ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening.

OBJECTIVES: Primary cervical screening uses cytology to detect cancer precursor lesions [cervical intraepithelial neoplasia stage 3 or beyond (CIN3+)]. Human papillomavirus (HPV) testing could add sensitivity as an adjunct to cytology or as a first test, reserving cytology for HPV-positive women. This study addresses the questions: Does the combination of cytology and HPV testing achieve a reduction in incident CIN3+?; Is HPV testing cost-effective in primary cervical screening?; Is its use associated with adverse psychosocial or psychosexual effects?; and How would it perform as an initial screening test followed by cytology for HPV positivity? DESIGN: ARTISTIC was a randomised trial of cervical cytology versus cervical cytology plus HPV testing, evaluated over two screening rounds, 3 years apart. Round 1 would detect prevalent disease and round 2 a combination of incident and undetected disease from round 1. SETTING: Women undergoing routine cervical screening in the NHS programme in Greater Manchester. PARTICIPANTS: In total 24,510 women aged 20-64 years were enrolled between July 2001 and September 2003. INTERVENTIONS: HPV testing was performed on the liquid-based cytology (LBC) sample obtained at screening. Women were randomised in a ratio of 3:1 to have the HPV test result revealed and acted upon if persistently positive in cytology-negative cases or concealed. A detailed health economic evaluation and a psychosocial and psychosexual assessment were also performed. MAIN OUTCOME MEASURES: The primary outcome was CIN3+ in round 2. Secondary outcomes included an economic assessment and psychosocial effects. A large HPV genotyping study was also conducted. RESULTS: In round 1 there were 313 CIN3+ lesions, representing a prevalence in the revealed and concealed arms of 1.27% and 1.31% respectively (p = 0.81). Round 2 (30-48 months) involved 14,230 (58.1%) of the women screened in round 1 and only 31 CIN3+ were detected; the CIN3 rate was not significantly different between the revealed and concealed arms. A less restrictive definition of round 2 (26-54 months) increased CIN3+ to 45 and CIN3+ incidence in the arms was significantly different (p = 0.05). There was no difference in CIN3+ between the arms when rounds 1 and 2 were combined. Prevalence of high-risk HPV types was age-dependent. Overall prevalence of HPV16/18 increased with severity of dyskaryosis. Mean costs per woman in round 1 were 72 pounds and 56 pounds for the revealed and concealed arms (p < 0.001); an age-adjustment reduced these mean costs to 65 pounds and 52 pounds. Incremental cost-effectiveness ratio for detecting additional CIN3+ by adding HPV testing to LBC screening in round 1 was 38,771 pounds. Age-adjusted mean cost for LBC primary screening with HPV triage was 39 pounds compared with 48 pounds for HPV primary screening with LBC triage. HPV testing did not appear to cause significant psychosocial distress. CONCLUSIONS: Routine HPV testing did not add significantly to the effectiveness of LBC in this study. No significant adverse psychosocial effects were detected. It would not be cost-effective to screen with cytology and HPV combined but HPV testing, as either triage or initial test triaged by cytology, would be cheaper than cytology without HPV testing. LBC would not benefit from combination with HPV; it is highly effective as primary screening but HPV testing has twin advantages of high negative predictive value and automated platforms enabling high throughput. HPV primary screening would require major contraction and reconfiguration of laboratory services. Follow-up continues in ARTISTIC while maintaining concealment for a further 3-year round of screening, which will help in screening protocol development for the post-vaccination era.

A paediatric telecardiology service for district hospitals in south-east England: an observational study.

OBJECTIVES: To compare caseloads of new patients assessed by paediatric cardiologists face-to-face or during teleconferences, and assess NHS costs for the alternative referral arrangements. DESIGN: Prospective cohort study over 15 months. SETTING: Four district hospitals in south-east England and a London paediatric cardiology centre. PATIENTS: Babies and children. INTERVENTION: A telecardiology service introduced alongside outreach clinics. MEASUREMENTS: Clinical outcomes and mean NHS costs per patient. RESULTS: 266 new patients were studied: 75 had teleconsultations (19 of 42 newborns and 56 of 224 infants and children). Teleconsultation patients generally were younger (49% being under 1 year compared with 32% seen personally (p = 0.025)) and their symptoms were not as severe. A cardiac intervention was undertaken immediately or planned for five telemedicine patients (7%) and 30 conventional patients (16%). However, similar proportions of patients were discharged after being assessed (32% telemedicine and 39% conventional). During scheduled teleconferences the mean duration of time per patient in sessions involving real-time echocardiography was 14.4 min, and 8.5 min in sessions where pre-recorded videos were transmitted. Mean cost comparisons for telemedicine and face-to-face patients over 14-day and 6-month follow-up showed the telecardiology service to be cost-neutral for the three hospitals with infrequently-held outreach clinics (1519 UK pounds vs 1724 UK pounds respectively after 14 days). CONCLUSION: Paediatric cardiology centres with small cadres of specialists are under pressure to cope with ever-expanding caseloads of new patients with suspected anomalies. Innovative use of telecardiology alongside conventional outreach services should suitably, and economically, enhance access to these specialists.

