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Background Diagnostic mammography projections (DxMM) have been traditionally used in the assessment of women recalled after a suspicious screening mammogram. Digital breast tomosynthesis (DBT) reduces the tissue overlap effect, thus improving image assessment. Some studies have suggested DBT might replace DxMM with at least equivalent performance. Objective To evaluate the replacement of DxMM with DBT in women recalled at screening. Methods We searched PubMed, EMBASE, and the Cochrane Library databases to identify diagnostic paired cohort studies or RCTs comparing DBT vs DxMM, published in English that: reported accuracy outcomes, recruited women recalled for assessment at mammography screening, and included a reference standard. Subgroup analysis was performed over lesion characteristics. We provided pooled accuracy estimates and differences between tests using a quadrivariate model. We assessed the certainty of the evidence using the GRADE approach. Results We included ten studies that reported specificity and sensitivity. One study included 7060 women while the remaining included between 52 and 738 women. DBT compared with DxMM showed a pooled difference for the sensitivity of 2% (95% CI 1%–3%) and a pooled difference for the specificity of 6% (95%CI 2%–11%). Restricting the analysis to the six studies that included women with microcalcification lesions gave similar results. In the context of a prevalence of 21% of breast cancer (BC) in recalled women, DBT probably detects 4 (95% CI 2–6) more BC cases and has 47 (95%CI 16–87) fewer false‐positive results per 1000 assessments. The certainty of the evidence was moderate due to risk of bias. Conclusion The evidence in the assessment of screen‐recalled findings with DBT is sparse and of moderate certainty. DBT probably has higher sensitivity and specificity than DxMM. Women, health care providers and policymakers might value as relevant the reduction of false‐positive results and related fewer invasive diagnostic procedures with DBT, without missing BC cases., This systematic review found that in women of average risk of breast cancer with suspicious lesions at mammography screening, DBT probably has higher specificity difference (6%) than diagnostic views of 2D mammography in women recalled for assessment (moderate certainty evidence). The sensitivity is also probably higher with DBT; however, the difference was not so large (2%). The clinical impact of these results in a screening program is a probable reduction of 47 false positive results, including related invasive procedures, and most likely a small increase of 4 additional true BC lesions per 1000 women recalled for assessment. Our results were consistent in women with calcified lesions, but with a larger imprecision in the sensitivity differences. These results were taken into account by the GDG, together with other considerations (ie, feasibility) to issue a conditional recommendation in favor of DBT which is available on the ECIBC website (https://healthcare‐quality.jrc.ec.europa.eu/european‐breast‐cancer‐guidelines/diagnosis/DBT).

Background and Objective Guideline development groups or other health care decision makers frequently encounter situations that require a simultaneous comparison of multiple interventions. This sometimes becomes apparent either when they identify questions of interest, before they formulate recommendations, or it may surface only when recommendations have already been formulated based on pairwise comparisons. Methods Using examples from the World Health Organization, the European Commission, and a professional society, we developed a flexible approach to developing recommendations when a multiple-intervention comparison (MC) is needed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence to decision (EtD) frameworks. We iteratively refined this approach through user testing and then included a module in GRADE's official software GRADEpro to test the approach in two real and one theoretical guideline recommendations. Results We found the approach feasible and that all EtD criteria should be considered in an MC approach. We judged that guideline development groups and other decision makers will benefit from the availability of a network meta-analyses (NMA) of intervention effects to support decisions; however, NMA supports only one of many criteria, that is, the balance of health benefits and harms, and is therefore helpful, but not essential to the approach we propose. When similar but not identical comparators are used to address MC, challenges may arise with intransitivity and the relative rankings of interventions. Conclusion We successfully applied the MC approach and software module in generating recommendations across different scenarios and identified challenges. The MC approach allows guideline groups and other decision makers to transparently and critically assess multiple options for a given health question. Application of the approach by others may lead to refinement and allow for better understanding of its impact in developing recommendations and making choices.

Background During healthcare guideline development, panel members often have implicit, different definitions of health outcomes that can lead to misunderstandings about how important these outcomes are and how to balance benefits and harms. McMaster GRADE Centre researchers developed ‘health outcome descriptors’ for standardizing descriptions of health outcomes and overcoming these problems to support the European Commission Initiative on Breast Cancer (ECIBC) Guideline Development Group (GDG). We aimed to determine which aspects of the development, content, and use of health outcome descriptors were valuable to guideline developers. Methods We developed 24 health outcome descriptors related to breast cancer screening and diagnosis for the European Commission Breast Guideline Development Group (GDG). Eighteen GDG members provided feedback in written format or in interviews. We then evaluated the process and conducted two health utility rating surveys. Results Feedback from GDG members revealed that health outcome descriptors are probably useful for developing recommendations and improving transparency of guideline methods. Time commitment, methodology training, and need for multidisciplinary expertise throughout development were considered important determinants of the process. Comparison of the two health utility surveys showed a decrease in standard deviation in the second survey across 21 (88%) of the outcomes. Conclusions Health outcome descriptors are feasible and should be developed prior to the outcome prioritization step in the guideline development process. Guideline developers should involve a subgroup of multidisciplinary experts in all stages of development and ensure all guideline panel members are trained in guideline methodology that includes understanding the importance of defining and understanding the outcomes of interest.

