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1.  Administered Paricalcitol Dose and Survival in Hemodialysis Patients: A Marginal Structural Model Analysis 
Pharmacoepidemiology and drug safety  2012;21(11):1232-1239.
Purpose
Several observational studies have indicated that vitamin D receptor activators (VDRA), including paricalcitol, are associated with greater survival in maintenance hemodialysis (MHD) patients. However, patients with higher serum parathyroid hormone (PTH), a surrogate of higher death risk, are usually given higher VDRA doses, which can lead to confounding by indication and attenuate the expected survival advantage of high VDRA doses.
Methods
We examined mortality-predictability of low (>1 but <10 μg/week) versus high (≥10 μg/week) dose of administered paricalcitol over time in a contemporary cohort of 15,442 MHD patients (age 64±15 years, 55% men, 44% diabetes, 35% African Americans) from all DaVita dialysis clinics across the USA (7/2001-6/2006 with survival follow-ups until 6/2007) using conventional Cox regression, propensity score (PS) matching, and marginal structural model (MSM) analyses.
Results
In our conventional Cox models and PS matching models, low dose of paricalcitol was not associated with mortality either in baseline (hazard ratio (HR): 1.03, 95%confidence interval (CI): (0.97-1.09)) and (HR: 0.99, 95%CI: (0.86-1.14)) or time-dependent (HR: 1.04, 95%CI: (0.98-1.10)) and (HR: 1.12, 95%CI: (0.98-1.28)) models, respectively. In contrast, compared to high dose of paricalcitol, low dose was associated with a 26% higher risk of mortality (HR: 1.26, 95%CI: (1.19-1.35)) in MSM. The association between dose of paricalcitol and mortality was robust in almost all subgroups of patients using MSMs.
Conclusions
Higher dose of paricalcitol appears causally associated with greater survival in MHD patients. Randomized controlled trials need to verify the survival effect of paricalcitol dose in maintenance hemodialysis patients are indicated.
doi:10.1002/pds.3349
PMCID: PMC4304639  PMID: 22996597
Mortality; propensity score; marginal structural model; mineral and bone disorders; chronic kidney disease; paricalcitol
2.  Nutritional predictors of early mortality in incident hemodialysis patients 
Purpose
Low serum albumin concentration and low dietary protein intake are associated with protein-energy wasting (PEW) and higher mortality in maintenance hemodialysis patients. The role of these nutritional markers is less clear in clinical outcomes of the first several months of dialysis therapy, where mortality is exceptionally high.
Methods
In a cohort of 17,445 incident hemodialysis patients, we examined variation in serum albumin and the normalized protein catabolic rate (nPCR), a surrogate of dietary intake, and quarterly mortality in the first 2 years of dialysis therapy. Cox proportional hazard models were fitted to estimate the association between mortality and combined albumin/nPCR categories for eight quarters. We investigated the associations between mortality and baseline and subsequent serum albumin levels per cohort quarter as well as changes in albumin and nPCR over time.
Results
Patients were 64 ± 15 years old (mean ± SD) and included 45 % women, 24 % African Americans and 58 % diabetics. Correlations between quarterly serum albumin and nPCR varied from 0.18 to 0.25. Serum albumin <3.5 g/dL was consistently associated with high mortality as was nPCR <1 g/kg/day (except for qtr1). Low serum albumin and nPCR greater than 0.2 g/dLg/dL or g/kg/day, respectively, were associated with increased risk of death. Quarterly rise in nPCR (>+0.2 g/kg/day) showed reverse effect on mortality from the 2nd to the last quarter.
Conclusions
Low serum albumin and nPCR are associated with mortality. A rapid rise in nPCR by the end of the second year may indicate pre-existing PEW.
doi:10.1007/s11255-013-0459-2
PMCID: PMC3870190  PMID: 23703546
Hemodialysis; Mortality; Albumin; Protein catabolic rate
3.  COMPETING RISK BIAS TO EXPLAIN THE INVERSE RELATIONSHIP BETWEEN SMOKING AND MALIGNANT MELANOMA 
European journal of epidemiology  2013;28(7):10.1007/s10654-013-9812-0.
The relationship between smoking and melanoma remains unclear. Among the different results is the paradoxical finding that smoking was shown to be inversely associated with the risk of malignant melanoma in some large cohort and case-control studies, even after control for suspected confounding variables. Smoking is a known risk factor for many non-communicable diseases, including coronary heart disease, stroke, as well as other malignancies; it has been shown to be positively associated with other types of skin cancer, and there remains no clear biologic explanation for a possible protective effect on malignant melanoma. In this paper, we propose a plausible mechanism of bias from smoking-related competing risks that may explain or contribute to the inverse association between smoking and melanoma as spurious. Using directed acyclic graphs for formalization and visualization of assumptions, and Monte Carlo simulation techniques, we demonstrate how published inverse associations might be compatible with selection bias resulting from uncontrolled or unmeasured common causes of competing outcomes of smoking-related diseases and malignant melanoma. We present results from various scenarios assuming a true null as well as a true positive association between smoking and malignant melanoma. Under a true null assumption, we find inverse associations due to the biasing mechanism to be compatible with published results in the literature, especially after the addition of unmeasured confounding variables. This study could be seen as offering a cautionary note in the interpretation of published smoking-melanoma findings.
doi:10.1007/s10654-013-9812-0
PMCID: PMC3864891  PMID: 23700026
Bias (Epidemiology); Melanoma; Smoking
4.  Measuring Professionalism in Medicine and Nursing: Results of a European Survey 
PLoS ONE  2014;9(5):e97069.
