Development of the oral resistome during the first decade of life.

Antibiotic overuse has promoted the spread of antimicrobial resistance (AMR) with significant health and economic consequences. Genome sequencing reveals the widespread presence of antimicrobial resistance genes (ARGs) in diverse microbial environments. Hence, surveillance of resistance reservoirs, like the rarely explored oral microbiome, is necessary to combat AMR. Here, we characterise the development of the paediatric oral resistome and investigate its role in dental caries in 221 twin children (124 females and 97 males) sampled at three time points over the first decade of life. From 530 oral metagenomes, we identify 309 ARGs, which significantly cluster by age, with host genetic effects detected from infancy onwards. Our results suggest potential mobilisation of ARGs increases with age as the AMR associated mobile genetic element, Tn916 transposase was co-located with more species and ARGs in older children. We find a depletion of ARGs and species in dental caries compared to health. This trend reverses in restored teeth. Here we show the paediatric oral resistome is an inherent and dynamic component of the oral microbiome, with a potential role in transmission of AMR and dysbiosis.

Preliminary study of the oral mycobiome of children with and without dental caries.

Children's oral health is in a dire state, with dental decay (caries) being one of the most common chronic diseases. While the role of bacteria in the oral microbiome and dental caries is established, the contribution of fungi is relatively unknown. We assessed the oral mycobiome in childhood (n = 17), to determine if the composition of fungi varies between children with and without caries. Oral mycobiome composition was assessed by using Illumina MiSeq to sequence the ITS2 region, which was amplified from dental plaque. This revealed that the oral mycobiome in the investigated children contained 46 fungal species. Candida albicans was the most abundant species and was ubiquitous in all samples, indicating this species may not be involved in caries development as previously suggested. While the overall diversity of fungi was similar, independent of caries status (p > 0.05), we found caries influenced the abundance of specific fungi. Children without caries had a significantly higher abundance of 17 species compared to children with caries, which had three enriched species (p < 0.001). While the differentially abundant species between health and caries may be specific to an Australian population, our findings indicate the mycobiome plays a role in oral health.

A realist evaluation of value-based care delivery in home care: The influence of actors, autonomy and accountability.

The increasing demand for home care is occurring in tandem with the need for governments to contain health care costs, maximize appropriate resource utilization and respond to patient preferences for where they receive care. We describe the evaluation of the Integrated Client Care Project (ICCP), a government funded project designed to improve value for outcomes for patients referred to community wound care services in Ontario, Canada. We applied a realist evaluation methodology in order to unpack the influences of contextual and mechanistic choices on the intended outcomes of the ICCP implementation. We collected data through ethnographic methods including 36 months of field observation, 46 key informant interviews and contemporaneous document analysis. The findings presented here highlight how theoretical mechanisms were negatively impacted by strong contextual patterns and weak implementation which led to underwhelming outcomes. Autonomy of the participant organizations, lack of power within the implementation team to drive change, opacity of the goals of the program, and disregard for the impact of complex historical relations within the home care sector compounded to undermine the intended outcome.

VMG II transport medium stabilises oral microbiome samples for Next-Generation Sequencing.

Next-Generation Sequencing is providing insights into the critical role of the oral microbiome in dental diseases. Application of this method can require the collection of dental plaque from large cohorts in field-type conditions, which necessitates a transport medium to preserve the microbiome composition. We evaluated the use of two transport media, VMG II and RNAprotect® Bacteria Reagent (Qiagen), for room temperature storage of dental plaque. VMG II has not previously been assessed for suitability to store microbiome samples intended for deep sequencing. We compared the microbiome composition of dental plaque (total n=23) stored in either VMG II or RNAprotect Bacteria at room temperature with immediately-frozen plaque. 454 sequencing of 16S gene amplicons was used to assess the plaque microbial composition. While the bacterial diversity recovered was similar between storage conditions (p>0.1), the abundance of bacteria was influenced by storage environment. Dental plaque stored in VMG II was most similar to immediately-frozen material, with only one of the 324 bacterial species being differentially abundant (Neisseria, p<0.001). In comparison, dental plaque stored in RNAprotect Bacteria had 24 differentially abundant species compared with the immediately-frozen samples and a significantly different phylogenetic structure (p<0.01). We have identified VMG II as a new transport medium for room temperature storage of dental plaque samples being subject to Next-Generation Sequencing that stabilises oral microbial DNA makeup.

Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial.

BACKGROUND: Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes. METHODS: Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group. RESULTS: We identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care (n = 41) or PtDA intervention (n = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was - 22.1[- 30.23, - 13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care - 8.7 [- 14.61, - 2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group. CONCLUSION: Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes. TRIAL REGISTRATION: NCT01876173.

The effect and expense of redemption reintegration services versus usual reintegration care for young African Canadians discharged from incarceration.

African Canadians comprise 2.5% of the population, but represent 9.5% of federal inmates - an increase of 80% since 2003-2004. Recidivism among federal inmates is high (about 40%). This paper outlines the findings, at 9 months after enrolment during 2011-2012, of a randomised controlled trial testing the effectiveness and cost of Redemption Reintegration Services (RRS), a culturally specific, multi-level intervention for young African Canadian former inmates. Retention at 9 months was 95% of those randomised (n = 115 per group) to RRS (n = 114) or usual reintegration services (n = 105) offered by the municipality. The primary outcomes were recidivism and service costs. Mediating and moderating measures were Personality Strengths, Developmental Assets, Meaning in Life, the Structured Assessment of Violence Risk in Youth, the Youth Behaviour Checklist and Neighbourhood Vitality. Compared with the usual care group, the RRS group showed significant improvements in: self-reported Personality Strengths, Developmental Assets, the presence and search for Meaning in Life, social and individual risk factors, behaviour, and life events such as obtaining stable housing and enrolling in school. At 9 months, RRS participants generated significantly lower per person per annum expenditures for law enforcement services, housing services and total direct costs. Among RRS participants, 3.5% reported being re-charged for offences in the previous 9 months compared with 45.7% of the usual care group. The 2010-2011 average annual cost per person for incarceration was $114,364. The 48 individuals in the usual care group and 4 in RRS would generate costs of $5,489,472 and $457,456, respectively - a $5 million difference. We conclude that, at 9 months, RRS is more effective and less expensive than usual reintegration services for young African Canadians.

The Relationship Between Traumatic Injury in Children and Long-Term Use of Health and Social Services by Children and Their Families.

To increase understanding of relationships between general traumatic injury in children and long-term use of resources in the health care and social services (HSS) sectors by these children and their families 8-10 years after traumatic injury. This study was a cross-sectional retrospective cohort study of prognosis from 2001 to 2003 that quantified recent expenditures on and use of HSS by children and also by their parents. Forty-eight cases of children were selected from the Hamilton Health Sciences pediatric trauma database in the period from January 2001 to December 2003 after incurring a traumatic injury with Injury Severity Score greater than 12. The average total cost to the HSS system per child's family was $4,326.62 during the preceding 6 months. During the same period, average use of HSS was 7 visits. Total service costs incurred by caregivers of injured children increased with severity of the traumatic injury (p= .009). Caregiver HSS use was higher when the injury was caused by a motor vehicle accident than by other types of accidents (p< .001) and increased with the injury severity (p< .001). HSS use by children was related to gender (p< .001), injury mechanism (p< .001), age at accident (p< .001), and time since accident (p= .012), among other factors. Pediatric trauma appears to have long-term effects on expenditures on and use of HSS by the affected children and their families. The findings emphasize the need for long-term assessment and possible delivery of services to the families of the injured children.

Diet may influence the oral microbiome composition in cats.

