A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

Extent: 10p.Background: The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design: Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion: The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed.Jesia G Berry, Philip Ryan, Annette J Braunack-Mayer, Katherine M Duszynski, Vicki Xafis, Michael S Gold, the Vaccine Assessment Using Linked Data (VALiD) Working Grou

The effect of soil texture and vegetation on carbon accrual in restored grasslands

Settlement of the Midwest, with the subsequent conversion of tallgrass prairie to agricultural fields, has led to a drastic reduction of soil carbon (C). As agricultural fields are returned to grasslands, it is important to understand the factors influencing rates of C and nitrogen (N) accrual in order to better predict C storage rate and capacity. In this study, we first evaluated the effect of soil texture, plant productivity, species richness and C4 grass-legume complementarity on soil C and N. In addition, we used a chronosequence approach to estimate the rate of soil C and N accrual. Soil samples were collected at depths up to 90 cm from remnant prairies, high-diversity prairie restorations, medium and low-diversity plantings enrolled in the Conservation Reserve Program (CRP), and crop fields in Newton County, IN and Lee County, IL. Vegetation surveys and biomass collections were conducted in the prairie and conservation areas to estimate plant species richness, functional group abundance, and productivity. We found that soil silt + clay content was the most important predictor for soil C and N content, in Newton and Lee Counties. Difference among field treatments fell along lines of soil texture, as fields with high silt + clay content were the first to be converted to agriculture due to their greater productivity compared to the sandy prairie remnants. As predicted, soil C and N increased with plant productivity. However, we found soil C and N decreased with species richness. There was no effect of legumes on soil C and N content in C4 grass dominated grasslands. In our chronosequence study, soil C and N increased with time since restoration, however the pattern was not significant over the initial chronosequence when remnant prairies were excluded. After omitting remnant prairies, the relationship between C and time since restoration was strengthened when variance due to silt + clay content was accounted for in the Newton County MD and LD restorations and Lee County low silt + clay restoration chronosequence, through residual analysis. Standardized multiple linear regression (MLR) showed soil C and N increased with silt + clay content both counties, and decreased with species richness, particularly in Lee County. Standardized MLR showed C and N to increase with field age in Newton County, but decrease with field age in Lee County. This may be due to leaching of C and N because the oldest restorations were located in areas with greater slope and well-drained soils. Labile soil C decreased slightly with time since restoration in both Newton and Lee Counties

The use of citizens\u27 juries in health policy decision-making: a systematic review

Deliberative inclusive approaches, such as citizen juries, have been used to engage citizens on a range of issues in health care and public health. Researchers engaging with the public to inform policy and practice have adapted the citizen jury method in a variety of ways. The nature and impact of these adaptations has not been evaluated. We systematically searched Medline (PubMED), CINAHL and Scopus databases to identify deliberative inclusive methods, particularly citizens\u27 juries and their adaptations, deployed in health research. Identified studies were evaluated focussing on principles associated with deliberative democracy: inclusivity, deliberation and active citizenship. We examined overall process, recruitment, evidence presentation, documentation and outputs in empirical studies, and the relationship of these elements to theoretical explications of deliberative inclusive methods. The search yielded 37 papers describing 66 citizens\u27 juries. The review demonstrated that the citizens\u27 jury model has been extensively adapted. Inclusivity has been operationalised with sampling strategies that aim to recruit representative juries, although these efforts have produced mixed results. Deliberation has been supported through use of steering committees and facilitators to promote fair interaction between jurors. Many juries were shorter duration than originally recommended, limiting opportunity for constructive dialogue. With respect to citizenship, few juries\u27 rulings were considered by decision-making bodies thereby limiting transfer into policy and practice. Constraints in public policy process may preclude use of the ‘ideal’ citizens\u27 jury with potential loss of an effective method for informed community engagement. Adapted citizens\u27 jury models provide an alternative: however, this review demonstrates that special attention should be paid to recruitment, independent oversight, jury duration and moderation

Use of pharmacotherapies for the management of addictive behaviours in Australian clinical practice

Aims: To collect data on the behaviours associated with the prescription of pharmacotherapies (bupropion, acamprosate and naltrexone) for nicotine and alcohol dependence in Australian clinical practice. Design: Self-administered questionnaire. Setting: Australian clinical practice. Participants: Three specialties, psychiatrists, gastroenterologists and general practitioners (GPs) were defined by the Health Insurance Commission's derived major specialty classification codes and stratified by state (and territory) as well as rural and remote metropolitan area classification. A total of 2680 surveys were sent (670 psychiatrists, 82 gastroenterologists and 1928 GPs) with 1291 surveys used in the final analysis (329 psychiatrists, 37 gastroenterologists and 925 GPs). Interventions: A 10-page, 46-item survey was distributed by the HIC. The initial survey was sent in March 2003 and sent a subsequent two times to non-responding physicians. Measurements: Characteristics of physicians and their therapeutic preferences in managing patients with nicotine or alcohol dependence. Findings: The majority of physicians identified and provided advice to patients who smoked and consumed alcohol at levels harmful to health. Fourteen percent used a formal alcohol-screening instrument, 4% were familiar with the 5 As' of a smoking cessation strategy and less than a third had undertaken any formal training in providing brief advice. The majority of physicians perceived pharmacotherapies to be an effective treatment strategy and indicated adjuncts improved likelihood of behaviour modification. Predictors of pharmacotherapy prescribing included working in a large clinical practice, having an additional mental health qualification and training in provision of brief advice. Conclusions: Physicians are in a strong position, and are encouraged to, manage additive disorders. Scope exists to improve prescribing of pharmacotherapies for nicotine and alcohol dependence by enhancing appropriate counselling skills and making explicit the nature of a comprehensive treatment regime as an adjunct to medicines

