Other outcome parameters were unsuitable for meta- analysis , but seemed to favour ERAS .
Analysis shows a reduction in overall complications , but major complications were not reduced .
Length of stay was reduced significantly .
We state that ERAS seems safe , but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the st and ard of care .
Within ERAS protocol s included , no answer regarding the role for minimally invasive surgery ( i.e. laparoscopy ) was found .
BACKGROUND In recent years the Enhanced Recovery after Surgery ( ERAS ) postoperative pathway in (ileo-)colorectal surgery , aim ing at improving perioperative care and decreasing postoperative complications , has become more common .
OBJECTIVES We investigated the effectiveness and safety of the ERAS multimodal strategy , compared to conventional care after (ileo-)colorectal surgery .
The primary research question was whether ERAS protocol s lead to less morbidity and secondary whether length of stay was reduced .
Subgroup analysis and other (mis)uses of baseline data in clinical trials
BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings
Other outcome parameters were unsuitable for meta- analysis , but seemed to favour ERAS .
Analysis shows a reduction in overall complications , but major complications were not reduced .
Length of stay was reduced significantly .
We state that ERAS seems safe , but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the st and ard of care .
Within ERAS protocol s included , no answer regarding the role for minimally invasive surgery ( i.e. laparoscopy ) was found .
BACKGROUND In recent years the Enhanced Recovery after Surgery ( ERAS ) postoperative pathway in (ileo-)colorectal surgery , aim ing at improving perioperative care and decreasing postoperative complications , has become more common .
OBJECTIVES We investigated the effectiveness and safety of the ERAS multimodal strategy , compared to conventional care after (ileo-)colorectal surgery .
The primary research question was whether ERAS protocol s lead to less morbidity and secondary whether length of stay was reduced .