Objectives Vaccination is an important intervention for preventing disease and reducing disease severity. Universal vaccination programs have significantly reduced the incidence of many dangerous diseases among children worldwide. This study investigated the side effects after immunization in infants under 1 year of age in Lorestan Province, western Iran.
Methods This descriptive analytical study included data from all children <1 year old in Lorestan Province, Iran who were vaccinated according to the national schedule in 2020 and had an adverse event following immunization (AEFI). Data were extracted from 1084 forms on age, sex, birth weight, type of birth, AEFI type, vaccine type, and time of vaccination. Descriptive statistics (frequency, percentage) were calculated, and the chi-square test and Fisher exact test were used to assess differences in AEFIs according to the abovelisted variables.
Results The most frequent AEFIs were high fever (n=386, 35.6%), mild local reaction (n=341, 31.5%), and swelling and pain (n=121, 11.2%). The least common AEFIs were encephalitis (n=1, 0.1%), convulsion (n=2, 0.2%), and nodules (n=3, 0.3%). Girls and boys only showed significant differences in mild local reactions (p=0.044) and skin allergies (p=0.002). The incidence of lymphadenitis (p<0.001), severe local reaction (p<0.001), mild local reaction (p=0.007), fainting (p=0.032), swelling and pain (p=0.006), high fever (p=0.005), and nodules (p<0.001) showed significant differences based on age at vaccination.
Conclusions Immunization is a fundamental public health policy for controlling vaccine-preventable infectious diseases. Although vaccines such as the Bacillus Calmette-Guérin vaccine, oral poliovirus vaccine, and pentavalent vaccine are well-researched and reliable, AEFIs are inevitable.
Objectives The use of administrative data is an affordable alternative to conducting a difficult large-scale medical-record review to estimate the scale of adverse events. We identified adverse events from 2002 to 2013 on the national level in Korea, using International Classification of Diseases, tenth revision (ICD-10) Y codes.
Methods We used data from the National Health Insurance Service-National Sample Cohort (NHIS-NSC). We relied on medical treatment databases to extract information on ICD-10 Y codes from each participant in the NHIS-NSC. We classified adverse events in the ICD-10 Y codes into 6 types: those related to drugs, transfusions, and fluids; those related to vaccines and immunoglobulin; those related to surgery and procedures; those related to infections; those related to devices; and others.
Results Over 12 years, a total of 20 817 adverse events were identified using ICD-10 Y codes, and the estimated total adverse event rate was 0.20%. Between 2002 and 2013, the total number of such events increased by 131.3%, from 1366 in 2002 to 3159 in 2013. The total rate increased by 103.9%, from 0.17% in 2002 to 0.35% in 2013. Events related to drugs, transfusions, and fluids were the most common (19 446, 93.4%), followed by those related to surgery and procedures (1209, 5.8%) and those related to vaccines and immunoglobulin (72, 0.3%).
Conclusions Based on a comparison with the results of other studies, the total adverse event rate in this study was significantly underestimated. Improving coding practices for ICD-10 Y codes is necessary to precisely monitor the scale of adverse events in Korea.
Summary
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Objectives The purpose of this study was to assess the inter-rater reliability and intra-rater reliability of medical record review for the detection of hospital adverse events.
Methods We conducted two stages retrospective medical records review of a random sample of 96 patients from one acute-care general hospital. The first stage was an explicit patient record review by two nurses to detect the presence of 41 screening criteria (SC). The second stage was an implicit structured review by two physicians to identify the occurrence of adverse events from the positive cases on the SC. The inter-rater reliability of two nurses and that of two physicians were assessed. The intra-rater reliability was also evaluated by using test-retest method at approximately two weeks later.
Results In 84.2% of the patient medical records, the nurses agreed as to the necessity for the second stage review (kappa, 0.68; 95% confidence interval [CI], 0.54 to 0.83). In 93.0% of the patient medical records screened by nurses, the physicians agreed about the absence or presence of adverse events (kappa, 0.71; 95% CI, 0.44 to 0.97). When assessing intra-rater reliability, the kappa indices of two nurses were 0.54 (95% CI, 0.31 to 0.77) and 0.67 (95% CI, 0.47 to 0.87), whereas those of two physicians were 0.87 (95% CI, 0.62 to 1.00) and 0.37 (95% CI, -0.16 to 0.89).
Conclusions In this study, the medical record review for detecting adverse events showed intermediate to good level of inter-rater and intra-rater reliability. Well organized training program for reviewers and clearly defining SC are required to get more reliable results in the hospital adverse event study.
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