Background
Leveraging professionalism has been put forward as a strategy to drive improvement of patient care. We investigate professionalism as a factor influencing the uptake of quality improvement activities by physicians and nurses working in European hospitals.
Objective
To (i) investigate the reliability and validity of data yielded by using the self-developed professionalism measurement tool for physicians and nurses, (ii) describe their levels of professionalism displayed, and (iii) quantify the extent to which professional attitudes would predict professional behaviors.
Methods and Materials
We designed and deployed survey instruments amongst 5920 physicians and nurses working in European hospitals. This was conducted under the cross-sectional multilevel study “Deepening Our Understanding of Quality Improvement in Europe” (DUQuE). We used psychometric and generalized linear mixed modelling techniques to address the aforementioned objectives.
Results
In all, 2067 (response rate 69.8%) physicians and 2805 nurses (94.8%) representing 74 hospitals in 7 European countries participated. The professionalism instrument revealed five subscales of professional attitude and one scale for professional behaviour with moderate to high internal consistency and reliability. Physicians and nurses display equally high professional attitude sum scores (11.8 and 11.9 respectively out of 16) but seem to have different perceptions towards separate professionalism aspects. Lastly, professionals displaying higher levels of professional attitudes were more involved in quality improvement actions (physicians: b = 0.019, P<0.0001; nurses: b = 0.016, P<0.0001) and more inclined to report colleagues’ underperformance (physicians – odds ratio (OR) 1.12, 95% CI 1.01–1.24; nurses – OR 1.11, 95% CI 1.01–1.23) or medical errors (physicians – OR 1.14, 95% CI 1.01–1.23; nurses – OR 1.43, 95% CI 1.22–1.67). Involvement in QI actions was found to increase the odds of reporting incompetence or medical errors.
Conclusion
A tool that reliably and validly measures European physicians’ and nurses’ commitment to professionalism is now available. Collectively leveraging professionalism as a quality improvement strategy may be beneficial to patient care quality.
doi:10.1371/journal.pone.0097069
PMCID: PMC4029578  PMID: 24849320
5.  Personality Traits Affect Teaching Performance of Attending Physicians: Results of a Multi-Center Observational Study 
PLoS ONE  2014;9(5):e98107.
Background
Worldwide, attending physicians train residents to become competent providers of patient care. To assess adequate training, attending physicians are increasingly evaluated on their teaching performance. Research suggests that personality traits affect teaching performance, consistent with studied effects of personality traits on job performance and academic performance in medicine. However, up till date, research in clinical teaching practice did not use quantitative methods and did not account for specialty differences. We empirically studied the relationship of attending physicians' personality traits with their teaching performance across surgical and non-surgical specialties.
Method
We conducted a survey across surgical and non-surgical specialties in eighteen medical centers in the Netherlands. Residents evaluated attending physicians' overall teaching performance, as well as the specific domains learning climate, professional attitude, communication, evaluation, and feedback, using the validated 21-item System for Evaluation of Teaching Qualities (SETQ). Attending physicians self-evaluated their personality traits on a 5-point scale using the validated 10-item Big Five Inventory (BFI), yielding the Five Factor model: extraversion, conscientiousness, neuroticism, agreeableness and openness.
Results
Overall, 622 (77%) attending physicians and 549 (68%) residents participated. Extraversion positively related to overall teaching performance (regression coefficient, B: 0.05, 95% CI: 0.01 to 0.10, P = 0.02). Openness was negatively associated with scores on feedback for surgical specialties only (B: −0.10, 95% CI: −0.15 to −0.05, P<0.001) and conscientiousness was positively related to evaluation of residents for non-surgical specialties only (B: 0.13, 95% CI: 0.03 to 0.22, p = 0.01).
Conclusions
Extraverted attending physicians were consistently evaluated as better supervisors. Surgical attending physicians who display high levels of openness were evaluated as less adequate feedback-givers. Non-surgical attending physicians who were conscientious seem to be good at evaluating residents. These insights could contribute to future work on development paths of attending physicians in medical education.
doi:10.1371/journal.pone.0098107
PMCID: PMC4028262  PMID: 24844725
6.  Cell Phone Exposures and Hearing Loss in Children in the Danish National Birth Cohort 
Background
Children today are exposed to cell phones early in life, and may be the most vulnerable if exposure is harmful to health. We investigated the association between cell phone use and hearing loss in children.
Methods
The Danish National Birth Cohort (DNBC) enrolled pregnant women between 1996 and 2002. Detailed interviews were conducted during gestation, and when the children were 6 months, 18 months, and 7 years of age. We used multivariable-adjusted logistic regression, marginal structural models (MSM) with inverse-probability weighting, and doubly-robust estimation (DRE) to relate hearing loss at age 18 months to cell phone use at age seven years, and to investigate cell phone use reported at age seven in relation to hearing loss at age seven.
Results
Our analyses included data from 52,680 children. We observed weak associations between cell phone use and hearing loss at age seven, with odds ratios and 95% confidence intervals from the traditional logistic regression, MSM, and DRE models being 1.21 [0.99–1.46], 1.23 [1.01–1.49], and 1.22 [1.00–1.49], respectively.
