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National Collaborating Centre for Methods and Tools

June 2014 · Issue 88

In this issue:

Community Health Nurses of Canada honour NCCMT founder

Donna Ciliska receives award at CHNC 2014 conference

At this year’s annual Community Health Nurses’ of Canada (CHNC) conference in Kanata, Ontario, Dr. Donna Ciliska was presented the Honorary Lifetime Membership Award. The nomination, submitted by former student and now colleague at McMaster University Rebecca Ganann, cited Donna’s “pioneering work and research on evidence-informed nursing and knowledge translation.” Rebecca, a nurse and researcher herself, calls Donna “a superb mentor, a generous collaborator, and an inspiring role model.”

Former student Rebecca Ganann nominated Donna Ciliska for the award

Donna was the first scientific director of the National Collaborating Centre for Methods and Tools (NCCMT), initially sharing that position with fellow McMaster University nursing professor Helen Thomas. Under Donna’s leadership, the NCCMT developed and continues to maintain a strong relationship with community health nurses across Canada, delivering workshops and webinars to help build capacity in evidence-informed practice and knowledge translation.

Claire Betker, past president of the CHNC was delighted to hear that Donna was to receive the award, noting the importance of Donna’s ongoing dedication to building capacity among community health nurses. At one of the organization’s first national conferences, Claire clearly remembers stepping into the exhibit hall to see Donna herself staffing the NCCMT booth. Since then, Donna’s support of community health nurses personally and through NCCMT has continued. 

Claire considers Donna “a star” who manages to keep things at a level people can understand “while at the same time never letting go of her idealism, her rigour, and the need to be scientific.” Claire sites the EIPH wheel, developed by the NCCMT under Donna’s leadership as an example. “It makes the process of using research evidence understandable and accessible.”

In July, Donna will retire from the School of Nursing at McMaster University after more than 30 years of dedication and commitment to the fields of community nursing and public health. We are pleased that Donna will continue to work with the NCCMT on a part-time basis as Senior Knowledge Translation Advisor.

The NCCMT congratulates Donna for receiving this well-deserved award.

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New in Registry of Methods and Tools

An organizational change model to navigate change leaders, employee resistance and work-based identities
http://www.nccmt.ca/registry/view/eng/213.html

This method was developed in the context of recent law firm mergers in Australia. However, the principles regarding resistance to change can be applied within a public health setting. As such, public health can apply the principles of resistance to change when departments merge, or in other instances where resistance occurs, such as trying to develop evidence-based programs.

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New from Public Health+

Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial.

Background. The vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010-2011.Methods. A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009(H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed.Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. The VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%-93.4%). The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group.Conclusion. The 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.Clinical Trials Registration. NCT01051661.

The full text may be available from PubMed

Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial.

BACKGROUND: Administration of vaccines by needle-free technology such as jet injection might offer an alternative to needles and syringes that avoids the issue of needle phobia and the risk of needle-stick injury. We aimed to assess the immunogenicity and safety of trivalent influenza vaccine given by needle-free jet injector compared with needle and syringe. METHODS: For this randomised, comparator-controlled trial, we randomly assigned (1:1) healthy adults (aged 18-64 years) who attended one of four employee health clinics in the University of Colorado health system, with stratification by site, to receive one dose of the trivalent inactivated influenza vaccine Afluria given either intramuscularly with a needle-free jet injector (Stratis; PharmaJet, Golden, CO, USA) or with needle and syringe. Randomisation was done with a computer-generated randomisation schedule with a block size of 100. Because of the nature of the study, masking of participants was not possible. Immunogenicity was assessed by measurement of the hemagglutination inhibition antibody titres in serum for the three viral strains included in the vaccine. We included six coprimary endpoints: three strain-specific geometric mean titre ratios and the absolute differences in three strain-specific seroconversion rates. The immune response of the jet injector group was regarded as non-inferior to that of the needle and syringe group if both the upper bound of each of the three 95% CIs for the strain-specific geometric mean titre ratios was 1.5 or less, and the upper bound of the three 95% CIs for the strain-specific seroconversion rate differences was less than 10 percentage points. We used t test for group comparison. This study is registered with ClinicalTrials.gov, number NCT01688921. FINDINGS: During the 2012-13 influenza season of the northern hemisphere, we allocated 1250 participants to receive vaccination by needle-free jet injector (n=627) or needle and syringe (n=623). In the intention-to-treat immunogenicity population, all participants with two serum samples were included (575 in the jet injector group and 574 in the needle and syringe group). The immune response to Afluria when given by needle-free jet injector met the criteria for non-inferiority for all six coprimary endpoints. The jet injector group met the geometric mean titre criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI for the geometric mean titre ratios were 1.10 for A/H1N1, 1.17 for A/H3N2, and 1.04 for B strains). The jet injector group met the seroconversion rate criterion for non-inferiority for the A/H1N1, A/H3N2, and B strains (upper bound of the 95% CI of the seroconversion rate differences were 6.0% for A/H1N1, 7.0% for A/H3N2, and 5.7% for B strains). We recorded serious adverse events in three participants, none of which were study related. INTERPRETATION: The immune response to influenza vaccine given with the jet injector device was non-inferior to the immune response to influenza vaccine given with needle and syringe. The device had a clinically acceptable safety profile, but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe. The Stratis needle-free jet injector device could be used as an alternative method of administration of Afluria trivalent influenza vaccine. FUNDING: Biomedical Advanced Research and Development Authority (BARDA), PATH, bioCSL, and PharmaJet.

