Gynaecological cancer surveillance for women with Lynch syndrome: systematic review and cost-effectiveness evaluation.

Background: Lynch syndrome is an inherited condition which leads to an increased risk of colorectal, endometrial and ovarian cancer. Risk-reducing surgery is generally recommended to manage the risk of gynaecological cancer once childbearing is completed. The value of gynaecological colonoscopic surveillance as an interim measure or instead of risk-reducing surgery is uncertain.

A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

Objective: To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano.

Summary Background Data: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain.

Methods: Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure).

Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy.

Objective: To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong.

Methods: A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI).

Prophylactic levofloxacin to prevent infections in newly diagnosed symptomatic myeloma: the TEAMM RCT.

Background: Myeloma causes profound immunodeficiency and recurrent serious infections. There are approximately 5500 new UK cases of myeloma per annum, and one-quarter of patients will have a serious infection within 3 months of diagnosis. Newly diagnosed patients may benefit from antibiotic prophylaxis to prevent infection.

Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.

Background: Myeloma causes profound immunodeficiency and recurrent, serious infections. Around 5500 new cases of myeloma are diagnosed per year in the UK, and a quarter of patients will have a serious infection within 3 months of diagnosis. We aimed to assess whether patients newly diagnosed with myeloma benefit from antibiotic prophylaxis to prevent infection, and to investigate the effect on antibiotic-resistant organism carriage and health care-associated infections in patients with newly diagnosed myeloma.

Toward a Framework for Outcome-Based Analytical Performance Specifications: A Methodology Review of Indirect Methods for Evaluating the Impact of Measurement Uncertainty on Clinical Outcomes.

Background: For medical tests that have a central role in clinical decision-making, current guidelines advocate analytical performance specifications. Given that empirical (clinical trial-style) analyses are often impractical or unfeasible in this context, the ability to set such specifications is expected to rely on indirect studies to calculate the impact of test measurement uncertainty on downstream clinical, operational, and economic outcomes. Currently, however, a lack of awareness and guidance concerning available alternative indirect methods is limiting the production of outcome-based specifications.

Anal fistula plug versus surgeon's preference for surgery for trans-sphincteric anal fistula: the FIAT RCT.

Background: The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported.

Objectives: To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas.

Cost-Effectiveness of Pain Management Strategies in Advanced Cancer.

Objectives: Uncontrolled pain in advanced cancer is a common problem and has significant impact on individuals' quality of life and use of healthcare resources. Interventions to help manage pain at the end of life are available, but there is limited economic evidence to support their wider implementation. We conducted a case study economic evaluation of two pain self-management interventions (PainCheck and Tackling Cancer Pain Toolkit [TCPT]) compared with usual care.

Developing and feasibility testing of data collection methods for an economic evaluation of a supported selfmanagement programme for adults with a learning disability and type 2 diabetes.

Background: The challenges of conducting research with hard to reach vulnerable groups are particularly pertinent for people with learning disabilities. Data collection methods for previous cost and cost-effectiveness analyses of health and social care interventions targeting people with learning disabilities have relied on health care/health insurance records or data collection forms completed by the service provider rather than by people with learning disabilities themselves. This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported self-management programme for people with mild/moderate learning disabilities and type 2 diabetes.

Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy.

Objectives: To compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sjögren's syndrome (PSS) in a multicentre, multiobserver phase III trial substudy.

Methods: Subjects consenting to SGUS were randomised to rituximab or placebo given at weeks 0, 2, 24 and 26, and scanned at baseline and weeks 16 and 48. Sonographers completed a 0-11 total ultrasound score (TUS) comprising domains of echogenicity, homogeneity, glandular definition, glands involved and hypoechoic foci size.

Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial.

Objective: Treat-to-target approaches have proved to be effective in rheumatoid arthritis, but have not been studied in psoriatic arthritis (PsA). This study was undertaken to examine the cost-effectiveness of tight control (TC) of inflammation in early PsA compared to standard care.

Methods: Cost-effectiveness analyses were undertaken alongside a UK-based, open-label, multicenter, randomized controlled trial.

Patient Preferences for Pain Management in Advanced Cancer: Results from a Discrete Choice Experiment.

Background: Pain from advanced cancer remains prevalent, severe and often under-treated.

Aim: The aim of this study was to conduct a discrete choice experiment with patients to understand their preferences for pain management services and inform service development.

Methods: Focus groups were used to develop the attributes and levels of the discrete choice experiment.

Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome.

Objective: To investigate whether rituximab, an anti-B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjögren's syndrome (SS).

Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that included health economic analysis. Anti-Ro-positive patients with primary SS, symptomatic fatigue, and oral dryness were recruited from 25 UK rheumatology clinics from August 2011 to January 2014.

The Cost Effectiveness of Docetaxel and Active Symptom Control versus Active Symptom Control Alone for Refractory Oesophagogastric Adenocarcinoma: Economic Analysis of the COUGAR-02 Trial.

Background: The COUGAR-02 trial recently showed survival and quality-of-life benefits of docetaxel and active symptom control (DXL + ASC) over active symptom control (ASC) alone in patients with refractory oesophagogastric adenocarcinoma.

Aim: The aim of this study was to conduct an economic evaluation conforming to National Institute for Health and Care Excellence (NICE) technology appraisal guidance to evaluate the cost effectiveness of DXL + ASC versus ASC from the perspective of the English National Health Service (NHS).

Methods: Cost-utility analyses were conducted using trial data.

The economic burden of cancer in the UK: a study of survivors treated with curative intent.

Objective: We aim to describe the economic burden of UK cancer survivorship for breast, colorectal and prostate cancer patients treated with curative intent, 1 year post-diagnosis.

Methods: Patient-level data were collected over a 3-month period 12-15 months post-diagnosis to estimate the monthly societal costs incurred by cancer survivors. Self-reported resource utilisation data were obtained via the electronic Patient-reported Outcomes from Cancer Survivors system and included community-based health and social care, medications, travel costs and informal care.

The role of the senior health care worker in critical care.

This article identifies that the introduction of the support worker role in the critical care team facilitates flexibility when organizing and managing patient care. Qualified nurses' time can be used more effectively, enhancing the quality of the patient care delivered. Aspects of the qualified nurses' workload in critical care can be shared and delegated successfully to unqualified staff.