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Introduction to Grants Process. NCI Grant Policies. A final subcategory of adverse event is the ameliorable adverse event, a term first coined in a study of postdischarge of adverse events. Ameliorable adverse events are those that are not preventable, but the severity of the injury "could have been substantially reduced if different actions or procedures had been performed or followed. Ten days later, the patient presents to the emergency department with acute kidney injury and critically low potassium.
These adverse effects of diuresis are not preventable in themselves, but the severity could have been reduced by planning to have the patient come in for lab testing within a week of discharge. Studies of the epidemiology of adverse events, such as a recent series of reports by the Office of the Inspector General, use a two-stage record review process in which patient charts are independently reviewed by two clinically experienced reviewers in order to determine whether an adverse event occurred and if so, whether it was preventable.
It is important to note that even with highly trained reviewers, the level of agreement between reviewers with regard to the presence of an adverse event is usually only moderate. When an adverse event occurred, reviewers also may disagree about whether the event was preventable. Designating an adverse event as preventable requires some judgment about the degree to which the evidence supports specific prevention strategies and the feasibility of implementing these strategies.
As the science of patient safety advances, these judgments can change over time, such that more adverse events become regarded as preventable. For instance, after publication of the seminal paper on the central line bundle to prevent catheter-associated bloodstream infections, reviewers participating in adverse event studies might have begun to judge all central line—associated bloodstream infections as preventable. In summary, adverse events refer to harm from medical care rather than an underlying disease.
Important subcategories of adverse events include:. Detection of Safety Hazards. Levinson DR. Report No. In Conversation with Lucian Leape, MD. Incidence and types of preventable adverse events in elderly patients: population based review of medical records. Error in medicine. Incidence of adverse events and negligence in hospitalized patients. Diseases of medical progress. Healthcare Safety Investigation Branch. A decade of preventing harm. Austin M, Derk J. Responding to health information technology reported safety events: insights from patient safety event reports.
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Adverse events (SEAR/SPEAR)
Measurement of Patient Safety. Univariate and multivariate meta-regression analysis did not reveal any significance for any of the covariates. This analysis did not display any statistical significance. Sensitivity analysis of the low risk of bias studies RR 0. Fig 3 Forest plot of the subgroup analysis by dose of the risk ratio RR of serious adverse events in RCTs of naltrexone vs placebo.
The funnel plot for the main analysis is included as Fig. Fig 4 Funnel plot of weighted risk ratio RR of serious adverse events in RCTs of naltrexone vs placebo vs standard error. Summary of main findings This meta-analysis of 89 RCTs based on 11, participants showed no evidence of an increased risk of SAEs occurring for naltrexone compared to placebo. Strengths and limitations There were several strengths of this review. Comparison with the existing literature To our knowledge, this is the first large systematic review of SAEs in people taking naltrexone, excluding only those people taking opioids.
Implications for researchers, clinicians and policy makers The results of this review are supportive of the wider use of naltrexone and have the realistic potential to impact on clinical guidelines. Funding No external funding. Ethics approval and consent to participate Not applicable.
Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. References Joint Formulary Committee, editor. Global, regional, and national incidence, prevalence, and years lived with disability for diseases and injuries, — a systematic analysis for the Global Burden of Disease Study Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for causes of death, — a systematic analysis for the Global Burden of Disease Study Marketing status and perceived efficacy of drugs for supporting abstinence and reducing alcohol intake in alcohol use disorders: a survey among European Federation of Addiction Societies in Europe.
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Results from a multicentre usage study. The Naltrexone Usage Study Group. Arch Gen Psychiatry. Naltrexone: report of lack of hepatotoxicity in acute viral hepatitis, with a review of the literature. Addict Biol. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. Reporting of adverse drug reactions in randomised controlled trials - a systematic survey.
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Building a culture of candour: a review of the threshold for the duty of candour and of the incentives for care organisations to be candid. London: Royal College of Surgeons of England; Cochrane Handbook for Systematic Reviews of Interventions version 5. Chichester: Wiley; EudraLex volume Clinical trials.
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Chapter 9: Analysing data and undertaking meta-analyses.
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What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat Med. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials.
Am J Med. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews.