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Abstract Background Delays in diagnostic and therapeutic processes are a potentially preventable cause of morbidity and mortality. Process improvement depends on accurate knowledge about as-is processes, historically collected from front-line workers and summarized in flowcharts. Such flowcharts can now be generated by process discovery algorithms supplied with chronological records from real-world cases. However, these algorithms may generate incomprehensible flowcharts when applied to complex unstructured processes, which are common in healthcare. The aim of this study is to evaluate methods for analysing data from real-world cases to determine causes of delay in complex healthcare processes. Methods Physician insurance claims and hospital discharge data were obtained for patients undergoing carotid endarterectomy at a single tertiary hospital between 2008 and 2014. All patients were recently symptomatic with vision loss. A chronological record of physician visits and diagnostic tests (activities) was generated for each patient using claims data. Algorithmic process discovery was attempted using the Heuristic Miner. The effect of activity selection on treatment delay was investigated from two perspectives: activity-specific effects were measured using linear regression, and patterns of activity co-occurrence were identified using K means clustering. Results Ninety patients were included, with a median symptom-to-surgery treatment time of 34 days. Every patient had a unique sequence of activities. The flowchart generated by the Heuristic Miner algorithm was uninterpretable. Linear regression models of waiting time revealed beneficial effects of emergency and neurology visits, and detrimental effects of carotid ultrasound and post-imaging follow-up visits to family physicians and ophthalmologists. K-means clustering identified two co-occurrence patterns: emergency visits, neurology visits and CT angiography were more common in a cluster of rapidly treated patients (median symptom to surgery time of 18 days), whereas family physician visits, carotid ultrasound imaging and post-imaging follow-up visits to eye specialists were more common in a cluster of patients with treatment delay (median time of 57 days). Conclusions Routinely collected data provided a comprehensive account of events in the symptom-to-surgery process for carotid endarterectomy. Linear regression and K-means clustering can be used to analyze real-world data to understand causes of delay in complex healthcare processes.

Abstract Objectives Gout is caused by the response of the innate immune system to monosodium urate (MSU) crystals. A recent gout GWAS identified a signal of genetic association at a locus encompassing IL1RN-IL1F10. Colocalisation analysis using Genotype Tissue Expression Database (GTEx) eQTL data showed that the signal overlaps with genetic control of IL1RN/IL1F10 gene expression. We assess the functional implications of IL1RN rs9973741, the lead gout-associated variant. Methods We conducted functional validation of IL1RN rs9973741 in patients with gout and controls. The transcription level of IL1RN/IL1F10 was investigated in unstimulated or MSU-crystal co-stimulated PBMCs. Ex vivo functional assays were performed in PBMCs stimulated with C16 + MSU crystals or LPS for 24 h. Cytokine levels were assessed by ELISA. Results In unstimulated PBMCs, no association of IL1RN rs9973741 (gout risk allele G) to IL1RN expression was observed while IL-1F10 was hindered by low expression at both transcriptional and protein levels. However, G allele carriers showed lower IL1RN expression in PBMCs stimulated with C16/MSU crystal and lower concentrations of circulating IL-1Ra in both controls and gout patients. PBMCs depicted less spontaneous IL-1Ra release in GG homozygous controls and lower IL-1Ra production in response to C16 + MSU crystal costimulation in patients with gout. The G allele was associated with elevated IL-1β cytokine production in response to C16 + MSU crystal stimulation in controls. Conclusions The gout risk allele G associates with lower circulating IL-1Ra, lower IL-1Ra production in PBMC assays and elevated IL-1β production in PBMCs challenged with C16 + MSU crystals but not in unchallenged cells. Our data indicate that the genetic signal that associates with gout at IL1RN-IL1F10 region functions to alter expression of IL-1Ra when stimulated by MSU crystals.

