Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer.

PURPOSE: Characterizing oral adjuvant endocrine therapy (ET) non-initiation and non-persistence in young women with breast cancer can inform strategies to improve overall adherence in this population. METHODS: We identified 693 women with hormone receptor-positive, stage I-III breast cancer enrolled in a cohort of women diagnosed with breast cancer at age ≤ 40 years. Women were classified as non-initiators if they did not report taking ET in the 18 months after diagnosis. Women who initiated but did not report taking ET subsequently (through 5-year post-diagnosis) were categorized as non-persistent. We assessed ET decision-making and used logistic regression to identify factors associated with non-initiation/non-persistence and to evaluate the association between non-persistence and recurrence. RESULTS: By 18 months, 9% had not initiated ET. Black women had higher odds and women with a college degree had lower odds of non-initiation. Among 607 women who initiated, 20% were non-persistent. Younger age, being married/partnered, and reporting more weight problems were associated with higher odds of non-persistence; receipt of chemotherapy and greater hot flash and vaginal symptom burden were associated with lower odds of non-persistence. Adjusting for age and clinical characteristics, non-persistence was associated with lower odds of recurrence. Women who initiated were more likely to report shared decision-making than non-initiators (57% vs. 38%, p = 0.049), while women who were non-persistent were less likely to indicate high confidence with the decision than women who were persistent (40% vs. 63%, p < 0.001). CONCLUSION: Interventions to improve ET decision-making may facilitate initiation and address barriers to adherence in young breast cancer survivors. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , NCT01468246.

Patient-Reported Outcomes of Breast Reconstruction: Does the Quality of Decisions Matter?

BACKGROUND: Little is known about how the quality of decisions influences patient-reported outcomes (PROs). We hypothesized that higher decision quality for breast reconstruction would be independently associated with better PROs. METHODS: We conducted a prospective cohort study of patients undergoing mastectomy with or without reconstruction. Patients were enrolled before surgery and followed for 18 months. We used BREAST-Q scales to measure PROs and linear regression models to explore the relationship between decision quality (based on knowledge and preference concordance) and PROs. Final models were adjusted for baseline BREAST-Q score, radiation, chemotherapy, and major complications. RESULTS: The cohort included 101 patients who completed baseline and 18-month surveys. Breast reconstruction was independently associated with higher satisfaction with breasts (ß = 20.2, p = 0.0002), psychosocial well-being (ß = 14.4, p = 0.006), and sexual well-being (ß = 15.7, p = 0.007), but not physical well-being. Patients who made a high-quality decision had similar PROs as patients who did not. Among patients undergoing mastectomy with reconstruction, higher decision quality was associated with lower psychosocial well-being (ß = -14.2, p = 0.01). CONCLUSIONS: Breast reconstruction was associated with better PROs in some but not all domains. Overall, making a high-quality decision was not associated with better PROs. However, patients who did not have reconstruction had a trend toward better well-being after making a high-quality decision, whereas patients who did have reconstruction had poorer well-being after making a high-quality decision. Additional research on the relationship between decision quality and PROs is needed.

Performance of the shared decision-making process scale for use in evaluation of hereditary cancer genetic testing decisions.

This study aimed to evaluate feasibility, acceptability, reliability, and validity of the existing four-item Shared Decision Making (SDM) Process Scale for use in evaluating genetic testing decisions. Patients from a large hereditary cancer genetics practice were invited to participate in a two-part survey after completing pre-test genetic counseling. The online survey included the SDM Process Scale and the SURE scale, a measure of decisional conflict. SDM Process scores were compared to SURE scores to test convergent validity, and respondents were sent a second survey 1 week later to assess retest reliability. The response rate was 65% (n = 259/398) and missing data was low (<1%). SDM scores ranged from zero to four with a mean of 2.3 (SD = 1.1). Retest reliability was good, with intraclass correlation of 0.84, 95% confidence interval (0.79, 0.88). No relationship was found between SDM Process scores and decisional conflict (p = 0.46), likely because 85% of participants reported no decisional conflict. The four-item SDM Process Scale demonstrated feasibility, acceptability, and retest reliability, but not convergent validity with decisional conflict. These findings provide initial evidence for use of this scale to measure patient perceptions of SDM in pre-test counseling for hereditary cancer genetic testing.

Measuring shared decision-making in younger and older adults with depression.

