Quality of surgery and treatment and its association with hospital volume: A population-based study in more than 5000 Belgian ovarian cancer patients.

BACKGROUND: Different sets of quality indicators are used to identify areas for improvement in ovarian cancer care. This study reports transparently on how (surgical) indicators were measured and on the association between hospital volume and indicator results in Belgium, a country setting without any centralisation of ovarian cancer care. METHODS: From the population-based Belgian Cancer Registry, patients with a borderline malignant or invasive epithelial ovarian tumour diagnosed between 2014 and 2018 were selected and linked to health insurance and vital status data (n = 5119). Thirteen quality indicators on diagnosis and treatment were assessed and the association with hospital volume was analysed using logistic regression adjusted for case-mix. RESULTS: The national results for most quality indicators on diagnosis and systemic therapy were around the predefined target value. Other indicators showed results below the benchmark: genetic testing, completeness of staging surgery, lymphadenectomy with at least 20 pelvic/para-aortic lymph nodes removed, and timely start of chemotherapy after surgery (within 42 days). Ovarian cancer care in Belgium is dispersed over 100 hospitals. Lower volume hospitals showed poorer indicator results compared to higher volume hospitals for lymphadenectomy, staging, timely start of chemotherapy and genetic testing. In addition, surgery for advanced stage tumours was performed less often in lower volume hospitals. CONCLUSIONS: The indicators that showed poorer results on a national level were also those with poorer results in lower-volume hospitals compared to higher-volume hospitals, consequently supporting centralisation. International benchmarking is hampered by different (surgical) definitions between countries and studies.

Effectiveness of nirmatrelvir-ritonavir on severe outcomes of COVID-19 in the era of vaccination and Omicron: An updated meta-analysis.

Nirmatrelvir-ritonavir (NR) was approved to treat SARS-CoV-2 positive outpatients at high risk of progression to severe disease, based on a randomized trial in unvaccinated patients. Effectiveness in vaccinated patients and against Omicron has not yet been confirmed by clinical trial data, but a recent meta-analysis suggested good real-world effectiveness based on 12 studies. We updated this meta-analysis by searching Medline and Embase databases for studies assessing effectiveness of NR on mortality, hospitalization, composite outcome of hospitalization and/or death, and progression to severe disease, published between October 1, 2022 and May 22, 2023. Random effects meta-analysis and subgroup analysis for vaccinated patients was performed. A total of 32 studies were included in the meta-analysis. Pooled RR for the effect of NR on mortality, hospitalization, hospitalization and/or mortality, and progression to severe disease were 0.36 (95% confidence interval [CI]: 0.25-0.52), 0.43 (CI: 0.37-0.51), 0.52 (CI: 0.45-0.61) and 0.54 (CI: 0.41-0.73), respectively. A subgroup analysis on vaccinated patients indicated lower effectiveness of NR on mortality (RR: 0.55, CI: 0.45-0.68), but similar effectiveness for hospitalization, hospitalization and/or mortality, or progression to severe disease (RR: 0.52, 0.58, and 0.66, respectively). This updated meta-analysis robustly confirms the protective effects of NR on severe COVID-19 outcomes.

Association between hospital volume and outcomes in invasive ovarian cancer in Belgium: A population-based study.

OBJECTIVES: To study the association between hospital volume and outcomes in patients with invasive epithelial ovarian cancer (EOC). METHODS: This study included 3988 patients diagnosed with invasive EOC between 2014 and 2018, selected from the population-based database of the Belgian Cancer Registry (BCR), and coupled with health insurance and vital status data. The associations between hospital volume and observed survival since diagnosis were assessed with Cox proportional hazard models, while volume associations with 30-day post-operative mortality and complicated recovery were evaluated using logistic regression models. RESULTS: Treatment for EOC was very dispersed with half of the 100 centres treating fewer than six patients per year. The median survival of patients treated in centres with the highest-volume quartile was 2.5 years longer than in those with the lowest-volume quartile (4.2 years versus 1.7 years). When taking the case-mix of hospitals into account, patients treated in the lowest volume centres had a 47% higher hazard to die than patients treated in the highest volume centres (HR: 1.47, 95% CI: 1.11-1.93, p = 0.006) over the first five years after incidence. A similar association was found when focussing on the surgical volume of the hospitals and considering only operated patients with invasive EOC. Lastly, the 30-day post-operative mortality decreased significantly with increasing surgical volume. CONCLUSIONS: The large dispersion of care and expertise within Belgium and the volume-outcome associations observed in this study support the implementation of the concentration of care for patients with invasive EOC in reference centres.

