Systematic literature review on the effectiveness and safety of paediatric hospital-at-home care as a substitute for hospital care.

The hospital landscape is shifting to new care models to meet current challenges in demand, technology, available budgets and staffing. These challenges also apply to the paediatric population, leading to a reduction in paediatric hospital beds and occupancy rates. Paediatric hospital-at-home (HAH) care is used to substitute hospital care in an attempt to bring hospital services closer to children's homes. In addition, these models attempt to avoid fragmentation of care between hospitals and the community. An important prerequisite for this paediatric HAH care is that it is safe and at least as effective as standard hospital care. The aim of this systematic review is to analyse the evidence on the impact of paediatric HAH care on hospital utilisation, patient outcomes and costs. Four bibliographic databases (Medline, Embase, Cinahl and Cochrane Library) were systematically searched for RCTs and pseudo-RCTs that studied the effectiveness and safety of short-term paediatric HAH care with a focus on models as an alternative to acute hospital admissions. Pseudo-RCTs are defined as observational studies that mimic the design of an RCT, but without randomisation. Outcomes of interest were the length of stay, acute (re)admissions, adverse health outcomes, therapy adherence, parental satisfaction or experience and costs. Only articles written in English, Dutch and French conducted in upper-middle and high-income countries and published between 2000 and 2021 were included. Quality assessment was carried out by two assessors using the Cochrane Collaboration's tool for assessing the risk of bias. Reporting is done in accordance with the PRISMA guidelines. We identified 18 (pseudo) RCTs and 25 publications of low to very low quality. Most of the included RCTs focused on the neonatal population: phototherapy for neonatal jaundice, early discharge after birth combined with outpatient neonatal care. Other RCTs focused on chemotherapy for acute lymphoblastic leukaemia, diabetes type 1 education, oxygen therapy for acute bronchiolitis, an outpatient service for children with infectious diseases and antibiotic treatment for low-risk febrile neutropenia, cellulitis and perforated appendicitis. The identified study results show that paediatric HAH care is not associated with more adverse events or hospital readmissions. The impact of paediatric HAH care on costs is less clear.  Conclusions: This review suggests that paediatric HAH care is not associated with more adverse events or hospital readmissions for various clinical indications compared to a standard hospital. Because of the low to very low level of evidence, it is worthwhile to further investigate safety, efficacy and cost effects under strict and well-controlled conditions. This systematic review provides guidance on the essential elements that should be included in HAH care programmes for each type of indication and/or intervention. What is Known: • The hospital landscape is shifting new models of care to meet current challenges in demand, technology, staffing and models of care. Paediatric HAH care is one of these models. Previous literature reviews are inconclusive whether this is a safe and effective way of providing care. What is New: • New evidence suggests that paediatric HAH care for various clinical indications is not associated with adverse events or hospital readmissions compared to a standard hospital. Current evidence is characterised by a low level of quality.  • The current review provides guidance on the essential elements that should be included in HAH care programmes for each type of indication and/or intervention.

Positron emission tomography (PET) and magnetic resonance imaging (MRI) for assessing tumour resectability in advanced epithelial ovarian/fallopian tube/primary peritoneal cancer.

