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Biomedical subjects

A Szczepura

Publications and source records attributed to A Szczepura.

At least 19 recordsLinked to original sources

Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients.

OBJECTIVES: To evaluate selected molecular tests in diagnosis and screening of cytomegalovirus (CMV) infection in immunosuppressed patients. DESIGN: Clinical and cost-effectiveness were assessed through a prospective two-stage trial of CMV screening regimes in a routine service setting. Different molecular test results were fed back to clinicians in each stage, plus antigenaemia results. The technical performance of the molecular methods was assessed through an independent masked comparison of each molecular test against the established (antigenaemia) test. Scientists performing a particular test were blind to the other test results for that sample. Diagnostic and therapeutic impact were recorded prospectively for all tests, to include any effect on diagnostic certainty, changes to CMV therapy and any other reported impact on patient management. The cost of each test was estimated under different laboratory conditions. Prospective patients undergoing CMV screening were compared with consecutive historical controls in the same unit. Towards the end of the study, a survey of all UK virology laboratories was undertaken to identify current CMV screening practice and test preferences. In addition, all UK renal transplant surgeons and haematology transplant centres were surveyed in order to identify current clinical practice and perceptions of the benefits of CMV screening. SETTING: Study patients were recruited from University Hospital Wales (UHW), Cardiff. Staff in the Cardiff Public Health Laboratory Service virology laboratory performed the tests. PARTICIPANTS: A consecutive series of transplant patients was recruited to the prospective study over a 42-month period, totalling 98 renal and 140 haematology patients. A consecutive series of historical controls was identified, with 199 renal and 136 haematology patients who underwent transplants in the UHW during the 29 months prior to the prospective CMV screening trial. INTERVENTIONS: A predefined CMV screening protocol was applied to all patients in the prospective trial. Renal patients were tested every 4 weeks until 16 weeks post-transplant (five tests in total). Haematology patients were tested every 2 weeks until 12 weeks post-transplant, and then every 4 weeks until 24 weeks (10 tests in total). The assays used for CMV screening were as follows: non-molecular test, (1) pp65 antigenaemia assay; molecular tests, semi-quantitative in-house polymerase chain reaction (PCR), (2) single-round (PCR1) and (3) two-round, nested (PCR2); and qualitative commercial tests, (4) Roche Amplicor Assay (Amplicor) and (5) pp67 NASBA assay (NASBA). MAIN OUTCOME MEASURES: Test failure rates, sensitivity/specificity values and positive predictive value (PPV) and negative predictive value (NPV) were measured for each assay. The laboratory cost of undertaking various CMV tests was measured and other NHS costs associated with false-positive or false-negative test results were estimated. The likelihood of CMV disease and the likely impact of positive or negative test result on therapy and further investigations were recorded. On receipt of the test result, interim outcome measures were recorded to include the impact of test result on diagnostic certainty, changes to planned patient management (e.g. therapy, investigations) and perceived benefit. All definitive diagnoses of CMV disease, prescribing of CMV therapy and interim patient outcome at the end of the screening period were recorded. RESULTS: In haematology and renal transplant patients, all tests had a similar NPV (0.976--0.997 and 0.935--0.995, respectively) when used in CMV screening. PCR1 is the least expensive molecular test (7.80-13.70 UK pounds). Commercial tests, NASBA and Amplicor, are both more expensive (22.50-34.70 UK pounds NASBA; 23.20-29.20 UK pounds Amplicor). Antigenaemia costs 12.50-27.40 pounds depending on staff grade and batch size. Quantitative PCR (COBAS) is the most expensive at around 50 UK pounds per sample. No clear link between screening test results and CMV prescribing was detected; clinicians appear to consider screening results in the context of other factors. There was no evidence that the introduction of CMV screening led to reductions in CMV deaths or improved transplant success rates. For cost per positive test result, PCR1 was the most cost-effective screening test on this indicator (renal patients 116 UK pounds per true positive, haematology patients 518 pounds). Antigenaemia was the least cost-effective screening test (renal patients 643 UK pounds per true positive, haematology patients 2475 pounds). Cost-effectiveness analysis and cost per "beneficial result" (as judged by clinicians) confirmed that PCR1 remained the most cost-effective test. Modelling outputs for targeted screening protocols also supported this. CONCLUSIONS: The study findings offer some evidence that a CMV screening regime is more cost-effective than diagnostic testing alone, based on the cost per true positive detected and interim outcome such as changes in patient management. However, the study was unable to demonstrate any benefits in terms of longer term patient outcomes. If CMV screening is introduced, the use of antigenaemia pp65 is clearly less cost-effective than the use of molecular tests. The study identified the optimum test for CMV screening as an in-house molecular test (single-round PCR test). This test was less costly to perform and also resulted in lower costs linked to false positives and negatives than other tests. The in-house, semi-quantitative test was two to three times more cost-effective than the commercial molecular tests assessed; however changes to European Union legislation may mean that it may not be feasible to use in-house tests. The use of targeted screening (limiting CMV screening to high-risk transplants) as opposed to universal screening offers a significant improvement in the cost-effectiveness ratio for haematology transplant patients, but has limited impact in the case of renal transplants. Economic analyses could be expanded to model the cost-effectiveness of more frequent screening tests (as reported nationally), and screening in other "at risk" groups. Subgroup specific disease groups should be investigated across a larger population to allow more accurate modelling of the impact of CMV screening on disease progression. Further studies of CMV screening programmes should address a range of outcome measures, including patient outcomes.

