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The ecological sciences have experienced immense growth over the course of this century, and chances are that they will continue to grow well on into the next millennium. There are some good reasons for this – ecology encompasses some of the most pressing concerns facing humanity. With recent advances in data collection technology and ambitious field research, ecologists are increasingly calling upon multivariate statistics to explore and test for patterns in their data. The goal of FISH 560 (Applied Multivariate Statistics for Ecologists) at the University of Washington is to introduce graduate students to the multivariate statistical techniques necessary to carry out sophisticated analyses and to critically evaluate scientific papers using these approaches. It is a practical, hands-on course emphasizing the analysis and interpretation of multivariate analysis, and covers the majority of approaches in common use by ecologists. To celebrate the hard work of past students, I am pleased to announce the creation of the Electronic Journal of Applied Multivariate Statistics (EJAMS). Each year, students in FISH 560 are required to write a final paper consisting of a statistical analysis of their own multivariate data set. These papers are submitted to EJAMS at the end of quarter and are peer reviewed by two other class members. A decision on publication is based on the reviewers’ recommendations and my own reading the paper. In closing, there is a need for the rapid dissemination of ecological research using multivariate statistics at the University of Washington. EJAMS is committed to this challenge.

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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.

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1944/07/14 (N25).

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1943/02/04 (N7).

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1944/03-1944/04.