A randomized, open-label, single-visit, crossover study simulating triple-drug delivery with Ellipta compared with dual inhaler combinations in patients with COPD.

Background: Administering maintenance COPD therapy with a combination of multiple inhalers may increase inhaler errors. This study evaluated the potential benefits of using a single Ellipta dry powder inhaler (DPI) compared with two combinations of DPIs commonly used to deliver triple maintenance therapy. Methods: Patients receiving inhaled COPD medication were enrolled in this multicenter, randomized, open-label, placebo-device, crossover study with a 2×2 complete block design (NCT0298218), which comprised two substudies: Ellipta vs Diskus + HandiHaler (substudy 1) or Turbuhaler + HandiHaler (substudy 2). Patients demonstrated inhaler use after reading the relevant patient information leaflet (PIL). A trained investigator assessed user errors (critical errors [errors likely to result in no or significantly reduced medication being inhaled] and overall errors). The primary endpoint was the proportion of patients making ≥1 critical error after reading the PIL. The secondary endpoints included error rates during ≤2 reassessments following investigator instruction (if required), instruction time, and patient preference. Results: After reading the PIL, significantly fewer patients made critical errors with Ellipta compared with Diskus + HandiHaler (9% [7/80] vs 75% [60/80], respectively; P<0.001) or Turbuhaler + HandiHaler (9% [7/79] vs 73% [58/79], respectively; P<0.001). The number of patients making overall errors was also lower with Ellipta vs tested inhaler combinations (P<0.001 for each substudy). The median instruction time needed for error-free use was shorter with Ellipta in substudies 1 and 2 (2.7 and 2.6 minutes, respectively) vs either combination (10.6 [Diskus + HandiHaler] and 11.3 minutes [Turbuhaler + HandiHaler], respectively). Significantly more patients preferred Ellipta over Diskus + HandiHaler or Turbuhaler + HandiHaler overall for taking their COPD medication (81% vs 9% and 84% vs 4%, respectively) and per the number of steps for taking their COPD medication (89% vs 8% and 91% vs 5%, respectively). Conclusion: Fewer patients with COPD made critical errors with the single DPI, and patients required less instruction time, compared with each dual DPI combination.

TWOC around the clock: a multimodal approach to improving catheter care.

BACKGROUND: Urinary tract infections (UTI) are the second-largest group of healthcare-associated infections (HCAI). The Saving Lives Urinary Catheter Care Bundle was introduced to reduce catheter-associated urinary tract infections (CAUTI). In response, we implemented a catheter care group to examine ways to improve catheter care in an acute hospital NHS Trust. METHODS: We adopted a multimodal approach, revolving around four components: (1) Catheter Care Pathway; (2) HOUDINI checklist; (3) catheter magnets; and (4) use of bladder ultrasound scanners. RESULTS: The yearly CAUTI prevalence survey showed an annual reduction in CAUTI from 2012-2013 to 2014-2015 (3.5% to 2.4%). Evaluations of the multimodal approach have highlighted limitations, leading to priorities being established around provision of tools, education, and use of measurement and feedback. CONCLUSIONS: Our multimodal approach demonstrates CAUTI rate improvements are achievable, directly benefiting patients. However, long-term maintenance of multimodal components is required to ensure sustained benefit. Engagement and accountability have emerged as significant challenges to the effectiveness and longevity of the catheter care group. We suggest greater emphasis on such challenges if long-term national or international improvement is to be achieved.

Using inherent and elective behavior to improve hand hygiene monitoring in health care.

This study established a method for collecting hand hygiene (HH) performance data based on behavioral drivers (inherent or elective) that can be used by infection preventionists (IPs) to improve practice. Further, we explored the influence that task and setting has on HH behavior. A significant effect was found between task and setting that has implications for improving the usefulness of HH measurement, with positive feedback reported regarding the new measurement method.

Assessing user acceptance towards automated and conventional sink use for hand decontamination using the technology acceptance model.

