Characteristics and impact of interventions to support healthcare providers' compliance with guideline recommendations for breast cancer: a systematic literature review.

BACKGROUND: Breast cancer clinical practice guidelines (CPGs) offer evidence-based recommendations to improve quality of healthcare for patients. Suboptimal compliance with breast cancer guideline recommendations remains frequent, and has been associated with a decreased survival. The aim of this systematic review was to characterize and determine the impact of available interventions to support healthcare providers' compliance with CPGs recommendations in breast cancer healthcare. METHODS: We searched for systematic reviews and primary studies in PubMed and Embase (from inception to May 2021). We included experimental and observational studies reporting on the use of interventions to support compliance with breast cancer CPGs. Eligibility assessment, data extraction and critical appraisal was conducted by one reviewer, and cross-checked by a second reviewer. Using the same approach, we synthesized the characteristics and the effects of the interventions by type of intervention (according to the EPOC taxonomy), and applied the GRADE framework to assess the certainty of evidence. RESULTS: We identified 35 primary studies reporting on 24 different interventions. Most frequently described interventions consisted in computerized decision support systems (12 studies); educational interventions (seven), audit and feedback (two), and multifaceted interventions (nine). There is low quality evidence that educational interventions targeted to healthcare professionals may improve compliance with recommendations concerning breast cancer screening, diagnosis and treatment. There is moderate quality evidence that reminder systems for healthcare professionals improve compliance with recommendations concerning breast cancer screening. There is low quality evidence that multifaceted interventions may improve compliance with recommendations concerning breast cancer screening. The effectiveness of the remaining types of interventions identified have not been evaluated with appropriate study designs for such purpose. There is very limited data on the costs of implementing these interventions. CONCLUSIONS: Different types of interventions to support compliance with breast cancer CPGs recommendations are available, and most of them show positive effects. More robust trials are needed to strengthen the available evidence base concerning their efficacy. Gathering data on the costs of implementing the proposed interventions is needed to inform decisions about their widespread implementation. TRIAL REGISTRATION: CRD42018092884 (PROSPERO).

The GIN-McMaster guideline tool extension for the integration of quality improvement and quality assurance in guidelines: a description of the methods for its development.

BACKGROUND AND OBJECTIVES: Our objective was to develop an extension of the widely used GIN-McMaster Guideline Development Checklist and Tool for the integration of quality assurance and improvement (QAI) schemes with guideline development. METHODS: We used a mixed-methods approach incorporating evidence from a systematic review, an expert workshop and a survey of experts to iteratively create an extension of the checklist for QAI through three rounds of feedback. As a part of this process, we also refined criteria of a good guideline-based quality indicator. RESULTS: We developed a 40-item checklist extension addressing steps for the integration of QAI into guideline development across the existing 18 topics and created one new topic specific to QAI. The steps span from 'organization, budget, planning and training', to updating of QAI and guideline implementation. CONCLUSION: The tool supports integration of QAI schemes with guideline development initiatives and it will be used in the forthcoming integrated European Commission Initiative on Colorectal Cancer. Future work should evaluate this extension and QAI items requiring additional support for guideline developers and links to QAI schemes.

The 2022 ENCR Recommendations on recording and reporting of urothelial tumours of the urinary tract.

An updated European Network of Cancer registries (ENCR) Recommendations on Recording and Reporting of Urothelial Tumours of the Urinary Tract had been published in 2022. After the publication by the ENCR of the "Recommendations for coding bladder cancers" in 1995, knowledge about the biology and pathology of urinary tract tumors and their classification has varied and increased substantially. On the other hand, several studies have shown that cancer registries use different definitions, criteria for inclusion and coding of urothelial tumors. This great variability among registries affects not only the criteria for recording (registration, coding and classification) but also the criteria of reporting (counting in the statistics of incidence and survival) urinary tract tumors. This causes difficulties in the data comparability from different registries. Recording and reporting of urothelial tumors requires the application of standard criteria that must take into account the combination of the multiple aspects as the primary topography, the histological type, the grade, the extent of invasion, the multi-centricity, the progressions and the time interval between tumors. This led to the creation of a Working Group of the ENCR that developed these recommendations on the recording and reporting of urothelial tumors of the urinary tract. This article reports these recommendations and the rationale for each.

The ecosystem of health decision making: from fragmentation to synergy.

Clinicians, patients, policy makers, funders, programme managers, regulators, and science communities invest considerable amounts of time and energy in influencing or making decisions at various levels, using systematic reviews, health technology assessments, guideline recommendations, coverage decisions, selection of essential medicines and diagnostics, quality assurance and improvement schemes, and policy and evidence briefs. The criteria and methods that these actors use in their work differ (eg, the role economic analysis has in decision making), but these methods frequently overlap and exist together. Under the aegis of WHO, we have brought together representatives of different areas to reconcile how the evidence that influences decisions is used across multiple health system decision levels. We describe the overlap and differences in decision-making criteria between different actors in the health sector to provide bridging opportunities through a unifying broad framework that we call theory of everything. Although decision-making activities respond to system needs, processes are often poorly coordinated, both globally and on a country level. A decision made in isolation from other decisions on the same topic could cause misleading, unnecessary, or conflicted inputs to the health system and, therefore, confusion and resource waste.