BACKGROUND: Ovarian cancer is the leading cause of death from gynaecological cancer in developed countries. Surgery and chemotherapy are considered its mainstay of treatment and the completeness of surgery is a major prognostic factor for survival in these women. Currently, computed tomography (CT) is used to preoperatively assess tumour resectability. If considered feasible, women will be scheduled for primary debulking surgery (i.e. surgical efforts to remove the bulk of tumour with the aim of leaving no visible (macroscopic) tumour). If primary debulking is not considered feasible (i.e. the tumour load is too extensive), women will receive neoadjuvant chemotherapy to reduce tumour load and subsequently undergo (interval) surgery. However, CT is imperfect in assessing tumour resectability, so additional imaging modalities can be considered to optimise treatment selection. OBJECTIVES: To assess the diagnostic accuracy of fluorodeoxyglucose-18 (FDG) PET/CT, conventional and diffusion-weighted (DW) MRI as replacement or add-on to abdominal CT, for assessing tumour resectability at primary debulking surgery in women with stage III to IV epithelial ovarian/fallopian tube/primary peritoneal cancer. SEARCH METHODS: We searched MEDLINE and Embase (OVID) for potential eligible studies (1946 to 23 February 2017). Additionally, ClinicalTrials.gov, WHO-ICTRP and the reference list of all relevant studies were searched. SELECTION CRITERIA: Diagnostic accuracy studies addressing the accuracy of preoperative FDG-PET/CT, conventional or DW-MRI on assessing tumour resectability in women with advanced stage (III to IV) epithelial ovarian/fallopian tube/primary peritoneal cancer who are scheduled to undergo primary debulking surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts for relevance and inclusion, extracted data and performed methodological quality assessment using QUADAS-2. The limited number of studies did not permit meta-analyses. MAIN RESULTS: Five studies (544 participants) were included in the analysis. All studies performed the index test as replacement of abdominal CT. Two studies (366 participants) addressed the accuracy of FDG-PET/CT for assessing incomplete debulking with residual disease of any size (> 0 cm) with sensitivities of 1.0 (95% CI 0.54 to 1.0) and 0.66 (95% CI 0.60 to 0.73) and specificities of 1.0 (95% CI 0.80 to 1.0) and 0.88 (95% CI 0.80 to 0.93), respectively (low- and moderate-certainty evidence). Three studies (178 participants) investigated MRI for different target conditions, of which two investigated DW-MRI and one conventional MRI. The first study showed that DW-MRI determines incomplete debulking with residual disease of any size with a sensitivity of 0.94 (95% CI 0.83 to 0.99) and a specificity of 0.98 (95% CI 0.88 to 1.00) (low- and moderate-certainty evidence). For abdominal CT, the sensitivity for assessing incomplete debulking was 0.66 (95% CI 0.52 to 0.78) and the specificity 0.77 (95% CI 0.63 to 0.87) (low- and low-certainty evidence). The second study reported a sensitivity of DW-MRI of 0.75 (95% CI 0.35 to 0.97) and a specificity of 0.96 (95% CI 0.80 to 1.00) (very low-certainty evidence) for assessing incomplete debulking with residual disease > 1 cm. In the last study, the sensitivity for assessing incomplete debulking with residual disease of > 2 cm on conventional MRI was 0.91 (95% CI 0.59 to 1.00) and the specificity 0.97 (95% CI 0.87 to 1.00) (very low-certainty evidence). Overall, the certainty of evidence was very low to moderate (according to GRADE), mainly due to small sample sizes and imprecision. AUTHORS' CONCLUSIONS: Studies suggested a high specificity and moderate sensitivity for FDG-PET/CT and MRI to assess macroscopic incomplete debulking. However, the certainty of the evidence was insufficient to advise routine addition of FDG-PET/CT or MRI to clinical practice..In a research setting, adding an alternative imaging method could be considered for women identified as suitable for primary debulking by abdominal CT, in an attempt to filter out false-negatives (i.e. debulking, feasible based on abdominal CT, unfeasible at actual surgery).

α-Blockers for uncomplicated ureteric stones: a clinical practice guideline.

