Wednesday, October 21, 2009: 8:00 AM
Grand Ballroom, Salons 4 & 5 (Renaissance Hollywood Hotel)

* Candidate for the Lee B. Lusted Student Prize Competition

Session Chairs:
Holly B. Jimison, PhD and Sarah T. Hawley, PhD, MPH
8:00 AM
Victoria A. Shaffer, PhD1, Sara Tomek, PhD2, Lukas Hulsey, BS3 and Amanda Barr3, (1)Department of Psychology, Wichita, KS, (2)University of Alabama, Tuscaloosa, AL, (3)Wichita State University, Wichita, KS

Purpose: Previous research has shown the importance of considering both the format and type of information presented to patients in decision aids (Fagerlin et al., 2005; Ubel et al., 2001). This research was designed to evaluate the impact of testimonials in a patient decision aid for early stage breast cancer.

Method: 200 women were paid $100 to participate in a randomized controlled trial. Participants were asked to imagine they had been diagnosed with early stage breast cancer and must choose between two treatments: lumpectomy with radiation and mastectomy. The participants were randomly assigned to view one of two DVDs that contained facts about the treatments and their relative effectiveness. One of the DVDs included testimonials from women who had made this treatment choice (statistics + testimonials condition); the other contained no personal testimonials (statistics only condition). After watching the DVD, participants made a treatment choice and answered additional questions about their decision making process.  Participants also provided demographic data and completed the Subjective Numeracy Scale (Fagerlin et al., 2007), the Decision Making Styles Inventory (Nygren, 2000), the Test of Functional Health Literacy-short form (Parker et al., 1995), and the e-Health Literacy Scale (Norman & Skinner, 2006). 

Result: Preliminary results from 84 participants showed marginally significant group differences in treatment choice.  Participants in the statistics only condition were more likely to choose mastectomy than lumpectomy; however, participants in the statistics + testimonials condition were equally likely to choose either treatment.  Additionally, participant education, numeracy, and health literacy interacted with condition to affect treatment choice.  In the statistics + testimonials condition, higher levels of education and health literacy were associated with a preference for lumpectomy, while higher levels of numeracy were associated with a preference for mastectomy.

Conclusion: The inclusion of testimonials in a patient decision aid for breast cancer altered treatment choices made by participants.  In addition, the presence of testimonials evoked different treatment choices in participants with less education and low levels of numeracy and health literacy.  This research calls into question the current practice of creating a single decision aid for all patients.  Furthermore, patient characteristics, such as education, numeracy and literacy, should be considered when constructing and using patient decision aids.  Additional implications for the development of patient decision aids will be discussed.

8:15 AM
Theresa Yang, BA1, Karen R. Sepucha, PhD1, Sandra Feibelmann, MPH1, Andy Wolf, MD2 and Kerry Kilbridge, MD1, (1)Massachusetts General Hospital, Boston, MA, (2)University of Virginia, Charlottesville, VA

Purpose: We performed a series of qualitative interviews among socioeconomically diverse primary care patients from two academic practices to assess the comprehension of underlying concepts and medical terminology employed in the process of shared decision making with a widely distributed colorectal cancer (CRC) screening decision aid.

Method: Based on prior interviews exploring prostate cancer screening among underserved patients with low literacy skills, we used a modified Delphi technique to identify where specific health literacy skills or knowledge are ascribed to patients referencing the CRC screening decision aid produced by the Foundation for Informed Medical Decision Making. In a series of phone and face-to-face interviews of men and women eligible for CRC screening, we used qualitative and mixed methodologies to compare what patients know and understand about CRC screening, to the proficiencies assumed by the decision aid. We characterized differences in five empirical health literacy domains: 1) reading skills   2) numeracy skills   3) anatomic knowledge   4) comprehension of common medical terms   and 5) basic cancer biology concepts.

Result: We report preliminary results from the first 24 interviews of a planned, ongoing total accrual of 70 patients. Patients’ median age was 53. There were 29% of patients with less than a high school education and 32% of patients self-identified as minority race. Although most patients had adequate numeracy skills, an estimated 33% (15, 52) would be challenged by the reading skills required in the decision aid. Some misunderstanding of colon function or anatomy was manifest even among the most well-educated patients. Most patients, 83% (68, 98), had not heard of any other CRC screening tests except for colonoscopy. Although 63% (43, 82) of patients could correctly describe “how the doctor tested stool for blood”, only 29% (11, 47) had heard of  “fecal occult blood testing”. Cancer biology concepts were understood surprisingly well. Most patients reported that they preferred getting medical information from their physician. The request for using plainer, more accessible language for shared decision making was a recurring theme.

Conclusion: Patient decision aids may assume a level of health literacy that many patients do not possess. Few patients were familiar with CRC screening tests other than colonoscopy. Even among well-educated patients, anatomy and commonly used medical terms in CRC screening are frequently misunderstood.

