Medica, Elsevier’s pharmaceutical services division. A case study describes how a “company-sponsored journal” was “initially released in December of 2004 to physicians in Europe and Canada” and “now includes versions translated for subscribers in Spain and Greece” for a client competing in a “very crowded and mature” cardiovascular market. From a “shallow base of clinical support”, the journal was designed to “position the client as a market leader” and “prepare the specialist and primary markets for future indications”. The website leaves little doubt that when Excerpta Medica “partner[s] with our clients in the pharmaceutical and biotech industries to educate”, education is a euphemism for marketing. For example, the strategic services off ered on the “Medical education” page include “Product positioning” and “Key opinion leader (KOL) development”. The Lancet is used to sell Excerpta Medica. As recently as June 18, a group managing director wrote: “Communications agencies linked to publishers can leverage the content from within their company”. Describing The Lancet’s symposium series, in which a pharmaceutical company sponsors a meeting where the authors and a “local thought leader” discuss a recently published paper with the audience, he said “The unique assets of the Lancet brand help to attract audiences and give the meetings the required credibility and impact.” Although the relationship between medical publishing and service to the pharmaceutical industry is not unique to Elsevier, we question the compatibility of these two roles.