Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications

OBJECTIVES To identify factors associated with discrepant outcome reporting in randomized drug trials. STUDY DESIGN AND SETTING Cohort study of protocols submitted to a Swiss ethics committee 1988-1998: 227 protocols and amendments were compared with 333 matching articles published during 1990-2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes. RESULTS Overall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined. CONCLUSION Discrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.

Improvements in Implant Dentistry over the Last Decade: Comparison of Survival and Complication Rates in Older and Newer Publications

Purpose: The objective of this systematic review was to assess and compare the survival and complication rates of implant-supported prostheses reported in studies published in the year 2000 and before, to those reported in studies published after the year 2000. Materials and Methods: Three electronic searches complemented by manual searching were conducted to identify 139 prospective and retrospective studies on implant-supported prostheses. The included studies were divided in two groups: a group of 31 older studies published in the year 2000 or before, and a group of 108 newer studies published after the year 2000. Survival and complication rates were calculated using Poisson regression models, and multivariable robust Poisson regression was used to formally compare the outcomes of older and newer studies. Results: The 5-year survival rate of implant-supported prostheses was significantly increased in newer studies compared with older studies. The overall survival rate increased from 93.5% to 97.1%. The survival rate for cemented prostheses increased from 95.2% to 97.9%; for screw-retained reconstruction, from 77.6% to 96.8%; for implant-supported single crowns, from 92.6% to 97.2%; and for implant-supported fixed dental prostheses (FDPs), from 93.5% to 96.4%. The incidence of esthetic complications decreased in more recent studies compared with older ones, but the incidence of biologic complications was similar. The results for technical complications were inconsistent. There was a significant reduction in abutment or screw loosening by implant-supported FDPs. On the other hand, the total number of technical complications and the incidence of fracture of the veneering material was significantly increased in the newer studies. To explain the increased rate of complications, minor complications are probably reported in more detail in the newer publications. Conclusions: The results of the present systematic review demonstrated a positive learning curve in implant dentistry, represented in higher survival rates and lower complication rates reported in more recent clinical studies. The incidence of esthetic, biologic, and technical complications, however, is still high. Hence, it is important to identify these complications and their etiology to make implant treatment even more predictable in the future.

Exploring the publications in three major orthodontic journals: a comparative analysis of two 5-year periods.

OBJECTIVE To analyze the types of articles and authorship characteristics of three orthodontic journals--American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), The Angle Orthodontist (AO), and European Journal of Orthodontics (EJO)--published between 2008 and 2012 and to assess the differences in content within this period and an earlier period of 1998 to 2002. MATERIALS AND METHODS Each journal's content was accessed through the web edition. From each article, the following parameters were recorded: article type, number of authors, number of affiliations, source of article (referring to the first author's affiliation), and geographic origin. Descriptive statistics were performed and selected parameters were analyzed with the Pearson chi-square or Fisher exact test for independence at the .05 level of significance. RESULTS Review of differences between the two periods showed that the number of publications was almost double. The percentages of multi-authored articles increased. Fewer studies derived from the United States/Canada and European Union countries. Increases for articles from non-European Union countries, Asia, and other countries were found. Characteristics of the second period showed that the EJO and AO published more research articles, whereas the AJODO regularly published case reports and other articles. Approximately 75% of all studies derived from orthodontic departments. CONCLUSIONS The publications from 1998-2002 and 2008-2012 were significantly different both in terms of numbers and characteristics. Within 2008-2012 there were notable differences between the three journals concerning the type and origin of the publications.

The Hundred Most-Cited Publications in Orthopaedic Knee Research

BACKGROUND: Despite its limitations, citation analysis remains one of the best currently available tools for quantifying the impact of articles. Bibliometric studies list the "best-sellers" in a single location, and they have been published frequently in many fields during recent years. The purpose of the present study was to report the qualities and characteristics of citation classics in orthopaedic knee research. METHODS: The database of the Institute for Scientific Information (ISI) was utilized for identification of articles published from 1945 to March 2014. All knee articles that had been published in sixty-five orthopaedic and twenty-nine rheumatology journals and that had been cited at least 200 times were identified. The top 100 were selected for further analysis of authorship, source journal, number of citations, citation rate (both since publication and in 2013), geographic origin, article type, and level of evidence. RESULTS: The publication dates of the 100 most-cited articles ranged from 1948 to 2007, with the greatest number of articles published in the 1980s. Citations per article ranged from 2640 to 287. All articles were published in eleven of the ninety-four journals. The leading countries of origin were the U.S. followed by the U.K. and Sweden. The two main focus areas were sports traumatology and degenerative disease. The number of citations per article was also greatest for articles published in the 1980s. Basic research articles were cited more quickly, but not more often, than clinical articles. Most articles represented Level-IV evidence, followed by Levels II, III, and I. CONCLUSIONS: This bibliometric study is likely to include a list of intellectual milestones in orthopaedic knee research. It is apparent that a high level of evidence is not mandatory for an article to gain a large number of citations. Bibliometric reports provide a reflection of the quality of cited research published in a specific field and should therefore provoke thinking within the scientific community.

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

OBJECTIVES To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. STUDY DESIGN AND SETTING Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. RESULTS The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. CONCLUSION The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

OBJECTIVE To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. DESIGN Cohort of protocols of randomised controlled trial and subsequent full journal publications. SETTING Six research ethics committees in Switzerland, Germany, and Canada. DATA SOURCES 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. RESULTS Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. CONCLUSIONS Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials.