Effect of melatonin cream on acute radiation dermatitis in patients with primary breast cancer: A double-blind, randomized, placebo-controlled trial.

AIM: This was a double-blind, placebo-controlled randomized study investigating whether melatonin can protect against radiation dermatitis in women receiving radiation therapy for primary breast cancer. METHODS: Patients were included before radiation therapy and followed once weekly throughout treatment with a 3-week follow-up. Patients applied 1 g of cream to the irradiated skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or placebo. Our outcomes were the Radiation Therapy Oncology Group's (RTOG) acute radiation morbidity scoring criteria for skin, a pixel analysis of erythema in clinical photographs, and patients' use of corticosteroid cream. Outcomes were evaluated once weekly throughout the trial. The primary outcomes were RTOG-score and pixel analysis at 2 weeks follow-up. Secondary outcomes were the use of corticosteroid cream and analyses of RTOG-scores and pixel analyses throughout the trial. RESULTS: Sixty-five patients were included, 17 dropped out, totaling 26 and 22 patients randomized to melatonin and placebo, respectively. RTOG-scores and pixel analyses at 2 weeks follow-up showed no difference p = .441 and p = .890, respectively). There was no difference in the use of corticosteroid cream (p = .055). Using logistic regression, the melatonin group had a higher likelihood of having a low RTOG-score (p = .0016). The logistic regression showed no difference between the groups for the pixel analyses. CONCLUSION: Our primary outcome showed no difference in RTOG-scores at 2 weeks follow-up, however, the RTOG-score over the entire duration of the study demonstrated a protective effect of melatonin. Further studies are warranted investigating higher doses of melatonin, and whether corticosteroids may influence the effect of melatonin cream against radiation dermatitis.

Diarrhoea-causing microorganisms are rare in adult patients undergoing diagnostic laparoscopy for suspected appendicitis: a prospective observational cohort study.

We investigated if diarrhoea-causing bacteria, including Yersinia species, could mimic the symptoms of appendicitis and lead to surgery. This prospective observational cohort study (NCT03349814) included adult patients undergoing surgery for suspected appendicitis. Rectal swabs were analysed with polymerase chain reaction (PCR) for Yersinia, Campylobacter, Salmonella, Shigella and Aeromonas spp. Blood samples were analysed routinely and with an in-house ELISA serological test for Yersinia enterocolitica antibodies. We compared patients without appendicitis and patients with appendicitis confirmed by histopathology. The outcomes included PCR-confirmed infection with Yersinia spp., serologic-confirmed infection with Y. enterocolitica, PCR-confirmed infection with other diarrhoea-causing bacteria and Enterobius vermicularis confirmed by histopathology. A total of 224 patients were included, 51 without and 173 with appendicitis, and followed for 10 days. PCR-confirmed infection with Yersinia spp. was found in one patient (2%) without appendicitis and no patients (0%) with appendicitis (p = 0.23). Serology was positive for Y. enterocolitica for the same patient without appendicitis and two patients with appendicitis (p = 0.54). Campylobacter spp. were detected in 4% vs 1% (p = 0.13) of patients without and with appendicitis, respectively. Infection with Yersinia spp. and other diarrhoea-causing microorganisms in adult patients undergoing surgery for suspected appendicitis was rare.

Quality-of-life outcomes following topical melatonin application against acute radiation dermatitis in patients with early breast cancer: A double-blind, randomized, placebo-controlled trial.

The aim of this double-blind, placebo-controlled, randomized study was to investigate whether topical melatonin administered during radiation therapy could increase the quality of life in patients with primary breast cancer. Patients were followed from the first radiation fraction until 3 weeks after the last. The patients applied 1 g of cream to the irradiated area of the skin twice daily, consisting of either 25 mg/g melatonin and 150 mg/g dimethyl sulfoxide, or a placebo cream. Outcomes were the European Organisation for Research and Treatment of Cancer's quality-of-life questionnaires for breast cancer (QLQ-C30 and QLQ-BR23) on the last day of radiation therapy. As a secondary outcome, we evaluated the breast symptom (BS) scores over the entire duration of the trial in a repeated measures linear model. We included 65 patients and had 17 drop-outs, thus totaling 26 and 22 patients in the melatonin and placebo groups, respectively. BS scores on the last day of radiation did not differ between groups (p = .333). However, the linear model analyzing BS for the entire duration showed that melatonin significantly decreased the symptoms (p = .001). There was no difference in the BS score on the last day of radiation, however, we found that the patients in the melatonin group had significantly lower BS scores over the entire duration of the trial.

