London after Tomlinson. Clinical research.

Sir Bernard Tomlinson''s report focuses on London''s health services, but his proposals have major implications for the future of clinical research--not just in London but in the United Kingdom as a whole. They must be seen in the context of a widely perceived decline in British research and development which also threatens clinical research. This article examines the implications of Tomlinson''s proposals and related strategies and recommends the construction of a research market for the patient costs of clinical research to complement the NHS market for patient services introduced in 1991. These arrangements would help sustain the clinical research base and guarantee excellence.     

Screening and self examination for breast cancer.

Breast cancer is the major form of cancer in women, with nearly 30,000 new cases and over 15,000 deaths in the United Kingdom each year. Breast screening by mammography has been shown in randomised trials to reduce mortality from breast cancer in women aged 50 and over. An NHS breast screening programme has been in operation in the United Kingdom since 1988. Its aim is to reduce mortality from breast cancer by 25% in the population of women invited to be screened. The uptake of mammography among the eligible population may be the single most important determinant if the programme is to be effective. Primary care teams have an important part to play in encouraging women to attend for screening and in providing information, advice, and reassurance at all stages of the screening process. To date, routine breast self examination has not been shown to be an effective method of screening for breast cancer and should not therefore be promoted as a primary screening procedure. There is, however, a case to be made for women to become more "breast aware."     

Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey

ObjectiveTo assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers'' involvement in randomised trials coordinated by these centres.DesignNational surveys using structured questionnaires with some open ended sections.Setting 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser.ParticipantsNamed contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers.ResultsOf the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients.ConclusionsConsumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.     

Prescriptions for medical research. I--Management within the Medical Research Council.

In their submission to the government in advance of the white paper on science policy in the United Kingdom the Medical Research Council commends the MRC''s own approach to managing directly funded research. But a series of semi-structured interviews with the directors of some of the MRC''s units suggests a gap between the MRC''s model of managed research and the reality. Although such units are theoretically managed from MRC head office (and units are charged an overhead for this), in practice each unit runs its own affairs. Between major reviews average contact time with the head office contact person is seven hours a year. The first paper argues that a purchaser-provider split would recognise the benefits of decentralisation and allow units to bid for research funds from several sources, the successful ones guaranteeing their survival through a rolling series of research programmes. The second paper criticises the MRC''s cumbersome peer review system. Reliance on outside experts atrophies the scientific skills of head office staff and builds delays into decision making. A purchaser-provider model would allow the head office scientific staff to act like commercial research and development managers, commissioning research, and using the outcome, rather than peer review, as a criterion for continued funding.     

New procedures affecting the conduct of clinical trials in the United Kingdom.

Changes have recently been introduced to facilitate the conduct of clinical trials of new drugs in the United Kingdom. These changes became necessary because early developmental work on new drugs was going abroad to the detriment of British industry and with a loss of skill in our departments of clinical pharmacology. The scheme also gives formal recognition to the part played by ethics committees in considering approval of the ethical aspects of clinical trials of new drugs.     

Changing trends in gynaecological surgical workload.

A reduction has been recorded in National Health Service gynaecological bed occupancy in Winchester and Wessex. At least part of this change may be explained by an increase in private hospital practice. NHS managers should plan for similar changes elsewhere in the United Kingdom.     

Screening for colorectal cancer.

In the United Kingdom there are almost 31,000 new cases of colorectal cancer each year and nearly 20,000 deaths. It is the second most common cause of all deaths from cancer in the United Kingdom. The efficacy of screening with faecal occult blood tests to detect and treat tumours at an early stage, and thereby to reduce mortality, is currently being assessed in several randomised controlled trials. In general, faecal occult blood tests have a low sensitivity and only moderate levels of uptake among the population invited for screening. Until the studies in Denmark, Sweden, and Nottingham report their findings, there is no case for providing such screening routinely to an asymptomatic population. Detecting and removing premalignant adenomas by flexible sigmoidoscopy could be more effective than detecting early localised, asymptomatic cancers in reducing deaths from colorectal cancer. It is estimated that screening people at about the age of 60 by a single flexible sigmoidoscopy examination with appropriate colonoscopic surveillance could prevent 5500 cases of colorectal cancer and 3500 deaths in the United Kingdom each year. A randomised controlled trial to confirm these observations should be seen as a priority.     

Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial.

Though the Nuremberg medical trial was a United States military tribunal, British forensic pathologists supplied extensive evidence for the trial. The BMJ had a correspondent at the trial, and he endorsed a utilitarian legitimation of clinical experiments, justifying the medical research carried out under Nazism as of long term scientific benefit despite the human costs. The British supported an international medical commission to evaluate the ethics and scientific quality of German research. Medical opinions differed over whether German medical atrocities should be given publicity or treated in confidence. The BMJ''s correspondent warned against medical researchers being taken over by a totalitarian state, and these arguments were used to oppose the NHS and any state control over medical research.     

