Quality assurance in follow-up and initial treatment ... - Semantic Scholar

International Journal for Quality in Health Care 2002; Volume 15, Number 1: pp. 000–000

Quality assurance in follow-up and initial treatment for screening mammography programs in 22 countries CARRIE N. KLABUNDE1, HE´LE`NE SANCHO-GARNIER2, STEPHEN TAPLIN3, STEINAR THORESEN4, NORIAKI OHUCHI5 AND RACHEL BALLARD-BARBASH1 FOR THE INTERNATIONAL BREAST CANCER SCREENING NETWORK (IBSN) 1

National Cancer Institute (NCI), Bethesda, MD, 3Center for Health Studies, Group Health Cooperative of Puget Sound, Seattle, Washington, DC, USA, 2Epidaure, Montpellier, France, 4The Cancer Registry of Norway, Oslo, Norway, 5Division of Surgical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan

Abstract Objective. To describe the quality assurance activities related to follow-up evaluation of abnormal screening mammograms and subsequent initial treatment of women determined to have breast cancer for the screening programs represented in the International Breast Cancer Screening Network (IBSN). Design. Analysis of data from a survey that included questions about screening program policies, standards, and procedures for follow-up of women with abnormal mammograms, as well as the data and measures that programs use to assess the adequacy of follow-up and initial treatment. Setting and participants. IBSN representatives in 23 countries completed a comprehensive questionnaire between May and December 1998. Results. Two-thirds of IBSN countries reported that they have a written policy or guidelines for follow-up of an abnormal mammogram; 64% require accreditation of the cytology or pathology laboratories that analyze breast specimens, or subject pathology laboratories to external audits. Of the 22 activities and measures related to quality of follow-up and initial treatment that we examined, all countries had in place at least half of them, although countries were more likely to have implemented activities and measures related to data collection and evaluation than to processes of care. Conclusions. Population-based screening mammography programs cannot achieve the goal of reducing breast cancer mortality if women with abnormal mammograms do not receive appropriate, timely follow-up and initial treatment. This study shows that IBSN countries vary in their implementation of procedures and measures to assure the quality of followup and initial treatment for women with abnormal screening mammograms. There is more emphasis on collecting and evaluating data than establishing mechanisms to ensure that the processes of care for follow-up and initial treatment are of high quality. Keywords: breast cancer, follow-up, mammography, quality assurance, screening, treatment

Clinical trial evidence demonstrating breast cancer mortality reductions in asymptomatic women receiving mammography has prompted many countries to establish population-based screening mammography programs [1]. While the ultimate goal of such programs is to achieve reductions in breast cancer mortality comparable to those established in clinical trials, this goal will not be realized if a high proportion of women in the target population do not attend for screening, and if women with abnormal screening mammograms do

not receive appropriate and timely follow-up and initial treatment [2–6]. Population-based programs also must carefully monitor the outcomes associated with diagnostic followup of abnormal mammograms to ensure that women are not being subjected to unnecessary invasive procedures (e.g. fineneedle aspiration cytology, core biopsy, open biopsy) [2]. Moreover, several countries have begun to examine the impact of their population-based programs on breast cancer mortality [7–11]. Because mortality reduction can be attributable to

Address reprint requests to Carrie Klabunde, NCI/DCCPS/ARP, Health Services and Economics Branch, EPN Room 4005, 6130 Executive Boulevard, Bethesda, MD 20892-7344, USA. E-mail: [email protected]

 2002 International Society for Quality in Health Care and Oxford University Press

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C. N. Klabunde et al.

Figure 1 Diagram of the screening mammography process, including follow-up and treatment. Adapted with permission from Klabunde et al. [15].

screening as well as to receipt of state-of-the-art treatment, countries engaging in such evaluation require comprehensive data on all aspects of the breast cancer early detection continuum, from screening to follow-up of abnormal results and treatment of identified breast cancers. For these reasons, population-based screening mammography is best viewed as a process that extends beyond the mammography examination itself to include follow-up of women with abnormal results and, if cancer is detected, assessment of treatment received (Figure 1). Furthermore, evaluation of program performance and impact requires data on cancer outcomes which ideally are obtained through access to a high-quality cancer registry operating within the geographic region targeted by the screening program [2]. Defined as a system of procedures, checks, audits, and corrective actions to ensure that health services and reporting activities are of the highest achievable quality [12], quality assurance is crucial in achieving optimal screening program

