Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment : A Systematic Review of the Literature.

Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.Peer reviewedFinal Published versio

Health service changes to address diabetes in pregnancy in a complex setting: perspectives of health professionals

Background: Australian Aboriginal and Torres Strait Islander women have high rates of gestational and pre-existing type 2 diabetes in pregnancy. The Northern Territory (NT) Diabetes in Pregnancy Partnership was established to enhance systems and services to improve health outcomes. It has three arms: a clinical register, developing models of care and a longitudinal birth cohort. This study used a process evaluation to report on health professional's perceptions of models of care and related quality improvement activities since the implementation of the Partnership. Methods: Changes to models of care were documented according to goals and aims of the Partnership and reviewed annually by the Partnership Steering group. A 'systems assessment tool' was used to guide six focus groups (49 healthcare professionals). Transcripts were coded and analysed according to pre-identified themes of orientation and guidelines, education, communication, logistics and access, and information technology. Results: Key improvements since implementation of the Partnership include: health professional relationships, communication and education; and integration of quality improvement activities. Focus groups with 49 health professionals provided in depth information about how these activities have impacted their practice and models of care for diabetes in pregnancy. Co-ordination of care was reported to have improved, however it was also identified as an opportunity for further development. Recommendations included a central care coordinator, better integration of information technology systems and ongoing comprehensive quality improvement processes. Conclusions: The Partnership has facilitated quality improvement through supporting the development of improved systems that enhance models of care. Persisting challenges exist for delivering care to a high risk population however improvements in formal processes and structures, as demonstrated in this work thus far, play an important role in work towards improving health outcomes.R. Kirkham, J.A. Boyle, C. Whitbread, M. Dowden, C. Connors, S. Corpus, L. McCarthy, J. Oats, H.D. McIntyre, E. Moore, K. O’Dea, A. Brown, L. Maple-Brown (On behalf of the NT Diabetes in Pregnancy Partnership

"The Right Way at the Right Time": Insights on the Uptake of Falls Prevention Strategies from People with Dementia and Their Caregivers.

Strong evidence exists for effective falls prevention strategies for community-dwelling older people. Understanding the translation of these strategies into practice for people with dementia has had limited research focus. People with dementia desire to have their voice heard, to engage meaningfully in the health-care decision-making process, making it a priority for researchers and practitioners to better understand how to engage them in this process. This paper reports on the qualitative aspects of a series of studies, which aimed to identify the views of people with dementia and their caregivers regarding perceptions of falls prevention and the successes and challenges of adopting falls prevention strategies. Twenty five people with dementia and their caregivers were interviewed in their homes at baseline, and 24 caregivers and 16 people with dementia were interviewed at completion of a 6-month individualized falls prevention intervention. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed. Five themes were identified at baseline: perceptions of falls; caregivers navigating the new and the unpredictable; recognition of decline; health services - the need for an appropriate message; and negotiating respectful relationships. At 6?months, caregivers and people with dementia decided on "what we need to know" with firm views that the information regarding falls risk reduction needed to be in "the right way?…?at the right time." Rather than caregivers and people with dementia being only recipients of knowledge, they felt they were "more than just empty vessels to be filled" drawing on a "variety of resources" within their circle of influence to be able to positively "adapt to change." The voices of people with dementia and their caregivers add an important dimension to understanding the translation of falls prevention knowledge for this population. Insights from this study will enable community care health professionals to understand that people with dementia and their caregivers can, and wish to, contribute to implementing falls prevention strategies through their resourcefulness and inclusion in the therapeutic partnership

Original XPCTM Effect on Salmonella Typhimurium and Cecal Microbiota from Three Different Ages of Broiler Chickens When Incubated in an Anaerobic In Vitro Culture System

