Efficacy and Safety of Inhaled Glycopyrronium Bromide in COPD: A Randomized, Parallel Group, Dose-Ranging Study (GLIMMER).

This Phase II, randomized, parallel group study was conducted as part of US regulatory requirements to identify the most appropriate dose of the long-acting muscarinic antagonist glycopyrronium bromide (GB) for use in a single-inhaler triple-therapy combination with the inhaled corticosteroid beclomethasone dipropionate plus the long-acting ß2-agonist formoterol fumarate. Eligible subjects were adults with COPD and post-bronchodilator forced expiratory volume in 1 s (FEV1) 40-80% predicted. Subjects were randomized to receive inhaled double-blind GB 6.25, 12.5, 25 or 50 µg or placebo, all twice daily (BID), or open-label tiotropium 18 µg once daily for six weeks. The primary objective was to evaluate the efficacy of GB versus placebo in terms of FEV1 area under the curve between 0 and 12 h at Week 6. Of 733 subjects randomized, 682 (93.0%) completed the study. For the primary endpoint, all GB doses were superior to placebo (p < 0.05), with a dose-response up to 25 µg BID, and 25 and 50 µg BID both superior to 6.25 µg BID (p < 0.05). Results for the secondary spirometry endpoints were consistent with the primary endpoint. Overall, the efficacy of GB 25 and 50 µg BID was broadly consistent with that of tiotropium. The incidence of adverse events, both overall and for the most common preferred terms, was low and similar in all treatment groups, including placebo (overall, 22.3-29.3%). Based on the totality of the efficacy and safety data, the optimal GB dose is 25 µg BID.

Order From Chaos: An Initiative to Improve Opioid Prescribing in Rheumatology Using Lean A3.

OBJECTIVE: Use an established quality improvement method, Lean A3, to improve the process of opioid prescribing in an academic rheumatology ambulatory clinic. METHODS: This retrospective pre-postintervention analysis of rheumatology records included patients prescribed opioids at least once during the study period. Lean A3 was used to develop a Controlled Substance Visit Protocol to standardize eight recommended elements of the opioid prescribing workflow. Analyses included changes in the recommended workflow elements and changes in opioid prescribing volume. RESULTS: Improvements were observed in seven of the eight recommended elements. Patient education, including treatment agreements and consent forms (39% completion for both preimplementation) increased to 78% and 80%, respectively (P < 0.001 for both). Risk assessment, as measured by the Current Opioid Misuse Measure, increased from 0.5% to 76% (P < 0.001). Best practices in prescribing, including prescribing in multiples of seven to avoid weekend refill requests, increased from 1% to 79% (P < 0.001). Monitoring parameters, including standardized functional assessment (0% vs. 86%), prescription drug monitoring program queries (49% vs. 84%), and urine testing (1% vs. 32%) all increased (P < 0.001). Visits scheduled at least quarterly for patients on chronic opioids did not change (P = 0.18). Overall, the number of patients prescribed opioids (185 vs. 160; P < 0.001) and annual prescription opioid morphine milligram equivalents (MMEs) (1 933 585 MME vs. 1 386 368 MME; P < 0.001) decreased. CONCLUSION: The Lean A3 method is a successful quality improvement tool for improving and sustaining opioid prescribing within a single academic rheumatology clinic. This method has potential applicability to similar clinics interested in improving opioid prescribing.

Nurse telephone education for promoting a treat-to-target approach in recently diagnosed rheumatoid arthritis patients: A pilot project.

OBJECTIVE: The aim of the present study was to implement a nurse telephone education programme for patients with recently diagnosed rheumatoid arthritis (RA) that promotes shared decision-making and a treat-to-target approach. METHODS: This was a pilot project of newly diagnosed adult RA patients conducted between November 2015 and December 2016. A rheumatology clinic nurse telephoned patients to offer disease education. A toolkit was mailed to patients. Measures included call attempts, call time, a qualitative description of free-text notes and the proportion of patients who adhered to their next clinic visit. Data were analysed descriptively and qualitatively. RESULTS: Twenty-six patients participated in the nurse calls. Most patients were female (65%), with a median age of 54 years (range 22-78 years). Median call length was 14.5 min, with a range of 8-23 min. Qualitative notes indicated that patients overwhelmingly supported the nurse calls. Nineteen patients (73%) were adherent to their follow-up visit. CONCLUSION: This preliminary project successfully implemented an educational programme that included a nurse-facilitated, RA-specific, telephone call and toolkit. This educational programme could be a model for similar educational efforts by other clinics.

What does quality healthcare look like to adolescents and young adults? Ask the experts!