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benefit. In recognition of this vital role, the International Breast Cancer Screening Network (IBSN), a voluntary consortium of 25 countries with population-based breast cancer screening programs, undertook an assessment of the scope of quality assurance activities for screening mammography across member countries in 1998. The goal of the IBSN is to obtain and analyze data on the policies, administration, performance, and outcomes of population-based breast cancer screening. Descriptions of the organization, funding, coverage policies, and operating procedures for the screening programs in IBSN countries have been published elsewhere [13,14]. The quality assurance assessment consisted of four major components: organization of quality assurance, technical quality control, quality assurance in follow-up and initial treatment, and quality assurance for data collection systems. Each component is summarized in a separate paper [15–17]. This report describes the quality assurance activities related to follow-up diagnostic evaluation of abnormal screening

QA in follow-up and treatment

mammograms and subsequent initial treatment of women determined to have breast cancer for the screening programs represented in the IBSN. Both the extent to which quality assurance activities include processes of care and the collection and evaluation of data are considered. The assessment covers the major themes of organization of screening, assuring quality in the follow-up of abnormal screening mammograms, and accessibility of data on initial treatment and tumor characteristics.

Methods A working group comprised of IBSN representatives from eight countries was formed in October 1997 to develop and implement the quality assurance assessment. Between November 1997 and April 1998, the working group constructed a comprehensive questionnaire designed to assess the following aspects of screening mammography quality assurance: organization of quality assurance; site visits and accreditation; quality control; quality assurance for data systems; quality assurance in follow-up and initial treatment; and program performance and impact measures. Existing screening mammography guidance documents addressing quality assurance [2, 18–20] were consulted in the development of the questionnaire. The section on quality assurance in follow-up and initial treatment included questions about program policies, standards, and procedures in general, as well as those specific to surgical evaluation, cytology, and pathology. Items asking about calculation of measures to evaluate the adequacy of follow-up and access to data on treatment and tumor characteristics also were included. Thus, the questionnaire section on quality assurance in follow-up and initial treatment covered activities related to both processes of care and the collection and evaluation of data. Questionnaire drafts were reviewed by working group members and experts in screening mammography and questionnaire design. The finalized questionnaire was mailed in late May 1998 to IBSN representatives in the 23 countries participating in the IBSN at that time. Representatives from countries with organized screening programs and opportunistic screening (i.e. screening occurring outside of organized programs) were asked to respond for the quality measures of their organized programs. Representatives from countries with multiple organized screening programs were asked to provide, if possible, a summary response that reflected the majority of programs. Because the United States does not have an organized national or regional screening program comparable to those found in many European and other countries with more centralized health care systems, the questionnaire was sent to a representative from the National Cancer Institute (NCI) who is responsible for a program of surveillance research focusing on communitybased screening mammography within a multi-region, organized mammography registry system [21]. Thus, data for the United States reflect a diverse subset of health care facilities engaged in screening mammography and contributing data on mammography practice and outcomes to a

centralized statistical center. Investigators in this mammography registry system are evaluating mammography performance and outcomes within defined populations, an objective common to all of the screening programs represented in the IBSN. While the facilities providing data to the registry system are not a census of all facilities, they are generally representative of screening mammography practice in the United States and cover diverse geographical regions in the country. Completed questionnaires were received from all 23 countries. Data were coded and entered into a Microsoft Access database. Responses were reviewed by the working group in October 1998. After clarification of missing or unclear responses by re-contacting each country’s IBSN representative as needed, responses were finalized in December 1998. Because the Republic of Ireland was in the process of developing a new national breast cancer screening program after concluding a pilot program, Ireland’s response is excluded from this report due to incomplete data. Comparisons were made between seven countries with population-based screening programs that are national in scope and 13 countries with screening programs that are more locally organized. In some cases, these are pilot programs that eventually may be expanded to encompass a larger geographical area within the country. For example, data provided for Japan reflect the pilot program in Miyagi prefecture; implementation of a national screening mammography program began in Japan in 2000. Data for Germany are included in this report, although it should be noted that a population-based screening program was in the planning and implementation stages in Germany at the time of the survey. As described above, data for the United States represent an organized mammography registry system, and are summarized separately. Nearly all of the countries with organized screening mammography programs also have opportunistic screening. However, because few of these countries collect or assess data on opportunistic screening, it is impossible to summarize opportunistic screening practice. Therefore, most countries are not able to examine cancer outcomes among women who are diagnosed outside of organized screening programs. In this assessment, we report data obtained from organized screening programs and registries, the only data currently available for international comparisons of screening mammography practice.

