Effectiveness of community pharmacies in improving seasonal influenza uptake-an evaluation using the Donabedian framework.

Background: Community pharmacies are now commissioned nationally in England to provide a seasonal influenza vaccination service. However, there is little evidence about the effectiveness of a pharmacy-based immunization service in improving uptake. Methods: The Donabedian framework was used to evaluate a community pharmacy service in the West Midlands from a commissioning perspective. A mixed methods approach was adopted, including provider and patient surveys, data from the national influenza vaccination returns and an electronic pharmacy data recording system. Results: Patient satisfaction with the service was high. There was no increase in uptake rates. Impact on reaching new patients was limited. The service had an appropriate information system to record activity. Promotion and signposting for the service was weak. Poor engagement with stakeholders led to dissatisfaction and General Practitioner complaints. Commissioners responded to emerging issues to ensure the pharmacies' set up was compliant with the Service Level Agreement. Conclusions: Improvements in convenience and choice for patients did not result in an increase in uptake rates. With a national pharmacy influenza programme, local arrangements to optimize the service may be limited. Clear arrangements for activity transfer and recording, partnership working and a good communications strategy are crucial in achieving a positive outcome.

Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes: What Systems Are in Development?

BACKGROUND: Closed-loop artificial pancreas device (APD) systems are externally worn medical devices that are being developed to enable people with type 1 diabetes to regulate their blood glucose levels in a more automated way. The innovative concept of this emerging technology is that hands-free, continuous, glycemic control can be achieved by using digital communication technology and advanced computer algorithms. METHODS: A horizon scanning review of this field was conducted using online sources of intelligence to identify systems in development. The systems were classified into subtypes according to their level of automation, the hormonal and glycemic control approaches used, and their research setting. RESULTS: Eighteen closed-loop APD systems were identified. All were being tested in clinical trials prior to potential commercialization. Six were being studied in the home setting, 5 in outpatient settings, and 7 in inpatient settings. It is estimated that 2 systems may become commercially available in the EU by the end of 2016, 1 during 2017, and 2 more in 2018. CONCLUSIONS: There are around 18 closed-loop APD systems progressing through early stages of clinical development. Only a few of these are currently in phase 3 trials and in settings that replicate real life.

Learning, assessment and professional identity development in public health training.

BACKGROUND: Professional identity formation is important for new recruits to training programmes. The integration of the accumulation of knowledge and assessment is a key aspect in its acquisition. This study assessed this interaction in Public Health Training in one English region. METHODS: Semi-structured interviews were held with 15 registrars from the West Midlands Public Health Training Programme. Pre-interview questionnaires gathered background information. A thematic content analysis approach was taken. RESULTS: There was a lack of integration between academic and workplace learning, the professional examination process and professional identity development. Registrars considered sitting the examination and their workplace learning as two parallel processes. Passing the examination was considered a key part in the early development of a professional identity but this was replaced by the opinions of others by the third year of training. Having a Masters' in Public Health was less important but played a different role in their perceived acceptance by the wider Public Health workforce. CONCLUSION: The lack of integration between assessment and learning seemed to have a detrimental effect on professional identity development. A review of how these two aspects might combine in a more positive manner is needed.

Minimal Effect of Daytime Napping Behavior on Nocturnal Sleep in Pregnant Women.

STUDY OBJECTIVES: To assess whether daytime naps negatively impact nocturnal sleep. DESIGN: Longitudinal, prospective cohort design. PARTICIPANTS: 161 pregnant women recruited and evaluated in early gestation (10-20 weeks). MEASUREMENTS AND RESULTS: Daily sleep information was collected in three 2-week periods (10-12, 14-16, and 18-20 weeks gestation) with a daily sleep diary and an actigraph. The average number of naps, as well as the average length of each nap, were calculated from sleep diaries. Women were categorized first as non nappers (0 naps/2-week period), moderate nappers (1-3 naps/2-week period), or frequent nappers (≥ 4 naps/2-week period). Then, based on the average nap length, they were categorized as short (< 90 min) or long (≥ 90 min) nappers. Nocturnal sleep parameters included SOL, WASO, SE, and TST. SAS procedure MIXED was used for modeling the main effects of nap group and time, and time by nap group interactions. Women who took naps had a decrease in diary-assessed nocturnal TST, but not actigraphy-assessed TST. This observation was group- and time-specific. There were no other group differences. Women who napped ≥ 90 min had poorer diary-assessed SE and lower diary-assessed TST than those who took shorter naps. Length of nap was not associated with any other sleep measures. CONCLUSIONS: The number of daytime naps have minimal impact on nocturnal sleep parameters; however, long nappers did exhibit modestly impaired sleep continuity and sleep quality. Overall, we propose that daytime naps provide a beneficial countermeasure to the sleep disruption commonly reported by pregnant women. This may be clinically beneficial given that sleep continuity and quality are important correlates of pregnancy outcomes. COMMENTARY: A commentary on this article appears in this issue on page 593.

