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Biomedical subjects

D Coyle

Publications and source records attributed to D Coyle.

At least 19 recordsLinked to original sources

Factors influencing the effectiveness of clinical supervision.

Clinical supervision is widely accepted as an essential prerequisite for high quality nursing care. This paper reports findings from a study that aims to identify the factors that may influence the effectiveness of clinical supervision for community mental health nurses (CMHNs) in Wales, UK. Two hundred and sixty (32%) CMHNs from an estimated total population of 817 completed the Manchester Clinical Supervision Scale (MCCS) and a demographic questionnaire. The MCCS is a 36-item questionnaire measuring the quality and effectiveness of the supervision received. Three-quarters of CMHNs reported having participated in six or more sessions of supervision in their current posts. Clinical supervision was more positively evaluated where sessions lasted for over one hour, and took place on at least a once-monthly basis. Perceived quality of supervision was also higher for those nurses who had chosen their supervisors, and where sessions took place away from the workplace. These findings have important implications for the organization and delivery of mental health nursing services.

Adult↗

Etanercept for the treatment of rheumatoid arthritis.

BACKGROUND: Etanercept is a soluble tumour necrosis factor alpha-receptor DMARD for the treatment of rheumatoid arthritis (RA). OBJECTIVES: To assess the efficacy and safety of etanercept for the treatment of RA. SEARCH STRATEGY: Five electronic databases were searched from 1966 to February 2003 with no language restriction. SELECTION CRITERIA: All randomized controlled trials (minimum 6 month duration) comparing three possible combinations 1) etanercept (10 mg or 25 mg twice weekly) with methotrexate (MTX) to MTX alone 2) etanercept to MTX, or 3) etanercept to placebo were eligible. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data and assessed the methodological quality of the trails. The American College of Rheumatology (ACR) core set of disease activity measures for RA clinical trials, radiographic, withdrawals and toxicity outcomes were analyzed. MAIN RESULTS: Three trials were included in this review. Two trials compared an experimental group who were started on etanercept compared to a control group; both groups had the same ongoing background therapy of nonsteroidals in both trials plus in one trial one group was on stable methotrexate. In these two trials the ACR 20, ACR 50 and ACR 70 response rates at 6 months were statistically significantly and clinically important with etanercept 25 mg subcutaneous injections (SC) twice weekly. Sixty-four percent of people receiving etanercept ache vied an ACR 20 response compared to 15% of controls and the number needed to treat (NNT) with etanercept is 2 people. Thirty-nine percent of those receiving etanercept achieved an ACR 50 response compared to 4% of taking control treatment and the NNT is three. Fifteen percent of people taking etanercept achieved an ACR 70 compared to 1% of controls with a NNT of 7 people. In the third trial of starting etanercept compared to starting methotrexate the number of participants who achieved an ACR 20, 50 or response at 6 and 12 months were not statistically significant for either etanercept dose. Etanercept treatment showed a statistically significantly and clinically important affect on joint damage as measured by the Sharp erosion score. Among participants who received etanercept 72% had no increase in their erosion score compared to 60% of participants in the methotrexate group. Withdrawal and toxicity results were acceptable. REVIEWER'S CONCLUSIONS: Etanercept 25 mg SC twice weekly was more efficacious than control treatment for ACR 20, 50 and 70 at 6 months, and over 12 months it slowed joint damage.

Antirheumatic Agents↗

The assessment of the economic return from controlled clinical trials. A framework applied to clinical trials of colorectal cancer follow-up.

Clinical trials can be considered health interventions as their primary aim is to impact on the health of a population. Given that resources are scarce for both health care and health related research, trials could be designed such that they can be demonstrated to be cost-effective, i.e., the costs of conducting the trial are justified given the forecasted long-term benefits. We demonstrate how a model can be used to predict the cost-effectiveness of undertaking a clinical trial comparing alternative regimens of colorectal cancer follow-up. The model forecasts costs and survival under two scenarios, with and without conducting a clinical trial, with the outcome assessed in terms of years to payback for the clinical trial. The methodology shown can be used both to provide information on appropriate trial design and/or in prioritizing between potential trials.

Journal Article↗

The economic evaluation of pharmacotherapies for Parkinson's disease.