Purpose Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence. Methods We searched for systematic reviews and quantitative or qualitative primary studies in MEDLINE and Embase up to May 2019. The eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and cross-checked by a second author. We conducted a narrative synthesis attending to the modality of the healthcare process, methods to measure adherence, the scope of the CGs, and population characteristics. Results Out of 8137 references, we included 41 primary studies conducted in eight European countries. Most followed a retrospective cohort design (19/41; 46%) and were at low or moderate risk of bias. Adherence for overall breast cancer care process (from diagnosis to follow-up) ranged from 54 to 69%; for overall treatment process [including surgery, chemotherapy (CT), endocrine therapy (ET), and radiotherapy (RT)] the median adherence was 57.5% (interquartile range (IQR) 38.8-67.3%), while for systemic therapy (CT and ET) it was 76% (IQR 68-77%). The median adherence for the processes assessed individually was higher, ranging from 74% (IQR 10-80%), for the follow-up, to 90% (IQR 87-92.5%) for ET. Internal factors that potentially impact on healthcare providers' adherence were their perceptions, preferences, lack of knowledge, or intentional decisions. Conclusions A substantial proportion of breast cancer patients are not receiving CGs-recommended care. Healthcare providers' adherence to breast cancer CGs in Europe has room for improvement in almost all care processes. CGs development and implementation processes should address the main factors that influence healthcare providers' adherence, especially patient-related ones. Registration: PROSPERO (CRD42018092884)., The systematic review was carried out by the Iberoamerican Cochrane Center under Framework Contract 443094 for procurement of services between European Commission Joint Research Centre and Asociacion Colaboracion Cochrane Iberoamericana. YS is funded by China Scholarship Council (No. 201707040103). MR is funded by Sara Borrell contract (CD16/00157). AVM received a training Grant D43 TW007393 Fogarty International Centre of the US National Institutes of Health for the Emerging Diseases and Climate Change Research Unit of the School and Public Health Administration at Universidad Peruana Cayetano Heredia.

Background Although mammography screening is recommended in most European countries, the balance between the benefits and harms of different screening intervals is still a matter of debate. This review informed the European Commission Initiative on Breast Cancer (BC) recommendations. Methods We searched PubMed, EMBASE, and the Cochrane Library to identify RCTs, observational or modelling studies, comparing desirable (BC deaths averted, QALYs, BC stage, interval cancer) and undesirable (overdiagnosis, false positive related, radiation related) effects from annual, biennial, or triennial mammography screening in women of average risk for BC. We assessed the certainty of the evidence using the GRADE approach. Results We included one RCT, 13 observational, and 11 modelling studies. In women 50–69, annual compared to biennial screening may have small additional benefits but an important increase in false positive results; triennial compared to biennial screening may have smaller benefits while avoiding some harms. In younger women (aged 45–49), annual compared to biennial screening had a smaller gain in benefits and larger harms, showing a less favourable balance in this age group than in women 50–69. In women 70–74, there were fewer additional harms and similar benefits with shorter screening intervals. The overall certainty of the evidence for each of these comparisons was very low. Conclusions In women of average BC risk, screening intervals have different trade-offs for each age group. The balance probably favours biennial screening in women 50–69. In younger women, annual screening may have a less favourable balance, while in women aged 70–74 years longer screening intervals may be more favourable.

Background In 2017, the European Commission’s Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). Methods A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. Results Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. Conclusions The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

Objective To propose a taxonomy and framework that identifies and presents actionable statements in guidelines. Study design and setting We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework. Results The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process. Conclusion The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.

Objectives Mammography screening is generally accepted in women aged 50–69, but the balance between benefits and harms remains controversial in other age groups. This study systematically reviews these effects to inform the European Breast Cancer Guidelines. Methods We searched PubMed, EMBASE and Cochrane Library for randomised clinical trials (RCTs) or systematic reviews of observational studies in the absence of RCTs comparing invitation to mammography screening to no invitation in women at average breast cancer (BC) risk. We extracted data for mortality, BC stage, mastectomy rate, chemotherapy provision, overdiagnosis and false-positive-related adverse effects. We performed a pooled analysis of relative risks, applying an inverse-variance random-effects model for three age groups (Results We identified 10 RCTs including 616,641 women aged 38–75. Mammography reduced BC mortality in women aged 50–69 (relative risk (RR) 0.77, 95%CI (confidence interval) 0.66–0.90, high certainty) and 70–74 (RR 0.77, 95%CI 0.54–1.09, high certainty), with smaller reductions in under 50s (RR 0.88, 95%CI 0.76–1.02, moderate certainty). Mammography reduced stage IIA+ in women 50–69 (RR 0.80, 95%CI 0.64–1.00, very low certainty) but resulted in an overdiagnosis probability of 23% (95%CI 18–27%) and 17% (95%CI 15–20%) in under 50s and 50–69, respectively ( moderate certainty). Mammography was associated with 2.9% increased risk of invasive procedures with benign outcomes ( low certainty). Conclusions For women 50–69, high certainty evidence that mammography screening reduces BC mortality risk would support policymakers formulating strong recommendations. In other age groups, where the net balance of effects is less clear, conditional recommendations will be more likely, together with shared decision-making.

Background Although quality indicators are frequently derived from guidelines, there is a substantial gap in collaboration between the corresponding parties. To optimise workflow, guideline recommendations and quality assurance should be aligned methodologically and practically. Learning from the European Commission Initiative on Breast Cancer (ECIBC), our objective was to bring the key knowledge and most important considerations from both worlds together to inform European Commission future initiatives. Methods We undertook several steps to address the problem. First, we conducted a feasibility study that included a survey, interviews and a review of manuals for an integrated guideline and quality assurance (QA) scheme that would support the European Commission. The feasibility study drew from an assessment of the ECIBC experience that followed commonly applied strategies leading to separation of the guideline and QA development processes. Secondly, we used results of a systematic review to inform our understanding of methodologies for integrating guideline and QA development. We then, in a third step, used the findings to prepare an evidence brief and identify key aspects of a methodological framework for integrating guidelines QA through meetings with key informants. Results Seven key themes emerged to be taken into account for integrating guidelines and QA schemes: (1) evidence-based integrated guideline and QA frameworks are possible, (2) transparency is key in clearly documenting the source and rationale for quality indicators, (3) intellectual and financial interests should be declared and managed appropriately, (4) selection processes and criteria for quality indicators need further refinement, (5) clear guidance on retirement of quality indicators should be included, (6) risks of an integrated guideline and QA Group can be mitigated, and (7) an extension of the GIN-McMaster Guideline Development Checklist should incorporate QA considerations. Discussion We concluded that the work of guideline and QA developers can be integrated under a common methodological framework and we provided key findings and recommendations. These two worlds, that are fundamental to improving health, can both benefit from integration.