Culture confirmation of tuberculosis cases in Birmingham, UK.

BACKGROUND: The proportion of culture-confirmed tuberculosis (TB) cases in Birmingham had gradually decreased to less than 65% in 2008. Reasons for this were unclear, therefore this study assessed diagnostic methods used for confirming TB and reviewed factors involved in positive culture. METHODS: A cross-sectional study was carried out. A list of notified TB cases for Birmingham in those aged 16 y and over in 2009 was collated. Where no positive culture was recorded, further data were collected from hospital databases and case notes. RESULTS: Of 449 TB cases, 419 (93%) had samples taken for culture testing. Of all cases, 309 (69%) were confirmed by culture testing; of those receiving culture testing, 73% were confirmed. Pulmonary TB was identified as a predictor of positive culture in both the unadjusted and adjusted analyses: odds ratio (OR) 2.05, 95% confidence interval (CI) 1.32-3.19, and OR 2.32, 95% CI 1.29-4.17, respectively. Gender, age, ethnicity, UK born, and treatment delay were not significantly associated with positive culture. Of 140 cases not confirmed by culture, 129 (92%) had their diagnosis supported by at least one other test. CONCLUSION: The vast majority of TB cases had microbiological specimens taken to help confirm the disease. Furthermore, culture confirmation rates in Birmingham were meeting national targets in 2009. However culture confirmation rates were significantly lower in extrapulmonary TB, therefore further work is suggested in this group. The role of other investigations (e.g. interferon-gamma release assay (IGRA), Mantoux) is unclear. Further collaboration between clinicians, histopathologists, and microbiologists is advised to ensure samples are sent appropriately and culture confirmation is optimized.

Comparison of five actigraphy scoring methods with bipolar disorder.

The goal of this study was to compare 5 actigraphy scoring methods in a sample of 18 remitted patients with bipolar disorder. Actigraphy records were processed using five different scoring methods relying on the sleep diary; the event-marker; the software-provided automatic algorithm; the automatic algorithm supplemented by the event-marker; visual inspection (VI) only. The algorithm and the VI methods differed from the other methods for many actigraphy parameters of interest. Particularly, the algorithm method yielded longer sleep duration, and the VI method yielded shorter sleep latency compared to the other methods. The present findings provide guidance for the selection of signal processing method based on sleep parameters of interest, time-cue sources and availability, and related scoring time costs for the study.

A geographically-restricted but prevalent Mycobacterium tuberculosis strain identified in the West Midlands Region of the UK between 1995 and 2008.

BACKGROUND: We describe the identification of, and risk factors for, the single most prevalent Mycobacterium tuberculosis strain in the West Midlands region of the UK. METHODOLOGY/PRINCIPAL FINDINGS: Prospective 15-locus MIRU-VNTR genotyping of all M. tuberculosis isolates in the West Midlands between 2004 and 2008 was undertaken. Two retrospective epidemiological investigations were also undertaken using univariable and multivariable logistic regression analysis. The first study of all TB patients in the West Midlands between 2004 and 2008 identified a single prevalent strain in each of the study years (total 155/3,056 (5%) isolates). This prevalent MIRU-VNTR profile (32333 2432515314 434443183) remained clustered after typing with an additional 9-loci MIRU-VNTR and spoligotyping. The majority of these patients (122/155, 79%) resided in three major cities located within a 40 km radius. From the apparent geographical restriction, we have named this the "Mercian" strain. A multivariate analysis of all TB patients in the West Midlands identified that infection with a Mercian strain was significantly associated with being UK-born (OR =  9.03, 95%CI = 4.56-17.87, p<0.01), Black Caribbean (OR = 5.68, 95%CI = 2.96-10.91, p < 0.01) resident in Wolverhampton (OR = 9.29, 95%CI = 5.69-15.19, p < 0.01) and negatively associated with age >65 years old (OR = 0.25, 95% CI = 0.09-0.67, p < 0.01). A second more detailed investigation analyzed a cohort of 82 patients resident in Wolverhampton between 2003 and 2006. A significant association with being born in the UK remained after a multivariate analysis (OR = 9.68, 95% CI = 2.00-46.78, p < 0.01) and excess alcohol intake and cannabis use (OR = 6.26, 95%CI = 1.45-27.02, p =  .01) were observed as social risk factors for infection. CONCLUSIONS/SIGNIFICANCE: The continued consistent presence of the Mercian strain suggests ongoing community transmission. Whilst significant associations have been found, there may be other common risk factors yet to be identified. Future investigations should focus on targeting the relevant risk groups and elucidating the biological factors that mediate continued transmission of this strain.

