Biomedical subjects
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Up to 40% of referrals from primary care to 'breast cancer family clinics' prove to be of women whose assessed risk falls below the guidelines' threshold for management in secondary or tertiary care, despite recommendations that they should be screened out at primary care level. A randomised trial, involving 87 such women referred to the Tayside Familial Breast Cancer Service compared two ways of communicating risk information, letter or personal interview. Both were found to be acceptable to referred women and to their family doctors, although the former expressed a slight preference for interview. Only four women returned to their family doctors with continuing concerns about breast cancer. Nevertheless, understanding of information provided by either route was unsatisfactory, with apparent confusion about both absolute and relative risks of breast cancer. Substantial minorities appear to believe that they are at no increased risk at all, or even below the population level of risk, while others remain convinced that their personal risk has been underestimated. Family history record forms, completed by the referred women, preferably with the assistance of relatives, are crucial to full assessment of familial risk but one quarter of women referred to the Tayside Familial Breast Cancer Service currently do not complete and return these forms ahead of their clinic appointment. Further collaboration between primary care and the Breast Cancer Family Service is required to improve provision for concerned women whose risks fall below the threshold for special surveillance and to maximise effective use of the family history record form.
BACKGROUND: Pulmonary artery catheterization was adopted about 30 years ago and widely disseminated without rigorous evaluation as to whether it benefited critically ill patients. The technique is used to measure cardiac output and pressures in the pulmonary circulation to guide diagnosis and treatment. Clinicians believe these data can improve patients' outcomes, even in the absence of consensus about the specific interpretation of the data. OBJECTIVES: To assess the effect of pulmonary artery catheterization on mortality and cost of care in adult intensive care patients. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2006); MEDLINE (all records to April 2006); EMBASE (all records to April 2006); CINAHL (all records to April 2006) and reference lists of articles. We contacted manufacturers and researchers in the field. SELECTION CRITERIA: We included all randomized controlled trials in adults, comparing management with and without a pulmonary artery catheter (PAC). DATA COLLECTION AND ANALYSIS: We screened the titles and abstracts of the electronic search results and obtained the full text of studies of possible relevance for independent review. We determined the final results of the literature search by consensus between the authors. We did not contact study authors for additional information. MAIN RESULTS: We identified 12 studies. Mortality was reported as hospital, 28-day, 30-day, or intensive care unit. We considered studies of high-risk surgery patients (eight studies) and general intensive care patients (four studies) separately for the meta-analysis. The pooled odds ratio for the studies of general intensive care patients was 1.05 (95% confidence interval (CI) 0.87 to 1.26) and for the studies of high-risk surgery patients 0.99 (95% CI 0.73 to 1.24). Of the eight studies of high-risk surgery patients, five evaluated the effectiveness of pre-operative optimization but there was no difference in mortality when these studies were examined separately. Pulmonary artery catheterization did not affect intensive care unit (reported by 10 studies) or hospital (reported by nine studies) length of stay. Four studies, conducted in the United States, measured costs based on hospital charges billed to patients, which on average were higher in the PAC groups. AUTHORS' CONCLUSIONS: To date, there have been two multi-centre trials of the effectiveness of PACs for managing critically ill patients admitted to intensive care, although only one was adequately powered. Efficacy studies are needed to determine optimal management protocols and patient groups who could benefit from management with a PAC.
Surveillance of surgical site infection (SSI) is an important infection control activity. The Caesarean section procedure was selected, as part of the Scottish Surveillance of Healthcare Associated Infection Programme, to monitor and report upon the incidence of SSI. Data were collected prospectively for 715 patients undergoing a Caesarean section procedure for 35 weeks during the latter months of 2002 and the first quarter of 2003. Of these, 80 (11.2%) patients developed an SSI, 57 (71%) of which were detected by postdischarge surveillance. Risk factors associated with infection were analysed. The choice of subcuticular suture rather than staples to close the surgical site was associated with a significantly lower incidence of infection (P=0.021). Obese women experienced significantly more infections than women with a normal body mass index (P=0.028). Dissemination of the surveillance results has made clinicians aware of the influence of body mass index and choice of skin closure in relation to SSI in this patient population. Analysis of these data has led to a review of local practice. The results also indicate the importance of postdischarge surveillance if SSIs are to be detected in this patient group. Continuous data collection and timely dissemination of the results are important factors acting as the catalyst for a review of practice.
