Family satisfaction in the intensive care unit, a cross-sectional study from Norway.

BACKGROUND: Becoming critically ill represents not just a great upheaval for the patient in question, but also for the patient's closest family. In recent years, there has been a change in how the quality of the public health service is measured. There is currently a focus on how patients and their families perceive the quality of treatment and care. It can be challenging for patients to evaluate their stay in an intensive care unit (ICU) due to illness and treatment. Earlier studies show that the perceptions of the family and the patient may concur. It is important, therefore, to ascertain the family's level of satisfaction with the ICU stay. The aim of the study was to describe how the family evaluate their satisfaction with the ICU stay. A further aim was to identify which demographic variables were associated with differences in family satisfaction. METHOD: The study had a cross-sectional design. A sample of 57 family members in two ICUs in Norway completed the questionnaire: Family satisfaction in the intensive care unit 24 (FS-ICU 24). Statistical analysis was conducted using the Mann-Whitney U test (U), Kruskal Wallis, Spearman rho and a performance-importance plot. RESULTS: The results showed that families were very satisfied with a considerable portion of the ICU stay. Families were less satisfied with the information they received and the decision-making processes than with the nursing and care performed during the ICU stay. The results revealed that two demographic variables - relation to the patient and patient survival - significantly affected family satisfaction. CONCLUSION: Although families were very satisfied with the ICU stay, several areas were identified as having potential for improvement. The results showed that some of the family demographic variables were significant for family satisfaction. The findings are clinically relevant since the results can strengthen intensive care nurses' knowledge when meeting the family of the intensive care patient.

[The development of mucosal vaccines]. / Slimhinnevaksiner i utvikling.

The live oral polio vaccine was the first mucosal vaccine accepted for general use. Since then, similar vaccines have been developed against typhoid fever, cholera and rotavirus infection, and a nasal vaccine against influenza has recently been registered in the USA. The only non-living mucosal vaccine on the market today is an oral cholera vaccine consisting of inactivated Vibrio cholerae and the B subunit of cholera toxin. Several groups of scientists are at present working on the development of other mucosal vaccines based on inactivated microbes or parts of them. Results from animal trials at the Norwegian Institute of Public Health, suggest that non-living nasal vaccines can provide protective immunity and may be combined with the same types of vaccines for injection. Clinical trials with nasal vaccines consisting of beta-propiolactone inactivated influenza particles, showed that it was possible to achieve serum concentrations of antibodies at levels providing protection against influenza. IgA antibodies, which were formed in nasal secretions, were specifically aimed at influenza and ought to hinder the spread of the disease. By optimizing the immunization regimes so that the immunological memory is better exploited, and by adding adjuvants to the formulations, it is probable that non-living mucosal vaccines can be realistic alternatives to several of the vaccines now given by injection.

Immunization of teenagers with a fifth dose of reduced DTaP-IPV induces high levels of pertussis antibodies with a significant increase in opsonophagocytic activity.

Waning vaccine-induced immunity against Bordetella pertussis is observed among adolescents and adults. A high incidence of pertussis has been reported in this population, which serves as a reservoir for B. pertussis. A fifth dose of reduced antigen of diphtheria-tetanus-acellular-pertussis and inactivated polio vaccine was given as a booster dose to healthy teenagers. The antibody activity against B. pertussis antigens was measured prior to and 4 to 8 weeks after the booster by different assays: enzyme-linked immunosorbent assays (ELISAs) of IgG and IgA against pertussis toxin (PT) and filamentous hemagglutinin (FHA), IgG against pertactin (PRN), opsonophagocytic activity (OPA), and IgG binding to live B. pertussis. There was a significant increase in the IgG activity against PT, FHA, and PRN following the booster immunization (P < 0.001). The prebooster sera showed a geometric mean OPA titer of 65.1 and IgG binding to live bacteria at a geometric mean concentration of 164.9 arbitrary units (AU)/ml. Following the fifth dose, the OPA increased to a titer of 360.4, and the IgG concentration against live bacteria increased to 833.4 AU/ml (P < 0.001 for both). The correlation analyses between the different assays suggest that antibodies against FHA and PRN contribute the most to the OPA and IgG binding.

Effectiveness of a 2+1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway.

The 7-valent pneumococcal conjugate vaccine (PCV-7) was licensed in Norway in 2001. In July 2006, PCV-7 was introduced in the Norwegian Childhood Vaccination Programme in a 2+1 dose schedule, with immunizations administered at 3, 5 and 12 months of age. PCV-7 was offered through the vaccination programme to all children born from January 2006, i.e. a catch-up for children aged 3-6 months. Prior to 2006 the use of PCV-7 was negligible. The effectiveness of the PCV-7 vaccination programme was assessed using data on invasive pneumococcal disease (IPD) incidence obtained from the Norwegian Surveillance System for Communicable Diseases, serotype distribution from the National Reference Laboratory for Pneumococci, and vaccine coverage and vaccination status from the Norwegian National Vaccination Register. Vaccine coverage quickly reached high levels; 95% of children >3 months born from January 2006 had received at least one immunization with PCV-7. The incidence rate of IPD among children <2 years rapidly declined; the rate of vaccine serotype IPD in this age group fell from an average of 47.1 cases/100,000 population in the 2 years prior to PCV-7 introduction to 13.7 cases/100,000 population in 2007. The incidence rate of nonvaccine serotype IPD remained stable. The vaccine programme effectiveness was estimated to be 74% (95% CI 57-85%). No vaccine failure was seen after complete primary immunization with two vaccine doses. Our findings indicate that PCV-7 provides highly effective protection against vaccine serotype IPD when administered in a 2+1 dose schedule.

Immunogenicity and safety of a combination of two serogroup B meningococcal outer membrane vesicle vaccines.

MenBvac and MeNZB are safe and efficacious vaccines against serogroup B meningococcal disease. MenBvac is prepared from a B:15:P1.7,16 meningococcal strain (strain 44/76), and MeNZB is prepared from a B:4:P1.7-2,4 strain (strain NZ98/254). At 6-week intervals, healthy adults received three doses of MenBvac (25 microg), MeNZB (25 microg), or the MenBvac and MeNZB (doses of 12.5 microg of each vaccine) vaccines combined, followed by a booster 1 year later. Two-thirds of the subjects who received a monovalent vaccine in the primary schedule received the other monovalent vaccine as a booster dose. The immune responses to the combined vaccine were of the same magnitude as the homologous responses to each individual vaccine observed. At 6 weeks after the third dose, 77% and 87% of the subjects in the combined vaccine group achieved serum bactericidal titers of > or = 4 against strains 44/76 and NZ98/254, respectively, and 97% and 93% of the subjects achieved a fourfold or greater increase in opsonophagocytic activity against strains 44/76 and NZ98/254, respectively. For both strains, a trend of higher responses after the booster dose was observed in all groups receiving at least one dose of the respective strain-specific vaccine. Local and systemic reactions were common in all vaccine groups. Most reactions were mild or moderate in intensity, and there were no vaccine-related serious adverse events. The safety profile of the combined vaccine was not different from those of the separate monovalent vaccines. In conclusion, use of either of the single vaccines or the combination of MenBvac and MeNZB may have a considerable impact on the serogroup B meningococcal disease situation in many countries.

A non-living nasal influenza vaccine can induce major humoral and cellular immune responses in humans without the need for adjuvants.

Twenty-eight healthy adult volunteers were immunized intranasally with an inactivated whole-virus influenza vaccine based on the strain A/New Caledonia/20/99 (H1N1), either in saline or mixed with formaldehyde-inactivated Bordetella pertussis as a mucosal adjuvant, or in a thixotropic vehicle with mucoadhesive properties. After four doses, all groups of vaccinees developed significant IgG- and IgA-antibody responses, measured by ELISA, in respectively serum and nasal secretions. None of the volunteers had demonstrable hemagglutination inhibition (HAI) antibodies in serum before being immunized, whereas more than 80% of them reached HAI titers>or=40, considered protective, after immunizations. In addition, cellular immune responses, measured as significant increases in CD4+ T-cell proliferation and granzyme B-producing cytotoxic T-cells, were detected against the vaccine strain as well as against heterologous virus strains (H3N2). However, no additive effect on these responses could be demonstrated with use of B. pertussis or the thixotropic substance in the present vaccines. It appeared, actually, that the mucoadhesive vehicle containing the thixotropic substance was less efficient than were the two other formulations. An influenza vaccine made as a simple particulate formulation of inactivated virus, and given repeatedly onto the nasal mucosa, may thus be an attractive alternative to currently available vaccines.