Abstract Background A shortage of healthcare workers in low- and middle-income countries (LMICs) combined with a rising burden of non-communicable diseases (NCDs) like hypertension and diabetes mellitus has resulted in increasing gaps in care delivery for NCDs. As community health workers (CHWs) often play an established role in LMIC healthcare systems, these programs could be leveraged to strengthen healthcare access. The objective of this study was to explore perceptions of task shifting screening and referral for hypertension and diabetes to CHWs in rural Uganda. Methods This qualitative, exploratory study was conducted in August 2021 among patients, CHWs and healthcare professionals. Through 24 in-depth interviews and ten focus group discussions, we investigated perceptions of task shifting to CHWs in the screening and referral of NCDs in Nakaseke, rural Uganda. This study employed a holistic approach targeting stakeholders involved in the implementation of task shifting programs. All interviews were audio-recorded, transcribed verbatim, and analyzed thematically guided by the framework method. Results Analysis identified elements likely to be required for successful program implementation in this context. Fundamental drivers of CHW programs included structured supervision, patients’ access to care through CHWs, community involvement, remuneration and facilitation, as well as building CHW knowledge and skills through training. Additional enablers comprised specific CHW characteristics such as confidence, commitment and motivation, as well as social relations and empathy. Lastly, socioemotional aspects such as trust, virtuous behavior, recognition in the community, and the presence of mutual respect were reported to be critical to the success of task shifting programs. Conclusion CHWs are perceived as a useful resource when task shifting NCD screening and referral for hypertension and diabetes from facility-based healthcare workers. Before implementation of a task shifting program, it is essential to consider the multiple layers of needs portrayed in this study. This ensures a successful program that overcomes community concerns and may serve as guidance to implement task shifting in similar settings.

Abstract Background and purpose Studies of carotid endarterectomy (CEA) require stratification by symptomatic vs asymptomatic status because of marked differences in benefits and harms. In administrative datasets, this classification has been done using hospital discharge diagnosis codes of uncertain accuracy. This study aims to develop and evaluate algorithms for classifying symptomatic status using hospital discharge and physician claims data. Methods A single center’s administrative database was used to assemble a retrospective cohort of participants with CEA. Symptomatic status was ascertained by chart review prior to linkage with physician claims and hospital discharge data. Accuracy of rule-based classification by discharge diagnosis codes was measured by sensitivity and specificity. Elastic net logistic regression and random forest models combining physician claims and discharge data were generated from the training set and assessed in a test set of final year participants. Models were compared to rule-based classification using sensitivity at fixed specificity. Results We identified 971 participants undergoing CEA at the Vancouver General Hospital (Vancouver, Canada) between January 1, 2008 and December 31, 2016. Of these, 729 met inclusion/exclusion criteria (n = 615 training, n = 114 test). Classification of symptomatic status using hospital discharge diagnosis codes was 32.8% (95% CI 29–37%) sensitive and 98.6% specific (96–100%). At matched 98.6% specificity, models that incorporated physician claims data were significantly more sensitive: elastic net 69.4% (59–82%) and random forest 78.8% (69–88%). Conclusion Discharge diagnoses were specific but insensitive for the classification of CEA symptomatic status. Elastic net and random forest machine learning algorithms that included physician claims data were sensitive and specific, and are likely an improvement over current state of classification by discharge diagnosis alone.

Abstract Objectives Hyperuricemia is a metabolic condition central to gout pathogenesis. Urate exposure primes human monocytes towards a higher capacity to produce and release IL-1β. In this study, we assessed the epigenetic processes associated to urate-mediated hyper-responsiveness. Methods Freshly isolated human peripheral blood mononuclear cells or enriched monocytes were pre-treated with solubilized urate and stimulated with LPS with or without monosodium urate (MSU) crystals. Cytokine production was determined by ELISA. Histone epigenetic marks were assessed by sequencing immunoprecipitated chromatin. Mice were injected intraarticularly with MSU crystals and palmitate after inhibition of uricase and urate administration in the presence or absence of methylthioadenosine. DNA methylation was assessed by methylation array in whole blood of 76 participants with normouricemia or hyperuricemia. Results High concentrations of urate enhanced the inflammatory response in vitro in human cells and in vivo in mice, and broad-spectrum methylation inhibitors reversed this effect. Assessment of histone 3 lysine 4 trimethylation (H3K4me3) and histone 3 lysine 27 acetylation (H3K27ac) revealed differences in urate-primed monocytes compared to controls. Differentially methylated regions (e.g. HLA-G, IFITM3, PRKAB2) were found in people with hyperuricemia compared to normouricemia in genes relevant for inflammatory cytokine signaling. Conclusion Urate alters the epigenetic landscape in selected human monocytes or whole blood of people with hyperuricemia compared to normouricemia. Both histone modifications and DNA methylation show differences depending on urate exposure. Subject to replication and validation, epigenetic changes in myeloid cells may be a therapeutic target in gout.