BACKGROUND: This study examined the performance of the shared decision-making (SDM) Process scale in patients with depression, compared alternative wording of two items in the scale and explored performance in younger adults. METHODS: A web-based non-probability panel of respondents with depression aged 18-39 (younger) or 40-75 (older) who talked with a health-care provider about starting or stopping treatment for depression in the past year were surveyed. Respondents completed one of two versions of the SDM Process scale that differed in the wording of pros and cons items and completed measures of decisional conflict, decision regret and who made the decision (mainly the respondent, mainly the provider or together). A subset of respondents completed a retest survey by 1 week. We examined how version and age group impacted SDM Process scores and calculated construct validity and retest reliability. We hypothesized that patients with higher SDM Process scores would show less decisional conflict using the SURE scale (range = 0-4); top score = no conflict versus other and less regret (range 1-4; higher scores indicated more regret). RESULTS: The sample (N = 494) was majority White, non-Hispanic (82%) and female (72%), 48% were younger and 23% had a high school education or less. SDM Process scores did not differ by version (P = 0.09). SDM Process scores were higher for younger respondents (M = 2.6, SD = 1.0) than older respondents (M = 2.3, SD = 1.1; P = 0.001). Higher SDM Process scores were also associated with no decisional conflict (M = 2.6, SD = 0.99 vs. M = 2.1, SD = 1.2; P < 0.001) and less decision regret (r = -0.18, P < 0.001). Retest reliability was intraclass correlation coefficient = 0.81. CONCLUSIONS: The SDM Process scale demonstrated validity and retest reliability in younger adults, and changes to item wording did not impact scores. Although younger respondents reported more SDM, there is room for improvement in SDM for depression treatment decisions.

Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients (n = 28) and clinicians (n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382.

"I don't want to take chances.": A qualitative exploration of surgical decision making in young breast cancer survivors.

OBJECTIVE: Young women with unilateral breast cancer are increasingly choosing contralateral prophylactic mastectomy (CPM), despite its limited medical benefit for most women. The purpose of this study was to better understand this choice through a qualitative exploration of surgical decision-making in young survivors, including how issues particular to younger women affected their decision and the post-surgical experience. METHODS: Women age ≤ 40 years with stage 0 to III breast cancer, 1 to 3 years from diagnosis who had undergone breast cancer surgery were recruited to participate. Four focus groups were conducted: 2 with women who had bilateral mastectomy and 2 with women who kept their contralateral breast. Focus groups were recorded and transcribed with identifiers removed. Emergent themes were identified by thematic content analysis using NVivo 11. RESULTS: Of the 20 participants, median age at diagnosis was 37 years. Emergent themes were categorized into the following domains: (1) emotions/feelings surrounding surgery/decision about surgery; (2) factors affecting the decision; (3) communication and interaction with the healthcare team; (4) impact on post-surgical life and recovery; and (5) support needs. Young women who chose CPM often were concerned about a future breast event, despite this low risk, suggesting some gain peace of mind by choosing CPM. Young survivors also had many physical and emotional concerns after surgery for which they did not always feel prepared. CONCLUSIONS: Informational resources and decision aids may enhance patient-doctor communication and help young survivors better understand risk and manage expectations surrounding short and longer-term physical and emotional effects after surgery.

How Informed Is the Decision About Breast Reconstruction After Mastectomy?: A Prospective, Cross-sectional Study.

OBJECTIVE: To assess how informed patients are about breast reconstruction, and how involved they are in decision making. SUMMARY BACKGROUND DATA: Breast reconstruction is an important treatment option for patients undergoing mastectomy. Wide variations in who gets reconstruction, however, have led to concerns about decision making. METHODS: We conducted a prospective cross-sectional study of patients planning mastectomy at a single site, over 20 months. Before surgery, patients completed a survey with validated scales to assess knowledge about breast reconstruction and involvement in decision making. Factors associated with knowledge were examined in a multivariable linear regression model. RESULTS: A total of 145 patients enrolled (77% enrollment rate), and 126 remained eligible. The overall knowledge score was 58.5% (out of 100%). Knowledge about risk of complications was especially low at 14.3%. Knowledge did not differ by treatment (reconstruction or not). On multivariable analysis, non-white race was independently associated with lower knowledge. Most patients (92.1%) reported some discussion with a provider about reconstruction, and most (90.4%) reported being asked their preference. More patients reported discussing the advantages of reconstruction (57.9%) than the disadvantages (27.8%). CONCLUSIONS: Women undergoing mastectomy in this sample were highly involved in decision making, but had major deficits in knowledge about the procedure. Knowledge about the risk of complications was particularly low. Providers seemed to have discussed the advantages of reconstruction more than its disadvantages.