Conclusions
Our findings could have been affected by various biases and are not sufficient to conclude that cell phone exposures have an effect on hearing. This is the first large-scale epidemiologic study to investigate this potentially important association among children, and replication of these findings is needed.
doi:10.1111/ppe.12036
PMCID: PMC3625978  PMID: 23574412
7.  Medical Students Perceive Better Group Learning Processes when Large Classes Are Made to Seem Small 
PLoS ONE  2014;9(4):e93328.
Objective
Medical schools struggle with large classes, which might interfere with the effectiveness of learning within small groups due to students being unfamiliar to fellow students. The aim of this study was to assess the effects of making a large class seem small on the students' collaborative learning processes.
Design
A randomised controlled intervention study was undertaken to make a large class seem small, without the need to reduce the number of students enrolling in the medical programme. The class was divided into subsets: two small subsets (n = 50) as the intervention groups; a control group (n = 102) was mixed with the remaining students (the non-randomised group n∼100) to create one large subset.
Setting
The undergraduate curriculum of the Maastricht Medical School, applying the Problem-Based Learning principles. In this learning context, students learn mainly in tutorial groups, composed randomly from a large class every 6–10 weeks.
Intervention
The formal group learning activities were organised within the subsets. Students from the intervention groups met frequently within the formal groups, in contrast to the students from the large subset who hardly enrolled with the same students in formal activities.
Main Outcome Measures
Three outcome measures assessed students' group learning processes over time: learning within formally organised small groups, learning with other students in the informal context and perceptions of the intervention.
Results
Formal group learning processes were perceived more positive in the intervention groups from the second study year on, with a mean increase of β = 0.48. Informal group learning activities occurred almost exclusively within the subsets as defined by the intervention from the first week involved in the medical curriculum (E-I indexes>−0.69). Interviews tapped mainly positive effects and negligible negative side effects of the intervention.
Conclusion
Better group learning processes can be achieved in large medical schools by making large classes seem small.
doi:10.1371/journal.pone.0093328
PMCID: PMC3988014  PMID: 24736272
8.  Deepening our understanding of quality improvement in Europe (DUQuE): overview of a study of hospital quality management in seven countries 
Introduction and Objective
This paper provides an overview of the DUQuE (Deepening our Understanding of Quality Improvement in Europe) project, the first study across multiple countries of the European Union (EU) to assess relationships between quality management and patient outcomes at EU level. The paper describes the conceptual framework and methods applied, highlighting the novel features of this study.
Design
DUQuE was designed as a multi-level cross-sectional study with data collection at hospital, pathway, professional and patient level in eight countries.
Setting and Participants
We aimed to collect data for the assessment of hospital-wide constructs from up to 30 randomly selected hospitals in each country, and additional data at pathway and patient level in 12 of these 30.
Main outcome measures
A comprehensive conceptual framework was developed to account for the multiple levels that influence hospital performance and patient outcomes. We assessed hospital-specific constructs (organizational culture and professional involvement), clinical pathway constructs (the organization of care processes for acute myocardial infarction, stroke, hip fracture and deliveries), patient-specific processes and outcomes (clinical effectiveness, patient safety and patient experience) and external constructs that could modify hospital quality (external assessment and perceived external pressure).
Results
Data was gathered from 188 hospitals in 7 participating countries. The overall participation and response rate were between 75% and 100% for the assessed measures.
Conclusions
This is the first study assessing relation between quality management and patient outcomes at EU level. The study involved a large number of respondents and achieved high response rates. This work will serve to develop guidance in how to assess quality management and makes recommendations on the best ways to improve quality in healthcare for hospital stakeholders, payers, researchers, and policy makers throughout the EU.
doi:10.1093/intqhc/mzu025
PMCID: PMC4001699  PMID: 24671120
quality management systems; clinical indicators; clinical effectiveness; quality of healthcare; hospitals; cross-national research; patient outcomes
9.  Measuring clinical management by physicians and nurses in European hospitals: development and validation of two scales 
Objective
Clinical management is hypothesized to be critical for hospital management and hospital performance. The aims of this study were to develop and validate professional involvement scales for measuring the level of clinical management by physicians and nurses in European hospitals.
Design
Testing of validity and reliability of scales derived from a questionnaire of 21 items was developed on the basis of a previous study and expert opinion and administered in a cross-sectional seven-country research project ‘Deepening our Understanding of Quality improvement in Europe’ (DUQuE).
Setting and Participants
A sample of 3386 leading physicians and nurses working in 188 hospitals located in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.
Main Outcome Measures
Validity and reliability of professional involvement scales and subscales.
Results
Psychometric analysis yielded four subscales for leading physicians: (i) Administration and budgeting, (ii) Managing medical practice, (iii) Strategic management and (iv) Managing nursing practice. Only the first three factors applied well to the nurses. Cronbach's alpha for internal consistency ranged from 0.74 to 0.86 for the physicians, and from 0.61 to 0.81 for the nurses. Except for the 0.74 correlation between ‘Administration and budgeting’ and ‘Managing medical practice’ among physicians, all inter-scale correlations were <0.70 (range 0.43–0.61). Under testing for construct validity, the subscales were positively correlated with ‘formal management roles’ of physicians and nurses.
Conclusions
The professional involvement scales appear to yield reliable and valid data in European hospital settings, but the scale ‘Managing medical practice’ for nurses needs further exploration. The measurement instrument can be used for international research on clinical management.
doi:10.1093/intqhc/mzu014
PMCID: PMC4001689  PMID: 24615595
clinical management; professional involvement; quality systems; hospital management
10.  Involvement of patients or their representatives in quality management functions in EU hospitals: implementation and impact on patient-centred care strategies 
Objective
The objective of this study was to describe the involvement of patients or their representatives in quality management (QM) functions and to assess associations between levels of involvement and the implementation of patient-centred care strategies.
