Results from a randomized trial of a web-based,tailored decision aid for women at high risk for breast cancer

Objective

To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.

Methods

Postmenopausal women, age 46–74, with BCRAT 5-year risk ≥1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n = 690), Time 1 control (n = 160), or 3-month control (n = 162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women's decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.

Results

Intervention participants had significantly lower decisional conflict levels at post-test (p < 0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p < 0.001) compared to control participants.

Conclusion

GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.

Practice implications

Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients’ decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.     

Fostering informed decisions: A randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer

Objective

Screening asymptomatic men for prostate cancer is controversial and informed decision making is recommended. Within two prostate cancer screening programs, we evaluated the impact of a print-based decision aid (DA) on decision-making outcomes.

Methods

Men (N = 543) were 54.9 (SD = 8.1) years old and 61% were African-American. The 2(booklet type: DA vs. usual care (UC)) × 2(delivery mode: Home vs. Clinic) randomized controlled trial assessed decisional and screening outcomes at baseline, 2-months, and 13-months.

Results

Intention-to-treat linear regression analyses using generalized estimating equations revealed that DA participants reported improved knowledge relative to UC (B = .41, p < .05). For decisional conflict, per-protocol analyses revealed a group by time interaction (B = −.69, p < .05), indicating that DA participants were less likely to report decisional conflict at 2-months compared to UC participants (OR = .49, 95% CI: .26–.91, p < .05).

Conclusion

This is the first randomized trial to evaluate a DA in the context of free mass screening, a challenging setting in which to make an informed decision. The DA was highly utilized by participants, improved knowledge and reduced decisional conflict.

Practice implications

These results are valuable in understanding ways to improve the decisions of men who seek screening and can be easily implemented within many settings.     

Entertainment education for prostate cancer screening: a randomized trial among primary care patients with low health literacy

Objective

To evaluate an entertainment-based patient decision aid for prostate cancer screening among patients with low or high health literacy.

Methods

Male primary care patients from two clinical sites, one characterized as serving patients with low health literacy (n = 149) and the second as serving patients with high health literacy (n = 301), were randomized to receive an entertainment-based decision aid for prostate cancer screening or an audiobooklet-control aid with the same learner content but without the entertainment features. Postintervention and 2-week follow-up assessments were conducted.

Results

Patients at the low-literacy site were more engaged with the entertainment-based aid than patients at the high-literacy site. Overall, knowledge improved for all patients. Among patients at the low-literacy site, the entertainment-based aid was associated with lower decisional conflict and greater self-advocacy (i.e., mastering and obtaining information about screening) when compared to patients given the audiobooklet. No differences between the aids were observed for patients at the high-literacy site.

Conclusion

Entertainment education may be an effective strategy for promoting informed decision making about prostate cancer screening among patients with lower health literacy.

Practice implications

As barriers to implementing computer-based patient decision support programs decrease, alternative models for delivering these programs should be explored.     

A systematic review of menopausal symptom management decision aid trials

Objective

To systematically review the literature regarding the effects of menopausal symptom management decision aids.

Methods

Using pre-designated inclusion and exclusion criteria, relevant articles were located using the PubMed.gov online search engine and reviewing reference lists of relevant articles. Full-text, English-language, peer-reviewed articles relevant to testing decision aids in uncontrolled trials (UCT) and randomized controlled trials (RCT) were reviewed.

Results

The 18 articles represented 15 trials focused on natural health products decision aids (1 UCT, 1 RCT) or hormone therapy decision aids (1 UCT, 12 RCT). Whereas the natural health products aid was intended for women deciding about menopausal symptom management strategies, decision aids for hormone therapy were intended for a broader group of menopausal women and included indications for symptom management, prevention of heart disease, and prevention of osteoporosis. Many trials occurred prior to two pivotal events: the 2002 announcement of the Women's Health Initiative findings and the 2006 publication of the International Patient Decision Aids Standards. Study limitations may help explain contradictory findings for outcomes such as decisional conflict, decisional confidence, decisional satisfaction, knowledge and values, and decisions.

