Hormone therapy, health outcomes and the role of nutrition in transgender individuals: A scoping review.

OBJECTIVE: The objective of this scoping review is to describe the extent, range, and nature of available literature examining nutrition-related intermediate and long-term health outcomes in individuals who are transgender. Specific sub-topics examined include 1) dietary intake, 2) nutrition-related health disparities, 3) validity and reliability of nutrition assessment methods, 4) the effects of nutrition interventions/exposures, and 5) hormone therapy. METHODS: A literature search was conducted using MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, and other databases for peer-reviewed articles published from January 1999 until December 5, 2019 to identify studies addressing the research objective and meeting eligibility criteria. Conference abstracts and registered trials published or registered in the five years prior to the search were also included. Findings were reported in a study characteristics table, a bubble chart and heat maps. RESULTS: The search of the databases identified 5403 studies, including full peer-reviewed studies, systematic reviews, conference abstracts and registered trials. Following title/abstract screening, 189 studies were included in the narrative analysis. Ten studies reported dietary intake in transgender individuals, 64 studies reported nutrition-related health disparities in transgender compared to cisgender individuals, one study examined validity and reliability of nutrition assessment methods, two studies reported nutrition interventions, and 127 studies reported on the intermediate and health effects of hormone therapy. CONCLUSION: Individuals who are transgender have unique nutrition needs, which may vary according to the stage and type of gender-affirmative therapy that they are undergoing. There is scant research examining effective nutrition therapy methods for nutrition professionals working with transgender individuals. More research is needed in order to inform evidence-based clinical practice guidelines for nutrition practitioners working with transgender individuals.

An efficient, cost-effective method for determining the growth rate of sulfate-reducing bacteria using spectrophotometry.

The use of sulfate reducing bacteria (SRBs) in laboratory studies is a common approach for investigating microbially influenced corrosion (MIC). The characteristic formation of black iron sulfide precipitates during SRB growth, however, preclude the use of traditional spectrophotometric approaches for capturing growth data instead necessitating labour-intensive or technically specialized approaches. As such, an understanding of SRB growth responses to experimental conditions is often missing from MIC studies. Bernardez and de Andrade Lima (2015) have outlined a spectrophotometric approach for estimating SRB cell mass via the addition of HCl. This method has potential for the study SRB growth however its applicability is currently limited by the use of large aliquot volumes (45 mL), which restrict the number of timepoints that can sampled from one culture, and the extensive time devoted to cell preparation prior to OD readings. •We demonstrate an improved method for capturing SRB growth data via spectrophotometry following acidification. We incorporate lower sample volumes and adapt the method described in Bernardez and de Andrade Lima (2015) to a high throughput microtiter plate approach that increases the efficiency of this method and its applicability to growth rate studies.•Our results allay theoretical concerns that acidification may distort growth rate analysis by impacting cells differently depending on their metabolic state.•We further demonstrate that this method (acid-amended OD measurements) is more accurate and far more cost efficient than traditional methods (dilution spread-plate counting) and popular molecular methods (quantitative PCR) currently in use in SRB growth research.

Retrospective cost-effectiveness of the 23-valent pneumococcal polysaccharide vaccination program in Australia.

