Objective To evaluate the performance of a routine incident reporting system in identifying patient safety incidents. Design Two stage retrospective review of patients' case notes and analysis of data submitted to the routine incident reporting system on the same patients. Setting A large NHS hospital in England. Population 1006 hospital admissions between January and May 2004: surgery (n = 311), general medicine (n = 251), elderly care (n = 184), orthopaedics (n = 131), urology (n = 61), and three other specialties (n = 68). Main outcome measures Proportion of admissions with at least one patient safety incident; proportion and type of patient safety incidents missed by routine incident reporting and case note review methods. Results 324 patient safety incidents were identified in 230/1006 admissions (22.9%; 95% confidence interval 20.3% to 25.5%). 270 (83%) patient safety incidents were identified by case note review only, 21 (7%) by the routine reporting system only, and 33 (10%) by both methods. 110 admissions (10.9%; 9.0% to 12.8%) had at least one patient safety incident resulting in patient harm, all of which were detected by the case note review and six (5%) by the reporting system. Conclusion The routine incident reporting system may be poor at identifying patient safety incidents, particularly those resulting in harm. Structured case note review may have a useful role in surveillance of routine incident reporting and associated quality improvement programmes.
Background: Patients with irritable bowel syndrome (IBS) often feel they have some form of dietary intolerance and frequently try exclusion diets. Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies. Aims: To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food. Patients: A total of 150 outpatients with IBS were randomised to receive, for three months, either a diet excluding all foods to which they had raised IgG antibodies (enzyme linked immunosorbant assay test) or a sham diet excluding the same number of foods but not those to which they had antibodies. Methods: Primary outcome measures were change in IBS symptom severity and global rating scores. Noncolonic symptomatology, quality of life, and anxiety/depression were secondary outcomes. Intention to treat analysis was undertaken using a generalised linear model. Results: After 12 weeks, the true diet resulted in a 10% greater reduction in symptom score than the sham diet (mean difference 39 (95% confidence intervals (CI) 5-72); p = 0.024) with this value increasing to 26% in fully compliant patients (difference 98 (95% CI 52-144); p,0.001). Global rating also significantly improved in the true diet group as a whole (p = 0.048, NNT = 9) and even more in compliant patients (p = 0.006, NNT = 2.5). All other outcomes showed trends favouring the true diet. Relaxing the diet led to a 24% greater deterioration in symptoms in those on the true diet (difference 52 (95% CI 18-88); p = 0.003). Conclusion: Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research.
Objectives To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE). Design Interrupted time series analysis, review of case notes, survey, and interviews. Setting Acute and primary care trusts in England and Wales. Participants All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts. Main outcome measuresRates of prescribing and use of procedures and medical devices relative to evidence based guidance. Results 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued. Conclusions Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context.
The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.
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