Parent perspectives on consent for the linkage of data to evaluate vaccine safety: A randomised trial of opt-in and opt-out consent

Background We examined parents’ consent preferences and understanding of an opt-in or opt-out invitation to participate in data linkage for post-marketing safety surveillance of childhood vaccines. Methods A single-blind parallel-group randomised controlled trial: 1129 families of babies born at a South Australian hospital in 2009 were sent information at 6 weeks post-partum, explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance, with 4 weeks to opt in or opt out by reply form, telephone, or email. At 10 weeks post-partum, 1026 (91%) parents were followed up by telephone interview. Results In both the opt-in (n = 564) and opt-out arms (n = 565), four-fifths of the parents recalled receiving the information (81% vs. 83%, P = 0.35), three-fifths reported reading it (63% vs. 67%, P = 0.11), but only two-fifths correctly identified the health records to be linked (43% vs. 39%, P = 0.21). Parents who actively consented (opted in) were more likely than those who passively consented (did not opt out) to recall the information (100% vs. 83%, P \u3c 0.001), report reading it (94% vs. 67%, P \u3c 0.001), and correctly identify the data sources (60% vs. 39%, P \u3c 0.001). Most parents supported data linkage for vaccine safety surveillance (94%) and trusted its privacy protections (84%). Most parents wished to have minimal or no direct involvement, preferring either opt-out consent (40%) or no consent (30%). A quarter (24%) of parents indicated opt-in consent should be sought; of these, 8% requested consent prior to every use, 5% preferred to give broad consent just once and 11% preferred periodic renewal. Three-fifths of the parents gave higher priority to rapid vaccine safety surveillance (61%) rather than first seeking parental consent (21%), and one in seven was undecided (15%). Although 91% of parents reported that their babies were fully immunised (76%) or under-immunised (15%), and trusted vaccines as safe (90%), three-fifths (62%) were very or somewhat concerned about serious reactions. Limitations The context of data linkage is limited to vaccine safety surveillance. Only recall and understanding retained at 1 month post enrolment were measured. Conclusions This trial demonstrates that informed consent for a population-based surveillance programme cannot realistically be achieved using mail-based opt-in and opt-out approaches. While recall and understanding of the study’s purpose were better among parents who actively consented (opted in) compared with parents who passively consented (did not opt out), participation was substantially lower (21% vs. 96% respectively). Most parents appeared to have a poor understanding of data linkage for vaccine safety surveillance; nonetheless, they supported data linkage. They preferred a system utilising opt-out consent or no consent to one using opt-in consent

Process trumps potential public good:better vaccine safety through linked cross-jurisdictional immunisation data in Australia

OBJECTIVE:To provide insights into complexities of seeking access to state and federal cross-jurisdictional data for linkage with the Australian Childhood Immunisation Register (ACIR). We provide recommendations for improving access and receipt of linked datasets involving Australian Government-administered data. METHODS:We describe requirements for linking eleven federal and state data sources to establish a national linked dataset for safety evaluation of vaccines. The required data linkage methodology for integrating cross-jurisdictional data sources is also described. RESULTS:Extensive negotiation was required with 18 different agencies for 21 separate authorisations and 12 ethics approvals. Three variations of the 'best practice' linkage model were implemented. Australian Government approval requests spanned nearly four years from initial request for data, with a further year before ACIR data transfer to the linkage agency. CONCLUSIONS:Integration of immunisation registers with other data collections is achievable in Australia but infeasible for routine and rapid identification of vaccine safety concerns. Lengthy authorisation requirements, convoluted disparate application processes and inconsistencies in data supplied all contribute to delayed data availability. Implications for public health: Delayed data access for safety surveillance prevents timely epidemiological reviews. Poor responsiveness to safety concerns may erode public confidence, compromising effectiveness of vaccination programs through reduced participation.Katherine M. Duszynski, Nicole L. Pratt, John W. Lynch, Annette Braunack-Mayer, Lee K. Taylor, Jesia G. Berry, Vicki Xafis, Jim Buttery, Michael S. Gold, on behalf of the Vaccine Assessment Using Linked Data, VALiD, Working Grou