BACKGROUND: The Australian infant pneumococcal vaccination program was funded in 2005 using the 7-valent pneumococcal conjugate vaccine (PCV7) and the 13-valent conjugate vaccine (PCV13) in 2011. The PCV7 and PCV13 programs resulted in herd immunity effects across all age-groups, including older adults. Coincident with the introduction of the PCV7 program in 2005, 23-valent pneumococcal polysaccharide vaccine (PPV23) was funded for all Australian adults aged over 65 years. METHODS: A multi-cohort Markov model with a cycle length of one year was developed to retrospectively evaluate the cost-effectiveness of the PPV23 immunisation program from 2005 to 2015. The analysis was performed from the healthcare system perspective with costs and quality-adjusted life years discounted at 5% annually. The incremental cost-effectiveness ratio (ICER) for PPV23 doses provided from 2005 to 2015 was calculated separately for each year when compared to no vaccination. Parameter uncertainty was explored using deterministic and probabilistic sensitivity analysis. RESULTS: It was estimated that PPV23 doses given out over the 11-year period from 2005 to 2015 prevented 771 hospitalisations and 99 deaths from invasive pneumococcal disease (IPD). However, the estimated IPD cases and deaths prevented by PPV23 declined by more than 50% over this period (e.g. from 12.9 deaths for doses given out in 2005 to 6.1 in 2015), likely driven by herd effects from infant PCV programs. The estimated ICER over the period 2005 to 2015 was approximately A$224,000/QALY gained compared to no vaccination. When examined per year, the ICER for each individual year worsened from $140,000/QALY in 2005 to $238,000/QALY in 2011 to $286,000/QALY in 2015. CONCLUSION: The cost-effectiveness of the PPV23 program in older Australians was estimated to have worsened over time. It is unlikely to have been cost-effective, unless PPV23 provided protection against non-invasive pneumococcal pneumonia and/or a low vaccine price was negotiated. A key policy priority should be to review of the future use of PPV23 in Australia, which is likely to be more cost-effective in certain high-risk groups.

The role of timeliness in the cost-effectiveness of older adult vaccination: A case study of pneumococcal conjugate vaccine in Australia.

While the impact of the timeliness of vaccine administration has been well-studied for childhood vaccinations, there has been little detailed quantitative analysis on the potential impact of the timeliness of vaccinations in older adults. The aim of this study was to explore the impact of implementing more realistic observed uptake distributions, taking into the account reduced vaccine efficacy but higher pneumococcal disease burden with increasing age beyond 65 years. A multi-cohort Markov model was constructed to evaluate the cost-effectiveness of a pneumococcal (PCV13) immunisation program in Australia, assuming two different uptake modelling approaches. The approach using an estimate of observed uptake was compared with a scenario in which the total cumulative uptake was delivered at the recommended age of vaccination. We found these two approaches produced different results both in terms of cases prevented and cost-effectiveness. The impact of the non-timely uptake in adult programs may sometimes have positive and other times negative effects, depending on several factors including the age-specific disease rates and the duration of vaccine protection. Our study highlights the importance of using realistic assumptions around uptake (including non-timely vaccination) when estimating the impact of vaccination in adults.

Cost-effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) in older Australians.

BACKGROUND: The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been funded under the Australia National Immunisation Program (NIP) since January 2005 for those aged >65years and other risk groups. In 2016, PCV13 was accepted by the Pharmaceutical Benefits Advisory Committee (PBAC) as a replacement for a single dose of PPV23 in older Australian adults. METHODS: A single-cohort deterministic multi-compartment (Markov) model was developed describing the transition of the population between different invasive and non-invasive pneumococcal disease related health states. We applied a healthcare system perspective with costs (Australian dollars, A$) and health effects (measured in quality adjusted life-years, QALYs) attached to model states and discounted at 5% annually. We explored replacement of PPV23 with PCV13 at 65years as well as other age based vaccination strategies. Parameter uncertainty was explored using deterministic and probabilistic sensitivity analysis. RESULTS: In a single cohort, we estimated PCV13 vaccination at the age of 65years to cost ∼A$11,120,000 and prevent 39 hospitalisations and 6 deaths from invasive pneumococcal disease and 180 hospitalisations and 10 deaths from community acquired pneumonia. The PCV13 program had an incremental cost-effectiveness ratio of ∼A$88,100 per QALY gained when compared to a no-vaccination, whereas PPV23 was ∼A$297,200 per QALY gained. To fall under a cost-effectiveness threshold of A$60,000 per QALY, PCV13 would have to be priced below ∼A$46 per dose. The cost-effectiveness of PCV13 in comparison to PPV23 was ∼A$35,300 per QALY gained. CONCLUSION: In comparison to no-vaccination, we found PCV13 use in those aged 65years was unlikely to be cost-effective unless the vaccine price was below A$46 or a longer duration of protection can be established. However, we found that in comparison to the PPV23, vaccination with PCV13 was cost-effective. This partly reflects the poor value for money estimated for PPV23 use in Australia.

Beyond expectations: Post-implementation data shows rotavirus vaccination is likely cost-saving in Australia.