BACKGROUND: Periodontal disease is highly prevalent amongst domestic cats, causing pain, gingival bleeding, reduced food intake, loss of teeth and possibly impacts on overall systemic health. Diet has been suggested to play a role in the development of periodontal disease in cats. There is a complete lack of information about how diet (composition and texture) affects the feline oral microbiome, the composition of which may influence oral health and the development of periodontal disease. We undertook a pilot study to assess if lifelong feeding of dry extruded kibble or wet (canned and/or fresh meat combinations) diets to cats (n = 10) with variable oral health affected the microbiome. RESULTS: Oral microbiome composition was assessed by amplifying the V1-V3 region of the 16S gene from supragingival dental plaque DNA extracts. These amplicons were sequenced using Illumina technology. This deep sequencing revealed the feline oral microbiome to be diverse, containing 411 bacterial species from 14 phyla. We found that diet had a significant influence on the overall diversity and abundance of specific bacteria in the oral environment. Cats fed a dry diet exclusively had higher bacterial diversity in their oral microbiome than wet-food diet cats (p < 0.001). Amongst this higher diversity, cats on dry-food diets had a higher abundance of Porphyromonas spp. (p < 0.01) and Treponema spp. (p < 0.01). CONCLUSIONS: While we observed differences in the oral microbiome between cats on the two diets assessed, the relationship between these differences and gingival health was unclear. Our preliminary results indicate that further analysis of the influence of dietary constituents and texture on the feline oral microbiome is required to reveal the relationship between diet, the oral microbiome and gingival health in cats.

Investing in Uncertainty: Young Adults with Life-Limiting Conditions Achieving Their Developmental Goals.

BACKGROUND: With improvements in pediatric care and technology, more young adults (YAs) with life-limiting conditions (LLCs) are surviving into adulthood. However, they have limited expectations to live beyond the first decade of adulthood. This study describes the monumental efforts required for YAs with LLCs to achieve their goals in an abbreviated life. OBJECTIVES: The experiences and aspirations of YAs with LLCs to achieve their goals are relatively unknown. This report focuses on their experiences of living with uncertainty and its impact on achieving developmental goals. DESIGN: This study is one component of a larger descriptive study using an innovative bulletin board focus group to examine life experiences of YAs with LLCs. RESULTS: YAs with LLCs share the aspirations and goals of all YAs. Some participants demonstrated a striking capacity to navigate system barriers and achieve their goals, whereas others "got stuck" resulting in lost opportunities. Successful personal life investments were possible if resources were made available, coordinated, navigable, and responsive to new and special requests. Transformative changes to health, social care, and community services are necessary to support their YA ambitions. CONCLUSIONS: This study gave voice to those who were previously unheard and demonstrates the monumental hurdles YAs with LLCs face to achieve their goals. A palliative approach to care can mitigate unnecessary hardships and support their goals.

Age-dependent changes in Porphyromonas gingivalis and Prevotella species/phylotypes in healthy gingiva and inflamed/diseased sub-gingival sites.

OBJECTIVES: Early colonisation of oral surfaces by periodontal pathogens presents a significant risk factor for subsequent development of destructive disease affecting tissues that support the dentition. The aims of the present study were to establish the age-dependent relationship between sub-gingival profiles of 22 Prevotella species/phylotypes in children, adolescents and adults from an isolated Aboriginal community and, further, to use this information to identify Prevotella species that could serve as microbial risk indicators. MATERIALS AND METHODS: DNA isolated from sub-gingival plaque samples (three healthy sites and three inflamed/diseased sites) from adults, adolescents and children was screened for Porphyromonas gingivalis load and 22 Prevotella species/phylotypes by species-specific PCR. RESULTS: A noticeable feature in adolescents was the marked increase in colonisation by P. gingivalis across all test sites. The mean number of Prevotella species/phylotypes colonising inflamed/diseased sub-gingival sites increased with age. Progressive partitioning of selected Prevotella species/phylotypes to healthy or inflamed/diseased sites was evident. Prevalence of Prevotella intermedia, Prevotella oral clone P4PB_24 and Prevotella oris increased significantly with age in diseased sites. Similarly, significant age-dependent increase in colonisation of healthy as well as inflamed/diseased sub-gingival sites was apparent for Prevotella oralis, Prevotella multiformis, Prevotella denticola, Prevotella strain P4P_53 and Prevotella oral clone BR014. CONCLUSION: Early colonisation of children by P. gingivalis, P. intermedia and Prevotella oral clone P4PB_24 provides indication of risk for subsequent development of periodontal disease. CLINICAL RELEVANCE: In the present study, the complexity of Prevotella species within gingival sites is explored as a basis for evaluating contribution of Prevotella species to disease.

