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Biomedical subjects

J Hutton

Publications and source records attributed to J Hutton.

At least 37 records · Page 2Linked to original sources
PubMed2000

A comparison of the cost-effectiveness of stroke care provided in London and Copenhagen.

OBJECTIVES: This study compared the relative cost-effectiveness of stroke care provided in London and Copenhagen. METHODS: Hospitalized stroke patients at centers in London (1995-96) and Copenhagen (1994-95) were included. Each patient's use of hospital and community health services was recorded for 1 year after stroke. Center-specific unit costs were collected and converted into dollars using the Purchasing Power Parity Index. An incremental cost-effectiveness ratio (ICER) was calculated comparing a Copenhagen model of stroke care to a London model, using regression analysis to adjust for case-mix differences. RESULTS: A total of 625 patients (297 in Copenhagen, 328 in London) were included in the analysis. Most patients in London (85%) were admitted to general medical wards, with 26% subsequently transferred to a stroke unit. In Copenhagen, 57% of patients were directly admitted to a stroke or neurology unit, with 23% then transferred to a separate rehabilitation hospital. The average length of total hospital stay was 11 days longer in Copenhagen. Patients in Copenhagen were less likely to die than those in London; for patients with cerebral infarction the hazard ratio after case-mix adjustment was 0.53 (95% CI from 0.35 to 0.80). However, a lower proportion of patients with hemorrhagic stroke died in London. The ICER of using the Copenhagen compared with the London model of care ranged from $21,579 to $37,444 per life-year gained for patients with cerebral infarctions. CONCLUSIONS: The ICERs of the Copenhagen compared with the London model of care were within a range generally regarded as cost-effective.

Aged↗
PubMed2000

Intravascular ultrasound-guided interventions in coronary artery disease: a systematic literature review, with decision-analytic modelling, of outcomes and cost-effectiveness.

BACKGROUND: Intravascular ultrasound (IVUS) is the generic name for any ultrasound technology used in vivo within the blood vessels. More specifically, intracoronary ultrasound enables imaging of the coronary arteries from within the lumen. This review concentrates on the role of intracoronary ultrasound as an adjunct to interventional cardiology. OBJECTIVES: (1) To identify the literature on IVUS for guiding coronary interventions, and to synthesise evidence about outcomes compared with outcomes when IVUS guidance has not been used. (2) To use this evidence, together with other information about costs and outcomes, to model the cost effectiveness of IVUS guidance. (3) To synthesise the evidence on the reproducibility of measurements of cross-sectional area made using IVUS. METHODS DATA SOURCES: (1) Electronic searches of MEDLINE, EMBASE, Science Citation Index, Index to Scientific and Technical Proceedings, Engineering Compendex, Engineering Page One, Cochrane Library, Inside (British Library), 1990-98. (2) Contacting experts and centres of expertise, 1990-99. (3) Internet search, 1990-99. METHODS STUDY SELECTION: Studies of IVUS-guided coronary interventions performed on humans were included in the review. Non-English language studies were also included when they covered IVUS-guided stenting or angioplasty. Control evidence regarding outcomes without IVUS guidance was sought only from randomised controlled trials (RCTs). Studies investigating the reproducibility of measurements of cross-sectional area were included only if the results were expressed in terms of the mean and standard deviation of paired differences. METHODS DATA EXTRACTION: Checklists that covered study details, patient characteristics and results were completed independently by three reviewers. Consensus was reached on any disagreements. Local data were gathered on the costs of IVUS-guided stenting. METHODS DATA SYNTHESIS: Overall event rates were calculated by pooling patient results from the included studies. A decision-analytic model was used to combine information from the literature with cost estimates, in order to predict cost-effectiveness in terms of cost per restenosis event avoided by the use of IVUS guidance. The analysis was performed from the perspective of the healthcare provider. Sensitivity analysis was undertaken. A simple extrapolation was made to long-term outcome so that cost-utility (using quality-adjusted life years (QALYs)) could be estimated. The minimum detectable change in cross-sectional area was estimated from the reproducibility results. RESULTS: Only one study on IVUS-guided angioplasty satisfied the inclusion criteria, and there were no studies on IVUS-guided atherectomy or other IVUS-guided interventions that satisfied the inclusion criteria. Of the 15 articles on IVUS-guided stenting that satisfied the inclusion criteria, seven presented data on outcomes at 6 months post-intervention. The angiographic restenosis rate was 16 +/- 1%. This compared with 24 +/- 2% derived from five articles on stenting without IVUS guidance. Data for follow-up periods longer than 6 months were presented in only two studies. Data from a total of five studies were included in the decision-analytic model. The cost per restenosis event avoided was 1545 pound sterling. After extrapolation to long-term outcome, the calculated cost per QALY was 6438 pound sterling. The baseline QALY gain was only 0.03 years. Sensitivity analysis resulted in large differences between the best- and worst-case scenarios, for example, from a saving of 5000 pound sterling to a cost of 24,000 pound sterling restenosis event avoided. The smallest changes in cross-sectional area that could be measured were 1.6 mm2 by a single observer and 1.9 mm2 by different observers. CONCLUSIONS: Implications for healthcare: The evidence available is too weak for there to be any reliable implications for clinical practice. (ABSTRACT TRUNCATED)