Development and evaluation of a new survey instrument to measure the quality of colorectal cancer screening decisions.

BACKGROUND: Guidelines for colorectal cancer screening recommend that patients be informed about options and be able to select preferred method of screening; however, there are no existing measures available to assess whether this happens. METHODS: Colorectal Cancer Screening Decision Quality Instrument (CRC-DQI) includes knowledge items and patients' goals and concerns. Items were generated through literature review and qualitative work with patients and providers. Hypotheses relating to the acceptability, feasibility, discriminant validity and retest reliability of the survey were examined using data from three studies: (1) 2X2 randomized study of participants recruited online, (2) cross-sectional sample of patients recruited in community health clinics, and (3) cross-sectional sample of providers recruited from American Medical Association Master file. RESULTS: 338 participants were recruited online, 94 participants were recruited from community health centers, and 115 physicians were recruited. The CRC-DQI was feasible and acceptable with low missing data and high response rates for both online and paper-based administrations. The knowledge score was able to discriminate between those who had seen a decision aid or not (84% vs. 64%, p < 0.001) and between providers, online patients and clinic patients (89% vs. 74% vs. 41%, p < 0.001 for all comparisons). The knowledge score and most of the goals had adequate retest reliability. About half of the participants received a test that matched their goals (47% and 51% in online and clinic samples respectively). Many respondents who had never been screened had goals that indicated a preference for colonoscopy. A minority of respondents in the online (21%) and in clinic (2%) samples were both well informed and received a test that matched their goals. CONCLUSIONS: The CRC-DQI demonstrated good psychometric properties in diverse samples, and across different modes of administration. Few respondents made high quality decisions about colon cancer screening.

Measuring decision quality: psychometric evaluation of a new instrument for breast cancer chemotherapy.

BACKGROUND: Women diagnosed with early stage (I or II) breast cancer face a highly challenging decision - whether or not to undergo adjuvant chemotherapy. We developed a decision quality instrument for chemotherapy for early stage breast cancer and sought to evaluate its performance. METHODS: Cross-sectional, mailed survey of recent breast cancer survivors, providers, and healthy controls and a retest survey of survivors. The decision quality instrument includes questions on knowledge and personal goals. It results in a knowledge score and concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, validity, and reliability of the survey instrument were examined. RESULTS: Responses were received from 352 patients, 89 providers and 35 healthy controls. The decision quality instrument was feasible to implement with few missing data. The knowledge scores had good retest reliability (intraclass correlation coefficient (ICC) =0.75). Knowledge scores discriminated between providers and patients (mean difference 31.1%, 95% CI 26.9, 35.3) and between patients and healthy controls (mean difference 11.2, 95% CI 5.4, 17.1). Most providers reported that the knowledge items covered essential content. Two of the five goal items had a ceiling effect, and one goal had low content validity. The goal items had moderate retest reliability (ICC's 0.57 to 0.78). In the multivariable model of treatment, none of the patient goals was associated with receipt of chemotherapy. Age and hormone receptor status were the only variables independently associated with chemotherapy. Most patients (77.6%) had treatment concordant with that predicted by the model. Patients who had concordant treatment had similar levels of confidence and regret as those who did not. CONCLUSIONS: The Decision Quality Instrument is a reliable and valid measure of patient knowledge about chemotherapy, but its ability to measure concordance with patient goals is limited. In this sample, patient goals were not associated with treatment, and most patients reported they were not asked their preference, suggesting that goals were not adequately considered in decision making.

Uncertainty tolerance among primary care physicians: Relationship to shared decision making-related perceptions, practices, and physician characteristics.