The full text may be available from PubMed

Print-based self-help interventions for smoking cessation.

BACKGROUND: Many smokers give up smoking on their own, but materials giving advice and information may help them and increase the number who quit successfully. OBJECTIVES: The aims of this review were to determine: the effectiveness of different forms of print-based self-help materials, compared with no treatment and with other minimal contact strategies; the effectiveness of adjuncts to print-based self help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group trials register. Date of the most recent search April 2014. SELECTION CRITERIA: We included randomized trials of smoking cessation with follow-up of at least six months, where at least one arm tested a print-based self-help intervention. We defined self help as structured programming for smokers trying to quit without intensive contact with a therapist. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on the participants, the nature of the self-help materials, the amount of face-to-face contact given to intervention and to control conditions, outcome measures, method of randomization, and completeness of follow-up.The main outcome measure was abstinence from smoking after at least six months follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a fixed-effect model. MAIN RESULTS: We identified 74 trials which met the inclusion criteria. Many study reports did not include sufficient detail to judge risk of bias for some domains. Twenty-eight studies (38%) were judged at high risk of bias for one or more domains but the overall risk of bias across all included studies was judged to be moderate, and unlikely to alter the conclusions.Thirty-four trials evaluated the effect of standard, non-tailored self-help materials. Pooling 11 of these trials in which there was no face-to-face contact and provision of structured self-help materials was compared to no intervention gave an estimate of benefit that just reached statistical significance (n = 13,241, risk ratio [RR] 1.19, 95% confidence interval [CI] 1.04 to 1.37). This analysis excluded two trials with strongly positive outcomes that introduced significant heterogeneity. Six further trials without face-to-face contact in which the control group received alternative written materials did not show evidence for an effect of the smoking self-help materials (n = 7023, RR 0.88, 95% CI 0.74 to 1.04). When these two subgroups were pooled, there was no longer evidence for a benefit of standard structured materials (n = 20,264, RR 1.06, 95% CI 0.95 to 1.18). We failed to find evidence of benefit from providing standard self-help materials when there was brief contact with all participants (5 trials, n = 3866, RR 1.17, 95% CI 0.96 to 1.42), or face-to-face advice for all participants (11 trials, n = 5365, RR 0.97, 95% CI 0.80 to 1.18).Thirty-one trials offered materials tailored for the characteristics of individual smokers, with controls receiving either no materials, or stage matched or non-tailored materials. Most of the trials used more than one mailing. Pooling these showed a benefit of tailored materials (n = 40,890, RR 1.28, 95% CI 1.18 to 1.37) with moderate heterogeneity (I(2) = 32%). The evidence is strongest for the subgroup of nine trials in which tailored materials were compared to no intervention (n = 13,437, RR 1.35, 95% CI 1.19 to 1.53), but also supports tailored materials as more helpful than standard materials. Part of this effect could be due to the additional contact or assessment required to obtain individual data, since the subgroup of 10 trials where the number of contacts was matched did not detect an effect (n = 11,024, RR 1.06, 95% CI 0.94 to 1.20). In two trials including a direct comparison between tailored materials and brief advice from a health care provider, there was no evidence of a difference, but confidence intervals were wide (n = 2992, RR 1.13, 95% CI 0.86 to 1.49).Only four studies evaluated self-help materials as an adjunct to nicotine replacement therapy, with no evidence of additional benefit (n = 2291, RR 1.05, 95% CI 0.88 to 1.25). A small number of other trials failed to detect benefits from using additional materials or targeted materials, or to find differences between different self-help programmes. AUTHORS` CONCLUSIONS: Standard, print-based self-help materials increase quit rates compared to no intervention, but the effect is likely to be small. We did not find evidence that they have an additional benefit when used alongside other interventions such as advice from a healthcare professional, or nicotine replacement therapy. There is evidence that materials that are tailored for individual smokers ar

The full text may be available from PubMed

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NCCMT is funded by the Public Health Agency of Canada and affiliated with McMaster University.
Production of this newsletter has been made possible through a financial contribution from the Public Health Agency of Canada.
The views expressed herein do not necessarily represent the views of the Public Health Agency of Canada.
Contact us at nccmt@mcmaster.ca or www.nccmt.ca.