Background: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.

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In developing CI capability, organisations need to move to a level of development in which strategic goals are communicated and deployed and where improvement activity is guided by a process of monitoring and measurement against these strategic objectives. Policy deployment of this kind is more prevalent in Japanese examples and in a handful of cases in Western firms. Implementing it poses significant challenges and requires a different and additional toolkit of enabling resources. This paper reports on the experience of policy deployment in Japan and in Western enterprises and explores some of the implementation issues raised.

Background: Postoperative pain associated with open haemorrhoidectomy remains problematic. Haemorrhoidectomy performed using bloodless bipolar diathermy ± Ligasure TM ± may have advantages over conventional open haemorrhoidectomy in terms of operating time and postoperative pain.Methods: Thirty-four patients were randomized to undergo Ligasure TM (18 patients) or diathermy (16) haemorrhoidectomy. The operating time, amount of pain and postoperative analgesic requirement, postoperative complications and overall patient satisfaction were documented.Results: The median duration of operation was shorter in the Ligasure TM haemorrhoidectomy group (5´1 versus 9´2 min; P < 0´001). There was no statistically signi®cant difference in the postoperative pain score, but the median analgesic requirement was lower in the Ligasure TM group (850 versus 1600 mg tramadol; P = 0´013). Patient satisfaction was similar in both groups.Conclusion: Ligasure TM haemorrhoidectomy is quick and bloodless and, although as painful as diathermy haemorrhoidectomy, is associated with a reduced analgesic requirement.

SUMMARYChanges in the V H -region repertoire of isolator piglets reared for 6 weeks under germ-free (GF) conditions and those colonized (COL) with a de®ned exclusion¯ora on the 1st day of life were compared. Although serum immunoglobulin levels were 20±100-fold higher in COL piglets than GF piglets, an analysis of peripheral blood B cells (PBBs) indicated that: GF and COL piglets used the same four V H genes and two D H segments during the 6-week period; proportional usage of V H genes and D H segments was the same as in fetal animals; and V H and D H usage did not differ between COL and GF animals. This pattern differed from the PBBs from 6-week-old conventional (CONV) piglets. When the sequences of 73 splenic CDR3 segments were analysed, D H usage and mutation frequency were the same in sequences from both 6-week-old GF and COL piglets; mutations were infrequent and occurred with the same frequency as in 110-day fetal spleen. However, the median CDR3 length in COL piglets was shifted upward due to 3k D H N-nucleotide additions. Neither COL nor GF animals made speci®c serum antibodies to phosphoryl choline given parenterally on a T-cell dependent carrier. In contrast to the near absence of a colonization effect in PBBs and splenic DNA, rearranged variable heavy-chain gene segments (VDJs) recovered from the DNA of mucosal lymphoid tissues of COL piglets showed pronounced differences from those recovered from GF animals in usage of D H A-, D H B-and V H B-and in the frequency of point mutation. The mucosal VDJ transcripts and those from the spleen were similarly affected by colonization. This effect on mucosal lymphoid tissue was consistent with the ®ve-fold selective increase in serum immunoglobulin A (IgA) levels relative to IgM and IgG. Comparison of IgM and IgA transcripts from mucosal tissues suggested that IgA and IgM clones diversify in parallel. Our ®ndings are the ®rst to show that colonization of the gastrointestinal tract of offspring separated from their mothers, differs from`conventionalized' GF animals in that colonization preferentially in¯uences diversi®cation and expansion of the preimmune IgM and IgA repertoire in mucosal lymphoid tissues but not in PBBs and seldom/modestly in VDJs from splenic DNA.

Competitive advantage increasingly rests upon a dynamic capability to compete successfully in an environment of frequent, challenging and, often, unpredictable change. Sustaining competitive advantage through price alone is no longer a viable strategy for most firms. Firms need to succeed in markets where a range of non-price advantages are expected by customers. Order-winning criteria include rate of innovation, fitness for purpose, volume flexibility, variety, extreme customisation and, above all, rapid responsiveness. Increasing global and local competition mean that companies unable to respond to these customer demands are unlikely to survive. Deployment of the principles and practices of agile enterprise appears to offer a solution. This paper, based upon preliminary findings of the Agile Manufacturing Research Group (AMRG), discusses these issues and, through the introduction of the agile wheel reference model (AWRM), identifies the specific policies and practices that support agility.

The ability to identify factors responsible for disease in all species depends on the ability to separate those factors which are environmental from those that are intrinsic. This is particularly important for studies on the development of the adaptive immune response of neonates. Studies on laboratory rodents or primates have been ambiguous because neither the effect of environmental nor maternal factors on the newborn can be controlled in mammals that: (i) transmit potential maternal immunoregulatory factors in utero and (ii) are altricial and cannot be reared after birth without their mothers. Employing the newborn piglet model can address each of these concerns. However, it comes at the price of having first to characterize the immune system of swine and its development. This review focuses on the porcine B cell system, especially on the methods used for its characterization in fetal studies and neonatal piglets. Understanding these procedures is important in the interpretation of the data obtained. Studies on neonatal piglets have (a) provided valuable information on the development of the adaptive immune system, (b) lead to important advances in evolutionary biology, (c) aided our understanding of passive immunity and (d) provided opportunities to use swine to address specific issues in veterinary and biomedical research and immunotherapy. This review summarizes the history of the development of the piglet as a model for antibody repertoire development, thus providing a framework to guide future investigators.

Ligasure haemorrhoidectomy is quick and bloodless and, although as painful as diathermy haemorrhoidectomy, is associated with a reduced analgesic requirement.