NICE cancer guidance: a description of the institute's clinical guideline programme.
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Biomedical subjects
Publications and source records attributed to P Littlejohns.
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OBJECTIVE: To explore the relation between work and family life among hospital consultants and their attitude towards the choices and constraints that influence this relation. DESIGN: Qualitative study of consultants' experiences and views based on tape recorded semistructured interviews. SETTING: Former South Thames health region in southeast England. PARTICIPANTS: 202 male and female NHS hospital consultants aged between 40 to 50 years representing all hospital medical specialties. RESULTS: Three types of relation between work and family life (career dominant, segregated, and accommodating) were identified among hospital consultants. Most consultants had a segregated relation, although female consultants were more likely than male consultants to have a career dominant or an accommodating relation. Many male consultants and some female consultants expressed considerable dissatisfaction with the balance between their career and family life. A factor influencing this dissatisfaction was the perceived lack of choice to spend time on their personal or family life, because of the working practices and attitudes within hospital culture, if they wanted a successful career. CONCLUSIONS: Consultants are currently fitting in with the profession rather than the profession adapting to enable doctors to have fulfilling professional and personal lives. Current government policies to increase the medical workforce and promote family friendly policies in the NHS ought to take account of the need for a fundamental change in hospital culture to enable doctors to be more involved in their personal or family life without detriment to their career progress.
Before implementing a guideline, reassurance is needed that the guideline is valid, reproducible and reliable. A method for assessing guideline validity has now been developed for general use. Guideline producers need to consider suitable strategies for implementing their guidelines. When designing and evaluating a guideline implementation strategy, three key questions need to be addressed: what are the most suitable intervention techniques; what are the desired effects of the guideline; and what will be the relevance of changes achieved? The time scale for the evaluation should also be determined carefully.
BACKGROUND: Ambulance services produce a large quantity of data, which can yield valuable summary statistics. For strategic planning purposes, an economic framework is proposed, and the following four resource allocation questions are answered, using data from the Surrey Ambulance Service: (1) To satisfy government response time targets, how many additional ambulances will be required, ceteris paribus? (2) To minimize average response time (r*) with given resources, how should ambulances be rostered temporally? (3) Which innovations are worth undertaking? (4) How would an increase in demand affect r*? METHODS: The 'Ambulance Response Curve' --the relation between response time and the number of available but not-in-use ambulances--is used to estimate how much r* will be reduced by deploying an additional ambulance. Estimating the marginal cost of an ambulance allows us to estimate the opportunity cost of each second of response time, and to compare the cost of three 'innovations' with that of increasing resources. The time savings of adding an extra ambulance at each of the 168 h of the week are examined. RESULTS: In 1997-1998, r* was 8 min 52 s. An additional ambulance reduces r* by 8.9 s. Each reduction of 1 s in r* costs 28,000 pounds per year. Fourteen additional ambulances are required to meet response time targets if the 8.9 s reduction per ambulance is maintained. r* reduces by 4.6 s when ambulances are shifted from early mornings to Saturday evenings. Activation time reduces by 38 s when crews sit in their ambulances. A 1 min decrease in overall call time decreases r* by 1.1 s. Answering only 10 per cent of all calls reduces r* by 63 s. An increase of demand of 10 per cent increases r* by 7.8 s. CONCLUSIONS: Ambulance services will be better able to determine which innovations are worth undertaking. Policy makers will be better placed to determine funding levels to achieve response time targets.
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BACKGROUND: Delayed presentation of symptomatic breast cancer is associated with lower survival. Understanding of the factors that influence delay is important for the development of strategies to shorten delays. We did a systematic review to assess the quality and strength of evidence on risk factors for delays by patients and providers. METHODS: We generated hypotheses about the relation between each putative risk factor and delay, against which we tested studies. We did searches to identify papers containing original data related to risk factors for delays by patients (n=86) and providers (n=28). We critically appraised the papers for inclusion in the review according to predefined criteria. The small number of studies of adequate quality did not allow formal meta-analysis. We therefore assigned strength of evidence according to a combination of the number and size of studies supporting, not supporting, or refuting the hypotheses. FINDINGS: Most studies were deemed to be of poor quality and were excluded. Among 23 studies of adequate quality, however, there was strong evidence for an association between older age and delay by patients, and strong evidence that marital status was unrelated to delays by patients. Younger age and presentation with a breast symptom other than a lump were strong risk factors for delays by providers. Moderate evidence was shown for several other factors. INTERPRETATION: The strength of the current evidence is inadequate to inform the development of specific strategies to shorten delays by patients or providers. Clarification of the findings of this review through a major programme of primary research is urgently required.