As well as the significant clinical effects of Parkinson's disease (PD), the disease places a high economic burden on society. Given the scarcity of health care resources, it is becoming increasingly necessary to demonstrate that new therapies for PD provide value for money in comparison with other potential interventions. This paper outlines the basic techniques of cost-effectiveness analysis and its application to PD. These techniques are illustrated by a recent economic evaluation of entacapone for use in Canada.

Antiparkinson Agents↗

The cost of allogeneic red blood cells--a systematic review.

Several reports suggest that the cost of RBCs may have risen over time, but there exists very little published evidence of that. The objective was to determine whether published studies documenting cost data on RBCs suggest an increase over time and to assess the quality of cost studies. We used the terms 'cost', 'allogeneic/allogenic' and 'blood' to identify cost studies between 1966 and 2002 from Medline, ISIesource and Ingenta electronic databases. Furthermore, we manually searched a number of transfusion and health economics journals for completeness. We included studies that used an established methodology and conducted an economic evaluation using primary/secondary cost data to calculate the cost of RBCs and RBC transfusion. Studies without allogeneic RBCs as comparator were excluded. Two individuals independently reviewed the studies and included studies upon reaching a consensus. Fourteen studies qualified the selection criteria and were included in the review. Ten studies were identified from Medline, two from Ingenta, one from ISIesource and one was a conference paper. Of the 14 studies reviewed, 10 had focused on RBC transfusion and four had focused on both RBCs and RBC transfusion. Ten studies were from the US, and two each from Canada and the UK, respectively. Two studies had explicit objective of cost calculation, and others had calculated costs towards fulfilling other objectives. Most of the reviewed studies were dated and of poor quality. Despite these limitations, it appears that the cost of RBCs has increased over time in the UK, Canada and the US. More studies are needed to fully assess the trend of costs over time. Future cost studies should try to follow the economic evaluation guidelines for greater research implications.

Canada↗

Cancer physicians' attitudes toward colorectal cancer follow-up.

BACKGROUND: The optimal follow-up strategy for colorectal cancer is unknown. MATERIALS AND METHODS: We surveyed all Canadian radiation oncologists, medical oncologists and surgeons specializing in colorectal cancer to assess their recommendations for follow-up after potentially curative treatment, the beliefs and attitudes underlying these practices, and the cost implications of different follow-up strategies. RESULTS: One hundred and sixty practitioners (58%) returned completed surveys. Most recommended clinical assessments every 3-4 months in the first 2 years including carcino-embryonic antigen testing, gradually decreasing in frequency over 5 years. Ninety per cent recommend a surveillance colonoscopy in the first year. The majority felt that specialist involvement in follow-up was important because of the increased opportunities for patients to contribute to research (76%) and teaching (73%). About half felt that specialists were more efficient at providing follow-up than primary care physicians, but these same physicians recommended significantly longer and more expensive follow-up routines on average than others. Primary care physicians were felt to be important allies, especially in managing the psychosocial concerns of patients. CONCLUSIONS: Surveillance practices are generally in keeping with published recommendations. Most specialists feel that they should remain involved in follow-up, but this may result in increased resource utilization.

Adult↗

Surveillance mammography after treatment of primary breast cancer: a systematic review.

As the prevalence of diagnosed breast cancer increases, it is important to define how best to provide long-term follow-up. Whereas many aspects of follow-up remain controversial, guidelines recommend surveillance mammograms as the only investigation to be performed routinely. We conducted a systematic review of the literature to elucidate the effect of routine surveillance mammograms on detecting ipsilateral recurrence (IR) and contralateral breast cancers (CBC). The systematic review yielded 15 articles. All were observational studies and ranked as level II-2 or III evidence. There were no randomized controlled trials identified. Most of the ten studies on detection of IR did not report on outcomes after detection. When reported, most studies found that the method of detection of IR did not influence overall survival or disease-free survival. Two of the nine studies on detection of CBC found that the CBC was detected at an earlier stage than the initial breast cancer, but did not report on long-term outcomes. This systematic review highlights the need for further research to help better define the optimum surveillance mammography regimen.

Journal Article↗

Analyzing differences in the costs of treatment across centers within economic evaluations.

