Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship – emphasising the importance of responsibility and accountability – have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors’ Network of the European Society of Cardiology.     

Ten Years after the International Committee of Medical Journal Editors’ Clinical Trial Registration Initiative,One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis

Introduction

Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy.

Methods

We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria.

Results

Considering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated.

Conclusion

Ten years after the ICMJE’s clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures.     

Molecular genetics of aging in the fly: Is this the end of the beginning?

How we age and what we can do about it have been uppermost in human thought since antiquity. The many false starts have frustrated experimentalists and theoretical arguments pronouncing the inevitability of the process have created a nihilistic climate among scientists and the public. The identification of single gene alterations that substantially extend life span in nematodes and flies however, have begun to reinvigorate the field. Drosophila's long history of contributions to aging research, rich storehouse of genetic information, and powerful molecular techniques make it an excellent system for studying the molecular mechanisms underlying the process of aging. In recent years, Drosophila has been used to test current theories on aging and explore new directions of potential importance to the biology of aging. One such example is the surprising finding that, as opposed to the commonly held assumption that adult life is a period of random passive decline in which all things are thought to fall apart, the molecular life of the adult fly appears to be a state of dynamic well-regulated change. In the fly, the level of expression of many different genes changes in an invariant, often age-dependent, manner. These as well as other molecular genetic studies and demographic analyses using the fly have begun to challenge widely held ideas about aging providing evidence that aging may be a much more dynamic and malleable process than anticipated. With the enormous success that Drosophila molecular genetics has demonstrated in helping understand complex biological phenomena such as development there is much optimism that similar approaches can be adapted to assist in understanding the process of aging.     

Are fibre supplements really necessary in diverticular disease of the colon? A controlled clinical trial.

Fifty-eight patients with uncomplicated diverticular disease of the colon took bran crispbread, ispaghula drink, and placebo for four months each in a randomised, cross-over, double-blind controlled trial. Assessments were made subjectively, using a monthly self-administered questionnaire, and objectively, by examining a seven-day stool collection at the end of each treatment period. In terms of a pain score, lower bowel symptom score (the pain score and sensation of incomplete emptying, straining, stool consistency, flatus, and aperients taken), and total symptom score (belching, nausea, vomiting, dyspepsia, and abdominal distension) fibre supplementation conferred no benefit. Symptoms of constipation, however, when assessed alone, were significantly relieved. Both fibre regimens produced the expected changes in stool weight, consistency, and frequency. It is concluded that dietary fibre supplements in the commonly used doses do no more than relieve constipation. Perhaps the impression that fibre helps diverticular disease is simply a manifestation of Western civilisation''s obsession with the need for regular frequent defecation.     

Does Plant Species Richness Guarantee the Resilience of Local Medical Systems? A Perspective from Utilitarian Redundancy

Resilience is related to the ability of a system to adjust to disturbances. The Utilitarian Redundancy Model has emerged as a tool for investigating the resilience of local medical systems. The model determines the use of species richness for the same therapeutic function as a facilitator of the maintenance of these systems. However, predictions generated from this model have not yet been tested, and a lack of variables exists for deeper analyses of resilience. This study aims to address gaps in the Utilitarian Redundancy Model and to investigate the resilience of two medical systems in the Brazilian semi-arid zone. As a local illness is not always perceived in the same way that biomedicine recognizes, the term “therapeutic targets” is used for perceived illnesses. Semi-structured interviews with local experts were conducted using the free-listing technique to collect data on known medicinal plants, usage preferences, use of redundant species, characteristics of therapeutic targets, and the perceived severity for each target. Additionally, participatory workshops were conducted to determine the frequency of targets. The medical systems showed high species richness but low levels of species redundancy. However, if redundancy was present, it was the primary factor responsible for the maintenance of system functions. Species richness was positively associated with therapeutic target frequencies and negatively related to target severity. Moreover, information about redundant species seems to be largely idiosyncratic; this finding raises questions about the importance of redundancy for resilience. We stress the Utilitarian Redundancy Model as an interesting tool to be used in studies of resilience, but we emphasize that it must consider the distribution of redundancy in terms of the treatment of important illnesses and the sharing of information. This study has identified aspects of the higher and lower vulnerabilities of medical systems, adding variables that should be considered along with richness and redundancy.