Recently there has been an upsurge of interest in strategies for detecting at-risk patients in order to trigger the timely intervention of a Medical Emergency Team (MET), also known as a Rapid Response Team (RRT). We review a real-time automated system, BioSign, which tracks patient status by combining information from vital signs monitored non-invasively on the general ward. BioSign fuses the vital signs in order to produce a single-parameter representation of patient status, the Patient Status Index. The data fusion method adopted in BioSign is a probabilistic model of normality in five dimensions, previously learnt from the vital sign data acquired from a representative sample of patients. BioSign alerts occur either when a single vital sign deviates by close to +/-3 standard deviations from its normal value or when two or more vital signs depart from normality, but by a smaller amount. In a trial with high-risk elective/emergency surgery or medical patients, BioSign alerts were generated, on average, every 8 hours; 95% of these were classified as 'True' by clinical experts. Retrospective analysis has also shown that the data fusion algorithm in BioSign is capable of detecting critical events in advance of single-channel alerts.
During anaesthesia monitoring is used as part of a complex feedback-control system to keep the patient in a safe physiological 'envelope' and so is central to the conduct of a modern anaesthetic. The utility of basic monitoring is universally acknowledged and will never be assessed using randomized controlled trials. However, each time a new monitoring device is introduced, it can be assessed to see if it adds to the safety and effectiveness of anaesthetics. This review highlights some of the studies that have assessed new monitors in anaesthesia, critical care, and other areas of acute care.
We have analysed 13 autosomal STR loci in four endogamous tribal populations from two eastern states (Orissa and Nagaland) of India. The Gadaba, Kuvi Khond and Lotha Naga populations have not been analysed for microsatellite genetic variation previously. The allele frequencies for all loci are within the range observed in the geographical region and racial background, though some alleles showed greater variation. Departures from the Hardy-Weinberg equilibrium were tested by three methods and two loci (THO1 and TPOX) showed significant departures for all measures in Gadaba and Lotha Naga populations. The exclusion probability and discrimination probability were high for all analysed loci in all populations. There is no evidence for association of alleles among the STR loci studied. This allele frequency information will be useful for forensic, paternity and population genetic studies.
BACKGROUND: An uncontrolled pilot study demonstrated that daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), might be effective for the treatment of active ulcerative colitis. METHODS: A randomised, double blind, placebo controlled trial was conducted to evaluate the efficacy of daclizumab induction therapy in patients with active ulcerative colitis. A total of 159 patients with moderate ulcerative colitis were randomised to receive induction therapy with daclizumab 1 mg/kg intravenously at weeks 0 and 4, or 2 mg/kg intravenously at weeks 0, 2, 4, and 6, or placebo. The primary end point was induction of remission at week 8. Remission was defined as a Mayo score of 0 on both endoscopy and rectal bleeding components and a score of 0 or 1 on stool frequency and physician's global assessment components. Response was defined as a decrease from baseline in the Mayo score of at least 3 points. RESULTS: Two per cent of patients receiving daclizumab 1 mg/kg (p = 0.11 v placebo) and 7% of patients receiving 2 mg/kg (p = 0.73) were in remission at week 8, compared with 10% of those who received placebo. Response occurred at week 8 in 25% of patients receiving daclizumab 1 mg/kg (p = 0.04) and in 33% of patients receiving 2 mg/kg (p = 0.30) versus 44% of those receiving placebo. Daclizumab was well tolerated. The most frequently reported adverse events in daclizumab treated patients compared with placebo treated patients were nasopharyngitis (14.6%) and pyrexia (10.7%). CONCLUSION: Patients with moderate ulcerative colitis who are treated with daclizumab are not more likely to be in remission or response at eight weeks than patients treated with placebo.
AIM: To assess the Scottish newborn screening programme for congenital hypothyroidism from 1994 to 2003 (period 2) for performance and compare with an initial audit covering 1979 to 1993 (period 1). DESIGN: Performance data-age at blood spot sampling, notification by screening laboratory, start of treatment, and the prevalence of late testing, notification or treatment-were compared, together with the incidence of congenital hypothyroidism. RESULTS: Comparing data for period 2 with period 1, the mean annual incidence of true congenital hypothyroidism was 1:3655 live births v 1:4363. Median age for Guthrie sampling (all referrals) was 6 v 7 days (p<0.0001). Late sampling (>10 days) had fallen from 10.7% to 7%. For infants requiring repeat sampling before notification, the median (range) interval between initial and final repeat samples was 11 (1 to 52) compared with 14 (3 to 73) days. Median age at notification for true congenital hypothyroidism was 10 v 12 days (p <0.0001). Late notification (>15 days) was justifiable (mild TSH elevation) in 10 of 13 patients in period 2. Median age at start of treatment for true congenital hypothyroidism had improved to 11 days from 13.5 days. For true congenital hypothyroidism, late treatment (>16 days) occurred in 7% of patients compared with 19% (p<0.0001). CONCLUSIONS: There has been an improvement in performance measures for the congenital hypothyroidism screening programme in Scotland. However, late sampling, occurring primarily in inpatients and which is never justified, remains a problem, while the interval between initial and recall sampling is a further source of delay.