Objective To evaluate the impact of preoperative MRI in the management of Ductal carcinoma in situ (DCIS). Methods We searched the PubMed, EMBASE and Cochrane Library databases to identify randomised clinical trials (RCTs) or cohort studies assessing the impact of preoperative breast MRI in surgical outcomes, treatment change or loco-regional recurrence. We provided pooled estimates for odds ratios (OR), relative risks (RR) and proportions and assessed the certainty of the evidence using the GRADE approach. Results We included 3 RCTs and 23 observational cohorts, corresponding to 20,415 patients. For initial breast-conserving surgery (BCS), the RCTs showed that MRI may result in little to no difference (RR 0.95, 95% CI 0.90 to 1.00) (low certainty); observational studies showed that MRI may have no difference in the odds of re-operation after BCS (OR 0.96; 95% CI 0.36 to 2.61) (low certainty); and uncertain evidence from RCTs suggests little to no difference with respect to total mastectomy rate (RR 0.91; 95% CI 0.65 to 1.27) (very low certainty). We also found that MRI may change the initial treatment plans in 17% (95% CI 12 to 24%) of cases, but with little to no effect on locoregional recurrence (aHR = 1.18; 95% CI 0.79 to 1.76) (very low certainty). Conclusion We found evidence of low to very low certainty which may suggest there is no improvement of surgical outcomes with pre-operative MRI assessment of women with DCIS lesions. There is a need for large rigorously conducted RCTs to evaluate the role of preoperative MRI in this population. Key Points • Evidence of low to very low certainty may suggest there is no improvement in surgical outcomes with pre-operative MRI. • There is a need for large rigorously conducted RCTs evaluating the role of preoperative MRI to improve treatment planning for DCIS.

BackgroundBreast cancer (BC) clinical guidelines offer evidence-based recommendations to improve quality of healthcare for patients with or at risk of BC. Suboptimal adherence to recommendations has the potential to negatively affect population health. However, no study has systematically reviewed the impact of BC guideline adherence -as prognosis factor- on BC healthcare processes and health outcomes. The objectives are to analyse the impact of guideline adherence on health outcomes and on healthcare costs.MethodsWe searched systematic reviews and primary studies in MEDLINE and Embase, conducted in European Union (EU) countries (inception to May 2019). Eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and crosschecked by a second. We used random-effects meta-analyses to examine the impact of guideline adherence on overall survival and disease-free survival, and assessed certainty of evidence using GRADE.ResultsWe included 21 primary studies. Most were published during the last decade (90%), followed a retrospective cohort design (86%), focused on treatment guideline adherence (95%), and were at low (80%) or moderate (20%) risk of bias. Nineteen studies (95%) examined the impact of guideline adherence on health outcomes, while two (10%) on healthcare cost. Adherence to guidelines was associated with increased overall survival (HR=0.67, 95%CI 0.59-0.76) and disease-free survival (HR=0.35, 95%CI 0.15-0.82), representing 138 more survivors (96 more to 178 more) and 336 patients free of recurrence (73 more to 491 more) for every 1000 women receiving adherent CG treatment compared to those receiving non-adherent treatment at 5years follow-up (moderate certainty). Adherence to treatment guidelines was associated with higher costs, but adherence to follow-up guidelines was associated with lower costs (low certainty).ConclusionsOur review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival. BC guidelines should be rigorously implemented in the clinical setting.Trial registrationPROSPERO (CRD42018092884)., The systematic review was carried out by the Iberoamerican Cochrane Center under Framework contract 443094 for procurement of services between European Commission Joint Research Centre and Asociacion Colaboracion Cochrane Iberoamericana.; AVM received a training grant D43 TW007393 Fogarty International Centre of the US National Institutes of Health for the Emerging Diseases and Climate Change Research Unit of the School and Public Health Administration at Universidad Peruana Cayetano Heredia.

The European Union Council Recommendation of 2 December 2003 on cancer screening suggests the implementation of organised, population- based breast cancer screening programmes based on mammography every other year for women aged 50 to 69 years, ensuring equal access to screening, taking into account potential needs for targeting particular socioeconomic groups. A European survey on coverage and participation, and key organisational and policy characteristics of the programmes, targeting years 2010 and 2014, was undertaken in 2014. Overall, 27 countries contributed to this survey, 26 of the 28 European Union member states (92.9%) plus Norway. In 2014, 25 countries reported an ongoing population- based programme, one country reported a pilot programme and another was planning a pilot. In eight countries, the target age range was broader than that proposed by the Council Recommendation, and in three countries the full range was not covered. Fifteen countries reported not reaching some vulnerable populations, such as immigrants, prisoners and people without health insurance, while 22 reported that participation was periodically monitored by socioeconomic variables (e.g. age and territory). Organised, population- based breast cancer screening programmes based on routine mammograms are in place in most EU member states. However, there are still differences in the way screening programmes are implemented, and participation by vulnerable populations should be encouraged. (C) 2016 The Authors. Published by Elsevier Inc.