BACKGROUND: Most patients with breast cancer are detected after symptoms occur rather than through screening. The impact on survival of delays between the onset of symptoms and the start of treatment is controversial and cannot be studied in randomised controlled trials. We did a systematic review of observational studies (worldwide) of duration of symptoms and survival. METHODS: We identified 87 studies (101,954 patients) with direct data linking delay (including delay by patients) and survival. We classified studies for analysis by type of data in the original reports: category I studies had actual 5-year survival data (38 studies, 53,912 patients); category II used actuarial or multivariate analyses (21 studies, 25,102 patients); and category III was all other types of data (28 studies, 22,940 patients). We tested the main hypothesis that longer delays would be associated with lower survival, and a secondary hypothesis that longer delays were associated with more advanced stage, which would account for lower survival. FINDINGS: In category I studies, patients with delays of 3 months or more had 12% lower 5-year survival than those with shorter delays (odds ratio for death 1.47 [95% CI 1.42-1.53]) and those with delays of 3-6 months had 7% lower survival than those with shorter delays (1.24 [1.17-1.30]). In category II, 13 of 14 studies with unrestricted samples showed a significant adverse relation between longer delays and survival, whereas four of five studies of only patients with operable disease showed no significant relation. In category III, all three studies with unrestricted samples supported the primary hypothesis. The 13 informative studies showed that longer delays were associated with more advanced stage. In studies that controlled for stage, longer delay was not associated with shorter survival when the effect of stage on survival was taken into account. INTERPRETATION: Delays of 3-6 months are associated with lower survival. These effects cannot be accounted for by lead-time bias. Efforts should be made to keep delays by patients and providers to a minimum.
BACKGROUND: Clinical guidelines are pervading all aspects of health care. Their potential benefits are vast--from decreasing unjustified variation in treatment, to improving outcomes for patient, to containing escalating costs. However, there is increasing concern that many of the guidelines produced may be of low quality and recommend ineffective treatment. A framework to appraise the methodologic quality of clinical guidelines, commissioned by the NHS in 1997, was developed and validated in the United Kingdom (UK) under the auspices of the National Research and Development Programme. THE INDEPENDENT APPRAISAL SERVICE: This framework is now used to assess all national guidelines funded by the National Health Service (NHS) in the UK as part of an independent appraisal service. The appraisal provides a basis for policymakers to decide which guidelines should be commended for use in the NHS. Each guideline is appraised by a minimum of six appraisers. Twenty-one guidelines had been appraised as of July 1999. The mean time for completion of the appraisals, from receipt of the guidelines to dispatch of the reports, was just over ten weeks. There has been a marked improvement in the quality of documentation for national guidelines--including the search strategy and synthesis of evidence--in the past three years, although some areas of development remain inadequately reported. POLICY IMPLICATIONS: Ensuring that the clinical guidelines are sound before recommending their use is essential to policymakers responsible for guideline programs, and a formal appraisal should be an integral part of those programs.
