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1.  The effect of MELatOnin on Depression, anxietY, cognitive function and sleep disturbances in patients with breast cancer. The MELODY trial: protocol for a randomised, placebo-controlled, double-blinded trial 
BMJ Open  2012;2(1):e000647.
Introduction
Breast cancer represents about one-third of all cancer diagnoses and accounts for about 15% of cancer deaths in women. Many of these patients experience depression, anxiety, sleep disturbances and cognitive dysfunction. This may adversely affect quality of life and also contribute to morbidity and mortality. Melatonin is a regulatory circadian hormone having, among others, a hypnotic and an antidepressive effect. It has very low toxicity and very few adverse effects compared with the more commonly used antidepressants and hypnotics.
Methods and analysis
The objective of this double-blind, randomised, placebo-controlled trial is to investigate whether treatment with oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore, the authors will examine whether a specific clock-gene, PER3, is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction. The MELODY trial is a prospective double-blinded, randomised, placebo-controlled trial in which the authors intend to include 260 patients. The primary outcome is depressive symptoms measured by the Major Depression Inventory. The secondary outcomes are anxiety measured by a Visual Analogue Scale, total sleep time, sleep efficiency, sleep latency and periods awake measured by actigraphy and changes in cognitive function measured by a neuropsychological test battery. Tertiary outcomes are fatigue, pain, well-being and sleep quality/quantity measured by Visual Analogue Scale and sleep diary and sleepiness measured by the Karolinska Sleepiness Scale. The PER3 genotype is also to be determined in blood samples.
Article summary
This is a protocol article on the MELODY trial. The objective of this double-blind randomized, placebo-controlled trial is to investigate whether daily treatment with 6 mg oral melatonin has a prophylactic or ameliorating effect on depressive symptoms, anxiety, sleep disturbances and cognitive dysfunction in women with breast cancer. Furthermore to examine whether a specific clock-gene PER3 is correlated with an increased risk of depressive symptoms, sleep disturbances or cognitive dysfunction.
doi:10.1136/bmjopen-2011-000647
PMCID: PMC3278491  PMID: 22240653
2.  Fate of manuscripts rejected by a non-English-language general medical journal: a retrospective cohort study 
BMJ Open  2011;1(1):e000147.
Objective
The objective of this study was to determine whether, where and when manuscripts were published following rejection by the Journal of the Danish Medical Association, a general medical journal published in Danish. Similar previous studies have focused on specialty/subspecialty journals published in English.
Design
Manuscripts rejected during a 4-year period were searched for in PubMed and Embase in order to assess the percentage of manuscripts subsequently published in other journals. In addition, characteristics of both the published manuscripts and the journals in which they were evaluated.
Results
Of 198 rejected manuscripts, 21 (10.6%) were eventually published after a median of 685 days (range 209–1463). The majority of these were original research, published in English-language specialty/subspecialty journals. The median number of citations per article was 2–3 (IQR 0.5–9.5, depending on the database searched).
Conclusions
10.6% of the rejected manuscripts were eventually published in other journals, mainly English-language specialty journals. This proportion was considerably lower than that for other journals that have studied the fate of rejected manuscripts. Manuscript translation could be a barrier for resubmitting to English-language journals with larger readerships, thus hindering the dissemination of knowledge to the international community.
Article summary
Article focus
To determine whether, where and when manuscripts were published following rejection by a general medical journal published in a language other than English
Key messages
10.6% of the rejected manuscripts were eventually published in other journals, a proportion considerably lower than that for other journals that have studied the fate of rejected manuscripts
Manuscript translation could be a barrier for resubmitting to English-language journals with larger readerships. Scientific journals publishing in small languages should consider publishing original research in a major language such as English in order to facilitate the dissemination of scientific results
Strengths and limitations of this study
PubMed and Embase were used to search for rejected manuscript eventually published in other (indexed) journals; previous studies have searched only PubMed for rejected manuscripts. However, even when searching both databases, the number of search results (published manuscripts) would most likely be an underestimate, as some manuscripts could be published in non-indexed journals.
This study deals with a general medical journal published in a small language; previous studies have focused on specialty/subspecialty journals published in English.
doi:10.1136/bmjopen-2011-000147
PMCID: PMC3191426  PMID: 22021776
Medical journalism; medical ethics
3.  Early closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial 
BMJ Open  2011;1(1):e000162.
Objective
The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal).
Background
Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7–9% and minor complications varying from 4–5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality.
Design and methods
Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0–12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation).
Discussion
The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome.
Clinical trials identifier
NCT01287637.
Article summary
Article focus
Frequency of complications 0–12 months after initial surgery; comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6, and 12 months after surgery (stoma creation); and comparison of the total costs of the two groups at 6 and 12 months after the initial surgery (stoma creation).
Key messages
The significance of the study is the aim of making evidence-based recommendations for timing of the closure of a temporary ileostomy after surgery for rectal cancer.
Strengths and limitations of the study
The dimensions of the study (sample size: 200 patients) allow us to make recommendations. The recommendations will be of central importance to future patients. The results not only incorporate complications and mortality but integrate patient-reported outcome. The limitation is that the follow-up period is limited to 12 months.
doi:10.1136/bmjopen-2011-000162
PMCID: PMC3191573  PMID: 22021780

Results 1-3 (3)