Introduction Two statistical sources provide data on hospital stays and discharges for all Spanish hospitals: Hospital Morbidity Survey (acronym in Spanish: EMH) and Statistics of Health Establishments providing Inpatient Care (acronym in Spanish: EESCRI). Our aim is to contrast these two statistical sources to define their accuracy and relevance in psychiatric epidemiology studies. Material and methodology The analysis is based on two aspects: (1) Compare the number of psychiatric stays and hospital discharges from 1990 to 2009. (2) Analyse and compare how the average stay is provided. Results The differences between the two statistical sources are significant and increase over time. In 2005–2009 the EMH records 121% of hospitalisations (577,078 vs 475,414) and 46% (14,239,527 vs 30,821,412) of psychiatric stays, compared with EESCRI. Moreover, the average stay estimated by EESCRI shows serious methodological problems, particularly in settings of prolonged hospitalisation (psychiatric hospitals); the estimations are potentially below the real value. Conclusions Surprisingly, the questionnaires completed by hospitals to develop the EESCRI provide data on assisted morbidity quite different from that provided by the EMH, despite both statistical sources having the same inpatient records for data processing. It is difficult to attribute these differences to sampling error, as the EMH has a very high sampling fraction, which minimises the sampling error. Given the mismatch between sources, we recommend using the EMH, as it offers more reliable data and allows an accurate determination of the length of stays.

Background: There is still lack of consensus on the benefit-harm balance of breast cancer screening. In this scenario, women's values and preferences are crucial for developing health-related recommendations. In the context of the European Commission Initiative on Breast Cancer, we conducted a systematic review to inform the European Breast Guidelines. Methods: We searched Medline and included primary studies assessing women's values and preferences regarding breast cancer screening and diagnosis decision making. We used a thematic approach to synthesise relevant data. The quality of evidence was determined with GRADE, including GRADE CERQual for qualitative research. Results: We included 22 individual studies. Women were willing to accept the psychological and physical burden of breast cancer screening and a significant risk of overdiagnosis and false-positive mammography findings, in return for the benefit of earlier diagnosis. The anxiety engendered by the delay in getting results of diagnostic tests was highlighted as a significant burden, emphasising the need for rapid and efficient screening services, and clear and efficient communication. The confidence in the findings was low to moderate for screening and moderate for diagnosis, predominantly because of methodological limitations, lack of adequate understanding of the outcomes by participants, and indirectness. Conclusions: Women value more the possibility of an earlier diagnosis over the risks of a false-positive result or overdiagnosis. Concerns remain that women may not understand the concept of overdiagnosis. Women highly value time efficient screening processes and rapid result delivery and will accept some discomfort for the peace of mind screening may provide.

**Purpose:** The aim was to identify factors affecting treatment adherence and to assess the clinical, economic and management impact of growth hormone deficiency treatment using an electronic auto-injector for recombinant human growth hormone (r-hGH) administration in children. **Patients and Methods:** A literature review was conducted in PubMed up to 31JUL2013, including the following search terms: “growth hormone deficiency”, “human-recombinant growth hormone” and “treatment adherence”. An economic model was developed to estimate the economic benefits of using an electronic injection device. In order to quantify this benefit, potential savings due to growth hormone cartridge optimization were analyzed. **Results:** From the literature review, the following key factors were found to affect treatment adherence: type of device used, discomfort, complexity of treatment regimens, long-term treatment, age and patient or family understanding of treatment benefits were assessed. A better adjustment to prescribed daily dose (accuracy up to 0.01 mg) with the electronic device results in a better optimization of vials and could save an average of 5% of total treatment costs in terms of doses not wasted, amounting to €245 of potential savings per patient and year of treatment. **Conclusion:** The use of an electronic device for r-hGH administration and monitoring may provide a better identification of responder and adherent patients. It may also generate savings in annual r-hGH consumption by hospitals and regional healthcare services.

To analyze the prevalence of hospitalization attributable to psychosis in Spain over the last three decades. Longitudinal analysis (1980–2009) of age-adjusted hospital discharges rates associated with psychosis (ICD9 290–8) in all Spanish hospitals. Data source: Spanish Hospital Morbidity Survey. The hospitalization rate associated with psychotic episodes had been gradually increasing since 1980 until 2004; an abrupt turnaround observed in 2004 marks the beginning of a steady decline in the rate. The turning point described is not observed for each of the psychotic diagnoses separately analyzed. However, it is clearly seen when data are grouped in diagnosis-related groups (organic-psychosis, functional psychosis and substance-induced psychosis) since the time course of the diseases within the major diagnostic groups are interrelated as evidenced by shared turning points which collectively display a common time course pattern. Main hospital indicators and antipsychotic drug prescriptions were analyzed for any possible turning point in mid-2000s. Psychiatric hospital beds and length of stays remained stable by 2004; the hospitalizations associated with non-psychotic psychiatric pathologies show no turning point in 2004. However, an abrupt change on antipsychotic drug prescriptions is precisely observed in 2004. After decades of linear growth, hospitalizations for psychotic patients begin to decline in 2004, coinciding with the start of last generation atypical antipsychotic drug consumption in Spain. Some of the psychotic diagnostic rates evolve in an interrelated manner which calls into question the diagnosis and nosological boundaries between some of these pathologies.

Psycho-oncology addresses the psychological, social, behavioural, and ethical aspects of cancer. Identification and proper management of the patients' psychosocial needs, as well as the needs of their caregivers and family are essential for a person-centred concept of breast cancer care. The aim of this overview is to describe how psychosocial support in breast cancer is incorporated in cancer-related policy documents, such as national cancer plans and breast cancer care certification schemes. post-print 163 KB

Description The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers. Methods An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence. Recommendations This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.