Widening inequalities in MMR vaccine uptake rates among ethnic groups in an urban area of the UK during a period of vaccine controversy (1994-2000).

We examined MMR vaccine uptake among ethnic groups in Birmingham, UK between 1994 and 2000, a period incorporating adverse MMR vaccine publicity. From 1994 to 2000 overall uptake: (1) fell significantly from 91.1% in 1994 to 89.8% (chi(2) for trend p<0.001) in 2000, (2) in Asian children significantly increased (chi(2) for trend p<0.001), and (3) in White children significantly decreased (chi(2) for trend p<0.001). Differences between ethnic groups with the highest (Asian) and the lowest (Black Caribbean) uptake rates increased from 2.1% in 1994 (p=ns) to 6.8% in 2000 (p<0.001). This study suggests underlying ethnic inequalities in MMR vaccine uptake and differential response to adverse vaccine publicity.

Cluster of human tuberculosis caused by Mycobacterium bovis: evidence for person-to-person transmission in the UK.

BACKGROUND: Despite a recent resurgence in the incidence of bovine tuberculosis in UK cattle herds, no associated rise in the number of cases in man has been noted. Disease due to human Mycobacterium bovis infection usually occurs in older patients, in whom drinking unpasteurised milk in the past is the probable source of infection. Person-to-person transmission is very rare. METHODS: After identification of two epidemiologically-linked cases of human M bovis infection through routine laboratory and surveillance activities, all patients identified with M bovis infection in the Midlands from 2001-05 (n=20) were assessed by DNA fingerprinting (MIRU-VNTR and spoligotyping), with additional interviews for patients with a clustered strain. FINDINGS: A cluster of six cases was identified. All clustered cases were young and UK-born; five patients had pulmonary disease, and one patient died due to M bovis meningitis, with four patients possessing factors predisposing to tuberculosis. All patients had common social links through visits to bars in two different areas. With the exception of the first case, there was an absence of zoonotic links or consumption of unpasteurised dairy products, suggesting that person-to-person transmission had occurred. INTERPRETATION: This report of several instances of M bovis transmission between people in a modern urban setting emphasises the need to maintain control measures for human and bovine tuberculosis. Transmission and subsequent disease was probably due to a combination of host and environmental factors. Prospective surveillance and DNA fingerprinting identified the cluster, enabling health protection teams to set up control measures and prevent further transmission.

Diurnal variation in regional brain glucose metabolism in depression.

BACKGROUND: This study compared diurnal variation in mood and regional cerebral metabolic rate of glucose (rCMRglc) in depressed and healthy subjects. METHODS: Depressed and healthy subjects were investigated using [18F]-fluoro-deoxyglucose positron emission tomography scans during morning and evening wakefulness. All subjects completed subjective mood ratings at both times of day. Statistical parametric mapping was used to compare rCMRglc between the two groups across time of day. RESULTS: Depressed patients showed evening mood improvements compared with healthy subjects. Compared with healthy subjects, depressed patients showed smaller increases in rCMRglc during evening relative to morning wakefulness in lingual and fusiform cortices, midbrain reticular formation, and locus coeruleus and greater increases in rCMRglc in parietal and temporal cortices. Depressed patients had hypermetabolism in limbic-paralimbic regions and hypometabolism in frontal and parietal cortex at both times of day compared with healthy subjects. CONCLUSIONS: Variation in rCMRglc differs across times of day in depressed and healthy subjects. In depressed patients, evening mood improvements were associated with increased metabolic activity in ventral limbic-paralimbic, parietal, temporal, and frontal regions and in the cerebellum. This increased metabolic pattern during evening wakefulness may reflect partial normalization of primary and compensatory neural systems involved in affect production and regulation.

A pilot study of subjective daytime alertness and mood in primary insomnia participants using ecological momentary assessment.