BACKGROUND AND AIMS: Clinical adrenal insufficiency has been reported with doses of inhaled fluticasone proprionate (FP) > 400 microg/day, the maximum dose licensed for use in children with asthma. Following two cases of serious adrenal insufficiency (one fatal) attributed to FP, adrenal function was evaluated in children receiving FP outwith the licensed dose. METHODS: Children recorded as prescribed FP > or = 500 microg/day were invited to attend for assessment. Adrenal function was measured using the low dose Synacthen test (500 ng/1.73 m2 intravenously) and was categorised as: biochemically normal (peak cortisol response > 500 nmol/l); impaired (peak cortisol < or = 500 nmol/l); or flat (peak cortisol < or = 500 nmol/l with increment of < 200 nmol/l and basal morning cortisol < 200 nmol/l). RESULTS: A total of 422 children had been receiving FP alone or in combination with salmeterol; 202 were not investigated (137 FP within license; 24 FP discontinued); 220 attended and 217 (age 2.6-19.3 years) were successfully tested. Of 194 receiving FP > or = 500 microg/day, six had flat responses, 82 impaired responses, 104 were normal, and in 2 the LDST was unsuccessful. Apart from the index child, the other five with flat responses were asymptomatic; a further child with impairment (peak cortisol 296 nmol/l) had encephalopathic symptoms with borderline hypoglycaemia during an intercurrent illness. The six with flat responses and the symptomatic child were all receiving FP doses of > or = 1000 microg/day. CONCLUSION: Overall, flat adrenal responses in association with FP occurred in 2.8% of children tested, all receiving > or = 1000 microg/day, while impaired responses were seen in 39.6%. Children on above licence FP doses should have adrenal function monitoring as well as a written plan for emergency steroid replacement.
The further integration of primary care within the wider health system is an imperative for reform in all countries. The aim of this paper is to determine the factors associated with general practitioner (GP) integration using the GP Integration Index which has been recently developed and is demonstrating good reliability. The analysis is based on a database derived from an Australia-wide mail questionnaire survey of 1874 GPs drawn from a 20% stratified random sample of 123 Divisions of General Practice (47.8% adjusted response rate). The GP Integration Index measures the level of GPs' integration with the health care system based upon a description of their own behaviour. It consists of nine GP integration factors, and their two associated higher-order factors-Primary Care Management (PCM) and Community Health Role (CHR)-as well as five GP integration enabling factors. A multivariate multilevel analysis was undertaken. An explanatory model for both PCM and CHR was tested based on the GP integration factors as well as general practice, GP and regional characteristics. CHR and PCM were most strongly associated with GP integration enabling factors (mainly at the individual-level) and, for CHR only, with urban-rural location (mainly at the area-level). The most important single explanatory variable for both PCM and CHR was the GP integration enabling factor, "Knowledge of local resources." The important explanatory variables were those reflecting the way GPs work, rather than their broad 'classification' within individual or GP-setting groupings. Based on these results, some revision to the proposed model was necessary. We conclude that processes of care factors (as compared to structure of care factors) are more important in relation to GP integration than previously recognised. Future policy initiatives to promote GP integration should focus on programs to improve GP's knowledge of local resources.
Serum immunoreactive trypsin (IRT) is used as a screening test for cystic fibrosis (CF) in neonates in many countries. Variations in IRT levels are observed in healthy and cystic neonates within the first few weeks of life. Fifteen percentage of CF neonates present with meconium ileus (MI). We hypothesised that there may be differences in serum IRT levels in cystic babies with simple and complicated MI. The aim of this study was to investigate the serum levels of IRT in neonates with CF presenting with MI. IRT levels were sequentially measured in neonates (n = 29) with CF with intestinal obstruction due to simple or complicated MI. These were compared to levels obtained from non-cystic neonates/controls admitted with a variety of other intra-abdominal pathologies (n = 49) IRT levels were significantly higher in the CF-MI group than the non-cystic controls (P < 0.001). There was no statistical difference in IRT levels between the simple or complicated MI groups. In the MI group there was no statistical difference between those who required operation, no difference between the pre- and post-operative IRT levels and no significant relationship between IRT levels and birth weight or gestation. Serum IRT levels are significantly elevated in neonates with CF and MI compared with non-cystic, non-MI neonates. The results of this observational study highlight that a single raised level of IRT in a neonate should prompt the analysis for CF regardless of any underlying surgical pathology.