Algorithms↗
PubMed1999

The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials.

Recent cases of fraud in clinical trials have attracted considerable media attention, but relatively little reaction from the biostatistical community. In this paper we argue that biostatisticians should be involved in preventing fraud (as well as unintentional errors), detecting it, and quantifying its impact on the outcome of clinical trials. We use the term 'fraud' specifically to refer to data fabrication (making up data values) and falsification (changing data values). Reported cases of such fraud involve cheating on inclusion criteria so that ineligible patients can enter the trial, and fabricating data so that no requested data are missing. Such types of fraud are partially preventable through a simplification of the eligibility criteria and through a reduction in the amount of data requested. These two measures are feasible and desirable in a surprisingly large number of clinical trials, and neither of them in any way jeopardizes the validity of the trial results. With regards to detection of fraud, a brute force approach has traditionally been used, whereby the participating centres undergo extensive monitoring involving up to 100 per cent verification of their case records. The cost-effectiveness of this approach seems highly debatable, since one could implement quality control through random sampling schemes, as is done in fields other than clinical medicine. Moreover, there are statistical techniques available (but insufficiently used) to detect 'strange' patterns in the data including, but no limited to, techniques for studying outliers, inliers, overdispersion, underdispersion and correlations or lack thereof. These techniques all rest upon the premise that it is quite difficult to invent plausible data, particularly highly dimensional multivariate data. The multicentric nature of clinical trials also offers an opportunity to check the plausibility of the data submitted by one centre by comparing them with the data from all other centres. Finally, with fraud detected, it is essential to quantify its likely impact upon the outcome of the clinical trial. Many instances of fraud in clinical trials, although morally reprehensible, have a negligible impact on the trial's scientific conclusions.

Biometry↗
PubMed1999

Assessing the potential cost effectiveness of pneumococcal vaccines in the US: methodological issues and current evidence.

Pneumococcal disease imposes a notable burden on society, particularly in the elderly and those at high risk of complications. Preventive strategies, especially vaccines, are possibly the best way to minimise such a burden. We report on the conduct and results of a preliminary exploratory review of the economics of pneumococcal vaccines in the elderly population in the US. After extensive electronic and manual searches, we identified 5 economic evaluations that fulfilled our study criteria. From these we extracted key economic variables and assessed the quality of the studies against the criteria in the checklist for authors and peer reviewers of economic submissions to the British Medical Journal. We found variation of quality of study design such as a lack of clarity in the treatment of indirect costs and a failure to present the data on resource use and costs separately. We carried out supplementary searches to assess the quality of the epidemiological and efficacy evidence upon which the economic models were based and found contradictory evidence of effects of the vaccines, which included the results of 2 meta-analyses. One of these meta-analyses reported that retrospective studies, especially case-control studies, tended to underestimate the protective efficacy of the vaccine by as much as 20%. We believe that a well resourced Cochrane review of the clinical evidence of the effects of the vaccines should be carried out before any further economic studies. No more economic modelling should take place before such a review is undertaken.

Bacterial Vaccines↗
PubMed1999

Cost-effectiveness analysis of antiplatelet therapy in the prevention of recurrent stroke in the UK. Aspirin, dipyridamole and aspirin-dipyridamole.

