Cary S. Kaufman MD, FACS

Associate Clinical Professor of Surgery

University of Washington Department of Surgery

Bellingham Regional Breast Center

Bellingham, Washington, USA

 

 

Working Towards a Global Approach to High Quality Breast Cancer Care

There is a timely opportunity for those interested in improving the quality of breast cancer care in the world.  Multiple groups from varied countries who have provided breast cancer care are currently interested in defining and optimizing breast care.  Although each group has or will have developed their own set of guidelines and measures for optimal breast cancer care, it is an opportune time to collaborate between groups to achieve the best results in defining high quality care globally.

In the US, there are three national groups who are defining high quality care.  They are the National Accreditation Program for Breast Centers (1), the National Quality Measures for Breast Centers (2) and the Cancer LinQ program of the American Society of Clinical Oncologists (3).  Each of these programs, in their unique and different ways, have defined their view of high quality breast cancer care.  (Please note that the term accreditation is used in the US as certification is used in Europe.)

In Europe there is a mixture of quality programs offered or in development by individual countries including Germany, Italy, France, Spain, and many others.  In addition, there is an ongoing collaborative effort called the European Union Initiative on Breast Cancer (4) that is currently developing and crystalizing universal comprehensive guidelines and quality measures for breast cancer care for their member states.  This project is estimated to be complete by 2018.

From of global standpoint, the International Senologic Society (5) has developed and instituted an accreditation program for breast centers that is available for all member countries and organizations.   In addition, the Breast Centres Network (6) from the European Society of Oncologists has over 200 members who have voluntarily demonstrated the case volume and clinical structure available to provide high quality care.

The above collection of strategies directed to defining and optimizing the quality breast cancer care underscore the importance of defining and assessing breast cancer care.  This collection also demonstrate the redundancy of these efforts and the likelihood to have multiple non-uniform recommendations to assess aspects of breast care.  This lack of harmony between eventual guidelines and quality measures make it difficult for breast centers to comply with the variety of certifying agencies.  Whether it be an existing breast center that is trying to improve itself or a new breast center wishing to incorporate the essential quality measures in their center, it is unhelpful to have a spectrum of quality programs with different definitions of quality breast care.

Another aspect of assessing breast cancer care that must be addressed is the disparity in levels of resources available to varied breast centers and countries.  The concept of high quality breast care must be interpreted according to whom and in what environment?  Typically the World Banks separation of countries according to their per-capita gross national income has divided countries into four groups; high income, upper-middle income, lower-middle income and low income countries.  It is most helpful to utilize these dividing points when discussing optimal breast care since many options are influenced by fiscal issues.

What might be considered high quality care in a high income country may be impractical or unachievable in low-middle or low income countries.  Likewise, care considered high quality in an upper-middle income country may be considered extravagant in a similar upper-middle income country.  The National Comprehensive Cancer Network (7) has provided an initial set of documents that adjusts their overall breast cancer treatment guidelines into the four resource based levels.  Moving forward it will be necessary for future guidelines to be regionally appropriate in order to be fully functional.

These income adjusted guidelines are a step in the right direction but may also fail in achieving the desired goals of improving breast cancer care due to the lack of homogeneity in breast center care.  Even within an income group, the breast care may vary widely.  This can be due to the local availability of resources as well as local issues of governmental or payer control.  For example, in a country with a breast center within driving range of a radiation center, they may have a higher breast conservation rate than a center 200 miles away from the closest radiation facility.  These local and regional differences are often found with the differences between large cities and rural sites, government hospitals and community hospitals, centralized research facilities versus remote public sites. In these cases, applying an income based quality system for each site within a specific country will lack in many respects.  For a center in a particular income bracket, the site may perform exceptionally well in some aspects of breast care, while in other aspects they may perform poorly.  These differences may be less related to clinical quality but more related to their local resource environment.

When income modified written guidelines are utilized, improvements in breast cancer care may be variable across similar countries, across similar states, across similar cities and even across similar neighborhoods.  In the US, the quality of care may widely vary within the same hospital depending on the experience of the person performing the procedure, where the likelihood of having breast surgery without a prior needle biopsy varied from 10% to 37% (8). 

It is the individualized assessment of clinical breast care where certification or accreditation comes in to ensure provision of uniform high quality care.  The groups mentioned earlier in this paper have all agreed that some version of external on-site review or survey is necessary to confirm adherence to existing quality care guidelines.  The on-site survey or audit needs to interpret the level of care provided by an individual site, the available resources, the process of patient evaluation, and the coordination and administration of breast care services.  In this way, the auditor or surveyor can compile the issues and unique situational nuances and provide a quality assessment that written compliance with guidelines will not provide.  Each individual breast center has their own set of circumstances which promote or hinder certain levels of care.  This information can only be obtained by a direct evaluation by a professional experienced in the breast care field.

Each organization has established a method of audit of breast cancer care.  But each organization has defined quality care in different ways.  Most have looked at common breast care metrics, such as the measurement of estrogen receptor activity in breast cancer patients.  For each quality metric one must define the numerator and denominator.  Not all organizations define these the same way.  There are other quality measures that are not agreed upon for use as quality metrics.  Some of these include the indications for use of Trastuzumab, the use of genomic profiles, and even the use of breast conserving therapy and radiation therapy.  Many of the basic guidelines utilized by these organizations may be similar but often the definitions of the population to be included may vary.  It would be valuable for breast centers to have a harmonized uniform definition of quality metrics so that data management may be efficient and uniformly comparable. 