INTRODUCTION: The growing movement of innovative approaches to chronic disease management in Europe has not been matched by a corresponding effort to evaluate them. This paper discusses challenges to evaluation of chronic disease management as reported by experts in six European countries. METHODS: We conducted 42 semi-structured interviews with key informants from Austria, Denmark, France, Germany, The Netherlands and Spain involved in decision-making and implementation of chronic disease management approaches. Interviews were complemented by a survey on approaches to chronic disease management in each country. Finally two project teams (France and the Netherlands) conducted in-depth case studies on various aspects of chronic care evaluation. RESULTS: We identified three common challenges to evaluation of chronic disease management approaches: (1) a lack of evaluation culture and related shortage of capacity; (2) reluctance of payers or providers to engage in evaluation and (3) practical challenges around data and the heterogeity of IT infrastructure. The ability to evaluate chronic disease management interventions is influenced by contextual and cultural factors. CONCLUSIONS: This study contributes to our understanding of some of the most common underlying barriers to chronic care evaluation by highlighting the views and experiences of stakeholders and experts in six European countries. Overcoming the cultural, political and structural barriers to evaluation should be driven by payers and providers, for example by building in incentives such as feedback on performance, aligning financial incentives with programme objectives, collectively participating in designing an appropriate framework for evaluation, and making data use and accessibility consistent with data protection policies. The DISMEVAL project was funded under the European Commission’s Seventh Framework Programme (FP7) (grant no. 223277). The views expressed in this paper are those of the authors alone and the European Commission is therefore not liable for any use that may be made of the information contained herein. We would like to express our gratitude to interview participants for kindly giving their time and sharing their knowledge. Sí

Background and objectives: Dental injuries incurred during endotracheal intubation are more frequent in patients with previous oral pathology. The study objectives were to develop an oral health questionnaire for preanaesthesia evaluation, easy to apply for personnel without special dental training; and establish a cut-off value for detecting persons with poor oral health. Methods: Validation study of a self-administered questionnaire, designed according to a literature review and an expert group's recommendations. The questionnaire was applied to a sample of patients evaluated in a preanaesthesia consultation. Rasch analysis of the questionnaire psychometric properties included viability, acceptability, content validity and reliability of the scale. Results: The sample included 115 individuals, 50.4% of men, with a median age of 58 years (range: 38–71). The final analysis of 11 items presented a Person Separation Index of 0.861 and good adjustment of data to the Rasch model. The scale was unidimensional and its items were not biased by sex, age or nationality. The oral health linear measure presented good construct validity. The cut-off value was set at 52 points. Conclusions: The questionnaire showed sufficient psychometric properties to be considered a reliable tool, valid for measuring the state of oral health in preoperative anaesthetic evaluations. Resumo: Justificativa e objetivo: As lesões dentárias que ocorrem durante a intubação traqueal são mais frequentes em pacientes com patologia oral prévia. O objetivo do estudo foi desenvolver um questionário de saúde bucal para avaliação no período pré-anestesia, de fácil aplicação por pessoal sem formação odontológica, e estabelecer um valor de corte para detectar pessoas com má saúde bucal. Métodos: Estudo de validação de um questionário autoadministrado, projetado de acordo com uma revisão da literatura e recomendações de um grupo de especialistas. O questionário foi aplicado a uma amostra de pacientes avaliados em uma consulta pré-anestesia. A análise Rasch das propriedades psicométricas do questionário incluiu viabilidade, aceitabilidade, validade de conteúdo e confiabilidade da escala. Resultados: A amostra incluiu 115 indivíduos, 50,4% de homens, com idade mediana de 58 anos (variação: 38-71). A análise final dos 11 itens apresentou um índice de separação dos indivíduos de 0,861 e um bom ajuste dos dados ao modelo de Rasch. A escala foi unidimensional e seus itens não foram influenciados pelo sexo, idade ou nacionalidade. A medida linear da saúde bucal apresentou boa validade de construto. O valor de corte foi fixado em 52 pontos. Conclusões: O questionário mostrou propriedades psicométricas suficientes para ser considerado uma ferramenta confiável, válida para medir o estado de saúde bucal nas avaliações pré-anestesia antes da operação. Keywords: Patient safety, Dental injury, Oral health, Oral hygiene, Questionnaire, Palavras-chave: Segurança do paciente, Lesão dentária, Saúde bucal, Higiene bucal, Questionário

The aim of this study was to measure the use of mammography and the factors associated with testing among Spanish women, after the introduction of screening programmes in Spain. We conducted a cross-sectional population survey of a representative sample of women aged 40-70 (2409 women). Data collection took place in October 2000, using a questionnaire addressing the dependent variable (mammography use) and the independent variables (socio-demographic and socio-health factors, and women's knowledge and attitudes). Mammography use was defined as having received at least one screening test in the previous 2 years. Data analysis consisted of univariate and multivariate analyses. 48.1% (95% confidence interval (CI) 46.0-50.2) of women had received screening mammography. The main factors associated with testing were: mammography invitation from the screening programme (odds ratio (OR) 4.81; 95% CI 3.85-6.01); gynaecologist visit (OR 4.32; 95% CI 3.45-5.41); and intention to have a mammogram (OR 2.94; 95% CI 2.00-4.32). Other test-related factors were: not rejecting test for discomfort or fear of cancer; mammography perceived as necessary; age 56-65; upper/upper-middle socio-economic status. In conclusion, after the introduction of screening programmes, almost half of Spanish women aged 40-70 had received mammography. Invitation to screening, gynaecologist visit and women's attitudes are the main reasons for undergoing testing. Women over 65 years of age and/or those in a lower socio-economic level warrant special attention.