Costs of NHS maternity care for women with multiple pregnancy compared with high-risk and low-risk singleton pregnancy.

OBJECTIVE: To compare antenatal and obstetric costs for multiple pregnancy versus singleton pregnancy risk groups and to identify factors driving cost differentials. DESIGN: Observational study over 15 months (2001-02). SETTING: Four district hospitals in southeast England. POPULATION: Consecutive women with multiple pregnancy and singleton women with risk factors for fetal congenital heart disease (CHD) (pregestational diabetes, epilepsy, or family history of CHD) or Down syndrome, and a sample of low-risk singleton women. METHODS: Clinical care was audited from the second trimester anomaly scan until postnatal discharge, and the resource items were costed. Multiple regression analysis determined predictors of costs. MAIN OUTCOME MEASURES: NHS mean costs of antenatal and obstetric care for different types of pregnancy. RESULTS: A total of 959 pregnancies were studied. Three percent of 243 women with multiple pregnancy reached 40 weeks of gestation compared with 54-55% of 163 low-risk and 322 Down syndrome risk women and 36% of 231 cardiac risk women. Antenatal costs for cardiac risk (1,153 pounds sterling) and multiple pregnancy (1,048 pounds sterling) were nearly double the costs for other two groups (P < 0.001). As 63% of multiple births were delivered by caesarean section, the obstetric cost for multiple pregnancy (3,393 pounds sterling) was 1,000 pounds sterling greater overall. Pregestational diabetes was the most influential factor driving singleton costs, resulting in similar total costs for multiple pregnancy women (4,442 pounds sterling) and for women with diabetes (4,877 pounds sterling). CONCLUSIONS: Our analyses confirm that multiple pregnancies are substantially more costly than most singleton pregnancies. Identifying women with diabetes as equally costly is pertinent because of the findings of the Confidential Enquiry into Maternal and Child Health that standards of maternal care for diabetics often are inadequate.

Assessing the wellbeing of cytoscreeners: experience in two NHS cytology laboratories.

OBJECTIVE: Cervical screening programmes in England are in transition as the liquid-based cytology (LBC) method replaces conventional Papanicolaou screening and staff in NHS laboratories are trained to analyse LBC smears. Cytoscreeners and biomedical scientists undertake routine microscopy of slides, but the scientists usually have a wider professional role. Attitudinal surveys were carried out in laboratories where LBC was partially introduced. METHODS: Staff in two cytology laboratories in Greater Manchester were surveyed twice over 6 months. The questionnaire assessed work pressures using scales from the Measures of Work Characteristics instrument, work-related stress using the General Survey version of the Maslach Burnout Inventory, job intentions and job satisfaction. RESULTS: Cytoscreeners, many aged over 50 years, formed over 60% of respondents in both surveys (27/42 in the first survey), and biomedical scientists and doctors, 30%. Both groups were under moderate pressure from work demands in each survey, but cytoscreeners had significantly less autonomy over their working methods (P < 0.001). Although both groups experienced similar levels of exhaustion, cytoscreeners were much more cynical or indifferent towards work in the second survey (P = 0.008) and had lower expectations of being effective (P < 0.001). For the cytoscreeners, there were strong negative correlations in both surveys between cynicism and the work characteristics of influencing decisions and autonomy/control. CONCLUSIONS: The strength of the relationship between work performance and wellbeing serves to emphasize the importance of the new LBC technology in ameliorating low morale where it exists. Further attitudinal research involving larger samples of laboratories is warranted to assess the full impact of this innovation.

Liquid-based cytology can improve efficiency of cervical smear readers: evidence from timing surveys in two NHS cytology laboratories.