Better Care and Better Value for Canadians: A Review of RCT Studies of Nurse Interventions.

This review is focused on the effectiveness of nursing interventions for patient outcomes and healthcare costs. It was guided by ecological and economic evaluation frameworks. Restricting the first-tier search of over 4,000 articles to randomized controlled trials (RCTs) yielded 203 studies and 9 additional trials that used identical methods of cost evaluation. Of 212 RCTs, 37 met the eligibility criteria. Of the 37 articles, 29 came from the literature search and 8 came from the first author's research unit, which used identical methods of economic evaluation. Of the first 29 studies, 26 found that nurse interventions were more or equally effective and less or equally costly compared to usual care, as was true of 7 of the 9 RCTs with comprehensive economic evaluations. It is effective and efficient to deploy specialty-trained nurses to lead teams of professionals, including physicians, assembled to address complex patient needs. A nurse-led model of proactive and supplemental care for the chronically ill, versus the on-demand, physician-led model now in place, would be more or equally effective and less or equally costly.

La présente revue porte sur l'efficacité des interventions infirmières en ce qui concerne les résultats pour les patients et les coûts liés aux soins. Sa réalisation a été orientée par un cadre d'évaluation économique et écologique. Restreinte aux essais cliniques randomisés, la première étape de la recherche, effectuée à partir d'un bassin de plus de 4 000 articles, a permis de dégager du lot 203 études et 9 essais cliniques supplémentaires utilisant des méthodes identiques d'évaluation des coûts. Sur ces 212 études et essais, 37 répondaient aux critères d'admissibilité, et parmi ces 37 articles admissibles, 29 provenaient du dépouillement de la littérature et 8 de l'unité de recherche de la première auteure, qui utilise exactement les mêmes méthodes d'évaluation économique. Dans le groupe des 29 premières études, 26 constataient une efficacité des interventions infirmières égale ou supérieure aux soins réguliers pour un coût égal ou inférieur, constatation également présente dans 7 des 9 essais cliniques randomisés ayant fait l'objet d'une évaluation économique approfondie. Il est donc efficace et rentable de déployer du personnel infirmier spécialisé pour diriger des équipes de professionnels, y compris les médecins, mises sur pied pour donner des soins aux patients ayant des besoins complexes. Ainsi, pour les patients souffrant de maladies chroniques, un modèle de soins proactifs supplémentaires dirigé par du personnel infirmier serait, par rapport au modèle actuel de soins sur demande dirigé par des médecins, plus efficace ou également efficace, et ce, pour un coût égal ou inférieur.

An interprofessional nurse-led mental health promotion intervention for older home care clients with depressive symptoms.

