Mark Sculpher

Long-term results of RITA-1 trial: clinical and cost comparisons of coronary angioplasty and coronary-artery bypass grafting

Summary Background Percutaneous transluminal coronary angioplasty (PTCA) and coronary-artery bypass grafting (CABG) are both effective intervention strategies for patients with coronary heart disease. We report comparative long-term clinical and health-service cost findings for these interventions in the first Randomised Intervention Treatment of Angina (RITA-1) trial. Methods 1011 patients with coronary heart disease (45% single-vessel, 55% multivessel) were randomly assigned initial treatment strategies of PTCA or CABG. Information on clinical events, subsequent intervention, symptomatic status, exercise testing, and use of health-care resources is available for a median 6·5 years of follow-up. Analyses were by intention to treat. Findings The predefined primary endpoint of death or nonfatal myocardial infarction occurred in 87 (17%) PTCA-group patients and 80 (16%) CABG-group patients (p=0·64). Similarly, there was no significant treatment difference in deaths alone (39 PTCA, 45 CABG), of which 46% were cardiac related. In both groups, the risk of cardiac death or myocardial infarction was more than five times higher in the first year than in subsequent years of follow-up. 26% of patients assigned PTCA subsequently also had CABG, and a further 19% required additional nonrandomised PTCA. Most of these reinterventions occurred within a year of randomisation, and from 3 years onwards the reintervention rate averaged 4% per year. In the CABG group the reintervention rate averaged 2% per year. The prevalence of angina was consistently higher in the PTCA group, with an absolute average 10% excess compared with the CABG group (p Interpretation Initial strategies of PTCA and CABG led to similar long-term results in terms of survival and avoidance of myocardial infarction and to similar long-term healthcare costs. Choice of approach, therefore, rests on weighing the more invasive nature of CABG against the greater risk of recurrent angina and reintervention over many years after PTCA.

Randomised trial comparing hysterectomy and transcervical endometrial resection: effect on health related quality of life and costs two years after surgery.

Objective To compare the impact of endometrial resection and abdominal hysterectomy on a range of health outcomes and health service costs, based on longer term follow up of patients randomised to a clinical trial.

The Episode-Free Day as a Composite Measure of Effectiveness

SummaryThe construction of a composite effectiveness measure was explored using clinical data collected routinely in trials of drug therapies for asthma. The measure is the episode-free day (EFD), where an ‘episode’ is either an asthma attack, the need for rescue medication, sleep disturbance caused by asthma, or an adverse event. The EFD measure was used in a retrospective cost-effectiveness analysis of a previous Phase III controlled clinical trial of formoterol versus salbutamol, in which 145 patients with bronchial asthma were randomised to receive maintenance therapy with either inhaled formoterol or inhaled salbutamol over a 12-week period. Average and incremental cost-effectiveness ratios were assessed for the 2 drugs in terms of the total expected cost of drug plus rescue therapy, and EFD rates. The analysis suggests that, with relatively little addition to clinical data collection, economically and clinically meaningful composite measures can be constructed to assist in making cost-effectiveness comparisons between alternative asthma therapies.

Results of the economic evaluation of the first study - A multinational prospective economic evaluation

We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

The economic evaluation of the FIRST study : design of a prospective analysis alongside a multinational phase III clinical trial

Prospective economic assessments of new pharmaceutical therapies are increasingly being incorporated into phase III clinical trials. We report on the design of an economic evaluation integrated into the Flolan International Randomized Survival Trial (FIRST). Economic evaluation was considered a critical component of the assessment of this therapy given the resources required to administer epoprostenol (Flolan), a therapy that would require lifelong continuous intravenous infusion. Economic secondary endpoints were incorporated in the clinical trial. The economic evaluation of the treatment was integrated into all aspects of study development, including study design, implementation, and monitoring. Since this was a multinational trial, special care was required to ensure that the protocol design was appropriate for all study countries. The economic assessment required the development of several methodologic components: a set of background economic concepts to guide protocol development, a set of resource items to be recorded when required for study participants; a set of data collection instruments for assessment of health-related quality of life for study patients; and a protocol for a resource costing exercise for the study. We report the data elements included in the study design, as well as a discussion of some of the issues faced in developing the economic evaluation for this trial.

A survey of women's preferences regarding alternative surgical treatments for menorrhagia.

Menorrhagia represents a major health burden to a large number of women in the UK. A range of medical and surgical treatments is now available for the condition, but each has its own advantages and limitations.

Commentary: Markov models of medical prognosis

Named after a turn of the century Russian mathematician, Markov models are used to describe stochastic processes–that is, random processes that evolve over time. Increasingly, such models are being applied in medical and health services research.1 Hogan et al use a Markov model to address an epidemiological question; such methods have also been used in clinical2 and economic evaluations.3 4 The most common application of Markov models in health is to characterise the possible prognoses experienced by a given group of patients. This entails modelling the progress over time of a notional group of patients through a finite number of health states. Patients are initially placed in one of the health states, and the probabilities of transition to …