For example , mammography screening does not seem to create anxiety in women who are given a clear result after a mammogram .
The incidence of breast cancer and mortality increases with age , and the GDG extrapolated that the absolute health benefits are greater in women aged 45 to 49 than those aged 40 to 44 years .
However , for the 45- to 49-year age group , the higher breast cancer incidence and mortality compared with women between the ages of 40 and 44 , as well as observational evidence showing a greater benefit in this age group ( 33 ) , led the GDG to judge that the balance of health effects probably favors screening , although the required re sources for screening likely differ across setting s ( 34 , 35 ) .
Other EtD criteria also were generally in favor of implementing organized mammography screening in this age group .
Despite intensified efforts by the European Council since 2003 , the implementation of organized , population -based mammography screening is not uniform across Europe and depends greatly on the policies in place in different countries , the organization of health care , and available re sources ( 1 ) .
Since the last edition of the European Guidelines on Breast Cancer Screening and Diagnosis was published in 2006 ( 2 ) , new evidence regarding breast cancer and innovation in guideline methodology prompted the European Commission Initiative on Breast Cancer ( ECIBC ) to develop new evidence -based recommendations ( in short , the European Breast Guidelines ) .
These guidelines inform women , health professionals , and policymakers about important questions related to organized mammography screening and breast cancer diagnosis , but recommendations may apply in context s in which organized screening programs are not in place .
Women generally consider these undesirable effects acceptable ( low certainty of evidence ) , and a systematic review suggested that women place a relatively low value on the psychosocial and physical effects of false-positive results and overdiagnosis ; however , some studies raised concerns about whether women fully underst and the result ing implication s ( 15 ) .
How Often Should Women Attend an Organized Mammography Screening Program ?
Methods for Development of the European Commission Initiative on Breast Cancer Guidelines
In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from
For example , mammography screening does not seem to create anxiety in women who are given a clear result after a mammogram .
The incidence of breast cancer and mortality increases with age , and the GDG extrapolated that the absolute health benefits are greater in women aged 45 to 49 than those aged 40 to 44 years .
However , for the 45- to 49-year age group , the higher breast cancer incidence and mortality compared with women between the ages of 40 and 44 , as well as observational evidence showing a greater benefit in this age group ( 33 ) , led the GDG to judge that the balance of health effects probably favors screening , although the required re sources for screening likely differ across setting s ( 34 , 35 ) .
Other EtD criteria also were generally in favor of implementing organized mammography screening in this age group .
Despite intensified efforts by the European Council since 2003 , the implementation of organized , population -based mammography screening is not uniform across Europe and depends greatly on the policies in place in different countries , the organization of health care , and available re sources ( 1 ) .
Since the last edition of the European Guidelines on Breast Cancer Screening and Diagnosis was published in 2006 ( 2 ) , new evidence regarding breast cancer and innovation in guideline methodology prompted the European Commission Initiative on Breast Cancer ( ECIBC ) to develop new evidence -based recommendations ( in short , the European Breast Guidelines ) .
These guidelines inform women , health professionals , and policymakers about important questions related to organized mammography screening and breast cancer diagnosis , but recommendations may apply in context s in which organized screening programs are not in place .
Women generally consider these undesirable effects acceptable ( low certainty of evidence ) , and a systematic review suggested that women place a relatively low value on the psychosocial and physical effects of false-positive results and overdiagnosis ; however , some studies raised concerns about whether women fully underst and the result ing implication s ( 15 ) .
How Often Should Women Attend an Organized Mammography Screening Program ?