Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE.

OBJECTIVE: This study evaluated the effect of cognitive behavioral therapy (CBT) plus lifestyle counseling in primary care on hemoglobin A1c (HbA1c) in rural adult patients with type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. RESEARCH DESIGN AND METHODS: This study was a randomized controlled trial of a 16-session severity-tailored CBT plus lifestyle counseling intervention compared with usual care. Outcomes included changes in HbA1c, RRD, depressive symptoms, self-care behaviors, and medication adherence across 12 months. RESULTS: Patients included 139 diverse, rural adults (mean age 52.6 ± 9.5 years; 72% black; BMI 37.0 ± 9.0 kg/m2) with T2D (mean HbA1c 9.6% [81 mmol/mol] ± 2.0%) and comorbid depressive or distress symptoms. Using intent-to-treat analyses, patients in the intervention experienced marginally significant improvements in HbA1c (-0.92 ± 1.81 vs. -0.31 ± 2.04; P = 0.06) compared with usual care. However, intervention patients experienced significantly greater improvements in RRD (-1.12 ± 1.05 vs. -0.31 ± 1.22; P = 0.001), depressive symptoms (-3.39 ± 5.00 vs. -0.90 ± 6.17; P = 0.01), self-care behaviors (1.10 ± 1.30 vs. 0.58 ± 1.45; P = 0.03), and medication adherence (1.00 ± 2.0 vs. 0.17 ± 1.0; P = 0.02) versus usual care. Improvement in HbA1c correlated with improvement in RRD (r = 0.3; P = 0.0001) and adherence (r = -0.23; P = 0.007). CONCLUSIONS: Tailored CBT with lifestyle counseling improves behavioral outcomes and may improve HbA1c in rural patients with T2D and comorbid depressive and/or RRD symptoms.

Evaluation of the current landscape of respiratory nurse specialists in the UK: planning for the future needs of patients.

INTRODUCTION: The National Health Service currently faces significant challenges and must optimise effective workforce planning and management. There are increasing concerns regarding poor workforce planning for respiratory medicine; a greater understanding of the role of respiratory nurse specialists will inform better workforce planning and management. METHODS: This was a survey study. Two surveys were administered: an organisational-level survey and an individual respiratory nurse survey. RESULTS: There were 148 and 457 respondents to the organisational and individual nurse survey, respectively. Four main themes are presented: (1) breadth of service provided; (2) patient care; (3) work environment; and (4) succession planning. The majority of work conducted by respiratory nurse specialists relates to patient care outside the secondary care setting including supporting self-management in the home, supporting patients on home oxygen, providing hospital-at-home services and facilitating early discharge from acute care environments. Yet, most respiratory nursing teams are employed by secondary care trusts and located within acute environments. There was evidence of multidisciplinary working, although integrated care was not prominent in the free-text responses. High workload was reported with one-quarter of nursing teams short-staffed. Respiratory nurses reported working unpaid extra hours and a lack of administrative support that often took them away from providing direct patient care. Nearly half of the present sample either plan to retire or are eligible for retirement within 10 years. CONCLUSIONS: This survey report provides a current snapshot of the respiratory nurse specialist workforce in the UK. This workforce is an ageing population; the results from this survey can be used to inform succession planning and to ensure a viable respiratory nurse specialist workforce in future.

Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation.

BACKGROUND: There are no completed randomised trials of the use of corticosteroids in patients with severe influenza infection. Corticosteroid use in influenza is widespread, non-systematic and marked by controversy. A recent meta-analysis of observational studies of adjuvant corticosteroids in influenza found an association with increased mortality but there were important concerns regarding the risks of bias. OBJECTIVES: To (1) evaluate whether or not low-dose corticosteroids given as an adjunct to standard treatment is beneficial in patients who are hospitalised with severe pandemic influenza and (2) develop an 'off-the-shelf' clinical trial that is ready to be activated in a future pandemic. DESIGN: Multicentre, pragmatic, blinded, randomised placebo-controlled trial. SETTING: Thirty to 40 hospitals in the UK. PARTICIPANTS: Adults (≥ 16 years) admitted to hospital with an influenza-like illness during a pandemic. INTERVENTION: Five-day course of dexamethasone (Dexsol®, Rosemont Pharmaceuticals Ltd) 6 mg daily, started within 24 hours of admission. MAIN OUTCOME MEASURE: Admission to Intensive Care Unit, or death, within 30 days of admission to hospital. RESULTS: This trial has not yet been activated. It is currently set up with full ethics and regulatory approvals in place, ready for rapid activation at the onset of the next pandemic. Hurdles to setting up a pandemic trial include planning for pandemic-level pressures on UK NHS resources and co-enrolment of patients to multiple pandemic studies, ensuring adequate geographical distribution of participating sites, maintaining long-term low-level engagement with site investigators, addressing future trial-specific training needs of local investigators and resilience planning in trial management. Identified threats to trial delivery include changes to research capabilities or policies during the hibernation phase, lack of staff resources during a pandemic and the influence of media at the time of a pandemic. A mismatch in the approach to informed consent required by current regulations to that preferred by patients and the public was identified. CONCLUSIONS: This study demonstrates that advance set-up of a trial to be conducted during a pandemic, with full regulatory approvals in place, is possible. Regular review during the hibernation phase will be required. This study serves as a model for the development of other 'off-the-shelf' trials as part of preparedness planning for public health emergencies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72331452. European Union Drug Regulating Authorities Clinical Trials number: 2013-001051-12. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 16. See the NIHR Journals Library website for further project information.