Clinical data integration model. Core interoperability ontology for research using primary care data.

INTRODUCTION: This article is part of the Focus Theme of METHODS of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". BACKGROUND: Primary care data is the single richest source of routine health care data. However its use, both in research and clinical work, often requires data from multiple clinical sites, clinical trials databases and registries. Data integration and interoperability are therefore of utmost importance. OBJECTIVES: TRANSFoRm's general approach relies on a unified interoperability framework, described in a previous paper. We developed a core ontology for an interoperability framework based on data mediation. This article presents how such an ontology, the Clinical Data Integration Model (CDIM), can be designed to support, in conjunction with appropriate terminologies, biomedical data federation within TRANSFoRm, an EU FP7 project that aims to develop the digital infrastructure for a learning healthcare system in European Primary Care. METHODS: TRANSFoRm utilizes a unified structural / terminological interoperability framework, based on the local-as-view mediation paradigm. Such an approach mandates the global information model to describe the domain of interest independently of the data sources to be explored. Following a requirement analysis process, no ontology focusing on primary care research was identified and, thus we designed a realist ontology based on Basic Formal Ontology to support our framework in collaboration with various terminologies used in primary care. RESULTS: The resulting ontology has 549 classes and 82 object properties and is used to support data integration for TRANSFoRm's use cases. Concepts identified by researchers were successfully expressed in queries using CDIM and pertinent terminologies. As an example, we illustrate how, in TRANSFoRm, the Query Formulation Workbench can capture eligibility criteria in a computable representation, which is based on CDIM. CONCLUSION: A unified mediation approach to semantic interoperability provides a flexible and extensible framework for all types of interaction between health record systems and research systems. CDIM, as core ontology of such an approach, enables simplicity and consistency of design across the heterogeneous software landscape and can support the specific needs of EHR-driven phenotyping research using primary care data.

An eligibility criteria query language for heterogeneous data warehouses.

INTRODUCTION: This article is part of the Focus Theme of METHODS of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". OBJECTIVES: The increasing availability of electronic clinical data provides great potential for finding eligible patients for clinical research. However, data heterogeneity makes it difficult for clinical researchers to interrogate sources consistently. Existing standard query languages are often not sufficient to query across diverse representations. Thus, a higher-level domain language is needed so that queries become data-representation agnostic. To this end, we define a clinician-readable computational language for querying whether patients meet eligibility criteria (ECs) from clinical trials. This language is capable of implementing the temporal semantics required by many ECs, and can be automatically evaluated on heterogeneous data sources. METHODS: By reference to standards and examples of existing ECs, a clinician-readable query language was developed. Using a model-based approach, it was implemented to transform captured ECs into queries that interrogate heterogeneous data warehouses. The query language was evaluated on two types of data sources, each different in structure and content. RESULTS: The query language abstracts the level of expressivity so that researchers construct their ECs with no prior knowledge of the data sources. It was evaluated on two types of semantically and structurally diverse data warehouses. This query language is now used to express ECs in the EHR4CR project. A survey shows that it was perceived by the majority of users to be useful, easy to understand and unambiguous. DISCUSSION: An EC-specific language enables clinical researchers to express their ECs as a query such that the user is isolated from complexities of different heterogeneous clinical data sets. More generally, the approach demonstrates that a domain query language has potential for overcoming the problems of semantic interoperability and is applicable where the nature of the queries is well understood and the data is conceptually similar but in different representations. CONCLUSIONS: Our language provides a strong basis for use across different clinical domains for expressing ECs by overcoming the heterogeneous nature of electronic clinical data whilst maintaining semantic consistency. It is readily comprehensible by target users. This demonstrates that a domain query language can be both usable and interoperable.

Semi automated transformation to OWL formatted files as an approach to data integration. A feasibility study using environmental, disease register and primary care clinical data.

