A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer.

PURPOSE: Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. METHODS: The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis. RESULTS: During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual. CONCLUSION: The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02632435.

A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy.

PURPOSE: All vascular access strategies foradministering chemotherapy in early stage breast cancer (EBC) are associated with risks and benefits. As the most effective type of access is unknown a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. METHODS: The trial methodology utilized broad eligibility criteria and the integrated consent model incorporating oral consent. EBC patients receiving non-trastuzumab-containing chemotherapy were randomized to peripheral access or central line insertion. The a priori definition of feasibility was: > 25% of patients approached agreed to randomisation and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications. RESULTS: Of 159 patients approached, 150 (94.3%) agreed to randomisation, 77 (51.3%) were randomized to peripheral and 73 (48.7%) to central access. 6/26 (23.1%) of medical oncologists approached patients. Rates of complications per chemotherapy cycles in the peripheral vs central access groups with risk difference (RD) (95% CI) were: thrombotic events requiring anticoagulation [1 (0.3%) vs. 3 (1.0%), RD - 0.7(- 1.9,0.5)], line infections [0 (0%) vs. 1 (0.3%), RD - 0.3(- 0.9,0.3)], phlebitis [2 (0.6%) vs. 0 (0%), RD 0.3(- 0.3,0.8)], and tissue infiltrations [4 (1.1%) vs. 1 (0.3%), RD 0.8(- 0.4,2.1)]. Overall, 8.0% (6/75) and 7.7% (5/65) of patients had at least one of these complications in the peripheral and central access arms respectively [RD - 0.9(- 9.4,7.6)]. The study was terminated early due to slow accrual. CONCLUSION: While meeting its a priori feasibility criteria for patient engagement, the slow accrual means that conducting a large pragmatic trial would require overcoming the barriers to physician recruitment. TRIAL REGISTRATION: NCT02688998.

Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC).

PURPOSE: Optimal primary febrile neutropenia (FN) prophylaxis (i.e. ciprofloxacin or granulocyte-colony stimulating factors [G-CSF]) for patients receiving docetaxel-cyclophosphamide (TC) chemotherapy is unknown. We assessed the feasibility of using a novel pragmatic comparative effectiveness trial to compare these standard-of-care options. METHODS: Early-stage breast cancer patients receiving TC chemotherapy were randomised to either ciprofloxacin or G-CSF. Trial methodology consists of broad eligibility criteria, simply-defined endpoints, integrated consent model incorporating oral consent, and web-based randomisation in the clinic. Primary feasibility endpoints included patient and physician engagement (if > 50% of patients approached agree to participate and if > 50% of physicians approached patients for the study). Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process. RESULTS: Of 204 patients approached, 91.2% (186/204) agreed to randomisation. Sixteen of twenty (80%) participating medical oncologists randomised patients. Median patient age was 57.7 (range 31.8-84.1). The 186 patients received 557 cycles of chemotherapy. Overall incidences of first events by patient (n = 186) were as follows: FN (18/186, 21.43%), treatment-related hospitalisation (11/186, 13.10%), chemotherapy reduction (19/186, 22.62%), chemotherapy discontinuation (16/186, 19.05%), and chemotherapy delays (5/186, 5.95%). A total of 37.77% (69/186) of patients and 12.39% (69/557) of chemotherapy cycles had at least one of these first events. Patients were highly satisfied with the oral consent process. CONCLUSION: This study met its feasibility endpoints. This model offers a means of comparing standard-of-care treatments in a practical and cost-efficient manner. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov : NCT02173262.

Psychotic symptoms, functioning and coping in adolescents with mental illness.