OBJECTIVE: To develop an evidence-based recommendation concerning the use of α-blockers for uncomplicated ureteric stones based on an up-to-date Cochrane review, as the role of medical expulsive therapy for uncomplicated ureteric stones remains controversial in the light of new contradictory trial evidence. METHODS: We applied the Rapid Recommendations approach to guideline development, which represents an innovative approach by an international collaborative network of clinicians, researchers, methodologists and patient representatives seeking to rapidly respond to new, potentially practice-changing evidence with recommendations developed according to standards for trustworthy guidelines. RESULTS: The panel suggests the use of α-blockers in addition to standard care over standard care alone in patients with uncomplicated ureteric stones (weak recommendation based on low-quality evidence). The panel judged that the net benefit of α-blockers was small and that there was considerable uncertainty about patients' values and preferences. This means that the panel expects that most patients would choose treatment with α-blockers but that a substantial proportion would not. This recommendation applies to both patients in whom the presence of ureteric stones is confirmed by imaging, as well as patients in whom the diagnosis is made based on clinical grounds only. CONCLUSION: The Rapid Recommendations panel suggests the use of α-blockers for patients with ureteric stones. Shared decision-making is emphasised in making the final choice between the treatment options.

Radiofrequency and Microwave Ablation Compared to Systemic Chemotherapy and to Partial Hepatectomy in the Treatment of Colorectal Liver Metastases: A Systematic Review and Meta-Analysis.

PURPOSE: To assess safety and outcome of radiofrequency ablation (RFA) and microwave ablation (MWA) as compared to systemic chemotherapy and partial hepatectomy (PH) in the treatment of colorectal liver metastases (CRLM). METHODS: MEDLINE, Embase and the Cochrane Library were searched. Randomized trials and comparative observational studies with multivariate analysis and/or matching were included. Guidelines from National Guideline Clearinghouse and Guidelines International Network were assessed using the AGREE II instrument. RESULTS: The search revealed 3530 records; 328 were selected for full-text review; 48 were included: 8 systematic reviews, 2 randomized studies, 26 comparative observational studies, 2 guideline-articles and 10 case series; in addition 13 guidelines were evaluated. Literature to assess the effectiveness of ablation was limited. RFA + systemic chemotherapy was superior to chemotherapy alone. PH was superior to RFA alone but not to RFA + PH or to MWA. Compared to PH, RFA showed fewer complications, MWA did not. Outcomes were subject to residual confounding since ablation was only employed for unresectable disease. CONCLUSION: The results from the EORTC-CLOCC trial, the comparable survival for ablation + PH versus PH alone, the potential to induce long-term disease control and the low complication rate argue in favour of ablation over chemotherapy alone. Further randomized comparisons of ablation to current-day chemotherapy alone should therefore be considered unethical. Hence, the highest achievable level of evidence for unresectable CRLM seems reached. The apparent selection bias from previous studies and the superior safety profile mandate the setup of randomized controlled trials comparing ablation to surgery.

First- and second-line bevacizumab in ovarian cancer: A Belgian cost-utility analysis.

BACKGROUND: Currently, in Belgium, bevacizumab is reimbursed for ovarian cancer patients, based on a contract between the Minister and the manufacturer including confidential agreements. This reimbursement will be re-evaluated in 2018. OBJECTIVE: To support the reimbursement reassessment by calculating the cost-effectiveness of bevacizumab: (1) in addition to first-line chemotherapy; (2) in the treatment of recurrent ovarian cancer (platinum-sensitive or platinum-resistant). METHODS: A health economic model has been developed for the Belgian situation according to the Belgian guidelines for economic evaluations. The lifetime Markov model was set up from the perspective of the health care payer (government and patient), including direct healthcare related costs. Results are expressed as the extra costs per quality-adjusted life year (QALY). Calculations were based on results of four international trials. Both probabilistic and one-way sensitivity analyses were performed. RESULTS: Incremental cost-effectiveness ratios (ICERs) of first-line bevacizumab are on average 158 000/QALY (GOG-0218 trial) and 443 000/QALY (ICON7 trial). The most favourable scenario is based on the stage IV subgroup of the GOG-0218 trial (€52 000/QALY). Since subgroup findings are often exploratory and require confirmatory studies, results of the economic evaluation based on this subgroup analysis should be considered with caution. For second-line bevacizumab, ICERs are on average €587 000/QALY (OCEANS trial) and €172 000/QALY (AURELIA trial). Sensitivity analysis shows that results are most sensitive to the price of bevacizumab. CONCLUSION: From a health economic perspective, ICERs of bevacizumab are relatively high. The most favourable results are found for first-line treatment of stage IV ovarian cancer patients. Price reductions have a major impact on the estimated ICERs. It is recommended to take these findings into account when re-evaluating the reimbursement of bevacizumab in ovarian cancer.

