Objectives To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. Design 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between 1983 and 1999). Results Multiple publication: 21 studies contributed to at least two publications each, and three studies contributed to five publications. Selective publication: studies showing significant effects of drug were published as stand alone publications more often than studies with non-significant results. Selective reporting: many publications ignored the results of intention to treat analyses and reported the more favourable per protocol analyses only. Conclusions The degree of multiple publication, selective publication, and selective reporting differed between products. Thus, any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.

The prevalence of breathing obstruction was determined in a cohort of 4-year-old children. Craniofacial morphology was studied in obstructed children and compared with data from a control group of 4-year-old children with ideal occlusion. Dental arch morphology was compared in obstructed and non-obstructed children in the group. Parents of 95.5 per cent of the study base of 644 children answered a questionnaire concerning their child's nocturnal behaviour and related questions. The 48 children who, based on parental report, snored every night or stopped breathing when snoring (the 'snoring group'), showed a higher rate of disturbed sleep, mouth-breathing, and a history of throat infections as compared with the rest of the cohort. These children were examined by both an orthodontist and an otorhinolaryngologist and, when indicated, they were also monitored in a sleep laboratory. Twenty-eight of the children were diagnosed as having a breathing obstruction (4.3 per cent of the cohort) and six children (0.9 per cent) had sleep apnoea (mean apnoea-hypopnoea index of 17.3), using the same definition as that for adults. Cephalometric values among the obstructed children differed from those of a Swedish sample of the same age with ideal occlusion. Thy had a smaller cranial base angle and a lower ratio of posterior/anterior total face height. Small, but not significant differences were seen for NSL-ML and NL-ML. Compared with 48 asymptomatic children from the same cohort, the obstructed children had a narrower maxilla, a deeper palatal height, and a shorter lower dental arch. In addition, the prevalence of lateral crossbite was significantly higher among the obstructed children.

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IntroductionNational competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs).ObjectiveThe aim of this study was to assess current European NCA safety communication practices and to investigate European GPs’ awareness of and preferences for safety communications on medicines.MethodsWeb-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, The Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters, and/or in a direct email. From this survey, data from GPs were used and descriptive analyses were conducted.ResultsCurrent NCA practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs, i.e. urgent communication letters for serious safety issues) on their website in addition to distribution to individual HCPs. Educational materials were available on the NCA’s website in 10 countries (40%), and 21 NCAs (81%) indicated they had their own bulletin/newsletter, which is often presented on the NCA’s website (15 countries; 60%). More than 90% of the 1766 GPs who completed the survey were aware of DHPCs. The most preferred senders of safety information were NCAs and professional bodies, while the preferred channels for keeping up to date with safety information were medicines reference books and clinical guidelines. GPs found the repetition of safety issues useful (range of 80% in the UK to 97% in Italy). Preference for an electronic copy rather than a hardcopy varied per country (36% in Sweden to 72% in Spain).ConclusionsNCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-017-0535-0) contains supplementary material, which is available to authorized users.

One hundred and twenty-two children between 1 1/2 and 14 years of age with symptoms suggesting tonsillar obstruction have been investigated. Each patient's history was analysed and the symptoms scored according to their incidence and severity. In addition, the size of the tonsils was evaluated. Eighty-five patients were chosen for tonsillectomy. The children with signs and symptoms of tonsillar obstruction improved greatly immediately after tonsillectomy. Severe symptoms of obstruction were observed in children with nearly normal tonsil size, as well as in those with very large tonsils. It is therefore just as important to obtain a careful history as it is to evaluate the size of the tonsils before deciding about surgery.