Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial

Objective To determine whether preoperative assessments carried out by appropriately trained nurses are inferior in quality to those carried out by preregistration house officers. Design Randomised controlled equivalence/non-inferiority trial. Setting Four NHS hospitals in three trusts. Three of the four were teaching hospitals. Participants All patients attending for assessment before general anaesthesia for general, vascular, urological, or breast surgery between April 1998 and March 1999. Intervention Assessment by one of three appropriately trained nurses or by one of several preregistration house officers. Main outcome measures History taken, physical examination, and investigations ordered. Measures evaluated by a specialist registrar in anaesthetics and placed in four categories: correct, overassessment, underassessment not affecting management, and underassessment possibly affecting management (primary outcome). Results 1907 patients were randomised, and 1874 completed the study; 926 were assessed by house officers and 948 by nurses. Overall 121/948 (13%) assessments carried out by nurses were judged to have possibly affected management compared with 138/926 (15%) of those performed by house officers. Nurses were judged to be non-inferior to house officers in assessment, although there was variation among them in terms of the quality of history taking. The house officers ordered considerably more unnecessary tests than the nurses (218/926 (24%) v 129/948 (14%). Conclusions There is no reason to inhibit the development of nurse led preoperative assessment provided that the nurses involved receive adequate training. However, house officers will continue to require experience in preoperative assessment

Permissible variation in the 3' non-coding region of the haemagglutinin genome segment of the H5N1 candidate influenza vaccine virus NIBRG-14 [corrected].

The candidate H5N1 vaccine virus NIBRG-14 was created in response to a call from the World Health Organisation in 2004 to prepare candidate vaccine viruses (CVVs) to combat the threat of an H5N1 pandemic. NIBRG-14 was created by reverse genetics and is composed of the neuraminidase (NA) and modified haemagglutinin (HA) genes from A/Vietnam/1194/2004 and the internal genes of PR8, a high growing laboratory adapted influenza A(H1N1) strain. Due to time constraints, the non-coding regions (NCRs) of A/Vietnam/1194/2004 HA were not determined prior to creating NIBRG-14. Consequently, the sequence of the primers used to clone the modified A/Vietnam/1194/2004 HA was based upon previous experience of cloning H5N1 viruses. We report here that the HA 3' NCR sequence of NIBRG-14 is different to that of the parental wild type virus A/Vietnam/1194/2004; however this does not appear to impact on its growth or antigen yield. We introduced additional small changes into the 3'NCR of NIBRG-14; these had only minor effects on viral growth and antigen content. These findings may serve to assure the influenza vaccine community that generation of CVVs using best-guess NCR sequences, based on sequence alignments, are likely to produce robust viruses

Yield analysis of viruses.

<p>Panel A shows data for viruses with PR8 internal genes (in blue) compared to Chr/16 wt (in red). Panel B shows data for viruses with A(H1N1)pdm09 internal genes (in red) compared to NIB-74xp (in blue). In each panel the asterisks (*) denote statistically significant differences to NIB-74xp (p<0.05), and a triangle (Δ) denotes a statistically significant difference to Chr/16 wt (p<0.05). The black bars denote statistically significant differences (p<0.05) between the other viruses. (i) Total protein yield for each virus measured by BCA assay. (ii) HA content of each virus, expressed as percentage HA relative to the total of the four major viral protein bands (HA1, HA2, NP, M1), as measured by SDS-PAGE analysis. (iii) Average yield of total HA protein calculated from percentage HA and total protein concentration data. (iv) Average yield of HA as measured by SRD assay. All data are the average of at least three independent experiments and error bars denote standard deviation.</p

Ribbon trace of globular head region of HA monomer shown as a side view, with the amino acids of interest highlighted.

<p>HA residue 222 is shown in Cyan, residue 223 is shown in purple, residue 187 is shown in red, residue 190 is shown in pink, residue 216 is shown in green, residue 186 is shown in blue, residue 119 is shown in orange and residue 129 is shown in yellow.</p

Antigenic analysis of viruses by haemagglutination inhibition assay.

<p>Antigenic analysis of viruses by haemagglutination inhibition assay.</p

Panel of viruses created and used for yield studies.

<p>Panel of viruses created and used for yield studies.</p