BACKGROUND: Although severe sepsis constitutes an important burden for healthcare systems, there is limited nationwide data on its epidemiology in European countries. Our objective was to examine the most recent epidemiological characteristics and trends of severe sepsis in Spain, from a population perspective. METHODS: Analysis of the 2006-2011 National Hospital Discharge Registry. Cases were identified by combining specific ICD-9CM codes. We estimated demographics, clinical characteristics and outcomes and calculated age- and sex-adjusted estimations of incidence and mortality rates. Trends were assessed in terms of annual percent change (APC) in rates using joinpoint regression analysis. RESULTS: Over the 6-year period we identified 240939 cases of severe sepsis nationwide representing 1.1% of all hospitalisations and 54% of hospitalisations with sepsis. Incidence was 87 cases per 100,000 population. Overall 58% of cases were men, 66% were over the age of 65 and about 67% had associated comorbidities. Bacteremia was coded in 16% of records. Almost 54% of cases had one organ dysfunction, 26% two and around 20% three or more dysfunctions. In-hospital case-fatality was 43% and associated with age, gender, comorbidities and organ dysfunctions, among others. We found significant demographic and clinical changes over time with an increase in the mean age of cases, comorbidities, number of organ dysfunctions and in the number of cases with gram-negative pathogens. Furthermore, even with gender disparities, standardised incidence and mortality rates increased with an overall APC of 8.6% (95% CI 5.1, 12.1) and 6% (95% CI 1.9, 10.3), respectively. Conversely, we detect a significant decrease in case-fatality rates with an overall APC of -3.24% (95% CI: -4.2, -2.2). CONCLUSIONS: This nationwide population-based study shows that hospitalizations with severe sepsis are frequent and associated with substantial in-hospital mortality in Spain. Furthermore it indicates that the incidence and mortality rates of severe sepsis have notably increased in recent years, showing also a significant increase in the age and severity of the affected population. Despite this, there has been a significant decreasing trend in case-fatality rates over time. This information has significant implications for health-care system planning and may prove useful to estimate future care requirements. Funding for this study was provided by the Spanish National I + D Program (grant number STPY 1346/09). The funding body had no further role in study design, data collection, analysis, interpretation, writing of the report, or the decision to submit the paper for publication. We especially thank the Subdirección General de Información Sanitaria e Innovación (MSSI) for providing the data used in this study. Sí

El tratamiento de niños con deficiencia de hormona de crecimiento (GH) ha evolucionado considerablemente desde que empezó a utilizarse la de cadáveres humanos (1958), hasta la llegada de la hormona humana recombinante (1985). Este avance biotecnológico permitió ampliar su uso al disponer de las cantidades necesarias, así como por la mayor seguridad biológica de ésta y los refinamientos significativos en su dosificación y frecuencia de administración, con notables resultados en la talla final de estos niños. Sin embargo, tanto la existencia de fenotipos no respondedores como, más comúnmente, la falta de cumplimiento terapéutico, pueden constituir importantes limitaciones de eficacia con la consiguiente repercusión económica para los sistemas sanitarios, que puede paliarse mediante innovaciones en los dispositivos de administración.

A better assessment of the incidence and mortality due to envenomation should improve the antivenom supply and consequently management of snakebites. Currently, in most countries, notification of snakebite is insufficient and irregular. An alternative is to consider data from the literature to estimate the incidence and mortality. The gaps and bias resulting from this method can be corrected using a meta-analytic model adjusted with a randomized coefficient, which provides an average incidence and mortality taking into account the relative weight and representativeness of each sample. The aim of the present study is to compare the results of the application of the meta-analytic model with the national notifications of snakebites in different European countries. To achieve this goal, a questionnaire was sent to health services of all European countries asking for the incidence, mortality and some parameters defining the population at risk of snakebites in Europe. Notifications were compared with the results of a recently published meta-analysis of literature data. Results showed an acceptable agreement, although significant differences in the incidence of snakebites occurred in some countries. The discussion emphasizes the limitations regarding notifications and underlines the potential biases that restrict the reliability of data from the literature. Finally, pending reliable notification of snakebites in all European countries, analyzing data from the literature is likely to be an acceptable and simple solution.

BACKGROUND: Self-management support is a key component of effective chronic care management, yet in practice appears to be the least implemented and most challenging. This study explores whether and how self-management support is integrated into chronic care approaches in 13 European countries. In addition, it investigates the level of and barriers to implementation of support strategies in health care practice. METHODS: We conducted a review among the 13 participating countries, based on a common data template informed by the Chronic Care Model. Key informants presented a sample of representative chronic care approaches and related self-management support strategies. The cross-country review was complemented by a Dutch case study of health professionals' views on the implementation of self-management support in practice. RESULTS: Self-management support for chronically ill patients remains relatively underdeveloped in Europe. Similarities between countries exist mostly in involved providers (nurses) and settings (primary care). Differences prevail in mode and format of support, and materials used. Support activities focus primarily on patients' medical and behavioral management, and less on emotional management. According to Dutch providers, self-management support is not (yet) an integral part of daily practice; implementation is hampered by barriers related to, among others, funding, IT and medical culture. CONCLUSIONS: Although collaborative care for chronic conditions is becoming more important in European health systems, adequate self-management support for patients with chronic disease is far from accomplished in most countries. There is a need for better understanding of how we can encourage both patients and health care providers to engage in productive interactions in daily chronic care practice, which can improve health and social outcomes. This study was conducted with support from the DISMEVAL consortium. It draws on additional information from DISMEVAL partners and key informants who contributed information on approaches to chronic disease management in selected countries: Fadila Farsi, Hélène Labrosse (DISMEVAL partner, Centre Anticancereux Leon Berard: cancer networks France), Taavi Lai (Estonia, Latvia, Lithuania); Péter Gaál and Márton Csere (Hungary); Walter Ricciardi, Antonio G. De Belvis, Maria Lucia Specchia, TD Luca Valerio (Italy); Liubove Murauskiene, Marija Veniute (Lithuania); and Isabelle Peytremann-Bridevaux, Bernard Burnand and Ignazio Cassis (Switzerland); and was undertaken in cooperation with nine Dutch primary care groups: Regionale Huisartsenzorg Maastricht/Heuvelland, Diabetes Zorgsysteem West-Friesland, Groninger Huisartsen Coöperatie, Huisartsenzorg Drenthe Medische Eerstelijns Ketenzorg, Eerstelijns Centrum Tiel, Coöperatie Zorgcirkels Woerden, Zorggroep Zwolle, Huisartsenketenzorg Arnhem, Cohesie Cure & Care. The DISMEVAL-project was funded under the European Commission’s Seventh Framework Programme (FP7) (grant no. 223277). See www.dismeval. eu for additional information. Sí