BACKGROUND: Universal vaccination against rotavirus was included in the funded Australian National Immunisation Program in July 2007. Predictive cost-effectiveness models assessed the program before introduction. METHODS: We conducted a retrospective economic evaluation of the Australian rotavirus program using national level post-implementation data on vaccine uptake, before-after measures of program impact and published estimates of excess intussusception cases. These data were used as inputs into a multi-cohort compartmental model which assigned cost and quality of life estimates to relevant health states, adopting a healthcare payer perspective. The primary outcome was discounted cost per quality adjusted life year gained, including or excluding unspecified acute gastroenteritis (AGE) hospitalisations. RESULTS: Relative to the baseline period (1997-2006), over the 6years (2007-2012) after implementation of the rotavirus program, we estimated that ∼77,000 hospitalisations (17,000 coded rotavirus and 60,000 unspecified AGE) and ∼3 deaths were prevented, compared with an estimated excess of 78 cases of intussusception. Approximately 90% of hospitalisations prevented were in children <5years, with evidence of herd protection in older age groups. The program was cost-saving when observed changes (declines) in both hospitalisations coded as rotavirus and as unspecified AGE were attributed to the rotavirus vaccine program. The adverse impact of estimated excess cases of intussusception was far outweighed by the benefits of the program. CONCLUSION: The inclusion of herd impact and declines in unspecified AGE hospitalisations resulted in the value for money achieved by the Australian rotavirus immunisation program being substantially greater than predicted bypre-implementation models, despite the potential increased cases of intussusception. This Australian experience is likely to be relevant to high-income countries yet to implement rotavirus vaccination programs.

Retrospective economic evaluation of childhood 7-valent pneumococcal conjugate vaccination in Australia: Uncertain herd impact on pneumonia critical.

BACKGROUND: Retrospective cost-effectiveness analyses of vaccination programs using routinely collected post-implementation data are sparse by comparison with pre-program analyses. We performed a retrospective economic evaluation of the childhood 7-valent pneumococcal conjugate vaccine (PCV7) program in Australia. METHODS: We developed a deterministic multi-compartment model that describes health states related to invasive and non-invasive pneumococcal disease. Costs (Australian dollars, A$) and health effects (quality-adjusted life years, QALYs) were attached to model states. The perspective for costs was that of the healthcare system and government. Where possible, we used observed changes in the disease rates from national surveillance and healthcare databases to estimate the impact of the PCV7 program (2005-2010). We stratified our cost-effectiveness results into alternative scenarios which differed by the outcome states included. Parameter uncertainty was explored using probabilistic sensitivity analysis. RESULTS: The PCV7 program was estimated to have prevented ∼5900 hospitalisations and ∼160 deaths from invasive pneumococcal disease (IPD). Approximately half of these were prevented in adults via herd protection. The incremental cost-effectiveness ratio was ∼A$161,000 per QALY gained when including only IPD-related outcomes. The cost-effectiveness of PCV7 remained in the range A$88,000-$122,000 when changes in various non-invasive disease states were included. The inclusion of observed changes in adult non-invasive pneumonia deaths substantially improved cost-effectiveness (∼A$9000 per QALY gained). CONCLUSION: Using the initial vaccine price negotiated for Australia, the PCV7 program was unlikely to have been cost-effective (at conventional thresholds) unless observed reductions in non-invasive pneumonia deaths in the elderly are attributed to it. Further analyses are required to explore this finding, which has significant implications for the incremental benefit achievable by adult PCV programs.

A review of economic evaluations of 13-valent pneumococcal conjugate vaccine (PCV13) in adults and the elderly.

The 13-valent pneumococcal conjugated vaccine (PCV13) is already recommended for some adult groups and is being considered for wider use in many countries. In order to identify the strengths and limitations of the existing economic evaluation studies of PCV13 in adults and the elderly a literature review was conducted. The majority of the studies identified (9 out of 10) found that PCV13 was cost-effective in adults and/or the elderly. However, these results were based on assumptions that could not always be informed by robust evidence. Key uncertainties included the efficacy of PCV13 against non-invasive pneumonia and the herd immunity effect of childhood vaccination programs. Emerging trial evidence on PCV13 in adults from the Netherlands offers the ability to parameterize future economic evaluations with empirical efficacy data. However, it is important that these estimates are used thoughtfully when they are transferred to other settings.