Design
A cross-sectional, multilevel study design that surveyed quality managers and department heads and data from an organizational audit.
Setting
Randomly selected hospitals (n = 74) from seven European countries (The Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey).
Participants
Hospital quality managers (n = 74) and heads of clinical departments (n = 262) in charge of four patient pathways (acute myocardial infarction, stroke, hip fracture and deliveries) participated in the data collection between May 2011 and February 2012.
Main Outcome Measures
Four items reflecting essential patient-centred care strategies based on an on-site hospital visit: (1) formal survey seeking views of patients and carers, (2) written policies on patients' rights, (3) patient information literature including guidelines and (4) fact sheets for post-discharge care. The main predictors were patient involvement in QM at the (i) hospital level and (ii) pathway level.
Results
Current levels of involving patients and their representatives in QM functions in European hospitals are low at hospital level (mean score 1.6 on a scale of 0 to 5, SD 0.7), but even lower at departmental level (mean 0.6, SD 0.7). We did not detect associations between levels of involving patients and their representatives in QM functions and the implementation of patient-centred care strategies; however, the smallest hospitals were more likely to have implemented patient-centred care strategies.
Conclusions
There is insufficient evidence that involving patients and their representatives in QM leads to establishing or implementing strategies and procedures that facilitate patient-centred care; however, lack of evidence should not be interpreted as evidence of no effect.
doi:10.1093/intqhc/mzu022
PMCID: PMC4001693  PMID: 24615596
quality management; quality measurement; patient-centred care; hospital care, hospital, patient involvement
11.  A checklist for patient safety rounds at the care pathway level 
Objective
To define a checklist that can be used to assess the performance of a department and evaluate the implementation of quality management (QM) activities across departments or pathways in acute care hospitals.
Design
We developed and tested a checklist for the assessment of QM activities at department level in a cross-sectional study using on-site visits by trained external auditors.
Setting and participants
A sample of 292 hospital departments of 74 acute care hospitals across seven European countries. In every hospital, four departments for the conditions: acute myocardial infarction (AMI), stroke, hip fracture and deliveries participated.
Main Outcome Measures
Four measures of QM activities were evaluated at care pathway level focusing on specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies and clinical review (CR).
Results
Participating departments attained mean values on the various scales between 1.2 and 3.7. The theoretical range was 0–4. Three of the four QM measures are identical for the four conditions, whereas one scale (EBOP) has condition-specific items. Correlations showed that every factor was related, but also distinct, and added to the overall picture of QM at pathway level.
Conclusion
The newly developed checklist can be used across various types of departments and pathways in acute care hospitals like AMI, deliveries, stroke and hip fracture. The anticipated users of the checklist are internal (e.g. peers within the hospital and hospital executive board) and external auditors (e.g. healthcare inspectorate, professional or patient organizations).
doi:10.1093/intqhc/mzu019
PMCID: PMC4001694  PMID: 24615594
quality improvement; quality management; external quality assessment; measurement of quality; surgery; professions; hospital care
12.  DUQuE quality management measures: associations between quality management at hospital and pathway levels 
Objective
The assessment of integral quality management (QM) in a hospital requires measurement and monitoring from different perspectives and at various levels of care delivery. Within the DUQuE project (Deepening our Understanding of Quality improvement in Europe), seven measures for QM were developed. This study investigates the relationships between the various quality measures.
Design
It is a multi-level, cross-sectional, mixed-method study.
Setting and Participants
As part of the DUQuE project, we invited a random sample of 74 hospitals in 7 countries. The quality managers of these hospitals were the main respondents. Furthermore, data of site visits of external surveyors assessing the participating hospitals were used.
Main Outcome Measures
Three measures of QM at hospitals level focusing on integral systems (QMSI), compliance with the Plan-Do-Study-Act quality improvement cycle (QMCI) and implementation of clinical quality (CQII). Four measures of QM activities at care pathway level focusing on Specialized expertise and responsibility (SER), Evidence-based organization of pathways (EBOP), Patient safety strategies (PSS) and Clinical review (CR).
Results
Positive significant associations were found between the three hospitals level QM measures. Results of the relationships between levels were mixed and showed most associations between QMCI and department-level QM measures for all four types of departments. QMSI was associated with PSS in all types of departments.
Conclusion
By using the seven measures of QM, it is possible to get a more comprehensive picture of the maturity of QM in hospitals, with regard to the different levels and across various types of hospital departments.
doi:10.1093/intqhc/mzu020
PMCID: PMC4001696  PMID: 24615597
quality management; quality improvement; external quality assessment; measurement of quality; organization science, healthcare system; patient safety; hospital care
13.  The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals 
Objective
To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals.
Design
A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways.
Setting and Participants
Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.
Main Outcome Measure
Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways.
Results
Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke).