OBJECTIVES: Assessments of health technologies increasingly include economic evaluations conducted alongside clinical trials. One particular concern with economic evaluations conducted alongside clinical trials is the generalizability of results from one setting to another. Much of the focus relating to this topic has been on the generalizability of results between countries. However, the characteristics of clinical trial design require further consideration of the generalizability of cost data between centers within a single country, which could be important in decisions about adoption of the new technology. METHODS: We used data from a multicenter clinical trial conducted in the United Kingdom to assess the degree of variation in costs between patients and between treatment centers and the determinants of the degree of such variation. RESULTS: The variation between patients was statistically significant for both the experimental and conventional treatments. However, the degree of variation between centers was only statistically significant for the experimental treatment. Such variation appeared to be a result of hospital practice, such as payment mechanisms for staff and provision of hostel accommodation, rather than variations in physical resource use or substantive differences in cost structure. CONCLUSIONS: Multicenter economic evaluations are necessary for determining the variations in hospital practice and characteristics that can in turn determine the generalizability of study results to other settings. Such analyses can identify issues that may be important in adopting a new health technology. Analysis is required of similar large multicenter trials to confirm these conclusions.

Bronchial Neoplasms↗

A stepwise multivariate analysis of factors that contribute to stress for mental health nurses working in the community.

AIMS: The aim of the study was to examine the variety, frequency and severity of stressors experienced by community mental health nurses (CMHNs) in Wales. BACKGROUND: Numerous studies undertaken throughout the United Kingdom (UK) have indicated that those health professionals working as part of community teams are experiencing increasing levels of stress and burnout. Sample sizes have tended to be small and participants have been drawn mainly from sites in England. METHODS: A questionnaire booklet, which included a number of validated measures, was distributed to 614 CMHNs. These included Maslach Human Services Survey, Community Psychiatric Nursing (CPN) Stress Questionnaire, PsychNurse Coping Questionnaire, Rosenberg Self-Esteem Scale and General Health Questionnaire GHQ-12. The study was the largest of its kind conducted in the UK. RESULTS: Data were collected from 301 CMHNs, representing a response rate of 49%. Community mental health nurses identified the most stressful issues as trying to maintain a good quality service in the midst of long waiting lists and poor resources and having too many interruptions while trying to work in the office. The best demographic predictors of high stress scores were having an unsupportive line manager, working with a specific client group and not having job security. These factors accounted for 20% of the variance in the total stress score. When the results from the psychometric instruments were included, 46% of the variance in the total stress score was accounted for. The predictive variables were emotional exhaustion, working with a specific client group, job security and alcohol consumption. CONCLUSIONS: These findings indicate that there is a need to create more supportive environments both in terms of job security and management support, especially for those working in the fields of severe mental illness and rehabilitation.

Adult↗

Canadian CT head rule study for patients with minor head injury: methodology for phase II (validation and economic analysis).

Prospective validation on a new set of patients is an essential test of a new decision rule. However, many clinical decision rules are not prospectively assessed to determine their accuracy, reliability, clinical sensibility, or potential impact on practice. This validation process is important because many statistically derived rules or guidelines do not perform well when tested in a new population. The methodologic standards for a validation study are similar to those described in the article on phase I for derivation studies in the August 2001 issue of Annals of Emergency Medicine. The goal of phase II is to prospectively assess the accuracy, reliability, and acceptability of the decision rule in a new set of patients with minor head injury. This will determine the clinical utility of the rule and is essential if such a rule is to be widely adopted into clinical practice.

Canada↗

The effectiveness of a home visit to prevent childhood injury.

OBJECTIVE: To examine the effectiveness of a home visit program to improve home safety and decrease the frequency of injury in children. We examined the effects of the program on 1) parental injury awareness and knowledge; 2) the extent that families used home safety measures; 3) the rate of injury; and 4) the cost effectiveness of the intervention. DESIGN: A randomized, controlled trial. SETTING: A multicenter trial conducted at 5 hospitals in 4 Canadian urban centers. PARTICIPANTS: Children <8 years old, initially enrolled in an injury case-control study, were eligible to participate. Intervention. Subsequent to a home inspection conducted to determine baseline hazard rates for both groups, participants in the intervention group received a single home visit that included the provision of an information package, discount coupons, and specific instruction regarding home safety measures. MAIN RESULTS: The median age was 2 years, with males comprising ~60% of participants. The experimental groups were comparable at outset in terms of case-control status, age, gender, and socioeconomic status. Parental injury awareness and knowledge was high; 73% correctly identified injury as the leading cause of death in children, and an intervention effect was not demonstrated. The adjusted odds ratios (ORs) for the home inspection items indicated that significant safety modifications only occurred in the number of homes having hot water not exceeding 54 degrees C (OR: 1.31, 95% confidence interval [CI]: 1.14, 1.50) or the presence of a smoke detector (OR: 1.45, 95% CI: 0.94, 2.22). However, the intervention group reported home safety modifications of 62% at 4 months and significantly less injury visits to the doctor compared with the nonintervention group (rate ratio: 0.75; 95% CI: 0.58, 0.96). The total costs of care for injuries were significantly lower in the intervention group compared with the nonintervention group with a cost of $372 per injury prevented. CONCLUSIONS: An intervention using a single home visit to improve the extent to which families use safety measures was found to be insufficient to influence the long-term adoption of home safety measures, but was effective to decrease the overall occurrence of injuries. Future programs should target a few, well-focused, evidence-based areas including the evaluation of high-risk groups and the effect of repeated visits on outcome.

