Continuous quality improvement: reducing informed consent form signing errors.

BACKGROUND: Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors. METHODS: We used the plan-do-check-act (PDCA) cycle to help improve the correctness and validity of ICF signing. RESULTS: Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05). CONCLUSIONS: The proportions of other error types-multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF-did not differ significantly.

Epidemiology of medical adverse events: perspectives from a single institute in Taiwan.

BACKGROUND/PURPOSE: Epidemiology data of medical adverse events (MAEs) are crucial for patient safety policymaking. However, no epidemiological data on MAE exist in Taiwan. In this study, we aimed to investigate the incidence of MAEs at a major medical center in northern Taiwan. METHODS: The Harvard Medical Practice Study methodology was modified using a criterion-based screening algorithm and critical medical record review process to investigate the risks and incidences of MAEs. A Criterion-Based Screening for Medical Adverse Events (CBSMAE) checklist was developed, and a three-tier strategy was applied to screen and review 2007 inpatient hospitalizations from a single institution. RESULTS: A total of 2934 charts was sampled (Tier 1) and 950 possible MAEs were identified (Tier 2). One hundred and sixty-one probable MAE cases were subsequently critically reviewed (Tier 3). Nineteen (0.7%) MAE cases were confirmed. The MAEs involved 10 women and nine men (mean age, 70 years). Most MAEs were from the surgery department [11 (57.9%) patients]. The major admission diagnoses were cardiac diseases [7 (36.8%) patients] with a cardiac problem [13 (31.7%) patients] as the major comorbidity. Major MAE attributes were a staff technique problem [12 (46.2%) patients] and patients' underlying conditions (likelihood rating, 2.2). Eight (42.1%) patients required additional medical management, four (21.1%) patients had a disability, and five (26.3%) patients had in-hospital mortality. Night MAEs (47.4%) were considered preventable. CONCLUSION: Surgical patients with cardiac conditions were at risk of MAE, particularly patients who received invasive procedures. The epidemiology information from this study can serve as baseline data to monitor a patient safety improvement campaign.

Vertigo and stroke: a national database survey.

OBJECTIVE: To investigate the association between vertigo and stroke in Taiwan using the Bureau of National Health Insurance research database. METHODS: Information on adult patients with an index vertigo attack in 2006 was retrieved from Bureau of National Health Insurance research database. All patients with specific diagnostic codes for vertigo were included. Occurrence of stroke during a 1-year follow-up period was identified. Risk factors for stroke were examined. Using χ test, t test, and a multilevel logistic regression model, patients with vertigo were categorized into stroke and nonstroke groups for comparative analyses. An age- and sex- matched control cohort was prepared for comparison. RESULTS: Patients with vertigo (n = 527,807) (mean age, 55.1 yr) accounted for 3.1% of the general Taiwanese adult population. The prevalence of stroke among vertigo patients of 0.5% (mean age, 67.8 yr) was slightly higher than that of the control group (0.3%; mean age, 72.3 yr; p < 0.0001). The types of stroke were ischemic (66.7%), nontypical (29.0%), and hemorrhage (4.3%). The prevalence of stroke increased with age (p < 0.001). Patients with vertigo had higher prevalence of comorbid conditions (p < 0.0001); those with diabetes mellitus, hypertension, dyslipidemia, coronary artery disease, or atrial fibrillation had a higher prevalence of stroke (p < 0.001). Hypertension was the most significant predictor of stroke (odds ratio, 3.77; 95% confidence interval, 3.36-4.23; p < 0.001). CONCLUSION: Patients with vertigo had higher chance to develop stroke than the control group. Some strokes may initially manifest as peripheral vertigo, and some central vertigo may eventually evolve into a stroke. Middle aged male, diabetes, hypertension, dyslipidemia, coronary artery disease, and atrial fibrillation are risk factors for subsequent stroke in vertigo patients.

Incidence and recurrence of acute otitis media in Taiwan's pediatric population.

OBJECTIVE: To report the incidence and recurrence of acute otitis media (AOM) in Taiwan's pediatric population. METHODS: Information from children (aged <= 12 years) with a diagnosis of AOM was retrieved from the 2006 National Healthcare Insurance claims database. We calculated the cumulative incidence rate and the incidence density rate of recurrent AOM within one year after the initial diagnosis in 2006. We used a multivariate logistic regression model to assess the predictors for recurrence of AOM. RESULTS: The annual incidence rate of AOM was estimated to be 64.5 cases per 1,000 children. The overall one-year cumulative incidence rate of recurrence was 33.1%, and the incidence density rate was 33.5 cases per 100 person-years, with the highest figure (41.2 cases per 100 person-years) noted for children aged 0-2 years. Recurrence was significantly associated with age, gender, place of treatment, and physician specialty. CONCLUSION: AOM remains a major threat to children's health in Taiwan. Male children and very young children require more aggressive preventive strategies to reduce the risk of recurrence.

Epidemiology of vertigo: a National Survey.

OBJECTIVE: To investigate the epidemiology of vertigo among the general adult population in Taiwan using the National Health Insurance claims database. STUDY DESIGN: Cross-sectional study. SETTING: Data were retrieved from the 2006 National Health Insurance claims database.Subjects and Methods. Claims data were retrieved for patients 18 years or older with a diagnosis of vertigo (International Classification of Diseases, Ninth Revision, Clinical Modification codes 078.81, 386.XX, or 780.4) from January to December 2006. The authors describe the prevalence and recurrence of vertigo and the medical resource utilization associated with its treatment. Logistic regression models are used to assess the independent effects of age, sex, seasonal variation, institutional level of care, and specialty of care on the risk of vertigo recurrence. RESULTS: A total of 527,807 adult patients (mean ± SD age, 55.1 ± 17.3 years; 1:1.96 ratio of men to women) experienced vertigo in 2006. The prevalence of vertigo was 3.13 cases per 100 adults. Within 1 year of their index vertigo attack, 199,210 patients (37.7%) experienced recurrence. The prevalence and recurrence of vertigo increased significantly with age (P < .001 for both, x² test). Age, sex, seasonal variation, institutional level of care, and specialty of care had various effects on the risk of vertigo recurrence. CONCLUSION: Vertigo is a major health burden among the general adult population and tends to recur, particularly among older women

Incidence and recurrence of acute otitis media in Taiwan's pediatric population

OBJECTIVE: To report the incidence and recurrence of acute otitis media (AOM) in Taiwan's pediatric population. METHODS: Information from children (aged <= 12 years) with a diagnosis of AOM was retrieved from the 2006 National Healthcare Insurance claims database. We calculated the cumulative incidence rate and the incidence density rate of recurrent AOM within one year after the initial diagnosis in 2006. We used a multivariate logistic regression model to assess the predictors for recurrence of AOM. RESULTS: The annual incidence rate of AOM was estimated to be 64.5 cases per 1,000 children. The overall one-year cumulative incidence rate of recurrence was 33.1 percent, and the incidence density rate was 33.5 cases per 100 personyears, with the highest figure (41.2 cases per 100 person-years) noted for children aged 0-2 years. Recurrence was significantly associated with age, gender, place of treatment, and physician specialty. CONCLUSION: AOM remains a major threat to children's health in Taiwan. Male children and very young children require more aggressive preventive strategies to reduce the risk of recurrence.