Perceptions of a service redesign by adults living with type 2 diabetes

<b>Aim:</b> This article is a report of a study conducted to explore the perceptions of adults with type 2 diabetes towards the service redesign. <b>Background:</b> Diabetes is reaching epidemic proportions and the management of this chronic illness is changing in response to this challenge. In the United Kingdom, there is ongoing restructuring of healthcare services for people with chronic illnesses to ensure that their general health and clinical needs are met predominantly in primary care. <b>Method:</b> An explorative qualitative approach was used. Eight focus groups were conducted with 35 people with type 2 diabetes in one urban location between 2003 and 2004. Five focus groups were conducted with people who had recently experienced the restructured service and three groups with people who had up to 2 years' experience of the new service. Concurrent data collection and thematic analysis were conducted by three researchers and credibility and verification sought by feedback to participants. <b>Findings:</b> Five main themes were identified: impact of living with diabetes; understanding diabetes; drivers for organizational change; care in context and individual concerns. Participants identified issues for ongoing development of the service. <b>Conclusion:</b> People with type 2 diabetes appreciate their care management within the primary care setting where there has been investment in staff to deliver this care. Healthcare resources are required to support the development of staff and the necessary infrastructure to undertake management in primary care. Policy makers need to address the balance of resources between primary and secondary care

Should Canada adopt managed access agreements in Canada for expensive drugs?

Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement decision models and frameworks, such as managed access agreements (MAAs), may address this decision challenge. Here, we provide a comprehensive overview of the legal limitations, considerations, and implications for adopting MAAs in Canadian jurisdictions. We begin with an overview of current drug reimbursement processes in Canada, terminology and definitions of the different types of MAAs, and select international experiences with MAAs. We discuss the legal barriers to MAA governance frameworks, design and implementation considerations, and legal and policy implications of MAAs. Finally, we provide recommendations to guide policy development for implementing MAAs in Canada, based on existing literature, international experience, and our legal analysis. We conclude that legal and policy barriers likely prevent the adoption of a pan-Canadian MAA governance framework. More feasible is a quasi-federal or provincial approach, building on existing infrastructure

Conditional drug approval as a path to market for oncology drugs in Canada: Challenges and recommendations for assessing eligibility and regulatory responsiveness

International drug regulators use conditional drug approval mechanisms to facilitate faster patient access to drugs based on a lower evidentiary standard typically required of drug approvals. Faster and earlier access is justified by limiting eligibility to drugs intended for serious and life-threatening diseases and by requiring post-market evidence collection to confirm clinical benefit. One such mechanism in Canada, the Notice of Compliance with Conditions (NOC/c) policy, was introduced in 1998. Today, most of the drugs approved under the NOC/c policy are for oncology indications. We analyze oncology drugs approvals under the NOC/c policy to inform discussions of two tradeoffs applied to conditional drug approvals, eligibility criteria and post-market evidence. Our analysis informs recommendations for Canada\u27s proposed regulatory reforms approach to conditional approvals pathways. Our analysis demonstrates that under the current policy, eligibility criteria are insufficiently defined, resulting in their inconsistent application by Health Canada. Regulatory responsiveness to post-market evidence from post-market clinical trial and foreign jurisdiction regulatory decisions is slow and insufficient. In the absence of sufficient regulatory responsiveness, physicians and patients must make clinical decisions without the benefit of the best available evidence. Together, our analysis of the two core tradeoffs in Canada\u27s conditional drug approval provides insight to inform the further development of Canada\u27s proposed agile regulatory approach to drugs and devices that will expand the use of terms and conditions

Frequency of a very brief intervention by physiotherapists to increase physical activity levels in adults:A pilot randomised controlled trial

Background: There is evidence that brief physical activity interventions by health professionals can increase physical activity levels. In addition, there is some evidence that simply measuring physical activity alone can increase physical activity behaviour. However, preliminary work is required to determine the effects of potential measurement frequency. The aim of this pilot study was to examine whether frequency of physical activity measurement, with very brief advice from a physiotherapist, influenced objectively measured physical activity in insufficiently active adults. Methods: Using concealed allocation and blinded assessments, eligible participants (n = 40) were randomised to a lower-measurement-frequency (baseline and 18-weeks) or higher-measurement-frequency group (baseline, 6, 12 and 18-weeks). The primary outcome was daily minutes of moderate-to-vigorous physical activity (accelerometry). Secondary outcomes included functional aerobic capacity (STEP tool), quality-of-life (AQoL-6D), body mass index, waist circumference, waist-to-hip ratio and blood pressure. Results: Between-group comparisons were not significant in intention-to-treat analyses. However, there was a trend for the higher-measurement-frequency group to complete more daily minutes of moderate-to-vigorous physical activity at 18-weeks (mean difference 19.6 vs - 11.9 mins/week, p = 0.084), with a medium effect size (Cohen's d = 0.58). This was significant in per-protocol analysis (p = 0.049, Cohen's d = 0.77). Within-group comparisons indicated both groups increased their aerobic fitness (p ≤ 0.01), but only the higher-measurement-frequency group decreased their waist circumference (mean decrease 2.3 cm, 95%CI 0.3-4.3, p = 0.024), diastolic blood pressure (mean decrease 3.4 mmHg, 95%CI 0.03-6.8, p = 0.048) and improved their quality-of-life for independent living (mean increase 3.3, 95%CI 0.2-6.4, p = 0.031). Conclusion: Very brief physical activity interventions by physiotherapists may be an efficient approach to increase physical activity in community-dwelling adults. A larger trial is warranted. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000566437, http://www.ANZCTR.org.au/ACTRN12616000566437.aspx, registered 2 May 2016.</p