Managing uncertainty in forecasting health workforce demand using the Robust Workforce Planning Framework: the example of midwives in Belgium.

BACKGROUND: In Belgium, the Planning Commission for Medical Supply is responsible for monitoring human resources for health (HRH) and ultimately proposing workforce quotas. It is supported by the Planning Unit for the Supply of the Health Professions. This Unit quantifies and forecasts the workforce in the healthcare professions on the basis of a stock and flow model, based on trends observed in the past. In 2019, the Planning Unit asked the KCE (Belgian Health Care Knowledge Centre) to develop additional forecasting scenarios for the midwifery workforce, to complement the standard historical trend approach. The aim of this paper is to present the development of such forecasting scenarios. METHODS: The Robust Workforce Planning Framework, developed by the Centre for Workforce Intelligence in the UK was used to develop alternative midwifery workforce scenarios. The framework consists of four steps (Horizon scanning, Scenario generation, Workforce modelling, and Policy analysis), the first two of which were undertaken by KCE, using two online surveys and five workshops with stakeholders. RESULTS: Three alternative scenarios are proposed. The first scenario (close to the current situation) envisages pregnancy and maternity care centred on gynaecologists working either in a hospital or in private practice. The second scenario describes an organisation of midwife-led care in hospitals. In the third scenario, care is primarily organised by primary care practitioners (midwives and general practitioners) in outpatient settings. CONCLUSIONS: The Robust Workforce Planning Framework provides an opportunity to adjust the modelling of the health workforce and inform decision-makers about the impact of their future decisions on the health workforce.

Diagnosis and treatment of gonorrhoea: 2019 Belgian National guideline for primary care.

OBJECTIVES: Gonorrhoea continues to be a public health concern in Belgium with pharyngeal and rectal infections increasing in persons with high-risk sexual behaviour. Belgian health care practitioners rely on international guidance when managing gonorrhoea resulting in non-adapted suboptimal care for the Belgian patient. This guideline will rectify this situation. METHODS: This guideline was developed following an evidence-based approach and involving a guideline development group (GDG). Research questions were prioritised by the GDG and researchers conducted a systematic review of the evidence that was assessed using GRADE approach. RESULTS: The guideline offers recommendations for gonorrhoea diagnosis, treatment and management for primary care professionals in Belgium and applies a risk group approach. This approach aims for improved identification of at-risk persons and targeted testing of at-risk groups; it includes behavioural questioning when deciding on diagnostic sampling and provides clear advice on treatment. The guideline defines when to add surveillance testing for antibiotic resistance, and what consists of good follow-up. RESULTS: A concerted application of this guideline by all stakeholders in Belgium may result in improving the diagnosis of infections and eventually addressing the emerging multi-drug resistance.

Diagnosis and treatment of syphilis: 2019 Belgian National guideline for primary care.

OBJECTIVES: In the last 10 years, Belgium and countries of the European Economic Area and other high-income countries observed an increasing trend in syphilis diagnoses. Men who have sex with men (MSM) are the most affected population explained by high rates of unprotected sex, a greater number of sexual partners, and risk compensation as a result of pre-exposure prophylaxis use. The 2019 European Centre for Disease Prevention and Control (ECDC) technical report on syphilis proposed interventions such as enhanced screening of specific populations at risk. This guideline will address these issues. METHODS: We performed a systematic review of the evidence for diagnosing and treating syphilis. RESULTS: Based on the results, recommendations were formulated for primary health care professionals in Belgium. This syphilis guideline addresses prioritised testing, the sample and test for the diagnosis, the treatment of a person with syphilis including syphilis serology follow-up, and partner management. CONCLUSION: The identification and management of patients with syphilis will benefit from the application of this guideline.

