Purpose:    The human papillomavirus (HPV) is a common infection that has been linked to several cancers. A vaccine has been developed for adolescents. This study measures the influences of the attitudes of daughter and mother on the decision to immunize the daughter.  

Methods:    The Theory of Planned Behavior guided the development and analysis of survey data collected from 72 mother-and-daughter dyads. Additional information was collected regarding the relationship between mother and daughter.  Two structural equation models (SEM) were created; one to relate the mother’s behavioral attitude, subjective norms, and perceived behavioral control with her intention and decision whether to vaccinate the daughter. The second expanded the model to include variables related to the dyad. Additional analyses compared whether the daughter shared similar attitudes and beliefs to her mother.

Results:    Mothers (average age = 44 years) were mainly Caucasian (73%), at least high school educated (62%), and married (64%). Their daughters (average age = 15 years) were mainly in grade 9 or lower (69%) and only 35% reported being in a dating relationship.    The mother’s intention to vaccinate was predicted by her behavioral attitude (B=.39, p<.001), normative beliefs (B=.31, p<.001), and perceived behavioral control (B=.31, p<.001); intention predicted her vaccine decision (B=.31, p<.001). The basic SEM was a good fitting model (RMSEA=.001, PCLOSE=.52). The three variables strongly predicted intention (r-square = .68, p<.001); regressing perceived behavioral control and intention on the decision (yes or no) to vaccinate resulted in an odds ratio = .33 (p<.001). The addition of variables related to the mother’s relationship to her daughter and her parenting style did not significantly improve the model’s predictability. The mother and daughter did not always hold the same attitudes toward vaccination; only their normative beliefs were correlated (r=.42, p<.001).

Conclusion:    In the decision to vaccinate an adolescent female against different cancer-causing strains of HPV, there appears to be little shared decision making. Mainly, the attitudes and beliefs of the mother dictate whether the daughter receives the vaccine. Efforts to increase the HPV vaccine acceptance rates should focus on educating mothers about the benefits and risks associated with her decision.

Purpose: Breast cancer prevention has the potential to decrease the incidence of the disease, yet remains underused. We have developed a web-based tool that provides automated risk assessment and personalized decision support designed for collaborative use between patients and clinicians. We assessed the feasibility of using this tool in a primary care setting.

Methods: Women, 40-65, were recruited from a schedule of patients attending annual physicals in a primary care clinic at an academic hospital. Patients with a history of breast cancer, genetic testing, or chemoprevention education were excluded. Information used to assess breast cancer risk was gathered from phone interviews and medical records.  Patients were randomized to view the decision aid either before their appointment or with their PCP during their appointment. Feasibility of the decision aid was assessed through: 1) Visit duration; 2) Patient Acceptability; and 3) Clinician Satisfaction. The outcomes were gathered from surveys administered to patients before and after appointments, and to providers after appointments.

Results: 64 women were approached over 5-months. 42/64 (68%) consented and were enrolled. 26/42 (62%) patients viewed the decision aid. Use of the decision aid did not result in a longer visit (p=0.57). Nor did it negatively influence the provider’s satisfaction with the visit (p=0.28). A majority of patients had a positive review of the decision aid and thought it was helpful in making a decision. A higher number of subjects who viewed the decision aid were either at moderate or high risk as calculated by the Gail or BRCAPro models (p =0.0138).  15/42 (36%) patients were at moderate or high risk. The PCPs’ perceptions of these patients’ risk was in line with the calculated risk for 11/15 (73%) of the patients. While a discussion regarding breast cancer risk reduction occurred with 14/15 (93%) of these patients, PCPs chose to use the decision aid during the appointment with 6/15 (40%) of them.

Conclusions: Performing personalized risk assessment and use of the decision aid in the primary care setting was feasible and acceptable. These results suggest risk assessment alone is enough to encourage a discussion about breast cancer risk reduction for some providers. This method of risk assessment and decision support holds promise in the effort to reduce the incidence and burden of breast cancer.

Purpose: Guidelines recommend that treatment decisions for nonvalvular atrial fibrillation (NVAF) incorporate patient preferences. We designed a multicomponent decision tool to inform patients of their individual risks of stroke and bleed over a meaningful time period (5 years), assist patients in clarifying their priorities, and to facilitate patient-physician communication.