INTRODUCTION: This article is part of the Focus Theme of METHODS of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". BACKGROUND: Data heterogeneity is one of the critical problems in analysing, reusing, sharing or linking datasets. Metadata, whilst adding semantic description to data, adds an additional layer of complexity in the heterogeneity of metadata descriptors themselves. This can be managed by using a pre-defined model to extract the metadata, but this can reduce the richness of the data extracted. OBJECTIVES: to link the South London Stroke Register (SLSR), the London Air Pollution toolkit (LAP) and the Clinical Practice Research Datalink (CPRD) while transforming data into the Web Ontology Language (OWL) format. METHODS: We used a four-step transformation approach to prepare meta-descriptions, convert data, generate and update meta-classes and generate OWL files. We validated the correctness of the transformed OWL files by issuing queries and assessing results against the original source data. RESULTS: We have transformed SLSR LAP and CPRD into OWL format. The linked SLSR and CPRD OWL file contains 3644 male and 3551 female patients. The linked SLSR and LAP OWL file shows that there are 17 out of 35 outward postcode areas, where no overlapping data can support further analysis between SLSR and LAP. CONCLUSIONS:  Our approach generated a resultant set of transformed OWL formatted files, which are in a query-able format to run individual queries, or can be easily converted into other more suitable formats for further analysis, and the transformation was faithful with no loss or anomalies. Our results have shown that the proposed method provides a promising general approach to address data heterogeneity.

Meta-analysis: Helicobacter pylori'test and treat' compared with empirical acid suppression for managing dyspepsia.

BACKGROUND: Which of Helicobacter pylori'test and treat' or empirical acid suppression should be preferred for the initial management of uncomplicated dyspepsia is controversial. Aim To conduct an individual patient data meta-analysis of randomized controlled trials (RCTs) of 'test and treat' vs. empirical acid suppression in adults with uncomplicated dyspepsia in primary care. METHODS: Investigators provided original data sets for analysis. Effect of management strategy on symptom status and dyspepsia-related resource use at 12-month follow-up was examined by pooling symptom and cost data to obtain relative risk (RR) of remaining symptomatic at 12 months and weighted mean difference (WMD) in costs between the two strategies with 95% confidence intervals (CI). RESULTS: We identified three eligible RCTs containing 1547 patients, 791 (51%) of whom were assigned to 'test and treat'. There was no difference detected in symptom-cure at 12 months (RR = 0.99; 95% CI: 0.95-1.03). There was a nonsignificant trend towards cost-savings with 'test and treat' (WMD in costs = - 28.91 pound; 95% CI: - 68.48 pound to 10.65 pound). CONCLUSIONS: There was little difference in symptom-resolution or costs between the two strategies. A combination of patient and physician preference should determine the initial approach to the management of uncomplicated dyspepsia.

The Short-Form Leeds Dyspepsia Questionnaire validation study.

BACKGROUND: Assessment of symptoms should be the primary outcome measure in dyspepsia clinical trials. This requires a reliable, valid and responsive questionnaire that measures the frequency and severity of dyspepsia. The Leeds Dyspepsia Questionnaire fulfils these characteristics, but is long and was not designed for self-completion, so a shorter questionnaire was developed (the Short-Form Leeds Dyspepsia Questionnaire). AIM: To assess the acceptability, interpretability, internal consistency, reliability, validity and responsiveness of the Short-Form Leeds Dyspepsia Questionnaire in primary and secondary care. METHODS: Unselected primary and secondary care patients completed the Short-Form Leeds Dyspepsia Questionnaire. Test-retest reliability was assessed after 2 days. Validity was measured by comparison with general practitioners' diagnosis. Sensitivity analysis and logistic regression were employed to determine the most valid scoring system. Responsiveness was determined before and after treatment for endoscopically proven disease. RESULTS: The Short-Form Leeds Dyspepsia Questionnaire was administered to 388 primary care and 204 secondary care patients. The Pearson coefficient for test-retest reliability was 0.93. The Short-Form Leeds Dyspepsia Questionnaire had a sensitivity of 77% and a specificity of 75%. A highly significant response to change was observed (P < 0.005). CONCLUSIONS: The Short-Form Leeds Dyspepsia Questionnaire is a reliable, valid and responsive self-completed outcome measure for quantifying the frequency and severity of dyspepsia symptoms, which is shorter and more convenient than the Leeds Dyspepsia Questionnaire.