Biological Assay↗

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450].

BACKGROUND: The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast brace and Bledsoe boot) in comparison to Tubigrip, and (2) to compare the cost of each strategy, including subsequent health care costs. METHODS/DESIGN: Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. DISCUSSION: This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Ankle Injuries↗

Access to health care for ethnic minority populations.

This paper reviews the research evidence on access to health care by ethnic minority populations, and discusses what might need to be done to improve access to services. Research on the process of care, and the quality of care received, is considered as well as studies examining uptake of services. Changes in legal context are increasing the pressure on healthcare organisations to examine and adapt their services to ensure equitable access. Examples presented include a new UK population cancer screening programme. The main challenges for clinicians, managers, and policy makers in ensuring equitable access are discussed.

Delivery of Health Care↗

Evaluation of delivery of enhanced diabetes care to patients of South Asian ethnicity: the United Kingdom Asian Diabetes Study (UKADS).

AIMS: We tested the hypothesis that enhanced care for diabetes, tailored to the needs of the South Asian community with Type 2 diabetes, would improve risk factors for diabetic vascular complications and ultimately reduce morbidity and mortality. PATIENTS AND METHODS: The study was a cluster randomized controlled trial (RCT) with general practice the unit of randomization. Six West Midlands general practices with a high proportion of South Asian patients were randomized to 'enhanced care' using Asian link workers and extra community diabetes specialist nurse sessions (intervention) or continued standard practice care (control). RESULTS: Of 401 patients recruited to the study, 361 (90%), comprising 178 from Coventry and 183 from Birmingham were eligible and included in the analyses. The mean age at baseline (standard deviation, SD) was 58.9 (11.7 years) with median (interquartile range; IQR) duration of diabetes 6.5 (3-11) years. At one year follow-up there was a significant difference in reduction of systolic (4.6 mmHg, P = 0.035) and diastolic blood pressure (3.4 mmHg, P = 0.003) and total cholesterol (0.4 mmol/l, P = 0.005), comparing the intervention and control groups. After adjusting for baseline measurement and age, only differential reduction in diastolic blood pressure remained significant. There was no significant change in HbA(1c) and no difference between the groups. CONCLUSIONS: Using link workers and extra community diabetes specialist nurse input together with treatment protocols in primary care might prove a useful strategy in working towards NSF targets for diabetes management. In this study, small reductions in blood pressure and cholesterol were achieved. Improvement in glycaemic control may require longer and possibly different strategies. Further research is required to evaluate fully the effectiveness, including the costs and longer term sustainability of culturally sensitive initiatives.

Aged↗

Health utilities in evaluating intervention in the sleep apnoea/hypopnoea syndrome.

Formulating a rational health policy necessitates the ability to compare between different healthcare interventions and disease scenarios. Continuous positive airway pressure (CPAP) therapy with a conservative lifestyle strategy in sleep apnoea/hypopnoea syndrome (SAHS) was evaluated using health utility and quality-adjusted life years (QALYs) as outcome measures. A total 71 SAHS (apnoea/hypopnoea index > or = 15 h(-1)) patients completed a randomised, parallel group study over 3 months using utilities derived by the standard gamble approach (Usg) and European quality of life questionnaire (Euroqol) (Ueq). The severely impaired health status at baseline improved by 23% (Usg 0.32 to 0.55) adding 8 QALYs in the CPAP group, compared to a 4% improvement with 4.7 QALYs added in the lifestyle group (Usg 0.31 to 0.35). The Ueq showed a marginal change with CPAP (0.73 to 0.77) but did not demonstrate any improvement with lifestyle intervention. The health status impairment in sleep apnoea/hypopnoea syndrome patients is markedly improved by continuous positive airway pressure compared to a modest improvement with conservative lifestyle strategies using the standard gamble utility, which may be incorporated in effectiveness and economic analyses. The European quality of life questionnaire did not reflect a similar degree of impact and is probably not useful in this population.

