Assessment of Postresuscitation Volume Status by Bioimpedance Analysis in Patients with Sepsis in the Intensive Care Unit: A Pilot Observational Study.

Background. Bioimpedance analysis (BIA) is a novel method of assessing a patient's volume status. Objective. We sought to determine the feasibility of using vector length (VL), derived from bioimpedance analysis (BIA), in the assessment of postresuscitation volume status in intensive care unit (ICU) patients with sepsis. Method. This was a prospective observational single-center study. Our primary outcome was feasibility. Secondary clinical outcomes included ventilator status and acute kidney injury. Proof of concept was sought by correlating baseline VL measurements with other known measures of volume status. Results. BIA was feasible to perform in the ICU. We screened 655 patients, identified 78 eligible patients, and approached 64 for consent. We enrolled 60 patients (consent rate of 93.8%) over 12 months. For each 50-unit increase in VL, there was an associated 22% increase in the probability of not requiring invasive mechanical ventilation (IMV) (p = 0.13). Baseline VL correlated with other measures of volume expansion including serum pro-BNP levels, peripheral edema, and central venous pressure (CVP). Conclusion. It is feasible to use BIA to predict postresuscitation volume status and patient-important outcomes in septic ICU patients. Trial Registration. This trial is registered with clinicaltrials.gov NCT01379404 registered on June 7, 2011.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

BACKGROUND: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. METHODS: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. RESULTS: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). CONCLUSIONS: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

The effect of loss to follow-up on treatment of blunt traumatic thoracic aortic injury.

OBJECTIVE: Loss to follow-up (LTFU) can be a major difficulty for any clinical research study. The objective of this systematic review was to assess the extent of LTFU and its potential effect in studies of adult trauma patients with blunt thoracic aortic injuries (BTAIs). METHODS: Studies comparing management of BTAIs were systematically reviewed. Duplicate independent review was used for study selection, data abstraction, and critical appraisals. RESULTS: Thirty-six studies were included for synthesis, of which 94.1% applied a retrospective cohort design to prospective institutional databases. The mean LTFU at 1 year was 26.5% ± 31.6% for endovascular repair and 20.6% ± 34.2% for open repair groups. Not having a surgical/interventional specialist as a first or senior author was associated with a 39.7% higher LTFU at 1 year (P = .002). Studies with a higher risk of bias, later publication year, or North American origin were associated with a significantly higher risk for LTFU at 1 year (P ≤ .001). Nearly half of included studies assessed in-hospital outcomes exclusively. Only 38.2% explicitly reported LTFU data. Eight studies explicitly described the method of dealing with LTFU: eight used survival analysis and one used a national Social Security Death Index. Sensitivity analyses using plausible worst-case LTFU scenarios resulted in 14% to 17% of studies changing direction of effect. CONCLUSIONS: There is significant LTFU in trauma studies comparing operative methods for BTAIs. LTFU is generally handled and reported suboptimally, and sensitivity analyses suggest that study results are sensitive to differential LTFU. This has implications for the evidence-based choice of the operative method. Some protective factors that may aid in reducing LTFU were identified, one of which was involvement of a surgical or interventional specialist as a key author.

Nonbeneficial treatment Canada: definitions, causes, and potential solutions from the perspective of healthcare practitioners*.

OBJECTIVE: Many healthcare workers are concerned about the provision of nonbeneficial treatment in the acute care setting. We sought to explore the perceptions of acute care practitioners to determine whether they perceived nonbeneficial treatment to be a problem, to generate an acceptable definition of nonbeneficial treatment, to learn about their perceptions of the impact and causes of nonbeneficial treatment, and the ways that they feel could reduce or resolve nonbeneficial treatment. DESIGN: National, bilingual, cross-sectional survey of a convenience sample of nursing and medical staff who provide direct patient care in acute medical wards or ICUs in Canada. MAIN RESULTS: We received 688 responses (response rate 61%) from 11 sites. Seventy-four percent of respondents were nurses. Eighty-two percent of respondents believe that our current means of resolving nonbeneficial treatment are inadequate. The most acceptable definitions of nonbeneficial treatment were "advanced curative/life-prolonging treatments that would almost certainly result in a quality of life that the patient has previously stated that he/she would not want" (88% agreement) and "advanced curative/life-prolonging treatments that are not consistent with the goals of care (as indicated by the patient)" (83% agreement). Respondents most commonly believed that nonbeneficial treatment was caused by substitute decision makers who do not understand the limitations of treatment, or who cannot accept a poor prognosis (90% agreement for each cause), and 52% believed that nonbeneficial treatment was "often" or "always" continued until the patient died or was discharged from hospital. Respondents believed that nonbeneficial treatment was a common problem with a negative impact on all stakeholders (> 80%) and perceived that improved advance care planning and communication training would be the most effective (92% and 88%, respectively) and morally acceptable (95% and 92%, respectively) means to resolve the problem of nonbeneficial treatment. CONCLUSIONS: Canadian nurses and physicians perceive that our current means of resolving nonbeneficial treatment are inadequate, and that we need to adopt new techniques of resolving nonbeneficial treatment. The most promising strategies to reduce nonbeneficial treatment are felt to be improved advance care planning and communication training for healthcare professionals.

Abstract reporting in randomized clinical trials of acute lung injury: an audit and assessment of a quality of reporting score.

OBJECTIVES: To evaluate the quality of reporting among abstracts of randomized controlled trials (RCTs) in acute lung injury and to highlight important trial information for abstract inclusion. DESIGN: Audit of published RCT abstracts. SAMPLE: A total of 56 RCTs, identified in MEDLINE, EMBASE, HEALTHSTAR, CINAHL, and the Cochrane Central Register of Controlled Trials. MEASUREMENTS AND MAIN RESULTS: We used a research focus group and published literature on suggested content for abstracts of original articles to generate a list of 32 recommended items. The focus group reduced this list to a 20-item long form list of highly relevant criteria and a 12-item short form list of essential criteria for inclusion in abstracts of RCTs in acute lung injury. After pilot testing the abstract appraisal form, we evaluated abstracts independently and in duplicate. We scored the quality of reporting of each abstract by dividing the number of criteria fulfilled by the number applicable. Although abstracts described the study objectives and interventions well and the participants, outcomes, and conclusions to an intermediate extent, key deficiencies were noted in reporting the study methods, setting, and results. Mean quality of reporting scores were significantly higher for structured compared with unstructured abstracts using the 32-item, 20-item, and 12-item lists (p = .008, .014, and <.0001, respectively), especially for abstracts published after 1990 (p = .004, .017, and .001, respectively). The 20-item and 12-item lists correlated well with the 32-item list (r = .89 and .62, respectively) and with one another (r = .73). CONCLUSIONS: Key design features and results are frequently under-reported in RCT abstracts, particularly among unstructured abstracts. Checklists may aid authors and editors in prioritizing important criteria for inclusion in RCT abstracts.