Hand hygiene (HH) prevents harmful contaminants spreading in settings including domestic, health care and food handling. Strategies to improve HH range from behavioural techniques through to automated sinks that ensure hand surface cleaning. This study aimed to assess user experience and acceptance towards a new automated sink, compared to a normal sink. An adapted version of the technology acceptance model (TAM) assessed each mode of handwashing. A within-subjects design enabled N = 46 participants to evaluate both sinks. Perceived Ease of Use and Satisfaction of Use were significantly lower for the automated sink, compared to the conventional sink (p < 0.005). Across the remaining TAM factors, there was no significant difference. Participants suggested design features including jet strength, water temperature and device affordance may improve HH technology. We provide recommendations for future HH technology development to contribute a positive user experience, relevant to technology developers, ergonomists and those involved in HH across all sectors. Practitioner Summary: The need to facilitate timely, effective hand hygiene to prevent illness has led to a rise in automated handwashing systems across different contexts. User acceptance is a key factor in system uptake. This paper applies the technology acceptance model as a means to explore and optimise the design of such systems.

Effect of an Education Programme for South Asians with Asthma and Their Clinicians: A Cluster Randomised Controlled Trial (OEDIPUS).

BACKGROUND: People with asthma from ethnic minority groups experience significant morbidity. Culturally-specific interventions to reduce asthma morbidity are rare. We tested the hypothesis that a culturally-specific education programme, adapted from promising theory-based interventions developed in the USA, would reduce unscheduled care for South Asians with asthma in the UK. METHODS: A cluster randomised controlled trial, set in two east London boroughs. 105 of 107 eligible general practices were randomised to usual care or the education programme. Participants were south Asians with asthma aged 3 years and older with recent unscheduled care. The programme had two components: the Physician Asthma Care Education (PACE) programme and the Chronic Disease Self Management Programme (CDSMP), targeted at clinicians and patients with asthma respectively. Both were culturally adapted for south Asians with asthma. Specialist nurses, and primary care teams from intervention practices were trained using the PACE programme. South Asian participants attended an outpatient appointment; those registered with intervention practices received self-management training from PACE-trained specialist nurses, a follow-up appointment with PACE-trained primary care practices, and an invitation to attend the CDSMP. Patients from control practices received usual care. Primary outcome was unscheduled care. FINDINGS: 375 south Asians with asthma from 84 general practices took part, 183 registered with intervention practices and 192 with control practices. Primary outcome data were available for 358/375 (95.5%) of participants. The intervention had no effect on time to first unscheduled attendance for asthma (Adjusted Hazard Ratio AHR = 1.19 95% CI 0.92 to 1.53). Time to first review in primary care was reduced (AHR = 2.22, (1.67 to 2.95). Asthma-related quality of life and self-efficacy were improved at 3 months (adjusted mean difference -2.56, (-3.89 to -1.24); 0.44, (0.05 to 0.82) respectively. CONCLUSIONS: A multi-component education programme adapted for south Asians with asthma did not reduce unscheduled care but did improve follow-up in primary care, self-efficacy and quality of life. More effective interventions are needed for south Asians with asthma.

A case study of healthcare professional views on the meaning of data produced by hand hygiene auditing.

BACKGROUND: Measurement of hand hygiene (HH), crucial for patient safety, has acknowledged flaws stemming from methods available. Even direct observation, the World Health Organization gold standard, may lead to behaviour changes which can affect outcome validity. However, it remains important to understand current levels of HH to allow targeted interventions to be developed. This has resulted in wider adoption of auditing processes. AIM: This study addressed how healthcare professionals perceive data generated by HH auditing processes. METHODS: Qualitative study involving participatory observation and semi-structured interviews with 30 healthcare professionals recruited from a large National Health Service (NHS) two-hospital site in England. FINDINGS: Healthcare professionals perceived two main problems with HH measurement, both associated with feedback: (1) lack of clarity with regard to feedback; and (2) lack of association between training and measurement. In addition, concerns about data accuracy led the majority of participants (22/30) to conclude audit feedback is often 'meaningless'. CONCLUSION: Healthcare professionals require meaningful data on compliance with HH to engender change, as part of a multimodal strategy. Currently healthcare professionals perceive that data lack meaning, and are not seen as drivers to improve HH performance. Potential opportunities to change practice and improve HH are being missed.