Conclusions

There is a relatively scant contemporary literature related to menopausal symptom management decision aids. Additional methodologically sound studies are needed to develop and subsequently test decision aids that are based on (a) contemporary knowledge regarding the wide array of available therapies and (b) international standards for decision aids that include consideration of women's values and preferences.     

Computerised decision aids: a systematic review of their effectiveness in facilitating high-quality decision-making in various health-related contexts

Objective

To systematically review existing empirical evidence regarding the effectiveness of computerised decision aids (CDAs) in enabling high-quality decision-making in preference-sensitive health-related contexts.

Methods

Relevant studies were identified via Medline, CINAHL, and PsycINFO databases (1990–October 2010). Only randomised controlled trials with at least one decision quality or decision process variable outcome were included.

Results

Of 1467 identified articles, 28 studies met all inclusion criteria, evaluating 26 unique CDAs. CDAs performed better than standard consultations/education regarding improved knowledge and lower decisional conflict, and were found not to increase anxiety. CDAs facilitated greater satisfaction with the decision-making process than standard education. The effects on risk perceptions, value congruence with the chosen option, preferred roles in decision-making and decisional self-efficacy need further evaluation. A paucity of CDAs adhered to decision theories.

Conclusions

CDAs showed similar effects as non-computerised DAs on various outcomes. Further research into the potentially superior effects of CDAs on feeling informed, values-clarity, and decisional conflict is required.

Practice implications

The more remarkable effects on knowledge and risk perceptions were reported when unique features of interactive computerised media were used. The potential benefit of tailored information, values-clarification, and integration of CDAs into shared decision-making consultations remains unresolved.     

Shared decision making and other variables as correlates of satisfaction with health care decisions in a United States national survey

Objective

The purpose of this study was to examine the relationship between shared decision-making (SDM) and satisfaction with decision (SWD) within a larger survey of patient decision-making in health care consultations.

Methods

A randomly selected age-proportionate national sample of adults (aged 21–70 years) stratified on race, ethnicity, and gender (N = 488) was recruited from a health research volunteer registry and completed an online survey with reference to a recent health consultation. Measures included the Shared Decision Making-9 questionnaire (SDM-Q-9), Satisfaction With Decision (SWD) scale, sociodemographic, health, and other standardized decision-making measures. Forward selection weighted multiple regression analysis was used to model correlates of SWD.

Results

After controlling for sociodemographic variables, SDM-Q-9 total score was associated with SWD, adjusted R² = .368, p < .001. Three of nine SDM-Q-9 items accounted for significant proportions of variance in SWD.

Conclusion

SDM was positively associated with SWD and was strongest for three areas of SDM: patients being helped in a health care consultation with understanding information, with treatment preference elicitation, and with weighing options thoroughly.

Practice implications

By identifying variables such as SDM that are associated with SWD, health care interventions can better target modifiable factors to enhance satisfaction and other outcomes.     

A randomised controlled trial of lay-led self-management for people with multiple sclerosis

Objective

To determine the impact of the Chronic Disease Self-Management Course (CDSMC) on people with multiple sclerosis (MS).

Methods

2-group, randomised, controlled trial with Intervention Group (IG) and Waiting-List Control Group (WLCG). Additional data were collected from a Comparison Group (CG) who chose not to attend the CDSMC. Participants completed baseline questionnaires; IG participants attended the CDSMC immediately; all participants were assessed at 4-months and 12-months.