Control of varicella in the post-vaccination era in Australia: a model-based assessment of catch-up and infant vaccination strategies for the future.

In Australia, varicella vaccine was universally funded in late 2005 as a single dose at 18 months. A school-based catch-up programme for children aged 10-13 years without a history of infection or vaccination was funded until 2015, when those eligible for universal infant vaccination would have reached the age of high school entry. This study projects the impact of discontinuing catch-up vaccination on varicella and zoster incidence and morbidity using a transmission dynamic model, in comparison with alternative policy options, including two-dose strategies. At current vaccine coverage (83% at 2 years and 90% at 5 years), ceasing the adolescent catch-up programme in 2015 was projected to increase varicella-associated morbidity between 2035 and 2050 by 39%. Although two-dose infant programmes had the lowest estimated varicella morbidity, the incremental benefit from the second dose fell by 70% if first dose coverage increased from 83% to 95% by age 24 months. Overall zoster morbidity was predicted to rise after vaccination, but differences between strategies were small. Our results suggest that feasibility of one-dose coverage approaching 95% is an important consideration in estimating incremental benefit from a second dose of varicella vaccine.

Participatory methods for the assessment of the ownership status of free-roaming dogs in Bali, Indonesia, for disease control and animal welfare.

The existence of unowned, free-roaming dogs capable of maintaining adequate body condition without direct human oversight has serious implications for disease control and animal welfare, including reducing effective vaccination coverage against rabies through limiting access for vaccination, and absolving humans from the responsibility of providing adequate care for a domesticated species. Mark-recapture methods previously used to estimate the fraction of unowned dogs in free-roaming populations have limitations, particularly when most of the dogs are owned. We used participatory methods, described as Participatory Rural Appraisal (PRA), as a novel alternative to mark-recapture methods in two villages in Bali, Indonesia. PRA was implemented at the banjar (or sub-village)-level to obtain consensus on the food sources of the free-roaming dogs. Specific methods included semi-structured discussion, visualisation tools and ranking. The PRA results agreed with the preceding household surveys and direct observations, designed to evaluate the same variables, and confirmed that a population of unowned, free-roaming dogs in sufficiently good condition to be sustained independently of direct human support was unlikely to exist.

Economic evaluations of implemented vaccination programmes: key methodological challenges in retrospective analyses.

Post-implementation evaluation should play an important role in assessing the success of public health programmes; however, the value for money achieved by vaccine programmes after introduction has received relatively little attention to date. In this article we explore the methodological challenges in these analyses and offer direction for future evaluations in the area. We identify alternative approaches to addressing these challenges, which include the estimation of disease changes attributable to vaccination efforts, the hypothetical no vaccination comparator scenario and the full benefit achieved by implemented vaccination programmes. We also outline other important considerations such as the evolution of prices over time. Further work needs to be done to explore these issues and to determine how the application of different approaches may impact on the results of evaluations in various circumstances. As retrospective analyses are likely to become more frequent and influential, it is important that both the benefits and the limitations of post-implementation evaluations are recognised and understood. We argue that it would be useful to establish a methodological framework to provide standards and guidance on how to undertake such analyses in the future.

Sleep and activity monitoring for Returning Soldier Adjustment Assessment.

This paper describes the development of unobtrusive room sensors to discover relationships between sleep quality and the clinical assessments of combat soldiers suffering from post-traumatic stress disorder (PTSD) and mild traumatic brain injury (TBI). We consider the use of a remote room sensor unit composed of a Doppler radar, light, sound and other room environment sensors. We also employ an actigraphy watch. We discuss sensor implementation, radar data analytics and preliminary results using real data from a Warrior Transition Battalion located in Fort Gordon, GA. Two radar analytical approaches are developed and compared against the actigraphy watch estimates--one, emphasizing system knowledge; and the other, clustering on several radar signal features. The radar analytic algorithms are able to estimate sleep periods, signal absence and restlessness in the bed. In our test cases, the radar estimates are shown to agree with the actigraphy watch. PTSD and mild-TBI soldiers do often show signs of sporadic and restless sleep. Ongoing research results are expected to provide further insight.