Health Behavior↗

Creating a strategic management plan for magnetic resonance imaging (MRI) provision.

We were commissioned by the West Midlands NHS Regional Specialized Services Group (RSSG) to formulate a strategic plan for the management of Magnetic Resonance Imaging (MRI) within the West Midlands, UK. We needed to establish whether an increase in MRI provision was required, and if so to develop criteria to shape both the nature and location of MRI provision. We found that the UK had relatively low MRI provision per capita by international standards, and that the West Midlands region of the UK had less than the UK average level of MRI provision per capita. Within the region there was a 'mixed economy' of MRI provision involving fixed site scanners owned by the NHS and private companies, and private sector mobile MRI provision. There was little evidence of inappropriate MRI use, but considerable evidence of under-provision. Most MRI scanners in the region were heavily utilized, and average waiting times for MRI frequently exceeded guidelines (of a maximum 13-week wait for non-urgent MRI scans). Projections from NHS Trusts, MRI suppliers, and experts in the MRI field, led us to the conclusion that demand for MRI was likely to grow by between 12.5 and 18.5% per annum. This implies that 8-14 additional MRI scanners might be required within the West Midlands over the next 5 years, to meet existing, and rising demand for MRI. We therefore developed criteria (outlined in the paper) to enhance the productive and allocative efficiency of the deployment of MRI provision, whilst improving the configuration of MRI with reference to geographical equality of access to MRI.

Decision Making, Organizational↗

Quality of diagnostic services for cancer: a comparison of open access and conventional outpatient clinics.

OBJECTIVE AND STUDY DESIGN: To assess quality of a quick and early diagnosis route (QED) by determining effectiveness and cost-effectiveness of five clinics compared with three conventional outpatient clinics. Prospective economic evaluation. Six-month cohort of all referrals (November 1996-April 1997). SUBJECTS: All referrals for suspected cancers of: upper gastro-intestinal tract; urinary tract, prostate and testis; skin. EFFECTIVENESS: Median days saved between GP referral and date of: diagnostic appointment; consultant decision; intervention. RESULTS: GP referral to diagnostic appointment: QED was effective (median days) for all clinics. Diagnostic appointment to consultant decision: QED was effective for testicular and haematuria clinics. Consultant decision to intervention: QED was effective for haematuria, testicular and melanoma clinics. COST-EFFECTIVENESS: Extra (incremental) NHS cost per patient diagnosed. RESULTS: Less than 5 Pounds per day saved between GP referral and diagnostic appointment for: endoscopy; haematuria; prostate; testicular; melanoma. Less than 3 Pounds per day saved between GP referral and consultant decision for: testicular; haematuria. Less than 3 Pounds per day saved between GP referral and intervention for: endoscopy; haematuria; testicular; melanoma. CONCLUSION: A "quick and early" diagnostic route provides a higher quality service through improved effectiveness and cost-effectiveness compared to conventional outpatients.

Cohort Studies↗

Factors influencing audit in general practice.

Since 1990, the changes introduced in UK general practice, such as fund holding and national incentives, have altered the process of care. Audit, defined as "the systematic critical analysis of the quality of medical care, including the procedures used for diagnosis and treatment, the use of resources, and the resulting outcome and quality of life for patients", is one method of monitoring change and raising standards. Presents a successful co-ordinated audit in Warwickshire, 1991-1993, involving 53 general practices. Highlights and influence of attitudes and communication within practices on the success of audit strategies. Associates aspects of practice culture, such as team working and decision-making processes with successful audit. Postulates six descriptive practice types, largely related to culture factors. Suggests that if cultural factors within practices are identified, external assistance with audit may be more focused and effective.

Attitude of Health Personnel↗

Evidence based practice: clinicians' use and attitudes to near patient testing in hospitals.