Patterns and quality of care for head and neck cancer in Belgium: A population-based study.

OBJECTIVES: We evaluated the quality of care for patients with squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx in Belgium. METHODS: Data of the Belgian Cancer Registry were coupled with health insurance data and hospital discharge data. Quality of care and the association with hospital volume were evaluated based on six quality indicators. RESULTS: Half of the patients were treated with primary radiotherapy, with or without systemic therapy (49.7%) and 38.1% with surgery, with or without (neo)adjuvant therapy. Single-modality treatment was provided to 78.1% of early-disease patients. Of the patients with cN0 disease, 56.4% underwent neck dissection. Postoperative radiotherapy was completed timely in 48.5% of patients. Concomitant chemotherapy was administered to 58.2% of patients <70 years with locally advanced disease. Imaging of the neck after radiotherapy was performed appropriately in 32.7% of patients. Variability between centres was considerable. No clear relationship between hospital volume and results of the individual QIs was observed. CONCLUSIONS: Results show that for the measured QIs, targets are not met and variability between centres is considerable. Through individual feedback, centres are motivated to improve the quality of care for head and neck cancer patients in Belgium.

Improved survival in patients with head and neck cancer treated in higher volume centres: A population-based study in Belgium.

OBJECTIVES: The study investigated the association between hospital volume and observed survival of patients with a head and neck squamous cell carcinoma (HNSCC). METHODS: Overall, 9245 patients diagnosed with HNSCC between 2009 and 2014, were identified in the population-based Belgian Cancer Registry. This database was coupled with other databases providing information on diagnostic and therapeutic procedures, vital status, and comorbidities. The overall and relative survival probabilities were estimated using the Kaplan-Meier and the Ederer II methods, respectively. The relation between hospital volume and observed survival since diagnosis was then assessed using Cox proportional hazard models adjusted for potential confounders. RESULTS: The care for patients with HNSCC in Belgium was dispersed over more than 99 centres with half of the centres treating four or less patients with HNSCC per year. Survival probabilities were significantly better for patients treated in higher volume centres (>20 patients/year): the median survival of patients treated in these centres was 1.1 year longer (5.1 versus 4.0 years) than in lower volume centres. This association was confirmed in analyses taking the case-mix between hospitals into account: the hazard to die of any cause decreased on average with 0.4% per increase of one additionally treated patient. Beyond 20 assigned patients per year, there was no further decrease in the hazard to die. CONCLUSIONS: Statistically significant and clinically relevant improved survival probabilities were obtained in patients treated in higher volume centres (>20 patients/year) compared with their peers treated in lower volume centres. This supports the recommendation to concentrate the care for patients with HNSCC in reference centres.

Comorbidity in head and neck cancer: Is it associated with therapeutic delay, post-treatment mortality and survival in a population-based study?

OBJECTIVES: This study aims to investigate the relationship between comorbidities and therapeutic delay, post-treatment mortality, overall and relative survival in patients diagnosed with squamous cell carcinoma of the head and neck (HNSCC). PATIENTS AND METHODS: 9245 patients with a single HNSCC diagnosed between 2009 and 2014 were identified in the Belgian Cancer Registry. The Charlson Comorbidity Index (CCI) was calculated for 8812 patients (95.3%), distinguishing patients having none (0), mild (1-2), moderate (3-4) or severe comorbidity (>4). The relationship between CCI and therapeutic delay was evaluated using the Spearman correlation. Post-treatment mortality was modelled with logistic regression, using death within 30 days as the event. The association between comorbidity and survival was assessed using Cox proportional hazard models. RESULTS: Among 8812 patients with a known CCI, 39.2% had at least one comorbidity. Therapeutic delay increased from 31 to 36 days when the CCI worsened from 0 to 4 (rho = 0.087). After case-mix adjustment, higher baseline comorbidity was associated with increased post-surgery mortality (mild, OR 3.52 [95% CI 1.91-6.49]; severe, OR 18.71 [95% CI 6.85-51.12]) and post-radiotherapy mortality (mild, OR 2.23 [95% CI 1.56-3.19]; severe, OR 9.33 [95% CI 4.83-18.01]) and with reduced overall survival (mild, HR 1.39, [95% CI 1.31-1.48]; severe, HR 2.41 [95% CI 2.00-2.90]). That was also the case for relative survival in unadjusted analyses (mild, EHR 1.77 [95% CI 1.64-1.92]; severe, EHR = 4.15 [95% CI 3.43-5.02]). CONCLUSION: Comorbidity is significantly related to therapeutic delay, post-treatment mortality, 5-year overall and relative survival in HNSCC patients. Therapeutic decision support tools should optimally integrate comorbidity.

