Do Cochrane summaries help student midwives understand the findings of Cochrane systematic reviews: the BRIEF randomised trial.

BACKGROUND: Abstracts and plain language summaries (PLS) are often the first, and sometimes the only, point of contact between readers and systematic reviews. It is important to identify how these summaries are used and to know the impact of different elements, including the authors' conclusions. The trial aims to assess whether (a) the abstract or the PLS of a Cochrane Review is a better aid for midwifery students in assessing the evidence, (b) inclusion of authors' conclusions helps them and (c) there is an interaction between the type of summary and the presence or absence of the conclusions. METHODS: Eight hundred thirteen midwifery students from nine universities in the UK and Ireland were recruited to this 2 × 2 factorial trial (abstract versus PLS, conclusions versus no conclusions). They were randomly allocated to one of four groups and asked to recall knowledge after reading one of four summary formats of two Cochrane Reviews, one with clear findings and one with uncertain findings. The primary outcome was the proportion of students who identified the appropriate statement to describe the main findings of the two reviews as assessed by an expert panel. RESULTS: There was no statistically significant difference in correct response between the abstract and PLS groups in the clear finding example (abstract, 59.6 %; PLS, 64.2 %; risk difference 4.6 %; CI -0.2 to 11.3) or the uncertain finding example (42.7 %, 39.3 %, -3.4 %, -10.1 to 3.4). There was no significant difference between the conclusion and no conclusion groups in the example with clear findings (conclusions, 63.3 %; no conclusions, 60.5 %; 2.8 %; -3.9 to 9.5), but there was a significant difference in the example with uncertain findings (44.7 %; 37.3 %; 7.3 %; 0.6 to 14.1, p = 0.03). PLS without conclusions in the uncertain finding review had the lowest proportion of correct responses (32.5 %). Prior knowledge and belief predicted student response to the clear finding review, while years of midwifery education predicted response to the uncertain finding review. CONCLUSIONS: Abstracts with and without conclusions generated similar student responses. PLS with conclusions gave similar results to abstracts with and without conclusions. Removing the conclusions from a PLS with uncertain findings led to more problems with interpretation.

Isolated limb infusion for malignant melanoma: predictors of response and outcome.

PURPOSE: Isolated limb infusion (ILI) is an alternative to isolated limb perfusion (ILP) for the treatment of unresectable limb melanoma recurrence. The aims of this study were to determine the response rates of unresectable local and/or in-transit melanoma of the upper or lower limb to ILI and to identify factors predictive of survival. METHODOLOGY: A prospective database identified 74 patients (35 male and 39 female) with local and/or in-transit melanoma recurrence without metastatic disease who underwent hyperthermic ILI with melphalan at a single institution between January 1996 and December 2008. Three patients could not be evaluated for response. Median follow-up was 34 months. RESULTS: Of the 74 patients, the majority had N2c disease (57/74, 67%), while 17/74 (33%) patients had N3 disease. Median maximum temperature achieved was 38.1 degrees C and median tourniquet time was 32.5 min. Wieberdink III/IV complications occurred following 7/74 (10%) ILI and were associated with higher limb volumes and higher total melphalan dose. Complete response (CR) was seen following 17/71 (24%) ILI and the partial response rate was 30% (22/71). The median duration of CR was 43 months. Univariable analyses found that limb volume >8.0 l and maximum limb temperature >38.5 degrees C were the only independent factors predictive for a CR following ILI. Multivariate analyses identified CR and positive lymph nodes as the only independent prognostic factors for melanoma-specific survival. CONCLUSIONS: Patients who obtain CR have significantly improved survival compared with nonresponders. The challenge remains to improve CR rates and prospectively identify responders.

Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

BACKGROUND: Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. METHODS/DESIGN: The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. DISCUSSION: This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Our study presents significant differences in the anti-platelet agents used, the study design, and surgical and patient demographics that should contribute further evidence regarding the efficacy of anti-platelet agents. TRIAL REGISTRATION: Australia & New Zealand Clinical Trials Register (ACTRN12607000569404).

Clinicians' evaluations of fetal oximetry sensor placement in a multicentre randomised trial (the FOREMOST trial).

BACKGROUND: Fetal pulse oximetry (FPO) may improve the assessment of the fetal well-being in labour. Reports of health-care provider's evaluations of new technology are important in the overall evaluation of that technology. AIMS: To determine doctors' and midwives' perceptions of their experience placing FPO sensors. METHODS: We surveyed clinicians (midwives and doctors) following placement of a FPO sensor during the FOREMOST trial (multicentre randomised trial of fetal pulse oximetry). Clinicians rated ease of sensor placement (poor, fair, good and excellent). Potential influences on ease of sensor placement (staff category, prior experience in Birth Suite, prior experience in placing sensors, epidural analgesia, cervical dilatation and fetal station) were examined by ordinal regression. RESULTS: There were 281 surveys returned for the 294 sensor placement attempts (response rate 96%). Sensors were placed by midwives (29%), research midwives (48%), registrars (22%) and obstetricians (1%). The majority of clinicians had 1 or more years' Birth Suite experience, had placed six or more sensors previously, and rated ease of sensor placement as good. Advancing fetal station (P < 0.001) and the presence of epidural analgesia prior to sensor placement (P = 0.029) predicted improved ease of sensor placement. Having a clinician placing a sensor for the first time predicted a lower rating for ease of sensor placement (P = 0.001), compared to having placed one or more sensors previously. CONCLUSIONS: Clinicians with varying levels of Birth Suite experience successfully placed fetal oxygen saturation sensors, with the majority rating ease of sensor placement as good.