PurposeMissing data are a major problem in the analysis of data from randomised trials affecting power and potentially producing biased treatment effects. Specifically focussing on quality of life outcomes, we aimed to report the amount of missing data, whether imputation was used and what methods and was the missing mechanism discussed from four leading medical journals and compare the picture to our previous review nearly a decade ago.MethodsA random selection (50 %) of all RCTS published during 2013–2014 in BMJ, JAMA, Lancet and NEJM was obtained. RCTs reported in research letters, cluster RCTs, non-randomised designs, review articles and meta-analysis were excluded.ResultsWe included 87 RCTs in the review of which 35 % the amount of missing primary QoL data was unclear, 31 (36 %) used imputation. Only 23 % discussed the missing data mechanism. Nearly half used complete case analysis. Reporting was more unclear for secondary QoL outcomes. Compared to the previous review, multiple imputation was used more prominently but mainly in sensitivity analysis.ConclusionsInadequate reporting and handling of missing QoL data in RCTs are still an issue. There is a large gap between statistical methods research relating to missing data and the use of the methods in applications. A sensitivity analysis should be undertaken to explore the sensitivity of the main results to different missing data assumptions. Medical journals can help to improve the situation by requiring higher standards of reporting and analytical methods to deal with missing data, and by issuing guidance to authors on expected standard.Electronic supplementary materialThe online version of this article (doi:10.1007/s11136-016-1411-6) contains supplementary material, which is available to authorized users.
Objectives To determine whether preoperative dexamethasone reduces postoperative vomiting in patients undergoing elective bowel surgery and whether it is associated with other measurable benefits during recovery from surgery, including quicker return to oral diet and reduced length of stay. Design Pragmatic two arm parallel group randomised trial with blinded postoperative care and outcome assessment. Setting 45 UK hospitals. Participants 1350 patients aged 18 or over undergoing elective open or laparoscopic bowel surgery for malignant or benign pathology. Interventions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia compared with standard care. Main outcome measures Primary outcome: reported vomiting within 24 hours reported by patient or clinician. Secondary outcomes: vomiting with 72 and 120 hours reported by patient or clinician; use of antiemetics and postoperative nausea and vomiting at 24, 72, and 120 hours rated by patient; fatigue and quality of life at 120 hours or discharge and at 30 days; time to return to fluid and food intake; length of hospital stay; adverse events. Results 1350 participants were recruited and randomly allocated to additional dexamethasone (n=674) or standard care (n=676) at induction of anaesthesia. Vomiting within 24 hours of surgery occurred in 172 (25.5%) participants in the dexamethasone arm and 223 (33.0%) allocated standard care (number needed to treat (NNT) 13, 95% confidence interval 5 to 22; P=0.003). Additional postoperative antiemetics were given (on demand) to 265 (39.3%) participants allocated dexamethasone and 351 (51.9%) allocated standard care (NNT 8, 5 to 11; P<0.001). Reduction in on demand antiemetics remained up to 72 hours. There was no increase in complications. Conclusions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia significantly reduces both the incidence of postoperative nausea and vomiting at 24 hours and the need for rescue antiemetics for up to 72 hours in patients undergoing large and small bowel surgery, with no increase in adverse events. Trial registration EudraCT (2010-022894-32) and ISRCTN (ISRCTN21973627).
It is generally agreed that the tip of an inserted central venous catheter (CVC) should not lie within the right atrium. However, the tip of a CVC not inserted to an adequate depth could lie outside the superior vena cava, predisposing to thrombus formation and infection. A retrospective audit of the position of CVCs on chest radiographs in intensive care patients and the associated incidence of catheter-related infections was therefore undertaken. Chest radiographs of 100 patients who had central venous catheterisation were assessed using the electronic record system, measuring the distance of the CVC tip from the tracheal carina and the site of insertion. Comparisons were then made of the incidence of infection in the groups where the CVC tip was above or below the carina. In a significant proportion of patients (31%) the CVC tip lay too far below the carina. There was no significant difference in the incidence of catheter-related infections between the groups where the catheter was too far below the carina and too far above the carina. CVCs should not be placed too far below the carina as seen on the chest radiograph. Leaving a portion of CVC outside the skin does not appear to increase the incidence of infection in this small group of patients.
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