We performed a retrospective audit of blood glucose control after introducing a new protocol for insulin infusion. The audit showed a sustained reduction in the median blood glucose, which decreased from 7.0 to 6.8 mmol x l(-1), primarily because of a reduction in the proportion of values above 6 mmol x l(-1). When we examined the proportion of readings with previously published 'acceptable' ranges we found that small, probably clinically insignificant, changes in the accepted range have a major effect on apparent compliance with glycaemic control. This is because a large number of results fall within a narrow range of values. As a result there is a nearly 2.5-fold difference in compliance for a change in the upper limit of the target range of just 2.2 mmol x l(-1). Different target ranges have been recommended for tight glycaemic control. When comparing compliance with tight glycaemic control between intensive care units, target ranges should be identical.
AIM: To establish a clinically efficient, cost-effective quality assurance programme as part of a routine retinopathy screening service. METHODS: The operation of a quality assurance system as part of an ongoing retinal screening service is described. A random selection of 12% of images of all people reported to have retinopathy and of 2% reported to have no retinopathy are re-graded by a consultant ophthalmologist. Entry of the two sets of data into a purpose-designed excel spreadsheet allows automated calculation of sensitivity and specificity. RESULTS: The results of quality assurance from August 2001 to July 2003 are reported. Out of 8351 screening episodes, 498 were re-examined. Of the 62 cases identified by the ophthalmologist as having referable retinopathy, four false negatives for detection were identified. Three of these had been assigned to early re-screening by the retinal screener but were still regarded as false negative by the parameters of the quality assurance system. The sensitivity and specificity for detection of sight-threatening retinopathy were 93.5% (95% CI = 84.3-98.2%) and 97.8% (95% CI = 95.8-98.9%), respectively. CONCLUSION: A robust and cost-effective system has been developed to allow monitoring of performance of routine retinal screening which may be extended to meet current national recommendations.
BACKGROUND: Roll-your-own (RYO) cigarettes are often substantially less expensive than factory made (FM) cigarettes, and appear to be increasing in popularity-perhaps because smokers seek out less expensive options to maintain their nicotine addiction. There is surprisingly little research available on the actual prevalence of RYO cigarette usage, and even less on the attributes of those who smoke RYO cigarettes. OBJECTIVES: This study has two objectives: (1) to compare the prevalence of RYO versus FM cigarette usage among adult smokers in Australia, Canada, the United Kingdom, and the United States; and (2) to compare the attributes of exclusive FM smokers, exclusive RYO smokers, and those who report "mixed" RYO and FM use. DESIGN: The data were collected from the International Tobacco Control (ITC) Four Country Survey (ITC-4), a random digit dialed telephone survey of representative samples of over 9046 adult smokers from the following four countries: Australia (n = 2301), Canada (n = 2,206), the UK (n = 2400), and the USA (n = 2,139), surveyed between October and December 2002, and on 6075 smokers followed-up, on average, seven months later. RESULTS: The prevalence of RYO cigarette usage varied widely across the four countries, with a low of 6.7% in the USA, to 28.4% in the UK. Exclusive use of RYO cigarettes was more common in the UK than in the other three countries. The use of RYO cigarettes was associated with having a lower annual income, male sex, younger average age, higher level of nicotine addiction, a stronger belief that RYO tobacco is less harmful compared to other forms of tobacco, and a more positive perception of tobacco use. Prevalence of RYO use was relatively stable within each of the four countries between the baseline and follow-up survey. RYO use was unrelated to quitting activity at follow-up, although mixed RYO users who had made a quit attempt were more likely to relapse than either exclusive FM or exclusive RYO smokers. CONCLUSIONS: Patterns of RYO use vary considerably across Australia, Canada, the USA, and the UK. RYO smokers are a heterogeneous group; however, the factors associated with RYO use appear to be the same across the four countries studied.