Comparison of heating methods and the use of different tissues for sensory assessment of abnormal odours (boar taint) in pig meat.

Five heating methods (microwave, hotwire, boiling at 25 °C and 75 °C and melting) were used to generate cooking odours from backfat of entire male pigs and a 'composite' sample consisting of fat and muscle from the head along with salivary glands. The methods elicited significantly different scores for odours from 4 groups of 10 samples differing in their concentrations and ratios of skatole and androstenone. The odours (pork odour, abnormal odour, skatole odour and androstenone odour) were assessed by 3 experienced assessors. Correlations between skatole and androstenone concentrations and abnormal odour score in backfat were higher for skatole, suggesting it is the more important boar taint compound. In the composite sample, androstenone concentration was much higher than in backfat and androstenone was a more important contributor to boar taint. The microwave, hotwire and boiling (75 °C) methods produced the clearest separation between samples and the microwave method was considered the most suitable for on-line use.

CUSUM charts for monitoring clinical practice quality using primary care prescribing data: a case study of an initiative to encourage generic prescribing of proton pump inhibitors.

WHAT IS KNOWN AND OBJECTIVE: Expectations on organizations to monitor quality of care are growing. Whilst relevant data are increasingly becoming available it is, in many cases, difficult to distinguish real effects from background variation. Here, the potential usefulness of cumulative sum (CUSUM) charts for monitoring the use of medicines is explored through a case study of an initiative to encourage the prescribing of lowest cost proton pump inhibitors (PPI) in the context of implementation of national guidelines for the management of dyspepsia. METHODS: This was a longitudinal study involving analysis of routinely collected prescribing data, set in all 12 primary care trusts (PCT) in the North East Strategic Health Authority. In it, comparison (by subtraction) of the time-series of the percentage of generic PPI prescription items for Gateshead with the mean of the other 11 PCTs was used to reduce both variation and bias. This was followed by the construction of a CUSUM chart displaying the effect of the Gateshead initiative. RESULTS AND DISCUSSION: The simple process of comparison was very successful both in removing extraneous trends and reducing background variation, and the CUSUM highly effective for displaying the evidence for the hypothesized step-change in prescribing behaviour consequent on the Gateshead initiative. The effectiveness of the CUSUM here is strongly linked to the success of the preliminary comparison step. WHAT IS NEW AND CONCLUSION: CUSUM, a statistical process control technique, has already been tested as a tool for interpreting hospital and general practice mortality rates. Here, its potential for more general applications in quality monitoring is demonstrated using routinely collected prescribing data. Such data contain valuable information about changes in clinical practice and CUSUM charts, when coupled with the idea of removing time trends and extraneous variation by reference to average behaviour, can provide a simple but effective technique for extracting it.

Continuous remote vital sign/environment monitoring for returning soldier adjustment assessment.

A three-stage study to develop and test an unobtrusive room sensor unit and subject data management system to discover correlation between sensor-based time-series measurements of sleep quality and clinical assessments of combat veterans suffering from Post-traumatic Stress Disorder (PTSD) and mild Traumatic Brain Injury (TBI), is described. Experiments and results for testing sensitivity and robustness of the sensor unit and data management protocol are provided. The current sensitivity of remote vital sign monitoring system is below 20% and 10% for respiration and heart rates, respectively.

What factors predict differences in infant and perinatal mortality in primary care trusts in England? A prognostic model.

OBJECTIVE: To identify predictors of perinatal and infant mortality variations between primary care trusts (PCTs) and identify outlier trusts where outcomes were worse than expected. DESIGN: Prognostic multivariable mixed models attempting to explain observed variability between PCTs in perinatal and infant mortality. We used these predictive models to identify PCTs with higher than expected rates of either outcome. SETTING: All primary care trusts in England. Population For each PCT, data on the number of infant and perinatal deaths, ethnicity, deprivation, maternal age, PCT spending on maternal services, and "Spearhead" status. MAIN OUTCOME MEASURES: Rates of perinatal and infant mortality across PCTs. RESULTS: The final models for infant mortality and perinatal mortality included measures of deprivation, ethnicity, and maternal age. The final model for infant mortality explained 70% of the observed heterogeneity in outcome between PCTs. The final model for perinatal mortality explained 80.5% of the between-PCT heterogeneity. PCT spending on maternal services did not explain differences in observed events. Two PCTs had higher than expected rates of perinatal mortality. CONCLUSIONS: Social deprivation, ethnicity, and maternal age are important predictors of infant and perinatal mortality. Spearhead PCTs are performing in line with expectations given their levels of deprivation, ethnicity, and maternal age. Higher spending on maternity services using the current configuration of services may not reduce rates of infant and perinatal mortality.