Abstract Background Studies evaluating treatment responses for chronic nonbacterial osteomyelitis (CNO) are lacking. We aimed to measure and compare response rates of medical treatments, time to response of medical treatments among patients with CNO of the mandible, and describe bacterial contamination rates from biopsy. Methods We conducted a retrospective chart review of all patients diagnosed with CNO of mandible between 2003 and 2017 and extracted demographic, clinical, laboratory, imaging and surgical data. Detailed medication use and response to medications were recorded. The primary outcome was response to medical treatments defined as improvement of presenting symptoms, inflammatory markers, and imaging if available. Medical treatments included nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, disease modifying anti rheumatic drugs (DMARDs), anti-tumor necrosis factor (TNF) therapy, and pamidronate. Descriptive analysis was performed when appropriate. Multivariable logistic regression and Kaplan-Meier curves were applied to compare the responses to medical treatments and time to full response. Results We identified 22 patients with a median age of 11 and 36% were female. Four patients (18%) had multifocal bone lesions. CT findings (n = 21) showed lytic lesions (62%) and sclerosis (90%). MRI (n = 14) revealed hyperintensity within bone marrow (100%), soft tissue (71%) and bony expansion (71%). Non-antibiotic treatments including NSAIDs (n = 18), glucocorticoids (n = 10), DMARDs (n = 9), anti-TNF therapy (n = 5) and pamidronate (n = 6) were applied. Rates of full responses to anti-TNF therapy (60%) and pamidronate (67%) were higher than that to NSAIDs (11%) (p

Abstract Background E-mental health holds promise for people with severe mental illness, but has a limited evidence base. This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery Programme (e-IMR). Method In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n = 60; 41 in intervention group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management, self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T0), halfway (T1), and at twelve months (T2). The data were analysed using mixed model for repeated measurements in four models: in 1) we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled for interaction effects, and in 4) we performed sub-group analyses within the intervention group. Results Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management (p = .01) and recovery (p = .02) at T1, and for general health perception (p = .02) at T2, all in favour of the intervention group. In model 2, the confounding covariate gender explained the effects at T1 and T2, except for self-management. In model 3, the interacting covariate non-completer explained the effects for self-management (p = .03) at T1. In model 4, the sub-group analyses of e-IMR-users versus non-users showed no differences in effect. Conclusion Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process evaluation of the intervention. Trial registration The Dutch Trial Register (NTR4772)

Abstract Background People with overweight or obesity are at increased risk for disease later in life which cause important health costs. The aim of this study was to estimate the health status and the corresponding costs in a sample of females with overweight or obesity which were participating in a Randomized Controlled Trial (RCT) exploring the effect of lifestyle habits changes on ectopic adipose tissue. Methods Sixty-two non-diabetic premenopausal females without major comorbidities of overweight and obesity were recruited among patients visiting endocrinologists at the obesity clinic of the University Hospital of Antwerp and the University of Antwerp. A RCT-embedded cost-of-illness approach with societal perspective, based on self-reported questionnaires and cost diaries (3 months recall) was applied to estimate the prevalence of different comorbidities and the related direct and indirect costs in this sample of overweight or obese females. The European Quality-of-Life-5D questionnaire was used to define the health state and the corresponding utility index of the participants. Results The average direct health costs and health utilities observed in this sample were comparable with the general Flemish female population. This may partially be explained by the strict inclusion criteria of the RCT (i.e. overweight or obesity without diabetes type 2 or cardiovascular diseases). However, 15% of the participants had five or more comorbidities resulting in higher average costs and lower average health utility as compared to the general population, only 3 participants were diagnozed with the metabolic syndrome. In this subsample productivity was low due to high average absenteeism, yielding important total costs for the society. Conclusion Secondary prevention to avoid health deterioration in overweight or obese females without major comorbidies is needed to contain health care costs. Trial registration ClinicalTrials.gov: NCT02831621, approval of the ethics committee of the University Hospital of Antwerp (number: 14/17/205 -ref: 7543075363).

