Routine Care Data Research Articles

A national syndromic surveillance system for England and Wales using calls to a telephone helpline

Routine primary care data provide the means to monitor a variety of syndromes which could give early warning of health protection issues. In the United Kingdom, a national syndromic surveillance system, operated jointly by the UK Health Protection Agency (HPA) and NHS Direct (a national telephone health helpline), examines symptoms reported to NHS Direct. The aim of the system is to identify an increase in syndromes indicative of common infections and diseases, or the early stages of illness caused by the deliberate release of a biological or chemical agent. Data relating to 11 key symptoms/syndromes are received electronically from all 22 NHS Direct call centres covering England and Wales and analysed by the HPA on a daily basis. Statistically significant excesses in calls are automatically highlighted and assessed by a multi-disciplinary team. Although the surveillance system has characterised many sudden rises in syndromes reported to NHS Direct, no evidence of a biological or chemical attack has been detected. Benefits of this work, however, are early warning and tracking of rises in community morbidity (e.g. influenza-like illness, heatstroke); providing reassurance during times of perceived high risk (e.g. after the 7 July 2005 London bombs and December 2005 Buncefield oil depot fire); and timely surveillance data for influenza pandemic planning and epidemic modeling.

SZ1 EFFECTIVENESS AND COSTS OF ATYPICAL VERSUS TYPICAL ANTIPSYCHOTIC TREATMENT FOR SCHIZOPHRENIA IN ROUTINE CARE

In two recent randomised clinical trials, a meta-analysis and in an effectiveness study analysing routine data from the U.S. Veterans Administration the superiority of the newer atypical drugs over typical antipsychotic drugs, concerning both their efficacy and their side-effect profile, has been questioned.To analyse the effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care.Cohort study using routine care data from a statutory sickness fund with 5.4 million insured in Germany. To be included, patients had to be discharged with a diagnosis of schizophrenia in 2003 and fulfil membership criteria. Main outcome measures were rehospitalisation rates, mean hospital bed days, mean length of stay, cost of inpatient and pharmaceutical care to the sickness fund during follow-up and medication used to treat side-effects.3121 patients were included into the study. There were no statistically significant differences in the effectiveness of atypical and typical antipsychotics on rehospitalisation during follow-up (rehospitalisation rate ratio 1.07, 95% confidence interval 0.86 to 1.33). However, there were consistent observations of atypical antipsychotics being more effective for severe cases of schizophrenia (14.6% of study population; >61 prior bed days per year in 2000-2002) in the follow-up period, whereas for the other severity strata typical antipsychotics seemed more effective in reducing various rehospitalisation outcomes. Patients treated with atypical antipsychotics received significantly less prescriptions for anticholinergics or tiaprid (relative risk 0.26, 95% confidence interval 0.18 to 0.38).The effectiveness of atypical antipsychotics for schizophrenia on rehospitalisation measures appeared similar to that of typical antipsychotics. With the exception of severe cases, the higher costs for atypical antipsychotics were not offset by savings from reduced inpatient care. Major limitations include the lack of statistical power for subgroup analyses, the lack of clinical severity scale data and of life-course medical history data which both increase the risk of residual confounding by disease severity.This study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care.From a clinical perspective, this study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care.Routine data studies can yield valuable information for policy decision-makers on the costs and the effectiveness of pharmaceuticals in routine care, complementing efficacy data from randomised clinical trials currently used for licensing and reimbursement decisions.The non-significant differences in the effectiveness of atypical compared to typical antipsychotics according to severity of disease should be investigated in a prospective observational study or in a randomised clinical trial.