BACKGROUND: Depressive symptoms in older home care clients are common but poorly recognized and treated, resulting in adverse health outcomes, premature institutionalization, and costly use of health services. The objectives of this study were to examine the feasibility and acceptability of a new six-month interprofessional (IP) nurse-led mental health promotion intervention, and to explore its effects on reducing depressive symptoms in older home care clients (≥ 70 years) using personal support services. METHODS: A prospective one-group pre-test/post-test study design was used. The intervention was a six-month evidence-based depression care management strategy led by a registered nurse that used an IP approach. Of 142 eligible consenting participants, 98 (69%) completed the six-month and 87 (61%) completed the one-year follow-up. Outcomes included depressive symptoms, anxiety, health-related quality of life (HRQoL), and the costs of use of all types of health services at baseline and six-month and one-year follow-up. An interpretive descriptive design was used to explore clients', nurses', and personal support workers' perceptions about the intervention's appropriateness, benefits, and barriers and facilitators to implementation. RESULTS: Of the 142 participants, 56% had clinically significant depressive symptoms, with 38% having moderate to severe symptoms. The intervention was feasible and acceptable to older home care clients with depressive symptoms. It was effective in reducing depressive symptoms and improving HRQoL at six-month follow-up, with small additional improvements six months after the intervention. The intervention also reduced anxiety at one year follow-up. Significant reductions were observed in the use of hospitalization, ambulance services, and emergency room visits over the study period. CONCLUSIONS: Our findings provide initial evidence for the feasibility, acceptability, and sustained effects of the nurse-led mental health promotion intervention in improving client outcomes, reducing use of expensive health services, and improving clinical practice behaviours of home care providers. Future research should evaluate its efficacy using a randomized clinical trial design, in different settings, with an adequate sample of older home care recipients with depressive symptoms. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01407926.

Estimating treatment effects in randomised controlled trials with non-compliance: a simulation study.

OBJECTIVE: Randomised controlled trials (RCTs) are often considered as the gold standard for assessing new health interventions. Patients are randomly assigned to receive an intervention or control. The effect of the intervention can be estimated by comparing outcomes between groups, whose prognostic factors are expected to balance by randomisation. However, patients' non-compliance with their assigned treatment will undermine randomisation and potentially bias the estimate of treatment effect. Through simulation, we aim to compare common approaches in analysing non-compliant data under different non-compliant scenarios. SETTINGS: Based on a real study, we simulated hypothetical trials by varying three non-compliant factors: the type, randomness and degree of non-compliance. We compared the intention-to-treat (ITT), as-treated (AT), per-protocol (PP), instrumental variable (IV) and complier average casual effect (CACE) analyses to estimate large (50% improvement over the control), moderate (25% improvement) and null (same as the control) treatment effects. Different approaches were compared by the bias of estimate, mean square error (MSE) and 95% coverage of the true value. RESULTS: For a large or moderate treatment effect, the ITT estimate was considerably biased in all scenarios. The AT, PP, IV and CACE estimates were unbiased when non-compliant behaviours were random. The IV estimate was unbiased when non-compliant behaviours were symmetrically dependent on patients' conditions. The PP estimate was mostly unbiased when patients in the control group did not have access to the intervention. When the intervention was not different from the control, the ITT was less biased than the other approaches. Similar results were found when comparing the MSE and 95% coverage. CONCLUSIONS: The standard ITT analysis under non-compliance is biased when the intervention has a moderate or large effect. Alternative analyses can provide unbiased or less biased estimates. Based on the results, we make some suggestions on choosing optimal approaches for analysing specific non-compliant scenarios.

Bacterial profile of dentine caries and the impact of pH on bacterial population diversity.

Dental caries is caused by the release of organic acids from fermentative bacteria, which results in the dissolution of hydroxyapatite matrices of enamel and dentine. While low environmental pH is proposed to cause a shift in the consortium of oral bacteria, favouring the development of caries, the impact of this variable has been overlooked in microbial population studies. This study aimed to detail the zonal composition of the microbiota associated with carious dentine lesions with reference to pH. We used 454 sequencing of the 16S rRNA gene (V3-V4 region) to compare microbial communities in layers ranging in pH from 4.5-7.8 from 25 teeth with advanced dentine caries. Pyrosequencing of the amplicons yielded 449,762 sequences. Nine phyla, 97 genera and 409 species were identified from the quality-filtered, de-noised and chimera-free sequences. Among the microbiota associated with dentinal caries, the most abundant taxa included Lactobacillus sp., Prevotella sp., Atopobium sp., Olsenella sp. and Actinomyces sp. We found a disparity between microbial communities localised at acidic versus neutral pH strata. Acidic conditions were associated with low diversity microbial populations, with Lactobacillus species including L. fermentum, L. rhamnosus and L. crispatus, being prominent. In comparison, the distinctive species of a more diverse flora associated with neutral pH regions of carious lesions included Alloprevotella tanerrae, Leptothrix sp., Sphingomonas sp. and Streptococcus anginosus. While certain bacteria were affected by the pH gradient, we also found that ∼ 60% of the taxa associated with caries were present across the investigated pH range, representing a substantial core. We demonstrated that some bacterial species implicated in caries progression show selective clustering with respect to pH gradient, providing a basis for specific therapeutic strategies.