Results Characteristics of the screening mammography programs in the 22 responding countries are displayed in Table 1. All countries except Belgium and the United States reported having one or more organized programs designed to screen a designated target population in a systematic fashion. The Belgian program represented in this paper covers the city of Brussels and the region of Wallonia; an organized, populationbased screening program encompassing all of Belgium began implementation in 2001. As indicated by the number of

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programs, mammography facilities, X-ray units, and the proportion of the target population reached, screening programs vary considerably in size and scope. Furthermore, a variety of approaches to implementing quality assurance for these programs is evident, with nine countries doing so on a national basis, seven subnationally, and four using a combined national/subnational approach. In two countries (Belgium and Uruguay), screening mammography quality assurance is the responsibility of the individual mammography facilities. All but three countries (Belgium, Greece, and Hungary) have established linkages between screening program and cancer registry data, an important requirement for assessing program performance and impact [6]. In about half of these countries, though, the linkage is not fully computerized. Assuring quality in the follow-up of abnormal screening mammograms Sixteen countries (73%) reported that the screening mammography program is responsible for carrying out the followup diagnostic evaluation of an abnormal mammogram (Table 2). In the six countries in which screening mammography programs do not have this responsibility (Israel, The Netherlands, Belgium, Canada, Uruguay, United States), women with an abnormal mammogram are either referred to dedicated assessment centers or to their primary physician for further evaluation. Fifteen countries (68%) indicated that they have a written policy or guideline that delineates the steps to be taken to ensure follow-up of an abnormal mammogram. Fourteen countries (64%) have established standards for the percentage of all screening mammograms that are deemed to be abnormal; these standards range from 5–7% for all screens, 2–10% for first screens, and 1–7% for subsequent screens. Slightly over half (55%) of the countries have a specified time limit for follow-up of an abnormal mammogram; the time limit varied from 1 week (Denmark, Norway) to 1 month (Belgium, Spain, Greece, Japan, Uruguay). Five countries (23%) have established standards for a minimum percentage of abnormal mammograms that should have follow-up with fine needle aspiration, core biopsy, or open biopsy; of these countries, only Norway specifies standards for all three procedures. All countries reported having a set procedure for initiating surgical evaluation of women with abnormal mammograms (Table 3). Requiring the woman with an abnormal screen to contact the surgeon’s office to arrange evaluation is a more commonly used procedure (13 countries) than direct contact of the surgeon’s office by screening program staff (11 countries) or direct evaluation by a surgeon in the screening program (seven countries). Furthermore, as can be seen in Table 3, some countries use more than one mechanism for initiating surgical evaluation. In all countries, open biopsies are performed by surgeons, and in two, physicians other than surgeons also perform open biopsies: Uruguay (radiologists) and the United States (family physicians in certain rural areas). Five countries (23%) indicated that physicians who perform open biopsies are required to have certification in this procedure.

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Fourteen countries (64%) require accreditation of the cytology or pathology laboratories that analyze breast specimens, or subject pathology laboratories to periodic external audits (Table 4). Four countries (Australia, Netherlands, United Kingdom, United States) have all three of these quality assurance mechanisms in place; seven (Belgium, Denmark, Portugal, Sweden, Greece, Hungary, Japan) require accreditation of cytology and pathology laboratories but not external audits of pathology laboratories; two (Spain, Germany) subject pathology laboratories to periodic external audits; and one (Uruguay) requires accreditation of pathology laboratories. The remaining eight countries (Finland, Iceland, Israel, Luxembourg, Canada, France, Italy, Norway) do not have quality assurance requirements specific to cytology and pathology laboratories. All countries, however, indicated that screening programs have access to cytology and pathology data on breast lesions, and all but one (Portugal) reported that screening program staff must actively obtain these data, although in about two-thirds of the countries, cytology and pathology reports are also routinely forwarded to the screening program, thereby somewhat lessening the program’s data collection burden. Countries reported that screening programs use a variety of measures and procedures to evaluate the adequacy of follow-up to an abnormal mammogram (Table 5). All countries calculate and monitor a recall rate for their programs. Seventeen (77%) convene multi-disciplinary case conferences to review abnormal screening mammograms that subsequently are determined to be breast cancer, with 14 of these including a radiologist, pathologist, and surgeon in the case conference. Seventeen (77%) actively assess a benignto-malignant biopsy ratio, while the remaining five countries indicated that they have the data to do so although they do not currently assess this measure. Thirteen countries (59%) assess the sensitivity of screening mammography, with another six reporting that they could calculate this measure although they do not do so at present. Sixteen countries (73%) specify a target breast cancer detection rate, and all but one (Uruguay) assess the rate of interval cancers. Seventeen (77%) conduct radiological reviews of interval cancers. Access to data on initial treatment and tumor characteristics Eighteen of the 22 countries (82%) indicated that they are able to access data on surgery, radiation therapy, chemotherapy, hormonal therapy, tumor size, and lymph node involvement for women with abnormal mammograms who are diagnosed with breast cancer (Table 6). However, in nearly half of these countries (44%), access to data on adjuvant therapy (i.e. radiation therapy, chemotherapy, hormonal therapy) was reported to be with at least some difficulty. Only one country (Belgium) indicated that the screening program does not obtain data on either initial treatment or tumor characteristics. Two countries (United Kingdom, Canada) obtain data on surgery but not adjuvant therapy, while three (Finland, Canada, Denmark) do not obtain data on nodal involvement. Of the 21 countries that reported having access to data

