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Patient safety in ambulatory care from the patient's perspective: a retrospective, representative telephone survey

Por: Geraedts · M. · Krause · S. · Schneider · M. · Ortwein · A. · Leinert · J. · de Cruppe · W.

Data 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.


Retrospective cross-sectional study.


Computer-assisted telephone interviews with randomly recruited citizens aged ≥40 years in Germany who were asked about their experiences with PSPs in ambulatory care.


10 037 citizens ≥40 years.


A 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.


1422 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.


PSPs 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.

Discovery of biomarkers for the presence and progression of left ventricular diastolic dysfunction and HEart faiLure with Preserved ejection Fraction in patients at risk for cardiovascular disease: rationale and design of the HELPFul case-cohort study in

Por: Valstar · G. B. · Bots · S. H. · Groepenhoff · F. · Gohar · A. · Rutten · F. H. · Leiner · T. · Cramer · M. J. M. · Teske · A. J. · Suciadi · L. P. · Menken · R. · Pasterkamp · G. · Asselbergs · F. W. · Hofstra · L. · Bots · M. L. · den Ruijter · H. M.

Left ventricular diastolic dysfunction (LVDD) is a common condition in both sexes that may deteriorate into heart failure (HF) with preserved ejection fraction (pEF), although this seems to happen more often in women than in men. Both LVDD and HFpEF often go unrecognised, necessitating the discovery of biomarkers that aid both the identification of individuals with LVDD at risk of developing HF and identification of individuals most likely to benefit from treatment.

Methods and analysis

HELPFul is an ongoing case-cohort study at a Dutch cardiology outpatient clinic enrolling patients aged 45 years and older without history of cardiovascular disease, who were referred by the general practitioner for cardiac evaluation. We included a random sample of patients and enriched the cohort with cases (defined as an E/e’ ≥8 measured with echocardiography). Information about medical history, cardiovascular risk factors, electrocardiography, echocardiography, exercise test performance, common carotid intima-media thickness measurement and standard cardiovascular biomarkers was obtained from the routine care data collected by the cardiology outpatient clinic. Study procedure consists of extensive venous blood collection for biobanking and additional standardised questionnaires. Follow-up will consist of standardised questionnaires by mail and linkage to regional and national registries. We will perform cardiac magnetic resonance imaging and coronary CT angiography in a subgroup of patients to investigate the extent of macrovascular and microvascular coronary disease.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of the University Medical Center Utrecht. Results will be disseminated through national and international conferences and in peer-reviewed journals in cardiovascular disease.

Trial registration


Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design

Por: van Hamersvelt · R. W. · Isgum · I. · de Jong · P. A. · Cramer · M. J. M. · Leenders · G. E. H. · Willemink · M. J. · Voskuil · M. · Leiner · T.

Anatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFRCT] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFRCT and DL for the identification of functionally significant coronary artery stenosis.

Methods and analysis

Seventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFRCT and DL separately and combined for the identification of functionally significant coronary artery stenosis.

Ethics and dissemination

Ethical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.

Trial registration number

NCT03139006; Pre-results.