OBJECTIVE: Cervical screening programmes in England and Wales were advised by the National Institute for Clinical Excellence in 2003 to adopt liquid-based cytology (LBC) in place of conventional Papanicolaou (Pap) cytology to facilitate laboratory efficiency. Pilot evaluations in England and Scotland monitored daily or weekly workloads of smear readers and concluded that LBC could increase hourly throughput rates. This study, instead, used timing surveys to determine screening rates. METHODS: Two National Health Service cytology laboratories in Manchester and Stockport were partially converted to the LBC ThinPrep process for a cervical screening trial. Three 1-week timing surveys were conducted over 7 months. The surveys covered all LBC-trained staff. The first survey in Manchester also covered staff undertaking conventional Pap screening. The smear readers used timers to record time taken for examining and reporting each slide. RESULTS: In Manchester, in the first survey, nearly 1 minute per slide was saved by the LBC method during primary microscopy. In both laboratories, the mean microscopy time for primary screening of LBC slides was reduced by almost 1 minute between the first and second surveys. There was no difference between the second and third surveys. Microscopy by cytopathologists was also 1 minute per slide quicker with LBC than conventional Pap. The LBC inadequate rates for both laboratories were <2.0%. Organizational factors impacted on the hourly LBC primary screening rates in the laboratories, the rate for Stockport being higher than the rates in the pilot evaluations. CONCLUSIONS: The timing surveys confirm that the LBC ThinPrep technology can improve laboratory efficiency. However, decision-makers should also consider the overall costs and benefits of introducing the technology in screening programmes, including the capital investment and workforce implications.

Assessing economics of treatments for gynecological cancer where clinical effectiveness meets value for money.

During the last 10 years, the management of gynecological cancer has been undergoing a great deal of change. This is due to a drive to reduce ineffective treatment and associated morbidity while at the same time maximizing the benefits of currently available treatment. The foundation for this approach has been high-quality clinical trials which have been performed in increasing numbers. These trials can provide strong evidence that treatments are equivalent or that a new drug adds superiority to previous treatment. The access that women have to the most effective forms of treatment often depends on the availability of healthcare resources and their affordability within the healthcare system. Healthcare decision makers increasingly require not just clinical effectiveness of treatments but also cost-effectiveness to be demonstrated. While health economic methods have been applied to many forms of cancer treatment and screening, there have been very few rigorous economic studies performed in gynecological cancer. This article discusses how economic analysis can be incorporated into clinical trials and how it can provide the sort of value for money determination that payers of healthcare are now requiring. Economic analysis may add a little to the cost of trials, but in the end, it may increase access to treatment by convincing decision makers of cost-effectiveness.

Ambulance emergency services for patients with coronary heart disease in Lancashire: achieving standards and improving performance.

OBJECTIVES: To examine the performance of a rural ambulance trust during two time periods, 1996/97 and 2001, with respect to achieving standards for ambulance journey times and delivery of clinical care for patients with suspected acute myocardial infarction (AMI). METHODS: Audit datasets on two cohorts of patients with chest pain and suspected AMI were assembled by the Lancashire Ambulance Service NHS Trust in north west England: 3706 patients during 1996/97 and 3423 in 2001. They were transported to four hospitals. The analyses covered journey timings, role of rapid response vehicles (RRV), and clinical procedures and the results were compared with prevailing national standards. RESULTS: Hourly and daily usage patterns were similar in the two periods. During 1996/97 the national rural target of 95% of response times being within 19 minutes was achieved (96% of calls), unlike the target of 50% within eight minutes (45.3% of calls). During 2001, 2684 (78.4%) calls had response times within eight minutes thus exceeding the revised national target of 75%. RRVs were despatched for 1214 (35.5%) of calls in 2001, and the mean response time (SD) for these vehicles was significantly shorter than for front line ambulances (0:05:53 (0:02:49) versus 0:07:04 (0:04:19), p<0.001), likewise the mean call to hospital time (0:32:38 (0:09:28) v 0:35:01 (0:12:09), p<0.001). Patients in 2001 were more likely to be given aspirin by the ambulance crews (74% of cases), while the rate of cannulation was lower. CONCLUSION: A significant improvement has been achieved in the performance of ambulance services in Lancashire since 1996, because of recently introduced strategies, notably RRVs, and in the presence of more demanding national standards and targets.

Cost analysis of a hospital-at-home initiative using discrete event simulation.

