Quality indicators in breast cancer care Rosselli Del Turco, M; Ponti, A; Bick, U ...
European journal of cancer (1990),
09/2010, Letnik:
46, Številka:
13
Journal Article, Conference Proceeding
Recenzirano
Abstract To define a set of quality indicators that should be routinely measured and evaluated to confirm that the clinical outcome reaches the requested standards, Eusoma has organised a workshop ...during which twenty four experts from different disciplines have reviewed the international literature and selected the main process and outcome indicators available for quality assurance of breast cancer care. A review of the literature for evidence-based recommendations have been performed by the steering committee. The experts have identified the quality indicators also taking into account the usability and feasibility. For each of them it has been reported: definition, minimum and target standard, motivation for selection and level of evidence (graded according to AHRO). In overall 17 main quality indicators have been identified, respectively, 7 on diagnosis, 4 on surgery and loco-regional treatment, 2 on systemic treatment and 4 on staging, counselling, follow-up and rehabilitation. Breast Units in Europe are invited to comply with these indicators and monitor them during their periodic audit meetings.
Abstract Introduction In recognition of the advances and evidence based changes in clinical practice that have occurred in recent years and taking into account the knowledge and experience ...accumulated through the voluntary breast unit certification programme, Eusoma has produced this up-dated and revised guidelines on the requirements of a Specialist Breast Centre (BC). Methods The content of these guidelines is based on evidence from the recent relevant peer reviewed literature and the consensus of a multidisciplinary team of European experts. The guidelines define the requirements for each breast service and for the specialists who work in specialist Breast Centres. Results The guidelines identify the minimum requirements needed to set up a BC, these being an integrated Breast Centre, dealing with a sufficient number of cases to allow effective working and continuing expertise, dedicated specialists working with a multidisciplinary approach, providing all services throughout the patients pathway and data collection and audit. It is essential that the BC also guarantees the continuity of care for patients with advanced (metastatic) disease offering treatments according to multidisciplinary competencies and a high quality palliative care service. The BC must ensure that comprehensive support and expertise may be needed, not only through the core BC team, but also ensure that all other medical and paramedical expertise that may be necessary depending on the individual case are freely available, referring the patient to the specific care provider depending on the problem. Conclusions Applying minimum requirements and quality indicators is essential to improve organisation, performance and outcome in breast care. Efficacy and compliance have to be constantly monitored to evaluate the quality of patient care and to allow appropriate corrective actions leading to improvements in patient care.
The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast centres to establish minimum standards and ensure specialist multidisciplinary ...care. Prospectively collected anonymous information on primary breast cancer cases diagnosed and treated in the units is transferred annually to a central EUSOMA data warehouse for continuous monitoring of quality indicators (QIs) to improve quality of care. Units have to comply with the EUSOMA Breast Centre guidelines and are audited by peers. The database was started in 2006 and includes over 110,000 cancers from breast centres located in Germany, Switzerland, Belgium, Austria, The Netherlands, Spain, Portugal and Italy. The aim of the present study is assessing time trends of QIs in EUSOMA-certified breast centres over the decade 2006–2015.
Previously defined QIs were calculated for 22 EUSOMA-certified breast centres (46122 patients) during 2006–2015.
On the average of all units, the minimum standard of care was achieved in 8 of 13 main EUSOMA QIs in 2006 and in all in 2015. All QIs, except removal of at least 10 lymph nodes at axillary clearance and oestrogen receptor–negative tumours (T > 1 cm or N+) receiving adjuvant chemotherapy, improved significantly in this period. The desirable target was reached for two QIs in 2006 and for 7 of 13 QIs in 2015.
The EUSOMA model of audit and monitoring QIs functions well in different European health systems and results in better performance of QIs over the last decade. QIs should be evaluated and adapted on a regular basis, as guidelines change over time.
•The time trends of quality indicators in EUSOMA-certified breast centres over the decade 2006–2015 are evaluated.•The EUSOMA model of audit and monitoring QIs functions well in different European health systems.•Audit and measuring quality indicators result in better performance.
This article is an update of the requirements of a specialist breast centre, produced by EUSOMA and endorsed by ECCO as part of Essential Requirements for Quality Cancer Care (ERQCC) programme, and ...ESMO.