AIM: To survey the use made of laboratory services for urgent tests and clinicians' attitudes to near patient testing. METHODS: A questionnaire was sent to clinicians working in acute hospitals within Trent and North West Thames Regions. RESULTS: 197 replies were received. Most demand came from intensive care units. Overall, clinicians requested a median of six urgent tests a day. Blood glucose and dip stick urine testing were the most commonly performed bedside tests, but 41% of clinicians did not use ward testing. The most frequently cited indication for bedside testing was the need for speed. 85% of clinicians trusted results obtained in their central hospital laboratory, but there was an almost equal division between those who did (34%) and those who did not (38%) trust the results from near patient testing. A slightly larger proportion indicated they would accept responsibility (44%) for results obtained on the ward than would not (35%). Most staff indicated that better transport to the laboratory would remove the need for near patient testing. CONCLUSIONS: Clinicians have demonstrated an apparent need for rapid response testing but there is a strong preference for rapid transport systems and central laboratory analysis rather than bedside testing as a solution to this problem. There is a need to investigate the clinical and cost-effectiveness of near patient testing as a solution to rapid response testing.

Attitude of Health Personnel↗

Interests in health care technology assessment (HCTA) and HCTA training needs in eight European countries: COMETT-ASSESS.

Between mid-1991 and mid-1992, nearly 300 different organisations involved in European health care contributed their views to a survey covering a range of topics relevant to health care technology assessment (HCTA) and economic appraisal of health technologies. Organisations who participated included manufacturers, health care institutions, professional associations, health care reimbursement or funding agencies, academic institutions and policy making agencies in eight European countries. The study was carried out as part of a larger project, COMETT-ASSESS, funded partially by the EC COMETT programme, to design and deliver training in health care technology assessment and socioeconomic evaluation. The survey demonstrates a high level of interest in assessment of health care technologies among European organisations, regardless of the type of organisation. Eight out of ten organisations report high-medium levels of interest in using HCTA in their decision making. A similar proportion report high-medium interest in increasing their general understanding of HCTA, and 2 out of 3 in carrying out assessments. All organisations clearly identify a need to train their staff in HCTA. The two key groups of staff requiring training are managers and clinicians. Manufacturers also report a need to train their marketing staff. The principal reason for training is in order to improve the use staff make of HCTA in their decision-making. This finding indicates that it may not be sufficient for European countries to develop effective HCTA dissemination strategies which improve the flow of information on technology assessment results; decision-makers within the organisations targeted will also need training, if they are to use this information effectively. As well as a need to train decision-makers, organisations also report a need to train their researchers, and to a lesser extent their own trainers. When it comes to the types of technologies which need to be assessed, organisations consistently report that they are interested in assessment of accepted health technologies, as well as new or recently introduced ones. In contrast, to date the major emphasis in many HCTA programmes has been on technologies which are yet to enter the service setting. More thought now needs to be given to developing methodologies for assessing technologies once they have reached the service setting. For this the presence of a skilled and well-trained group of health personnel will also be necessary.(ABSTRACT TRUNCATED AT 400 WORDS)

Cost-Benefit Analysis↗

Near patient testing in general practice: attitudes of general practitioners and practice nurses, and quality assurance procedures carried out.

BACKGROUND: The evaluation of near patient testing in British general practice has largely been confined to studies examining individual tests or comparing equipment. AIM: This study set out to determine the attitudes of practice staff to near patient testing, and the extent to which staff undertook quality assessment. METHOD: Four types of near patient testing machines were introduced into 12 general practices in two regions of England, south west Thames and west Midlands. General practitioner and practice nurse attitudes to near patient testing were assessed by semi-structured interview before and six months after the introduction of the machines. The extent to which routine quality assurance procedures were carried out within the surgery and as part of local and national schemes was examined. RESULTS: Although 80% of general practitioners anticipated changing patient management with near patient testing, only two fifths reported having done so after six months. Nurses generally were enthusiastic at the outset, although one third were unhappy about incorporating near patient testing into their work schedules. Time pressure was the most important factor restricting uptake of near patient testing. Nurses performed quality control regularly but complete local external quality assurance procedures were established in only half the practices. All the practices participated in a national scheme for cholesterol assays. CONCLUSION: General practitioners in this study did not find near patient testing a very useful addition to their resources. Pressure on nurses' time was the most frequently reported limitation.

Attitude of Health Personnel↗

Effectiveness and cost of different strategies for information feedback in general practice.