Conclusions
Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.
doi:10.1093/intqhc/mzu023
PMCID: PMC4001697  PMID: 24257160
accreditation; certification; health care quality assessment; quality management; patient safety
14.  Predischarge Postpartum Methicillin Resistant Staphylococcus aureus Infection and Group B Streptococcus Carriage at the Individual and Hospital Levels 
Background. We sought to characterize the relationship between individual group B streptococcus (GBS) colonization and pre-discharge postpartum methicillin resistant Staphylococcus aureus (MRSA) infection in United States women delivering at term. We also sought to examine the association between hospital GBS colonization prevalence and MRSA infection. Materials and Methods. Data was from the Nationwide Inpatient Sample, a representative sample of United States community hospitals. Hierarchical regression models were used to estimate odds ratios adjusted for patient age, race, expected payer, and prepregnancy diabetes and hospital teaching status, urbanicity, ownership, size, and geographic region. We used multiple imputation for missing covariate data. Results. There were 3,136,595 deliveries and 462 cases of MRSA infection included in this study. The odds ratio for individual GBS colonization was 1.2 (95% confidence interval: 0.9 to 1.5). For a five-percent increase in the hospital prevalence of GBS colonization, the odds ratio was 0.9 (95% CI: 0.1 to 5.6). Conclusions. The odds ratio estimate for the association of hospital GBS prevalence with MRSA infection is too imprecise to make conclusions about its magnitude and direction. Barring major bias in our estimates, individual GBS carriage does not appear to be strongly associated with predischarge postpartum MRSA infection.
doi:10.1155/2014/515646
PMCID: PMC3963373  PMID: 24729672
15.  Evidence-based organization and patient safety strategies in European hospitals 
Objective
To explore how European hospitals have implemented patient safety strategies (PSS) and evidence-based organization of care pathway (EBOP) recommendations and examine the extent to which implementation varies between countries and hospitals.
Design
Mixed-method multilevel cross-sectional design in seven countries as part of the European Union-funded project ‘Deepening our Understanding of Quality improvement in Europe’ (DUQuE).
Setting and participants
Seventy-four acute care hospitals with 292 departments managing acute myocardial infarction (AMI), hip fracture, stroke, and obstetric deliveries.
Main outcome measure
Five multi-item composite measures—one generic measure for PSS and four pathway-specific measures for EBOP.
Results
Potassium chloride had only been removed from general medication stocks in 9.4–30.5% of different pathways wards and patients were adequately identified with wristband in 43.0–59.7%. Although 86.3% of areas treating AMI patients had immediate access to a specialist physician, only 56.0% had arrangements for patients to receive thrombolysis within 30 min of arrival at the hospital. A substantial amount of the total variance observed was due to between-hospital differences in the same country for PSS (65.9%). In EBOP, between-country differences play also an important role (10.1% in AMI to 57.1% in hip fracture).
Conclusions
There were substantial gaps between evidence and practice of PSS and EBOP in a sample of European hospitals and variations due to country differences are more important in EBOP than in PSS, but less important than within-country variations. Agencies supporting the implementation of PSS and EBOP should closely re-examine the effectiveness of their current strategies.
doi:10.1093/intqhc/mzu016
PMCID: PMC4001691  PMID: 24578501
patient safety; quality improvement; quality management; practice variations; appropriate healthcare; hospital care; effectiveness
16.  Effect of the Learning Climate of Residency Programs on Faculty’s Teaching Performance as Evaluated by Residents 
PLoS ONE  2014;9(1):e86512.
Background
To understand teaching performance of individual faculty, the climate in which residents’ learning takes place, the learning climate, may be important. There is emerging evidence that specific climates do predict specific outcomes. Until now, the effect of learning climate on the performance of the individual faculty who actually do the teaching was unknown.
Objectives
This study: (i) tested the hypothesis that a positive learning climate was associated with better teaching performance of individual faculty as evaluated by residents, and (ii) explored which dimensions of learning climate were associated with faculty’s teaching performance.
Methods and Materials
We conducted two cross-sectional questionnaire surveys amongst residents from 45 residency training programs and multiple specialties in 17 hospitals in the Netherlands. Residents evaluated the teaching performance of individual faculty using the robust System for Evaluating Teaching Qualities (SETQ) and evaluated the learning climate of residency programs using the Dutch Residency Educational Climate Test (D-RECT). The validated D-RECT questionnaire consisted of 11 subscales of learning climate. Main outcome measure was faculty’s overall teaching (SETQ) score. We used multivariable adjusted linear mixed models to estimate the separate associations of overall learning climate and each of its subscales with faculty’s teaching performance.
Results
In total 451 residents completed 3569 SETQ evaluations of 502 faculty. Residents also evaluated the learning climate of 45 residency programs in 17 hospitals in the Netherlands. Overall learning climate was positively associated with faculty’s teaching performance (regression coefficient 0.54, 95% confidence interval: 0.37 to 0.71; P<0.001). Three out of 11 learning climate subscales were substantially associated with better teaching performance: ‘coaching and assessment’, ‘work is adapted to residents’ competence’, and ‘formal education’.
Conclusions
Individual faculty’s teaching performance evaluations are positively affected by better learning climate of residency programs.
doi:10.1371/journal.pone.0086512
PMCID: PMC3904911  PMID: 24489734
17.  The Relationship between Social Capital and Quality Management Systems in European Hospitals: A Quantitative Study 
PLoS ONE  2013;8(12):e85662.
Background
Strategic leadership is an important organizational capability and is essential for quality improvement in hospital settings. Furthermore, the quality of leadership depends crucially on a common set of shared values and mutual trust between hospital management board members. According to the concept of social capital, these are essential requirements for successful cooperation and coordination within groups.