30 18 25 10 40 20 60 100 2 25

1988 1991 1989 1990 1995 1990 1990 1986 1999 1989 1991 1989 1996 30 20

54 100 100 100 98 100 100

1991 1986 1987 1997 1992 1989 1988

8 7 10 2 1 128

811

35 163 1 900 26 7 7 2 26

1 10 1 26 22 1 1 1 26 3 3 1 1 1

35 11 3 42 10 55 94

1 1 1 1 1 1 1

166

8 7 10 3 2

40 179 1 1000 43 15 7 2 60

35+ 97 5 44 10 62 315

National, state6

National, state State State6 State Facilities

Facilities National, state State National6 State National State State6 National6

National National6 National National National National6 National, state

Yes5

Yes5 No No Yes7 Yes7

No Yes5,7 Yes5 Yes5,7 Yes7 Yes5 Yes7 Yes5,7 Yes5

Yes5 Yes5 Yes5 Yes5 Yes7 Yes5 Yes5,7

1 Percentage target population: the proportion of the national population of women deemed eligible to attend for screening and covered by organized screening programs within the country. 2 Mammography facility: a location at which women obtain screening mammography. Contains one or more X-ray units plus the staff required to perform the procedure. 3 Organization of Quality Assurance: state = state, provincial, local 4 Data for the screening program or mammography registry system are linked to cancer registry data. 5 Linkage of screening and cancer registry data is computerized. 6 Countries in which screening mammography quality assurance is required by law. 7 Linkage of screening and cancer registry data is manual. 8 Year implemented and percentage of target population covered by organized screening are blank because at the time of the survey, Belgium and the United States had not implemented organized, population-based screening programs. 9 Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. 10 Program in implementation phase. 11 The number of geographical regions participating in the mammography registry program.

National programs Australia Yes Finland Yes Iceland Yes Israel Yes Luxembourg Yes The Netherlands Yes United Kingdom Yes State, provincial, local programs Established program No Belgium8 Canada9 Yes Denmark Yes France9 Yes Italy9 Yes Norway Yes Portugal Yes Spain Yes Sweden9 Yes Pilot program Yes Germany10 Greece Yes Hungary Yes Japan Yes Uruguay Yes Registry program United States8 No

Organized Year Target Programs or Facilities2 X-ray units Organization of Linkage to 1 (%) registries (n) (n) (n) quality assurance3 cancer registry4 Screening implemented population .............................................................................................................................................................................................................................................................................................................

Table 1 Organization of screening mammography programs represented in the International Breast Cancer Screening Network, 1998


453

454

Yes Yes Yes No No No Yes

Yes No Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes No No

Yes Yes Yes No Yes No Yes

No No Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes No

No

No

No 7% No 3–5% No

No No No No No No No No 5%

No No 5% 5% No No No

No

7% 7% 7% No No

No No No 8% 6% 5% 4–5% No No

10% No 6% No No 2% 10%

No

5% 3% 5% No No

No No No 5% 4% 3% 2–3% No No

5% No 4% No No 1% 7%

No

Yes Yes No Yes Yes

Yes No Yes No No Yes Yes Yes No

(1 month)1 (1 month)1

(3 weeks)1 (1 month)1

(5 working days)1 (2–3 weeks)1 (1 month)1

(1–2 weeks)1

(1 month)1

Yes (10 working days)1 No No No No Yes (10 working days)1 Yes (3 weeks)1

No

No 3% No 1–2% No

No No No No No 1% No No No

No No No No No No No

No

No No No No No

No No No No No 1% No No No

2% No No No No No No

MM, mammogram; FNAC, fine needle aspiration cytology. 1 The screening program also monitors compliance with the time limit. 2 Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. 3 Program in implementation phase.