OBJECTIVE: Understand how physicians' uncertainty tolerance (UT) in clinical care relates to their personal characteristics, perceptions and practices regarding shared decision making (SDM). METHODS: As part of a trial of SDM training about colorectal cancer screening, primary care physicians (n = 67) completed measures of their uncertainty tolerance in medical practice (Anxiety subscale of the Physician's Reactions to Uncertainty Scale, PRUS-A), and their SDM self-efficacy (confidence in SDM skills). Patients (N = 466) completed measures of SDM (SDM Process scale) after a clinical visit. Bivariate regression analyses and multilevel regression analyses examined relationships. RESULTS: Higher UT was associated with greater physician age (p = .01) and years in practice (p = 0.015), but not sex or race. Higher UT was associated with greater SDM self-efficacy (p < 0.001), but not patient-reported SDM. CONCLUSION: Greater age and practice experience predict greater physician UT, suggesting that UT might be improved through training, while UT is associated with greater confidence in SDM, suggesting that improving UT might improve SDM. However, UT was unassociated with patient-reported SDM, raising the need for further studies of these relationships. PRACTICE IMPLICATIONS: Developing and implementing training interventions aimed at increasing physician UT may be a promising way to promote SDM in clinical care.

Disclosing Recovery: A pilot randomized controlled trial of a patient decision aid to improve disclosure processes for people in treatment for opioid use disorder.

INTRODUCTION: People engaged in treatment for opioid use disorder (OUD) report struggling with whether and how to disclose, or share information about their OUD history and/or treatment with others. Yet, disclosure can act as a gateway to re-establishing social connection and support during recovery. The current study describes a pilot randomized controlled trial of Disclosing Recovery: A Decision Aid and Toolkit, a patient decision aid designed to facilitate disclosure decisions and build disclosure skills. METHODS: Participants (n = 50) were recruited from a community-based behavioral health organization in 2021-2022 and randomized to receive the Disclosing Recovery intervention versus an attention-control comparator. They responded to surveys immediately after receiving the intervention as well as one month following the intervention at a follow-up appointment. Primary outcome analyses examined indicators of implementation of the intervention to inform a future efficacy trial. Secondary outcome analyses explored impacts of the intervention on the decision-making process, disclosure rates, and relationships. RESULTS: Participants were successfully recruited, randomized, and retained, increasing confidence in the feasibility of future efficacy trials to test the Disclosing Recovery intervention. Moreover, participants in the Disclosing Recovery intervention agreed that the intervention is acceptable, feasible, and appropriate. They additionally reported a higher quality of their decision-making process and decisions than participants in the comparator condition. At their follow-up appointment, participants with illicit opioid use who received the Disclosing Recovery intervention were less likely to disclose than those who received the comparator condition. Moreover, significant interactions between illicit opioid use and the intervention condition indicated that participants without illicit opioid use who received the Disclosing Recovery intervention reported greater closeness to and social support from their planned disclosure recipient than those who received the comparator condition. CONCLUSIONS: The Disclosing Recovery intervention appears to be an acceptable, feasible, and appropriate patient decision aid for addressing disclosure processes among people in treatment for OUD. Moreover, preliminary results suggest that it shows promise in improving relationship closeness and social support in patients without illicit opioid use. More testing is merited to determine the intervention's efficacy and effectiveness in improving relationship and treatment outcomes for people in treatment for OUD.

Decision dissonance: evaluating an approach to measuring the quality of surgical decision making.

BACKGROUND: Good decision making has been increasingly cited as a core component of good medical care, and shared decision making is one means of achieving high decision quality. If it is to be a standard, good measures and protocols are needed for assessing the quality of decisions. Consistency with patient goals and concerns is one defining characteristic of a good decision. A new method for evaluating decision quality for major surgical decisions was examined, and a methodology for collecting the needed data was developed. METHODS: For a national probability sample of fee-for-service Medicare beneficiaries who had a coronary artery bypass graft (CABG), a lumpectomy or a mastectomy for breast cancer, or surgery for prostate cancer during the last half of 2008, a mail-survey of selected patients was carried out about one year after the procedures. Patients' goals and concerns, knowledge, key aspects of interactions with clinicians, and feelings about the decisions were assessed. A decision dissonance score was created that measured the extent to which patient ratings of goals ran counter to the treatment received. The construct and predictive validity of the decision dissonance score was then assessed. RESULTS: When data were averaged across all four procedures, patients with more knowledge and those who reported more involvement reported significantly lower Decision Dissonance Scores. Patients with lower Decision Dissonance Scores also reported more confidence in their decisions and feeling more positively about how the treatment turned out, and they were more likely to say that they would make the same decision again. CONCLUSIONS: Surveying discharged surgery patients is a feasible way to evaluate decision making, and Decision Dissonance appears to be a promising approach to validly measuring decision quality.

Establishing the effectiveness of patient decision aids: key constructs and measurement instruments.