This review presents a geographic distribution of the three autochthonous venomous snake species, which are the only viperids present in Spain, among the Iberian fauna: Vipera aspid; Vipera seoianei and Vipera latasti. This is followed by a detailed descriptive analysis of hospital care provided to patients admitted into hospital due to venomous bites, in the period from 1997 to 2009, using the data from the Spanish hospital discharge registry database. This analysis reveals that in Spain, during this period, 1649 cases were recorded, which means that hospital care was required for more than one hundred cases per year, of which nearly 1% of the cases resulted in death. Cases were recorded in all the Autonomous communities, but more than half (54, 14%) were concentrated in the following four regions: Cataluña, Castilla and León, Galicia and Andalucía. It is notable that this concentration of cases is not associated only with the population demographics of the community, but is also the result of the concurrence of very diverse factors of exposure including: habitat of venomous fauna, volume of rural population, farming activities, and practice of outdoor leisure activities. We also carried out a gross economic calculation for the use of hospital resources by each snakebite case requiring hospital care in Spain, which provided us with an approximate figure of 2000€ per case., We would like to thank Dra. María Ángeles Gogorcena Aoiz, from the Institute of Health Information of the Ministry of Health, Social Services and Equality, for her help in accessing the data from the hospital discharge registry database. We would also like to thank Mr. Mario García París, Mr. Jesús Dorda and Ms. Soledad Alonso, from the National Museum of Natural Sciences of Madrid who have provided us the images of the three autochthonous viper species that appear in the article. This work is a partial result of the research agreement signed between the Instituto de Salud Carlos III and Instituto Bioclon S.L. de C.V. partially funded by “Fondo de Cooperación Internacional en Ciencia y Tecnología entre México y la Unión Europea” (FONCICYT) (application number 93608). It is part of a research project (ref. PI08/90612) of the Spanish National R&D plan. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

The deinstitutionalisation reform in Spain started after 1980 with the aim of reducing the need for hospitalisation, length of stay and the number of psychiatric hospital beds, as well as fostering psychiatric patient's involvement in the community. The aim of this study was to review how this reform process has affected the management of schizophrenic patients from 1980 to 2004.Longitudinal (1980-2004) study describing variables related to hospital morbidity in schizophrenia patients.Hospital admission rate has gradually increased from 1980 to 2004 from 3.71 admissions per 10,000 inhabitants to 5.89, respectively. Considering the type of admission, emergency or elective, whilst the latter has slightly decreased from 2.24 in 1980 to 1.72 in 2004, the first has almost tripled from 1.47 to 4.17. The point-prevalence of schizophrenic patients receiving inpatient treatment each year has decreased 78% in this period. Length of stay, in days per admission episode, has also decreased from 148 days in 1980 to 35 days in 2004.One of the main impacts of the psychiatric health care reform in Spain has been the considerable reduction in hospital capacity devoted to schizophrenic patients, based on the significant decrease in point-prevalence. Thus, it seems relevant to design new studies to quantify the resource reallocation to other areas of care, such as pharmacological treatment and community services.

BACKGROUND: Percutaneous radiofrequency ablation (RFA) has gained popularity in the treatment of hepatocellular carcinoma (HCC). However, its role versus other conventional minimally invasive therapies is still a matter of debate. The purpose of this work is to analyse the efficacy and safety of RFA versus that of ethanol injection (PEI), the percutaneous standard approach to treat nonsurgical HCC. METHODS: Systematic review and meta-analysis of randomised or quasi-randomised controlled trials published up to August 2008 in PubMed, ISI Web of Science and The Cochrane Library. Overall survival, local recurrence rate and adverse effects were considered as primary outcomes. Studies were critically appraised and estimates of effect were calculated according to the random-effects model. Inconsistency across studies was evaluated using the I2 statistic. Sensitivity analyses were conducted to explore statistical heterogeneity. RESULTS: Six studies were eligible. The studies reported data on 396 patients treated by RFA and 391 treated by PEI. In general, subjects were in Child-Pugh class A (74%) and had unresectable HCC (mean size 2.5 cm). Mean follow-up was 25 +/- 11 months. The survival rate showed a significant benefit for RFA over PEI at one, two, three and four years. The advantage in survival increased with time with Relative Risk values of: 1.28 (95%CI:1.12-1.45) and 1.24 (95%CI:1.05-1.48) for RFA versus PEI at 3- and 4-years respectively. Likewise, RFA achieved significantly lower rates of local recurrence (RR: 0.37, 95%CI: 0.23-0.59). The overall rate of adverse events was higher with RFA (RR:2.55, 95%CI: 1.8-3.6) yet no significant differences were found concerning major complications (RR:1.85, 95%CI: 0.68-5.01). There was not enough evidence supporting a better cost-effectiveness ratio for RFA compared to PEI. CONCLUSION: Available evidence from adequate quality controlled studies support the superiority of RFA versus PEI, in terms of better survival and local control of the disease, for the treatment of patients with relatively preserved liver function and early-stage non-surgical HCC. However, the higher rate of adverse events displayed is something that will have to be tested with appropriate weighting of the possible benefits in each individual case. Overall cost-effectiveness of RFA needs further evaluation. This study was commissioned by the Health Technology Assessment Programme on behalf of the Ministry of Health & Consumer Affairs and was partially funded by the Spanish National I+D Program Ministry of Science & Technology (to C Bouza, Z Saz and JM Amate, grant SEC 2001-0138 and PI08/90612). The funding body had no further role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. Sí