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.

Non-surgical interventions for late rectal problems (proctopathy) of radiotherapy in people who have received radiotherapy to the pelvis.

BACKGROUND: This is an update of a Cochrane review first published in 2002, and previously updated in 2007. Late radiation rectal problems (proctopathy) include bleeding, pain, faecal urgency, and incontinence and may develop after pelvic radiotherapy treatment for cancer. OBJECTIVES: To assess the effectiveness and safety of non-surgical interventions for managing late radiation proctopathy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 11, 2015); MEDLINE (Ovid); EMBASE (Ovid); CANCERCD; Science Citation Index; and CINAHL from inception to November 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing non-surgical interventions for the management of late radiation proctopathy in people with cancer who have undergone pelvic radiotherapy for cancer. Primary outcomes considered were: episodes of bowel activity, bleeding, pain, tenesmus, urgency, and sphincter dysfunction. DATA COLLECTION AND ANALYSIS: Study selection, 'Risk of bias' assessment, and data extraction were performed in duplicate, and any disagreements were resolved by involving a third review author. MAIN RESULTS: We identified 1221 unique references and 16 studies including 993 participants that met our inclusion criteria. One study found through the last update was moved to the 'Studies awaiting classification' section. We did not pool outcomes for a meta-analysis due to variation in study characteristics and endpoints across included studies.Since radiation proctopathy is a condition with various symptoms or combinations of symptoms, the studies were heterogeneous in their intended effect. Some studies investigated treatments targeted at bleeding only (group 1), some investigated treatments targeted at a combination of anorectal symptoms, but not a single treatment (group 2). The third group focused on the treatment of the collection of symptoms referred to as pelvic radiation disease. In order to enable some comparison of this heterogeneous collection of studies, we describe the effects in these three groups separately.Nine studies assessed treatments for rectal bleeding and were unclear or at high risk of bias. The only treatments that made a significant difference on primary outcomes were argon plasma coagulation (APC) followed by oral sucralfate versus APC with placebo (endoscopic score 6 to 9 in favour of APC with placebo, risk ratio (RR) 2.26, 95% confidence interval (CI) 1.12 to 4.55; 1 study, 122 participants, low- to moderate-quality evidence); formalin dab treatment (4%) versus sucralfate steroid retention enema (symptom score after treatment graded by the Radiation Proctopathy System Assessments Scale (RPSAS) and sigmoidoscopic score in favour of formalin (P = 0.001, effect not quantified, 1 study, 102 participants, very low- to low-quality evidence), and colonic irrigation plus ciprofloxacin and metronidazole versus formalin application (4%) (bleeding (P = 0.007, effect not quantified), urgency (P = 0.0004, effect not quantified), and diarrhoea (P = 0.007, effect not quantified) in favour of colonic irrigation (1 study, 50 participants, low-quality evidence).Three studies, of unclear and high risk of bias, assessed treatments targeted at something very localised but not a single pathology. We identified no significant differences on our primary outcomes. We graded all studies as very low-quality evidence due to unclear risk of bias and very serious imprecision.Four studies, of unclear and high risk of bias, assessed treatments targeted at more than one symptom yet confined to the anorectal region. Studies that demonstrated an effect on symptoms included: gastroenterologist-led algorithm-based treatment versus usual care (detailed self help booklet) (significant difference in favour of gastroenterologist-led algorithm-based treatment on change in Inflammatory Bowel Disease Questionnaire-Bowel (IBDQ-B) score at six months, mean difference (MD) 5.47, 95% CI 1.14 to 9.81) and nurse-led algorithm-based treatment versus usual care (significant difference in favour of the nurse-led algorithm-based treatment on change in IBDQ-B score at six months, MD 4.12, 95% CI 0.04 to 8.19) (1 study, 218 participants, low-quality evidence); hyperbaric oxygen therapy (at 2.0 atmospheres absolute) versus placebo (improvement of Subjective, Objective, Management, Analytic - Late Effects of Normal Tissue (SOMA-LENT) score in favour of hyperbaric oxygen therapy (HBOT), P = 0.0019) (1 study, 150 participants, moderate-quality evidence, retinol palmitate versus placebo (improvement in RPSAS in favour of retinol palmitate, P = 0.01) (1 study, 19 participants, low-quality evidence) and integrated Chinese traditional plus Western medicine versus Western medicine (grade 0 to 1 radio-proctopathy after treatment in favour of integrated Chinese traditional medicine, RR 2.55, 95% CI 1.30 to 5.02) (1 study, 58 participants, low-quality evidence).The level of evidence for the majority of outcomes was downgraded using GRADE to low or very low, mainly due to imprecision and study limitations.  AUTHORS' CONCLUSIONS: Although some interventions for late radiation proctopathy look promising (including rectal sucralfate, metronidazole added to an anti-inflammatory regimen, and hyperbaric oxygen therapy), single small studies provide limited evidence. Furthermore, outcomes important to people with cancer, including quality of life (QoL) and long-term effects, were not well recorded. The episodic and variable nature of late radiation proctopathy requires large multi-centre placebo-controlled trials (RCTs) to establish whether treatments are effective. Future studies should address the possibility of associated injury to other gastro-intestinal, urinary, or sexual organs, known as pelvic radiation disease. The interventions, as well as the outcome parameters, should be broader and include those important to people with cancer, such as QoL evaluations.