BACKGROUND: Despite clinical guidelines penetrating every aspect of clinical practice and health policy, doubts persist over their ability to improve patient care. We have designed and tested a generic critical appraisal instrument, that assesses whether developers have minimized the biases inherent in creating guidelines, and addressed the requirements for effective implementation. DESIGN: Thirty-seven items describing suggested predictors of guideline quality were grouped into three dimensions covering the rigour of development, clarity of presentation (including the context and content) and implementation issues. The ease of use, reliability and validity of the instrument was tested on a national sample of guidelines for the management of asthma, breast cancer, depression and coronary heart disease, with 120 appraisers. A numerical score was derived to allow comparison of guidelines within and between diseases. RESULTS: The instrument has acceptable reliability (Cronbach's alpha coefficient, 0.68-0.84; intra-class correlation coefficient, (0.82-0.90)). The results provided some evidence of validity (Pearson's correlation coefficient between appraisers' dimension scores and their global assessment was 0.49 for dimension one, 0.63 for dimension two and 0.40 for dimension three). The instrument could differentiate between national and local guidelines and was easy to apply. There was variation in the performance of guidelines with most not achieving a majority of criteria in each dimension. CONCLUSIONS: Use of this instrument should encourage developers to create guidelines that reflect relevant research evidence more accurately. Potential users or groups adapting guidelines for local use could apply the instrument to help decide which one to follow. The National Health Service Executive is using the instrument to assist in deciding which guidelines to recommend to the UK National Health Service. This methodology forms the basis of a common approach to assessing guideline quality in Europe.
Despite enormous investment world-wide in computerized health information systems their overall benefits and costs have rarely been fully assessed. A major new initiative in South Africa provides the opportunity to evaluate the introduction of information technology from a global perspective and assess its impact on public health. The Northern Province is implementing a comprehensive integrated hospital information system (HIS) in all of its 42 hospitals. These include two mental health institutions, eight regional hospitals (two acting as a tertiary complex with teaching responsibilities) and 32 district hospitals. The overall goal of the HIS is to improve the efficiency and effectiveness of health (and welfare) services through the creation and use of information, for clinical, administrative and monitoring purposes. This multi-site implementation is being undertaken as a single project at a cost of R130 million (which represents 2.5 per cent of the health and welfare budget on an annual basis). The implementation process commenced on 1 September 1998 with the introduction of the system into Mankweng Hospital as the pilot site and is to be completed in the year 2001. An evaluation programme has been designed to maximize the likelihood of success of the implementation phase (formative evaluation) as well as providing an overall assessment of its benefits and costs (summative evaluation). The evaluation was designed as a form of health technology assessment; the system will have to prove its worth (in terms of cost-effectiveness) relative to other interventions. This is more extensive than the traditional form of technical assessment of hardware and software functionality, and moves into assessing the day-to-day utility of the system, the clinical and managerial environment in which it is situated (humanware), and ultimately its effects on the quality of patient care and public health. In keeping with new South African legislation the evaluation process sought to involve as many stakeholders as possible at the same time as creating a methodologically rigorous study that lived within realistic resource limits. The design chosen for the summative assessment was a randomized controlled trial (RCT) in which 24 district hospitals will receive the HIS either early or late. This is the first attempt to carry out an RCT evaluation of a multi-site implementation of an HIS in the world. Within this design the evaluation will utilize a range of qualitative and quantitative techniques over varying time scales, each addressing specific aims of the evaluation programme. In addition, it will attempt to provide an overview of the general impact on people and organizations of introducing high-technology solutions into a relatively unprepared environment. The study should help to stimulate an evaluation culture in the health and welfare services in the Northern Province as well as building the capacity to undertake such evaluations in the future.
BACKGROUND: In most health authorities in the UK, general public health physicians provide out-of-hours cover for specialists in communicable disease control. Although communicable disease control was part of their specialist training, there is no current formal mechanism to enable these doctors to keep up to date. The Faculty of Public Health Medicine has an active Continuing Professional Development Programme. A new initiative aimed to assess the knowledge of general public health physicians who take part in on-call communicable disease control rotas, or may do so in the future, by means of an educational clinical audit exercise. METHODS: Experts in communicable disease control developed a questionnaire containing a selection of scenarios, covering six different situations that might arise on-call. This was circulated to all members of the Faculty, but participation was voluntary. Answers were marked against model answers agreed by the experts. Results were analysed by positions held by participants. RESULTS: Response was unacceptably low. Overall scores ranged from 15 per cent to 89 per cent with a mean of 63 per cent. There was a trend of improvement in marks from those not normally involved in on-call (mean score 56.1 per cent (95 per cent confidence interval 51.6-60.7 per cent)) through Directors of Public Health (58.4 (54.9-62.0) per cent), Consultants (62.8 (60-65.6) per cent), and specialist registrars (67.9 (65.2-70.6) per cent), to Consultants in Communicable Disease Control (70.9 (68.1-73.6) per cent). CONCLUSION: The public health physicians who took part in this audit appear to be competent in their knowledge of communicable disease control, and particularly good at dealing with meningitis and salmonella, which are frequently encountered out of hours.