National programs Australia Finland Iceland Israel Luxembourg The Netherlands United Kingdom State, provincial, local programs Established program Belgium Canada2 Denmark France2 Italy2 Norway Portugal Spain Sweden2 Pilot program Germany3 Greece Hungary Japan Uruguay Registry program United States

Has policy or guideline for follow-up of abnormal MM

No

No 1% No 0.5% No

No No No No No 1% 0.6% No No

2% No No No No No No

Sets standards for percentage of Specifies time limit for Specifies minimum percentage abnormal screening MMs follow-up of abnormal of abnormal MMs for ............................................................. MM ordering: ........................................................ All screens First Subsequent FNAC Core Open screen screens biopsy biopsy .............................................................................................................................................................................................................................................................................................................

Program is responsible for carrying out followup of abnormal MM

Table 2 Follow-up of abnormal screening mammogram results by screening mammography programs represented in the International Breast Cancer Screening Network, 1998


X

X

X X

X

X

X

X X X

X

X X X

X

X

X

X

X X X X X X

X

X X X X X X X X X

X X X X X X X

X X X

X X

X X

X X X

X

X

X

X X

X3

X

X

X

X

X

X X

X

X

X

X X X X X

X X X X X X

2

Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. Program in implementation phase. 3 In Uruguay, radiologists but not surgeons are required to be certified in breast surgery.

1

National programs Australia Finland Iceland Israel Luxembourg The Netherlands UK State, provincial, local programs Established program Belgium Canada1 Denmark France1 Italy1 Norway Portugal Spain Sweden1 Pilot program Germany2 Greece Hungary Japan Uruguay Registry program United States

Open biopsies are performed by:

Physicians who perform open biopsies are required to be certified for breast surgery ............................................................................................................. ............................................................................... ............................................... Direct evaluation Direct contact Woman contacts Surgeons Radiologists Other physicians Yes No by surgeon in the between screening surgeon’s office to screening program program staff and arrange evaluation surgeon’s office .............................................................................................................................................................................................................................................................................................................

Procedure for initiating surgical evaluation

Table 3 Standards and procedures for surgical evaluation in the screening programs represented in the International Breast Cancer Screening Network, 1998


455

456

Yes No No No No Yes Yes

No No No No No No No Yes No Yes No No No No Yes

Yes1 No No No No Yes1 Yes

Yes No Yes1 No No No Yes1 No Yes1 No Yes1 Yes1 Yes1 Yes1 Yes1

Pathology labs undergo external audits

X

X X X X X

X X

X X X X X X

X X X X X X X

X

X

X X X X

X X

X X

X X X

X

X X X X X

X X X X X X X X X

X X X X X X X

X

X X X X X

X X

X X X X X X

X X X X X X X

2

Accreditation is required for the cytology/pathology laboratories used by the screening program. Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. 3 Program in implementation phase.

1

National programs Australia Yes1 Finland No Iceland No Israel No Luxembourg No The Netherlands Yes United Kingdom Yes State, provincial, local programs Established program Belgium Yes No Canada2 Denmark Yes1 France2 No No Italy2 Norway No Portugal Yes1 Spain No Sweden2 Yes1 Pilot No Germany3 Greece Yes1 Hungary Yes1 Japan Yes1 Uruguay No Registry program United States Yes1

Country has accreditation for pathology labs

X

X

X X X X

X X X

X X X X X X

Screening program has data access to: ................................................................................................................................................... Cytology Pathology .............................................. .................................................................................................. Active Passive Benign + Malignant Active Passive access access malignant only access access .............................................................................................................................................................................................................................................................................................................