BACKGROUND: Establishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality. The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness. METHODS: This updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration's review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required. RESULTS: The 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs. CONCLUSIONS: Evidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on PtDA effectiveness.

Evaluation of the shared decision-making process scale in cancer screening and medication decisions.

OBJECTIVES: Examine reliability and validity of the Shared Decision-Making (SDM) Process scale for cancer screening and medication decisions. METHODS: Secondary data analysis from 6174 participants who made decisions about cancer screening (breast, colon or prostate) or medication (menopause, depression, hypertension or high cholesterol). Key measures included the SDM Process scale, decisional conflict, decision regret, and decision quality. Construct validity was examined by testing whether higher SDM Process scores were associated with lower regret, lower decisional conflict and higher decision quality. Meta-analyses summarized data across studies. Some studies assessed the scale's reliability. RESULTS: Average SDM Process scores ranged from 1.2 to 2.5. There was a moderate-to-large, positive association between scores and lack of decisional conflict (cancer screening: d=0.61, CI(0.38, 0.84), p < .001; medications: d=0.36, CI(0.29, 0.44), p < .001). High scores were associated with lower decision regret (cancer screening: d=-0.24, CI(-0.37, -0.11), p < .001; medications: d=-0.30, CI(-0.40,-0.20), p < .001). There was no relationship with decision quality. Retest reliability was acceptable (ICC>0.7) for seven of eight clinical samples. CONCLUSIONS: The SDM Process scale demonstrated construct validity and retest reliability in cancer screening and medication decisions. PRACTICE IMPLICATIONS: The validated SDM Process scale is a short, patient reported metric to evaluate the current state of SDM.

Shared Decision Making for Elective Surgical Procedures in Older Adults with and without Cognitive Insufficiencies.

PURPOSE: Older adults are prone to cognitive impairment, which may affect their ability to engage in aspects of shared decision making (SDM) and their ability to complete surveys about the SDM process. This study examined the surgical decision-making processes of older adults with and without cognitive insufficiencies and evaluated the psychometric properties of the SDM Process scale. METHODS: Eligible patients were 65 y or older and scheduled for a preoperative appointment before elective surgery (e.g., arthroplasty). One week before the visit, staff contacted patients via phone to administer the baseline survey, including the SDM Process scale (range 0-4), SURE scale (top scored), and the Montreal Cognitive Assessment Test version 8.1 BLIND English (MoCA-blind; score range 0-22; scores < 19 indicate cognitive insufficiency). Patients completed a follow-up survey 3 mo after their visit to assess decision regret (top scored) and retest reliability for the SDM Process scale. RESULTS: Twenty-six percent (127/488) of eligible patients completed the survey; 121 were included in the analytic data set, and 85 provided sufficient follow-up data. Forty percent of patients (n = 49/121) had MoCA-blind scores indicating cognitive insufficiencies. Overall SDM Process scores did not differ by cognitive status (intact cognition x¯ = 2.5, s = 1.0 v. cognitive insufficiencies x¯ = 2.5, s = 1.0; P = 0.80). SURE top scores were similar across groups (83% intact cognition v. 90% cognitive insufficiencies; P = 0.43). While patients with intact cognition had less regret, the difference was not statistically significant (92% intact cognition v. 79% cognitive insufficiencies; P = 0.10). SDM Process scores had low missing data and good retest reliability (intraclass correlation coefficient = 0.7). CONCLUSIONS: Reported SDM, decisional conflict, and decision regret did not differ significantly for patients with and without cognitive insufficiencies. The SDM Process scale was an acceptable, reliable, and valid measure of SDM in patients with and without cognitive insufficiencies. HIGHLIGHTS: Forty percent of patients 65 y or older who were scheduled for elective surgery had scores indicative of cognitive insufficiencies.Patient-reported shared decision making, decisional conflict, and decision regret did not differ significantly for patients with and without cognitive insufficiencies.The Shared Decision Making Process scale was an acceptable, reliable, and valid measure of shared decision making in patients with and without cognitive insufficiencies.

Getting patients back for routine colorectal cancer screening: Randomized controlled trial of a shared decision-making intervention.