Eradication therapy for peptic ulcer disease in Helicobacter pylori positive patients.

BACKGROUND: Peptic ulcer disease is the cause for dyspepsia in about 10% of patients. 95% of duodenal and 70% of gastric ulcers are associated with Helicobacter pylori. Eradication of H pylori reduces the relapse rate of ulcers but the magnitude of this effect is uncertain. OBJECTIVES: The primary outcomes were the proportion of peptic ulcers healed initially and proportion of patients free from relapse following successful healing. Eradication therapy was compared to placebo or pharmacological therapies in H. pylori positive patients. Secondary aims included symptom relief and adverse effects. SEARCH STRATEGY: Searches were conducted on the Cochrane Central register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) on The Cochrane Library (Issue 3 2002) MEDLINE (1966 to July 2002) and EMBASE (1980 to July 2002). Reference lists from trials selected by electronic searching were handsearched to identify further relevant trials. Published abstracts from conference proceedings from the United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were handsearched. The search was updated in September 2003, November 2004 and November 2005. Members of the Cochrane UGPD Group, and experts in the field were contacted and asked to provide details of outstanding clinical trials and any relevant unpublished materials SELECTION CRITERIA: Randomised controlled trials of short and long-term treatment of peptic ulcer disease in H. pylori positive adults were analysed. Patients received at least one week of H pylori eradication compared with ulcer healing drug, placebo or not treatment. Trials were included if they reported assessment from 2 weeks onwards. DATA COLLECTION AND ANALYSIS: Data were collected on ulcer healing, recurrence, relief of symptoms and adverse effects. MAIN RESULTS: 63 trials were eligible. Data extraction was not possible in 7 trials, and 56 trials were included. In duodenal ulcer healing, eradication therapy was superior to ulcer healing drug (UHD) (34 trials, 3910 patients, relative risk [RR] of ulcer persisting = 0.66; 95% confidence interval [CI] = 0.58, 0.76) and no treatment (2 trials, 207 patients, RR = 0.37; 95% CI 0.26, 0.53). In gastric ulcer healing, no significant differences were detected between eradication therapy and UHD (14 trials, 1572 patients, RR = 1.25; 95% CI = 0.88, 1.76). In preventing duodenal ulcer recurrence no significant differences were detected between eradication therapy and maintenance therapy with UHD (4 trials, 319 patients, relative risk [RR] of ulcer recurring = 0.73; 95% CI = 0.42, 1.25), but eradication therapy was superior to no treatment (27 trials 2509 patients, RR = 0.20; 95% CI = 0.15, 0.26). In preventing gastric ulcer recurrence, eradication therapy was superior to no treatment (11 trials, 1104 patients, RR = 0.29; 95% CI 0.20, 0.42). AUTHORS' CONCLUSIONS: A 1 to 2 weeks course of H. pylori eradication therapy is an effective treatment for H. pylori positive peptic ulcer disease.

Variation in the use of H. pylori tests in UK general practice--a qualitative study.