Head and Neck Cancer in Belgium: Quality of Diagnostic Management and Variability Across Belgian Hospitals Between 2009 and 2014.

Aims: The study assessed the quality of diagnosis and staging offered to patients with a head and neck squamous cell carcinoma (HNSCC) and the variability across Belgian hospitals. Methods: In total, 9,245 patients diagnosed with HNSCC between 2009 and 2014, were identified in the population-based Belgian Cancer Registry (BCR). The BCR data were coupled with other databases providing information on diagnostic and therapeutic procedures reimbursed by the compulsory health insurance, vital status data, and comorbidities. The use of diagnosis and staging procedures was assessed by four quality indicators (QI) (i.e., use of dedicated head and neck imaging studies, use of PET-CT, TNM reporting and interval between diagnosis and start of treatment), for which a target was defined before the analysis. The association between the binary QIs and observed survival was assessed using Cox proportional hazard models adjusted for potential confounders. Results: Overall, 82.5% of patients received staging by MRI and/or CT of the head and neck region before the start of treatment. In 47.6% of stage III-IV patients eligible for treatment with curative intent, a whole-body FDG-PET(/CT) was performed. The proportion of patients whose cTNM and pTNM stage was reported to the BCR was 80.5 and 78.4%, respectively. The median interval from diagnosis to first treatment with curative intent was 32 days (IQR: 19-46). For none of these QIs the pre-set targets were reached and a substantial variability between centers was observed for all quality indicators. No binary QI was significantly associated with observed survival. Conclusions: The four quality indicators related to diagnosis and staging in HNSCC all showed substantial room for improvement. For none of them the pre-set targets were met at the national level and the variability between centers was substantial. Each Belgian hospital received an individual feedback report in order to stimulate reflection and quality improvement processes.

Association between surgical volume and post-operative mortality and survival after surgical resection in lung cancer in Belgium: A population-based study.

OBJECTIVES: The existence of a relationship between hospital surgical volume and outcome after lung cancer surgery remains an ongoing debate. We aimed to evaluate the association between volume and 60-day mortality, 1- and 3-year observed survival (OS) in non-small cell lung cancer (NSCLC) patients in Belgium. METHODS: Patients diagnosed with NSCLC in 2010-2011 were identified in the database of the Belgian Cancer Registry, excluding patients with multiple tumours. Regression models were applied to assess the relationship between hospital surgical volume, 60-day mortality and 1- and 3-year OS, adjusting for different patient and tumour characteristics. Surgical volume was taken into account as a continuous variable in the models. RESULTS: In 2010-2011 a total of 9,817 patients with NSCLC were diagnosed in Belgium and 2,084 of them underwent surgery. After adjusting for patient and tumour characteristics, a relationship between hospital surgical volume and patients' outcome was found. Postoperative mortality and survival improved with increasing annual surgical volume up to 10 interventions. However, no further gain in outcome has been observed above 10. While the 60-day postoperative mortality is 3.5% for hospitals with an annual volume larger than 10, the predicted mortality rate for a hospital with an annual volume of only 5 interventions is 6.5%. Similar results were observed for 1- and 3-year OS. CONCLUSION: In Belgium, a higher hospital surgical volume is associated with improved outcome in NSCLC patients after surgical resection. Minimally 10 surgical interventions per year seem to be required to achieve an optimal performance.