Accidents, Home↗

Cost effectiveness of nasal calcitonin in postmenopausal women: use of Cochrane Collaboration methods for meta-analysis within economic evaluation.

OBJECTIVE: To assess the cost effectiveness of nasal calcitonin (Miacalcin) compared with no therapy, alendronate or etidronate in the treatment of postmenopausal women with previous osteoporotic fracture. DESIGN AND SETTING: Meta-analysis followed by economic analysis. PERSPECTIVE: A Canadian provincial Ministry of Health. METHODS: The meta-analysis of randomised controlled clinical trials was based on the recommendations of the Cochrane Collaboration. Economic analysis was conducted within a Markov model using probabilities and costs derived from Canadian sources. RESULTS: The meta-analysis found evidence of the positive effect of both nasal calcitonin and alendronate in reducing the risks of hip, wrist and vertebral fractures in postmenopausal women. However, there was a lack of evidence of the effect of etidronate on hip and wrist fractures. For a 65-year-old woman, with 5 years' therapy, the incremental cost per quality-adjusted life-year (QALY) gained for nasal calcitonin was 46,500 Canadian dollars ($Can) compared with no therapy and $Can32,600 compared with etidronate (1998 values). Comparison with alendronate was highly sensitive to the inclusion of one specific trial. CONCLUSIONS: Given the results of the analysis, based on current evidence, nasal calcitonin can be considered at the margins of being cost effective when compared with no therapy. Compared with active therapy, nasal calcitonin can be considered more cost effective than etidronate, but its cost effectiveness versus alendronate is inconclusive.

Aged↗

A clinical and economic review of disease-modifying antirheumatic drugs.

Rheumatoid arthritis is one of the most common chronic systemic inflammatory diseases, affecting approximately 1% of the adult population. Disease-modifying antirheumatic drugs (DMARDs) have been the mainstay of treatment for rheumatoid arthritis when combined with physical therapy and aspirin (acetylsalicylic acid) or nonsteroidal anti-inflammatory drugs. Recently, a number of new biological therapies have been introduced for the treatment of this condition and will have a major impact on the future management of this disabling disease. In this review, we summarise data on the efficacy and tolerability of the currently available DMARDs, including gold compounds, antimalarials, penicillamine, cytotoxic drugs (azathioprine and cyclophosphamide), sulfasalazine, methotrexate, leflunomide, cyclosporin, anti-tumour necrosis factor agents, combination therapy and apheresis. A literature review and quality assessment of economic evaluations of DMARDs is presented, illustrating that there has been a paucity of economic evaluations on these agents and showing the variable quality of those studies that are available. The manuscript also addresses the pharmacoeconomic implications of the new agents for rheumatoid arthritis; the need for formal long term economic evaluations in order to determine the cost effectiveness of these costly, but highly effective, new treatments is emphasised.

Antirheumatic Agents↗

The psychometric properties of patient preferences in osteoporosis.