OBJECTIVES: To evaluate the cost effectiveness from a UK health and social services perspective of antiplatelet therapies tested in the Second European Stroke Prevention Study (ESPS-2) in preventing recurrent stroke. To demonstrate the value of modelling studies in this area. DESIGN AND SETTING: A decision-analytic model was developed to evaluate health outcomes and associated costs. Sources of data for efficacy, adverse events, background event risks, disability and mortality were ESPS-2, the Oxfordshire Community Stroke Project and UK national statistics. Published national unit costs were applied to clinician panel estimates of resource use for acute stroke, rehabilitation and long term care. Outcome measures were strokes or disabled life-years averted, and disability-free, stroke-free or quality-adjusted life-years gained. PATIENTS AND INTERVENTIONS: 30-day survivors of ischaemic stroke treated with low dose aspirin, modified-release dipyridamole; the coformulation of low dose aspirin plus modified-release dipyridamole, or no antiplatelet therapy. MAIN OUTCOME MEASURES AND RESULTS: The model predicted that over 5 years the coformulation prevented 29 more strokes than aspirin alone per 1000 patients, at an additional cost of 1900 Pounds per stroke averted (1996 values). Over 5 years, each antiplatelet therapy was cost saving compared with no therapy. Results were sensitive to the cost of acute care, the cost of long term care of disabled stroke survivors, the effectiveness of therapy and the background risk of recurrent stroke. In sensitivity analyses, the cost effectiveness did not exceed 7000 Pounds per stroke averted or 11,000 Pounds per quality-adjusted life-year (QALY) gained, except when varying the effectiveness parameter. CONCLUSIONS: Application of a decision-analytic model to the results of ESPS-2 indicated that first-line therapy with the coformulation of modified-release dipyridamole and low dose aspirin to patients with a previous ischaemic stroke is likely to generate significant health benefits at modest extra costs to health and social services. The extra costs of treatment are balanced by the savings in future costs of acute care and long term care of the disabled. Future economic evaluations in this area should pay particular attention to the cost perspective, the duration of analysis, the selection of trials from which effectiveness data are derived, and the impact of the pooling of outcome events with potentially different economic consequences.

Aged↗
PubMed1998

Cost-utility model comparing docetaxel and paclitaxel in advanced breast cancer patients.

Relevant data from direct comparisons in clinical trials are not available for economic evaluations of docetaxel and paclitaxel in the management of metastatic breast cancer. A modified Markov model is used to estimate the incremental cost in US$ per quality-adjusted life-year (QALY) for docetaxel versus paclitaxel in managing metastatic breast cancer patients in the US. The model incorporates the latest available clinical trial data (response rates of 47.8% for docetaxel and 25% for paclitaxel, chemotherapy-specific toxicities, time to progression, and 1-year survival) from studies against other comparators. Medical care resources were estimated by US oncologists and costed using US data sources. Utility scores were obtained from 29 US oncology nurses. The base case and subsequent sensitivity analyses show that docetaxel management of advanced breast cancer is more costly per patient but yields higher health benefits than paclitaxel therapy. The cost per QALY gained by docetaxel is $8615, and ranges between $3943 and $9416 in sensitivity analyses. These results confirm those of an earlier model using preliminary data and compare favorably with other cost-utility results in this patient group.

Antineoplastic Agents, Phytogenic↗
PubMed1997

The identification of bias in studies of the diagnostic performance of imaging modalities.

The demand for evidence-based healthcare is increasing nationally and internationally and it is equally necessary in both diagnostic and therapeutic practice. Evidence may be collected and combined by means of a systematic literature review of published and unpublished data on a well-defined topic. The output of such reviews is then available to guide health policy, influence good practice or direct research. Published guidelines are available on the performance of systematic reviews, especially those of randomized controlled trials. Although there is an extensive literature base of research data in diagnostic imaging there are few such trials, but it is still possible to perform systematic reviews. With the alternative study designs encountered it is important to be aware of the main threats to study validity. In this paper the biases likely to be encountered in studies of diagnostic performance are reviewed, with particular reference to diagnostic imaging tests. The biases are sub-divided into three categories. The first category is patient selection and covers the validity of generalizing results beyond the study population. The other two, concerning study design and execution and the interpretation of results, affect the likely validity of the results of a study. An understanding of these factors is an essential prerequisite for those undertaking or using a systematic literature review in the field of diagnostic imaging. The definitions form the foundations of a defensible review protocol.

Bias↗
PubMed1996

A new decision model for cost-utility comparisons of chemotherapy in recurrent metastatic breast cancer.

