Sabine Stordeur

Leadership styles across hierarchical levels in nursing departments.

BACKGROUND Some researchers have reported on the cascading effect of transformational leadership across hierarchical levels. One study examined this effect in nursing, but it was limited to a single hospital. OBJECTIVES To examine the cascading effect of leadership styles across hierarchical levels in a sample of nursing departments and to investigate the effect of hierarchical level on the relationships between leadership styles and various work outcomes. METHODS Based on a sample of eight hospitals, the cascading effect was tested using correlation analysis. The main sources of variation among leadership scores were determined with analyses of variance (ANOVA), and the interaction effect of hierarchical level and leadership styles on criterion variables was tested with moderated regression analysis. RESULTS No support was found for a cascading effect of leadership across hierarchical levels. Rather, the variation of leadership scores was explained primarily by the organizational context. Transformational leadership had a stronger impact on criterion variables than transactional leadership. Interaction effects between leadership styles and hierarchical level were observed only for perceived unit effectiveness. CONCLUSIONS The hospitals structure and culture are major determinants of leadership styles.

Transactional and Transformational Leadership in Nursing: Structural Validity and Substantive Relationships

Confirmatory factor analysis in a large sample of nurses (N = 1059) working in Belgium was conducted to examine the dimensionality and nomological validity of Basss (1985) transactional and transformational leadership model. Three transactional factors (Passive and Active management-by-exception, and Contingent reward) and three transformational factors (Charisma, Intellectual stimulation, and Individualized consideration) from the Multifactor Leadership Questionnaire (Form 5X-rater) were examined. Results showed that the six-factor solution displayed the best absolute fit indices. However, because of high interscale correlations and lack of differential relationships with criterion variables, transformational facets and Contingent reward could reasonably be combined to form a single factor, Active leadership. Complementary analyses conducted to detect potential higher-order factors in the MLQ model revealed that Active leadership is best viewed as a second-order factor subsuming transformational and Contingent reward leadership.

Effect of hospital volume on processes of care and 5-year survival after breast cancer: A population-based study on 25 000 women

PURPOSE To compare processes of care and survival for breast cancer by hospital volume in Belgium, based on 11 validated process quality indicators. METHODS Three databases were linked at the patient level: the Cancer Registry, the population and the claims databases. All women with a diagnosis of invasive breast cancer between 2004 and 2006 were selected. Hospitals were classified according to their annual volume of treated patients: <50 (very low), 50-99 (low), 100-149 (medium) and ≥ 150 patients (high). Cox and logistic regression models were used to test differences in 5-year survival and in achievement of process indicators across volume categories, adjusting for age, tumor grade and stage. RESULTS A total of 25178 women with invasive breast cancer were treated in 111 hospitals. Half of the hospitals (N=57) treated <50 patients per year. Six of eleven process indicators showed higher rates in high-volume hospitals: multidisciplinary team meeting, cytological and/or histological assessment before surgery, use of neoadjuvant chemotherapy, breast-conserving surgery rate, adjuvant radiotherapy after breast-conserving surgery, and follow-up mammography. Higher volume was also associated with improved survival. The 5-year observed survival rates were 74.9%, 78.8%, 79.8% and 83.9% for patients treated in very-low-, low-, medium- and high-volume hospitals respectively. After case-mix adjustment, patients treated in very-low- or low-volume hospitals had a hazard ratio for death of 1.26 (95% CI 1.12, 1.42) and 1.15 (95% CI 1.01, 1.30) respectively compared with high-volume hospitals. CONCLUSION Survival benefits reported in high-volume hospitals suggest a better application of recommended processes of care, justifying the centralization of breast cancer care in such hospitals.

