Prolonged tracheal intubation in the trauma patient. Recursive cumulative meta-analysis: a diagnostic for the evolution of total randomized evidence from group and individual patient data. Tracheostomy in ventilator dependent trauma patients: a prospective, randomized intention-to-treat study. Difference in patient's acceptance of early versus late initiation of psychosocial support in breast cancer.
Over a 15-month period, 74 trauma patients who were expected to require extended intubation were studied prospectively to evaluate the appropriateness of tracheostomy. Patients were randomized to receive either early (34) or late (40) tracheostomies. The patients also were grouped to determine the difference of early versus late tracheostomy on the development of laryngotracheal pathology and respiratory infections; length of intubation and type of patient injury were studied as possible differential factors. Fifteen per cent (11/74) of the patients developed major laryngotracheal pathology as identified by endoscopy, and respiratory infections developed in 54% (40/74), but there was no significant difference in the complication incidence between the early and late tracheostomy groups. Significantly more complications occurred in rigid-posture, head-injured patients than in any other trauma grouping, but there was no significant difference in the complication incidence between the two tracheostomy groups within that classification. We conclude that patients can undergo translaryngeal intubation for up to 2 weeks without significantly increasing complications relative to transtracheal intubation. Meta-analyses of randomized evidence may include published, unpublished, and updated data in an ongoing estimation process that continuously accommodates more data. Synthesis may be performed either with group data or with meta-analysis of individual patient data (MIPD). Although MIPD with updated data is considered the gold standard of evidence, there is a need for a careful study of the impact different sources of data have on a meta-analysis and of the change in the treatment effect estimates over sequential information steps. Unpublished data and late-appearing data may be different from early-appearing data. Updated information after the end of the main study follow-up may be affected by cross-overs, missing information, and unblinding. The estimated treatment effect may thus depend on the completeness and updating of the available evidence. To address these issues, we present recursive cumulative meta-analysis (RCM) as an extension of cumulative metaanalysis. Recursive cumulative meta-analysis is based on the principle of recalculating the results of a cumulative meta-analysis with each new or updated piece of information and focuses on the evolution of the treatment effect as a more complete and updated picture of the evidence becomes available. An examination of the perturbations of the cumulative treatment effect over sequential information steps may signal the presence of bias or heterogeneity in a meta-analysis. Recursive cumulative meta-analysis may suggest whether there is a true underlying treatment effect to which the meta-analysis is converging and how treatment effects are sequentially altered by new or modified evidence. The method is illustrated with an example from the conduct of an MIPD on acyclovir in human immunodeficiency virus infection. The relative strengths and limitations of both metaanalysis of group data and MIPD are discussed through the RCM perspective. Tracheostomy is a commonly performed procedure in ventilator dependent patients. Many critical care practitioners believe that performing a tracheostomy early in the postinjury period decreases the length of ventilator dependence as well as having other benefits such as better patient tolerance and lower respiratory dead space. We conducted a randomized, prospective, single institution study comparing the length ventilator dependence in critically ill multiple trauma patients who were randomized to two different strategies for performance of a tracheostomy. We hypothesized that earlier tracheostomy would reduce the number of days of mechanical ventilation, frequency of pneumonia and length of intensive care unit (ICU) stay.
                Patients were eligible if they were older than 15 years and either a Glasgow Coma Score (GCS) >4 with a negative brain computed tomography (CT) (no anatomic head injury), or a GCS >9 with a positive head CT (known anatomic head injury). Patients who required tracheostomy for facial/neck injuries were excluded. Patients were randomized to an intention to treat strategy of tracheostomy placement before day 8 or after day 28.
                The study was halted after the first interim analysis. There were 60 enrolled patients, who had comparable demographics between groups. There was no significant difference between groups in any outcome variable including length of ventilator support, pneumonia rate, or death.
                A strategy of tracheostomy before day 8 postinjury in this group of trauma patients did not reduce the number of days of mechanical ventilation, frequency of pneumonia or ICU length of stay as compared with the group with a tracheostomy strategy involving the procedure at 28 days postinjury or more. The present study was performed to assess the difference in acceptance of psychosocial counseling and resulting benefits between patients with breast cancer with early or late onset. In a prospective randomized controlled study conducted over 6 months, 41 women with a new diagnosis of early breast cancer (group 1) and 43 patients with advanced breast cancer (group 2) received individually tailored psychosocial support and were compared against controls. This therapy was free of charge, and the duration of support was determined by the patients' wishes and needs. Among the patients with new onset of disease acceptance of the psychosocial counseling was high, and these patients experienced significant improvements in their quality of life. In contrast, acceptance of psychosocial counseling was low in the advanced breast cancer group and the therapy did not improve quality of life over the observation period of 6 months. Early psychosocial support in patients with breast cancer meets with a high acceptance rate and improves quality of life.
Updated evidence is of low quality, and potential differences between early and late tracheostomy need to be better investigated by means of randomized controlled trials. At present there is no specific information about any subgroup or individual characteristics potentially associated with better outcomes with either early or late tracheostomy.