It is widely recognised that developmentally appropriate services for adolescents and young people improve both healthcare experience and health outcomes. However, there is limited evidence of using young people's expertise to evaluate services, or of young people participating in service developments or design to meet their healthcare needs. This report covers both the process and outcomes of a collaborative project with a group of young people (aged 17-25 years) who are 'experts by experience'. We used qualitative mixed methodology to derive themes from narrative accounts of these young people's healthcare experiences to develop an assessment framework that they identified as being relevant to evaluating services. Informing young people about other assessment measures currently in use (including the Department of Health's You're Welcome quality criteria) enabled the group to further develop their views and refine their proposed assessment framework. This paper is co-authored with young people, enabling them to directly voice their views about healthcare services. Reflections on this process and recommendations for working more collaboratively with young people to evaluate healthcare services are also given.

Young adult cancer services in the UK: the journey to a national network.

The past decade has seen the development of a network of specialist teenage and young adult cancer centres across the UK. These provide expertise in treatment across the spectrum of malignancies that occur in young adults, supported by multi-disciplinary teams that are able to provide the psycho-social support so necessary for this age group, and in a hospital environment that encourages social interaction while delivering expert medical care. The development of teenage and young adult (TYA) cancer as a specialty gained establishment backing in 2005, through NICE guidance which mandated that all 16- to 24-year-olds should be referred to specialist TYA cancer centres. The foundation of this achievement was set by a handful of committed individuals and the Teenage Cancer Trust, a charity that has acted as patient advocate and political pressure group, and that has brought to public attention the need for change while providing support for specialist staff and hospitals.

Seizures in 204 comatose children: incidence and outcome.

PURPOSE: Seizures are common in comatose children, but may be clinically subtle or only manifest on continuous electroencephalographic monitoring (cEEG); any association with outcome remains uncertain. METHODS: cEEG (one to three channels) was performed for a median 42 h (range 2-630 h) in 204 unventilated and ventilated children aged ≤15 years (18 neonates, 61 infants) in coma with different aetiologies. Outcome at 1 month was independently determined and dichotomized for survivors into favourable (normal or moderate neurological handicap) and unfavourable (severe handicap or vegetative state). RESULTS: Of the 204 patients, 110 had clinical seizures (CS) before cEEG commenced. During cEEG, 74 patients (36%, 95% confidence interval, 95% CI, 32-41%) had electroencephalographic seizures (ES), the majority without clinical accompaniment (non-convulsive seizures, NCS). CS occurred before NCS in 69 of the 204 patients; 5 ventilated with NCS had no CS observed. Death (93/204; 46%) was independently predicted by admission Paediatric Index of Mortality (PIM; adjusted odds ratio, aOR, 1.027, 95% CI 1.012-1.042; p < 0.0005), Adelaide coma score (aOR 0.813, 95% CI 0.700-0.943; p = 0.006), and EEG grade on admission (excess slow with >3% fast, aOR 5.43, 95% CI 1.90-15.6; excess slow with <3% fast, aOR 8.71, 95% CI 2.58-29.4; low amplitude, 10th centile <9 µV, aOR 3.78, 95% CI 1.23-11.7; and burst suppression, aOR 10.68, 95% CI 2.31-49.4) compared with normal cEEG, as well as absence of CS at any time (aOR 2.38, 95% CI 1.18-4.81). Unfavourable outcome (29/111 survivors; 26%) was independently predicted by the presence of ES (aOR 15.4, 95% CI 4.7-49.7) and PIM (aOR 1.036, 95% CI 1.013-1.059). CONCLUSION: Seizures are common in comatose children, and are associated with an unfavourable outcome in survivors. cEEG allows the detection of subtle CS and NCS and is a prognostic tool.

Open fractures: it doesn't come out in the wash.

BACKGROUND: Six hours from injury to washout is considered the gold standard in the treatment of open traumatic fractures. Despite this being our hospital policy, the rural nature of our Level I trauma center causes delays in discovery and transport, creating a unique randomization of time to washout. We hypothesized that orthopedic complications after open fractures are related to the severity of the fractures, not the timing of the washout. METHODS: Patients and fractures were reviewed retrospectively over 6.3 years, evaluating for demographics, injury severity, location of fracture, mechanism of injury, Gustilo fracture grade, and time from injury to initial washout. Orthopedic wound complication rates were compared using logistic regression. RESULTS: A total of 1,487 open fractures in 1,278 patients were reviewed. Time from injury to washout was 26 to 4,749 min (mean, 510 min), with 48 patients having no washout. Overall, 8.2% of fractures (n=122) had an orthopedic complication, rates of which increased with severity (Injury Severity Score, Abbreviated Injury Score [AIS], and Gustilo class) and blunt injuries but were not related to time to washout. Penetrating injuries showed no difference in complication rates according to time to washout. Lower extremity fractures had a higher rate of complications than those of the upper extremity (odds ratio 2.2), likely because of differences in fracture grade. By multivariable logistic regression, only fracture grade, Revised Trauma Score (RTS), and male gender were independent predictors of wound complications; penetrating trauma was predictive of low risk. Time to washout was not an independent predictor of wound complications. CONCLUSIONS: Although grossly contaminated fractures should not be left unattended, the degree of initial injury, as judged by fracture grade and physiology (RTS), was predictive of orthopedic wound complications, whereas time to washout was not. Hence, there is little benefit of washout in Gustilo grade 1/AIS 1 fractures or penetrating injuries, regardless of grade, and adherence to a specific time to washout is not beneficial.