More than one-third of Cochrane reviews had gift authors, whereas ghost authorship was rare.

OBJECTIVES: To determine the prevalence of gift and ghost authors in Cochrane reviews and to investigate possible predictors of gift authorship. STUDY DESIGN AND SETTING: An Internet-based survey was sent in April 2019 to 1,226 first authors of Cochrane reviews published between October 2016 and December 2018. Three reminders were sent. Responses were anonymized before data extraction. RESULTS: A total of 666 of 1,226 (54%) first authors completed the survey. The prevalence of gift authors was 41% and 2% reported ghost authorships. Of the first authors, 15% were not aware of the authorship criteria from the International Committee of Medical Journal Editors. In a multivariable analysis, factors associated with the existence of gift authorship were: first author was not aware of the International Committee of Medical Journal Editors authorship guidelines (odds ratio (OR) 2.08, 95% confidence interval (CI) 1.23-3.51, P = 0.006), increasing number of authors (P < 0.001), and first author had offered an inappropriate authorship previously in their academic career (OR 1.96, 95% CI 1.23-3.13, P = 0.005). CONCLUSION: A substantial proportion of Cochrane reviews showed evidence of gift authorship, whereas ghost authorship was less prevalent. Thus, there is a need to increase awareness of this persistent issue in Cochrane reviews.

Half of Cochrane reviews were published more than 2 years after the protocol.

OBJECTIVES: The objective of the study is to examine the time from publication of the protocol for a Cochrane review to publication of the Cochrane review for the entire Cochrane Database of Systematic Reviews (CDSR). STUDY DESIGN AND SETTINGS: Cochrane reviews from the CDSR published between 1995 and 2019 were assessed. Characteristics of the reviews were extracted, and time from publication of protocol to publication of review was calculated. These times were grouped for relevant characteristics and visualized through charts and tables to illustrate trends. RESULTS: Of the total 8,201 reviews in the CDSR, 6,764 were included. The median publication time was 2 years (range 0 days to 21.7 years). Reviews that were published more than 5 years after the protocol made up 11% of all included reviews, whereas 19% of reviews were published within a year. The median publication time for the individual Cochrane Review Groups ranged from 15 to 39 months. CONCLUSION: Half of Cochrane reviews were published later than Cochrane's aim of 2 years. Furthermore, the Cochrane Review Groups' median times from publication of protocol to publication of review varied widely.

[Illegitimate authorships still exist and may ruin the integrity of science].

Previous studies have revealed the existence of illegitimate authorship, e.g. gift authors and ghostwriters, in Scandinavian journals as well as in international high-impact medical journals. In order to obtain transparent and accountable research it is important to eliminate inappropriate authorships, and in this review, we argue, this could be done by extending the knowledge of the authorship criteria and the different types of illegitimate authorship, especially through the education of both students and doctors.

Increasing number of authors in Cochrane reviews.

OBJECTIVE: To investigate authorship trends in Cochrane reviews from 1996 to 2018, and to examine if the authorship criteria from the International Committee of Medical Journal Editors (ICMJE) were met for Cochrane reviews with more than 15 authors based on the text in the section "Contributions of authors." METHODS: The median number of authors per review was calculated, and authorship trends within each editorial group were analyzed. The section "Contributions of authors" was assessed about the first and second authorship criteria from the ICMJE for reviews with more than 15 authors. RESULTS: A total of 7447 Cochrane reviews were studied based on data from the Cochrane Database of Systematic Reviews. The median number of authors per Cochrane review was 3 in 1996 (IQR 2.5-3, range 2-3), 4 in 2007 (IQR 3-5, range 1-13), and 5 in 2018 (IQR 4-7, range 2-22). Within each editorial group, the total number of authors either increased (26/55, 47%) or was unchanged (29/55, 53%). Based on the text in "Contributions of authors," 59% (16/27) of the reviews with more than 15 authors had authors that did not fulfil the ICMJE authorship criteria. However, the text in "Contributions of authors" was often difficult to interpret. CONCLUSIONS: The number of authors per Cochrane review gradually increased from 1996 to 2018. The ICMJE authorship criteria were probably not met by all authors in more than half of the reviews with more than 15 authors.