Thousands of colonoscopies were canceled during the initial surge of the COVID-19 pandemic. As facilities resumed services, some patients were hesitant to reschedule. The purpose of this study was to determine whether a decision aid plus telephone coaching would increase colorectal cancer (CRC) screening and improve patient reports of shared decision making (SDM). A randomized controlled trial assigned adults aged 45-75 without prior history of CRC who had a colonoscopy canceled from March to May 2020 to intervention (n = 400) or usual care control (n = 400) arms. The intervention arm received three-page decision aid and call from decision coach from September 2020 through November 2020. Screening rates were collected at 6 months. A subset (n = 250) in each arm was surveyed 8 weeks after randomization to assess SDM (scores range 0-4, higher scores indicating more SDM), decisional conflict, and screening preference. The sample was on average, 60 years old, 53% female, 74% White, non-Hispanic, and 11% Spanish speaking. More intervention arm patients were screened within 6 months (35% intervention vs 23% control, p < 0.001). The intervention respondents reported higher SDM scores (mean difference 0.7 [0.4, 0.9], p < 0.001) and less decisional conflict than controls (-21% [-35%, -7%], p = 0.003). The majority in both arms preferred screening versus delaying (68% intervention vs. 65% control, p = 0.75). An SDM approach that offered alternatives and incorporated patients' preferences resulted in higher screening rates. Patients who are overdue for CRC screening may benefit from proactive outreach with SDM support.

Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery.

BACKGROUND: The purpose of this paper is to examine the acceptability, feasibility, reliability and validity of a new decision quality instrument that assesses the extent to which patients are informed and receive treatments that match their goals. METHODS: Cross-sectional mail survey of recent breast cancer survivors, providers and healthy controls and a retest survey of survivors. The decision quality instrument includes knowledge questions and a set of goals, and results in two scores: a breast cancer surgery knowledge score and a concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, discriminant validity, content validity, predictive validity and retest reliability of the survey instrument were examined. RESULTS: We had responses from 440 eligible patients, 88 providers and 35 healthy controls. The decision quality instrument was feasible to implement in this study, with low missing data. The knowledge score had good retest reliability (intraclass correlation coefficient=0.70) and discriminated between providers and patients (mean difference 35%, p<0.001). The majority of providers felt that the knowledge items covered content that was essential for the decision. Five of the 6 treatment goals met targets for content validity. The five goals had moderate to strong retest reliability (0.64 to 0.87). The concordance score was 89%, indicating that a majority had treatments concordant with that predicted by their goals. Patients who had concordant treatment had similar levels of confidence and regret as those who did not. CONCLUSIONS: The decision quality instrument met the criteria of feasibility, reliability, discriminant and content validity in this sample. Additional research to examine performance of the instrument in prospective studies and more diverse populations is needed.

Using Standardized Videos to Examine the Validity of the Shared Decision Making Process Scale: Results of a Randomized Online Experiment.

BACKGROUND: The Shared Decision Making (SDM) Process scale is a brief, patient-reported measure of SDM with demonstrated validity in surgical decision making studies. Herein we examine the validity of the scores in assessing SDM for cancer screening and medication decisions through standardized videos of good-quality and poor-quality SDM consultations. METHOD: An online sample was randomized to a clinical decision-colon cancer screening or high cholesterol-and a viewing order-good-quality video first or poor-quality video first. Participants watched both videos, completing a survey after each video. Surveys included the SDM Process scale and the 9-item SDM Questionnaire (SDM-Q-9); higher scores indicated greater SDM. Multilevel linear regressions identified if video, order, or their interaction predicted SDM Process scores. To identify how the SDM Process score classified videos, area under the curve (AUC) was calculated. The correlation between SDM Process score and SDM-Q-9 assessed construct validity. Heterogeneity analyses were conducted. RESULTS: In the sample of 388 participants (68% white, 70% female, average age 45 years) good-quality videos received higher SDM Process scores than poor-quality videos (Ps < 0.001), and those who viewed the good-quality high cholesterol video first tended to rate the videos higher. SDM Process scores were related to SDM-Q-9 scores (rs > 0.58; Ps < 0.001). AUC was poor (0.69) for the high cholesterol model and fair (0.79) for the colorectal cancer model. Heterogeneity analyses suggested individual differences were predictive of SDM Process scores. CONCLUSION: SDM Process scores showed good evidence of validity in a hypothetical scenario but were lacking in ability to classify good-quality or poor-quality videos accurately. Considerable heterogeneity of scoring existed, suggesting that individual differences played a role in evaluating good- or poor-quality SDM conversations.