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

OBJECTIVES High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. METHODS The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. RESULTS In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. CONCLUSIONS For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Regional Variation in Thyroid Cancer Incidence in Belgium Is Associated With Variation in Thyroid Imaging and Thyroid Disease Management

CONTEXT Increased thyroid cancer incidence is at least partially attributed to increased detection and shows considerable regional variation. OBJECTIVE We investigated whether regional variation in cancer incidence was associated with variations in thyroid disease management. DESIGN We conducted a retrospective population-based cohort study that involved linking data from the Belgian Health Insurance database and the Belgian Cancer Registry to compare thyroid-related procedures between regions with high and low cancer incidence. MAIN OUTCOME MEASURES Primary outcome measures were rates of TSH testing, imaging, fine-needle aspiration cytology (FNAC), and thyroid surgery. Secondary study outcomes were proportions of subjects with thyrotoxicosis and nodular disease treated with surgery, of subjects treated with surgery preceded by FNAC or with synchronous lymph node dissection, and of thyroid cancer diagnosis after surgery. RESULTS The rate of TSH testing was similar, but the rate of imaging was lower in the low incidence region. The rate of FNAC was similar, whereas the rate of surgery was lower in the low incidence region (34 [95% CI 33; 35 ] vs 80 [95% CI 79; 81 ] per 100,000 person years in the high incidence region; P < .05). In the low incidence region compared to the high incidence region, surgery represented a less chosen therapy for euthyroid nodular disease patients (47% [95% CI 46; 48] vs 69% [95% CI 68; 70]; P < .05), proportionally more surgery was preceded by FNAC, more cancer was diagnosed after total thyroidectomy, and thyroid cancer patients had more preoperative FNAC and synchronous lymph node dissection. CONCLUSION Regional variation in thyroid cancer incidence, most marked for low-risk disease, is associated with different usage of thyroid imaging and surgery, supporting variable detection as a key determinant in geographic variation.

Developing and measuring a set of process and outcome indicators for breast cancer

PURPOSE This study aimed at developing and measuring a set of indicators to monitor the quality of breast cancer care, to make comparisons over time and to support quality improvement for all practitioners and centres involved in the care of breast cancer women. METHODS Quality indicators were identified from a systematic literature search and the 2010 Belgian evidence-based clinical practice guideline. The selection process involved an expert panel evaluating reliability, relevance, interpretability and actionability of each indicator. The quality indicators were tested using the Belgian Cancer Registry data linked with claims data for all women registered with breast cancer in Belgium between 2001 and 2006 (n=50,039). RESULTS The selection process led to a final set of 32 indicators. Of these, 12 were measurable using the available data, while 1 indicator was measurable using proxy information. Five-year relative survival was 98%, 87%, 68% and 29% for pStage I, II, III and cStage IV respectively. Overall 5-year survival slightly improved for pStage II, III and cStage IV between 2001 and 2004. Of the surgically treated women, 60% underwent breast conserving surgery, 85% received adjuvant systemic treatment and 86% were irradiated postoperatively. In 80% of women treated for breast cancer, at least one mammography was performed within one year after the last treatment. CONCLUSION The present study demonstrates the feasibility to develop a multidisciplinary set of quality indicators for breast cancer. Using national cancer registry data linked to claims data, 13 indicators were measurable, showing results that largely correspond to other studies in the field.

Quality indicators for testicular cancer: A population-based study

PURPOSE This study aimed at developing and measuring an indicator set to monitor the quality of testicular cancer care, to make comparisons over time and to support quality improvement for all practitioners and centres involved in the care of testicular cancer patients. METHODS Quality indicators were identified from a systematic literature search and from the 2010 Belgian evidence-based clinical practice guidelines. The selection process involved an expert panel evaluating reliability, relevance, interpretability and actionability of each indicator. The quality indicators were pilot tested using the Belgian Cancer Registry (BCR) data linked with claims data for 1307 men with testicular cancer diagnosed between 2001 and 2006. The variability between centres was displayed using funnel plots. RESULTS Of the 12 finally selected indicators, 5 were fully and 1 was partly measurable, while 2 indicators were measurable using proxy information. Five-year relative survival was 97%, 95% and 76% for pStage I-III, respectively. Overall 5-year survival slightly improved from 91% in 2001 to 94% in 2004. Between 2004 and 2006, 14 of 97 centres performed ≥10 orchidectomies. Large variability was found between centres. The nine centres with a 5-year observed survival below the lower limit treated less than 20 patients between 2001 and 2006. CONCLUSIONS The present study demonstrates the feasibility to develop a multidisciplinary set of quality indicators for testicular cancer. Using national cancer registry data linked to claims data, eight indicators were measurable, showing a mixed picture of the quality of care for testicular cancer patients in Belgium.