Results

216 baseline questionnaires were returned; 73% were female, mean age 51.1 years, mean disease duration 12.0 years. Results showed that the CDSMC had an impact on self-management self-efficacy (ES 0.30, p = 0.009 for the IG) and MSIS physical status (ES 0.12 for the IG, p = 0.005). There were no other statistically significant changes. However, trends towards improvement on depression (ES 0.21 for the IG, p = 0.05) and MS self-efficacy (ES 0.16 for the IG, p = 0.04) were noted. All improvements were maintained at 12-months. At baseline, CG participants were older, had longer disease duration (p < 0.01) and less anxiety (p = 0.009) compared to RCT participants.

Conclusion

The CDSMC provides some small positive effects for people with MS. Motivation to attend may be linked to psychological distress and disease duration.

Practice implications

The CDSMC may be of value for those with mild anxiety/depression who need extra support. Attendance early in the disease course is recommended.     

Validating the Medical Data Interpretation Test in a Dutch population

Objective

To validate the Dutch translation of the Medical Data Interpretation Test.

Methods

A test–retest design with a 2-week interval was used.

Results

The intraclass correlation coefficient (ICC = .82), the limits-of-agreement interval (LOA = −8.96 to 2.48) and the test–retest reliability (Pearson's r = 86) suggest that the Dutch translation has good reproducibility. Construct validity was tested by two hypotheses, both of which were confirmed. University participants had higher test scores than non-university participants (p = .02), and males did not score differently than females (p = .61).

Conclusion

The results suggest that the Dutch version of the Medical Data Interpretation Test is an adequate scale to assess ability to interpret medical data.

Practice implications

Assessing patients’ numeracy skills before a counseling session will enable the counselor to adjust subsequent communication accordingly and, as such, improve the session's effectiveness.     

Evaluation of a natural health product decision aid: A tool for middle aged women considering menopausal symptom relief

Objective

To evaluate the effectiveness of a self-administered decision aid for menopausal women facing decisions about natural health products.

Study design

This pre-/post-test study included peri- or post-menopausal women, aged 45–64 considering the use of a natural health product for management of menopausal symptoms. They were recruited from a Women's Health Center.

Outcome measures

The primary outcome was decisional conflict and secondary outcomes included knowledge, strength of values, and decision preference.

Results

Of 24 women, the typical participant was 50–64 years of age, Caucasian, married, and well educated. Compared to baseline, after using the decision aid, women's total decisional conflict was reduced from 63% to 24% (p < 0.001) and knowledge improved from 76% to 87% (p = 0.001). Of the 24 women, 10 were unsure of their choice at baseline and 3-post use of the decision aid (p = 0.015). There was a trend for women preferring natural health products (n = 12) to be more likely to rate the non-chemical aspect as important and the cost of the natural health product as less important; women who preferred not to take natural health products (n = 3) rated the non-chemical aspect as less important and the costs as more important.

Conclusions

The natural health product decision aid improved the quality of decisions by enhancing knowledge and reducing decisional conflict. As well, women were more likely to make a choice that was consistent with their values.     

The impact of different modalities for activating patients in a community health center setting

Objective

Decision aids are designed to assist patients in understanding their health care choices but lower SES populations are less activated and may not be prepared to benefit. Activating interventions may help prepare patients for using decision aids.

Methods

We evaluated the impact of a decision aid video (DA) and the Patient Activation Intervention (PAI) on patient's level of activation measured by the Patient Activation Measure (PAM) and their decision-making confidence measured by the decision self-efficacy (DSE) scale. Patients were randomized into control, PAI alone, DA alone, and DA + PAI groups.

Results

PAM and DSE scores increased significantly in all groups with repeated measures. Restricting analyses to those with pre-intervention PAM scores at stages 1 or 2, the change in PAM scores was significant only for the intervention groups. The change in DSE scores was significantly only in the DA group.

Conclusion

These findings provide support for the utility of the DA, the PAI, and the DA + PAI in activating lower SES individuals. The DA alone changed DSE scores in the least activated patients while the PAI and DA both changed PAM scores.

Practice implications

Interventions directed at increasing patient engagement in their care may be useful particularly for less activated patients from lower SES populations.     

