[«KCE Trials¼ : innovation based on practice oriented clinical trials]. / «KCE Trials¼ : des essais cliniques plus proches de la pratique.

Many questions in healthcare can only be answered after the conduct of clinical trials. For medicinal products and medical devices the industry finances most studies to bring their products to market. However, there is a need for further research in certain areas e.g. children, older people and comparative research of different treatment options (comparative effectiveness). In addition, interventions that are less industry-driven such as surgery, radiotherapy, psychotherapy, diet, physical medicine, needappropriately funded large scale clinical trials. Such clinical trials can be a good investment for the government and the healthcare payer. At the end of 2015 the Belgian Healthcare Knowledge Centre (KCE) received the mission and budget to run a programme of practice-oriented comparative clinical trials. Two years later the recruitment of patients in the first trials is ongoing. In addition to its yearly national calls for trial proposals, early in 2018 KCE launched its first international common call for comparative clinical trials with its Dutch counterpart ZonMw (BeNeFIT).

Les études cliniques financées par l'industrie, essentiellement effectuées dans le but d'obtenir la mise sur le marché de médicaments et de dispositifs médicaux, laissent de nombreuses questions cliniques sans réponse satisfaisante. Ainsi, par exemple, les produits y sont généralement comparés à un placebo, alors que la question réellement pertinente pour le clinicien serait une comparaison avec d'autres options thérapeutiques. De même, les domaines qui présentent un intérêt moindre pour l'industrie sont rarement explorés par des études à large échelle; c'est le cas, notamment, de la chirurgie, de la radiothérapie, des psychothérapies, de l'alimentation et de la médecine physique. Un programme d'études cliniques non commerciales, financé par les pouvoirs publics, permet de remédier à ces problèmes tout en constituant un excellent investissement pour les autorités de santé et le contribuable. Fin 2015, le Centre fédéral d'Expertise des Soins de Santé (KCE) a été chargé de mettre sur pied un tel programme d'études cliniques comparatives et axées sur la pratique. Deux ans plus tard, le recrutement des premiers essais bat son plein. Un appel annuel à sujets d'études a été mis en place et, début 2018, un premier appel international conjoint du KCE et de son homologue néerlandais le ZonMw a également été lancé (BeNeFIT).

Patterns of care for non-small cell lung cancer patients in Belgium: A population-based study.

Guidelines recommend surgery for Stage I-II, chemoradiation for Stage III and systemic therapy for Stage IV non-small cell lung cancer (NSCLC). However, patient related factors and patient preferences influence treatment decisions. We investigated patterns of care for Belgian NSCLC patients in 2010-2011, based on population-based data from the Belgian Cancer Registry and administrative databases. The relationship between patient characteristics, institutional diagnostic volume, type of treatment and survival was investigated. Overall, 20.8% of patients received no oncological treatment. 59% and 22.1% of Stage I-II patients received primary surgery or (chemo)radiation respectively. 34% of Stage III patients received chemoradiation and 17% of Stage IIIA patients had surgery. 70% of Stage IV patients received chemotherapy or targeted therapy. Moderate variability between centres was observed. For Stage IV, systemic therapy was less frequently used in higher volume centres and 1-year survival was lower in centres that had ≥ 50 new patients yearly. Although not all NSCLC patients received treatment as ideally recommended by guidelines, these results do not necessarily represent poor quality of care as patient characteristics and preferences need to be taken into account. Treatment options targeted towards patients with co-morbidity or unfit patients is warranted to improve outcomes of all NSCLC patients.

The European Organization for Research and Treatment for Cancer (EORTC) strategy for quality assurance in surgical clinical research: Assessment of the past and moving towards the future.

AIMS: Quality assurance (QA) in a surgical trial must be planned and implemented from study development to completion. Elements of quality must be consistently described in a protocols, case report forms (CRFs) and reported in publications. The purpose of this review was to evaluate the most common surgical parameters and how consistently they were described in EORTC study documents where surgery was included. This was the preliminary step in mapping out the challenges of developing a surgical QA strategy in EORTC. METHODS: A systematic review of EORTC surgical protocols from 1980 to 2013 was performed. Two independent reviewers selected and reviewed the protocols. Data extraction was done using a questionnaire developed by EORTC QA committee. The results were compared across the time period. RESULTS: The most common quality parameters described in protocols were surgical technique, definition of resectability, surgical margins and methods of assessing adverse events using the Common Terminology Criteria for Adverse Event (CTCAE). However, these were not consistently reported in publications. A general improvement in the method of protocol development was observed since year 2000 after standardization measures by EORTC. A new surgical chapter template has been proposed. CONCLUSION: There is a need to consistently define and report surgical parameters from protocol development to publication as a first step to QA. A standard surgical chapter in the EORTC protocol template can help address this need. A framework to consistently implement QA for future surgical trials is needed and the rationale for this is described in this review.

Pooled analysis of the surgical treatment for colorectal cancer liver metastases.