OBJECTIVES: To examine whether, from a National Health Service (NHS) and local authority social services' viewpoint, a hospital-at-home service was cost saving compared with conventional inpatient care. METHODS: The subjects of this part-retrospective and part-prospective cost analysis were 51 elderly medical and orthopaedic surgical patients assessed at Hillingdon Hospital, West London, as being suitable for hospital-at-home care. Thirty patients received hospital-at-home care, provided for up to 14 days, while 21 patients remained in hospital and received standard inpatient care. All direct costs to the NHS hospital, community health services' provider and social services' department during the initial episode of care and the three months after discharge were collected for each group of patients. Costs and clinical event data were entered in a discrete event simulation model which generated baseline results. Uncertainty surrounding the model's parameters was explored using sensitivity analysis. RESULTS: The baseline simulation performed with 1000 patients in each group showed the mean cost per patient for hospital-at-home care and three-month follow-up to be around three-fifths the mean cost per patient of inpatient care and follow-up. Most of the excess cost in the inpatient group was attributable to the initial period of hospitalisation. Under all assumptions used in the sensitivity analysis, the hospital-at-home service was less costly. CONCLUSIONS: For elderly patients assessed as needing no more than 14 days of hospital care, hospital-at-home care is cost saving to health and social care agencies when compared with conventional inpatient care.

A review of research in the United Kingdom to evaluate the implementation of clinical guidelines in general practice.

BACKGROUND: An advisory group for the NHS research and development (R&D) programme recommended in 1993 that the impact of clinical guidelines at the interface between primary and secondary care should be a research priority area. In 1994, a systematic review of 91 published evaluations of implementing clinical guidelines identified only seven UK general practice studies. OBJECTIVE: In this inquiry we aimed to determine the number of randomized studies of clinical guideline implementation in primary care being conducted in the UK in 1996 and to review the research designs. METHODS: A national health research register was interrogated for all projects relating to clinical guidelines. The investigators were contacted to establish the nature of their project and to identify implementation studies that they knew to be going on elsewhere. Copies of protocols or briefing documents were obtained from the project teams for the identified studies. RESULTS: Thirteen randomized studies in general medical practice and one in general dental practice were identified. Guidelines were being introduced to aid diagnostic decision-making, prescribing practice or referral to hospital-based services. Eight strategies for promoting guideline adherence were being evaluated. Six studies proposed to conduct economic evaluations of the intervention packages. CONCLUSION: Twelve of the 14 studies were funded by the NHS R&D programme. Since there will be a considerable time delay before all 14 studies and a number of newer studies are fully reported, it seems imperative that information of the sort collected in this inquiry be made available, preferably in the National Research Register.

A decision analytic approach to commissioning ambulance cardiac services.

The paper discusses how a decision analytic framework has been used by an English health authority in relation to the commissioning of ambulance cardiac services. Strategies for the management by ambulance personnel of victims of cardiac arrest and persons with acute chest pain of cardiac origin were modelled in a decision-event tree, and a bibliographic database established. The international research literature prior to 1997 was searched in order to derive probability values for the tree. However, after checking whether the subgroupings of results in the papers were in accordance with the variables in the tree, the number of useful papers on acute chest pain was found to be only two. In the almost complete absence of information--even from small observational studies--on the management of the great majority of patients with cardiac symptoms transported by ambulance, the local ambulance service and the main providers of hospital services in the district are now collaborating in field studies of cardiac care in order to improve the inputs into the model.

Health services research in the United Kingdom 1990-1992.

BACKGROUND: Shortly before the National Health Service (NHS) research and development (R&D) strategy was launched in April 1991, the Department of Health commissioned a study to collect information on current health services research and related work in the United Kingdom. The term 'health services research' was interpreted as research that could usefully inform the contracting arrangements in the reformed NHS. METHODS: The information was collected from funding agencies, in particular the UK health departments, the Medical Research Council and medical research charities; academic departments and research units and centres; NHS authorities; and research registers and directories. A total of 6185 projects that were either in progress or completed between January 1990 and mid-1992 were identified. RESULTS: Forty-three per cent of projects were disease related; 33 per cent assessed health technologies. Patterns were evident in the database. Sixty-three per cent of the projects on diseases were covered by five categories: cancer, the largest category with a quarter of the disease projects; perinatal medicine; cardiovascular disease and stroke; HIV and AIDS; and mental illness. Conditions that cause severe discomfort but are not life threatening were poorly represented. Clinical trials formed 25 per cent of the health technology projects, but only 6 per cent of the trials assessed surgical procedures. Less than 10 per cent of all health technology projects contained a costing component. In England, 34 per cent of projects with identified funding sources were supported by medical charities and other independent bodies, 31 per cent by NHS authorities, 20 per cent by the Department of Health and 15 per cent by the research councils. CONCLUSION: This collection of information represents a 'snapshot' of the scope of health services research against which it will be possible to measure the changes promoted by the NHS R&D programme.