The clinical pathway concept appeared for the first time at the New England Medical Center (Boston, USA) in 1985 inspired by Zander and Bower . Clinical pathways were a result of the adaptation of the documents used in industrial quality management, the Standard Operating Procedures, whose goals are to improve efficiency in the use of resources and to finish work in a set time. They also aim to re-centre the focus on the patient’s overall journey, rather than the contribution of each specialty or caring function independently. The difference between a pathway and a guideline is that a guideline defines the numerous acceptable treatment options that fall within the standard of care, whereas a pathway drives physicians toward a single treatment with predictable toxicities and minimal cost. Although the majority of patients are treated according to the pathway, it is possible for the team not to comply with the pathway for a particular case, but the reasons to do this have to be clearly documented.
Literature data on the use of clinical pathways for breast cancer care are limited to a few small studies. Kasahara and Tawaraya, in Japan, used five clinical pathways for the treatment of breast cancer patients . They concluded that the clinical pathway brought standardization in their institution. The clinical pathway proved to be useful in coping with alternative operating methods, increased the use of adjuvant chemotherapy and increased the number of patients treated as outpatients. Santoso et al. showed, in a prospective analysis of a mastectomy clinical pathway over a seven month period in Singapore, that implementation of the clinical pathway improved consistency in patient treatment, the quality of patient outcome, and reduced costs of care and length of stay . Hwang et al. found, in a retrospective analysis of 29 patients undergoing a transverse rectus abdominis breast reconstruction included in a clinical pathway compared to 40 similar non-pathway patients, that implementation of the reconstruction clinical pathway resulted in significant declines in length of stay and hospital costs but had no effect on complication rates . Lee et al. showed that a clinical pathway for deep inferior epigastric perforans flap breast reconstruction reduced operating time and costs, and improved quality measures and staff satisfaction . Ryhanen et al. demonstrated that clinical pathways can be used to increase patients’ knowledge of their disease and empowerment .
Goebel et al. concluded that clinical pathways can prevent malpractice lawsuits in breast cancer and radiation therapy . In their retrospective analysis from the LexisNexis and Westlaw legal databases, they found that if physicians had adhered to clinical pathways, 49 out of 72 law-suits decided in favor of the plaintiff patient could have been avoided. In a recent project in Michigan it was suggested that the use of a breast cancer pathway reduces errors and costs, and increases efficiency . These authors also found that patient satisfaction had increased since pathways were implemented. Particularly in an era of personalized medicine, clinical pathways are a tool to establish a model of care that drives oncologists towards evidence based medicine with measurable outcomes in order to achieve high quality patient outcomes at an affordable cost.
The present paper is the first to describe a prospective long-term analysis of the use of a clinical pathway to optimize management of large cohorts of patients with operable breast cancer. It clearly shows that a pathway can be a useful tool to assure uniform care and to improve adherence to guidelines. Continuous registration of quality indicators, treatment related data and regular feedback of the outcomes to the breast team improved quality of care significantly. Evaluation of the pathway data allows for corrective measures to improve care. When, for example, we noted more postoperative pain on day two in 2008 or more vomiting in 2010, a meeting was organized with the anesthetists, in order to improve the pathway. These corrective measures were effective and reduced these symptoms adequately. It should be mentioned that the exact “cocktail” of medication used for general anesthesia is not part of the pathway and depends on the preference of the anesthetist. A striking reduction in patient satisfaction was noted in 2009 when our original breast nurse moved up in the organization and was replaced by two full time breast nurses due to the increased workload. Particularly information for patients on how to prepare for their stay in the hospital, the waiting times during the hospital stay and compliance of doctors and nurses with appointments during the patients hospital stay was significantly lower. Special sessions were held with the breast nurses individually and with the entire core team, to bring this back to normal.
A recent Taiwanese study shows that when breast cancer patients are diagnosed and treated in complete accordance with widely accepted standards of care, they survive longer and have better outcomes . This prospective study followed 1,378 newly diagnosed breast cancer patients from 1995 to 2001 in a single cancer hospital, tracking 10 indicators of care quality and assessing the progression of disease up to June 2007. Adherence to all 10 quality indicators by patients was associated with better overall (HR: 0.46; 95% CI: 0.33 to 0.63) and progression-free survival (HR: 0.51; 95% CI: 0.39 to 0.67). Adherence to either the four treatment indicators, or the six diagnostic indicators by patients was also associated with a significant improvement of survival. In the present study 4-year progression free survival was significantly better in the cohort of patients treated in 2006 to 2008 compared to 2004 to 2005 and 2002 to 2003. Similar results were obtained after data were stratified for T1 tumors only and T2-T4 tumors. Although our survival results can partly be explained by an evolution in the case mix, with considerably more patients with small tumors and negative lymph nodes in more recent years, better adherence to guidelines is likely to be beneficial for the outcome of the patients. In 2010 more than 97%, 97% and 95% of patients had state of the art adjuvant radiotherapeutic, anti-hormonal or cytostatic treatment, respectively, when indicated (according to the Sankt Gallen guidelines), compared to 98%, 85% and 72% in 2003. A benchmarking system of the quality of breast cancer care by a nationwide voluntary collaborative network of breast centers in Germany showed similar results . Monitoring pre-defined quality indicators significantly improved preoperative histological confirmation of diagnosis (58% in 2003) to 88% in 2008, appropriate endocrine therapy in hormone receptor positive patients (27 to 93%), appropriate radiotherapy after breast conserving therapy (20 to 79%) and appropriate radiotherapy after mastectomy (8 to 65%).