A multipurpose TNM stage ontology for cancer registries.

BACKGROUND: Population-based cancer registries are a critical reference source for the surveillance and control of cancer. Cancer registries work extensively with the internationally recognised TNM classification system used to stage solid tumours, but the system is complex and compounded by the different TNM editions in concurrent use. TNM ontologies exist but the design requirements are different for the needs of the clinical and cancer-registry domains. Two TNM ontologies developed specifically for cancer registries were designed for different purposes and have limitations for serving wider application. A unified ontology is proposed to serve the various cancer registry TNM-related tasks and reduce the multiplication effects of different ontologies serving specific tasks. The ontology is comprehensive of the rules for TNM edition 7 as required by cancer registries and designed on a modular basis to allow extension to other TNM editions. RESULTS: A unified ontology was developed building on the experience and design of the existing ontologies. It follows a modular approach allowing plug in of components dependent upon any particular TNM edition. A Java front-end was developed to interface with the ontology via the Web Ontology Language application programme interface and enables batch validation or classification of cancer registry records. The programme also allows the means of automated error correction in some instances. Initial tests verified the design concept by correctly inferring TNM stage and successfully handling the TNM-related validation checks on a number of cancer case records, with a performance similar to that of an existing ontology dedicated to the task. CONCLUSIONS: The unified ontology provides a multi-purpose tool for TNM-related tasks in a cancer registry and is scalable for different editions of TNM. It offers a convenient way of quickly checking validity of cancer case stage information and for batch processing of multi-record data via a dedicated front-end programme. The ontology is adaptable to many uses, either as a standalone TNM module or as a component in applications of wider focus. It provides a first step towards a single, unified TNM ontology for cancer registries.

Impact of the first wave of the COVID-19 pandemic on cancer registration and cancer care: a European survey.

BACKGROUND: The coronavirus disease COVID-19 pandemic posed a number of challenges to the oncology community, particularly the diagnosis and care of cancer patients while ensuring safety from the virus for both patients and professionals: minimization of visits to the hospital, cancellation of the screening programmes and the difficulties in the management and operation of cancer registries (CRs) while working remotely. This article describes the effects in the medium term of the first wave of the COVID-19 pandemic on cancer registration in Europe, focusing on changes in cancer detection and treatment, possible reduction of CR resources and difficulties in the access to data sources. METHODS: A questionnaire was distributed in June 2020 to the directors of 108 CRs from 34 countries affiliated to the European Network of Cancer Registries, providing a 37% response rate. RESULTS: The results of the survey showed that cancer-screening programmes were mostly stopped or slowed down in the majority of regions covered by the respondent CRs. Cancer diagnostics and treatments were severely disrupted. The cancer registration process was also disrupted, due to changes in the work modalities for the personnel, as well as to the difficulties in accessing sources and/or receiving the notifications. In some CRs, staff was allocated to different activities related to controlling the pandemic. Several CRs reported that they were investigating the impact of COVID-19 on cancer care via dedicated studies. CONCLUSIONS: A careful analysis will be necessary for proper interpretation of temporal and geographical variations of the 2020 cancer burden indicators.

The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers.

INTRODUCTION: Europe is an important focus for compiling accurate and up-to-date world cancer statistics owing to its large share of the world's total cancer burden. This article presents incidence and mortality estimates for 25 major cancers across 40 individual countries within European areas and the European Union (EU-27) for the year 2020. METHODS: The estimated national incidence and mortality rates are based on statistical methodology previously applied and verified using the most recently collected incidence data from 151 population-based cancer registries, mortality data and 2020 population estimates. RESULTS: Estimates reveal 4 million new cases of cancer (excluding non-melanoma skin cancer) and 1.9 million cancer-related deaths. The most common cancers are: breast in women (530,000 cases), colorectum (520,000), lung (480,000) and prostate (470,000). These four cancers account for half the overall cancer burden in Europe. The most common causes of cancer deaths are: lung (380,000), colorectal (250,000), breast (140,000) and pancreatic (130,000) cancers. In EU-27, the estimated new cancer cases are approximately 1.4 million in males and 1.2 million in females, with over 710,000 estimated cancer deaths in males and 560,000 in females. CONCLUSION: The 2020 estimates provide a basis for establishing priorities in cancer-control measures across Europe. The long-established role of cancer registries in cancer surveillance and the evaluation of cancer control measures remain fundamental in formulating and adapting national cancer plans and pan-European health policies. Given the estimates are built on recorded data prior to the onset of coronavirus disease 2019 (COVID-19), they do not take into account the impact of the pandemic.