The cost burden of diabetes mellitus: the evidence from Germany—the CoDiM Study

The aim of this study was to identify the health care costs of diabetic patients in Germany in 2001, focusing on the influence of age, sex, and type of treatment. Annual direct costs of medical care and indirect costs of inability to work and early retirement in diabetic subjects were compared with costs of age- and sex-matched non-diabetic control subjects. The analysis was based on routine health care data from a random sample (18.75%) taken from a database of 1.9 million insured persons. Incremental differences in medical and national expenditure between subjects with and without diabetes were calculated. Annual direct mean costs per diabetic patient were 5,262 Euro, and indirect costs were 5,019 Euro. In the control group, mean direct and indirect costs were 2,755 Euro and 3,691 Euro, respectively. Analysis of cost components revealed that the high costs associated with the care of diabetic patients could be largely attributed to inpatient care and overall medication costs. Hypoglycaemic drugs amounted to only one-quarter of the medication costs. The total health care costs were correlated with the type of treatment. Direct excess costs increased with increasing age in insulin-treated patients, but were unaffected by age in patients receiving other types of treatment. The Costs of Diabetes Mellitus (CoDiM) study is the first comprehensive study to provide estimates of costs associated with diabetes care in Germany. Direct costs of diabetic patients account for 14.2% of total health care costs, which includes the proportion that specifically accounts for diabetes-related costs (6.8%).

Randomised studies in general practice: how to integrate the electronic patient record

The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet. The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the computer randomises the patients. Follow-up is documented by normal routine care in the EPR. Although the randomised database study has many methodological advantages, it has never been tested. Our software system is meant as a tool to implement and facilitate evaluation of the randomised database approach.

The Utrecht Health Project: Optimization of routine healthcare data for research

Research on the impact of changes in healthcare policy, developments in community and public health and determinants of health and disease during lifetime may effectively make use of routine healthcare data. These data, however, need to meet minimal criteria for quality and completeness. Research opportunities are further improved when routine data are supplemented with a standardized 'baseline' assessment of the full population. This formed the basis for a new study initiated in a newly developed large residential area in Leidsche Rijn, part of the city of Utrecht, the Netherlands. All new inhabitants are invited by their general practitioner to participate in the Utrecht Health Project (UHP). Informed consent is obtained and an individual health profile (IHP) is made by dedicated research nurses. The IHP is the starting point for the UHP research database as well as for the primary care electronic medical records. Follow-up data are collected through continuous linkage with the computerized medical files recorded by the general practitioners. UHP staff in each practice takes care of quality management of registration as well as data handling. Currently, over 60% of invited new residents in the area have given informed consent with participation steadily increasing. The Utrecht Health Project combines key elements of traditional epidemiologic cohort studies with the current power of routine electronic medical record keeping in primary care. The research approach optimizes routine health care data for use in scientific research.

Challenges in Current Drug Delivery from the Potential Application of Pharmacogenomics and Personalized Medicine in Clinical Practice

The recent technological achievements in biotechnology and recombinant DNA technology have provided multiple new methods, molecular targets, and DNA-based diagnostics to pharmaceutical research that can be utilized in assays for screening and developing potential biotechnology-based drugs, as well as in biomedicine, health and pharmaceutical care. Furthermore, such advances opened up new opportunities by applying genetic information data in pharmacotherapy and drug delivery, thus ensuring better drug efficacy and safety in clinical practice. Now the concepts of personalized medicine and pharmacogenomics are likely improving the area of pharmacodynamics and pharmacokinetics, since they favor differentiation of the conventional clinical diagnosis and drug selection into separate molecular subtypes of individuals belonging within a group of patients suffering from the same disease. Genetic polymorphisms have already been detected and analyzed in genes encoding drug-metabolizing enzymes, transporters as well as targets (e.g. receptors). The potential of applying genotyping and haplotyping analysis in future pharmaceutical care could eventually lead to pharmacotyping, i.e. individualized drug delivery profiling based on genetic-bioinformatic data in routine patient care. However, the steps towards this direction of drug delivery in clinical practice still have a long way to go to be fully achieved; until then, the critical evaluation of all available clinical data including pharmacodynamic, pharmacokinetic and genomic must be assessed for ensuring drug efficacy and safety. In this way, there has been great progress in elucidating genetic determinants contributing to the observed interindividual differences in drug disposition and effects, thus implementing current drug delivery with molecular genetics and diagnostics.

Monitoring serum levels of gentamicin in neonates.

