Introduction: Helicobacter pylori screening and treatment has been proposed as a cost‐effective method of preventing gastric cancer. Aim: To assess, in a randomized controlled trial, the efficacy of therapy in eradicating H. pylori as part of a screening programme, and to report the adverse events associated with this strategy. Methods: Subjects between the ages of 40–49 years were randomly selected from the lists of 36 primary care centres. Participants attended their local practice and H. pylori status was determined by 13C‐urea breath test. Infected subjects were randomized to receive omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 7 days (OCT) or identical placebos. Eradication was determined by a 13C‐urea breath test 6 months and 2 years after the first visit. Successful eradication was defined as two negative 13C‐urea breath tests or one negative and one missing test. Adverse events and compliance were assessed at the 6‐month visit. Results: A total of 32 929 subjects were invited to attend, 8407 were evaluable, and 2329 (28%) of these were H. pylori‐positive. A total of 1161 subjects were randomized to OCT and 1163 to placebo; over 80% returned for a repeat 13C‐urea breath test on at least one occasion. The eradication rates in those allocated to OCT were as follows: intention‐to‐treat, 710 out of 1161 (61%; 95% confidence interval: 58–64%); evaluable 710 out of 967 (73%; 95% CI: 71–76%); took all medication 645 out of 769 (84%; 95% CI: 81–87%). Adverse events occurred in 45% of the treatment group and in 18% of the placebo group (relative risk 2.5; 95% CI: 2.1–2.9). Compliance, male gender, no antibiotic prescription in the subsequent 2 years and experiencing a bitter taste with the medication were independently associated with treatment success. Conclusions: The OCT regimen has an eradication rate of 61% in intention‐to‐treat analysis and is therefore less successful in treating H. pylori as part of a screening programme compared with hospital studies in dyspeptic patients.
ObjectivesTo link five national datasets (three registries, two administrative) and create longitudinal health care trajectories for patients with congenital heart disease (CHD), describing the quality and the summary statistics of the linked dataset.DesignBespoke linkage of record-level patient identifiers across five national datasets. Generation of spells of care defined as periods of time-overlapping events across the datasets.SettingNational congenital heart disease audit (NCHDA) procedures in public (NHS) hospitals in England and Wales, paediatric and adult intensive care datasets (PICANet and ICNARC-CMP), administrative hospital episodes (HES inpatient, outpatient, A&E), and mortality registry data.ParticipantsPatients with any CHD procedure recorded in NCHDA between April 2000 and March 2017 from public hospitals.Primary and secondary outcome measuresPrimary outcomes: Number of linked records, number of unique patients and number of generated spells of care (e.g. inpatient stays, outpatient appointments).Secondary outcomes: Quality and completeness of linkage.ResultsThere were 143,862 records in NCHDA relating to 96,041 unique patients. We identified 65,797 linked PICANet patient admissions, 4,664 linked ICNARC-CMP admissions, and over 6 million linked HES episodes of health care (1.1M Inpatient, 4.7M Outpatient). The 96,041 unique patients had 4,908,153 spells of care comprising 6,481,600 records after quality checks. Considering only years where datasets overlapped, 95.6% surgical procedure records were linked to a corresponding HES record, 93.9% paediatric (cardiac) surgery procedure records were linked to a corresponding PICANet admission, and 76.8% adult surgery procedure records were linked to a corresponding ICNARC-CMP record.ConclusionsWe successfully linked four national datasets to the core dataset of all CHD procedures performed between 2000 and 2017. This will enable a much richer analysis of longitudinal patient journeys and outcomes. We hope that our detailed description of the linkage process will be useful to others looking to link national datasets to address important research priorities.Strengths and limitations of this studyStrengthsWe linked five national established, high quality, datasets using bespoke methods for the pre-processing of identifiers and establishing matches to maximise linkageIn our final dataset, data consistency has been checked at patient level using year and month of birth, postcodes, and diagnosis codes, and also clinically sense-checked at spell level for spells containing congenital heart procedures.We created meaningful spells of care for each patient in the dataset covering inpatient and outpatient interactions with secondary and tertiary care, covering up to 20 years of life of patients with congenital heart disease (CHD), representing an important step to understanding patient care for people with CHD.LimitationsData completeness, quality and availability were worse in earlier years, meaning that linkage was poorer for earlier eras.We do not yet have data on hospital care for patients outside England or on longer term adult follow-up for patients whose full CHD history is captured, since most cardiac procedures start in early live – the national CHD audit (NCHDA) started on April 2000.
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