pH gradient and distribution of streptococci, lactobacilli, prevotellae, and fusobacteria in carious dentine.

OBJECTIVES: Caries process comprises acidogenic and aciduric bacteria that are responsible for lowering the pH and subsequent destruction of hydroxyapatite matrix in enamel and dentine. The aim of this study was to identify the correlation between the pH gradient of a carious lesion and proportion and distribution of four bacterial genera; lactobacilli, streptococci, prevotellae, and fusobacteria with regard to total load of bacteria. MATERIALS AND METHODS: A total of 25 teeth with extensive dentinal caries were sampled in sequential layers. Using quantitative real-time PCR of 16S rRNA gene, we quantified the total load of bacteria as well as the proportion of the above-mentioned genera following pH measurement of each sample with a fine microelectrode. RESULTS: We demonstrated the presence of a pH gradient across the lesion with a strong association between the quantity of lactobacilli and the lowest pH range (pH 4.5-5.0; p = 0.003). Streptococci had a tendency to occupy the most superficial aspect of the carious lesion but showed no correlation to any pH value. Prevotellae showed clear preference for the pH range 5.5-6.0 (p = 0.042). The total representation of these four genera did not reach more than one quarter of the total bacterial load in most carious samples. CONCLUSION: We revealed differential colonization behavior of bacteria with respect to pH gradient and a lower than expected abundance of lactobacilli and streptococci in established carious lesions. The data indicate the numerical importance of relatively unexplored taxa within the lesion of dentinal caries. CLINICAL RELEVANCE: The gradient nature of pH in the lesion as well as colonization difference of examined bacterial taxa with reference to pH provides a new insight in regard to conservative caries management.

A sensitivity analysis of the Children's Treatment Network trial: a randomized controlled trial of integrated services versus usual care for children with special health care needs.

BACKGROUND: The value of integrated care through comprehensive, coordinated, and family-centered services has been increasingly recognized for improving health outcomes of children with special health care needs (CSHCN). In a randomized controlled trial (RCT), the integrated care provided through the Children's Treatment Network (CTN) was compared with usual care in improving the psychosocial health of target CSHCN. In this paper, we aimed to estimate the effect of CTN care by conducting multiple analyses to handle noncompliance in the trial. METHODS: The trial recruited target children in Simcoe County and York Region, ON, Canada. Children were randomized to receive CTN or usual care and were followed for 2 years. The CTN group received integrated services through multiple providers to address their specific needs while the usual care group continued to receive care directed by their parents. The outcome was change in psychosocial quality of life at 2 years. We conducted intention-to-treat, as-treated, per-protocol, and instrumental variable analyses to analyze the outcome. RESULTS: The trial randomized 445 children, with 229 in the intervention group and 216 in the control group. During follow-up, 52% of children in the intervention group did not receive complete CTN care for various reasons. At 2 years, we did not find a significant improvement in psychosocial quality of life among the children receiving CTN care compared with usual care (intention-to-treat mean difference 1.50, 95% confidence interval -1.49 to 4.50; P = 0.32). Other methods of analysis yielded similar results. CONCLUSION: Although the effect of CTN care was not significant, there was evidence showing benefits of integrated care for CSHCN. More RCTs are needed to demonstrate the magnitude of such an effect. The CTN study highlights the key challenges in RCTs when assessing interventions involving integrated care, and informs further RCTs including similar evaluations.