Newborn infants in intensive care units demonstrated a higher incidence of gestational age below 31 week. Obstetrical and neonatal diseases procedures required for the management of critically ill neonates are associated with an increased risk of infections. Gentamicin is an aminoglycoside antibiotic often used to treat gram-negative bacillary infections and suspected sepsis in neonates. The risk of toxicity or poor efficacy is further increased due to the recognised wide intra and interpatient variability of the newborn. The present work involved 49 infants of 31.3 +/- 4.1 (mean +/- SD) weeks of gestational age, weighing 1.7 +/- 0.8 kg and were treated with standard doses of gentamicin (3.8 +/- 0.9 mg/kg/day). Routine clinical care data were retrospectively collected from the medical records in the neonatal intensive-care unit at Coimbra University Hospital. Data analysis demonstrated that potentially toxic serum levels were observed in 49% of newborn infants (trough > 2 mg/L). Additionally, the obtained results also showed that 7.5% of peak concentrations were found to be higher than 10 mg/L. Potentially sub-therapeutic concentrations were observed in 15% of the patients (peak > 6 mg/L).

Application of a diagnostic decision rule in children with meningeal signs: a cost-minimization study.

Recently, we developed a diagnostic rule for the diagnosis and treatment of children with meningeal signs. This rule may provide the physician with a rationale to decide on the use of diagnostic and treatment procedures in these children and to improve their care. In this study, we estimated cost savings of the rule compared with current practice. Routine care data of 360 children visiting the emergency department of the Sophia Children's Hospital with meningeal signs between 1988 and 1998 were used. Costs of diagnostic tests and treatment were estimated by using financial accounts of an academic and a general pediatric hospital. The number of procedures actually performed and the resulting cost estimates (i.e. unit costs x volume) were compared with the estimated figures after application of the decision rule. The population of children with meningeal signs comprised 99 with bacterial meningitis (27%), 36 with another serious bacterial infection (10%), and 225 with a self-limiting disease (63%). Application of the rule would reduce lumbar punctures by 12% and hospitalizations for empirical treatment by 15% with the same diagnostic accuracy as current practice. Cost savings were estimated at Euro292 per patient (relative reduction 10%) and were mainly achieved in the treatment course (Euro259). A diagnostic decision rule for children with meningeal signs has the potential to improve the appropriate use of medical resources, to be cost-effective, and to ascertain the absence of bacterial meningitis earlier.

Diagnostic research on routine care data: Prospects and problems

A diagnosis in practice is a sequential process starting with a patient with a particular set of signs and symptoms. To serve practice, diagnostic research should aim to quantify the added value of a test to clinical information that is commonly available before the test will be applied. Routine care databases commonly include all documented patient information, and therefore seem to be suitable to quantify a tests' added value to prior information. It is well known, however, that retrospective use of routine care data in diagnostic research may cause various methodologic problems. But, given the increased attention of electronic patient records including data from routine patient care, we believe it is time to reconsider these problems. We discuss four problems related to routine care databases. First, most databases do not label patients by their symptoms or signs but by their final diagnosis. Second, in routine care the diagnostic workup of a patient is by definition determined by previous diagnostic (test) results. Therefore, routinely documented data are subject to so-called workup bias. Third, in practice, the reference test is always interpreted with knowledge of the preceding test information, such that in scientific studies using routine data the diagnostic value of a test under evaluation is commonly overestimated. Fourth, routinely documented databases are likely to suffer from missing data. Per problem we discuss methods that are presently available and may (partly) overcome each problem. All this could contribute to more frequent and appropriate use of routine care data in diagnostic research. The discussed methods to overcome the above problems may well be similarly useful to prospective diagnostic studies.