BACKGROUND: Although serology is the main Helicobacter pylori test used by general practitioners in the UK, there is no information available on variation in requesting rates. AIM: To explore the reasons for any variation in H. pylori serology testing by general practices in the UK using qualitative methods. METHODS: Serology requesting rates were determined using laboratory and population data. Staff from randomly selected practices in the lowest and highest quintiles of testing attended focus groups to discuss the management of H. pylori and dyspepsia. Transcribed data were analysed using an interpretative phenomenological approach. RESULTS: Serology submission varied 600-fold (0.1-59/1000 population/year) and H. pylori positivity rate 17-100%. Low-testing practices were less aware of the benefits of H. pylori testing and had shorter endoscopy waiting times. They preferred endoscopy diagnosis over serology test. Three high-testing practices had a high non-white population with high H. pylori positivity. Most staff knew little about the predictive value of serology, the availability of urea breath test on prescription or the existence of a stool test. CONCLUSIONS: Seroprevalence of H. pylori is still high in dyspeptics, especially in non-white populations. Laboratories and primary care trusts should audit H. pylori requests and endoscopy referrals, target education at high endoscopy referrers and low H. pylori testers and inform clinicians of the more accurate H. pylori tests and NICE dyspepsia guidance.

Review article: prevalence and epidemiology of gastro-oesophageal reflux disease.

There are considerable uncertainties around the definition and the appropriate clinical diagnostic criteria for gastro-oesophageal reflux disease (GERD), a common condition that appears to be increasing in prevalence in the Western world. Prevalence studies of GERD are hampered by whether any heartburn symptom is included, or just predominant or even 'sole' heartburn, and also by the time frame over which the symptoms have been evaluated. A systematic search of Medline using the keywords 'GERD' 'prevalence' and 'community' yielded three papers, two original articles and one systematic review of studies that surveyed symptoms in unselected subjects. Heartburn is a common symptom in Europe ranging from a prevalence of 38% in Northern Europe to 9% in Italy. Comparable 6-month data from the USA suggest an even higher prevalence with a rate of 42%. GERD is also a long-term, relapsing disorder. A population survey in Sweden found GERD symptoms over time at 18% of the population surveyed. In summary, although symptoms and quality of life improve with acid suppression therapy, costs are high and the potential benefit of long-term treatment is rare, but serious complications of GERD are unknown.

Systematic review and modelling of the investigation of acute and chronic chest pain presenting in primary care.

OBJECTIVES: To ascertain the value of a range of methods - including clinical features, resting and exercise electrocardiography, and rapid access chest pain clinics (RACPCs) - used in the diagnosis and early management of acute coronary syndrome (ACS), suspected acute myocardial infarction (MI), and exertional angina. DATA SOURCES: MEDLINE, EMBASE, CINAHL, the Cochrane Library and electronic abstracts of recent cardiological conferences. REVIEW METHODS: Searches identified studies that considered patients with acute chest pain with data on the diagnostic value of clinical features or an electrocardiogram (ECG); patients with chronic chest pain with data on the diagnostic value of resting or exercise ECG or the effect of a RACPC. Likelihood ratios (LRs) were calculated for each study, and pooled LRs were generated with 95% confidence intervals. A Monte Carlo simulation was performed evaluating different assessment strategies for suspected ACS, and a discrete event simulation evaluated models for the assessment of suspected exertional angina. RESULTS: For acute chest pain, no clinical features in isolation were useful in ruling in or excluding an ACS, although the most helpful clinical features were pleuritic pain (LR+ 0.19) and pain on palpation (LR+ 0.23). ST elevation was the most effective ECG feature for determining MI (with LR+ 13.1) and a completely normal ECG was reasonably useful at ruling this out (LR+ 0.14). Results from 'black box' studies of clinical interpretation of ECGs found very high specificity, but low sensitivity. In the simulation exercise of management strategies for suspected ACS, the point of care testing with troponins was cost-effective. Pre-hospital thrombolysis on the basis of ambulance telemetry was more effective but more costly than if performed in hospital. In cases of chronic chest pain, resting ECG features were not found to be very useful (presence of Q-waves had LR+ 2.56). For an exercise ECG, ST depression performed only moderately well (LR+ 2.79 for a 1 mm cutoff), although this did improve for a 2 mm cutoff (LR+ 3.85). Other methods of interpreting the exercise ECG did not result in dramatic improvements in these results. Weak evidence was found to suggest that RACPCs may be associated with reduced admission to hospital of patients with non-cardiac pain, better recognition of ACS, earlier specialist assessment of exertional angina and earlier diagnosis of non-cardiac chest pain. In a simulation exercise of models of care for investigation of suspected exertional angina, RACPCs were predicted to result in earlier diagnosis of both confirmed coronary heart disease (CHD) and non-cardiac chest pain than models of care based around open access exercise tests or routine cardiology outpatients, but they were more expensive. The benefits of RACPCs disappeared if waiting times for further investigation (e.g. angiography) were long (6 months). CONCLUSIONS: Where an ACS is suspected, emergency referral is justified. ECG interpretation in acute chest pain can be highly specific for diagnosing MI. Point of care testing with troponins is cost-effective in the triaging of patients with suspected ACS. Resting ECG and exercise ECG are of only limited value in the diagnosis of CHD. The potential advantages of RACPCs are lost if there are long waiting times for further investigation. Recommendations for further research include the following: determining the most appropriate model of care to ensure accurate triaging of patients with suspected ACS; establishing the cost-effectiveness of pre-hospital thrombolysis in rural areas; determining the relative cost-effectiveness of rapid access chest pain clinics compared with other innovative models of care; investigating how rapid access chest pain clinics should be managed; and establishing the long-term outcome of patients discharged from RACPCs.