Methods: We conducted a pilot, clustered randomized controlled trial, in which patients assigned to one group of providers completed the decision tool before seeing their primary care physician and patients assigned to a second group received usual care. Data were collected pre- and post visit to assess outcomes. Visits were audiotaped. The primary outcome variables were the Informed and Values Clarity subscales of the low-literacy version of the Decisional Conflict Scale ⁶. Secondary outcomes were: knowledge, anxiety, worry, rationale for preferred treatment, and discussion of NVAF-related outcomes. Between group differences were measured using a linear regression model which included sociodemographic characteristics, quality of life, and baseline scores. A sample size of 135 was calculated assuming, Type 1 error of 0.05, power of 0.80, two-tailed, an effect size (Cohen's d) of 0.5 after inflating the initial estimate by 5% for possible missing values.

Results: 69 patients were enrolled in the intervention group and 66 in the control group. Participants in the intervention group had lower scores on the Informed [11.9 (-21.1, -2.7)] and Values Clarity subscales [-14.6 (-22.6, -6.6)]. Participants in the intervention group were more likely to be able to name the medications for reducing stroke risk (61% vs 31%, p<0.001) and to know their side effects (49% vs 37%, p=0.07), although the latter did not reach statistical significance. The risk of stroke was discussed more frequently in the intervention than control group (71% vs 12%, p<0.0001), as was the risk of bleed (71% vs 21%, p<0.0001). Between groups differences for remaining outcomes are presented in the table.

Conclusion: The tool was effective at improving perceived knowledge and value clarity and at increasing physician-patient communication.

	Intervention (mean)	Control (mean)	Difference (95% CI)	P-Value
Accuracy: stroke risk	9.1	14.2	-5.2 (-1.9, -8.4)	<.001
Accuracy: bleeding risk	8.7	13.1	-4.4 (1.4, -7.5)	<.001
Anxiety	13.0	13.4	-0.38 (-1.4, .67)	0.46
Worry: stroke risk	1.8	1.6	0.18 (-0.31, .66)	0.47
Worry: bleeding risk	1.5	1.9	-0.43 (-1.1, .29)	0.24

 

Purpose: To examine the impact of an online decision aid (DA) intervention on informed decision making about chemoprevention.

Method: Women aged 46-74 at high risk of breast cancer were recruited from 2 U.S. HMOs. Participants were randomly assigned to 1 of 3 groups: intervention group (viewed online DA and answered post-test chemoprevention questions); standard control group (did not receive DA but answered post-test chemoprevention questions), or 3-month follow-up control group (did not receive DA or answer post-test chemoprevention questions). 585 women completed post-test and 3-month follow-up questionnaires. Using Marteau, Dormandy, and Michie’s (2001) definition of informed decisions, we created a dichotomous composite variable, “informed decision,” equal to “1” for women with sufficient knowledge (correctly answered at least 50% of gist knowledge questions) who also made a decision about chemoprevention consistent with their attitudes toward the drugs. Women with insufficient knowledge or with decisions inconsistent with their attitudes received a score of “0.”

Result: At post-test, 54% of the intervention group and 6% of the standard control group made informed decisions, OR=17.69, p<.001, 95% CI=7.56, 41.38. Informed decisions may be based on prior knowledge despite current knowledge having dropped off, so we assessed post-test knowledge with decision-making at follow-up; the intervention group (44%) made informed decisions more frequently than the standard control group (3%), OR=25.67, p<.001, CI=7.99, 82.49. At follow-up there was a trend toward the intervention group making more informed decisions (18%) than either of the control groups (12% standard control vs. 8% 3-month control), but overall this difference was not statistically significant, X²(2)=5.396, p=.067. Post-test sufficient knowledge occurred more frequently in the intervention group (62%) compared to standard control (7%), Χ²(1)=97.528, p<.001. At follow-up, the intervention group (25%) was more likely than either control group (15% standard control vs. 12% 3-month control) to have retained sufficient knowledge for an informed decision Χ²(2)=10.71, p=.005.