Percutaneous coronary invervention versus coronary artery bypass grafting: a meta-analysis.

OBJECTIVE: To compare the effectiveness of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with coronary artery disease. METHODS: MEDLINE, Embase, and Cochrane Central were searched, and randomized controlled trials were included. Outcomes were assessed at maximum available follow-up. RESULTS: This meta-analysis includes 31 trials with 15,004 patients. As regards death, more patients died after PCI compared with CABG across all types of patients (odds ratio [OR], 1.1; 95% confidence interval [CI], 1.0-1.3; P = .05) as well as in patients with multivessel disease (OR, 1.2; 95% CI, 1.0-1.4; P = .02) or diabetes (OR, 1.6; 95% CI, 1.2-2.1; P < .01). Myocardial infarction occurred as frequently after PCI (OR, 1.2; 95% CI, 0.9-1.5; P = .28). Repeat revascularization was more common after PCI (OR, 4.5; 95% CI, 3.5-5.8; P < .01), with a progressive decline in ORs from the pre-stent era (OR, 7.0; 95% CI, 5.1-9.7; P < .01), to the bare metal stent era (OR, 4.5; 95% CI, 3.6-5.5; P < .01), and to the drug-eluting stent era (OR, 2.5; 95% CI, 1.8-3.4; P < .01). Stroke was more common after CABG (OR, 0.7; 95% CI, 0.5-0.9; P = .01). CONCLUSIONS: Compared with PCI, CABG had a lower risk of death in multivessel disease or diabetes patients eligible for either intervention, a lower risk of repeat revascularization, but a higher risk of stroke.

The cost-utility of left ventricular assist devices for end-stage heart failure patients ineligible for cardiac transplantation: a systematic review and critical appraisal of economic evaluations.

