Patientensicherheit in der Ambulanten Versorgung

Background: In Germany, there has been no survey instrument to record the epidemiology of adverse patient safety problems (PSP) in the ambulatory health care sector. In contrast to the inpatient sector, it is unclear for the ambulatory heath care sector how often patients experience PSP in which specialist disciplines, whether those affected by PSP report experienced PSP to the physicians and whether socio-demographic factors such as ‘age’, ‘gender’ or ‘chronic diseases’ favour the occurrence of PSP in the ambulatory sector. Method: Designed as a retrospective cross-sectional study, a questionnaire was first developed on the basis of a systematic literature review and qualitative guided interviews with physicians (N=10) and patients in ambulatory care (N=20). Subsequently, the operationalised questionnaire was applied as a survey instrument PATIENT SAFETY PROBLEMS IN AMBULATORY CARE (PSP-AMB) after qualitative and quantitative pre-testing in form of computer-assisted telephone interviews (CATI). Statistical analyses were conducted using SPSS, version 5 and comprised descriptive analyses, including 95% confidence intervals (95%-CI), chi-square analyses (x2) and binary logistic analyses naming the odds ratio (OR) to test whether significant associations exist between the reporting and further reaction behaviour in relation to the ‘medical treatment areas’, ‘PSP with/without harm’ and ‘socio-demographic factors’. Results: PSP-AMB surveys 32 types of PSP in seven areas of medical treatment: (1) anamnesis/diagnostic procedures, (2) medication, (3) vaccination/injection/infusion; (4) outpatient surgery, (5) office administration, (6) aftercare and (7) other areas. The »PSP-ONE-YEAR-INCIDENCE« (PSP of the last 12 months before the survey), the »PSP-40+-PREVALENCE« (PSP with harm since the age of 40) as well as, by means of »PROXY-INTERVIEWS«, PSP with the serious consequences of death or severe need for care of parents and biological children ≥40 years are surveyed. Detailed questions per affirmed PSP also capture the specialist group, harmful consequences and how people deal with PSP. Finally, the »SOCIO-DEMOGRAPHY« of the participants is recorded. Between May and October 2018, 10,037 randomly recruited citizens ≥40 years (participation rate: 12.4%) were interviewed nationwide. The dropout rate was 8.3%. The sample represents the German population ≥40 years (2017: 22.5 million men and 24.7 million women; 57% of the total population). The descriptive analyses of the »PSP-ONE-YEAR-INCIDENCE« indicate an incidence of 14.2% in the ambulatory care sector. A total of 2,589 PSP was reported by 1,422 persons in the weighted sample (average 1.8 PSP/person). The medical treatment area anamnesis/diagnostic procedures was most frequently affected by PSP (61.1%, 95%-CI: 59.3-63.0); followed by medication (15.4%, 95%-CI: 14.0-16.8) and practice organisation (9.8%, 95%-CI: 8.7-11.0). More than half of the PSP were experienced in the context of specialist treatment (56.3%, 95%-CI: 48.0-65.6), 43.7% (95%-CI: 41.8-45.6) in a GP setting. About three quarters of the PSPs had harmful effects on the patients (74.7%, 95%-CI: 73.0-76.4). Most frequently, ‘unnecessarily prolonged pain’ (16.5%, 95%-CI: 15.6-17.5) and ‘deterioration of the health status’ (16.1%, 95%-CI: 15.1-17.1) were reported. 72.0% (95%-CI: 70.2-73.7) of the reported PSP were reported back by the patients or relatives, 64.3% (95%-CI: 62.5-66.2) of the PSP resulted in a further reaction: 38.4% (95%-CI: 36.5-40.1) of the PSP also led to a loss of confidence, a complaint (32.6%, 95%-CI: 30.9-34.5) or a change of physician (25.7%, 95%-CI: 24.0-27.4). Both the chi-square and binary logistic regression analyses show significant associations between (a) reporting and (b) further reaction behaviour and the factors ‘physician treatment area’ (a) x2=17, 13, p=.009 / (b) x2=97.58, p=.000, ‘PSP with/without harm’ (a) x2=111.84, p=.000 / (b) x2=265.39, p=.000 and patient characteristics ‘age between 40-59 years’ (a) OR 2.57 (95%-CI: 2.04-3.23) / (b) OR 2.60 (95%-CI: 2.06-3.28) or presence of a ‘chronic disease’ (a) OR 2.16 (95%-CI: 1.89-2.47) / (b) OR 2.14 (95%-CI: 1.87-2.46). Discussion and outlook: The study results show that PSP-AMB can be used specifically to collect epidemiological data on the incidence of specific PSP from the patient perspective. The data indicate that PSPs are often to be expected in outpatient care, that they sometimes have serious consequences and can lead to further use of the health care system. In addition, it can be observed that PSPs are often reported back by patients to their physician in charge or to another GP or specialist and can affect the physician-patient relationship.