Initial management strategies for dyspepsia.

BACKGROUND: This review considers management strategies (combinations of initial investigation and empirical treatments) for dyspeptic patients. Dyspepsia was defined to include both epigastric pain and heartburn. OBJECTIVES: To determine the effectiveness, acceptability, and cost effectiveness of the following initial management strategies for patients presenting with dyspepsia (a) initial pharmacological therapy (including endoscopy for treatment failures) (b) early endoscopy (c) testing for Helicobacter pylori and endoscope only those positive (d) H.pylori eradication therapy with or without prior testing. SEARCH STRATEGY: Trials were located through electronic searches and extensive contact with trialists. SELECTION CRITERIA: All randomised controlled trials of dyspeptic patients presenting in primary care. DATA COLLECTION AND ANALYSIS: Data was collected on dyspeptic symptoms, quality of life and use of resources. MAIN RESULTS: Twenty papers reporting 23 comparisons were found. Trials comparing proton pump inhibitors (PPI) with antacids (two trials) and H2 receptor antagonists (three trials), early endoscopy with initial acid suppression (five trials), H.pylori 'test and scope' v usual management (three trials), H.pylori test and treat v. endoscopy (four trials), and test and treat v. acid suppression alone in H.pylori positive patients (two trials), were pooled. PPIs were significantly more effective than both H2RAs and antacids. Relative risks (RR) and 95% CI were, for PPI: antacid 0.72 (0.64-0.80), PPI: H2RA 0.63 (0.47-0.85). Results for other drug comparisons were either absent or inconclusive. Initial endoscopy was associated with a small reduction in the risk of recurrent dyspeptic symptoms compared with initial prescribing (RR 0.89 (0.77-1.02). H.pylori test and endoscopy increases costs in primary care, but does not improve symptoms. H.pylori test and eradicate may be as effective as endoscopy- based management and reduces costs, by decreasing the proportion of patients that are endoscoped. 'Test and treat' may be more effective than acid suppression alone, RR 0.59 (0.42-0.83). REVIEWER'S CONCLUSIONS: PPIs are effective in the treatment of dyspepsia in these trials which may not adequately exclude patients with gastro-oesophageal reflux disease. The relative efficacy of H2RA and PPI is uncertain. Early investigation by endoscopy or H.pylori testing may benefit some patients with dyspepsia. The review will be updated in 2004 with an individual patient data meta-analysis of the economic data, and a subgroup analysis by age and predominant dyspeptic symptom.

Initial management strategies for dyspepsia.