Objectives
We assume that social capital within hospital management boards is an important factor in the development of effective organizational systems for overseeing health care quality. We hypothesized that the degree of social capital within the hospital management board is associated with the effectiveness and maturity of the quality management system in European hospitals.
Methods
We used a mixed-method approach to data collection and measurement in 188 hospitals in 7 European countries. For this analysis, we used responses from hospital managers. To test our hypothesis, we conducted a multilevel linear regression analysis of the association between social capital and the quality management system score at the hospital level, controlling for hospital ownership, teaching status, number of beds, number of board members, organizational culture, and country clustering.
Results
The average social capital score within a hospital management board was 3.3 (standard deviation: 0.5; range: 1-4) and the average hospital score for the quality management index was 19.2 (standard deviation: 4.5; range: 0-27). Higher social capital was associated with higher quality management system scores (regression coefficient: 1.41; standard error: 0.64, p=0.029).
Conclusion
The results suggest that a higher degree of social capital exists in hospitals that exhibit higher maturity in their quality management systems. Although uncontrolled confounding and reverse causation cannot be completely ruled out, our new findings, along with the results of previous research, could have important implications for the work of hospital managers and the design and evaluation of hospital quality management systems.
doi:10.1371/journal.pone.0085662
PMCID: PMC3877377  PMID: 24392027
18.  Congenital Cerebral Palsy, Child Sex and Parent Cardiovascular Risk 
PLoS ONE  2013;8(11):e79071.
Objective
Genes associated with cardiovascular disease may also be risk factors for congenital cerebral palsy (CP) and these associations may be modified by sex, since there is an increased risk of CP in male children. We investigated the association between CP of the child with cardiovascular disease in parents, taking sex of the child into consideration.
Methods
All parents of non-adopted singletons born in Denmark between 1973 and 2003 were included. Parents of a child with CP, confirmed by the Danish National CP registry, were considered exposed. Cox proportional hazards regressions were used to model risk of cardiovascular outcomes for exposed parents compared to all other parents beginning at the child’s 10th birthday.
Results
We identified 733,730 mothers and 666,652 fathers among whom 1,592 and 1,484, respectively, had a child with CP. The mean age for mothers at end of follow up was 50±8 years. After adjustment for maternal age, parental education, child’s sex, child’s residence, child being small for gestational age and maternal hypertensive disorder during pregnancy, mothers of CP male children had an excess risk of cardiovascular disease (HR: 1.52, 95% CI: 1.16-2.00), attributable mostly to an increased incidence of hypertension and cerebrovascular disease. After additional adjustment for preterm birth, the association was markedly attenuated for cardiovascular disease (1.34, 95%CI: 1.02 - 1.76), became nonsignificant for hypertension, but remained significant for cerebrovascular disease (HR: 2.73, 95% CI: 1.45- 5.12). There was no increased risk of cardiovascular events in mothers of female CP children, or fathers of CP children of any sex.
Conclusions
Women that have a male child with CP are at increased risk for premature cardiovascular disease. Part of this association may be related to risk factors for preterm births.
doi:10.1371/journal.pone.0079071
PMCID: PMC3815096  PMID: 24223882
19.  The Teacher, the Physician and the Person: Exploring Causal Connections between Teaching Performance and Role Model Types Using Directed Acyclic Graphs 
PLoS ONE  2013;8(7):e69449.
Background
In fledgling areas of research, evidence supporting causal assumptions is often scarce due to the small number of empirical studies conducted. In many studies it remains unclear what impact explicit and implicit causal assumptions have on the research findings; only the primary assumptions of the researchers are often presented. This is particularly true for research on the effect of faculty’s teaching performance on their role modeling. Therefore, there is a need for robust frameworks and methods for transparent formal presentation of the underlying causal assumptions used in assessing the causal effects of teaching performance on role modeling. This study explores the effects of different (plausible) causal assumptions on research outcomes.
Methods
This study revisits a previously published study about the influence of faculty’s teaching performance on their role modeling (as teacher-supervisor, physician and person). We drew eight directed acyclic graphs (DAGs) to visually represent different plausible causal relationships between the variables under study. These DAGs were subsequently translated into corresponding statistical models, and regression analyses were performed to estimate the associations between teaching performance and role modeling.
Results
The different causal models were compatible with major differences in the magnitude of the relationship between faculty’s teaching performance and their role modeling. Odds ratios for the associations between teaching performance and the three role model types ranged from 31.1 to 73.6 for the teacher-supervisor role, from 3.7 to 15.5 for the physician role, and from 2.8 to 13.8 for the person role.
Conclusions
Different sets of assumptions about causal relationships in role modeling research can be visually depicted using DAGs, which are then used to guide both statistical analysis and interpretation of results. Since study conclusions can be sensitive to different causal assumptions, results should be interpreted in the light of causal assumptions made in each study.
doi:10.1371/journal.pone.0069449
PMCID: PMC3720648  PMID: 23936020
20.  Prenatal and Postnatal Cell Phone Exposures and Headaches in Children 
Objective
Children today are exposed to cell phones early in life, and may be at the greatest risk if exposure is harmful to health. We investigated associations between cell phone exposures and headaches in children.
Study Design
The Danish National Birth Cohort enrolled pregnant women between 1996 and 2002. When their children reached age seven years, mothers completed a questionnaire regarding the child’s health, behaviors, and exposures. We used multivariable adjusted models to relate prenatal only, postnatal only, or both prenatal and postnatal cell phone exposure to whether the child had migraines and headache-related symptoms.
