Efficacy and safety of inhaled extrafine beclomethasone dipropionate in adults with asthma: a randomized, parallel-group, dose-ranging study (BEAM).

Introduction: This manuscript describes a Phase II, dose-ranging, randomized, double-blind, placebo- and active-controlled, parallel-group study conducted to identify the appropriate dose of beclomethasone dipropionate (BDP) to be used in a single-inhaler extrafine formulation triple combination of BDP, formoterol fumarate and glycopyrronium.Methods: Patients aged 18-75 years with poorly-controlled asthma, receiving low/medium-dose inhaled corticosteroid (ICS), and who had forced expiratory volume in the 1st second (FEV1) 50-85% predicted, were randomized to inhale BDP 50, 200 or 400 µg twice daily (BID; total daily doses of 100, 400 and 800 µg), placebo, or the active comparator QVAR® 160 µg BID, all via pressurized metered-dose inhalers for 8 weeks. The primary objective was to evaluate superiority of BDP over placebo for change from baseline in pre-dose morning FEV1 at Week 8. ClinicalTrials.gov: NCT03084718.Results: Of 610 patients randomized, 559 (91.6%) completed the study. For pre-dose morning FEV1 at Week 8, BDP 200 µg BID was superior to placebo, with a statistically significant difference of 113 ml (95% CI 18, 209); differences vs placebo for BDP 50 and 400 µg BID were not significant (44 [-52, 140] and 93 [-3, 188] ml, respectively). Secondary efficacy endpoint results supported the primary endpoint in identifying BDP 200 µg BID as the appropriate dose. Adverse events were experienced by 23.5, 25.0 and 30.6% patients with BDP 50, 200 and 400 µg BID, 34.7% with placebo, and 30.6% with the active comparator.Conclusion: In this dose-ranging study, BDP 200 µg BID offered the optimal balance of efficacy and safety in patients with asthma poorly controlled on low/medium-dose ICS.Supplemental data for this article is available online at at www.tandfonline.com/ijas .

Evaluation of a structured preceptorship programme.

Preceptorship is a period in which newly qualified staff nurses receive support from an experienced nurse to smooth their transition into the service. District nurses (DNs) from the authors' trust informally expressed the need for a better transition between the completion of district nursing education and entry into the workforce. Hence, a structured preceptorship programme was developed and delivered. This article describes this service initiative and its evaluation by preceptors (n=14) and preceptees (newly qualified DNs; n=13). Both groups valued having a structured preceptorship programme. Preceptees agreed that having a named preceptor was very important, and preceptors felt that the role which they played was rewarding. Both groups felt that the role of the DN was a specialist role and that the preceptorship programme helped to support newly qualified staff make the transition into qualified DNs, clinical team leaders and, ultimately, caseload holders. A large-scale study of DN practice is required to develop a national consensus on the structure and content of preceptorship programmes for district nursing.

Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

BACKGROUND: There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. METHODS: A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. RESULTS: Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. CONCLUSIONS: Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

Can a Checklist Facilitate Recognition of a Transfusion-Associated Adverse Event by Prelicensure Nursing Students?

BACKGROUND: Early identification of a transfusion-associated adverse event (TAAE) is key to patient safety. Research has indicated that use of a TAAE checklist resulted in greater frequency of TAAE recognition behaviors. PURPOSE: To explore whether use of a TAAE checklist resulted in greater frequency of TAAE recognition behaviors among nursing students. METHODS: A prospective, randomized controlled study was conducted with 62 nursing students playing the role of a registered nurse in a simulation of a patient exhibiting clinical indicators of a TAAE. Subjects were randomly assigned to have or not have a TAAE checklist. Time to recognition of the TAAE was measured. RESULTS: The checklist group (CG) identified TAAEs on average 4 minutes sooner than the non-CG (P < .001). CG subjects were also significantly less likely to miss TAAEs completely. CONCLUSIONS: A checklist may improve the safety of transfusions by promoting earlier recognition and treatment of TAAEs.

Perceptions of Institutional Support for "Second Victims" Are Associated with Safety Culture and Workforce Well-Being.