Quality indicators for oesophageal and gastric cancer: a population-based study in Belgium, 2004–2008

This study aimed at developing and measuring quality indicators for oesophageal cancer (OC) and gastric cancer (GC) and to support quality improvement for practitioners. Quality indicators were identified from a systematic literature search including clinical guidelines. The selection process involved experts evaluating relevance, reliability, interpretability and actionability of each indicator. Three national databases were linked: the cancer registry, the population registry and the claims database. Completeness and validity of the data were validated before being measured for 10,660 patients diagnosed between 2004 and 2008. From a final set of 29 indicators, 18 were measurable using the available data. In 2008, less than 50% of patients were discussed at a multidisciplinary team meeting and less than 90% underwent a computed tomography scan 1 month after incidence date for cancer staging. Five-year relative survival was 22% for OC and 34.3% for GC. The post-operative mortality in OC patients was 4.8% (30 days) and 9.9% (90 days), whereas it reached 5.6 and 12.0% respectively in GC patients. This study demonstrates the feasibility to develop a set of quality indicators for gastro-oesophageal cancer. A mixed picture of the quality of care was illustrated for some relevant care processes. Nevertheless, 5-year survival is higher than reported in neighbouring countries.

Quality of care and variability in lung cancer management across Belgian hospitals: a population-based study using routinely available data

Objective To evaluate the quality of care for all patients diagnosed with lung cancer in Belgium based on a set of evidence-based quality indicators and to study the variability of care between hospitals. Design, Setting, Participants A retrospective study based on linked data from the cancer registry, insurance claims and vital status for all patients diagnosed with lung cancer between 2010 and 2011. Evidence-based quality indicators were identified from a systematic literature search. A specific algorithm to attribute patients to a centre was developed, and funnel plots were used to assess variability of care between centres. Intervention None. Main outcome measure The proportion of patients who received appropriate care as defined by the indicator. Secondary outcome included the variability of care between centres. Results Twenty indicators were measured for a total of 12 839 patients. Good results were achieved for 60-day post-surgical mortality (3.9%), histopathological confirmation of diagnosis (93%) and for the use of PET-CT before treatment with curative intent (94%). Areas to be improved include the reporting of staging information to the Belgian Cancer Registry (80%), the use of brain imaging for clinical stage III patients eligible for curative treatment (79%), and the time between diagnosis and start of first active treatment (median 20 days). High variability between centres was observed for several indicators. Twenty-three indicators were found relevant but could not be measured. Conclusion This study highlights the feasibility to develop a multidisciplinary set of quality indicators using population-based data. The main advantage of this approach is that not additional registration is required, but the non-measurability of many relevant indicators is a hamper. It allows however to easily point to areas of large variability in care.

Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central

ABSTRACT Introduction: High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices. Areas covered: HTA and legal experts worked in close collaboration with medical specialists and government representatives making a legal analysis of what is possible under the (revised) European and national legislation. Expert commentary: At national level, measures for a better evidence-based introduction can be taken that are not in contradiction with the European regulation. From a legal point of view, all restrictive measures must be justified, necessary and proportional. Several measures are possible, a.o. making use of reference centres, applying the IDEAL framework or the 6-step plan set up by the Dutch Order of Medical Specialists. In conclusion, within the framework of the (revised) European legislation, measures at national level can be taken to temporarily restrict and follow up the use of high-risk medical devices with a greater focus on the therapeutic added value for the patients.