A diagnosis of early stage breast cancer sets off a series of preference-sensitive treatment decisions, including: (1) initial surgical choice between mastectomy and breast-conserving surgery; (2) whether to have breast reconstruction if mastectomy is chosen; and (3) whether or not to have adjuvant chemotherapy, hormone therapy (CHT), or both. Clinical guidelines and quality measures recognize that there is not one “right” answer for any of these decisions.(1
) Rather, consensus is growing that a high-quality decision for such preference-sensitive conditions is one that reflects the considered preferences of well-informed patients.(4
) In order to evaluate the quality of preference-sensitive decisions, instruments are needed that assess whether the patient is informed of the choices, understands the likelihood of positive and negative outcomes of each decision, and whether the treatment she gets reflects what is most important to her.
Although a number of studies have examined the degree to which breast cancer patients are informed about their treatment options, few have used measures of knowledge with proven reliability and validity. Four studies have reported knowledge for the surgical decision, (6
) one has assessed knowledge of reconstruction,(10
) two have assessed knowledge of chemotherapy,(11
) and none has assessed knowledge of hormone therapies. On close inspection of these studies’ measures, only one was a previously-validated knowledge instrument. It was validated in 1990 and is outdated for our purposes.(6
) The other instruments were created specifically for their particular studies. Two studies described how the items were generated, and both were developed using medical expert input without patient input.(6
) None of the studies reported reliability or validity of the knowledge instruments for the study sample.
Studies of patients’ preferences about breast cancer treatments have also been limited by the quality of measures. Several cross-sectional studies have identified patient concerns associated with choice of surgical treatment.(13
) Two studies have examined patients’ preferences and their association with decisions about reconstruction.(18
) Only one of these studies used previously validated instruments and reported information on the reliability or validity of the data.(18
) The others developed the items specifically for the study and did not report on reliability or validity. Although the issues explored by these studies had significant conceptual overlap, the wording and scaling tasks differed.
Studies of decision making about adjuvant chemotherapy and hormonal therapy (CHT) have taken the approach of measuring how much benefit a patient would need to gain in order to make the side effects of treatment worthwhile.(20
) Most studies have used structured interviews and time-tradeoff exercises to estimate the required level of benefits. Although the importance of weighing the benefits and harms seems obvious, the benefits and harms used in the exercises varied. Furthermore, all of the patients in these studies had taken the treatment (chemotherapy and/or hormonal therapy). How well these approaches would work in patients actually facing CHT decisions is not known.
A more transparent and rigorous process is needed to identify the key pieces of information that patients should understand and the salient issues that may determine their preference for one treatment over another. The authors and their colleagues have designed such a process for the development of decision quality instruments (DQIs) specific to common clinical decisions, including breast cancer treatment decisions.(25
) The development process for the instruments is summarized in the methods and . The first step in developing the instruments is to generate a core set of facts that is essential for patients to understand before making a decision, as well as a core set of salient goals and concerns that lead patients to prefer one treatment over another.
Development process for Decision Quality Instruments
Here, we report the results of cross-sectional surveys of breast cancer survivors and providers for three decisions: surgery for early stage breast cancer; breast reconstruction, and adjuvant chemotherapy and hormone therapy for early stage breast cancer. The purpose of the surveys was to assess the accuracy, importance, and completeness of the set of candidate facts and goals. A secondary aim was to determine whether or not a small, core set of information and goals, which providers and patients would both agree is essential, exists.