Running out of gas but not trauma patients: the effect of the price of gas on trauma admissions.

As fuel costs steadily rise and motor vehicle collisions continue to be a leading cause of morbidity and mortality, we examined the relationship between the price of gasoline and the rate of trauma admissions related to gasoline consumption (GRT). The National Trauma Registry of the American College of Surgeons data of a rural Level I trauma center were queried over 27 consecutive months to identify the rate of trauma admissions/month related to gas utilization compared with the number of nongasoline related trauma admissions, based on season and day of the week. The average price/gallon of regular gas in our region was obtained from the NorthCarolinaGasPrices. com database. A log linear model with a Poisson distribution was created. No significant association exists between the average price/gallon of gasoline and the GRT rate across the months, seasons, and weekday and weekend periods. As the price of gas continues to rise, the rate of rural GRT does not decrease. Over a longer period of time and with skyrocketing prices, this relationship may not hold true. These findings may also be explained by the rural area where limited alternative transportation opportunities exist and a trauma patient population participating in high risk behavior regardless of cost.

Neuropathic bladder and intermittent catheterization: social and psychological impact on families.

Clean intermittent catheterization (CIC) is the mainstay of management in neuropathic vesicourethral dysfunction, both to improve continence and, more importantly, to preserve renal function. We looked at the effects of this procedure on children, adolescents, and their families. In particular, we wished to see if there were any differences between those who successfully catheterized and those who did not. Forty families were enrolled into the study. Ages of children and adolescents (23 females, 17 males) ranged from 1 to 20 years. Most participants (n=31) had spina bifida. Other causes of bladder dysfunction included transverse myelitis, spinal cord injury, and spinal neuroblastoma. Parents were assessed using the Effects of Handicap on Parents semi-structured interview, the Socioemotional Functioning Interview, and a semi-structured interview, specifically designed for the study, which looked at family characteristics and experience related to diagnosis and catheterization. In addition, the Rutter Parental 'A' Scale Questionnaire was used to screen for emotional and behavioural disorders in the child. Results showed that CIC by carer or self-catheterization itself did not cause major emotional and behavioural problems but the bladder problem may act as a focus that puts considerable strain family relationships. Although most parents disliked CIC they complied with the suggested management. It is important that all those involved understand the aims of management and success can be achieved by combined input from medical, psychological, and specialist nursing staff. The problem is lifelong and continued support from a multidisciplinary team is essential.

Neuropathic bladder and intermittent catheterization: social and psychological impact on children and adolescents.

This paper describes part of larger study involving 40 families of children and adolescents with neuropathic bladder looking at the psychosocial impact of catheterization on them and their families. This study focuses on their experiences of clean intermittent catheterization (CIC) and self-catheterization (SC). Twenty-eight children and adolescents (11 males, 17 females; mean age 9 years, SD 2 years 7 months, range 5 to 20 years) with neuropathic bladder (mostly with spina bifida) participated in a semi-structured interview to explore their understanding of micturition and catheterization, and their views about the introduction and practical use of this technique. Participants were invited to draw self-portraits and figure diagrams to depict their understanding of CIC and SC. Age-appropriate self-esteem measures (Harter Pictorial Scale of Perceived Competence, the Self-Perception Profile, and the Culture-Free Self-Esteem Inventory) were administered to see if catheterization status affected emotional well-being. In an extension of this study, children's experiences of SC were explored by a postal questionnaire to all children successfully using SC who were attending the Paediatric Neuropathic Bladder Clinic. Children aged <5 years, those with learning difficulties, and those using indwelling catheters were excluded. From a total sample of 66 (31 females, 35 males), 52 parents and 42 children and adolescents (28 females and 14 males) responded. No significant difference was observed in self-esteem for those successfully catheterizing. Specific challenges involved learning SC and practical use of the technique. Concerns were leakage and being wet, and peers finding out about their continence management. Implications for the education, problem solving, and support of families and young people to promote cooperation and optimal benefits from catheterization are discussed.