BACKGROUND: This review considers management strategies (combinations of initial investigation and empirical treatments) for dyspeptic patients. Dyspepsia was defined to include both epigastric pain and heartburn. OBJECTIVES: To determine the effectiveness, acceptability, and cost effectiveness of the following initial management strategies for patients presenting with dyspepsia (a) initial pharmacological therapy (including endoscopy for treatment failures) (b) early endoscopy (c) testing for Helicobacter pylori and endoscope only those positive (d) H.pylori eradication therapy with or without prior testing. SEARCH STRATEGY: Trials were located through electronic searches and extensive contact with trialists. SELECTION CRITERIA: All randomised controlled trials of dyspeptic patients presenting in primary care. DATA COLLECTION AND ANALYSIS: Data was collected on dyspeptic symptoms, quality of life and use of resources. MAIN RESULTS: Eighteen papers reporting 20 comparisons were found. Trials comparing proton pump inhibitors (PPI) with antacids (two trials) and H2 receptor antagonists (three trials), early endoscopy with initial acid suppression (five trials), H.pylori 'test and scope' v usual management (three trials) and H.pylori test and treat v. endoscopy (three trials) were pooled. PPIs were significantly more effective than both H2RA s and antacids. Relative risks (RR) and 95% CI were, for PPI: antacid 0.72 (0.64-0.80), PPI: H2RA 0.63 (0.47-0.85). Results for other drug comparisons were either absent or inconclusive. Initial endoscopy was associated with a small reduction in the risk of recurrent dyspepstic symptoms compared with initial prescribing (RR 0.89 (0.77-1.02). H.pylori test and endoscopy increases costs in primary care, but does not improve symptoms. H.pylori test and eradicate may be as effective as endoscopy- based management and reduces costs, by decreasing the proportion of patients that are endoscoped. Further primary care-based trials are needed to compare 'test and treat' with empirical acid suppression. REVIEWER'S CONCLUSIONS: PPIs are effective in the treatment of dyspepsia in these trials which may not adequately exclude patients with gastro-oesophageal reflux disease. The relative efficacy of H2RA and PPI is uncertain. Early investigation by endoscopy or H.pylori testing may benefit some patients with dyspepsia. The review will be updated in 2002 with an individual patient data meta-analysis of the economic data, and a subgroup analysis by age and predominant dyspeptic symptom.

Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care.

OBJECTIVE: To determine the cost effectiveness of a strategy of near patient Helicobacter pylori testing and endoscopy for managing dyspepsia. DESIGN: Randomised controlled trial. SETTING: 31 UK primary care centres. PARTICIPANTS: 478 patients under 50 years old presenting with dyspepsia of longer than four weeks duration. INTERVENTIONS: Near patient testing for H pylori and open access endoscopy for patients with positive results. Control patients received acid suppressing drugs or specialist referral at general practitioner's discretion. MAIN OUTCOME MEASURES: Cost effectiveness based on improvement in symptoms and use of resources at 12 months; quality of life. RESULTS: 40% of the study group tested positive for H pylori. 45% of study patients had endoscopy compared with 25% of controls. More peptic ulcers were diagnosed in the study group (7.4% v 2.1%, P=0.011). Paired comparison of symptom scores and quality of life showed that all patients improved over time with no difference between study and control groups. No significant differences were observed in rates of prescribing, consultation, or referral. Costs were higher in the study group ( 367.85 pound sterling v 253.16 pound sterling per patient). CONCLUSIONS: The test and endoscopy strategy increases endoscopy rates over usual practice in primary care. The additional cost is not offset by benefits in symptom relief or quality of life.

Cost effectiveness of initial endoscopy for dyspepsia in patients over age 50 years: a randomised controlled trial in primary care.