STUDY OBJECTIVE: To estimate the net financial benefit of neonatal screening for phenylketonuria (PKU): by a simple pooling of cost data from the literature; and by a more complex modelling approach. DESIGN: A systematic literature review was conducted to identify papers containing data on the monetary costs and benefits of neonatal screening for PKU. The methodological quality of the studies was appraised, and data were extracted on resource use and expenditure. Monetary data were converted to common currency units, and standardised to UK incidence rates. Net benefits were calculated for median, best case and worst case scenarios, and the effect of excluding poor quality studies and data was tested. The net benefit was also estimated from a model based on data from the literature and assumptions appropriate for the current UK situation. Extensive sensitivity analysis was conducted. MAIN RESULTS: The direct net benefit of screening based on the median costs and benefits from the 13 studies identified was 143,400 Pounds per case detected and treated (39,000 Pounds and 241,800 Pounds for worst case and best case scenarios respectively). The direct net benefit obtained by the modelling approach was lower at 93,400 Pounds per case detected and treated. Screening remained cost saving under sensitivity analysis, except with low residential care costs (less than 12,300 Pounds per annum), or very low incidence rates (less than 1 in 27,000). CONCLUSIONS: The economic literature on PKU screening is of variable quality. The two methods of secondary analysis lead to the same conclusion: that neonatal PKU screening is worthwhile in financial terms alone in the UK, and that it justifies the infrastructure for collecting and testing neonatal blood samples. This result cannot necessarily be extrapolated to other countries.
BACKGROUND: Despite research evidence that guidelines can improve patient care, concerns remain over their cost-effectiveness. This is particularly so when there is a proliferation of guidelines for the same condition. Faced with differing recommendations, users will wish to make informed decisions on which guideline to follow. In creating a guideline appraisal instrument we have assessed guidelines developed in the United Kingdom (UK) for the management of a range of disorders including depression in primary care. AIM: To identify the number of UK clinical guidelines for the management of depression in primary care and to describe their quality and clinical content. METHOD: A survey was undertaken to identify all depression guidelines developed in the UK between January 1991 and January 1996. All guidelines produced by national organizations and a random sample of local guidelines were appraised using a validated instrument by six assessors: a national expert in the disease area, a general practitioner, a public health physician, a hospital consultant, a nurse specializing in the disease area, and a researcher on guideline methodology. The clinical content of each guideline was then assessed by one of the researchers (RB) according to a defined framework. RESULTS: Forty-five depression guidelines were identified. While there was a considerable range in the quality of the six national and three local guidelines appraised, at a group level their performance was similar to guidelines for other diseases. Clinical recommendations tended to reflect the joint consensus statement produced by the Royal College of General Practitioners and Royal College of Psychiatrists in 1992. The most obvious difference was in the style in which the guidelines were written and presented. CONCLUSION: A 'national template' was the starting place for most guidelines. Steps need to be taken to ensure that these templates are based on the best possible research evidence and professional opinion. Local clinicians should concentrate on effective dissemination and implementation strategies, rather than creating new guidelines.