BACKGROUND: A health technology assessment (HTA) of left ventricular assist devices (LVADs) as destination therapy in patients with end-stage heart failure was commissioned by the Dutch Health Care Insurance Board [College voor Zorgverzekeringen (CVZ)]. In this context, a systematic review of the economic literature was performed to assess the procedure's value for money. METHODS: A systematic search (updated in December 2013) for economic evaluations was performed by consulting various databases: the HTA database produced by the Centre for Reviews and Dissemination (CRD HTA), websites of HTA institutes, CRD's National Health Service Economic Evaluation Database (NHS EED), Medline (OVID) and EMBASE. No time or language restrictions were imposed and pre-defined selection criteria were used. The two-step selection procedure was performed by two people. References of the selected studies were checked for additional relevant citations. RESULTS: Six relevant studies were selected. Four economic evaluations relied on the results of the REMATCH trial to compare a pulsatile-flow LVAD with optimal medical therapy (OMT). These evaluations were performed before the publication of the HeartMate II (HM-II) Destination Therapy Trial which compared a pulsatile-flow with a continuous-flow LVAD. Two more recent economic evaluations combined the results of both trials to make an indirect comparison of a continuous-flow LVAD with OMT. In all studies, the largest part of the incremental cost was due to the reimplantation cost of an LVAD, with a device cost of €58,000-€75,000 and about €55,000 for the surgical procedure. The survival gain was highest with a continuous-flow LVAD, up to about three life-years gained (LYG) versus OMT in the most optimistic study. Quality of life (QoL) was improved but measures with a generic utility instrument were lacking, making estimates on quality-adjusted life-years (QALYs) gained more uncertain. Incremental cost-effectiveness ratios of the two most recent studies were on average €107,600 and $198,184 (ca.€145,800) per QALY gained. CONCLUSIONS: Although LVAD destination therapy improves survival and QoL, it remains questionable as to whether it offers value for money. This conclusion may alter if the price of the device/procedure decreases sufficiently, in combination with further improved outcomes for mortality, adverse events and QoL.

The Belgian Health System Performance Report 2012: snapshot of results and recommendations to policy makers.

Following the commitments of the Tallinn Charter, Belgium publishes the second report on the performance of its health system. A set of 74 measurable indicators is analysed, and results are interpreted following the five dimensions of the conceptual framework: accessibility, quality of care, efficiency, sustainability and equity. All domains of care are covered (preventive, curative, long-term and end-of-life care), as well as health status and health promotion. For all indicators, national/regional values are presented with their evolution over time. Benchmarking to results of other EU-15 countries is also systematic. The policy recommendations represent the most important output of the report.

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.

Cost-effectiveness of continuous-flow left ventricular assist devices.

OBJECTIVES: Mechanical circulatory support through left ventricular assist devices (LVADs) improves survival and quality of life for patients with end-stage heart failure who are ineligible for cardiac transplantation. Our aim was to calculate the cost-effectiveness of continuous-flow LVADs. METHODS: A cost-utility analysis from a societal perspective was performed. A lifetime Markov model was set up in which continuous-flow LVAD was compared with optimal medical therapy (OMT). The treatment effect was modeled indirectly combining the results of the REMATCH trial comparing OMT with a pulsatile-flow LVAD and the HeartMate II Destination Therapy Trial comparing a pulsatile-flow LVAD with a continuous-flow LVAD. Cost data were based on real-world financial data of sixty-nine patients with a HeartMate II implantation from the University Medical Centre Utrecht (the Netherlands). One-way and probabilistic sensitivity analyses were performed. RESULTS: Comparing the continuous-flow HeartMate II with OMT, 3.23 (95 percent confidence interval [CI], 2.18-4.49) life-years were gained (LYG) or 2.83 (95 percent CI, 1.91-3.90) quality-adjusted life-years (QALYs). The cost of an LVAD implant was approximately €126,000, of which the device itself represented the largest cost, being €70,000. Total incremental costs amounted to €299,100 (95 percent CI, 190,500-521,000). This resulted in an incremental cost-effectiveness ratio of €94,100 (95 percent CI, 59,100-160,100) per LYG or €107,600 (95 percent CI, 66,700-181,100) per QALY. Sensitivity analyses showed these results were robust. CONCLUSIONS: Although LVAD destination therapy improves survival and quality of life, it remains a relatively expensive intervention which renders the reimbursement of this therapy questionable.

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.

