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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN77253391.</p

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