OBJECTIVES: To evaluate the clinical and cost-effectiveness of managing critically ill patients in adult, general intensive care with or without pulmonary artery catheters (PACs). DESIGN: An open, multi-centre, randomised controlled trial with economic evaluation (cost-utility and cost-effectiveness analysis). SETTING: The setting was general (mixed medical/surgical) intensive care units (ICUs) in the UK admitting adults. PARTICIPANTS: Adult patients in participating ICUs deemed by the responsible treating clinician to require management with a PAC. INTERVENTIONS: These were insertion of a PAC and subsequent clinical management, at the discretion of the responsible treating clinicians, using data derived from the PAC. The control group were managed without a PAC but with the option of using alternative cardiac output monitoring devices. MAIN OUTCOME MEASURES: The main outcome measure was hospital mortality. Secondary outcome measures were length of stay in the ICU, length of stay in an acute hospital and organ-days of support in the ICU. For the economic evaluation, the main outcome measure was quality-adjusted life-years (QALYs) and the secondary outcome measure was hospital mortality. RESULTS: Sixty-five ICUs in the UK participated. Of these, 43 (66%) used alternative cardiac output monitoring devices in control group patients. A total of 1263 patients were identified as being eligible for the trial. Of these, 1041 (82.4%) were randomised and allocated to management with (n = 519) or without (n = 522) a PAC. There were no losses to follow-up. However, 27 patients (13 in the PAC group and 14 in the control group) were withdrawn from the trial because either the patient withdrew consent on recovering mental competency or the relatives withdrew agreement following randomisation. Data on 1014 patients were included in the analysis. Participants in the two groups had similar baseline characteristics. There was no difference in hospital mortality for patients managed with (68.4%) or without (65.7%) a PAC. The adjusted hazard ratio (PAC versus no PAC) was 1.09 [95% confidence interval (CI) 0.94 to 1.27]. There was no difference in the median length of stay in ICU, the median length of stay in an acute hospital or mean organ-days of support in ICU between the two groups. The economic evaluation found that the expected cost per QALY gained from the withdrawal of PAC was 2985 pounds. The expected cost per life gained from the withdrawal of PAC was 22,038 pounds. CONCLUSIONS: Clinical management of critically ill patients with a PAC, as currently practised in the UK, neither improves hospital survival for adult, general intensive care patients nor reduces length of stay in hospital. The lack of demonstrable benefit from a device previously believed to be beneficial could be explained by statistical chance, by misinterpretation of PAC-derived data, by ineffective treatment strategies based on data correctly interpreted using the current paradigm or by subsequent inaction following insertion of the device. It is also possible that detailed data on haemodynamics, however used, cannot modify the disease process sufficiently to influence disease outcome. The economic evaluation, using decision analysis techniques rather than conventional hypothesis testing, suggests that the withdrawal of the PAC from routine clinical practice in the NHS would be considered cost-effective in the current decision-making climate, and might result in lives or life-years being saved at modest cost. With the declining use of PACs in the UK and the findings of this report indicating no overall benefit from management with a PAC, it should now be possible to examine protocolised management with a PAC in selected groups of critically ill patients against appropriate controls, something that was difficult while PACs were the considered standard of care.
All the human and animal laboratory reports of zoonoses sent to Health Protection Scotland between 1993 and 2002 were identified. There were 24,946 reports from veterinary laboratories, and 94,718 (20 per cent) of the 468,214 reports from medical laboratories were considered to be zoonotic. The most common reports of zoonoses from people were Campylobacter, Salmonella, Cryptosporidium and Giardia species and Escherichia coli o157. The most common reports of zoonoses from animals were Salmonella, Cryptosporidium, Chlamydia and Campylobacter species and Mycobacterium avium paratuberculosis. For all the zoonoses in people, the National Health Service Board areas Borders, Dumfries and Galloway, Forth Valley, Grampian, Lanarkshire and Lothian had a higher than expected standardised incidence rate of infection, whereas Ayrshire and Arran, Fife, Greater Glasgow, Shetland, Tayside and Western Isles had a lower than expected rate. The organisms and diseases considered to be new and emerging were Rhodococcus species, Cyclospora cayetanensis, Leishmania species, Pneumocystis carinii (jiroveci) and bovine spongiform encephalopathy/variant Creutzfeldt-Jakob disease.
BACKGROUND: A policy of regular neonatal weight monitoring was introduced to a geographically defined population in 2000. This was combined with targeted breast feeding support for infants reaching specified intervention thresholds. AIMS: To look for evidence of compromise in breast feeding rates as a result of this policy change. METHODS: Breast feeding rates at 10 days and 6 weeks were compared for this intervention population and two local non-intervention groups for the years 1999 and 2001. The data were analysed using Poisson regression analysis and the Z-test. RESULTS: There was a 3.1% (95% CI 0.8% to 5.5%) rise in the deprivation corrected breast feeding rate at 6 weeks for the intervention population compared to an increase of 0.8% (95% CI -0.8% to 2.3%) for the combined control groups. Multivariate analysis showed that breast feeding rates were adversely influenced by deprivation, but were not significantly influenced by the intervention. CONCLUSION: No evidence was found to support claims that regular monitoring of newborn weight adversely affects breast feeding rates.