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Biomedical subjects

M Backhouse

Publications and source records attributed to M Backhouse.

6 recordsLinked to original sources
PubMed1998

Choice of NSAID and management strategy in rheumatoid arthritis and osteoarthritis. The impact on costs and outcomes in the UK.

OBJECTIVE: Although nonsteroidal anti-inflammatory drugs (NSAIDs) are an effective therapy for rheumatoid arthritis, they are associated with significant adverse effects, the management of which imposes additional costs on the healthcare system. Prescribing NSAIDs which have a lower risk of major adverse effects as the first-line NSAID for patients with rheumatoid arthritis and osteoarthritis may be expected to lead to an improvement in clinical outcomes and reduce overall treatment costs. This analysis examines data from a published randomised controlled trial of 5 NSAIDs to explore these hypotheses. DESIGN AND SETTING: Data from a clinical trial comparing 5 NSAIDs were combined with published cost data to construct 2 clinical decision models, reflecting alternative approaches to the management of major and minor adverse effects in the UK. INTERVENTIONS: The 5 NSAIDs evaluated in the analysis were nabumetone, diclofenac, ibuprofen, piroxicam and naproxen, although only the results for ibuprofen and nabumetone are reported. MAIN OUTCOME MEASURES AND RESULTS: The total cost of care per patient receiving nabumetone was estimated to be between 25 pounds sterling (Pound) and 41 Pounds more expensive than ibuprofen. In a hypothetical cohort of 100,000 patients, there were between 690 and 821 more major adverse effects using ibuprofen than nabumetone. The cost per life-year gained (LYG) from using nabumetone rather than ibuprofen ranged between 1880 Pounds and 2517 Pounds (1995 values), depending upon the management of adverse effects. CONCLUSIONS: These results indicate that: (i) prescribing the newer, currently more expensive, NSAIDs will not necessarily lead to cost savings; (ii) the management of adverse effects can have a significant impact on costs; and (iii) the additional cost may be justifiable in terms of the mortality and morbidity gains associated with the new lower-risk NSAIDs.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1996

The economic evaluation of the FIRST study: design of a prospective analysis alongside a multinational phase III clinical trial. Flolan International Randomized Survival 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.

Antihypertensive Agents↗
PubMed1996

Results of the economic evaluation of the first study. A multinational prospective economic evaluation. FIRST Investigators. Flolan International Randomized Survival Trial.

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.

Aged↗
PubMed1995

The analysis of censored treatment cost data in economic evaluation.

This article investigates the way in which the presence of censored cost data in clinical trials should dictate the inferential tests adopted when comparing treatment and nontreatment groups for the purpose of economic evaluation. The authors argue that the techniques of survival analysis are appropriate where censoring is present, and that bias will be imparted if cruder methods are used to analyze cost data, even if that data is drawn from a relevant population. The first section of the article discusses the problem of censoring and survival analysis, while the second examines three methods of dealing with censored cost data and possible biases resulting from them. The third section presents results from actual trial data using the three methods described in the preceding section. Conclusions are presented in section four, where it is argued that these methodological issues are likely to become more important as economists are called upon to evaluate the treatment of chronic conditions using data from clinical trials with finite end points.

Bias↗
PubMed1993

Assessing the economic benefits of antiherpes therapy.

Increasing pressures on health-care budgets mean that health-care treatments and programmes need not only to demonstrate that they are efficacious, but also that they deliver good value for money. In the context of pharmaceuticals it is likely that both in Australia and Ontario (Canada) evidence of cost effectiveness will become a mandatory requirement prior to reimbursement (government subsidy) of drugs. However, in most jurisdictions economic data will be one of a number of factors taken into account by decision makers, be they policy makers, members of formulary committees, or individual prescribers. Methods of economic evaluation have been developed for the assessment of healthcare treatments, but these have not been extensively applied to antiherpes therapy. However, this paper, based on a literature review of the clinical trials of acyclovir, shows that there are many indicators of potential economic benefit, depending on the clinical indication, in length or quality of life, savings in other health-care resources, or wider benefits (e.g., reductions in lost work time). If appropriate economic data are to be gathered in future for new antiherpes therapy, a more systematic approach is required, conducting economic evaluation alongside, or as an integral part of, clinical trials. This raises important logistical and methodological challenges. It is important that researchers acknowledge these challenges early so that they can be adequately addressed.

Acyclovir↗