To meet aspirations for comprehensive cancer control, healthcare organisations must consider the requirements in this article, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship.•The centrepiece of this article is the requirements section, comprising definitions; multidisciplinary structure; minimum case, procedure and staffing volumes; and detailed descriptions of the skills of, and resources needed by, members and specialisms in the multidisciplinary team in a breast centre.•These requirements are positioned within narrative on European breast cancer epidemiology, the standard of care, challenges to delivering this standard, and supporting evidence, to enable a broad audience to appreciate the importance of establishing these requirements in specialist breast centres.
We studied imaging, pathology and diagnostic aspects of false negative assessment (FNA) in women recalled for suspicious screening mammography.
Subjects were women aged 50-69 years undergoing ...biennial screening mammography within the Florence District screening programme from January 1992-December 2001 (339,953 consecutive screens). We identified all cancers occurring in women recalled to assessment and ascertained, and reviewed, all cases considered as negative on assessment and subsequently diagnosed with breast cancer. We compared imaging features, tumour histology and stage, and diagnostic testing on assessment for all women with cancer, and presentation and length of delay in women falsely negative on assessment.
Eleven thousand six hundred and twenty four women were recalled to diagnostic assessment (recall rate = 3.4%) predominantly for suspicious mammography (9,216 positive screens). Breast cancer was missed in 57 cases: a FNA rate of 0.50% (0.37-0.62%) and comprising 4.1% (3.0-5.1%) of cancers occurring in women recalled after a positive screen. Two types of abnormalities were significantly more frequent in FNA cases than cancers detected at assessment: mass with regular borders (21.1 vs. 5.6%, p = 10(-5)), and asymmetrical density (22.8 vs. 5.4%, p = 10(-5)). On review 56% of FNAs were benign or probably benign BI-RADS categories. FNA occurred in 1.4% of early recalls and in 0.4% of initial assessment (p=0.0001). Significantly fewer tests were performed when assessing missed cancers than detected cancers with the most significant difference noted for FNAC (29.8 vs. 96.0%, p=10(-6)); mammography as the only evaluation on assessment was more frequent in missed cancers (31.5% vs 0.2%, p = 10(-6)). The 57 missed cases were subsequently diagnosed at early recall (2 cases), next biennial screen (11 cases), or as interval breast cancers (44 cases) with a mean delay in diagnosis of 628 days. Tumour histology, size and nodal status did not significantly differ between cancers missed and cancers diagnosed on assessment.
False negatives on assessment represent a minority group in whom screening has failed. They might be reduced by adopting a more intensive diagnostic approach to assessment. Although there was no evidence of a worse prognosis in cancers missed at assessment, the delay in diagnosis is substantial and may impact long-term outcomes.
Abstract Aim of the study The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast units to establish minimum standards and ensure ...specialist multidisciplinary care. In the present study we assess the impact of EUSOMA certification for all breast units for which sufficient information was available before and after certification. Materials and methods For 22 EUSOMA certified breast units data of 30,444 patients could be extracted from the EUSOMA database on the evolution of QI's before and after certification. Results On the average of all units, the minimum standard of care was achieved for 12/13 QI's before and after EUSOMA certification (not met for DCIS receiving just one operation). There was a significant improvement of 5 QI's after certification. The proportion of patients with invasive cancer undergoing an axillary clearance containing >9 lymph nodes (91.5% vs 89.4%, p 0.003) and patients with invasive cancer having just 1 operation (83.1% vs 80.4%, p < 0.001) dropped, but remained above the minimum standard. The targeted standard of breast care was reached for the same 4/13 QI's before and after EUSOMA certification. Conclusion Although the absolute effect of EUSOMA certification was modest it further increases standards of care and should be regarded as part of a process aiming for excellence. Dedicated units already provide a high level of care before certification, but continuous monitoring and audit remains of paramount importance as complete adherence to guidelines is difficult to achieve.
Fenretinide, a vitamin A analogue, has been shown to inhibit breast carcinogenesis in preclinical studies. We determined the efficacy of fenretinide in preventing a second breast malignancy in women ...with breast cancer.