In the absence of comparative clinical and pharmacoeconomic trial data for docetaxel versus paclitaxel as second-line therapy for patients with anthracycline-resistant metastatic breast cancer, a computer-based decision-analysis model was designed to evaluate the comparative utility to patients of these two taxoids. The model used the Markov process to analyse disease states (response, stable disease, progressive disease) and toxicities (acute, cumulative) for each treatment during the period from commencement of up to six 3-weekly cycles of chemotherapy, to death. A cost-utility analysis was carried out using the model, with a probability, a cost and a utility determined for each health state. Response rates were obtained from clinical trial data supplemented by expert clinical opinion. Costs were taken from UK national databases and published sources and the published UK prices of docetaxel and paclitaxel. Utilities for the various health states were established by use of standard gamble and visual analogue methods assessed by 30 oncology nurses in the UK who were acting as proxy patients. The results of the model showed that response rate is the key parameter determining the utility and cost utility of treatments for metastatic breast cancer. Although the total per-patient cost associated with docetaxel was marginally higher than that for paclitaxel (8233 pounds vs 8013 pounds), the higher response rate associated with docetaxel produced an improvement in utility to the patient at an incremental healthcare cost that is acceptable according to available defined limits. Sensitivity analyses revealed that, although the model was sensitive to changes in response rate and drug costs, the cost-utility ratio for docetaxel versus paclitaxel varied within acceptable limits in response to all likely changes in key parameters. In summary, in the base case used in this model, docetaxel produces a substantially larger utility benefit than paclitaxel, at a small additional cost per QALY gained (equivalent to 7 pounds per additional day of perfect health).

Breast Neoplasms↗
PubMed1995

Technology and disability. Assessment needs and potential.

In assessing technologies for disabled people, the aims of habilitative or rehabilitative interventions, the concepts of disability and handicap, and the potential of existing and emerging technologies in various social arenas, as well as the structure of service delivery systems, are of importance. A discussion of these issues in the light of previous work on cost and effectiveness in the field is given.

Persons with Disabilities↗
PubMed1995

Measurements of blood pressure, oedema and proteinuria in a pregnant population of New Zealand.

This is the first report of the largest study of blood pressure measurement in pregnancy in a New Zealand population using standardized definitions and methodology. Over 3,800 women who delivered in an 8-month period in the Wellington region were included in the study. Blood pressure measurement and the presence of oedema and proteinuria were recorded from booking until delivery and in the puerperium. Only 2.7% of women were unable to be contacted after delivery for details on outcomes. The results established normal ranges for blood pressure throughout pregnancy. The data show that blood pressure greater than 140/90 until 35 weeks' gestation is outside 2 standard deviations at all gestations and justifies using these measurements as the definition of hypertension in pregnancy. The fall in blood pressure in the 2nd trimester was less than 1 mm Hg per week in both the systolic and diastolic pressures. This fall was smaller than previously recorded in other studies. Gestational hypertension was the commonest blood pressure abnormality occurring in 15.2% of the population. This represented 69% of the pregnant women with a hypertensive disorder. The overall incidence of both gestational hypertension and preeclampsia was 18.5% which is higher than reported in other parts of the world. In this study obesity was significantly associated with hypertensive disorders in pregnancy. An arm circumference of > 33 cm, one of the measurements of obesity, was found in 6.8% of the study population. Even after the effect of arm circumference was taken into account, hypertensive disorders were also more common in Pacific Island women.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗
PubMed1995

In vivo activity and in vitro specificity of CD4+ Th1 and Th2 cells derived from the spleens of diabetic NOD mice.

CD4+ T cell lines were generated from the spleens of diabetic NOD mice against crude membrane preparations derived from a rat insulinoma. Adoptive transfer of these lines into neonatal mice confirms that overt diabetes is induced by gamma-IFN-secreting Th1 cells, whereas transfer of IL-4-secreting Th2 cells resulted in a nondestructive peri-islet insulitis. Analysis of the antigens recognized by individual T cell clones from the Th1 line included reactivity against an insulinoma membrane fraction enriched in proteins of approximately 38 kD. Immune responses to the same antigen preparation have been associated with T cell clones derived from human insulin-dependent diabetes mellitus. The specificity of Th2 cells includes reactivity to a fraction enriched in proteins of 30 kD. The data suggest that in insulin-dependent diabetes mellitus the balance between beta cell destruction, associated with intra-islet infiltration, and nondestructive (potential protective) peri-islet insulitis may depend on both the antigens recognized, and the prevailing cytokine environment.

Animals↗
PubMed1995

History of high-velocity impact water trauma at Letterman Army Medical Center: a 54-year experience with the Golden Gate Bridge.

Three time frames were studied during the 54-year history of the Golden Gate Bridge from 1937 to 1991. During that period of time, there were 918 documented jumps from this majestic structure to the water 250 feet below. The last 15 years provided us with 297 consecutive patients, all brought to one institution, which were retrospectively reviewed and categorized as to site and type of injury for survivors and fatalities. This is the largest high-velocity water impact trauma series in the world. Certain unique characteristics of the Golden Gate Bridge and the San Francisco Bay lend itself to this extremely popular and successful form of suicide. These characteristics, as well as personal factors of free-fall water impact from each patient, are summarized and discussed in this paper.

Adolescent↗