Review of technologies available to improve hand hygiene compliance - are they fit for purpose?

Hand hygiene has been empirically proven to prevent cross-transmission of infection, which has led to the development of global guidelines such as the World Health Organization's 'My 5 Moments for Hand Hygiene.' Because of the relatively recent launch of these guidelines (2009) technology designed to assist in measuring hand hygiene compliance appears not to fully acknowledge the influence of the WHO 5 Moments for hand hygiene Consequently, they may not be fit for purpose (FFP). This paper uses a review of the literature on current hand hygiene technology to assess the extent to which these are FFP based on these global guidelines. The results show that there are a variety of technologies available to assist with the monitoring and measurement of hand hygiene levels. However, none appear to explicitly achieve detection of all WHO 5 Moments for hand hygiene, limiting their effectiveness. The authors conclude that a systems approach offers a potential aid for developers aspiring to meet domain specific FFP requirements. Human factors may help guide such developments to meet user and context specific needs.

Performance of an alternative laboratory-based algorithm for diagnosis of HIV infection utilizing a third generation immunoassay, a rapid HIV-1/HIV-2 differentiation test and a DNA or RNA-based nucleic acid amplification test in persons with established HIV-1 infection and blood donors.

BACKGROUND: The HIV-1 Western blot (WB) and immunofluorescence assay used to confirm HIV infections are less sensitive during seroconversion than immunoassays (IAs) used for screening. An alternative diagnostic algorithm has been proposed to detect early HIV-1 infection and differentiate HIV-1 from HIV-2. OBJECTIVES: We evaluated the performance of an algorithm with a third generation IA that when reactive was followed by a rapid test (Multispot) that differentiates HIV-1 from HIV-2. Multispot-reactive specimens were considered HIV-infected. Multispot-negative specimens were tested with a nucleic acid amplification test (NAAT) for resolution. STUDY DESIGN: WB-positive specimens [serum (n=2202), plasma (n=1109) and peripheral blood mononuclear cells (PBMCs) (n=1065)] were obtained from HIV-infected persons not taking antiretrovirals. HIV-uninfected specimens [plasma (n=1517) and PBMCs (n=1508)] with negative IA and NAAT results were obtained from blood donors. Specimens were tested with third generation IAs (Abbott rDNA, ADVIA Centaur, GS HIV1-2 Plus O, Ortho VITROS) in singlet, Multispot, and NAAT (APTIMA (RNA) and AMPLICOR (DNA)). We calculated algorithm sensitivity and specificity and the proportion of IA-reactive specimens requiring NAAT. RESULTS: Algorithm sensitivity was 99.95% with APTIMA and 100% with AMPLICOR. One WB-positive specimen reactive by all IAs and AMPLICOR was negative by Multispot and APTIMA. Algorithm specificity was 100% using APTIMA or AMPLICOR as NAAT. From 0.10% (Abbott) to 2.43% (VITROS) of IA-reactive specimens required NAAT. CONCLUSIONS: The proposed algorithm performs with high sensitivity and specificity in specimens from persons with established HIV infection and uninfected blood donors and appears to be a good alternative to the current algorithm.

Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial.