OBJECTIVE: This study was performed to determine whether health care worker (HCW) assessments of good institutional support for second victims were associated with institutional safety culture and workforce well-being. METHODS: HCWs' awareness of work colleagues emotionally traumatized by an unanticipated clinical event (second victims), their perceptions of level of institutional support for such colleagues, safety culture, and workforce well-being were assessed using a cross-sectional survey (SCORE [Safety, Communication, Operational Reliability, and Engagement] survey). Safety culture scores and workforce well-being scores were compared across work settings with high (top quartile) and low (bottom quartile) perceptions of second victim support. RESULTS: Of the 10,627 respondents (81.5% response rate), 36.3% knew at least one work colleague who had been traumatized by an unanticipated clinical event. Across 396 work settings, the percentage of respondents agreeing (slightly or strongly) that second victims receive appropriate support ranged from 0% to 100%. Across all respondents, significant correlations between perceived support for second victims and all SCORE domains (Improvement Readiness, Local Leadership, Teamwork Climate, Safety Climate, Emotional Exhaustion, Burnout Climate, and Work-Life Balance) were found. The 24.9% of respondents who knew an actual second victim and reported inadequate institutional support were significantly more negative in their assessments of safety culture and well-being than the 42.2% who reported adequate institutional support. CONCLUSION: Perceived institutional support for second victims was associated with a better safety culture and lower emotional exhaustion. Investment in programs to support second victims may improve overall safety culture and HCW well-being.

Survey of Nurses' Experiences Applying The Joint Commission's Medication Management Titration Standards.

BACKGROUND: Critical care nurses titrate continuous infusions of medications to achieve clinical end points. In 2017, The Joint Commission (TJC) placed restrictions on titration practice, decreasing nurses' autonomous decision-making. OBJECTIVES: To describe the practice and perceptions of nurses regarding the 2017 TJC accreditation/regulatory standards for titration of continuous medication infusions. METHODS: A survey of nurses' experiences titrating continuous medication infusions was developed, validated, and distributed electronically to members of the American Association of Critical-Care Nurses. RESULTS: The content validity index for the survey was 1.0 for relevance and 0.95 for clarity. A total of 781 nurses completed the survey; 625 (80%) perceived titration standards to cause delays in patient care, and 726 (93%) experienced moral distress (mean [SD], 4.97 [2.67]; scale, 0-10). Among respondents, 33% could not comply with titration orders, 68% reported suboptimal care resulting from pressure to comply with orders, 70% deviated from orders to meet patient needs, and 84% requested revised orders to ensure compliance. Suboptimal care and delays in care significantly and strongly (regression coefficients ≥0.69) predicted moral distress. CONCLUSIONS: Critical care nurses perceive TJC medication titration standards to adversely impact patient care and contribute to moral distress. The improved 2020 updates to the standards do not address delays and inability to comply with orders, leading to moral distress. Advocacy is indicated in order to mitigate unintended consequences of TJC medication management titration standards.

Use of a Transfusion Checklist by Student Nurses to Improve Patient Safety.

Better education around the recognition of transfusion-associated adverse events is warranted. It is unknown if checklist use improves recognition by student nurses. This study examined whether using a checklist could improve transfusion-associated adverse event recognition behaviors. There was an increased frequency of transfusion-associated adverse event management behaviors in the checklist group, but overall recognition was no greater than other groups. A transfusion-associated adverse event checklist may increase patient safety by promoting identification behaviors.

Sweat testing for cystic fibrosis: standards of performance in Australasia.

BACKGROUND: Accurate measurement of sweat chloride concentration is essential for the diagnosis of cystic fibrosis (CF). We surveyed all laboratories enrolled in the Royal College of Pathologists of Australasia Quality Assurance Program (QAP) for Sweat Electrolytes to determine how closely they comply with the Australian Guidelines for the performance of the sweat test for the diagnosis of CF. METHODS: A detailed questionnaire covering most aspects of sweat collection and analysis was sent to all participating laboratories in 2007. RESULTS: Twenty out of 38 laboratories completed the questionnaire. While adherence to accepted guidelines was noted in many areas, the following main variations were recorded: some laboratories were not doing enough sweat tests to maintain expertise; some were not collecting sweat for the recommended collection time; sweat conductivity was the only test available in some laboratories; there was a lack of agreement between the sweat chloride concentration used to indicate CF or define an equivocal result. CONCLUSIONS: There is room for improvement in the performance of the sweat test in some laboratories in Australasia. The Sweat Testing Working Party of the Australasian Association of Clinical Biochemists is the appropriate body to address the problems involved in sweat testing and to bring about change.

Implementation of a teacher-delivered sex education programme: obstacles and facilitating factors.