Country has accreditation for cytology labs

Table 4 Standards review and accessibility of cytology and pathology data for the screening mammography programs represented in the International Breast Cancer Screening Network, 1998


No

Yes Yes Yes No Yes

Yes Yes Yes No Yes Yes No Yes Yes

No Yes Yes No Yes Yes Yes

R,P,S,O

R,T,P,S R,P,S R,P,S

R,P,S,O R,P,S,O

R,P,S T,P,S

R,P,S R,T R,P,S

R,P,S R,T,P R,T,P,S,O

R,T,P,S,O R,S,O

Could

Yes Yes Yes Could Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Could Could Could Yes

Yes

Yes Yes Could Yes Yes

No Could Yes Yes Yes Yes Could Yes No

Yes Yes Could Yes Could Could No

No

No No Yes Yes No

Yes No No No No No Yes No Yes

Yes Yes No Yes No No Yes

No

Yes No Yes No No

No No No Yes Yes Yes No Yes No

Yes No No Yes Yes Yes Yes

No

Yes No Yes No No

No No No Yes Yes Yes No Yes No

Yes No No Yes Yes Yes Yes

Yes

Yes Yes Yes Yes No

Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes

Yes

Yes Yes Yes Yes No

No Yes Yes Yes Yes Yes Yes Yes Yes

Yes No Yes No No Yes Yes

Personnel: O, other health care professional; P, pathologist; R, radiologist; S, surgeon; T, technologist. 1 Recall rate: the number of women who are asked to return to the screening unit (i.e. who are physically recalled) for a repeat mammogram due to a technical inadequacy of the screening mammogram (e.g. technical recall), or clarification of a perceived abnormality detected at the screening examination (e.g. recall for further assessment) per women screened. 2 Benign/malignant ratio: the ratio of pathologically proven benign to malignant lesions surgically removed in any round of screening. 3 Sensitivity: the ratio of histologically proven malignancies correctly identified at the screening examination to histologically proven malignancies identified and not identified at the screening examination (i.e. true positives/true positives + false negatives). 4 Cancer detection rate: the number of breast cancers detected per 1000 women screened. 5 Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. 6 Program in implementation phase.

National programs Australia Yes Finland Yes Iceland Yes Israel Yes Luxembourg Yes The Netherlands Yes United Kingdom Yes State, provincial, local programs Established program Belgium Yes Yes Canada5 Denmark Yes Yes France5 Italy5 Yes Norway Yes Portugal Yes Spain Yes Yes Sweden5 Pilot program Yes Germany6 Greece Yes Hungary Yes Japan Yes Uruguay Yes Registry program United States Yes

Convenes case Personnel Assesses Assesses Specified target breast cancer Assesses Conducts conferences to involved in the benign/ sensitivity3 detection rate4 interval radiologic review abnormal case conference malignant of screening ................................................................. cancer rate review of screens that are biopsy All screens First Subsequent interval screens screens cancers determined to be ratio2 breast cancer .............................................................................................................................................................................................................................................................................................................

Assesses recall rate1

Table 5 Measures and procedures for evaluating adequacy of follow-up within the screening mammography programs represented in the International Breast Cancer Screening Network, 1998


457

458

Yes Yes Yes Yes1 Yes

Yes Yes Yes Yes1 Yes Yes

X

X

Yes X X X X

Yes

No No Yes Yes1 Yes1 Yes Yes Yes Yes1

No No Yes Yes1 Yes1 Yes Yes Yes Yes1

X

Yes1 Yes Yes Yes1 Yes1 Yes1 No

Yes Yes Yes Yes1 Yes1 Yes1 No

X X X X X X X

Yes

Yes Yes Yes Yes1 Yes

Yes Yes Yes Yes

No No Yes Yes1

Yes1 Yes Yes Yes1 Yes1 Yes1 No

Sometimes

Always Always Sometimes

Always Always

Always

Sometimes

Sometimes

Sometimes

Sometimes

Always Always Always

Always

Always

Sometimes

Always Sometimes

Sometimes

Always Always Always Always Sometimes

Always Always Always Always Always Always Always Always

Always Sometimes Always Always Always Always Always

Sometimes

Always Always Always

Always Always

Always

Always

Sometimes

Sometimes

Always Always Always Always Always

Always Always Always Always Always Always

Always Always Always Always Always

Always

2

Data are obtained, but with some difficulty. Screening programs in these countries do not obtain data on nodal assessment. 3 Screening program does not obtain data on surgery. 4 Countries with a decentralized (subnational) organization of screening mammography, but in which the totality of organized screening programs attains national coverage. 5 Program in implementation phase.