Does the use of shared decision-making consultation behaviors increase treatment decision-making satisfaction among Chinese women facing decision for breast cancer surgery?

Objective

To assess the extent to which breast surgical consultations used shared decision making (SDM), identify factors associated with use of SDM, and assess if using SDM increases decision-making satisfaction.

Methods

Two hundred and eighty-three video-recorded diagnostic-treatment decision consultations between breast surgeons and women with breast cancer were assessed using the Decision Analysis System for Oncology (DAS-O) coding system designed for assessing SDM behaviors. Women completed a questionnaire at pre-consultation, one-week post-consultation and one-month post-surgery. Patient outcomes included decision conflict, patient satisfaction with medical consultation, and decision regret.

Results

Overall, the level of SDM behaviors was low. The extent of SDM behavior within consultation was related to greater consultation duration (p < 0.001), more than one treatment being offered (p < 0.001), and fewer questions raised by patients/companions (p < 0.05). While use of SDM consultation did not influence post-consultation decision conflict, it increased satisfaction with information given and explained, patients’ feelings of trust and confidence in their surgeons, and reduced post-surgical decision regret.

Conclusion

These breast surgical consultations mostly adopted informed treatment decision-making approaches. Using SDM improved patient consultation and decision satisfaction.

Practice implications

The study findings highlight a need to reinforce the importance of SDM in consultations among breast surgeons.     

Quality of decision making is related to decision outcome for patients with cardiac arrhythmia

Objective

Clinical consultations with patients should be informed by the evidence-based and involve shared decision making (SDM). We aimed to determine the delivery of SDM by clinicians with patients referred for invasive treatment of cardiac electrical disease and to establish whether decisions made corresponded with patient and referring physician expectations.

Methods

Forty-nine outpatient consultations with two consultant cardiologists in one large tertiary centre were audio-recorded. Demographic data, diagnosis, reasons for referral and decision reached were compared directly with patient and referring physician expectations. The OPTION instrument was used to measure SDM. Patient expectations and satisfaction were elicited.

Results

Quality of SDM was good (mean OPTION score 49%) and there was broad patient satisfaction. While all patients were suitable for invasive treatment, and the majority (80%, n = 39) had been explicitly referred for it, only 59% (n = 29) opted to proceed. Consultation quality with respect to SDM was significantly greater for patients choosing a less invasive option.

Conclusion

These consultations often change expected management. Where decision making in the consultation is of higher quality, patients were more likely to change to a less invasive option.

Practice implications

Clinicians performing invasive cardiac treatment should be able to demonstrate high quality decision making.     

AASAP: a program to increase recruitment and retention in clinical trials

Objective

To evaluate a theory based, subject-centered, staff/subject communication program, AASAP (anticipate, acknowledge, standardize, accept, plan), to increase recruitment and retention in RCTs.

Methods

AASAP was evaluated with logistical regression by comparing rates of recruitment (at telephone screening, baseline assessment, initial intervention) and intervention retention (over 16 weeks) before (−AASAP) and after (+AASAP) it was introduced to a 3-arm RCT to reduce disease distress among highly distressed subjects with type 2 diabetes.

Results

Included were 250 subjects in −AASAP and 338 in +AASAP. Significant improvement in recruitment occurred at each of the 3 recruitment stages: agreed at screening (OR = 2.52; p < 0.001), attended baseline assessment (OR = 1.91; p < 0.001), attended initial intervention (OR = 1.46; p < 0.03). Higher education and shorter diabetes duration predicted better recruitment in −AASAP (OR = 2.23; p < 0.001), but not in +AASAP. AASAP also improved intervention retention over 16 weeks (OR = 3.46; p < 0.05).

Conclusion

AASAP is a structured program of subject/staff communication that helps improve external validity by enhancing both subject recruitment and retention.

Practical implications

AASAP can be taught to non-professional staff and can be adapted to a variety of health settings. It can also be used by clinicians to engage patients in programs of ongoing care.     

