Jim Reid

Intradermal Influenza Vaccine Administered Using a New Microinjection System Produces Superior Immunogenicity in Elderly Adults: A Randomized Controlled Trial

BACKGROUND Enhanced influenza vaccines are needed to provide improved protection for elderly individuals. The intradermal vaccination route was hypothesized to provide immunogenicity superior to that provided by the intramuscular vaccination route. METHODS In a multicenter, randomized study, 1107 volunteers >60 years of age received intradermal trivalent inactivated influenza vaccine containing 15 or 21 microg of hemagglutinin per strain or intramuscular control vaccine. Intradermal vaccines used a novel microinjection system designed to ensure easy, convenient, consistent vaccination. The primary end points of the study were the strain-specific hemagglutination inhibition geometric mean titers (GMTs) noted 21 days after vaccination. Groups were compared using noninferiority and superiority analyses. RESULTS For each strain, the GMTs noted in association with each intradermal vaccine were superior to those noted with the intramuscular control (adjusted P< .0001). Seroprotection rates, seroconversion rates, and mean titer increases were also superior for intradermally administered vaccine in all but one of the analyses undertaken. Systemic reactogenicity was comparable between routes. Local injection site reactions, particularly erythema but not pain, were more commonly associated with intradermal vaccination. CONCLUSIONS For the first time, the intradermal vaccination route has been used to elicit immune responses significantly superior to those noted in association with the conventional intramuscular vaccination route. This was done using an easy-to-use, reliable microinjection system. This superior response is expected to enhance annual protection against influenza in this vulnerable population. TRIAL REGISTRATION Clinicaltrials.gov registry number: NCT00296829.

Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St Georges Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD. Lung function/symptomatic benefits of daily tiotropium+olodaterol fixed-dose combination in moderate-very severe COPD http://ow.ly/DIKiY

Allergic rhinitis management pocket reference 2008

Allergic rhinitis is a major chronic respiratory disease because of its prevalence, impacts on quality of life and work/school performance, economic burden, and links with asthma. Family doctors (also known as ‘primary care physicians’ or ‘general practitioners’) play a major role in the management of allergic rhinitis as they make the diagnosis, start the treatment, give the relevant information, and monitor most of the patients. Disease management that follows evidence‐based practice guidelines yields better patient results, but such guidelines are often complicated and may recommend the use of resources not available in the family practice setting. A joint expert panel of the World Organization of Family Doctors (Wonca), the International Primary Care Airways Group (IPAG) and the International Primary Care Respiratory Group (IPCRG), offers support to family doctors worldwide by distilling the globally accepted, evidence‐based recommendations from the Allergic Rhinitis and its Impact on Asthma (ARIA) initiative into this brief reference guide.

Asthma management pocket reference 2008

Asthma is one of the most common chronic airways diseases worldwide, and its prevalence is increasing. Family doctors (sometimes called ‘primary care physicians’ or ‘general practitioners’) are frequently an asthma patient’s first point of contact with healthcare systems. Disease management that follows evidence‐based practice guidelines yields better patient results, but such guidelines are often complicated and may recommend the use of resources not available in the family practice setting. A joint expert panel of the World Organization of Family Doctors (Wonca), International Primary Care Airways Group (IPAG) and the International Primary Care Respiratory Group (IPCRG) offers support to family doctors worldwide by distilling the globally accepted, evidence‐based recommendations from the Global Initiative for Asthma (GINA) into this brief reference guide.

Beginning School With Asthma Independently Predicts Low Achievement in a Prospective Cohort of Children

BACKGROUND Concerns about the achievement of children with asthma and respiratory conditions are especially important in New Zealand, which has one of the worlds highest rates of childhood asthma. The present study evaluated whether entering school with asthma was associated with low achievement after the first year. METHODS A child cohort was recruited to a prospective study at time of first enrollment into randomly selected schools in Christchurch. Parent interviews covered demographics and respiratory status. Physician reports were sought for children with asthma, and all respiratory information was clinically reviewed. The childrens achievement in reading and math was individually assessed at school entry and reassessed after 12 months. Schools reported absences. Intelligence subtests were administered. RESULTS Two hundred ninety-eight children were recruited, including 55 (18.5%) with current asthma. At 1-year follow-up, retention was 93.7%. Children who entered school with asthma were more likely to be ≥ 6 months behind other participants in reading words (P = .023) and books (P = .026), but not in math (P = .167) at the end of the first year of school. Achievement was not related to asthma severity. Entering school with asthma reliably predicted low reading achievement independent of other known covariates of low achievement (high absenteeism, minority status, male gender, single-parent family, poor academic skills at school entry, and low socioeconomic status). CONCLUSIONS Entering school with asthma was a significant predictor of low achievement in reading at 12-month follow-up, independent of asthma severity, high absenteeism, or other covariates of low achievement.