BACKGROUND: Psychotic symptoms in the context of psychiatric disorders are associated with poor functional outcomes. Environmental stressors are important in the development of psychosis; however, distress may only be pathogenic when it exceeds an individual's ability to cope with it. Therefore, one interesting factor regarding poor functional outcomes in patients with psychotic symptoms may be poor coping. This paper aimed to address the question whether 1) psychotic symptoms are associated with poorer functioning and 2) whether poor coping moderated the association. METHODS: In a clinical case-clinical control study of 106 newly-referred adolescent patients with non-psychotic psychiatric disorders, coping was investigated using the Adolescents Coping Scale. Severity of impairment in socio-occupational functioning was assessed with the Children's Global Assessment Scale. RESULTS: Patients with non-psychotic psychiatric disorders and additional psychotic symptoms (N = 50) had poorer functioning and were more likely to use avoidance-oriented coping compared to patients with non-psychotic psychiatric disorders without psychotic symptoms (N = 56). No differences were found with respect to approach-oriented coping. When stratifying for poor/good coping, only those adolescent patients with psychotic symptoms who applied poor coping (i.e. less use of approach-oriented coping styles [OR 0.24, p < 0.015] and more use of avoidance-oriented coping [OR 0.23, p < 0.034]) had poorer functioning. However, these interactions were not significant. CONCLUSIONS: Non-adaptive coping and poorer functioning were more often present in adolescents with non-psychotic psychiatric disorders and additional psychotic symptoms. Due to small subgroups, our analyses could not give definitive conclusions about the question whether coping moderated the association between psychotic symptoms and functioning. Improvement of coping skills may form an important target for intervention that may contribute to better clinical and functional outcomes in patients with psychotic symptoms.

Staff experiences of wearing the Rainbow Badge in a paediatric hospital setting: a mixed-methods survey.

OBJECTIVE: This study aimed to assess staff's experience of wearing the Health Service Executive (HSE) Rainbow Badge, a symbol of inclusion for LGBTQ+ (lesbian, gay, bisexual, transgender, queer/questioning; + signifying inclusivity of all sexual and gender identities) people, in a paediatric hospital setting. DESIGN: This was a cross-sectional multisite observational study. Participants completed an anonymous online survey, consisting of open and closed-ended questions covering domains of: responses to the badge from staff and patients; experience and impact of wearing the badge; and further training needs. SETTING: All five sites (four clinical and one non-clinical) pertaining to the Children's Health Ireland healthcare group. PARTICIPANTS: All staff, clinical and non-clinical, who had signed up the HSE Rainbow Badge initiative were eligible to participate. RESULTS: A total of 151 eligible participants across a mix of disciplines participated, 29 (19.2%) of whom were members of the LGBTQ+ community. Over half (58.9%, n=89) of respondents said they learnt something new about barriers to care for LGBTQ+ young people from the initiative. Staff reported mostly positive responses to the badge; 5.1% reported mixed/negative responses from colleagues, 4.5% reported mixed/negative responses from young people and 3.7% reported mixed/negative responses from families. Open-ended questions were analysed using a thematic analysis framework. Five themes emerged: pride, a symbol of safety and inclusion, impact on workplace culture, awareness of LGBTQ+ issues and more to do for LGBTQ+ patients. CONCLUSIONS: This study demonstrates that the Rainbow Badge initiative increases staff awareness of LGBTQ+ issues and helps to create a safe, inclusive environment for staff, young people and families.

Cybersecurity and critical care staff: A mixed methods study.

INTRODUCTION: Cyberattacks on healthcare organisations are becoming increasingly common and represent a growing threat to patient safety. The majority of breaches in cybersecurity have been attributed to human error. Intensive care departments are particularly vulnerable to cyberattacks. The aim of this study was to investigate cybersecurity awareness, knowledge and behaviours among critical care staff. METHODS: This was a multi-site cross-sectional survey study administered to critical care staff. Cybersecurity awareness was evaluated using the validated HAIS-Q instrument. Knowledge and behaviours were evaluated by direct questioning and scenario-based multiple-choice questions. Free text options were also offered to respondents. Thematic analysis was performed on free text sections. RESULTS: Median scores of 12-15 in each of the HAIS-Q focus areas were achieved, indicating high levels of cybersecurity awareness among critical care staff. However, self-reported confidence in cybersecurity practices, especially identifying signs of cybersecurity breaches and reporting cybersecurity incidents, were relatively low. Participants responses to the scenarios demonstrated a lack of knowledge and awareness of some of the mechanisms of cyberattacks. Barriers to safe cybersecurity practices among staff that emerged from the qualitative analysis included: a lack of training and education; heavy workloads and staff fatigue; perceived lack of IT support and poor IT infrastructure. CONCLUSION: Critical care staff appear to have a high-level cybersecurity awareness. However, in practice safe cybersecurity practices are not always followed. ICU departments and hospitals must invest in the human aspect of cybersecurity to strength their cyber-defences and to protect patients.

