A detailed report of the resource use and costs associated with implementation of a short stay programme for breast cancer surgery.

BACKGROUND: Despite the increased attention for assessing the effectiveness of implementation strategies, most implementation studies provide little or no information on its associated costs. The focus of the current study was to provide a detailed report of the resource use and costs associated with implementation of a short stay programme for breast cancer surgery in four Dutch hospitals. METHODS: The analysis was performed alongside a multi-centre implementation study. The process of identification, measurement and valuation of the implementation activities was based on recommendations for the design, analysis and reporting of health technology assessments. A scoring form was developed to prospectively determine the implementation activities at professional and implementation expert level. A time horizon of 5 years was used to calculate the implementation costs per patient. RESULTS: Identified activities were consisted of development and execution of the implementation strategy during the implementation project. Total implementation costs over the four hospitals were €83.293. Mean implementation costs, calculated for 660 patients treated over a period of 5 years, were €25 per patient. Subgroup analyses showed that the implementation costs ranged from €3.942 to €32.000 on hospital level. From a local hospital perspective, overall implementation costs were €21 per patient, after exclusion of the costs made by the expert centre. CONCLUSIONS: We provided a detailed case description of how implementation costs can be determined. Notable differences in implementation costs between hospitals were observed. ISRCTN: ISRCTN77253391.

Prognostic Significance of Tumor-Positive Internal Mammary Sentinel Lymph Nodes in Breast Cancer: A Multicenter Cohort Study.

INTRODUCTION: The introduction of the sentinel lymph node biopsy (SLNB) in breast cancer has renewed interest in lymphatic drainage to the internal mammary (IM) nodes. The clinical impact of tumor positive IM nodes is not completely clear. This study evaluated the incidence and impact on overall survival of metastatic IM SLNs. METHODS: Between 1997 and 2010, 3685 patients underwent surgery including SLNB for primary breast cancer following an intratumoral or peritumoral radioactive-tracer injection. The presence of lymph node metastases was categorized according to the TNM-classification. Cumulative overall survival was estimated and the influence of metastases in the IM nodes and other factors was assessed by Cox-regression-analysis. RESULTS: In 754 patients (20.5 %) ipsilateral IM lymph nodes were visualized on preoperative lymphoscintigraphy, retrieval rate of IM SLNs was 81.0 %. IM metastases were detected in 130 patients (21.3 % of retrieved SLNs and 3.5 % of all patients respectively). The presence of IM metastases was associated with axillary metastases (p < 0.001). After a median follow-up of 61.2 months, 10.9 % of patients had died. In a multivariate analysis IM metastases did not have a significant effect on overall survival [HR] 1.20; CI: 0.73-1.98. In patients without axillary metastases (n = 2398), the presence of IM metastases (n = 43) was associated with worse survival [HR] 2.68; 95 % CI: 1.30-5.54. CONCLUSION: Overall, the presence of IM metastases did not effect overall survival independent of other prognostic factors including axillary metastases. However, the small subgroup of patients who had IM metastases alone had worse outcome than patients without any regional lymph node metastases.

Is there an indication for routine chest X-ray in initial staging of melanoma?

BACKGROUND: Our aim was to evaluate therapeutic consequences of preoperative staging with Chest X-ray (CXR) in patients with a primary melanoma planned for sentinel node biopsy (SNB). METHODS: From a prospective database, 248 medical records of patients treated for primary melanoma were extracted. CXRs were made prior to SNB, and examined by radiologists. Results were classified as follows: no metastasis, inconclusive, or suspect for metastasis. Furthermore, changes in planned treatment were recorded. RESULTS: CXR was performed in 227 (92%) cases. In 95% of these patients, the CXR showed no metastasis. In 5%, the CXR was inconclusive; all of these CXR results appeared to be false-positive after complementary radiodiagnostic imaging and/or follow-up. All patients received a SNB. CONCLUSION: Preoperative CXR did not identify pulmonary metastasis and did not change planned treatment strategies. We suggest that CXR has no added value in the routine workup of patients with a primary melanoma.

Cost-effectiveness of a short stay admission programme for breast cancer surgery.