1

National programs Australia X Finland2 Iceland X Israel X Luxembourg X The Netherlands X United Kingdom X State, provincial, local programs Established program Belgium2,3 X Canada2,4 Denmark2 X France4 X X Italy4 Norway X Portugal Spain X X Sweden4 Pilot program X Germany5 Greece X Hungary Japan X Uruguay X Registry program United States X

Radiation Chemo- Hormone Basis for assessment of nodal Surgery therapy therapy therapy Basis for tumor size estimates: involvement ................................... .............................................................................................. .................................................................... Active Passive Clinical Clinical Pathologists’s Palpation Pathologic access access assessment pre- assessment at measurement diagnosis surgery surgery .............................................................................................................................................................................................................................................................................................................

Table 6 Access to data on initial treatment and tumor characteristics for the screening programs represented in the International Breast Cancer Screening Network, 1998



on surgery, all but three (Finland, Portugal, Hungary) indicated that screening program staff actively seek these data, although about half of the countries noted that surgical reports are also routinely forwarded to the screening program. Among the countries that obtain data on tumor characteristics (i.e. assessments of tumor size and nodal status), pathological analysis was more often cited as the source of these data than was clinical assessment.

Discussion Quality assurance involves an ongoing process of monitoring health services to ensure the provision of appropriate care that contributes to desired outcomes [22]. In screening mammography, population-based programs strive to demonstrate a reduction in breast cancer mortality in the screened population by attempting to identify a high proportion of the breast cancer extant in the target population, optimize the rates of referral for follow-up diagnostic evaluation, and detect a high proportion of breast cancers with small tumor size and no nodal involvement [23]. Attainment of these goals necessitates careful attention to the processes of care involved in screening delivery, as well as the collection and evaluation of data on screening delivery and outcomes. In particular, programs must ensure not only high standards for screening but also that women with abnormal mammograms receive appropriate and timely follow-up diagnostic evaluation and, if cancer is detected, high-quality treatment. We assessed the extent to which the quality assurance activities of the screening mammography programs represented in the IBSN extend to follow-up of abnormal mammograms and, when breast cancer is identified, initial treatment. We examined approximately 22 different activities and measures addressing procedures and processes for followup of abnormal mammograms, and data collected on followup and initial treatment to facilitate evaluation of screening outcomes and program impact. Results show that all countries have in place at least half of the quality assurance activities and measures considered in this evaluation, although there is variation in the extent to which these mechanisms have been implemented. For example, four countries (Israel, Luxembourg, Belgium, Canada) have implemented approximately half of the activities and measures, while nine countries (Finland, Iceland, Netherlands, Denmark, France, Italy, Hungary, Uruguay, United States) have about two-thirds in place and another nine (Australia, United Kingdom, Norway, Portugal, Spain, Germany, Sweden, Greece, Japan) have implemented three-quarters or more. Countries with nationally organized screening programs did not appear to be more likely to have implemented these mechanisms than did countries with programs that were organized more locally. Most countries, however, appeared to place greater emphasis on quality assurance activities for follow-up and initial treatment that involve the collection and evaluation of data than the implementation of mechanisms addressing processes of care. We considered that nine of the mechanisms reflected such processes of follow-up care as having time limits for

investigation of abnormal results, requiring accreditation or external audits of cytology and pathology laboratories, and conducting case conferences to review abnormalities that are subsequently determined to be breast cancer. Another nine concerned collection of data on follow-up of abnormal screening mammograms such as assessing the recall rate, benign-to-malignant biopsy ratio, cancer detection rate, and interval cancer rate. On average, countries reported having five of the processes of care measures and seven of the data collection measures in place. This finding may reflect differences in screening program organization, as programs in slightly over one-quarter of the countries reported not having responsibility for carrying out the follow-up of an abnormal mammogram. It may also be an indication of the influence of quality assurance guidance documents, especially the European Guidelines for Quality Assurance in Mammography Screening [2], which place greater emphasis on the data that programs should collect to monitor follow-up and initial treatment than on specifying activities for ensuring highquality processes of care in follow-up and initial treatment. However, it is important to point out that we do not know which quality assurance mechanisms are associated with optimal screening mammography program performance. Furthermore, because the questionnaire that comprised the data source for this report covered multiple aspects of screening mammography quality assurance, we were limited in the number of items that could be included on the topic of quality assurance in follow-up and initial treatment. For example, monitoring the recall rate is at best an indirect means of assessing whether women with abnormal mammograms receive appropriate follow-up and initial treatment. A ‘time to follow-up’ or ‘lost to follow-up’ measure might be more informative. The rate of screen-detected, in situ breast cancers is also an important measure of program performance; however, these measures were not captured in our assessment. Likewise, we did not evaluate whether and how individual countries respond when screening mammography programs do not adhere to defined quality standards. Three countries appear to be particularly comprehensive in their implementation of quality assurance mechanisms related to follow-up and initial treatment. Australia reported having all but one of the indicators considered in this evaluation in place. Norway responded that it has implemented all of the measures with the exception of accreditation of cytology and pathology laboratories and external auditing of pathology laboratories. The United Kingdom is noteworthy because, despite the size and considerable complexity of this national program, it too has implemented nearly all of the quality assurance aspects we considered. All three countries have developed quality assurance guidelines specific to their screening programs [15,19,20]. The United Kingdom has been particularly active in this regard, having published separate sets of guidelines addressing quality assurance for cytology, pathology, and surgical services [24–26]. It should be noted that Canada has recently initiated efforts to develop and monitor quality assurance standards specific to follow-up and treatment [27]. Quality assurance in follow-up and treatment is integral to