The measurement of inequities in health: Lessons from the British experience

There has been an acrimonious debate about trends in inequality in health in the U.K. over the last couple of years. Whilst the acrimony is highly specific to the U.K. context, the terms of the debate contain general lessons for others who would venture into the same territory. This paper has focused on problems with using occupational classifications, with using groups of different size, with assessing trends in inequalities in death, with the measurement tool employed, with comparing patterns of ill-health and with the framework of explanation. The U.K. debate provides a good example of the first problem. Much of the debate has had to rely on the classification of occupation at the time of death by the Registrar General's Department. The scheme used was devised in 1911 and has persisted despite the massive changes in occupational structure since then. The groups now contain different occupational titles (2.1), and it is not at all clear what is being referred to by the RG scheme (2.2). Moreover, the balance of the RG groups has shifted dramatically (3.1). Any scheme applied regularly and routinely to mortality statistics over time will have these problems—it is not surprising that it is very difficult to interpret patterns of class death rates (3.2). The argument over trends in the U.K. has sometimes focused exclusively on the measurement tool—the standardized mortality ratios. Various alternatives have been proposed, in particular the Gini coefficient (4.1) which clearly answers a different, possibly rather uninteresting, question. The correct way of comparing ‘top’ and ‘bottom’ is to devise a method which produces a group of constant size in the different communities or at different times (4.2). The focus on death rather than survivorship is queried (4.3) as is the usual restriction to comparing rates of early death (4.4). Possibilities of comparing patterns of ill-health are examined in the fifth section. Whilst routine health care data or survey morbidity data are invaluable (5.1), it seems highly unlikely that they can be compared between communities or over time (5.2). The alternative is to develop a series of ‘risk’ indicators and these are discussed in Section 5.3. The examination of patterns of inequalities in death and ill-health highlights the complexity of discussing aetiology. We consider the balance between long-term and short-term effects and the possible role of (ill)-health on the social mobility process (6.1), and problems of directly relating low income to poor health (6.2).

The relationship between socioeconomic class and prevalence of schizophrenia, alcoholism, and affective disorders treated by inpatient care in a suburban area.

This study relates inpatient-treated prevalence of the three mental illnesses most often requiring inpatient treatment--schizophrenia, alcoholism, and affective disorders--to social class in a suburban area. Rates were developed for the total population, including those living in domiciliary care, for those living in households only, and for first-admission patients living in households. Log-linear models supported the finding that low socioeconomic status was related to a high prevalence of alcoholism and affective disorders. In contrast, socioeconomic status was not related to the prevalence of schizophrenia among those living in households or among first-admission patients living in households.

Clinical applications of a transcutaneous ultrasonic flow detector

The limits of human perception have been extended enormously by modern technological advances which permit acquisition of quantitative data from outer space or from the submicroscopic realms of atomic nuclei. Engineers employ exquisitely sensitive gauges to analyze the function of machines and components. Meanwhile, physicians still depend heavily on their unaided five senses to obtain clinical data in routine patient care. Recent developments in the use of nondestructive testing techniques for detecting the size, position, displacement, or flow in internal structures of the body provide a preview of things to come in clinical medicine. For example, a small device has been developed for detecting blood-flow velocity in deep and superficial vessels by merely applying a probe to the body surface. This instrument called a transcutaneous Doppler flow detector (Fig 1) is currently being evaluated for its applicability to clinical problems,^{1 -3}eg, locating and evaluating arterial occlusions,⁴detecting

Clinical Applications of A Transcutaneous Ultrasonic Flow Detector

The limits of human perception have been extended enormously by modern technological advances which permit acquisition of quantitative data from outer space or from the submicroscopic realms of atomic nuclei. Engineers employ exquisitely sensitive gauges to analyze the function of machines and components. Meanwhile, physicians still depend heavily on their unaided five senses to obtain clinical data in routine patient care. Recent developments in the use of nondestructive testing techniques for detecting the size, position, displacement, or flow in internal structures of the body provide a preview of things to come in clinical medicine. For example, a small device has been developed for detecting blood-flow velocity in deep and superficial vessels by merely applying a probe to the body surface. This instrument called a transcutaneous Doppler flow detector (Fig 1) is currently being evaluated for its applicability to clinical problems,^{1 -3}eg, locating and evaluating arterial occlusions,⁴detecting