Ultrasonographic assessment of the superficial digital flexor tendons of National Hunt racehorses in training over two racing seasons.

REASONS FOR PERFORMING STUDY: It is important to ascertain the prevalence of superficial digital flexor tendon (SDFT) injuries and to improve methods of predicting injury in National Hunt (NH) racehorses. OBJECTIVES: To establish: 1) the prevalence of SDFT tendinopathy in NH horses; 2) whether routine ultrasonography can be used to predict SDFT injuries; 3) whether previous tendinopathy predisposes to reinjury; 4) a normal range for the SDFT cross-sectional area (CSA); and 5) the effects of gender, age, background (ex-flat or ex-store), limb, training and rest periods on SDFT CSA. METHODS: Routine ultrasound assessment of the palmar metacarpal soft tissues of 263 NH racehorses was performed on up to 6 occasions over 2 NH racing seasons. RESULTS: The prevalence of SDFT pathology detected using ultrasonography was 24% (n = 148), with a nonsignificant variation between yards of 10-40%. No changes in SDFT CSA or ultrasonographic appearance were detected prior to injury. Older horses had a significantly higher prevalence of SDFT pathology compared to younger horses, and horses with tendinopathy were more likely to suffer an acute injury compared to horses with no evidence of pathology. A reference range for normal CSA measurements was established as 77-139 mm2 at level 4, from 142 horses with no ultrasonographic evidence of SDFT pathology. The CSA of normal horses did not vary significantly with age, limb or over 2 racing seasons, but did with sex and background. CONCLUSIONS: The study confirms that SDFT tendinopathy is common in NH horses, with substantial variation between training yards. Ultrasonography at 3 month intervals did not seem to predict acute SDFT injuries. POTENTIAL RELEVANCE: Variation in the prevalence of tendinopathy between yards suggests that training methods may influence injury rate. It was not possible to predict injury using routine ultrasonography and therefore other methods must be identified. A normal reference range for SDFT CSA is provided.

A comparison of organic and conventionally-produced lamb purchased from three major UK supermarkets: Price, eating quality and fatty acid composition.

Organic and conventional lamb loin chops, labelled as British lamb, were bought from three major UK supermarket chains (designated A, B and C) in the Bristol area on 10 occasions over a six week period. Samples (n=360) were from unknown production systems but representative of what is available to UK consumers. The nutritional quality of muscle was assessed in terms of its fatty acid composition and eating quality was assessed by a trained sensory panel. Lamb prices varied between £9 and £12.50 per kg, with a relatively modest price differential between organic and conventional lamb chops of £1.10, £1.88 and £1.16 £/kg for supermarkets A, B and C, respectively. On average, organic chops were 20g heavier than conventional chops. Chops were relatively lean, having just 14% of subcutaneous fat, approximately half that of a similar survey 10 years ago. Organic lamb had a better eating quality than conventional lamb in terms of juiciness (p<0.05), flavour (p<0.05) and overall liking (p<0.05) thus providing some evidence for the perception among consumers that organic products 'taste better'. Differences in juiciness were attributed to the higher intramuscular fat content of organic meat whilst differences in flavour were attributed to differences in fatty acid composition, in particular, the higher level of linolenic acid (18:3) and total n-3 PUFA in organic chops. Conventional chops had a higher percentage of linoleic acid (18:2). Chops from both productions systems had a favourable n-6:n-3 ratio. The most important difference between the three supermarkets was that lamb flavour was significantly lower in chops from supermarket A, probably due to differences in their 'display until' dates. Chops from supermarket A were also the cheapest.