We randomly assigned 2972 women, aged 30-70 years, with surgically removed stage I breast cancer or ductal carcinoma in situ to receive for 5 years either fenretinide orally (200 mg/day) or no treatment. The primary end point was the incidence of contralateral breast cancer or ipsilateral breast cancer 7 years after randomization. Other end points considered post hoc were the same outcomes stratified by menopausal status, incidence of distant metastases, overall mortality, and tumors in other organs. The hazards of breast cancer occurrence were determined by Cox proportional hazards regression analysis. Statistical tests were two-sided.
At a median observation time of 97 months, there were no statistically significant differences in the occurrence of contralateral breast cancer (P =.642) or ipsilateral breast cancer (P =.177) between the two arms. However, an interaction was detected between fenretinide treatment and menopausal status in both outcomes (P for interaction in both outcomes =.045), with a possible beneficial effect in premenopausal women (contralateral breast cancer: adjusted hazard ratio HR = 0.66, and 95% confidence interval CI = 0.41-1.07; ipsilateral breast cancer: adjusted HR = 0.65, and 95% CI = 0.46-0. 92) and an opposite effect in postmenopausal women (contralateral breast cancer: adjusted HR = 1.32, and 95% CI = 0.82-2.15; ipsilateral breast cancer: adjusted HR = 1.19, and 95% CI = 0.75-1. 89). There were no statistically significant differences between the two arms in tumors in other organs, incidence of distant metastasis, and all-cause mortality.
Fenretinide treatment of women with breast cancer for 5 years appears to have no statistically significant effect on the incidence of second breast malignancies overall, although a possible benefit was detected in premenopausal women. These studies, particularly the post hoc analyses, are considered exploratory and need to be confirmed.
The study evaluates the role of computer-aided detection (CAD) in improving the detection of interval cancers as compared to conventional single (CONV) or double reading (DOUBLE). With this purpose, ...a set of 89 negative cases was seeded with 31 mammograms reported as negative and developing interval cancer in the following 2-year interval (false negative (FN)=11, minimal signs (MS)=20). A total of radiologists read the set with CONV and then with CAD. Overall, there were 589 cancer and 1691 noncancer readings with both CONV and CAD. Double reading was simulated by combining conventional readings in all 171 possible combinations of 19 radiologists, resulting in a total of 5301 cancer and 15 219 noncancer readings. Conventional single, DOUBLE and CAD readings were compared in terms of sensitivity and recall rate. Considering all 19 readings, cancer was identified in 190 or 248 of 589 readings (32.2 vs 42.1%, chi(2)=11.80, df=1, P<0.01) and recalls were 287 or 405 of 1691 readings (16.9 vs 23.9%, chi(2)=24.87, df=1, P<0.01) at CONV or CAD, respectively. When considering FN and MS cases separately, sensitivity at CONV or CAD was 50.2 or 62.6% (chi(2)=6.98, df=1, P=0.01) for FN and 22.3 or 30.7% (chi(2)=6.47, df=1, P=0.01) for MS cases, respectively. Computer-aided detection (average of 19 readings) was slightly and not significantly less sensitive (sensitivity: 42.1 vs 46.1%, chi(2)=3.24, df=1, P=0.07) but more specific (recall rate 23.9 vs 26.1%, chi(2)=3.8, df=1, P=0.04) as compared to DOUBLE (average of 171 readings). Average sensitivity for FN cases only was 62.6% for CAD and 64.8% for DOUBLE (chi(2)=0.32, df=1, P=0.58). Corresponding values for MS cases were 30.7% for CAD and 35.7% for DOUBLE (chi(2)=3.53, df=1, P=0.06). Compared to CONV, CAD allowed for improved sensitivity, though with reduced specificity, both effects being statistically significant. Computer-aided detection was almost as sensitive as DOUBLE but significantly more specific. Computer-aided detection might be used in the current practice to improve sensitivity of conventional single reading. Based on estimates of screening sensitivity and FN/MS interval cancer expected frequency, the absolute increase of screening sensitivity expected by introducing CAD-assisted reading may be estimated around 0.9%. The use of CAD as a possible surrogate to conventional DOUBLE needs to be confirmed by further studies, which should include a cost-effective analysis.
