Objective To review the safety and efficacy of fluoridation of drinking water. Design Search of 25 electronic databases and world wide web. Relevant journals hand searched; further information requested from authors. Inclusion criteria were a predefined hierarchy of evidence and objectives. Study validity was assessed with checklists. Two reviewers independently screened sources, extracted data, and assessed validity. Main outcome measures Decayed, missing, and filled primary/permanent teeth. Proportion of children without caries. Measure of effect was the difference in change in prevalence of caries from baseline to final examination in fluoridated compared with control areas. For potential adverse effects, all outcomes reported were used. Results 214 studies were included. The quality of studies was low to moderate. Water fluoridation was associated with an increased proportion of children without caries and a reduction in the number of teeth affected by caries. The range (median) of mean differences in the proportion of children without caries was −5.0% to 64% (14.6%). The range (median) of mean change in decayed, missing, and filled primary/permanent teeth was 0.5 to 4.4 (2.25) teeth. A dose-dependent increase in dental fluorosis was found. At a fluoride level of 1 ppm an estimated 12.5% (95% confidence interval 7.0% to 21.5%) of exposed people would have fluorosis that they would find aesthetically concerning. Conclusions The evidence of a beneficial reduction in caries should be considered together with the increased prevalence of dental fluorosis. There was no clear evidence of other potential adverse effects.

Yale University and Medtronic.

No abstract

Objective To evaluate the incidence and consequences of uterine rupture in women who have had a delivery by caesarean section. Design Systematic review. Data sources Medline, HealthSTAR, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Centre for Reviews and Dissemination, reference lists, and national experts. Studies in all languages were eligible if published in full. Review methods Methodological quality was evaluated for each study by using criteria from the United States Preventive Services Task Force and the National Health Service Centre for Reviews and Dissemination. Uterine rupture was categorised as asymptomatic or symptomatic. Results We reviewed 568 full text articles to identify 71 potentially eligible studies, 21 of which were rated at least fair in quality. Compared with elective repeat caesarean delivery, trial of labour increased the risk of uterine rupture by 2.7 (95% confidence interval 0.73 to 4.73) per 1000 cases. No maternal deaths were related to rupture. For women attempting vaginal delivery, the additional risk of perinatal death from rupture of a uterine scar was 1.4 (0 to 9.8) per 10 000 and the additional risk of hysterectomy was 3.4 (0 to 12.6) per 10 000. The rates of asymptomatic uterine rupture in trial of labour and elective repeat caesarean did not differ significantly. Conclusions Although the literature on uterine rupture is imprecise and inconsistent, existing studies indicate that 370 (213 to 1370) elective caesarean deliveries would need to be performed to prevent one symptomatic uterine rupture.

Background Result summaries are now required to be reported in ClinicalTrials.gov for many trials of drugs and devices. Purpose To evaluate the consistency of reporting in trials that are both registered in the ClinicalTrials.gov results database and published in the literature. Data Sources ClinicalTrials.gov results database, matched publications identified through both ClinicalTrials.gov and a manual search of two electronic databases. Study Selection 10% random sample of Phase III or IV trials with results in the ClinicalTrials.gov results database, completed before January 1, 2009, with two or more arms. Data Extraction One reviewer extracted data from ClinicalTrials.gov results database and matching publications. A subsample was independently verified. Basic design features and results were compared between reporting sources and discrepancies were summarized. Data Synthesis Of 110 reviewed trials with results, most were industry-sponsored, parallel design, drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). There were 16 trials (15%) that reported the primary outcome description inconsistently and 22 (20%) in which the primary outcome value was reported inconsistently. A total of 38 trials inconsistently reported the number of individuals with a serious adverse event (SAE), of which 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported SAEs as zero or not occurring, and 21 reported a different number of SAEs. In 29 trials that reported deaths in ClinicalTrials.gov, 28% differed with the matched publication. Limitations Small sample that includes earliest results posted to the database and therefore may reflect inexperience with the submission process. Conclusions Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. It is unclear which reporting source contains the most accurate account of trial results. ClinicalTrials.gov may provide a more comprehensive description of trial adverse events than the publication.