Evaluating the need to reform the organisation of care for major trauma patients in Belgium: an analysis of administrative databases.

PURPOSE: In light of the international evolutions to establish inclusive trauma systems and to concentrate the care for the most severely injured in major trauma centres, we evaluated the degree of dispersion of trauma care in Belgium. METHODS: We used descriptive statistics to illustrate the dispersion of major trauma care in Belgium based on two independent administrative databases: the registry of Mobile Intensive Care Units (2009-2015) and the Belgian Hospital Discharge Dataset (2009-2014). RESULTS: Patients with a severe trauma (n = 3856 in 2015) were transported towards 145 different hospital sites (on a total of 198 hospital sites) resulting in a median of 17 cases per hospital site (min = 1; P25 = 4; P75 = 30; max = 165). A minority of major trauma patients is after admission transferred to another hospital (8%) with a median of 10 days after admission to the hospital (IQR 3.5-24). CONCLUSIONS: The dispersion of care for major trauma patients in Belgium is so high that a reorganisation of care for severe injured patients in major trauma centres concentrating professional expertise and specialised equipment is recommended to guarantee a high quality of care in a qualitative and sustainable way.

Use of health insurance data to identify and quantify the prevalence of main comorbidities in lung cancer patients.

BACKGROUND: Identifying comorbidities in lung cancer patients is a complex process in population-based studies and no gold standard exists. The current study aims to identify and measure the main comorbidities using administrative health insurance data, which were available on a population-based level. METHOD: A literature search was conducted to identify comorbidities in lung cancer patients and to select Anatomical Therapeutic Chemical codes to measure them. For each patient, the volume of delivered relevant drugs for each comorbidity in the year preceding the diagnosis of lung cancer was computed, based on the Defined Daily Doses reimbursed. Case definition rules were set by comparing the identification of comorbidities via health insurance data with the reporting of them in the medical files in a sample of hospitals. RESULTS: Four comorbidities were identified: chronic respiratory diseases, chronic cardiovascular diseases, diabetes mellitus and renal diseases. A very good to moderate agreement between the prevalence based on medical files versus health insurance data was obtained for diabetes mellitus (kappa = 0.83), chronic cardiovascular diseases (kappa = 0.64), chronic respiratory diseases (kappa = 0.48) but not for renal diseases (kappa = 0.22). Because only 27% of patients having renal diseases recorded in the medical files were identified using health insurance data, this comorbidity was not withheld. Among 12,839 lung cancer patients diagnosed in 2010-2011 in Belgium, 29.7% had chronic respiratory diseases, 57.5% had chronic cardiovascular diseases and 14.1% had diabetes mellitus. DISCUSSION: This study showed that it was possible to capture three major comorbidities in lung cancer patients using administrative health data, namely, diabetes mellitus, chronic cardiovascular diseases, and chronic respiratory diseases. However, the agreement was only moderate for the last one. A prerequisite for using this methodology is that administrative health data are available for all patients.

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.

Systematic review and meta-analysis of local resection or transanal endoscopic microsurgery versus radical resection in stage i rectal cancer: A real standard?

Current guidelines recommend radical resection for stage I rectal cancer. However, since screening programs are being installed, an increasing number of cancers are being detected in early stages. Endoscopic resection is often performed at the time of diagnosis. This systematic review was undertaken to review the evidence on endoscopic approach vs. radical resection for stage I rectal cancer. Recommendations were issued based on the GRADE methodology and risk stratification used in clinical practice. A systematic search (until March 2015) identified 2 meta-analyses and 1 additional randomized trial. For the primary outcomes (overall survival, disease-free survival, local recurrence-free survival and metastasis-free survival) no evidence could be found on the superiority of local or radical resection. Secondary outcomes (blood loss, hospital stay, operative time, number of permanent stomas and perioperative deaths) were in favour of local resection. The authors strongly recommend radical resection for T2 rectal cancer, but consider 'en bloc' local resection sufficient for pT1 sm1 rectal cancers when confirmed pathologically. Discussion by a multidisciplinary team and adequate surveillance remain mandatory.

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

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.

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.

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.

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.