Results
Our analyses included data from 52,680 children. Children with cell phone exposure had higher odds of migraines and headache-related symptoms than children with no exposure. The odds ratio for migraines was 1.30 (95% confidence interval: 1.01–1.68) and for headache-related symptoms was 1.32 (95% confidence interval: 1.23–1.40) for children with both prenatal and postnatal exposure.
Conclusions
In this study, cell phone exposures were associated with headaches in children, but the associations may not be causal given the potential for uncontrolled confounding and misclassification in observational studies such as this. However, given the widespread use of cell phones, if a causal effect exists it would have great public health impact.
doi:10.2174/1874309901206010046
PMCID: PMC3674098  PMID: 23750182
Cellular phone; child; electromagnetic frequency; environmental exposure; migraine; mobile phone; pain; radiofrequency
21.  Racial and Ethnic Differences in the Association of Body Mass Index and Survival in Maintenance Hemodialysis Patients 
Background
In maintenance hemodialysis (HD) patients, overweight and obesity are associated with survival advantages. Given greater survival of minority maintenance HD patients, we hypothesized that elevated body mass index (BMI) is more strongly associated with lower mortality among Blacks and Hispanics relative to non-Hispanic whites.
Study design
Retrospective, cohort study.
Setting and participants
We examined a 6 year (2001–2007) cohort of 109,605 maintenance HD patients including 39,090 Blacks, 17,417 Hispanics and 53,098 non-Hispanic white maintenance HD outpatients from DaVita dialysis clinics. Cox proportional hazards models examined the association between BMI and survival.
Predictor
Race and BMI.
Outcomes
All cause mortality.
Results
Patients were (mean±SD) 62±15 years old and included 45% women and 45% diabetics. Across 10 a priori selected BMI categories (<18 to ≥40 kg/m2) higher BMI was associated with greater survival in all 3 racial/ethnic groups. Hispanic and Black patients, however, experienced consistently higher survival gains compared to non-Hispanic Whites across almost all BMI categories. Hispanics in the ≥40 kg/m2 category had the lowest death hazard ratio (HR, 0.57; 95% confidence interval [CI], 0.49–0.68) compared to non-Hispanic Whites in the 21.5-<23 kg/m2 group (reference category). While the inverse association was observed for all subgroups, Black maintenance HD patients exhibited the largest decline in death HR with increasing BMI.
Limitations
Race and ethnicity categories were based on self-identified data.
Conclusions
Whereas survival advantage of high BMI is consistent across all racial/ethnic groups, Black maintenance HD patients had the strongest association of high BMI with improved survival.
doi:10.1053/j.ajkd.2011.03.023
PMCID: PMC3183288  PMID: 21658829
obesity; survival; hemodialysis; race; non-Hispanic white; Black; Hispanic
22.  Factors predicting doctors’ reporting of performance change in response to multisource feedback 
BMC Medical Education  2012;12:52.
Background
Multi-source feedback (MSF) offers doctors feedback on their performance from peers (medical colleagues), coworkers and patients. Researchers increasingly point to the fact that only a small majority of doctors (60–70 percent) benefit from MSF. Building on medical education and social psychology literature, the authors identified several factors that may influence change in response to MSF. Subsequently, they quantitatively studied the factors that advance the use of MSF for practice change.
Methods
This observational study was set in 26 non-academic hospitals in the Netherlands. In total, 458 specialists participated in the MSF program. Besides the collation of questionnaires, the Dutch MSF program is composed of a reflective portfolio and a facilitative interview aimed at increasing the acceptance and use of MSF. All specialists who finished a MSF procedure between May 2008 and September 2010 were invited to complete an evaluation form. The dependent variable was self-reported change. Three categories of independent variables (personal characteristics, experiences with the assessments and mean MSF ratings) were included in the analysis. Multivariate regression analysis techniques were used to identify the relation between the independent variables and specialists’ reported change in actual practice.
Results
In total, 238 medical specialists (response rate 52 percent) returned an evaluation form and participated in the study. A small majority (55 percent) of specialists reported to have changed their professional performance in one or more aspects in response to MSF. Regression analyses revealed that two variables had the most effect on reported change. Perceived quality of mentoring positively influenced reported change (regression coefficient beta = 0.527, p < 0.05) as did negative scores offered by colleagues. (regression coefficient beta = −0.157, p < 0.05). The explained variance of these two variables combined was 34 percent.
Conclusions
Perceived quality of mentoring and MSF ratings from colleagues seem to be the main motivators for the self-reported change in response to MSF by specialists. These insights could leverage in increasing the use of MSF for practice change by investing in the quality of mentors.
doi:10.1186/1472-6920-12-52
PMCID: PMC3422186  PMID: 22781214
Performance assessment; Mentoring; Multisource feedback; Physicians; Continuous medical education
23.  A systematic review of the effects of residency training on patient outcomes 
BMC Medicine  2012;10:65.
Background
Residents are vital to the clinical workforce of today and tomorrow. Although in training to become specialists, they also provide much of the daily patient care. Residency training aims to prepare residents to provide a high quality of care. It is essential to assess the patient outcome aspects of residency training, to evaluate the effect or impact of global investments made in training programs. Therefore, we conducted a systematic review to evaluate the effects of relevant aspects of residency training on patient outcomes.