Liver metastases in colorectal cancer patients decreases the expected 5 year survival rates by a factor close to nine. It is generally accepted that resection of liver metastases should be attempted whenever feasible. This manuscript addresses the optimal therapeutic plan regarding timing of resection of synchronous liver metastases and the use of chemotherapy in combination with resection of synchronous metachronous liver metastases. The aim is to pool all published results in order to attribute a level of evidence to outcomes and identify lacking evidence areas. A systematic search of guidelines, reviews, randomised controlled, observational studies and updating a meta-analysis was performed. Data were extracted and analysed. Data failed to demonstrate an effect of timing of surgery or use of chemotherapy on overall survival. Concomitant resection of liver metastases and the primary tumour may result in lower postoperative morbidity. Systemic peri-operative chemotherapy may improve progression free survival compared to surgery alone.

Patterns of care in surgery for ovarian cancer in Europe.

Quality of surgery is one of the most important determinants of the outcome in ovarian cancer patients. Surgery by a gynaecological oncologist in a specialised, high-volume environment and removal of all visible tumours are associated with a higher likelihood of favourable outcome for patients with advanced-stage ovarian cancer. Population-based studies in Europe however show that a substantial number of patients do not receive optimal surgical care. Less than half of the patients suffering from advanced-stage ovarian cancer are operated by a gynaecological oncologists. Also the proportion of patients operated in a high-volume or specialised hospital is lower than 50%. In a substantial number of patients, minimum standard procedures are not performed and optimal tumor debulking is not achieved. To improve the quality of care, efforts are needed to develop and implement robust evidence-based European guidelines, provide surgical training for gynaecological oncologists and establish comprehensive cancer networks with sufficient resources.

Surgical program building in advanced ovarian cancer: European perspective.

The majority of ovarian cancer patients are diagnosed with advanced-stage disease, for which standard treatment consists of cytoreductive surgery and platinum-based chemotherapy. As the maximum diameter of residual disease at the end of cytoreductive surgery is one of the most important prognostic factors, chances to achieve complete debulking of tumor should be optimized. Therefore, cytoreductive surgery is best performed in an expert center. To establish such an expert center, not only surgical skills and experience are needed. High quality surgical care is delivered by a multidisciplinary team of, among others, oncology nurses, anesthesiologists, pathologists, dieticians and physiotherapists. Furthermore, expert centers typically deliver comprehensive cancer care, including expertise in radiotherapy and chemotherapy, palliative care and patient support. Development and implementation of a surgical program aiming at establishing an expert center for cytoreductive surgery involves careful assessment of the pre-program pattern of care, training of care providers, establishment of a multidisciplinary team and referral pathway, availability of sufficient resources and infrastructure and a monitoring and quality assurance plan. The aim of this paper is to give guidance in programmatic development of an expert center for advanced ovarian cancer surgery from a European perspective.

Recurrent cervical cancer presenting as malignant pericarditis: case report and review of the literature.

Ante-mortem diagnosed metastatic pericardial effusion in cervical cancer patients is very rare. Symptomatic relief and treatment of the underlying disease offered by a multidisciplinary team, may prolong survival with a good quality of life to these often young patients.

Quality assurance for radical hysterectomy for cervical cancer: the view of the European Organization for Research and Treatment of Cancer--Gynecological Cancer Group (EORTC-GCG).

Radical hysterectomy combined with a pelvic lymphadenectomy or chemoradiation are traditionally the mainstays of treatment of International Federation of Gynecology and Obstetrics stages Ia2-IIa cervical cancer. The quality of radical surgery for cervical cancer influences local tumor control and survival. Hence, it is important to optimize and ensure the quality of surgical care for cervical cancer patients. In this paper, we discuss factors that are related to outcome after radical hysterectomy and propose a set of quality indicators that can be used to audit and improve the quality of surgical care for cervical cancer patients.

EORTC-GCG process quality indicators for ovarian cancer surgery.

INTRODUCTION: Surgery is the mainstay of staging and treatment of ovarian cancer. Optimal quality of ovarian cancer surgery implies complete staging and removal of all macroscopic tumour with minimal harm to the patient in order to ensure best patient outcome. However, variation in the quality of ovarian cancer surgery is apparent. In order to assess and improve the quality of care, quality indicators can be used. METHODS: To identify candidate quality indicators, a literature search was performed using relevant MESH terms. These were assessed for validity, feasibility and measurability. RESULTS: Five quality indicators for staging of presumed early-stage ovarian cancer and six for primary debulking surgery for advanced disease are proposed. CONCLUSION: The defined quality indicators can be used to monitor and improve the quality of surgery for ovarian cancer.

Professionals' and patients' views of routine follow-up: a questionnaire survey.

Traditionally, women who have been treated for a gynecological cancer have undergone long-term follow-up by hospital doctors. Recently, there has been interest in alternative models of follow-up, including nurse-based review. The project compares patients' and professionals' views of follow-up. A questionnaire was completed by 96 women attending routine follow-up clinics and by 32 professionals involved in delivering follow-up. A large majority of women (82/96, 92%) and professionals (25/34, 73%) thought that follow-up should be provided by a hospital doctor. However, professionals were more likely to think that specialist nurses and general practitioners should be involved in the provision of follow-up (P < 0.01). Professionals thought that the most important part of the follow-up visit was the consultation, whereas women thought it was the examination (P < 0.001). Women thought that detection of recurrence was the most important reason for continuing surveillance, whereas professionals regarded addressing patients' concerns as the primary reason for follow-up (P < 0.001). We conclude that the views of women undergoing follow-up after gynecological cancer differ significantly from the professionals providing follow-up care. These views must be considered when developing alternative follow-up strategies.