It takes a village to raise a child- A multidisciplinary approach to promoting paediatric health literacy in cystic fibrosis.

Background: In Northern Ireland, approximately 550 people with cystic fibrosis (PwCF) attend the regional paediatric and adult centres within the Belfast Health and Social Care Trust. This autosomal recessive chronic condition necessitates regular clinical monitoring and a high treatment burden, as well as time implications for the maintenance of respiratory devices. Development of health literacy skills at an early age and promoting children with CF (CwCF) to take an active role in their healthcare has many advantages relating to their long-term self-care in preparation for transition from paediatric to adult care, decision-making and partnership engagement with the CF-multidisciplinary team (CF-MDT).

BETA prime: a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors.

AdAPT-001 is an oncolytic adenovirus (OAV) with a transforming growth factor beta (TGF-ß) trap, which neutralizes the immunosuppressive and profibrotic cytokine, TGF-ß. The aim or purpose of this phase 1 study was to assess the safety and tolerability and, secondarily, the efficacy of AdAPT-001 after single intratumoral injection (IT) (Part 1) and multidose IT injection (Part 2) in patients with superficially accessible, advanced refractory solid tumors. Part 1 enrolled 9 patients with a 3 + 3 single dose-escalation safety run-in involving 2.

Data Management 101 for drug developers: A peek behind the curtain.

In drug development a frequently used phrase is "data-driven". Just as high-test gas fuels a car, so drug development "runs on" high-quality data; hence, good data management practices, which involve case report form design, data entry, data capture, data validation, medical coding, database closure, and database locking, are critically important. This review covers the essentials of clinical data management (CDM) for the United States.

REPLATINUM Phase III randomized study: RRx-001 + platinum doublet versus platinum doublet in third-line small cell lung cancer.

RRx-001 is a cysteine-directed anticancer alkylating agent with activity in a Phase II study in platinum refractory small cell lung cancer. Here, we describe the design of REPLATINUM, an open-label, Phase III trial. 120 patients with previously platinum-treated small cell lung cancer in third line will be randomized 1:1 to receive RRx-001 followed by four cycles of a platinum doublet, and then alternating cycles of RRx-001 and single agent platinum until progression versus four cycles of a platinum doublet.

A systematically structured review of biomarkers of dying in cancer patients in the last months of life; An exploration of the biology of dying.

Background: The Neuberger review made a number of recommendations to improve end of life care, including research into the biology of dying. An important aspect of the biology of dying is the identification of biomarkers as indices of disease processes. Biomarkers have the potential to inform the current, limited understanding of the dying process and assist clinicians in recognising dying, in particular how to distinguish dying from reversible acute deterioration.

Effectiveness of a hospital-initiated smoking cessation programme: 2-year health and healthcare outcomes.

Background: Tobacco-related illnesses are leading causes of death and healthcare use. Our objective was to determine whether implementation of a hospital-initiated smoking cessation intervention would reduce mortality and downstream healthcare usage.

Methods: A 2-group effectiveness study was completed comparing patients who received the 'Ottawa Model' for Smoking Cessation intervention (n=726) to usual care controls (n=641).

Economic evaluation of a hospital-initiated intervention for smokers with chronic disease, in Ontario, Canada.

Introduction: Cigarette smoking causes many chronic diseases that are costly and result in frequent hospitalisation. Hospital-initiated smoking cessation interventions increase the likelihood that patients will become smoke-free. We modelled the cost-effectiveness of the Ottawa Model for Smoking Cessation (OMSC), an intervention that includes in-hospital counselling, pharmacotherapy and posthospital follow-up, compared to usual care among smokers hospitalised with acute myocardial infarction (AMI), unstable angina (UA), heart failure (HF), and chronic obstructive pulmonary disease (COPD).

Cost-effectiveness of exercise programs in type 2 diabetes.

Background: A randomized controlled trial has shown that supervised, facility-based exercise training is effective in improving glycemic control in type 2 diabetes. However, these programs are associated with additional costs. This analysis assessed the cost-effectiveness of such programs.

Ottawa panel evidence-based clinical practice guidelines for aerobic walking programs in the management of osteoarthritis.

Objective: To update the Evidence-Based Clinical Practice Guidelines (EBCPGs) on aerobic walking programs for the management of osteoarthritis (OA) of the knee.