One of the reasons these quality variables are inconsistent is that there are relatively few existing level 1 randomized controlled studies of quality metrics for breast cancer care.  Most are level 2A or expert opinion, making harmonized quality measure uncommon.  This is an obvious target of a collaborative approach to developing quality measures.  Most organizations may agree that a measure in a specific area of breast care should have a quality measure, but the specifics may be elusive.  For example, fertility assessment prior to use of chemotherapy in a pre-menopausal woman may be a valuable area for a quality measure, but the exact wording, the definition of the numerator and denominator may vary among groups.  Likewise, use of targeted therapies such as Trastuzumab or Pertuzumab may have varied definitions of the numerator and denominator depending on the resource level of the country using the measure.

With so many groups focused on establishing quality measures for breast cancer care, it is obvious that collaboration is necessary to provide a uniform global approach to quality breast cancer care.  After all, breast cancer is the same disease, whether it is diagnosed in Italy or Slovakia, Rio de Janeiro or the Brazil Amazon, New York City or Grassy Butte, North Dakota.  It would be best if the differences found in breast care quality at breast centers were not related to the inadequate clinical knowledge of what the best quality care should be.   Guidance as to what should be done clinically is recognized by the organizations mentioned in this article.  We hope each member of those organizations will strive to cooperate and generate coherent, consistent, uniform quality measures for the optimal care of breast cancer patients that can be applied universally.

One of the challenges of establishing measures of quality care is that breast cancer management is a continuous variable, with changes ongoing year after year (9).  Changes in patterns of care were demonstrated with the uptake in use of sentinel node biopsy, and even more recently with the response to the Z-11 study where some patients forego axillary dissection in favor of axillary radiation.  With discussion and cooperation, a mutually agreeable quality measure can be generated for each of the areas of breast care.  Any individual quality measure is valid for a certain period of time, which will need revision, editing or replacement at regular intervals.  By establishing a collaborative approach to quality measures among these quality groups, these edits may be regularly applied, uniform and global. 

The steps to the next chapter in establishing a global approach to breast center quality measures may be seen as follows.  Those groups that believe they are primary in establishing and defining breast cancer care quality measures should declare themselves.  Once declared, a request to collaborate on defining breast cancer care quality measures should be sought.  For those organizations who are willing to cooperate, the next steps may be to identify the existing realms of breast care where quality measures are generally agreed upon.  Examples of these areas may be the use of needle biopsy rather than surgical biopsy; the use of breast conservation therapy; the use of radiation after lumpectomy in women under 70; the use of endocrine therapy for estrogen positive invasive cancers; the use of chemotherapy for estrogen negative invasive cancers; the data contained in a comprehensive pathology report as well as others.  These and other measures, in turn, need to be segregated according to regional resources. 

Once the commonly used quality measures are established, the less common and less uniformly written quality measures could be approached.  Not all organizations will agree on these measures or definitions, and this may take more time.  Yet, with the overall goal of providing a uniform global direction in breast cancer care, it is hoped that all organizations may participate in the development of optimal measures. 

Once a set of basic and uniform quality measures are established, a method to confirm compliance with these measures should be established.  Because these organizations already have their existing structure for on-site surveys, audits or on-line evaluations in place, these procedures will likely continue unchanged using a globally agreed upon set of quality measures and guidelines.  In some cases, a combined certification or accreditation program may be developed as the result of the cooperation described above.  An example of this collaboration is the newly formed combined Spanish/ISS certification program for breast centers in Spain where breast centers will have joint audit and receive dual certification.

Another final step might be the production of a white paper that describes the components of a breast center with attention to all the quality measures described by this collaborative program.  This document will be very useful to existing centers who wish to comply with global standards as well as any new program who wish to establish a high quality center.  When developing a new breast center, it is useful to have the tools to which your center will be judged, so that the center can incorporate quality metrics into their framework.  This document will also be valuable for centers who have obstacles of a political or governmental nature.  Those centers may use this global statement of optimal quality breast cancer care to validate their requests for financial help from governments or payers to provide the resources necessary to establish a high quality center.

Many of these goals have already been achieved individually by specific organizations mentioned above.  Yet, the achievable goal of providing high quality care for all women may be best achieved when these groups cooperate and agree where they can while maintaining their own independent identity.  Much can be achieved when organizations with similar goals join forces to improve the health of women across the globe. 

References

1. National Accreditation Program for Breast Centers found at: www.napbc-breast.org

2. National Quality Measures for Breast Centers found at: www2.nqmbc.org  

3. Cancer LinQ program of the American Society of Clinical Oncologists found at: www.cancerlinq.org  

4. European Union Initiative on Breast Cancer found at: http://ecibc.jrc.ec.europa.eu/overview   

5. International Senologic Society found at: www.sisbreast.org

6. Breast Centres Network (Senonetwork) found at: http://www.breastcentresnetwork.org 

7. National Comprehensive Cancer Network found at: http://www.nccn.org/framework/ 

8. Clarke-Pearson EM1, Jacobson AF, Boolbol SK, Leitman IM, Friedmann P, Lavarias V, Feldman SM. Quality assurance initiative at one institution for minimally invasive breast biopsy as the initial diagnostic technique. J Am Coll Surg. 2009 Jan;208(1):75-8. Epub 2008 Nov 7. 

9. Kaufman CS, Tucker FL, Rabinowitz B, Heckel T, Gass JS, et al. Changing Benchmarks of Quality Breast Care over 10 Years, Presented at ASCO Quality Conference February 26-27, 2016, Phoenix, AZ, USA

SIS Journal is the Electronic Journal of the Senologic International Society, the World Society of Breast Diseases. ISSN: 1688-8170