ObjectivesData on patient safety problems (PSPs) in ambulatory care are scarce. The aim of the study was to record the frequency, type, severity and point of origin of PSPs in ambulatory care in Germany.DesignRetrospective cross-sectional study.SettingComputer-assisted telephone interviews with randomly recruited citizens aged ≥40 years in Germany who were asked about their experiences with PSPs in ambulatory care.Participants10 037 citizens ≥40 years.MeasuresA new questionnaire was developed to record patient experiences with PSPs in ambulatory care. The study reported here targets patient experiences in the last 12 months. The questionnaire focuses on PSPs in seven areas of medical treatment: anamnesis/diagnostic procedures; medication; vaccination, injection, infusion; aftercare; outpatient surgery; office administration; other areas. For each PSP reported, detailed questions were asked about the specialist group concerned, and, on the most serious harm, the severity of the harm and its consequences. The target parameters are presented as proportions with 95% CIs.Results1422 of the respondents (14%) reported 2589 PSPs. The areas most frequently affected by PSPs were anamnesis/diagnostic procedures (61%) and medication (15%). General practitioners accounted for 44% of PSPs, orthopaedists for 15% and internists for 10%. 75% of PSPs were associated with harm, especially unnecessarily prolonged pain or deterioration of health; 35% of PSPs led to permanent harm. 804 PSPs (32%) prompted patients to see another doctor for additional treatment; 255 PSPs (10%) required inpatient treatment.ConclusionPSPs experienced by patients are widespread in ambulatory care in Germany. The study reveals in which areas of medical treatment efforts to prevent PSPs could make the greatest contribution to improving patient safety. It also demonstrates the valuable contribution of patient reports to the analysis of PSPs.
Background-The extent to which the prognosis for AIDS and death of patients initiating highly active antiretroviral therapy (HAART) continues to be affected by their characteristics at the time of initiation (baseline) is unclear.Methods-We analyzed data on 20,379 treatment-naive HIV-1-infected adults who started HAART in 1 of 12 cohort studies in Europe and North America (61,798 person-years of followup, 1844 AIDS events, and 1005 deaths).Results-Although baseline CD4 cell count became less prognostic with time, individuals with a baseline CD4 count <25 cells/µL had persistently higher progression rates than individuals with a baseline CD4 count >350 cells/µL (hazard ratio for AIDS = 2.3, 95% confidence interval [CI]: 1.0 to 2.3; mortality hazard ratio = 2.5, 95% CI: 1.2 to 5.5, 4 to 6 years after starting HAART). Rates of AIDS were persistently higher in individuals who had experienced an AIDS event before starting HAART. Individuals with presumed transmission by means of injection drug use experienced substantially higher rates of AIDS and death than other individuals throughout follow-up (AIDS hazard ratio = 1.6, 95% CI: 0.8 to 3.0; mortality hazard ratio = 3.5, 95% CI: 2.2 to 5.5, 4 to 6 years after starting HAART).Conclusions-Compared with other patient groups, injection drug users and patients with advanced immunodeficiency at baseline experience substantially increased rates of AIDS and death up to 6 years after starting HAART.
ObjectiveTo compare early and late responses to highly active antiretroviral therapy (HAART) in European and non-European HIV-1 infected patients in a Dutch cohort.
MethodsWe retrospectively analysed the response to HAART of 216 previously treatment-naive HIV-1-infected patients using the University Medical Centre Utrecht HIV database. African (n 5 51), Asian (n 5 7), and Central/South American (n 5 6) patients were classified as non-European, and others as European (n 5 152). Early failure was defined as a viral load that remained above 400 HIV-1 RNA copies/mL after 6 months of treatment with HAART. Late-phase failure was determined in patients who were successfully treated in the early phase and was defined as two consecutive viral load measurements above 400 copies/mL, a new AIDS-defining event or death.
ResultsIn the early phase, four of 152 (2.6%) European and eight of 64 (12.5%) non-European patients failed HAART. A significant increased risk of virological failure in the early phase of treatment was observed for non-Europeans as compared to Europeans (odds ratio 4.6; 95% confidence interval 1.1-20.2). Low serum drug levels in the absence of resistant virus were often seen at the time of early failure. No difference in late-phase failure was observed between the two groups (adjusted hazard ratio 0.6; 95% confidence interval 0.3-1.2).
ConclusionsNon-European patients had a 4.6 times higher risk of virological failure than their European counterparts in the first 6 months of treatment with HAART. This failure seemed to be associated with low serum drug levels at the time of failure. However, if HAART was successful in the early phase, response rates in the late phase were similar for Europeans and non-Europeans.
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