Immunisation schedules for non-replicating nasal vaccines can be made simple by allowing time for development of immunological memory.

Mice immunised intranasally with multiple doses of outer membrane vesicles (OMVs) from group B meningococci developed antibody responses that depended on the interval between doses. High levels of antibodies in saliva and extracts of faeces were induced within 4 weeks after an OMV vaccine had been given at weekly intervals, whereas the antibody responses in these samples were negligible when given four times at 1-day or 1-h intervals, or as one large dose. Only modest responses were obtained in serum after 4 weeks, however, whether the vaccine had been given repeatedly at any schedule, including the 1-week interval, or as one dose. On the other hand, two large doses given 8 weeks apart induced booster antibody responses in both serum and secretions that matched the responses from a second series of the four smaller doses. Intranasal immunisations may thus stimulate immunological memory more rapidly in secretions than in serum. In order to secure adequate systemic responses by a minimum of doses, nasal vaccines should therefore be given at intervals longer than 4 weeks, in harmony with the intervals recommended for injectable vaccines.

Bordetella pertussis can act as adjuvant as well as inhibitor of immune responses to non-replicating nasal vaccines.

In mice immunised intranasally with an inactivated whole-virus influenza (INV) vaccine, or ovalbumin (OVA), formalin-inactivated Bordetella pertussis (Bp) augmented antibody responses to the same degree as did cholera toxin (CT) when simply being mixed with INV or OVA. In order to study possible non-carrier effects of mucosal adjuvants, mice were given Bp or CT intranasally 1 day before or 1 day after the INV vaccines. At high antigen doses, both Bp and CT had an adjuvant effect on antibodies in serum also when given 1 day after the vaccine. However, Bp and CT inhibited such antibody responses in serum and saliva when given 1 day ahead of the vaccine. This inhibitory effect was most marked at low antigen doses, i.e. when the adjuvant effect was less obvious. In that event, Bp also inhibited responses in serum and saliva when given 1 day after the INV vaccine. The inhibition of these responses may thus depend on Bp and CT themselves being strongly immunogenic, and competing with INV for the functional capacity of the mucosal immune system.

Influence of intravenous anesthesia on mucosal and systemic antibody responses to nasal vaccines.

Inhalation of antigens may stimulate the immune system by way of the upper as well as the lower airways. We have shown that at least 1,000 times more live pneumococci were recovered from pulmonary tissue after being presented as drops of a liquid suspension onto the nares of anesthetized mice compared to the number of bacteria recovered from animals that were not anesthetized in the course of the challenge. Mice that were similarly immunized intranasally by inhalation of three different nonreplicating particulate vaccine formulations, i.e., a meningococcal outer membrane vesicle (OMV) vaccine, a formalin-inactivated whole-virus influenza (INV) vaccine, and the INV vaccine with OMVs as a mucosal adjuvant, during general intravenous anesthesia developed concentrations of vaccine-specific serum immunoglobulin G (IgG) antibodies that were four to nine times higher than in mice that were fully awake during immunizations. The concentrations of IgA antibodies in serum were also higher in anesthetized than in nonanesthetized mice and correlated positively with the corresponding levels of serum IgG antibodies in the anesthetized but not in the nonanesthetized mice. In saliva and feces, however, the concentrations of IgA antibodies were equally high whether or not the animals were dormant during immunizations. The results indicate that intrapulmonary antigen presentation, as a part of an intranasal immunization strategy, is of importance for systemic but not for mucosal antibody responses. A major portion of IgA antibodies in serum may thus be derived from nonmucosal sites.