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

BACKGROUND: Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. METHODS/DESIGN: A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. DISCUSSION: Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01876173.

Up against the System: A Case Study of Young Adult Perspectives Transitioning from Pediatric Palliative Care.

Advances in pediatric care have not provided the interdisciplinary support services required by those young adults with pediatric life-threatening conditions (pedLTCs) who live beyond childhood but have limited expectations to live past early adulthood. These young adults, the first generation to live into adulthood, face multiple challenges transitioning from a plethora of pediatric palliative services to scant adult health services. In a case study, using an innovative bulletin board focus group, we describe the complex interplay of the health, education, and social service sectors in this transition. Our descriptions include system deficits and strengths and the young adults' resilience and coping strategies to overcome those deficits and move forward with their lives. Young adults with pedLTC need knowledgeable providers, coordinated and accessible services, being respected and valued, and services and supports that promote independence. We recommend implementation of multidisciplinary solutions that are focused on young adult priorities to ensure seamless access to resources to support these young adults' health, educational, vocational, and social goals. The input and voice of young adults in the development of these services are imperative to ensure that multisystem services support their needs and life goals.

Nurse-led health promotion interventions improve quality of life in frail older home care clients: lessons learned from three randomized trials in Ontario, Canada.

OBJECTIVE: This paper explores the lessons learned from a series of three randomized controlled trials that included 498 community-living frail older adults (≥65 years) using home care services in Southern Ontario, Canada. Each study was designed to evaluate the effectiveness of different multi-component nurse-led health promotion and disease prevention (HPDP) interventions. METHODS: The nurse-led HPDP interventions were 6- or 12-month multi-component and evidence-based strategies targeting known risk factors for functional decline and frailty. Across the three studies, a common approach was used to measure the change in health-related quality of life (HRQOL) (SF-36) and the costs of use of health services (Health and Social Services Utilization Inventory) from baseline to the end of the intervention. RESULTS: The main lesson learned from the three studies is that nurse-led HPDP interventions for frail older home care clients provide greater improvements in HRQOL compared with usual home care. Such approaches are highly acceptable to this population and can be implemented using existing home care resources. Nurse-led HPDP interventions should include multiple home visits, multidimensional screening and assessment, multi-component evidence-based HPDP strategies, intensive case management, inter-professional collaboration, providers with geriatric training and experience, referral to and coordination of community services, and theory use. CONCLUSION: The results of the three trials underscore the need to reinvest in nurse-led HPDP interventions in home care to optimize HRQOL and promote ageing in place in the target population of frail older adults. More studies are needed to evaluate the effectiveness of additional nurse-led HPDP interventions in other contexts and settings.

Direct health care costs of treating seasonal affective disorder: a comparison of light therapy and fluoxetine.

Objective. To compare the direct mental health care costs between individuals with Seasonal Affective Disorder randomized to either fluoxetine or light therapy. Methods. Data from the CANSAD study was used. CANSAD was an 8-week multicentre double-blind study that randomized participants to receive either light therapy plus placebo capsules or placebo light therapy plus fluoxetine. Participants were aged 18-65 who met criteria for major depressive episodes with a seasonal (winter) pattern. Mental health care service use was collected for each subject for 4 weeks prior to the start of treatment and for 4 weeks prior to the end of treatment. All direct mental health care services costs were analysed, including inpatient and outpatient services, investigations, and medications. Results. The difference in mental health costs was significantly higher after treatment for the light therapy group compared to the medication group-a difference of $111.25 (z = -3.77, P = 0.000). However, when the amortized cost of the light box was taken into the account, the groups were switched with the fluoxetine group incurring greater direct care costs-a difference of $75.41 (z = -2.635, P = 0.008). Conclusion. The results suggest that individuals treated with medication had significantly less mental health care cost after-treatment compared to those treated with light therapy.