IntroductionThe opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings.Materials and methodsMethods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories.ResultsOur preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing.ConclusionsThe major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to “upon request” or “open” mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.

IntroductionThe aim of the IMPACT (IMProving Access to Clinical Trial data) Observatory is to assess the transformation of clinical trials (CT) related to the evolution of sharing of CT data. The objective of this study is to establish a baseline for monitoring CT data sharing by the Observatory.Materials and methodsIn this scoping review we searched for publications that address sharing, dissemination, transparency or reuse of CT data published prior to December 31st 2000. Two authors screened titles and abstracts of 1204 records received by Medline searches and added 47 publications from direct discovery. Four researchers extracted, coded, and analyzed the predefined information from 102 selected papers.ResultsWe found a growing recognition of the importance of data sharing prior to 2001. However, there were numerous obstacles including the ambiguity of the concept of data sharing, the absence of specific terminology and the lack of an “open” culture. By the end of 2000, data, metadata, and evidence based medicine were defined. Data sharing, registries, databases and re-analyses of individual patient data (IPD) emerged. The use of systematic reviews and IPD meta-analysis in decision making was promoted. Most arguments for broader data sharing came from oncology, paediatrics, rare diseases, AIDS, pregnancy, perinatal medicine, and media reporting related scandals.ConclusionsOur findings indicate that the year 2000 could be used as a baseline for monitoring the evolution of CT data sharing as basic prerequisites were set in place, including greater understanding that CT data sharing is essential for decision making and the advancements of the Internet.

We evaluated long‐term publication outcomes of a workshop on planning and writing a research article attended by medical professionals. A prospective cohort study included 243 participants (68 men and 175 women) attending 18‐h workshops on research planning and writing and 243 controls (78 men and 165 women) identified by participants as their professional peers. A total of 17 workshops was organized by the editors of the Croatian Medical Journal, Zagreb, Croatia, from 2003 to 2011. We measured the number of publications, citations and H‐indices in the Web of Science and Scopus databases from the time of each workshop to the end of 2017. While workshop participants and their controls had similar publication output before the workshops, workshop participants published significantly more scientific articles and had higher citation rates and H‐index after the workshops. For the subgroup of authors who were all followed up for 11 years (n = 398), the increase in the number of articles became apparent in the third post‐workshop year, and levelled out after the eighth post‐workshop year. Workshop attendance proved to be a significant predictor of post‐workshop publishing even when controlled for age, gender, and previous publications (OR = 3.547, CI = 2.320–5.423, p < 0.001), indicating that short‐term workshops on planning and writing research may be an important tool to increase long‐term scientific productivity of medical professionals.

The common toad produces venom (bufotoxin) that is produced in the parotid gland of the toad as well as in the skin. This toxic compound is a potent inhibitor of Na+/K+-ATPase activity. Physiological effects of bufotoxin are similar to those of digitalis and cause increased heart rate and muscle contractions. Ocular toxicity was described. A 67-year-old female patient was admitted to the emergency service because of sudden vision loss and a burning sensation in both eyes after she had been exposed to the poison of a toad. Slit lamp examination showed conjunctival hyperaemia and signs of ocular hypotonia. Topical antibiotic treatment was administered, and after 24 hours, corneal oedema and ocular hypotonia were in remission. Inhibition of Na+/K+-ATPase is a well-known effect of the toad venom. Na+/K+-ATPase is a part of corneal endothelial cells, ciliary body, and iris, and its inhibition caused by exposure to bufadienolides induces corneal dysfunction, decreased vision, and ocular hypotonia. Effects of bufadienolides on the decrease of ocular pressure appear to be very strong, with quick action. This rarely described effect of the bufotoxin can be used as a basis for further research of toad venom and its pharmacological potential. Purpose. To present a case of a 67-year-old female patient who experienced a sudden decrease in vision after exposure to the poison from a common toad (Bufo bufo).

Percepcije bolesnika o kvaliteti zdravstvenih usluga u velikoj mjeri mogu utjecati na kvalitetu zdravstvenih usluga. U tom pogledu, potrebna je vjerodostojna informacija o percepciji i očekivanjima bolesnika o kvaliteti zdravstvenih usluga. Bolesnike trebastaviti u samo središte pružanja zdravstvenih usluga tako da sudjeluju u donošenju odluka i preuzimaju kontrolu nad svojim zdravstvenim potrebama. Potreba za održivim poboljšanjem sigurnosti pacijenata i kvalitete skrbi nikada nije bila veća. Jedan od temeljnih koraka u postizanju i održavanju tog poboljšanja je da zdravstvene institucije postanu organizacije koje kontinuirano uče. U organizaciji koja uči, događaji u vezi sa sigurnošću pacijenata smatraju se prilikama za učenje i poboljšanje. Vrlo je važno da svi građani budu educirani o pitanjima sigurnosti. Pacijenti, bolesnici, zdravstveni djelatnici i menadžersko osoblje trebali bi se educirati o sigurnosti koristeći sve prikladne metode, uključujući predavanja, radionice, seminare i tiskanu ili elektroničku materiju.