Feed supplements are utilized in the poultry industry as a means for improving growth performance and reducing pathogens. The aim of the present study was to evaluate the effects of Diamond V Original XPCTM (XPC, a fermented product generated from yeast cultures) on Salmonella Typhimurium ST 97 along with its potential for modulation of the cecal microbiota by using an anaerobic in vitro mixed culture assay. Cecal slurries obtained from three broiler chickens at each of three sampling ages (14, 28, and 42 days) were generated and exposed to a 24 h pre-incubation period with the various treatments: XPC (1% XPC, ceca, and feeds), CO (ceca only), and NC (negative control) group consisting of ceca and feeds. The XPC, CO, and NC were each challenged with S. Typhimurium and subsequently plated on selective media at 0, 24, and 48 h. Plating results indicated that the XPC treatment significantly reduced the survival of S. Typhimurium at the 24 h plating time point for both the 28 and 42 days bird sampling ages, while S. Typhimurium reduction in the NC appeared to eventually reach the same population survival level at the 48 h plating time point. For microbiome analysis, Trial 1 revealed that XPC, CO, and NC groups exhibited a similar pattern of taxa summary. However, more Bacteroidetes were observed in the CO group at 24 and 48 h. There were no significant differences (P > 0.05) in alpha diversity among samples based on day, hour and treatment. For beta diversity analysis, a pattern shift was observed when samples clustered according to sampling hour. In Trial 2, both XPC and NC groups exhibited the highest Firmicutes level at 0 h but the Bacteroidetes group became dominant at 6 h. Complexity of alpha diversity was increased in the initial contents from older birds and became less complex after 6 h of incubation. Beta diversity analysis was clustered as a function of treatment NC and XPC groups and by individual hours including 6, 12, 24, and 48 h. Overall, addition of XPC influenced microbiome diversity in a similar fashion to the profile of the NC group

Preconception care of women with diabetes: a review of current guideline recommendations

<p>Abstract</p> <p>Background</p> <p>The prevalence of type 2 diabetes mellitus (T2DM) continues to rise worldwide. More women from developing countries who are in the reproductive age group have diabetes resulting in more pregnancies complicated by T2DM, and placing both mother and foetus at higher risk. Management of these risks is best achieved through comprehensive preconception care and glycaemic control, both prior to, and during pregnancy. The aim of this review was to compare the quality and content of current guidelines concerned with the preconception care of women with diabetes and to develop a summary of recommendations to assist in the management of diabetic women contemplating pregnancy.</p> <p>Methods</p> <p>Relevant clinical guidelines were identified through a search of several databases (MEDLINE, SCOPUS and The Cochrane Library) and relevant websites. Five guidelines were identified. Each guideline was assessed for quality using the AGREE instrument. Guideline recommendations were extracted, compared and contrasted.</p> <p>Results</p> <p>All guidelines were assessed as being of high quality and strongly recommended for use in practice. All were consistent in counselling about the risk of congenital malformation related to uncontrolled blood sugar preconceptionally, ensuring adequate contraception until glycaemic control is achieved, use of HBA1C to monitor metabolic control, when to commence insulin and switching from ACE inhibitors to other antihypertensives. Major differences were in the targets recommended for optimal metabolic control and opinion regarding the usage of metformin as an adjunct or alternative treatment before or during pregnancy.</p> <p>Conclusions</p> <p>International guidelines for the care of women with diabetes who are contemplating pregnancy are consistent in their recommendations; however some are more comprehensive than others. Having established current standards for the preconception care of diabetic women, there is now a need to focus on guideline implementation through an examination of the barriers and enablers to successful implementation, and the applicability of the recommendations in the local setting.</p

Antarctic ecosystems in transition – life between stresses and opportunities

Important findings from the second decade of the 21st century on the impact of environmental change on biological processes in the Antarctic were synthesised by 26 international experts. Ten key messages emerged that have stakeholder-relevance and/or a high impact for the scientific community. They address (i) altered biogeochemical cycles, (ii) ocean acidification, (iii) climate change hotspots, (iv) unexpected dynamism in seabed-dwelling populations, (v) spatial range shifts, (vi) adaptation and thermal resilience, (vii) sea ice related biological fluctuations, (viii) pollution, (ix) endangered terrestrial endemism and (x) the discovery of unknown habitats. Most Antarctic biotas are exposed to multiple stresses and considered vulnerable to environmental change due to narrow tolerance ranges, rapid change, projected circumpolar impacts, low potential for timely genetic adaptation, and migration barriers. Important ecosystem functions, such as primary production and energy transfer between trophic levels, have already changed, and biodiversity patterns have shifted. A confidence assessment of the degree of 'scientific understanding' revealed an intermediate level for most of the more detailed sub-messages, indicating that process-oriented research has been successful in the past decade. Additional efforts are necessary, however, to achieve the level of robustness in scientific knowledge that is required to inform protection measures of the unique Antarctic terrestrial and marine ecosystems, and their contributions to global biodiversity and ecosystem services