This pilot study compared daytime symptom ratings in primary insomniacs (n = 7) and age-matched controls (n = 8). Participants completed sleep diaries and rated their daytime symptoms using a Daytime Symptom Diary (DSD) 4 times per day for 1 week. DSD responses were collapsed into 4 domains: mood, subjective alertness, energy, and concentration. The level and variability of DSD domains, and correlations between the domains and sleep diary characteristics, were examined. Significant Group x Time of Day interactions were observed in values for each DSD domain, with the most consistent group differences occurring in the morning. Coefficients of variation for DSD domains were greater in the insomnia group. Frequent measures of daytime symptoms may be useful outcomes in insomnia studies.

Regional brain glucose metabolism during morning and evening wakefulness in humans: preliminary findings.

STUDY OBJECTIVES: The mechanisms that maintain wakefulness across the day, in the face in increasing sleep drive, are largely unknown. The goal of this pilot study was to examine regional relative brain glucose metabolism during morning and evening wakefulness in healthy humans. DESIGN: [18F]-fluorodeoxyglucose positron emission tomography scans were conducted during quiet wakefulness in the morning and in the evening. Statistical parametric mapping was used to compare relative regional glucose metabolism during the 2 scans. Subjects also completed subjective ratings of alertness. SETTING: University of Pittsburgh General Clinical Research Center and Positron Emission Tomography Facility. PATIENTS OR PARTICIPANTS: Thirteen healthy adults (10 women, 3 men; mean age, 37 years) INTERVENTIONS: None. MEASUREMENTS AND RESULTS: Relative regional glucose metabolism was significantly higher in the evening than in the morning in a large cluster of midline and brainstem structures. Volumes of interest centered on the pontine reticular formation, midbrain reticular formation, midbrain raphe, locus coeruleus, and posterior hypothalamus also showed higher relative metabolism in the evening than in the morning. Relative glucose metabolism was significantly lower in the evening than in the morning in clusters that included structures in the right temporal cortex and occipital lobe, including cuneus and medial occipital gyrus. CONCLUSIONS: Evening wakefulness is associated with increased relative metabolism in brainstem and hypothalamic arousal systems and decreased relative metabolism in posterior cortical regions. These patterns may reflect input from the circadian timing system to promote wakefulness, and/or the effects of increasing homeostatic sleep drive.

Functional neuroanatomical correlates of eye movements during rapid eye movement sleep in depressed patients.

In depressed patients, REM density, or the number of rapid eye movements (REMs) per minute of REM sleep, is a correlate of depression severity and clinical outcomes. We investigated the functional neuroanatomical correlates of average REM counts (RC), an automated analog of REM density, in depression. Thirteen medication-free depressed patients underwent all night polysomnography and positron emission tomography (PET) scans using [(18)F]fluoro-2-deoxy-d-glucose ([(18)F] FDG) during REM sleep. Regression analyses were conducted with Statistical Parametric Mapping (SPM-99). Average RC significantly and positively correlated with relative regional cerebral metabolic rate of glucose (rCMRglc) bilaterally in the striate cortex, the posterior parietal cortices, and in the medial and ventrolateral prefrontal cortices. Average RC were negatively correlated with rCMRglc in areas corresponding bilaterally to the lateral occipital cortex, cuneus, temporal cortices, and parahippocampal gyri. The areas where average RC was positively correlated with rCMRglc appear to constitute a diffuse cortical system involved in the regulation of emotion-induced arousal. The observed pattern of correlations suggests that average RC may be a marker of hypofrontality during REM sleep in depressed patients.

The relationship between granule growth mechanism, amount of liquid binder added and properties of the wet powder mass determined using a split bed shear tester.

The Peschl-split bed shear tester was utilised to study the formation of different liquid states during wet massing for granulation. Using lactose monohydrate as a model bulking agent the threshold between pendular and funicular state was found to be at about 6% (w/w) of liquid binder added to the wet mass, here a 5% colloidal solution of HPMC in water. The upper limit of the funicular state appeared to be at approximately 15% (w/w) of liquid binder. The threshold values obtained from the shear cell measurements did correlate with values obtained from dried granule characteristics such as granule density and compressive Young's modulus determined by Dynamic Mechanical Analysis. The compressive Young's modulus increased with an increasing density of the wet mass during the shear experiments and decreased with an increase in the angle of internal friction. The results suggest that stiffer granules were a result of densification, not the strength of liquid bridge bond formation.