Reporting of interventional clinical trial results in an academic center: a survey of completed studies.

BACKGROUND: The dissemination of clinical trial results is an important scientific and ethical endeavour. This survey of completed interventional studies in a French academic center describes their reporting status. METHODS: We explored all interventional studies sponsored by Rennes University Hospital identified on the French Open Science Monitor which tracks trials registered on EUCTR or clinicaltrials.gov, and provides an automatic assessment of the reporting of results. For each study, we ascertained the actual reporting of results using systematic searches on the hospital internal database, bibliographic databases (Google Scholar, PubMed), and by contacting all principal investigators (PIs). We describe several features (including total budget and numbers of trial participants) of the studies that did not report any results. RESULTS: The French Open Science Monitor identified 93 interventional studies, among which 10 (11%) reported results. In contrast, our survey identified 36 studies (39%) reporting primary analysis results and an additional 18 (19%) reporting results for secondary analyses (without results for their primary analysis). The overall budget for studies that did not report any results was estimated to be €5,051,253 for a total of 6,735 trial participants. The most frequent reasons for the absence of results reported by PIs were lack of time for 18 (42%), and logistic difficulties (e.g. delay in obtaining results or another blocking factor) for 12 (28%). An association was found between non-publication and negative results (adjusted Odds Ratio = 4.70, 95% Confidence Interval [1.67;14.11]). CONCLUSIONS: Even allowing for the fact that automatic searches underestimate the number of studies with published results, the level of reporting was disappointingly low. This amounts to a waste of trial participants' implication and money. Corrective actions are needed. TRIAL REGISTRATION: https://osf.io/q5hcs.

Association between individual and neighbourhood socioeconomic factors and masticatory efficiency: a cross-sectional analysis of the Paris Prospective Study 3.

BACKGROUND: There is a lack of evidence on the impact of socioeconomic factors on masticatory efficiency. The present study investigates the relationship between individual and neighbourhood socioeconomic factors (main exposure) and the number of masticatory units (MUs) used as surrogate of the masticatory efficiency (main outcome). METHODS: In this cross-sectional study nested in the Paris Prospective Study 3, 4270 adults aged 50-75 and recruited from 13 June 2008 to 31 May 2012 underwent a full-mouth examination. Number of MUs defined as pairs of opposing teeth or dental prostheses allowing mastication, number of missing teeth and gingival inflammation were documented. The individual component of the socioeconomic status was evaluated with an individual multidimensional deprivation score and education level. The neighbourhood component of the socioeconomic status was evaluated with the FDep99 deprivation index. Associations were quantified using marginal models. RESULTS: In multivariate analyses, having less than 5 MUs was associated with (1) the most deprived neighbourhoods (OR=2.27 (95% CI 1.63 to 3.17)), (2) less than 12 years of educational attainment (OR=2.20 (95% CI 1.66 to 2.92)) and (3) the highest individual score of deprivation (OR=3.23 (95% CI 2.24 to 4.65)). Associations with education and individual score of deprivation were consistent across the level of neighbourhood deprivation. Comparable associations were observed with the number of missing teeth. Associations with gingival inflammation were of lower magnitude; the relationship was present for deprivation markers but not for education. CONCLUSION: Poor masticatory efficiency is associated with low educational attainment and high deprivation scores.