8:30 AM
Karen R. Sepucha, PhD1, Jeffrey K. Belkora, PhD2, Yuchiao Chang, PhD1, Carol Cosenza, MSW3, Beverly Moy, MD, MPH1, Ann Partridge, MD, MPH4 and Clara Lee, MD, MPP5, (1)Massachusetts General Hospital, Boston, MA, (2)University of California, San Francisco, San Francisco, CA, (3)University of Massachusetts Boston, Boston, MA, (4)Dana-Farber Cancer Institute, Boston, MA, (5)University of North Carolina Chapel Hill, Chapel Hill, NC

Purpose: The purpose of this study was to validate decision-specific knowledge items to be included in decision quality instruments (DQIs) for three common breast cancer decisions: surgery for early stage disease (SURG), adjuvant systemic treatment (SYS) and breast reconstruction (REC).

Method: We conducted a cross sectional mailing survey of recent breast cancer survivors identified through cancer registries at four academic cancer centers. Patients completed two modules (either SURG and SYS or SURG and REC). Each module contained items covering knowledge of treatments and outcomes, and demographics. A subset of patient respondents completed the survey twice to examine test-retest reliability. Providers and healthy volunteers also completed the knowledge items. To assess clinical validity, we also asked providers to rate the extent to which each item was essential for patients to know. First, we eliminated items that did not perform well. Next, we calculated test-retest reliability and internal consistency (using Cronbach’s Alpha) for the reduced set.  Then, we used ANOVA to determine whether the items discriminated among providers, patients and healthy volunteers.  

Result: We received 445 SURG, 354 SYS and 91 REC eligible responses (overall response rate 59%). The sample was predominantly Caucasian (82.5%), college-educated (63.6%), with Stage 1 disease (60.7%) and a mean age of 54.9.  We eliminated 14 items across the three instruments, 7 for being too easy, 2 for being too hard and 5 for other problems. A majority of providers rated the items as essential for patients to know. The final SURG, REC, and SYS instruments had test-retest reliability of 0.72, 0 .75, and 0.57, respectively; and internal consistency of 0.74, 0.66, and 0.81. The instruments discriminated between higher levels of provider knowledge and lower levels of patient  knowledge (88% vs. 52% SURG, 73% vs. 40% SYS, 60% vs. 37% REC, p<0.001 for each). Patients were more informed than healthy volunteers (52% vs. 49% SURG, 40% vs. 28% SYS, 37% vs. 33% REC), however the difference was only significant for SYS p<0.001.

Conclusion: The three instruments covered essential information, were able to discriminate between well informed providers and less informed patients, and were reliable. The knowledge portion of the DQIs demonstrated both psychometric and clinical validity.    

8:45 AM
Jeffrey K. Belkora, PhD1, David W. Hutton, MS2, Dan H. Moore, PhD1 and Laura A. Siminoff3, (1)University of California, San Francisco, San Francisco, CA, (2)Stanford University, Stanford, CA, (3)Virginia Commonwealth University, Richmond, VA

Purpose: Adjuvant! is a well-validated, widely-used analytic model that provides 10-year recurrence and mortality risk predictions for women with breast cancer considering adjuvant therapies, i.e. endocrine or chemical therapies. One study found that, among patients who were at low risk for mortality, those randomized to reviewing Adjuvant! printouts with their doctors chose adjuvant therapy less frequently than controls. Were these patients influenced by the educational content of the printouts, or did some other dimension persuade them to avoid adjuvant therapy? We conducted secondary analyses to explore whether the Adjuvant! printouts influenced patient choice through educational or other means.

Method: The original study randomized 58 oncologists from 14 oncology practices in Cleveland, and San Antonio to review either Adjuvant! printouts (intervention) or general information pamphlets (control) with their patients. After the visit, patients reported their estimate of their 10-year baseline prognosis (survival without adjuvant therapy). Study personnel reviewed charts and recorded whether or not patients took adjuvant therapy. As a measure of patient knowledge, we calculated whether patients were accurate within 5% of the baseline Adjuvant! estimate. For those patients who were at relatively low risk (estimated 10-year survival > 85%), we asked: 1. Were Adjuvant! printouts associated with increased frequency of patient accuracy? 2. Was patient accuracy associated with frequency of adjuvant therapy? 3. Was there any residual association between use of printouts and adjuvant therapy after controlling for patient accuracy? We answered these questions by constructing frequency tables and testing the corresponding null hypotheses using chi-square statistics with one degree of freedom, at a two-sided 5% significance level.

Result: Twenty-eight of 234 women in the intervention and 20 of 171 in the control group were low-risk. For these patients: 1. Use of Adjuvant! printouts was associated with significantly increased frequency of patient accuracy (57% vs 25%, p=0.04). 2. Accurate patients were significantly less likely to take adjuvant therapy (11% vs 38%, p=0.04). 3. In subset analyses, neither the high (p=0.11) nor low (p=0.57) accuracy patients exhibited significant associations between use of printouts and adjuvant therapy. Therefore there was no residual association between use of printouts and adjuvant

Conclusion: Adjuvant! printouts appear to influence treatment choices by improving patient knowledge of prognosis, rather than through other persuasive mechanisms.

