What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata.

BACKGROUND: Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. METHODS: We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. DISCUSSION: Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality. TRIAL REGISTRATION: NCT03136367 at ClinicalTrials.gov Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.

Unexpected Outcomes of Measuring Decision Regret: Using a Breast Cancer Decision-Making Case Example.

Shared decision making can help patients feel supported and empowered when deciding between healthcare options. Decision regret can be a meaningful measure of the quality of that encounter. However, in a patient-engaged research study examining shared decision making for breast cancer surgery, decision regret was a difficult construct to assess, and asking questions about decision regret caused the patient to experience that emotion upon reflection. In this article, we consider the complexity of decision regret, and discuss the difficulty of measuring that emotion through existing instruments. We call for clarity in definitions of decision regret and offer suggestions for developing a set of questions that can capture regret in a more meaningful way.

US-based cross-sectional survey of clinicians' knowledge and attitudes about shared decision-making across healthcare professions and specialties.

OBJECTIVE: In this study, we aim to compare shared decision-making (SDM) knowledge and attitudes between US-based physician assistants (PAs), nurse practitioners (NPs) and physicians across surgical and family medicine specialties. SETTING: We administered a cross-sectional, web-based survey between 20 September 2017 and 1 November 2017. PARTICIPANTS: 272 US-based NPs, PA and physicians completed the survey. 250 physicians were sent a generic email invitation to participate, of whom 100 completed the survey. 3300 NPs and PAs were invited, among whom 172 completed the survey. Individuals who met the following exclusion criteria were excluded from participation: (1) lack of English proficiency; (2) area of practice other than family medicine or surgery; (3) licensure other than physician, PA or NP; (4) practicing in a country other than the US. RESULTS: We found few substantial differences in SDM knowledge and attitudes across clinician types, revealing positive attitudes across the sample paired with low to moderate knowledge. Family medicine professionals (PAs) were most knowledgeable on several items. Very few respondents (3%; 95% CI 1.5% to 6.2%) favoured a paternalistic approach to decision-making. CONCLUSIONS: Recent policy-level promotion of SDM may have influenced positive clinician attitudes towards SDM. Positive attitudes despite limited knowledge warrant SDM training across occupations and specialties, while encouraging all clinicians to promote SDM. Given positive attitudes and similar knowledge across clinician types, we recommend that SDM is not confined to the patient-physician dyad but instead advocated among other health professionals.

Adapting the Breast Cancer Surgery Decision Quality Instrument for Lower Socioeconomic Status: Improving Readability, Acceptability, and Relevance.

Introduction. Breast cancer is the second most common malignancy in women. The Decision Quality Instrument (DQI) measures the extent to which patients are informed and involved in breast surgery decisions and receive treatment that aligns with their preferences. There are limited data on the performance of the DQI in women of lower socioeconomic status (SES). Our aims were to 1) examine (and if necessary adapt) the readability, usability, and acceptability of the DQI and 2) explore whether it captures factors important to breast cancer surgery decisions among women of lower SES (relevance). Methods. We conducted semistructured cognitive interviews with women of lower SES (based on insurance status, income, and education) who had completed early-stage breast cancer treatments at three cancer centers. We used a two-step thematic analysis with dual independent coding. The study team (including Patient Partners and a Community Advisory Board) reviewed and refined suggested changes. The revised DQI was presented in two focus groups of breast cancer survivors. Results. We conducted 39 interviews. Participants found most parts of the DQI to be helpful and easy to understand. We made the following suggested changes: 1) added a glossary of key terms, 2) added two answer choices and an open text question in the goals and concerns subscale, 3) reworded the treatment intention question, and 4) revised the knowledge subscale instructions since several women disliked the wording and were unsure of what was expected. Discussion. The readability, usability, acceptability, and relevance of a measure that was primarily developed and validated in women of higher SES required adaptation for optimal use by women of lower SES. Further research will test these adaptations in lower SES populations.