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OBJECTIVE: To detect changes in mortality after surgery, with allowance being made for variations in case mix. DESIGN: Observational study of postoperative mortality from January 1992 to August 1995. SETTING: Regional cardiothoracic unit. SUBJECTS: 3983 patients aged 16 and over who had open heart operations. MAIN OUTCOME MEASURES: Preoperative risk factors and postoperative mortality in hospital within 30 days were recorded for all surgical heart operations. Mortality was adjusted for case mix using a preoperative estimate of risk based on additive Parsonnet factors. The number of operations required for statistical power to detect a doubling of mortality was examined, and control limits at a nominal significance level of P=0.01 for detection of an adverse trend were determined. RESULTS: Total mortality of 7.0% was 26% below the Parsonnet predictor (P<0.0001). There was a highly significant variation in annual case mix (Parsonnet scores 8.7-10.6, P<0.0001). There was no significant variation in mortality after adjustment for case mix (odds ratio 1-1.5, P=0.18) with monitoring by calendar year. With continuous monitoring, however, nominal 99% control limits based on 16 expected deaths were crossed on two occasions. CONCLUSIONS: Hospital league tables for mortality from heart surgery will be of limited value because year to year differences in death rate can be large (odds ratio 1.5) even when the underlying risk or case mix does not change. Statistical quality control of a single series with adjustment for case mix is the only way to take into account recent performance when informing a patient of the risk of surgery at a particular hospital. If there is an increase in the number of deaths the chances of the next patient surviving surgery can be calculated from the last 16 deaths.
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BACKGROUND: The relationship between breast cancer and socioeconomic deprivation is complex. Although women from more deprived areas are less likely to get breast cancer, in general they experience poorer survival. A number of reasons have been proposed, including differences in tumour stage and tumour biology, but recent studies suggest that treatment factors or host response are the most important. The introduction of a national health service breast screening programme (NHSBSP) means that an additional factor now has to be taken into account. As deprived women are less likely to attend for screening we set out to determine the nature of the relationship between prognostic factors evident at diagnosis, screening status and socio-economic deprivation, in order to assess the implications for the NHSBSP. METHODS: The NHSBSP computer systems and the Thames Cancer Registry (TCR) database were used to examine breast cancers diagnosed in women aged 50-64 y during the period 1988-1992. Cases had previously been classified into screen-detected, interval cancers, eligible but not yet invited, non-attenders and those not registered with the programme. A prognostic score was assigned to each case using TCR data on the morphology and extent of the disease. Socio-economic comparisons were made from the women's postcodes and census details using the Carstairs method. RESULTS: Screen-detected cases had a significantly better prognosis at diagnosis than those presenting with symptoms, and were less deprived than those who did not comply with the screening programme (by either failure to attend or not being registered). When the relationship between presentation status, deprivation and prognosis was assessed together, screen-detected cases had a better prognosis at diagnosis irrespective of deprivation level. CONCLUSION: The poor survival rate of deprived women with breast cancer due to host or treatment factors is likely to be compounded by poor attendance for screening. Unless the NHSBSP increases its efforts to target these women, the socio-economic gradient in breast cancer survival is likely to increase.
BACKGROUND: Developments in screening technology and increased understanding of the natural history and treatment of inborn errors of metabolism (IEMs) have produced pressure to extend neonatal screening programmes. This review aims to assess the evidence for the appropriateness of such programmes. METHODS: A formal systematic literature review was conducted. Exclusion and inclusion criteria were used to select papers for critical appraisal by pairs of reviewers. Standard criteria were used to assess the appropriateness of neonatal screening for various IEMs. Site visits were conducted to assess new technologies for newborn screening. RESULTS: A total of 1866 papers were identified and 407 systematically selected for full critical appraisal. Published evidence confirmed that universal newborn screening for phenylketonuria (PKU) meets all of the screening criteria and justifies the expense and infrastructure necessary for the collection and testing of neonatal blood spots. There was insufficient evidence in the literature to assess the cost-effectiveness of screening for any other IEMs. There was reasonable evidence to support inclusion in extended neonatal screening of four other IEMs: biotinidase deficiency, congenital adrenal hyperplasia (CAH), medium-chain acyl CoA dehydrogenase (MCAD) deficiency and glutaric aciduria type 1 (GA1). CONCLUSIONS: Large-scale trials of screening for biotinidase, CAH, MCAD and GA1 should be conducted, with careful evaluation to establish their clinical effectiveness and cost-effectiveness in practice. Screening for the latter two disorders would be dependent upon the use of tandem mass spectrometry (tandem MS). The application of tandem MS to newborn screening requires further evaluation. The extension of neonatal screening programmes to other IEMs is not currently justified.