Breast cancer treatment has deeply changed in the last decades, since clinical and oncological cure cannot be achieved without patient's satisfaction in term of aesthetic outcomes. Several methods ...have been proposed to objectively assess these results. However, Italian breast centers have not yet agreed on measurable, reproducible and validated aesthetic outcome indicators to monitor their performance.
The study was designed and conducted by Senonetwork, a not-for-profit association of Italian breast centers. Ten breast centers were selected based on specific eligibility criteria. This multicentre observational prospective study recruited 6515 patients with diagnosis of in situ or invasive breast cancer who underwent breast surgery in the years 2013–2016. Thirteen indicators of aesthetic results and of related quality of care were analyzed. Data collection and analysis were conducted using a common study database.
On average, seven out of ten centers were able to collect data on the proposed indicators with a proportion of missing values < 25%. By expert consensus based on study results, some seven indicators have been defined as “mandatory” while the remaining six have been defined as “recommended” because they require further refinement before they can be proposed for monitoring aesthetic outcomes or because there are doubts on the feasibility of data collection. The minimum standard is reached for 5 of 13 indicators. This finding and the wide range between centers reveal that there is ample room for improvement.
From the present study useful measurable aesthetic parameters have emerged, leading to the definition of target objectives that breast centers can use for benchmarking and improvement of quality of care.
The purpose of this study was to evaluate and compare the physical characteristics of five clinical systems for digital mammography (GE Senographe 2000D, Lorad Selenia M-IV, Fischer Senoscan, Agfa DM ...1000, and IMS Giotto) currently in clinical use. The basic performances of the mammography systems tested were assessed on the basis of response curve, modulation transfer function (MTF), noise power spectrum, noise equivalent quanta (NEQ), and detective quantum efficiency (DQE) in an experimental setting closely resembling the clinical one. As expected, all the full field digital mammography systems show a linear response curve over a dynamic range from
3.5
to
500
μ
Gy
(
0.998
<
R
2
<
1
)
. The presampling MTFs at 2, 3, and
5
lp
∕
mm
were found to be respectively 0.78, 0.64, and 0.37 for GE Senographe 2000D; 0.92, 0.85, and 0.69 for Lorad Selenia and Agfa DM1000; 0.75, 0.63, and 0.42 for Fischer Senoscan; and 0.91, 0.82, and 0.61 for the IMS Giotto. According to the pixel size of each digital system, the presampling MTF was calculated within a range up to the Nyquist frequency (
5
lp
∕
mm
for GE Senographe 2000D,
7.1
lp
∕
mm
for Lorad Selenia,
9.3
lp
∕
mm
for Fischer Senoscan, and
5.88
lp
∕
mm
for IMS Giotto detector). The NEQ becomes related to the exposure in a linear behavior starting from about
40.3
μ
Gy
for GE Senographe 2000D,
42.9
μ
Gy
for Lorad Selenia,
41.2
μ
Gy
for Agfa DM1000,
<
87.6
μ
Gy
for Fischer Senoscan, and
61.3
μ
Gy
for the IMS Giotto. Above those values, the systems can be considered “quantum noise limited,” that is the electronic noise is negligible if compared to the quantum noise. The DQE, for several emitted x-ray spectra for each system, i.e.,
28
kV
p
Mo–Mo, Mo–Rh, Rh–Rh, W–Al anode-filter combination, hardened by
40
mm
poly(methylmethacrylate) (PMMA) was evaluated. For the five different systems, the DQE at close to zero spatial frequency ranges between 0.25 and 0.63 at
131
μ
Gy
entrance surface air kerma to the detectors. The results of our quantitative analysis demonstrated a higher DQE for direct conversion technology when compared to that of the indirect conversion. The NEQ behavior of each system can be exploited to select the optimum exposure level set in clinical practice to ensure minimum patient dose though adequate image quality. The detailed results of the physical characterization of the digital systems reported in this work allow the quantitative comparison of different technologies as well as the definition of reference values for subsequent quality control tests. The method developed in this work is suitable to be reproduced in any medical physics department for the previously described goals.
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