Effect of hospital volume on processes of care and 5-year survival after breast cancer: a population-based study on 25000 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.

Atherosclerotic cardiovascular diseases in Belgium: a cost-of-illness analysis.

PURPOSE: This study aims to quantify costs of atherosclerotic cardiovascular diseases in Belgium in 2004. METHODS: Costs were estimated using data on prevalence, healthcare resource utilization and unit costs. Healthcare costs included expenditure on ambulatory care, hospital inpatient care, emergency care, and medications. Costs of prevention campaigns and costs of productivity loss were also included. RESULTS: Costs amounted to 3.5 billion euros in Belgium in 2004. Total costs consisted of 80 million euros related to prevention and screening, 1.3 billion euros related to pre-clinical disease, and 2.2 billion euros related to established disease. These costs were incurred by the Belgian third-party payer (58% of costs), patients (10%) and third parties (i.e. employers and supplementary health insurance) (32%). CONCLUSIONS: Atherosclerotic cardiovascular diseases impose a significant economic burden on Belgian society.

CoCanCPG. Coordination of cancer clinical practice in Europe.

All European countries are facing common challenges for delivering appropriate, evidence-based care to patients with cancer. Despite tangible improvements in diagnosis and treatment, marked differences in cancer survival exist throughout Europe. The reliable translation of new research evidence into consistent patient-oriented strategies is a key endeavour to overcome inequalities in healthcare. Clinical-practice guidelines are important tools for improving quality of care by informing professionals and patients about the most appropriate clinical practice. Guideline programmes in different countries use similar strategies to achieve similar goals. This results in unnecessary duplication of effort and inefficient use of resources. While different initiatives at the international level have attempted to improve the quality of guidelines, less investment has been made to overcome existing fragmentation and duplication of effort in cancer guideline development and research. To provide added value to existing initiatives and foster equitable access to evidence-based cancer care in Europe, CoCanCPG will establish cooperation between cancer guideline programmes. CoCanCPG is an ERA-Net coordinated by the French National Cancer Institute with 17 partners from 11 countries. The CoCanCPG partners will achieve their goal through an ambitious, stepwise approach with a long-term perspective, involving: 1. implementing a common framework for sharing knowledge and skills; 2. developing shared activities for guideline development; 3. assembling a critical mass for pertinent research into guideline methods; 4. implementing an appropriate framework for cooperation. Successful development of joint activities involves learning how to adopt common quality standards and how to share responsibilities, while taking into account the cultural and organisational diversity of the participating organisations. Languages barriers and different organisational settings add a level of complexity to setting up transnational collaboration. Through its activities, CoCanCPG will make an important contribution towards better access to evidence-based cancer practices and thus contribute to reducing inequalities and improving care for patients with cancer across Europe.

Standardization of search methods for guideline development: an international survey of evidence-based guideline development groups.

BACKGROUND: Effective literature searching is particularly important for clinical practice guideline development. Sophisticated searching and filtering mechanisms are needed to help ensure that all relevant research is reviewed. PURPOSE: To assess the methods used for the selection of evidence for guideline development by evidence-based guideline development organizations. METHODS: A semistructured questionnaire assessing the databases, search filters and evaluation methods used for literature retrieval was distributed to eight major organizations involved in evidence-based guideline development. RESULTS: All of the organizations used search filters as part of guideline development. The medline database was the primary source accessed for literature retrieval. The OVID or SilverPlatter interfaces were used in preference to the freely accessed PubMed interface. The Cochrane Library, embase, cinahl and psycinfo databases were also frequently used by the organizations. All organizations reported the intention to improve and validate their filters for finding literature specifically relevant for guidelines. DISCUSSION: In the first international survey of its kind, eight major guideline development organizations indicated a strong interest in identifying, improving and standardizing search filters to improve guideline development. It is to be hoped that this will result in the standardization of, and open access to, search filters, an improvement in literature searching outcomes and greater collaboration among guideline development organizations.