Abstract Background The aim of this study to compare the diagnostic accuracy of the metabolic syndrome (MetS) with the FINDRISC score to screen for type 2 diabetes mellitus T2DM in an overweight/obese population. Methods Subjects 18 years or older visiting the obesity clinic of the Antwerp University Hospital were consecutively recruited between 2012 and 2014. Every patient underwent a standard metabolic work-up including a clinical examination with anthropometry. Glucose status was tested using OGTT and Hba1c. FINDRISC questionnaire and MetS were examined. Results Of 651 subjects, 50.4% were diagnosed with prediabetes, whereas 11.1% was diagnosed with T2DM. FINDRISC score increased with worsening of glucose status 11 ± 3, 13 ± 4 and 15 ± 5 in respectively, subjects without T2DM, prediabetes and T2DM. 312 subjects had the MetS. The aROC of the FINDRISC to identify subjects with T2DM was 0.76 (95% CI 0.72–0.82), sensitivity was 64% and specificity was 63% with 13 as cutoff point. Adding FPG or HbA1c to FINDRISC, the aROC increased significantly to 0.91(95% CI 0.88–0.95) and 0.93(95% CI 0.90–0.97), respectively (p

Abstract Background Metabolic syndrome (MetS) refers to clustered cardiovascular risk factors (abdominal obesity, pre-diabetes, high blood pressure, dyslipidaemia). Therapies targeting oxidative stress may delay progression to atherosclerosis and diabetes. We investigated the anti-oxidative effect of a supplement combining red yeast rice and olive extract in patients with MetS. Methods A double-blind, placebo-controlled, randomised trial was conducted with 50 patients with MetS as defined by National Cholesterol Education Program Adult Treatment Panel III criteria. Forty-nine subjects randomly assigned to red yeast rice-olive extract (RYR-olive extract; 10.82 mg of monacolins and 9.32 mg of hydroxytyrosol per Cholesfytolplus capsule) or placebo completed the 8-week trial. Whereas effects on cardiovascular risk parameters of MetS have been reported recently, the observed significant 20% increase in oxidised low-density lipoprotein (OxLDL) prompted us to investigate other oxidative stress-related parameters: malondialdehyde (MDA), lipoprotein-associated phospholipase A2 (Lp-PLA2) and 8-hydroxy-2′-deoxyguanosine (8-OHdG). Statistical calculations included univariate quantitative analysis, multivariate linear regression and correlation analysis. Results The updated results indicate that an RYR-olive extract supplement significantly reduced Lp-PLA2 by 7% (p 0.05). Reductions in OxLDL (20%) and Lp-PLA2 (7%) were associated with each other (r = 0.740, p

Abstract Background With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly. Methods/design The CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation. Discussion The CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care. Trial registration The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797

Abstract Background Although it has been increasingly recognised that patient safety in primary care is important, little is known about the feasibility and effectiveness of different strategies to improve patient safety in primary care. In this study, we aimed to identify the most important strategies by consulting an international panel of primary care physicians and researchers. Methods A web-based survey was undertaken in an international panel of 58 individuals from eight countries with a strong primary care system. The questionnaire consisted of 38 strategies to improve patient safety. We asked the respondents whether these strategies were currently used in their own country, and whether they felt them to be important. Results Most of the 38 presented strategies were seen as important by a majority of the participants, but the use of strategies in daily practice varied widely. Strategies that yielded the highest scores (>70%) regarding importance included a good medical record system (82% felt this was very important, while 83% said it was implemented in more than half of the practices), good telephone access (71% importance, 83% implementation), standards for record keeping (75% importance, 62% implementation), learning culture (74% importance, 10% implementation), vocational training on patient safety for GPs (81% importance, 24% implementation) and the presence of a patient safety guideline (81% importance, 15% implementation). Conclusion An international panel of primary care physicians and researchers felt that many different strategies to improve patient safety were important. Highly important strategies with poor implementation included a culture that is positive for patient safety, education on patient safety for physicians, and the presence of a patient safety guideline.