BACKGROUND: Guidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown. METHODS: In a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years) and were allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo (n = 132). Follow-up assessments took place at three monthly intervals for a year at the patients' practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life. RESULTS: In patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91-1.36). Patients taking placebo were more likely to return to their usual ICS following exacerbation, placebo: 61/128 (48%); fluticasone: 34/132 (26%), OR: 2.35 (CI: 1.38-4.05). Exacerbation risk whilst taking randomised treatment was significantly raised in the placebo group 1.48 (CI: 1.17-1.86). Patients taking placebo exacerbated earlier (median time to first exacerbation: placebo (days): 44 (CI: 29-59); fluticasone: 63 (CI: 53-74), log rank 3.81, P = 0.05) and reported increased wheeze. In a post-hoc analysis, patients with mild COPD taking placebo had increased exacerbation risk RR: 1.94 (CI: 1.20-3.14). CONCLUSION: Withdrawal of long-term ICS in COPD patients in primary care increases risk of exacerbation shortens time to exacerbation and causes symptom deterioration. Patients with mild COPD may be at increased risk of exacerbation after withdrawal. TRIAL REGISTRATION: ClinicalTrials.gov NCT00440687.

Two optimized combination assays to examine apoptosis pathways in clinical samples.

BACKGROUND: A consequence of a number of diseases is an alteration in apoptosis. Currently, there is no single assay that measures the main stages of apoptosis, requiring that multiple assays be performed. This hinders studies on clinical samples that have limited cell numbers. Our objective was to combine and optimize assays that target specific stages of apoptosis for use in a typical clinical blood sample. METHODS: Two flow cytometric assays were developed for use on peripheral blood mononuclear cells (PBMC) collected in two 8-ml tubes from a single draw. One measures caspase-12 activity, the level of active caspase-3 and DNA fragmentation. The second assesses depolarization of the mitochondria and phosphatidylserine externalization. Cell populations present within the samples were determined by flow cytometry. Apoptosis was validated by ELISA. RESULTS: Each assay was optimized for use with cell numbers and sample volumes typical of clinical blood samples. Each combination assay effectively distinguished apoptotic from nonapoptotic blood cells. CONCLUSIONS: This combined optimized method comprised of two independent assays makes it possible to assay the major pathways of apoptosis in addition to determining the blood cell subsets that are affected.

Specialist nurse intervention to reduce unscheduled asthma care in a deprived multiethnic area: the east London randomised controlled trial for high risk asthma (ELECTRA).

OBJECTIVE: To determine whether asthma specialist nurses, using a liaison model of care, reduce unscheduled care in a deprived multiethnic area. DESIGN: Cluster randomised controlled trial. SETTING: 44 general practices in two boroughs in east London. PARTICIPANTS: 324 people aged 4-60 years admitted to or attending hospital or the general practitioner out of hours service with acute asthma; 164 (50%) were South Asian patients, 108 (34%) were white patients, and 52 (16%) were from other, largely African and Afro-Caribbean, ethnicities. INTERVENTION: Patient review in a nurse led clinic and liaison with general practitioners and practice nurses comprising educational outreach, promotion of guidelines for high risk asthma, and ongoing clinical support. Control practices received a visit promoting standard asthma guidelines; control patients were checked for inhaler technique. MAIN OUTCOME MEASURES: Percentage of participants receiving unscheduled care for acute asthma over one year and time to first unscheduled attendance. RESULTS: Primary outcome data were available for 319 of 324 (98%) participants. Intervention delayed time to first attendance with acute asthma (hazard ratio 0.73, 95% confidence interval 0.54 to 1.00; median 194 days for intervention and 126 days for control) and reduced the percentage of participants attending with acute asthma (58% (101/174) v 68% (99/145); odds ratio 0.62, 0.38 to 1.01). In analyses of prespecified subgroups the difference in effect on ethnic groups was not significant, but results were consistent with greater benefit for white patients than for South Asian patients or those from other ethnic groups. CONCLUSION: Asthma specialist nurses using a liaison model of care reduced unscheduled care for asthma in a deprived multiethnic health district. Ethnic groups may not benefit equally from specialist nurse intervention.