9:00 AM
Kirsten McCaffery, PhD1, Les Irwig, PhD1, Robin Turner, PhD1, Siew Foong Chan, MAppStat1, Petra Macaskill, PhD1, Mary Lewicka, MPH1, Judith Clarke, PhD1, Edith Weisberg, MBBS2 and Alexandra Barratt, MD, PhD1, (1)University of Sydney, Sydney, Australia, (2)Family Planning NSW, Sydney, Australia

Purpose: Management for mildly abnormal Pap smears (HPV triage or repeat Pap testing) has different psychosocial and practical implications for women. We assessed which of 3 different strategies, in which choice was and was not available, resulted in the best psychosocial outcomes over 1 year: clinician directed HPV or Pap testing or women’s informed choice of either test supported by a decision aid.

Method: Women (n=318) with a mildly abnormal Pap smear recruited through women’s health clinics across Australia were randomised to 1 of 3 arms, HPV testing (H), repeat Pap testing (P) or women’s informed choice (IC) of either test supported by a decision aid. Psychosocial outcomes were assessed at multiple time points over 12 months by postal questionnaire.

Result: At 2 weeks after triage, some psychosocial outcomes were worse for women directed to HPV testing compared to those directed to Pap testing (SF36 Vitality subscale: t= -1.63, df=131, P=0.10; intrusive thoughts χ2=8.14, df=1, P<0.01). Over the full year of follow up, distress was lowest among women directed to HPV testing and highest in the Pap testing arm (t= -2.89, df=135, P<0.01). There were few differences between women in the HPV triage and informed choice arm, although knowledge scores were higher compared to both clinician directed arms (mean score IC 8.1 vs H 7.3 vs P 7.2 out of 10, F=4.97, df=2, P<0.01). Intrusive thoughts were also lower in the informed choice arm (IC 13% vs H 25% vs P 17%, difference IC vs H =12%, 95%CI -1.1% to 25.1%). Women in the HPV triage and Informed Choice arms had high levels of satisfaction and were significantly more satisfied than those in the Pap testing arm. We compared informed choice versus clinician directed management (HPV and Pap combined). There was weak evidence in favor of choice for the SF36 mental component score (2.5, 95%CI -0.2 to 5.3, P=0.07) and the subscales vitality, social function and mental health.

Conclusion: Over the full year of follow-up, clinician directed HPV triage is better for women’s psychosocial health compared to repeat Pap testing. There is some indication that offering informed choice provides some benefit to women with respect to quality of life, improved knowledge and intrusive thoughts.

9:15 AM
Ronald E. Myers, PhD, Constantine Daskalakis, SCD, Elisabeth Kunkel, MD and Jeffrey Riggio, MD, Thomas Jefferson University, Philadelphia, PA

Purpose: Informed decision making (IDM) about prostate cancer screening is limited in primary care practice settings.  This study aimed to assess IDM and the impact of an in-person decision counseling intervention on IDM in physician-patient encounters.

Method: Physicians in two primary care practices completed a self-administered baseline survey.  Asymptomatic men who were 50-69 years of age, were eligible for prostate cancer screening, and had a scheduled office visit for non-acute care completed a baseline telephone survey.  Both surveys assessed personal background characteristics, knowledge, and perceptions about prostate cancer screening.  All participating patients were sent a brochure on prostate cancer screening before their scheduled office visit. At the visit, participants were randomized either to an enhanced intervention (EI) or a standard intervention (SI) group.  SI Group men met with a nurse educator and completed a practice satisfaction survey; while EI Group men met with a nurse educator to review the prostate brochure, identify and weight personal values related to screening, and clarify screening preference via a values comparison exercise.  A physician prompt to discuss screening was placed on the medical chart of all participants.  Subsequent physician-patient encounters were audio-recorded and coded.  A completeness of IDM score, based on the number of screening issues (0-9) discussed, was computed. Negative binomial regression was used to identify IDM predictors.

Result: In 144 physician-patient encounters, IDM scores were low (mean = 2.9, std. dev. = 2.1).  Positive patient predictors of IDM included exposure to decision counseling (p = 0.029), being African American (p = 0.031), belief that susceptibility to prostate cancer is low (p = 0.027), and worry about screening (p = 0.038).  Positive physician predictors of IDM were years in practice (p = 0.001), awareness that screening is controversial (p = 0.009), and confidence in approach used to discuss screening with patients (p = 0.01), although these associations did not follow a clear monotonic pattern.

Conclusion: Decision counseling, along with patient and physician characteristics, influenced prostate cancer screening IDM.  Research is needed to determine how to maximize the impact of this type of intervention in clinical interactions and on decision making in diverse populations.