Human follicle-stimulating hormone (hFSH; follitropin alfa) can be employed therapeutically to induce ovarian follicular development in assisted reproduction treatments. Current recombinant hFSH (r-hFSH) preparations available for clinical use are labeled either in terms of the bioactivity expressed in international units (IU) or in mass (μg). Several clinical trials have tried to assess the clinical implications of the physicochemical improvements in the dosing of follitropin alfa filled by mass (FbM). The aim of this study was to perform a meta-analysis of previous studies in order to assess the efficacy and safety of ovarian stimulation using follitropin alfa FbM compared with follitropin alfa filled by international units (FbIU). A literature search was carried out in scientific databases to find published articles and abstracts comparing both hormone preparations. A fixed effects model meta-analysis was performed. The variables studied include the average dose (IU), days of treatment, estradiol peak, follicles >14 mm, number of extracted oocytes, number of embryos obtained, number of cases of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancies. A total of six studies met the stated criteria and were included in the meta-analysis. In these studies, the average r-hFSH dose per patient was 230.29 IU less with administration of follitropin alfa FbM compared with FbIU, and the number of days of treatment was reduced by 0.48. In addition, a significantly greater number of oocytes (0.84) were extracted, more embryos (0.88) were obtained, and a higher peak level of estradiol (613.08 pmol/L) was achieved in the patients undergoing ovarian stimulation with follitropin alfa FbM. However, no statistically significant differences were observed in the number of follicles >14 mm, clinical pregnancies, or OHSS cases. Follitropin alfa FbM, a technologically modified formulation of r-hFSH, is as safe as follitropin alfa FbIU but requires a smaller dose over a shorter period to produce more oocytes and final embryos.

BACKGROUND: Spinal fractures are a common source of morbidity in cancer patients. Balloon Kyphoplasty (BKP) is a minimally invasive procedure designed to stabilize fractures and correct vertebral deformities. We performed a meta-analysis to determine the efficacy and safety of BKP for spinal fractures in cancer patients. METHODS: We searched several electronic databases up to September 2008 and the reference lists of relevant publications for studies reporting on BKP in patients with spinal fractures secondary to osteolytic metastasis and multiple myeloma. Outcomes sought included pain relief, functional capacity, quality of life, vertebral height, kyphotic angle and adverse events. Studies were assessed for methodological bias, and estimates of effect were calculated using a random-effects model. Potential reasons for heterogeneity were explored. RESULTS: The literature search revealed seven relevant studies published from 2003 to 2008, none of which were randomized trials. Analysis of those studies indicated that BKP resulted in less pain and better functional outcomes, and that these effects were maintained up to 2 years post-procedure. While BKP also improved early vertebral height loss and spinal deformity, these effects were not long-term. No serious procedure-related complications were described. Clinically asymptomatic cement leakage occurred in 6% of all treated levels, and new vertebral fractures in 10% of patients. While there is a lack of studies comparing BKP to other interventions, some data suggested that BKP provided similar pain relief as vertebroplasty and a lower cement leakage rate. CONCLUSION: It appears that there is level III evidence showing BKP is a well-tolerated, relatively safe and effective technique that provides early pain relief and improved functional outcomes in patients with painful neoplastic spinal fractures. BKP also provided long-term benefits in terms of pain and disability. However, the methodological quality of the original studies prevents definitive conclusions being drawn. Further investigation into the use of BKP for spinal fractures in cancer patients is warranted. This study was supported by the Spanish I+D Program (grant PI060816). Sí

Objectives: This study explores whether and how self-management support (SMS), a key element of well-coordinated chronic care, is integrated into existing chronic care approaches in 13 European countries [1]. Methodology: An expert review was conducted using a data template informed by the Chronic Care Model [2]. Key informants (researchers and policymakers) from the 13 countries presented a sample of exemplary chronic care approaches and related SMS strategies. This was complemented by interviews with 27 Dutch care professionals investigating SMS implementation in practice. Results: SMS remains relatively underdeveloped in Europe. Country-specific strategies are similar in involved providers (nurses) and settings (primary care), yet differ considerably in mode, format and materials used. SMS focuses mainly on patients medical and behavioral management, and less on emotional management. According to Dutch providers, barriers in financing and medical culture (e.g. length of consultation, patient-doctor communication) hamper implementation of SMS as an integral part of chronic care. Conclusion: While Europe might increasingly be talking the talk of patient participation in chronic care, it appears far from walking the walk. Care professionals experience difficulties in operationalizing SMS in their daily routines. Stronger integration with the health promotion field may help patients and professionals to engage in productive partnerships.