AIM: The aim of this study was to determine the effectiveness and relative cost of three forms of information feedback to general practices--graphical, graphical plus a visit by a medical facilitator and tabular. METHOD: Routinely collected, centrally-held data were used where possible, analysed at practice level. Some non-routine practice data in the form of risk factor recording in medical notes, for example weight, smoking status, alcohol consumption and blood pressure, were also provided to those who requested it. The 52 participating practices were stratified and randomly allocated to one of the three feedback groups. The cost of providing each type of feedback was determined. The immediate response of practitioners to the form of feedback (acceptability), ease of understanding (intelligibility), and usefulness of regular feedback was recorded. Changes introduced as a result of feedback were assessed by questionnaire shortly after feedback, and 12 months later. Changes at the practice level in selected indicators were also assessed 12 and 24 months after initial feedback. RESULTS: The resulting cost per effect was calculated to be 46.10 pounds for both graphical and tabular feedback, 132.50 pounds for graphical feedback plus facilitator visit and 773.00 pounds for the manual audit of risk factors recorded in the practice notes. The three forms of feedback did not differ in intelligibility or usefulness, but feedback plus a medical facilitator visit was significantly less acceptable. There was a high level of self-reported organizational change following feedback, with 69% of practices reporting changes as a direct result; this was not significantly different for the three types of feedback. There were no significant changes in the selected indicators at 12 or 24 months following feedback. The practice characteristic most closely related to better indicators of preventive practice was practice size, smaller practices performing significantly better. Separate clinics were not associated with better preventive practice. CONCLUSION: It is concluded that feedback strategies using graphical and tabular comparative data are equally cost-effective in general practice with about two thirds of practices reporting organizational change as a consequence; feedback involving unsolicited medical facilitator visits is less cost-effective. The cost-effectiveness of manual risk factor audit is also called into question.

Cost-Benefit Analysis↗

Impact of introducing near patient testing for standard investigations in general practice.

OBJECTIVE: To assess the clinical and economic impact of surgery based near patient testing in general practice for six commonly used biochemical and bacteriological tests. DESIGN: After four months' monitoring, equipment for two bacteriological and four biochemical tests was introduced without cost into 12 practices using a crossover design. Structured request forms were used to monitor laboratory investigations. SETTING: 12 general practices in west midlands and south west Thames with list sizes above 9000. MAIN OUTCOME MEASURES: Investigation rates per 1000 consultations. Changes from baseline rates. Reasons for requesting investigations and provisional diagnoses. Cost per test and sensitivity of costs to rate of use. RESULTS: Investigation rates for the six tests rose by 16.5% (from 78.6/1000 consultations to 91.6/1000) when equipment was available in the surgery and reverted to baseline rates when it was withdrawn. The average weekly number of tests when equipment was available ranged from 0.5 to 10.5 (mean 9.0). Cholesterol tests were used as an addition to laboratory testing, usually for screening. Midstream urine analysis was often done in the surgery instead of in the laboratory, although 30% of samples were tested by both methods. Doctors' reasons for investigation and conditions tested were largely unaffected by availability of surgery tests. Costs for surgery tests were higher for all tests except midstream urine. CONCLUSIONS: Availability of surgery based testing increased the number of tests performed. It was cost effective only for midstream urine analysis.

Cholesterol↗

Rush to arms.

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Cost-Benefit Analysis↗

Routine low-cost pathology tests: measuring the value in use of bacteriology tests in hospital and primary care.

The introduction of a managed market in health care in the NHS will encourage managers and clinicians to examine clinical services, such as pathology, more closely. However, simple cost-minimization may not be sufficient; the recent Audit Commission report on pathology emphasises a need to measure and monitor cost-effectiveness of clinical services such as pathology. This paper presents the findings of a study to measure the cost-effectiveness of one routine pathology test; the culture and antibiotic susceptibility test performed by all microbiology laboratories. Over 2,900 requests were examined and test results tracked in hospitals and general practices served by three laboratories. The findings show that, although average test costs are low for the three main user groups (4.3-5.9 pounds), the cost of producing an effect on patient management (change to therapy) is high at 54-67 pounds. In addition to therapy changes, the one major effect recorded was that of clinician reassurance. If all measured effects are weighted by their reported clinical utility, cost-utility ratios of 27.0 pounds +/- 1.0 pounds, 45.5 pounds +/- 4.5 pounds and 44.5 pounds +/- 3.5 pounds per patient management effect are calculated for general practitioner, outpatient and inpatient use respectively. A theoretical model is presented which will allow the comparative cost-effectiveness of a range of routine diagnostic tests to be measured through the use of a test-utility index, similar to the health index which is currently used to measure the outcome of medical interventions (QALYs).

Anti-Bacterial Agents↗