Abstract Background Patient safety can be at stake in both hospital and general practice settings. While severe patient safety incidents have been described, quantitative studies in large samples of patients in general practice are rare. This study aimed to assess patient safety in general practice, and to show areas where potential improvements could be implemented. Methods We conducted a retrospective review of patient records in Dutch general practice. A random sample of 1,000 patients from 20 general practices was obtained. The number of patient safety incidents that occurred in a one-year period, their perceived underlying causes, and impact on patients' health were recorded. Results We identified 211 patient safety incidents across a period of one year (95% CI: 185 until 241). A variety of types of incidents, perceived causes and consequences were found. A total of 58 patient safety incidents affected patients; seven were associated with hospital admission; none resulted in permanent disability or death. Conclusions Although this large audit of medical records in general practices identified many patient safety incidents, only a few had a major impact on patients' health. Improving patient safety in this low-risk environment poses specific challenges, given the high numbers of patients and contacts in general practice.

Abstract Background Chronic lymphocytic leukemia (CLL) is a highly variable disease with life expectancies ranging from months to decades. Cytogenetic findings play an integral role in defining the prognostic significance and treatment for individual patients. Results We have evaluated 25 clinical cases from a tertiary cancer center that have an established diagnosis of CLL and for which there was prior cytogenetic and/or fluorescence in situ hybridization (FISH) data. We performed microarray-based comparative genomic hybridization (aCGH) using a bacterial artificial chromosome (BAC)-based microarray designed for the detection of known constitutional genetic syndromes. In 15 of the 25 cases, aCGH detected all copy number imbalances identified by prior cytogenetic and/or FISH studies. For the majority of those not detected, the aberrations were present at low levels of mosaicism. Furthermore, for 15 of the 25 cases, additional abnormalities were detected. Four of those cases had deletions that mapped to intervals implicated in inherited predisposition to CLL. For most cases, aCGH was able to detect abnormalities present in as few as 10% of cells. Although changes in ploidy are not easily discernable by aCGH, results for two cases illustrate the detection of additional copy gains and losses present within a mosaic tetraploid cell population. Conclusions Our results illustrate the successful evaluation of CLL using a microarray optimized for the interrogation of inherited disorders and the identification of alterations with possible relevance to CLL susceptibility.

Abstract Background Recent genome-wide microarray-based research investigations have revealed a high frequency of submicroscopic copy number alterations (CNAs) in the myelodysplastic syndromes (MDS), suggesting microarray-based comparative genomic hybridization (aCGH) has the potential to detect new clinically relevant genomic markers in a diagnostic laboratory. Results We performed an exploratory study on 30 cases of MDS, myeloproliferative neoplasia (MPN) or evolving acute myeloid leukemia (AML) (% bone marrow blasts ≤ 30%, range 0-30%, median, 8%) by aCGH, using a genome-wide bacterial artificial chromosome (BAC) microarray. The sample data were compared to corresponding cytogenetics, fluorescence in situ hybridization (FISH), and clinical-pathological findings. Previously unidentified imbalances, in particular those considered submicroscopic aberrations (< 10 Mb), were confirmed by FISH analysis. CNAs identified by aCGH were concordant with the cytogenetic/FISH results in 25/30 (83%) of the samples tested. aCGH revealed new CNAs in 14/30 (47%) patients, including 28 submicroscopic or hidden aberrations verified by FISH studies. Cryptic 344-kb RUNX1 deletions were found in three patients at time of AML transformation. Other hidden CNAs involved 3q26.2/EVI1, 5q22/APC, 5q32/TCERG1,12p13.1/EMP1, 12q21.3/KITLG, and 17q11.2/NF1. Gains of CCND2/12p13.32 were detected in two patients. aCGH failed to detect a balanced translocation (n = 1) and low-level clonality (n = 4) in five karyotypically aberrant samples, revealing clinically important assay limitations. Conclusions The detection of previously known and unknown genomic alterations suggests that aCGH has considerable promise for identification of both recurring microscopic and submicroscopic genomic imbalances that contribute to myeloid disease pathogenesis and progression. These findings suggest that development of higher-resolution microarray platforms could improve karyotyping in clinical practice.

Abstract Background Insight into the frequency and seriousness of potentially unsafe situations may be the first step towards improving patient safety. Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. There is little concrete information about patient safety in primary care in the Netherlands. The overall aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. The objectives of this study are: to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients; to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals; and to provide insight into patient safety management in primary care practices. Design and methods The study consists of three parts: a retrospective patient record study of 1,000 records per practice type was conducted to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients (objective one); a prospective component concerns an incident-reporting study in each of the participating practices, during two successive weeks, to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals (objective two); to provide insight into patient safety management in Dutch primary care practices (objective three), we surveyed organizational and cultural items relating to patient safety. We analysed the incidents found in the retrospective patient record study and the prospective incident-reporting study by type of incident, causes (Eindhoven Classification Model), actual harm (severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care), and probability of severe harm or death. Discussion To estimate the frequency of incidents was difficult. Much depended on the accuracy of the patient records and the professionals' consensus about which types of adverse events have to be recognized as incidents.