Methods
The literature was searched from December 2004 to February 2011 using MEDLINE, Cochrane, Embase and the Education Resources Information Center databases with terms related to residency training and (post) graduate medical education and patient outcomes, including mortality, morbidity, complications, length of stay and patient satisfaction. Included studies evaluated the impact of residency training on patient outcomes.
Results
Ninety-seven articles were included from 182 full-text articles of the initial 2,001 hits. All studies were of average or good quality and the majority had an observational study design. Ninety-six studies provided insight into the effect of 'the level of experience of residents' on patient outcomes during residency training. Within these studies, the start of the academic year was not without risk (five out of 19 studies), but individual progression of residents (seven studies) as well as progression through residency training (nine out of 10 studies) had a positive effect on patient outcomes. Compared with faculty, residents' care resulted mostly in similar patient outcomes when dedicated supervision and additional operation time were arranged for (34 out of 43 studies). After new, modified or improved training programs, patient outcomes remained unchanged or improved (16 out of 17 studies). Only one study focused on physicians' prior training site when assessing the quality of patient care. In this study, training programs were ranked by complication rates of their graduates, thus linking patient outcomes back to where physicians were trained.
Conclusions
The majority of studies included in this systematic review drew attention to the fact that patient care appears safe and of equal quality when delivered by residents. A minority of results pointed to some negative patient outcomes from the involvement of residents. Adequate supervision, room for extra operation time, and evaluation of and attention to the individual competence of residents throughout residency training could positively serve patient outcomes. Limited evidence is available on the effect of residency training on later practice. Both qualitative and quantitative research designs are needed to clarify which aspects of residency training best prepare doctors to deliver high quality care.
doi:10.1186/1741-7015-10-65
PMCID: PMC3391170  PMID: 22742521
24.  Evaluation of physicians' professional performance: An iterative development and validation study of multisource feedback instruments 
Background
There is a global need to assess physicians' professional performance in actual clinical practice. Valid and reliable instruments are necessary to support these efforts. This study focuses on the reliability and validity, the influences of some sociodemographic biasing factors, associations between self and other evaluations, and the number of evaluations needed for reliable assessment of a physician based on the three instruments used for the multisource assessment of physicians' professional performance in the Netherlands.
Methods
This observational validation study of three instruments underlying multisource feedback (MSF) was set in 26 non-academic hospitals in the Netherlands. In total, 146 hospital-based physicians took part in the study. Each physician's professional performance was assessed by peers (physician colleagues), co-workers (including nurses, secretary assistants and other healthcare professionals) and patients. Physicians also completed a self-evaluation. Ratings of 864 peers, 894 co-workers and 1960 patients on MSF were available. We used principal components analysis and methods of classical test theory to evaluate the factor structure, reliability and validity of instruments. We used Pearson's correlation coefficient and linear mixed models to address other objectives.
Results
The peer, co-worker and patient instruments respectively had six factors, three factors and one factor with high internal consistencies (Cronbach's alpha 0.95 - 0.96). It appeared that only 2 percent of variance in the mean ratings could be attributed to biasing factors. Self-ratings were not correlated with peer, co-worker or patient ratings. However, ratings of peers, co-workers and patients were correlated. Five peer evaluations, five co-worker evaluations and 11 patient evaluations are required to achieve reliable results (reliability coefficient ≥ 0.70).
Conclusions
The study demonstrated that the three MSF instruments produced reliable and valid data for evaluating physicians' professional performance in the Netherlands. Scores from peers, co-workers and patients were not correlated with self-evaluations. Future research should examine improvement of performance when using MSF.
doi:10.1186/1472-6963-12-80
PMCID: PMC3349515  PMID: 22448816
25.  Performance indicators for public mental healthcare: a systematic international inventory 
BMC Public Health  2012;12:214.
Background
The development and use of performance indicators (PI) in the field of public mental health care (PMHC) has increased rapidly in the last decade. To gain insight in the current state of PI for PMHC in nations and regions around the world, we conducted a structured review of publications in scientific peer-reviewed journals supplemented by a systematic inventory of PI published in policy documents by (non-) governmental organizations.
Methods
Publications on PI for PMHC were identified through database- and internet searches. Final selection was based on review of the full content of the publications. Publications were ordered by nation or region and chronologically. Individual PI were classified by development method, assessment level, care domain, performance dimension, diagnostic focus, and data source. Finally, the evidence on feasibility, data reliability, and content-, criterion-, and construct validity of the PI was evaluated.
Results
A total of 106 publications were included in the sample. The majority of the publications (n = 65) were peer-reviewed journal articles and 66 publications specifically dealt with performance of PMHC in the United States. The objectives of performance measurement vary widely from internal quality improvement to increasing transparency and accountability. The characteristics of 1480 unique PI were assessed. The majority of PI is based on stakeholder opinion, assesses care processes, is not specific to any diagnostic group, and utilizes administrative data sources. The targeted quality dimensions varied widely across and within nations depending on local professional or political definitions and interests. For all PI some evidence for the content validity and feasibility has been established. Data reliability, criterion- and construct validity have rarely been assessed. Only 18 publications on criterion validity were included. These show significant associations in the expected direction on the majority of PI, but mixed results on a noteworthy number of others.
Conclusions
PI have been developed for a broad range of care levels, domains, and quality dimensions of PMHC. To ensure their usefulness for the measurement of PMHC performance and advancement of transparency, accountability and quality improvement in PMHC, future research should focus on assessment of the psychometric properties of PI.
doi:10.1186/1471-2458-12-214
PMCID: PMC3353215  PMID: 22433251

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