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the goal of demonstrating a reduction in breast cancer mortality attributable to population-based screening programs. As stated in the European Guidelines [2], ‘a high quality screening program can only lead to a long-term mortality reduction if the treatment of women detected at screening is of equally high quality’. Activities and measures that most programs should have in place to evaluate program impact on mortality include monitoring the cancer detection rate, interval cancer rate, recall rate, benign to malignant biopsy ratio, and size and nodal status of screen-detected tumors [23]. Furthermore, the most efficient means of accessing the cancer outcomes data necessary for such an evaluation usually requires linkage to a cancer registry located in the region targeted by the screening program. The results of the IBSN quality assurance assessment reported here and in a previous paper [16] suggest that only about one-quarter of IBSN countries have screening programs that have been operating for a time period of sufficient length, and with procedures and data of sufficient comprehensiveness to permit such evaluation. Australia, The Netherlands, the United Kingdom, Sweden, and the United States (through the Breast Cancer Surveillance Consortium) are among these countries. A few of these countries have begun to publish the results of their efforts to evaluate screening program impact on breast cancer mortality [11,28,29]. In summary, this study shows that IBSN countries vary in their implementation of procedures and measures to assure the quality of follow-up and initial treatment for women with abnormal screening mammograms. Most of the countries give greater attention to collecting and evaluating data on follow-up and initial treatment than to establishing mechanisms to ensure that the processes of care for follow-up and initial treatment are of high quality. We anticipate, however, that as more countries begin to assess the long-term impact of their population-based programs, they will increase their activities related to this integral component of the breast cancer early detection continuum.

Acknowledgements The following IBSN members and collaborators contributed data to this study: P. Jha, B. Chapple, Australia; A. Grivegne´ e, Belgium; F. Bouchard, Canada; E. Lynge, Denmark; M. Hakama, Finland; H. Sancho-Garnier, J. Stines, France; L. von Karsa, Germany; I. Garas, A. Linos, E. Riza, Greece; E. Szabo`, A. Petra`nyi, Hungary; B. F. Sigfu´ sson, Iceland; J. Buttimer, Ireland; G. Rennert, Israel; E. Paci, E. Gentile, M. Rosselli del Turco, Italy; N. Ohuchi, Japan; A. Scharpantgen, Luxembourg; M. Broeders, R. Holland, J. Hendricks, K. Siekman, J. Fracheboud, H. de Koning, The Netherlands; G. Skare, Norway; V. Rodrigues, Portugal; N. Ascunce, Spain; H. Malmquist, G. Svane, Sweden; S. Moss, J. Cooke, J. Patnick, United Kingdom; G. Pou, Uruguay; R. BallardBarbash, S. Taplin, B. Yankaskas, E. Hendrick, W. Barlow, USA. IBSN Quality Assurance Working Group members are: Rachel Ballard-Barbash (NCI, IBSN Chair), Franc¸ oise Bouchard (Canada), Mary Codd (Ireland), Andre Grivegne´ e

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(Belgium), Edward Hendrick (USA), Carrie Klabunde (NCI, Study Coordinator), Gonzalo Pou (Uruguay), Vitor Rodrigues (Portugal), He´ le`ne Sancho-Garnier (France), Astrid Scharpantgen (Luxembourg), and Stephen Taplin (USA). The authors wish to thank Cindy Mattingly and James Cucinelli of Information Management Services, Inc. (Silver Spring, MD, USA) for expert assistance with questionnaire design and database programming. Funding for this study was provided by the NCI (Bethesda, MD, USA).

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Accepted for publication 25 July 2002

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