BACKGROUND: Short stay (admission, surgery, and discharge the same day or within 24 hours) following breast cancer surgery is part of an established care protocol but as yet not well implemented in Europe. Alongside a before-after multi-centre implementation study, an economic evaluation was performed exploring the cost-effectiveness of a short stay programme (SSP) versus care as usual (CAU). MATERIAL AND METHODS: In the implementation study, 324 patients were included. In the economic evaluation a societal perspective was applied with a six week time horizon. Cost data were obtained from Case Record Forms and cost diaries. Effectiveness was assessed by calculating Quality Adjusted Life Years (QALYs), using the EuroQol-5D. Cost-effectiveness was expressed as the incremental costs per QALY. RESULTS: Mean societal costs decreased by euro955,- (95% CI euro - 2104,- to euro157,-) for patients in SSP (n=127) compared with CAU (n=135). Mean healthcare costs differed euro883,- (95% CI euro - 1560,- to euro870,-) in favour of SSP. The incremental cost-effectiveness ratio could not be calculated due to similar effectiveness for both groups, i.e. the difference in QALYs was zero. The cost-effectiveness acceptability curves showed that the probability that SSP was more cost-effective than CAU was over 90% in the base-case analysis. DISCUSSION: A short stay programme as implemented is cost-effective compared with care as usual. In achieving good and more efficient quality of care, larger scale implementation is warranted.

Sentinel lymph node biopsy in patients with thin melanoma: occurrence of nodal metastases and its prognostic value.

We identified the proportion of positive sentinel lymph node biopsies (SNBs) in patients treated for thin melanoma (Breslow thickness

Thick melanoma: prognostic value of positive sentinel nodes.

BACKGROUND: Sentinel lymph node biopsy (SNB) is a widely accepted procedure used to accurately stage patients with melanoma. Its value in patients with thick melanoma (Breslow thickness >4 mm) is reason for discussion because of the generally poor prognosis of these patients. The purpose of this study was to report on the incidence of SNB positivity in patients with thick melanoma and to analyze the prognostic value of SNB in these patients. METHODS: The prospective database of 248 patients with cutaneous melanoma, who underwent SNB in the Maaslandhospital Sittard between January 1994 and August 2007, was reviewed and completed. In 31 patients, SNB was performed for a thick melanoma. We analyzed survival (Kaplan-Meier) and survival differences (log-rank) in this group. RESULTS: In 64.5% of the patients with a thick melanoma, the SNB was positive. In our patients, SNB result was the only predictor for overall survival in patients with a thick melanoma (P = 0.045). CONCLUSIONS: To be accurately informed about a patient's prognosis and to decide whether subsequent completion lymph node dissection is indicated, SNB should not be omitted in patients with a primary thick melanoma.

Customized computed tomography-based boost volumes in breast-conserving therapy: use of three-dimensional histologic information for clinical target volume margins.

PURPOSE: To determine the difference in size between computed tomography (CT)-based irradiated boost volumes and simulator-based irradiated volumes in patients treated with breast-conserving therapy and to analyze whether the use of anisotropic three-dimensional clinical target volume (CTV) margins using the histologically determined free resection margins allows for a significant reduction of the CT-based boost volumes. PATIENTS AND METHODS: The CT data from 49 patients were used to delineate a planning target volume (PTV) with isotropic CTV margins and to delineate a PTV(sim) that mimicked the PTV as delineated in the era of conventional simulation. For 17 patients, a PTV with anisotropic CTV margins was defined by applying customized three-dimensional CTV margins, according to the free excision margins in six directions. Boost treatment plans consisted of conformal portals for the CT-based PTVs and rectangular fields for the PTV(sim). RESULTS: The irradiated volume (volume receiving > or =95% of the prescribed dose [V(95)]) for the PTV with isotropic CTV margins was 1.6 times greater than that for the PTV(sim): 228 cm(3) vs. 147 cm(3) (p < .001). For the 17 patients with a PTV with anisotropic CTV margins, the V(95) was similar to the V(95) for the PTV(sim) (190 cm(3) vs. 162 cm(3); p = NS). The main determinant for the irradiated volume was the size of the excision cavity (p < .001), which was mainly related to the interval between surgery and the planning CT scan (p = .029). CONCLUSION: CT-based PTVs with isotropic margins for the CTV yield much greater irradiated volumes than fluoroscopically based PTVs. Applying individualized anisotropic CTV margins allowed for a significant reduction of the irradiated boost volume.

Implementation of an ultra-short-stay program after breast cancer surgery in four hospitals: perceived barriers and facilitators.

BACKGROUND: The objective of this study was to identify barriers and facilitators that professionals see when implementing a program incorporating ultra-short hospital admission in the treatment of breast cancer. Such an intervention is an essential step when designing a strategy for implementation of a care program that is different from established daily routines. METHODS: In a prospective quasi-experimental study qualitative data were collected from four hospitals in the Netherlands between January 2005 and July 2006. Potential barriers and facilitators for successful implementation were extracted from detailed notes of all contacts between the researchers and each participating hospital. Subsequently, these items were categorized according to themes. RESULTS: Over 40 items were identified. Most barriers concerned organizational and program-related aspects, whereas the most common facilitators addressed organizational issues. Six of the 29 study recommendations were perceived as impeding or facilitating. Thirty of the 40 barriers were mentioned in one hospital only. Several key factors were found that determine the success of implementation of an ultrashort-stay program. Provision of care in the home setting should be assured. Policy makers and insurance companies should acknowledge that multidisciplinary care teams and teams integrating primary and secondary care fulfill important roles in delivering continuity of care. Specific strategies should be set out to convince everybody in the organization about the new ideas, particularly the minority of people who do not agree with the plans. CONCLUSIONS: A set of barriers and facilitators for implementation of the program was described that may be used by any professional preparing to perform breast cancer surgery in an ultrashort-stay facility. The systematic approach that led to this set may be used by any healthcare professional concerned with implementation and consolidation of innovative programs in healthcare in order to enhance the effectiveness of the chosen strategy.