Guideline-based quality assurance: a conceptual framework for the definition of key elements.

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.

Bringing two worlds closer together: a critical analysis of an integrated approach to guideline development and quality assurance schemes.

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.

An ontology-based approach for developing a harmonised data-validation tool for European cancer registration.

BACKGROUND: Population-based cancer registries constitute an important information source in cancer epidemiology. Studies collating and comparing data across regional and national boundaries have proved important for deploying and evaluating effective cancer-control strategies. A critical aspect in correctly comparing cancer indicators across regional and national boundaries lies in ensuring a good and harmonised level of data quality, which is a primary motivator for a centralised collection of pseudonymised data. The recent introduction of the European Union's general data-protection regulation (GDPR) imposes stricter conditions on the collection, processing, and sharing of personal data. It also considers pseudonymised data as personal data. The new regulation motivates the need to find solutions that allow a continuation of the smooth processes leading to harmonised European cancer-registry data. One element in this regard would be the availability of a data-validation software tool based on a formalised depiction of the harmonised data-validation rules, allowing an eventual devolution of the data-validation process to the local level. RESULTS: A semantic data model was derived from the data-validation rules for harmonising cancer-data variables at European level. The data model was encapsulated in an ontology developed using the Web-Ontology Language (OWL) with the data-model entities forming the main OWL classes. The data-validation rules were added as axioms in the ontology. The reasoning function of the resulting ontology demonstrated its ability to trap registry-coding errors and in some instances to be able to correct errors. CONCLUSIONS: Describing the European cancer-registry core data set in terms of an OWL ontology affords a tool based on a formalised set of axioms for validating a cancer-registry's data set according to harmonised, supra-national rules. The fact that the data checks are inherently linked to the data model would lead to less maintenance overheads and also allow automatic versioning synchronisation, important for distributed data-quality checking processes.

Adherence to breast cancer guidelines is associated with better survival outcomes: a systematic review and meta-analysis of observational studies in EU countries.

BACKGROUND: Breast 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. METHODS: We 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. RESULTS: We 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 5 years 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). CONCLUSIONS: Our 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 REGISTRATION: PROSPERO ( CRD42018092884 ).

Cancer cure for 32 cancer types: results from the EUROCARE-5 study.

BACKGROUND: Few studies have estimated the probability of being cured for cancer patients. This study aims to estimate population-based indicators of cancer cure in Europe by type, sex, age and period. METHODS: 7.2 million cancer patients (42 population-based cancer registries in 17 European countries) diagnosed at ages 15-74 years in 1990-2007 with follow-up to 2008 were selected from the EUROCARE-5 dataset. Mixture-cure models were used to estimate: (i) life expectancy of fatal cases (LEF); (ii) cure fraction (CF) as proportion of patients with same death rates as the general population; (iii) time to cure (TTC) as time to reach 5-year conditional relative survival (CRS) >95%. RESULTS: LEF ranged from 10 years for chronic lymphocytic leukaemia patients to <6 months for those with liver, pancreas, brain, gallbladder and lung cancers. It was 7.7 years for patients with prostate cancer at age 65-74 years and >5 years for women with breast cancer. The CF was 94% for testis, 87% for thyroid cancer in women and 70% in men, 86% for skin melanoma in women and 76% in men, 66% for breast, 63% for prostate and <10% for liver, lung and pancreatic cancers. TTC was <5 years for testis and thyroid cancer patients diagnosed below age 55 years, and <10 years for stomach, colorectal, corpus uteri and melanoma patients of all ages. For breast and prostate cancers, a small excess (CRS < 95%) remained for at least 15 years. CONCLUSIONS: Estimates from this analysis should help to reduce unneeded medicalization and costs. They represent an opportunity to improve patients' quality of life.

Healthcare providers' adherence to breast cancer guidelines in Europe: a systematic literature review.

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).

Systematic review on women's values and preferences concerning breast cancer screening and diagnostic services.

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.

Validated tools measuring women's satisfaction in breast cancer screening programmes: A systematic review.

International guidelines recommend assessing women's satisfaction with breast cancer screening programmes; however, validated tools are needed. A systematic review to identify and evaluate the quality of validated instruments for screening satisfaction, from 01/1965 until 11/2017 was performed. From 3283 individual citations, six instruments were identified. Evaluation of the MammoGraphy Questionnaire using the COSMIN checklist resulted in 'good' to 'excellent' scores in most assessed domains, while the other tools were mostly 'poor'/'fair' quality or did not provide enough information for assessment. Nevertheless, substantial changes in screening processes and programmes have been implemented in recent years. Thus, further development work is needed.