Presymptomatic testing for Huntington's disease in the United Kingdom. The United Kingdom Huntington's Disease Prediction Consortium.

OBJECTIVE--To evaluate the United Kingdom Huntington''s disease presymptomatic testing programme. DESIGN--Postal questionnaire survey to collect data on all tests performed by clinical genetics centres between 1987 and 1990. SETTING--Genetic centres providing presymptomatic testing in the United Kingdom. SUBJECTS--248 subjects at risk of Huntington''s disease who had presymptomatic testing at their request. MAIN OUTCOME MEASURES--Sex, age, prior risk, and risk after testing. RESULTS--The risk of carrying the Huntington disease gene was reduced for 151 (61%) of the applicants and raised for 97 (39%). 158 (64%) of the subjects were female and 90 (36%) male. The median age at which the results were given was 32.5 years. CONCLUSIONS--The demand for testing was lower than expected and may have reached its peak in 1990. The excess of low risk results was not fully explained by the age effect. All the genetics centres concerned have agreed a common service protocol which requires extensive pre-test counselling and post-test follow up. The worth of the procedure remains to be decided. The availability of a large body of pooled data from all the United Kingdom testing centres, which individually are likely to have only a few results, will form a valuable resource for monitoring the long term psychosocial impact of testing.     

Hunting the gowk?--Psychiatric community care in Scotland.

The implementation of the community care changes throughout the United Kingdom from 1 April will mark the culmination of a series of major health and social care reforms. The avowed aims of achieving value for money and improved consumer choice through the introduction of competitive internal markets have yet to be tested. The political complexion of Scotland means that any proposed change to the NHS has tended to be greeted with a mixture of suspicion and resistance. As a result very few self governing trusts and fundholding general practices exist north of the border. And although Scotland has not had a wide reaching policy of moving psychiatric patients out of hospitals, community care for mentally ill people has advanced spontaneously.     

Cost effectiveness analysis of intensive versus conventional follow up after curative resection for colorectal cancer

Objective To determine the cost effectiveness of intensive follow up compared with conventional follow up in patients with colorectal cancer.Design Incremental cost effectiveness analysis recognising differences in follow up strategies, based on effectiveness data from a meta-analysis of five randomised trials.Setting United Kingdom.Main outcome measures Taking a health service perspective, estimated incremental costs effectiveness ratios for each life year gained for five trials and four trials designed for early detection of extramural recurrences (targeted surveillance).Results Based on five year follow up, the numbers of life years gained by intensive follow up were 0.73 for the five trial model and 0.82 for the four trial model. For the five trials, the adjusted net (extra) cost for each patient was £2479 (€3550; $4288) and for each life year gained was £3402, substantially lower than the current threshold of NHS cost acceptability (£30 000). The corresponding values for the four trial model were £2529 and £3077, suggesting that targeted surveillance is more cost effective. The main predictor of incremental cost effectiveness ratios was surveillance costs rather than treatment costs. Judged against the NHS threshold of cost acceptability, the predicted incremental cost threshold was ninefold and the effectiveness threshold was 3%.Conclusions Based on the available data and current costs, intensive follow up after curative resection for colorectal cancer is economically justified and should be normal practice. There is a continuing need to evaluate the efficacy of specific surveillance tools: this study forms the basis for economic evaluations in such trials.     

Other cities,same problems.

London''s health care problems, particularly underfunding, are mirrored in other major cities in the United Kingdom and abroad. None has found the perfect solution, but the debates on the Tomlinson report provide an opportunity to review how to manage the three major areas of service provision, medical education, and research in London. Mr Robert Maxwell suggests that some aspects of the successful ambulatory care initiative in New York could be adapted by the capital''s primary care providers while the secondary services might learn from the rationalisation of specialist services in Paris.     

Hospital bed utilisation in the NHS,Kaiser Permanente,and the US Medicare programme: analysis of routine data

Objective To compare the utilisation of hospital beds in the NHS in England, Kaiser Permanente in California, and the Medicare programme in the United States and California.Design Analysis of routinely available data from 2000 and 2001 on inpatient admissions, lengths of stay, and bed days in populations aged over 65 for 11 leading causes of use of acute beds.Setting Comparison of NHS data with data from Kaiser Permanente in California and the Medicare programme in California and the United States; interviews with Kaiser Permanente staff and visits to Kaiser facilities.Results Bed day use in the NHS for the 11 leading causes is three and a half times that of Kaiser''s standardised rate, almost twice that of the Medicare California''s standardised rate, and more than 50% higher than the standardised rate in Medicare in the United States. Kaiser achieves these results through a combination of low admission rates and relatively short stays. The lower use of bed days in Medicare in California compared with Medicare in the United States suggests there is a “California effect” as well as a “Kaiser effect” in hospital utilisation.Conclusion The NHS can learn from Kaiser''s integrated approach, the focus on chronic diseases and their effective management, the emphasis placed on self care, the role of intermediate care, and the leadership provided by doctors in developing and supporting this model of care.     

