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Abstract 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)

Abstract Background Breast cancer is a common disease in Tunisia and is associated with high mortality rates. The “Instance Nationale de l’Evaluation et de l’Accréditation en Santé” (INEAS) and the Tunisian Society of Oncology decided to develop practice guidelines on the subject. While the development of de novo guidelines on breast cancer screening is a demanding process, guideline adaptation appears more appropriate and context sensitive. The objective of this paper is to describe the adaptation process of the European Guidelines on Breast Cancer Screening and Diagnosis to the Tunisian setting in terms of the methodological process, contextual differences between the source and adoloped guideline, and changes in the recommendations. Methods We used the ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE)-ADOLOPMENT methodology to prioritize the topic, select the source guideline, and prioritize the questions and the outcomes. Once the source guideline was selected—the European Breast Cancer Guidelines—the European Commission´s Joint Research Centre shared with the project team in Tunisia all relevant documents and files. In parallel, the project team searched for local studies on the disease prevalence, associated outcomes’ baseline risks, patients’ values and preferences, cost, cost-effectiveness, acceptability, and feasibility. Then, the adoloping panel reviewed the GRADE evidence tables and the Evidence to Decision tables and discussed whether their own judgments were consistent with those from the source guideline or not. They based their judgments on the evidence on health effects, the contextual evidence, and their own experiences. Results The most relevant contextual differences between the source and adoloped guidelines were related to the perspective, scope, prioritized questions, rating of outcome importance, baseline risks, and indirectness of the evidence. The ADOLOPMENT process resulted in keeping 5 out of 6 recommendations unmodified. One recommendation addressing “screening versus no screening with ultrasound in women with high breast density on mammography screening” was modified from ‘conditional against’ to ‘conditional for either’ due to more favorable ratings by the adoloping panel in terms of equity and feasibility. Conclusion This process illustrates both the feasibility of GRADE-ADOLOPMENT approach and the importance of consideration of contextual evidence. It also highlights the value of collaboration with the organization that developed the source guideline.

Abstract 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.

Abstract 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.

Abstract 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.

Summary: 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.

Abstract 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 ).

Abstract 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.

Introduction The Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable and undesirable people-important health outcomes. However, decision thresholds (DTs) that could help understand the magnitude of intervention effects and serve as reference for interpretation of findings are not yet available.The objective of this study is an approach to derive and use DTs for EtD judgments about the magnitude of health benefits and harms. We hypothesise that approximate DTs could have the ability to discriminate between the existing four categories of EtD judgments (Trivial, Small, Moderate, Large), support panels of decision-makers in their work, and promote consistency and transparency in judgments.Methods and analysis We will conduct a methodological randomised controlled trial to collect the data that allow deriving the DTs. We will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, we will investigate the validity of our DTs by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that our DTs approach would suggest if applied on the same guideline data.Ethics and dissemination The Hamilton Integrated Research Ethics Board reviewed this study as a quality improvement study and determined that it requires no further consent. Survey participants will be required to read a consent statement in order to participate in this study at the beginning of the trial. This statement reads: You are being invited to participate in a research project which aims to identify indicative DTs that could assist users of the GRADE EtD frameworks in making judgments. Your input will be used in determining these indicative thresholds. By completing this survey, you provide consent that the anonymised data collected will be used for the research study and to be summarised in aggregate in publication and electronic tools.PROTOCOL registration number NCT05237635.

Abstract Background Women treated for breast cancer are followed-up for monitoring of treatment effectiveness and for detecting recurrences at an early stage. The type of follow-up received may affect women’s reassurance and impact on their quality of life. Anxiety and depression among women with breast cancer has been described, but little is known about how the intensity of the follow-up can affect women’s psychological status. This study was undertaken to evaluate the effects of intensive vs. less-intensive follow-up on different health outcomes, to determine what are women’s preferences and values regarding the follow-up received, and also assess the costs of these different types of follow-up. Methods A systematic review following standard Cochrane Collaboration methods was carried out to assess the efficacy of intensive follow-up versus non-intensive follow-up in breast cancer patients. Two additional reviews on women’s preferences and economic evidence were also carried out. The search was performed up to January 2016 in: MEDLINE, EMBASE, PDQ, McMaster Health Systems Evidence, CENTRAL, and NHS EED (through The Cochrane Library). The quality of evidence was assessed by GRADE (for quantitative studies) and CerQUAL (for qualitative studies). Several outcomes including mortality, breast cancer recurrences, quality of life, and patient satisfaction were evaluated. Results Six randomised trials (corresponding to 3534 women) were included for the evaluation of health outcomes; three studies were included for women’s values and preferences and four for an economic assessment. There is moderate certainty of evidence showing that intensive follow-up, including more frequent diagnostic tests or visits, does not have effects on 5- or 10-year overall mortality and recurrences in women with breast cancer, compared with less intensive follow-up. Regarding women’s preferences and values, there was important variability among studies and within studies (low confidence due to risk of bias and inconsistency). Furthermore, intensive follow-up, as opposed to less intensive follow-up, is not likely to be cost-effective. Conclusions Less intensive follow-up appears to be justified and can be recommended over intensive follow-up. Resources could thus be mobilised to other aspects of breast cancer care, or other areas of healthcare.

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

**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.

Abstract 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.