Data Sources: A literature search was conducted using the electronic databases MEDLINE, PubMed, and the Cochrane Library for all studies related to aerobic walking programs for OA from 1966 until February 2011.

Study Selection: The literature search found 719 potential records, and 10 full-text articles were included according to the selection criteria.

Effect of exercise training on physical fitness in type II diabetes mellitus.

Unlabelled: Few studies have compared changes in cardiorespiratory fitness between aerobic training only or in combination with resistance training. In addition, no study to date has compared strength gains between resistance training and combined exercise training in type II diabetes mellitus (T2DM).

Purpose: We evaluated the effects of aerobic exercise training (A group), resistance exercise training (R group), combined aerobic and resistance training (A + R group), and sedentary lifestyle (C group) on cardiorespiratory fitness and muscular strength in individuals with T2DM.

Effects of aerobic exercise, resistance exercise or both, on patient-reported health status and well-being in type 2 diabetes mellitus: a randomised trial.

Aims/hypothesis: The Diabetes Aerobic and Resistance Exercise (DARE) study showed that aerobic and resistance exercise training each improved glycaemic control and that a combination of both was superior to either type alone in patients with type 2 diabetes mellitus. Here we report effects on patient-reported health status and well-being in the DARE Trial.

Methods: We randomised 218 inactive participants with type 2 diabetes mellitus in parallel to 22 weeks of aerobic exercise (n = 51), resistance exercise (n = 58), combined aerobic and resistance exercise (n = 57) or no exercise (control; n = 52).

Cost-effectiveness of cardiac rehabilitation program delivery models in patients at varying cardiac risk, reason for referral, and sex.

Background: Little is known about the relative cost-effectiveness of different secondary prevention cardiac rehabilitation (CR) program designs or how cost-effectiveness is influenced by patient clinical and demographic characteristics. The purpose of the study was (i) to evaluate the incremental cost-effectiveness of a standard 3-month CR program (SCR) versus a program distributed over 12 months (distributed CR, DCR); and (ii) to determine the effect of patient demographic characteristics (cardiac risk, cardiac diagnosis, sex) on incremental cost-effectiveness.

Methods: A two group cost-effectiveness analysis was conducted alongside a randomized controlled trial.

Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial.

Background: Previous trials have evaluated the effects of aerobic training alone and of resistance training alone on glycemic control in type 2 diabetes, as assessed by hemoglobin A1c values. However, none could assess incremental effects of combined aerobic and resistance training compared with either type of exercise alone.

Objective: To determine the effects of aerobic training alone, resistance training alone, and combined exercise training on hemoglobin A1c values in patients with type 2 diabetes.

Economic evaluation of cardiac rehabilitation: a systematic review.

Background: Economic evaluation is an important tool in the evaluation of competing healthcare interventions. Little is known about the economic benefits of different cardiac rehabilitation program delivery models.

Design: The goal of this study was to review and evaluate the methodological quality of published economic evaluations of cardiac rehabilitation services.

Impact of program duration and contact frequency on efficacy and cost of cardiac rehabilitation: results of a randomized trial.

Background: Secondary prevention through cardiac rehabilitation (CR) has been recommended for most patients with coronary artery disease (CAD). Although generally reimbursed for 3 months, to date, optimal CR program duration and frequency of patient contact has yet to be identified. This study compared standard (33 sessions for 3 months) versus distributed (33 sessions for 12 months) CR for effects on exercise variables, risk factors, health-related quality of life (HRQL), depressive symptoms, and direct costs to the cardiac health care system.

State of the Art Compendium: Canadian Thoracic Society recommendations for the management of chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is a common cause of disability and death in Canada. Moreover, morbidity and mortality from COPD continue to rise, and the economic burden is enormous. The main goal of the Canadian Thoracic Society's evidence-based guidelines is to optimize early diagnosis, prevention and management of COPD in Canada.

Borrelia burgdorferi-specific immune complexes in acute Lyme disease.

Context: Diagnosis of infection with Borrelia burgdorferi, the cause of Lyme disease (LD), has been impeded by the lack of effective assays to detect active infection.

Objective: To determine whether B. burgdorferi-specific immune complexes are detectable during active infection in LD.