The clinical skills experience of rural immersion medical students and traditional hospital placement students: A student perspective

Background: Recent decades have seen an international trend for the development of undergraduate medical programmes in rural locations. These have been considered educationally equivalent alternatives to traditional hospital-based programmes. A pilot Rural Medical Immersion Programme (RMIP) was launched at the University of Otago. Aims: To examine the clinical skills experience of RMIP students and to compare it to that of fifth-year students based in the traditional, often urban and hospital-based, rotations. Methods: An online questionnaire was completed by 23 medical students: six RMIP students and 17 hospital-based students. Students rated their level of experience in a variety of skills and their self-perceived competence for performing these skills after their fifth year. Total experience and confidence was compared using Mann–Whitney U test, as were subsets of skills. Results: There was no difference found in the total clinical skills experience and confidence between RMIP and traditional students. RMIP students reported greater experience of patient examination and patient education skills; traditional students reported greater experience and confidence in investigation and interpretative skills. Conclusion: Clinical skills experience of the RMIP students is at least equivalent to that of their peers in the tertiary hospital setting. However, attention may be needed in the development of ‘investigative and interpretative skills’ for rural immersion students.

β-Blockers in COPD: A Cohort Study From the TONADO Research Program

Background: Cardiovascular disease is a frequent comorbidity in patients with COPD. Many physicians, particularly pulmonologists, are reluctant to use &bgr;‐adrenoceptor blocking agents (&bgr;‐blockers) in patients with COPD, despite their proven effectiveness in preventing cardiovascular events. Methods: The large (5,162 patients) phase III TONADO 1 and 2 studies assessed lung function and patient‐reported outcomes in patients with moderate to very severe COPD receiving long‐acting bronchodilator treatment across 1 year. This post hoc analysis characterized lung‐function changes, patient‐reported outcomes, and safety in the subgroup of patients receiving &bgr;‐blockers in the studies. Results: In total, 557 of 5,162 patients (11%) received &bgr;‐blockers at baseline. Postbronchodilator FEV1 at baseline was higher in the &bgr;‐blocker group (1.470 L) compared with that in the no &bgr;‐blocker group (1.362 L). As expected, patients receiving &bgr;‐blockers had a more frequent history of cardiovascular comorbidities and medications. Lung function improved from baseline in patients with or those without &bgr;‐blocker treatment, and no relevant between‐group differences were observed in trough FEV1 or trough FVC at 24 or 52 weeks. No relevant differences were observed for St. Georges Respiratory Questionnaire results and Transition Dyspnea Index in patients with &bgr;‐blockers compared with those in patients without. Safety findings were comparable between groups. Conclusions: Lung function, overall respiratory status, and safety of tiotropium/olodaterol were not influenced by baseline &bgr;‐blocker treatment in patients with moderate to very severe COPD. Results from this large patient cohort support the cautious and appropriate use of &bgr;‐blockers in patients with COPD and cardiovascular comorbidity. Trial Registry: ClinicalTrials.gov; No.: NCT01431274 and No. NCT01431287; URL: www.clinicaltrials.gov

Training generalist doctors for rural practice in New Zealand

Targeted postgraduate training increases the likelihood young doctors will take up careers in rural generalist medicine. This article describes the postgraduate pathways that have evolved for these doctors in New Zealand. The Cairns consensus statement 2014 defined rural medical generalism as a scope of practice that encompasses primary care, hospital or secondary care, emergency care, advanced skill sets and a population-based approach to the health needs of rural communities. Even as work goes on to define this role different jurisdictions have developed their own training pathways for these important members of the rural healthcare workforce. In 2002 the University of Otago developed a distance-taught postgraduate diploma aimed at the extended practice of rural general practitioners (GPs) and rural hospital medical officers. This qualification has evolved into a 4-year vocational training program in rural hospital medicine, with the university diploma retained as the academic component. The intentionally flexible and modular nature of the rural hospital training program and university diploma allow for a range of training options. The majority of trainees are taking advantage of this by combining general practice and rural hospital training. Although structured quite differently the components of this combined pathway looks similar to the Australian rural generalist pathways. There is evidence that the program has had a positive impact on the New Zealand rural hospital medical workforce.

Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial

BACKGROUND Before pandemic H1N1 vaccines were available, the potential benefit of existing seasonal trivalent inactivated influenza vaccines (IIV3s) against influenza due to the 2009 pandemic H1N1 influenza strain was investigated, with conflicting results. This study assessed the efficacy of seasonal IIV3s against influenza due to 2008 and 2009 seasonal influenza strains and against the 2009 pandemic H1N1 strain. METHODS This observer-blind, randomized, placebo-controlled study enrolled adults aged 18-64years during 2008 and 2009 in Australia and New Zealand. Participants were randomized 2:1 to receive IIV3 or placebo. The primary objective was to demonstrate the efficacy of IIV3 against laboratory-confirmed influenza. Participants reporting an influenza-like illness during the period from 14days after vaccination until 30 November of each study year were tested for influenza by real-time reverse transcription polymerase chain reaction. RESULTS Over a study period of 2years, 15,044 participants were enrolled (mean age±standard deviation: 35.5±14.7years; 54.4% female). Vaccine efficacy of the 2008 and 2009 IIV3s against influenza due to any strain was 42% (95% confidence interval [CI]: 30%, 52%), whereas vaccine efficacy against influenza due to the vaccine-matched strains was 60% (95% CI: 44%, 72%). Vaccine efficacy of the 2009 IIV3 against influenza due to the 2009 pandemic H1N1 strain was 38% (95% CI: 19%, 53%). No vaccine-related deaths or serious adverse events were reported. Solicited local and systemic adverse events were more frequent in IIV3 recipients than placebo recipients (local: IIV3 74.6% vs placebo 20.4%, p<0.001; systemic: IIV3 46.6% vs placebo 39.1%, p<0.001). CONCLUSIONS The 2008 and 2009 IIV3s were efficacious against influenza due to seasonal influenza strains and the 2009 IIV3 demonstrated moderate efficacy against influenza due to the 2009 pandemic H1N1 strain. Funded by CSL Limited, ClinicalTrials.gov identifier NCT00562484.

Behavior Problems and Post-traumatic Stress Symptoms in Children Beginning School: A Comparison of Pre- and Post-Earthquake Groups

Introduction: Literature reviews caution that estimating the effects of disasters on the behavior of children following a disaster is difficult without baseline information and few studies report the effects of earthquakes on young children. In addition the relationship between age at the time of disaster and consequential behavior problems have not been reported for young children who experience disaster-related stress during a developmentally sensitive period. Methods: Behavior problems and symptoms of post-traumatic stress (PTS) were reported for two groups of children from nearby neighborhoods during their first term at school, using the Behavior Problem Index by teacher report, following approved informed consent procedures. Data on one group, “Pre-EQ” (N=297), was collected four years before the beginning of the earthquakes on children born 2001-2002. Data on the second group, “Post-EQ” (N=212), was collected approximately three to four years after the beginning of the earthquakes on children born 2007-2009 and living in heavily damaged neighborhoods. The Post-EQ group had significantly more children from high socioeconomic neighborhoods but no other significant differences on main demographic characteristics. Results: The mean behavior problem score was significantly higher in the Post-EQ group (Mean =6.11) as compared to the Pre-EQ group (Mean = 3.78). PTS symptoms were also significantly higher in the Post-EQ group (Mean =2.91) as compared to the Pre-EQ group (Mean=1.98) and more children had high PTS scores (20.9% v. 8.8%, OR= 2.73, 95%CI =1.57, 4.76). Model testing identified that a younger age at the time of exposure was the only significant predictor of high numbers of PTS symptoms in the Post-EQ group. Discussion: Rates of teacher-reported behavior problems in young children more than doubled following the Christchurch earthquakes. Younger children may be more vulnerable to the effects of earthquakes that occur during a developmentally sensitive period. Additional research is needed to consider the effects of age and duration of disaster effects to better understand the effects of disasters on children, their families and communities.