Conclusion: Women given a DA describing risks and benefits of tamoxifen and raloxifene were significantly more likely to make informed decisions about undergoing chemoprevention for breast cancer immediately after reading the DA. The intervention materials impacted knowledge and alignment of attitudes with decisions, but this effect faded over time. These results suggest that providing booster information and tools to help patients recall their initial decision processes may increase informed decision making.

Purpose: Current informed consent processes tend to emphasize information provision rather than careful deliberation and decision-making. The International Patient Decision Aids Standards (IPDAS) provide recommendations for working systematically through difficult decisions, such that decision makers will understand outcome probabilities, explicitly weigh benefits and harms, and consider which outcomes they value most. We assessed informed consent documents (ICDs) according to these recommendations.

Methods: 139 ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a 4-point scale (strongly agree, agree, disagree, strongly disagree), two raters assessed each ICD on 32 items. If the mean rating was within the “agree” range, the ICD was said to conform to that item.

Results: Overall agreement between raters was 95.1%. For the 12 items focused on providing information about options, conformity (i.e. the percentage of the sample rated ‘strongly agree’ or ‘agree’ to that item) was above 50% for only 3 items, while conformity was 0% for another 4 items. For 8 items focused on clear presentation of probabilities of outcomes, conformity was below 20% for all 8. For the 2 items focused on clarifying and expressing values, conformity was below 10%. For the 2 items focused on improving structured guidance in deliberation, conformity was below 5%. For the 4 items focused on using evidence to facilitate decision making, 1 item showed conformity in more than 50% of the sample, while the others showed conformity below 5%. For 4 items focused on disclosure and transparency, conformity was high (above 60% for 2, above 80% for the others). 

Conclusions: This study shows that existing ICDs do not conform to many standards known to encourage good-quality decision making. These standards make clear and testable predictions about how one might go about improving the extent to which trial participation decisions are fully informed.

Purpose:   The acuity of the chronically critically ill (CCI) and the increased rates of cognitive impairment in this emerging cohort enhances the complexity of shared decision making. Often surrogate decision makers (SDMs) are required to make complex health care decisions without certainty of the patient’s likelihood of survival or long-term quality of life. This cross-sectional study examines dispositional and situational factors that influence the satisfaction with decision support among SDMs of cognitively impaired CCI patients.

Methods:    A dispositional stress and coping framework guided the development of the path model and analysis of survey data collected from 216 SDMs of the CCI. A path model was created with Analysis of Moment Structure (AMOS version 19), which consisted of the following dispositional and situational factors: dispositional cognitive appraisal (threat, resources, and centrality subscales of the Stress Appraisal Measure), informational coping style (monitor subscale of the Abbreviated Miller Behavioral Style Scale), depressive symptoms (Center for Epidemiological Studies-Depression Scale), role stress (“How stressful has it been making decisions for your loved one?”), satisfaction with decision support (informational and decision support subscale of the revised Critical Care Family Satisfaction Survey for chronic critical illness), and the SDM’s gender.

Results:    On average, SDMs (mean age = 52 years) were Caucasian (62%), females (76%), high school educated (65%) and the spouse (34%), adult child (28%), or parent (22%) of a cognitively impaired CCI patient. Overall, the path model had an excellent model fit to our data (χ²= 14.9, df = 20, p=.78, TLI = 1.07, CFI = 1.00, RMSEA =.000). Threat appraisal (β=.40, p<.001) had a direct effect on informational coping style, and threat appraisal was correlated with centrality (r =.68, p<.001) and resources (r =-.20, p<.01). Gender (β=-.15, p<.05), informational coping style (β=.17, p<.05), and threat appraisal (β=.21, p<.05) had a direct effect on depressive symptoms. Depressive symptoms (β=.45, p<.001) had a direct effect on role stress, and role stress (β=-.14, p=.05) had a direct effect on satisfaction with decision support.

Conclusion:    Among SDMs of CCI patients, role stress directly impacts their appraisal of satisfaction with decision support. Interventional research that targets threat appraisal, adapts to informational coping style, and reduces depressive symptoms may reduce the SDM’s perception of role stress and enhance satisfaction with decision support.