BACKGROUND: Dyspepsia can be managed by initial endoscopy and treatment based on endoscopic findings, or by empirical prescribing. We aimed to determine the cost effectiveness of initial endoscopy compared with usual management in patients with dyspepsia over age 50 years presenting to their primary care physician. METHODS: 422 patients were recruited and randomly assigned to initial endoscopy or usual management. Primary outcomes were effect of treatment on dyspepsia symptoms and cost effectiveness. Secondary outcomes were quality of life and patient satisfaction. Total costs were calculated from individual patient's use of resources with unit costs applied from national data. Statistical analysis of uncertainty on incremental cost-effectiveness ratio (ICER) was done along with a sensitivity analysis on unit costs with cost-effectiveness acceptability curves. FINDINGS: In the 12 months following recruitment, 213 (84%) patients had an endoscopy compared with 75 (41%) controls. Initial endoscopy resulted in a significant improvement in symptom score (p=0.03), and quality of life pain dimension (p=0.03), and a 48% reduction in the use of proton pump inhibitors (p=0.005). The ICER was Pound Sterling1728 (UK Pound Sterling) per patient symptom-free at 12 months. The ICER was very sensitive to the cost of endoscopy, and could be reduced to Pound Sterling165 if the unit cost of this procedure fell from Pound Sterling246 to Pound Sterling100. INTERPRETATION: Initial endoscopy in dyspeptic patients over age 50 might be a cost-effective intervention.

Initial management strategies for dyspepsia.

BACKGROUND: This review considers management strategies (combinations of initial investigation and empirical treatments) for dyspeptic patients. OBJECTIVES: To determine the effectiveness, acceptability, and cost effectiveness of the following initial management strategies for patients presenting with dyspepsia (a) initial pharmacological therapy (including endoscopy for treatment failures) (b) early endoscopy (c) testing for Helicobacter pylori and endoscope only those positive (d) H.pylori eradication therapy with or without prior testing. SEARCH STRATEGY: Trials were located through electronic searches and extensive contact with trialists. SELECTION CRITERIA: All randomised controlled trials of dyspeptic patients presenting in primary care. DATA COLLECTION AND ANALYSIS: Data was collected on dyspeptic symptoms, quality of life and use of resources. MAIN RESULTS: Ten papers reporting 12 comparisons were found. Trials comparing proton pump inhibitors (PPI) with antacids (2 trials) and H2 receptor antagonists (3 trials), and of early endoscopy compared with initial acid suppression (3 trials) were pooled. PPIs were significantly more effective than both H2RA s and antacids. Relative risks (RR) and 95% CI were, for PPI: antacid 0.72 (0.64-0.80), PPI: H2RA 0.63 (0.47-0.85). Results for other drug comparisons were either absent or inconclusive. Early endoscopy was not more effective than initial prescribing (RR 0.90 (0.77-1.04), but current studies lack power. No eligible trials of H.pylori test and endoscopy or test and eradicate were found. REVIEWER'S CONCLUSIONS: PPIs are effective in the treatment of dyspepsia in these trials which may not adequately exclude patients with gastro-oesophageal reflux disease. The relative efficacy of H2RA and PPI is uncertain. Early investigation may benefit some patients with dyspepsia. The review will be updated shortly with several large trials that have recently been completed.

Systematic review of near patient test evaluations in primary care.

OBJECTIVE: To identify and qualitatively synthesise the findings from all studies that have examined the performance and effect of near patient tests in the primary care setting. DESIGN: Systematic review of published and unpublished research 1986-99. MAIN OUTCOME MEASURES: Test performance characteristics, measures of effect on clinical practice or patient outcome. RESULTS: 101 relevant publications were identified. The general quality of these papers was low, and consequently only 32 papers were assessed in detail. Although these papers gave some indication of the value of near patient testing in areas such as anticoagulation monitoring and group A beta haemolytic streptococcus testing, the research raised many more questions than it answered. Almost no reports were found of unbiased assessment of the effect of near patient tests in primary care on patient outcomes, organisational outcomes, or cost. CONCLUSIONS: Available research provides little evidence to guide the expansion of use of near patient testing in primary care. Further research is needed in areas of clinical practice where near patient tests might be most beneficial.