Abstract Background Primary care encompasses many different clinical domains and patient groups, which means that patient safety in primary care may be equally broad. Previous research on safety in primary care has focused on medication safety and incident reporting. In this study, the views of general practitioners (GPs) on patient safety were examined. Methods A web-based survey of a sample of GPs was undertaken. The items were derived from aspects of patient safety issues identified in a prior interview study. The questionnaire used 10 clinical cases and 15 potential risk factors to explore GPs' views on patient safety. Results A total of 68 GPs responded (51.5% response rate). None of the clinical cases was uniformly judged as particularly safe or unsafe by the GPs. Cases judged to be unsafe by a majority of the GPs concerned either the maintenance of medical records or prescription and monitoring of medication. Cases which only a few GPs judged as unsafe concerned hygiene, the diagnostic process, prevention and communication. The risk factors most frequently judged to constitute a threat to patient safety were a poor doctor-patient relationship, insufficient continuing education on the part of the GP and a patient age over 75 years. Language barriers and polypharmacy also scored high. Deviation from evidence-based guidelines and patient privacy in the reception/waiting room were not perceived as risk factors by most of the GPs. Conclusion The views of GPs on safety and risk in primary care did not completely match those presented in published papers and policy documents. The GPs in the present study judged a broader range of factors than in previously published research on patient safety in primary care, including a poor doctor-patient relationship, to pose a potential threat to patient safety. Other risk factors such as infection prevention, deviation from guidelines and incident reporting were judged to be less relevant than by policy makers.

Abstract Background Patients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs), which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety. The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study. Methods and design The patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took place on ward level. The results will be analysed separately for hospitals and nursing homes. Discussion Major challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program. Trial registration Trial registration: ClinicalTrials.gov ID [NCT00365430]

Abstract Primary or spontaneous coronary artery dissection (SCAD) is an unusual but increasingly recognized cause of acute myocardial ischemia and sudden cardiac death. Typically, SCAD presents in younger patients without conventional risk factors for coronary artery disease. It occurs more commonly in women than in men, and frequently during pregnancy or the postpartum period. Its pathophysiology is poorly understood, and there is considerable controversy regarding the optimal management of patients with SCAD-related myocardial ischemia. Therapeutic approaches include conservative medical therapy, coronary artery bypass graft surgery and percutaneous coronary intervention (PCI). We present four cases of SCAD to illustrate specific aspects of the presentation and management of this condition, with particular reference to the importance of intravascular ultrasound (IVUS) to aid diagnosis and guide subsequent PCI.

Abstract Background Intramural coronary haematoma following percutaneous coronary intervention in the absence of coronary dissection is a rare phenomenon. Case presentation A 69 year old lady with previous prosthetic aortic valve replacement underwent percutaneous coronary intervention (PCI) from the left mainstem to the left anterior descending artery (LAD) and kissing balloon inflations to the LAD and circumflex (Cx) arteries. Although intravascular ultrasound examination (IVUS) of both the LAD and Cx showed both vessels to be widely patent at the end of the procedure, she developed ischaemic chest pain six hours later. Repeat coronary angiography revealed a significant stenosis in the proximal Cx vessel, which was confirmed on IVUS to be intramural haematoma. Conclusion In patients taking warfarin in addition to standard antiplatelet therapy, kissing balloon inflations should be carried out with caution.

Abstract Background Platypnea-orthodeoxia describes the condition of combined dyspnea and hypoxia respectively, whilst in the upright position, which improves in the recumbent position. Case Report We present a case of platypnea-orthodeoxia due to a fenestrated atrial septal defect associated with an atrial septal aneurysm. Due to the fenestrated nature of the atrial septal defect, surgical rather than percutaneous correction was performed. Conclusion A high index of suspicion is required to diagnose the syndrome of platypnea-orthodeoxia. Careful echocardiographic evaluation is required to identify the syndrome, and to determine suitability for percutaneous repair.