A field experience of mass percutaneous BCG inoculation as an immunizing and diagnostic procedure: Follow-up phase

No Abstract

A field experience of mass percutaneous BCG inoculation as an immunizing and diagnostic procedure

No Abstract

LptO (PG0027) is required for lipid A 1-phosphatase activity in Porphyromonas gingivalis W50

ABSTRACT Porphyromonas gingivalis produces outer membrane vesicles (OMVs) rich in virulence factors, including cysteine proteases and A-LPS, one of the two lipopolysaccharides (LPSs) produced by this organism. Previous studies had suggested that A-LPS and PG0027, an outer membrane (OM) protein, may be involved in OMV formation. Their roles in this process were examined by using W50 parent and the Δ PG0027 mutant strains. Inactivation of PG0027 caused a reduction in the yield of OMVs. Lipid A from cells and OMVs of P. gingivalis W50 and the Δ PG0027 mutant strains were analyzed by matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS). Lipid A from W50 cells contained bis-P-pentaacyl, mono-P-pentaacyl, mono-P-tetraacyl, non-P-pentaacyl, and non-P-tetraacyl species, whereas lipid A from Δ PG0027 mutant cells contained only phosphorylated species; nonphosphorylated species were absent. MALDI-TOF/TOF tandem MS of mono-P-pentaacyl ( m / z 1,688) and mono-P-tetraacyl ( m / z 1,448) lipid A from Δ PG0027 showed that both contained lipid A 1-phosphate, suggesting that the Δ PG0027 mutant strain lacked lipid A 1-phosphatase activity. The total phosphatase activities in the W50 and the Δ PG0027 mutant strains were similar, whereas the phosphatase activity in the periplasm of the Δ PG0027 mutant was lower than that in W50, supporting a role for PG0027 in lipid A dephosphorylation. W50 OMVs were enriched in A-LPS, and its lipid A did not contain nonphosphorylated species, whereas lipid A from the Δ PG0027 mutant (OMVs and cells) contained similar species. Thus, OMVs in P. gingivalis are apparently formed in regions of the OM enriched in A-LPS devoid of nonphosphorylated lipid A. Conversely, dephosphorylation of lipid A through a PG0027-dependent process is required for optimal formation of OMVs. Hence, the relative proportions of nonphosphorylated and phosphorylated lipid A appear to be crucial for OMV formation in this organism. IMPORTANCE Gram-negative bacteria produce outer membrane vesicles (OMVs) by “blebbing” of the outer membrane (OM). OMVs can be used offensively as delivery systems for virulence factors and defensively to aid in the colonization of a host and in the survival of the bacterium in hostile environments. Earlier studies using the oral anaerobe Porphyromonas gingivalis as a model organism to study the mechanism of OMV formation suggested that the OM protein PG0027 and one of the two lipopolysaccharides (LPSs) synthesized by this organism, namely, A-LPS, played important roles in OMV formation. We suggest a novel mechanism of OMV formation in P. gingivalis involving dephosphorylation of lipid A of A-LPS controlled/regulated by PG0027, which causes destabilization of the OM, resulting in blebbing and generation of OMVs. </jats:p

Exercise is delayed in critically ill patients: a five year observational study in an Australian tertiary intensive care unit

Duration of bed rest among critically ill patients in ICU has been associated with development of persistent weakness that can last for more than five years. Commencing early exercise interventions in ICU is likely to reduce critically ill patients’ physical dysfunction. However, critically ill patients often experience prolonged periods of bed rest and inactivity. This study examined the timing of commencement of exercise interventions, including sitting out of bed and upright mobilisation, following physiological stability in critically ill patients and describes key clinical outcomes. Participants included consecutive patients admitted for >48 hours to a 25-bed Australian mixed medical and surgical adult ICU between July 2009 and June 2014. Time taken for patients to achieve neurological, cardiorespiratory and cardiovascular (physiological) stability was calculated and timing of initial sitting out of bed and upright mobilisation was recorded. A small number of patients (n=206, 6.0%) did not achieve physiological stability. A substantial proportion of patients (n=1377, 40.1%) did not complete any mobilisation or sitting activities. For patients (n=1851, 53.9%) who did undertake mobilisation or sitting activities, activity commenced a median (IQR) of 3.6 (2.0, 7.7) days after ICU admission. This represented a median (IQR) delay after physiological stability of 2.3 (1.3, 4.4) days for mobilisation and 2.7 (1.5, 5.7) days for sitting. In-hospital mortality was 14.3% (n=491) for patients who did not participate in exercise interventions, compared to 2.6% (n=89) for patients who exercised whilst in ICU