Interventions are unlikely to achieve their desired aims unless they are implemented as intended. This paper focuses on factors that impeded or facilitated the implementation of a specially designed sex education programme, SHARE, which 13 Scottish schools were allocated to deliver in a randomized trial. Drawing on qualitative and quantitative data provided by teachers, we describe how this intervention was not fully implemented by all teachers or in all schools. Fidelity to the programme was aided by intensive teacher training, compatibility with existing Personal and Social Education (PSE) provision, and senior management support. It was hindered by competition for curriculum time, brevity of lessons, low priority accorded to PSE by senior management, particularly in relation to timetabling, and teachers' limited experience and ability in use of role-play. The nature of the adoption process, staff absence and turnover, theoretical understanding of the package, and commitment to the research were also factors influencing the extent of implementation across and within schools. The lessons learned may be useful for those involved in designing and/or implementing other teacher-delivered school-based health promotion initiatives.

Heterosexual risk behaviour among young teenagers in Scotland.

This paper provides the first detailed data on the heterosexual sexual experience of a large sample of 14-year-olds in Scotland. The paper investigates the prevalence, nature and correlates of early heterosexual intercourse, and the extent and correlates of condom use. Questionnaires were administered in 24 schools under examination conditions (N=7630). Eighteen per cent of boys and 15% of girls reported having had intercourse. Sixty per cent reported condoms were "used throughout". The most important correlate of sexual experience was low level of parental monitoring; the key predictor for condom use was whether or not the respondent talked to their partner about protection before having sexual intercourse.

Limits of teacher delivered sex education: interim behavioural outcomes from randomised trial.

OBJECTIVE: To determine whether a theoretically based sex education programme for adolescents (SHARE) delivered by teachers reduced unsafe sexual intercourse compared with current practice. DESIGN: Cluster randomised trial with follow up two years after baseline (six months after intervention). A process evaluation investigated the delivery of sex education and broader features of each school. SETTING: Twenty five secondary schools in east Scotland. PARTICIPANTS: 8430 pupils aged 13-15 years; 7616 completed the baseline questionnaire and 5854 completed the two year follow up questionnaire. INTERVENTION: SHARE programme (intervention group) versus existing sex education (control programme). MAIN OUTCOME MEASURES: Self reported exposure to sexually transmitted disease, use of condoms and contraceptives at first and most recent sexual intercourse, and unwanted pregnancies. RESULTS: When the intervention group was compared with the conventional sex education group in an intention to treat analysis there were no differences in sexual activity or sexual risk taking by the age of 16 years. However, those in the intervention group reported less regret of first sexual intercourse with most recent partner (young men 9.9% difference, 95% confidence interval -18.7 to -1.0; young women 7.7% difference, -16.6 to 1.2). Pupils evaluated the intervention programme more positively, and their knowledge of sexual health improved. Lack of behavioural effect could not be linked to differential quality of delivery of intervention. CONCLUSIONS: Compared with conventional sex education this specially designed intervention did not reduce sexual risk taking in adolescents.

Reducing medical errors through barcoding at the point of care.

Medical errors are a major concern in health care today. Errors in point-of-care testing (POCT) are particularly problematic because the test is conducted by clinical operators at the site of patient care and immediate medical action is taken on the results prior to review by the laboratory. The Performance Improvement Program at Baystate Health System, Springfield, Massachusetts, noted a number of identification errors occurring with glucose and blood gas POCT devices. Incorrect patient account numbers that were attached to POCT results prevented the results from being transmitted to the patient's medical record and appropriately billed. In the worst case, they could lead to results being transferred to the wrong patient's chart and inappropriate medical treatment. Our first action was to lock-out operators who repeatedly made identification errors (3-Strike Rule), requiring operators to be counseled and retrained after their third error. The 3-Strike Rule significantly decreased our glucose meter errors (p = 0.014) but did not have an impact on the rate of our blood gas errors (p = 0.378). Neither device approached our ultimate goal of zero tolerance. A Failure Mode and Effects Analysis (FMEA) was conducted to determine the various processes that could lead to an identification error. A primary source of system failure was the manual entry of 14 digits for each test, five numbers for operator and nine numbers for patient account identification. Patient barcoding was implemented to automate the data entry process, and after an initial familiarization period, resulted in significant improvements in error rates for both the glucose (p = 0.0007) and blood gas devices (p = 0.048). Despite the improvements, error rates with barcoding still did not achieve zero errors. Operators continued to utilize manual data entry when the barcode scan was unsuccessful or unavailable, and some patients were found to have incorrect patient account numbers due to hospital transfer, multiple wristbands on a single patient, and selection of expired account numbers from previous hospitalizations when printing the barcoded wristbands. Barcoding can thus improve the incidence of identification errors, but hospitals need to take additional steps to ensure successful barcode scanning and to verify that patient wristbands contain correct information. Implementation of patient barcoding was successful in significantly reducing identification errors with POCT, improving patient care, and enhancing interdisciplinary communication.