Introduction of a breast cancer care programme including ultra short hospital stay in 4 early adopter centres: framework for an implementation study.

BACKGROUND: Whereas ultra-short stay (day care or 24 hour hospitalisation) following breast cancer surgery was introduced in the US and Canada in the 1990s, it is not yet common practice in Europe. This paper describes the design of the MaDO study, which involves the implementation of ultra short stay admission for patients after breast cancer surgery, and evaluates whether the targets of the implementation strategy are reached. The ultra short stay programme and the applied implementation strategy will be evaluated from the economic perspective. METHODS/DESIGN: The MaDO study is a pre-post-controlled multi-centre study, that is performed in four hospitals in the Netherlands. It includes a pre and post measuring period of six months each with six months of implementation in between in at least 40 patients per hospital per measurement period. Primary outcome measure is the percentage of patients treated in ultra short stay. Secondary endpoints are the percentage of patients treated according to protocol, degree of involvement of home care nursing, quality of care from the patient's perspective, cost-effectiveness of the ultra short stay programme and cost-effectiveness of the implementation strategy. Quality of care will be measured by the QUOTE-breast cancer instrument, cost-effectiveness of the ultra short stay programme will be measured by means of the EuroQol (administered at four time-points) and a cost book for patients. Cost-effectiveness analysis will be performed from a societal perspective. Cost-effectiveness of the implementation strategy will be measured by determination of the costs of implementation activities. DISCUSSION: This study will reveal barriers and facilitators for implementation of the ultra short stay programme. Moreover, the results of the study will provide information about the cost-effectiveness of the ultra short stay programme and the implementation strategy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77253391.

The patient's perspective of the quality of breast cancer care. The development of an instrument to measure quality of care through focus groups and concept mapping with breast cancer patients.

Quality of care is often described by professionals. However, in this study breast cancer patients participated in developing an instrument that reflects quality of care from the patient's perspective. Through focus groups and concept mapping patients' ideas on determinants of good quality of care were generated and categorised according to similarity and importance. Information from eight focus group interviews with a total of 72 participants yielded 221 quality of care aspects. Following reduction, 81 aspects were used for categorisation during six concept mapping sessions with 67 participants. After analysis, 55 aspects remained grouped into six clusters. This study was conducted with a large number of breast cancer patients, undergoing the full range of treatment modalities, in different hospitals, in different areas in the Netherlands. Therefore, this set of quality of care indicators can be considered valid and suitable for the evaluation of breast cancer care as experienced by patients.

Evaluation of early versus delayed lymphoscintigraphic imaging in detecting internal mammary sentinel lymph nodes in breast cancer: a multicenter study to establish an optimal lymphatic mapping protocol.

OBJECTIVE: Metastases in the internal mammary lymph nodes have an important prognostic value in breast cancer. Lymphatic mapping and sentinel node biopsy of internal mammary nodes improves staging and permits specific therapeutic strategies, thereby possibly improving final outcome. Therefore, optimal lymphoscintigraphic results are needed. Visualization of internal mammary lymph drainage, however, is influenced by several factors. We evaluated the effect of different time intervals between radioactive tracer injection and lymphoscintigraphy on visualization of internal mammary sentinel lymph nodes. METHODS: From February 1997 to August 2001 a total of 682 eligible breast cancer patients underwent sentinel lymph node mapping. The technique involved the injection of 370 MBq (10 mCi) (99m)Tc-nanocolloid peritumorally. In 470 patients (group A) the time interval between injection of the radiocolloid and lymphoscintigraphy was 16 h, compared to 2.5 h in 212 patients (group B). RESULTS: Patient characteristics showed no statistically significant difference between both groups for age and location of the tumour. Axillary hotspots were visualized in 97% in group A and 96% in group B. Lymphoscintigraphy showed internal mammary hotspots in 21% in group A, compared to 27% in group B. The mean number of internal mammary hotspots per patient was 1.9 in group A and 1.8 in group B. CONCLUSIONS: We found no significant differences between early and delayed lymphoscintigraphic imaging in visualizing internal mammary sentinel lymph nodes.