The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

Objectives: To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies.

Design: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS.

The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire.

Introduction: This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.

Method: Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD.

The development of a new measure of quality of life for children with congenital cardiac disease.

The purpose of the study was to develop a questionnaire measuring health-related R1 quality of life for children and adolescents with congenital heart disease, the ConQol, that would have both clinical and research applications. We describe here the process of construction of a questionnaire, the piloting and the development of a weighted scoring system, and data on the psychometric performance of the measure in a sample of 640 children and young people recruited via 6 regional centres for paediatric cardiology from across the United Kingdom. The ConQol has two versions, one designed for children aged from 8 to 11 years, and the other for young people aged from 12 to 16 years.

Eliciting social preference weights for Functional Assessment of Cancer Therapy-Lung health states.

Background: The Functional Assessment of Cancer Therapy-Lung (FACT-L) is a multidimensional measure of quality of life developed for use in the evaluation of interventions in lung cancer.

Objective: To develop a set of utility weights that could be used to convert FACT-L into a single index capable of being used in the economic analysis of clinical trial data.

Method: A core set of FACT-L items were valued in two versions of a 14-page postal survey of over 400 members of the UK general population.

A "new and improved" EQ-5D valuation questionnaire? Results from a pilot study.

Notwithstanding its widespread use, the standard questionnaire used to elicit visual analogue scale valuations for EQ-5D states is well known to suffer from problems with missing values (particularly for the state "dead") and logical inconsistencies. This contribution reports on efforts to redesign the questionnaire to overcome these problems and the results from its use in a pilot study. The redesigned questionnaire asks respondents to provide a numerical score for each state (instead of drawing lines to a visual analogue scale) and employs a new method for valuing "dead".