Stress and coping in parents of newly born twins.

OBJECTIVE: Research indicates that parents of twins have poorer psychosocial outcomes than parents of singletons. Parents who have conceived using assisted reproductive technology (ART) have been found to be at higher risk of negative psychosocial outcomes compared to parents who have conceived spontaneously. The current study aimed to model the factors associated with parenting stress of newly-born twins, using the Transactional Model of Stress. METHODS: Data were collected using a cross-sectional survey design with participants identified from delivery records across Northern Ireland. Mothers and fathers (n = 104) of twins aged between 1 and 12 months old returned a questionnaire pack containing the Parenting Stress Index, Impact on the Family Scale-Financial Burden, Coping Orientation to Problems Experienced - Brief Version, Multidimensional Scale of Perceived Social Support, General Health Questionnaire and a demographic questionnaire. RESULTS: There were no differences on psychological outcomes between parents who had conceived via ART and those who conceived spontaneously. Regression analyses found that social interaction and support is an important variable in terms of the psychological outcomes experienced by parents of twins. CONCLUSION: Parents of newly-born twins regardless of the mode of conception should be considered an at risk group for parental distress. Support groups such as the Twins and Multiple Births Association could be important in providing that crucial social interaction and support that seems to be important in the emotional well-being of parents of twins.

Do we miss depressive disorders and suicidal behaviours in clinical practice?

This study involved a detailed standardized initial research assessment which was carried out with 100 young people aged 12-15 years newly referred to a child and adolescent mental health service. The assessment involved the K-SADS interview with the young person and their parent, the Strengths and Difficulties Questionnaire, the Clinical Global Impression Scale, and the Children's Global Assessment Scale. Diagnoses resulting from these 'research assessments' were compared with clinical diagnoses, which were determined by case note analysis and discussion with the key clinician. Results showed that a clinical diagnosis of depressive disorder was made in only one-third of those who received a 'research assessment' diagnosis of depressive disorder, and suicidality was missed in a significant proportion of cases. Those with a diagnosis of depressive disorder had significantly more problems, more comorbidity, more suicidality and greater functional impairment than those without. It is important to keep depression and suicidality in mind when assessing young people with complex mental health difficulties. Unless specific pointers are sought, it is easy to miss these, which may mean that vulnerable young people do not benefit from potentially effective treatments.

Who attends outpatient adolescent mental health services?

OBJECTIVES: This study set out to profile the diagnoses and level of suicidal behaviour of adolescents aged 12-15 years newly referred to a Child and Adolescent Mental Health Service (CAMHS). Information on the nature and range of disorders and level of functional impairment among adolescents attending outpatient CAMHS is important for service planning and development. METHODS: A total of 100 newly referred adolescents were assessed using the KSADS-PL standardised interview. Overall level of functional impairment was measured using The Clinical Global Impressions Scale and The Children's Global Assessment Scale. RESULTS: Results showed that the majority of adolescents had more than one disorder, with almost one quarter having four or more disorders. Behavioural disorders were the most common diagnostic category, followed by anxiety disorders, and affective disorders. Although relatively uncommon, levels of functional impairment were highest in those with psychotic disorders, followed by substance abuse disorders. The most common pattern of comorbid disorders were depressive disorders plus anxiety disorders, followed by anxiety disorders plus behavioural disorders and depressive disorders plus behavioural disorders. One quarter of the young people had engaged in suicidal acts in the six months prior to attendance, while this had been the case in over one half of those with a depressive disorder. CONCLUSION: This study showed that adolescents attending CAMHS tend to have multiple disorders, high levels of suicidality, and are significantly functionally impaired. These factors need to be taken into account in the development of effective treatments.