Obstetric Anaesthesia Services in the United Kingdom

In a survey of obstetric anaesthetic services in the United Kingdom questionnaires were sent to 398 hospital maternity units and 347 general-practitioner maternity units, of which 344 and 272 respectively were returned. Many hospitals were unable to provide an anaesthetist for obstetric surgery only, and few consultant anaesthetist sessions were allocated to obstetric surgery, particularly in regional hospitals in England and Wales. Constant supervision of junior anaesthetic staff with under 12 months'' experience was lacking in several hospitals. Endotracheal intubation is widely used throughout the United Kingdom. Though regional analgesic techniques are used by most anaesthetists it is impossible to provide a 24-hour regional analgesic service in all but a few hospitals.     

There's a long, long trail a-winding: the complexities of GM foods regulation, a cautionary tale from the UK

The evolution of the regulatory process for genetically modified (GM) food in the United Kingdom is reviewed from its formal inception in 1988 to the present, drawing out lessons which have been learned from a series of cases brought to the committee for approval. The unexpected but highly professional anti-GM campaign is described, and issues regarding public perceptions of risk are discussed. Recent failures to find a consensus solution in the United Kingdom are described, and a proposal is made for a way forward.     

Bladder tumours among rodent operatives handling ANTU.

The rodenticide ANTU (alpha-naphthylthiourea) was used in the United Kingdom mainly in the late 1940s and early 1950s. The product then contained up to 0.2% of beta-naphthylamine as an impurity, and it was finally withdrawn in 1967 as a suspected carcinogen. Fourteen cases of urothelial tumours among rodent operatives exposed to ANTU are reported: in one district four out of 27 staff were affected, and in another area two out of 10. These cases strongly suggest that the early ANTU manufactured in the United Kingdom posed a cancer hazard to users. ANTU is still made or used in various countries, though the current product may be relatively pure and no longer contaminated by beta-naphthylamine. Recent laboratory evidence shows that even pure ANTU is mutagenic in the Ames test, and the safety of this rodenticide may need review.     

National census of availability of neonatal intensive care. British Association for Perinatal Medicine

ObjectiveTo determine whether availability of neonatal intensive care cots is a problem in any or all parts of the United Kingdom.DesignThree month census from 1 April to 30 June 1999 comprising simple data sheets on transfers out of tertiary units.SettingThe 37 largest high risk perinatal centres in the United Kingdom.ParticipantsOne obstetric specialist and one neonatal specialist in each centre.ResultsAll units provided data. The number of intensive care cots in each unit was between five and 16. During the three months 309 transfers occurred (equivalent to 1236 per year), of which 264 were in utero and 45 postnatal. Sixty five in utero transfers involved multiple births, hence the census related to 382 babies (1528 per year). There was considerable regional variation. The reason for transfer in most cases was “lack of neonatal beds”.ConclusionsCurrently most major perinatal centres in the United Kingdom are regularly unable to meet in-house demand; this has implications for the service as a whole. The NHS has set no standards to help health authorities and primary care groups develop services relating to this specialty; such a step may well be an appropriate lever for change.     

Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists

Background

Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.

Methods And Findings

We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.

Conclusions

Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.     

Is tuberculosis taken seriously in the United Kingdom?

Tuberculosis has been the subject of much concern in recent years. Notifications have increased, inadequacies in surveillance revealed, and policies for BCG immunisation and screening of immigrants questioned. Until recently the disease was given low priority in the United Kingdom. There is no overall strategic framework for tackling tuberculosis, and fears have been expressed about the future of local tuberculosis control programmes in the new market economy of the NHS. An action plan for tuberculosis within the context of a national programme is urgently required. Only then will a major impact on the incidence of the disease be seen.     

Evidence based medicine: an approach to clinical problem-solving.

Doctors within the NHS are confronting major changes at work. While we endeavour to improve the quality of health care, junior doctors'' hours have been reduced and the emphasis on continuing medical education has increased. We are confronted by a growing body of information, much of it invalid or irrelevant to clinical practice. This article discusses evidence based medicine, a process of turning clinical problems into questions and then systematically locating, appraising, and using contemporaneous research findings as the basis for clinical decisions. The computerisation of bibliographies and the development of software that permits the rapid location of relevant evidence have made it easier for busy clinicians to make best use of the published literature. Critical appraisal can be used to determine the validity and applicability of the evidence, which is then used to inform clinical decisions. Evidence based medicine can be taught to, and practised by, clinicians at all levels of seniority and can be used to close the gulf between good clinical research and clinical practice. In addition it can help to promote self directed learning and teamwork and produce faster and better doctors.