OBJECTIVE: Osteoporosis is a chronic disease manifested by wrist, vertebral, and hip fractures that results in significant morbidity and burden to society. About 30% of postmenopausal women have osteoporosis according to the WHO criteria. Women with one vertebral fracture have a 4-fold increased risk of a subsequent fracture. The goal of treatment is to prevent fractures and improve quality of life. Preferences or utilities are now recommended for incorporating quality of life into evaluations of the cost effectiveness of new therapeutic interventions. We evaluated the psychometric properties of preference based measures in osteoporosis. METHODS: Preference scenarios were constructed with a health state classification system. The reliability and validity of the feeling thermometer and the standard gamble was assessed by interviewing 42 women from 4 different patient groups. The sensitivity to change of the feeling thermometer and standard gamble was compared with the Health Utilities Index Mark 2 (HUI2) and SF-36. All subgroups were reassessed about 2 months after their first interview. RESULTS: Preference measurement was feasible in women of different age groups. The reliability coefficients for health states ranged from 0.65 to 0.87. The preference scores for the marker states demonstrated content validity. Convergent validity of the feeling thermometer was supported by a significant correlation with the HUI2 (r = 0.38, p < 0.05) and the physical health summary of the SF-36 (r = 0.56, p < 0.005). The standard gamble did not correlate with the HUI2 (r = 0.15) or the feeling thermometer (r = 0.09), but correlated with 2 domains of the SF-36. The preference measures were sensitive to change, with the efficiency scores ranging from 0.78 to 1.0. CONCLUSION: Preference measurements in the evaluation of osteoporosis are feasible. The feeling thermometer and standard gamble appear to be related to different aspects of health related quality of life. Both instruments were sensitive to change over a 2 month period.

Aged↗

Issues of consensus and debate for economic evaluation in rheumatology.

We report initial attempts at developing standards for the conduct of economic evaluations in rheumatology. We surveyed 25 clinicians and economists with an interest in rheumatology regarding the design and reporting of economic evaluations, with particular reference to 4 clinical scenarios relating to treatment for rheumatoid arthritis, osteoarthritis, and osteoporosis. The results demonstrated widespread agreement on a number of methodological issues such as statement of funding source, perspective, discounting, and allowance for uncertainty. However, there was lack of consensus over clinical variables including sources of data for efficacy estimates, specific clinical outcomes, methods of assessing quality of life, and choice of comparators. Some of the disagreement reflects lack of consensus in current general methodological guidelines. Consensus regarding the disease-specific clinical variables is crucial to standardizing analysis and facilitating comparisons within clinical scenarios.

Antirheumatic Agents↗

Decision framework for chemotherapeutic interventions for metastatic non-small-cell lung cancer.

BACKGROUND: Best supportive care has long been considered to be the standard therapy for metastatic non-small-cell lung cancer (NSCLC). There is now evidence from randomized trials that a number of chemotherapy regimens can palliate cancer-related symptoms and modestly improve survival. We show how cost-effectiveness analyses can be used to make choices between different (ambulatory) chemotherapy regimens. METHODS: Clinical algorithms describing the diagnosis, staging, and treatment of metastatic NSCLC were incorporated into Statistics Canada's Population Health Model. Using consistent methodology, we assessed the cost-effectiveness of several chemotherapeutic interventions: a combination of vindesine (VDS) plus cisplatin, etoposide (VP-16) plus cisplatin, vinblastine (VLB) plus cisplatin, vinorelbine (Navelbine; NVB) plus cisplatin, paclitaxel (Taxol) plus cisplatin, and gemcitabine (GEM) and NVB alone. We calculated the total chemotherapy costs in 1995 Canadian dollars, the cost per case, the average life-years saved, and the cost per life-year saved. Using the Population Health Model, we then constructed an advanced decision framework that rank-ordered the various treatment regimens so as to optimize benefit below various cost-effectiveness thresholds. RESULTS: One regimen (VLB plus cisplatin) appears to result in better survival and lower health care expenditures than best supportive care. By use of cost-effectiveness thresholds of $25,000 and $50,000 per life-year gained, NVB plus cisplatin is the preferred regimen. When quality of life is considered, however, GEM is preferred to NVB plus cisplatin at a threshold value of $50,000. At thresholds of $75 000 and $100,000, paclitaxel plus cisplatin at a dose of 135 mg/m(2) is the preferred regimen. At thresholds of $50,000 and above, best supportive care is the least preferred regimen. CONCLUSIONS: This decision framework allows the comparison of different treatment regimens based on various cost-effectiveness thresholds. Our analysis also supports the use of chemotherapy regimens and the abandonment of best supportive care as the standard of care for patients with advanced NSCLC. [J Natl Cancer Inst 2000;92:1321-9].

Algorithms↗