Appraisal of primary outcome measures used in trials of patient decision support

Objective

To appraise instruments used as primary outcome measures in trials measuring the effectiveness of patient decision support interventions.

Methods

Primary outcome measures were identified in trials of patient decision aids included in the 2003 Cochrane Review. Instruments were appraised for: use in calculating sample size, appropriateness, reliability, validity, responsiveness, precision, interpretability, acceptability, and feasibility.

Results

Of the 35 trials, there were 35 unique primary outcome measures and 8 instruments were appraised. Actual or preferred choice was the primary outcome measure in 18 trials. Two instruments met at least 6 of 8 appraisal criteria: Control Preference Scale (n = 2 trials) and Decisional Conflict Scale (n = 5 trials). The Decision Conflict Scale was used to calculate sample size in 4 trials.

Conclusion

Decision was the most consistent outcome measure. Most publications provided inadequate detail for appraising the instruments. Four instruments (Decisional Conflict, Control Preferences, Genetic Testing Knowledge Questionnaire, and McBride's Satisfaction with Decision) measured one or more International Patient Decision Aid Standards criteria for evaluating effectiveness.

Practice implications

Selecting relevant and high quality outcome measures remains challenging and is an important area for further research in the field of shared decision making.     

Does motivational interviewing counseling time influence HIV-positive persons’ self-efficacy to practice safer sex?

Objective

This study examined the impact of motivational interviewing (MI) counseling time on self-efficacy to practice safer sex for people living with HIV/AIDS (PLWHA).

Methods

In 4 month intervals we followed a cohort of 490 PLWHA for 12 months.We conducted hierarchical linear regression models to examine changes in safer sex self-efficacy when participants received zero, low to moderate (5–131 min) and high (132–320 min) doses of MI time. We conducted a similar analysis using number of counseling sessions as the predictor variable.

Results

Participants with low to moderate doses of MI counseling had 0.26 higher self-efficacy scores than participants with zero MI time (p = 0.01). Also, they had 0.26 lower self-efficacy scores than participants with high amounts of MI time (p = 0.04). Participants with high doses of MI had a 0.5 higher self-efficacy score than participants with zero amount of MI time (p < 0.0001). Participants who received 3–4 counseling sessions had 0.41 greater self-efficacy scores than participants who did not receive any sessions (p < 0.0001) but did not differ from participants receiving 1–2 sessions.

Conclusion

MI time is a key to enhancing safer sex self-efficacy among PLWHA.

Practice implications

Safer sex self-efficacy improves the more MI counseling time and sessions PLWHA receive.     

Audit and feedback using the brief Decision Support Analysis Tool (DSAT-10) to evaluate nurse-standardized patient encounters

Objective

To evaluate the brief Decision Support Analysis Tool (DSAT-10) for auditing the quality of nurse–standardized patient encounters, structuring feedback for nurses, and testing instrument reliability.

Methods

A systematic process was used to develop standardized patient scenarios, pilot-test scenarios, calibrate DSAT-10 coders, analyze taped telephone encounters using DSAT-10, and provide feedback. Inter-rater reliability was calculated using coder agreement, kappa, and intra-class correlation coefficients.

Results

Six scenarios portrayed patients’ decisional uncertainty from either: pressure from others (n = 2), unclear values (n = 2), or inadequate information (n = 2). Scenarios were easy to use over the telephone, produced realistic role performance, and were practical for audio-recording interactions. DSAT-10 analysis of 76 nurse–standardized patient encounters revealed nurses’ strengths (e.g., information provision) and their limitations (e.g., lack of discussion of values and/or support needs). Scores discriminated between trained and untrained nurses. The kappa coefficient over all items was 0.55 (95% CI: 0.49, 0.61) with higher agreement for encounters involving trained nurses (0.62; 95% CI: 0.43, 0.80).

Conclusion

Auditing nurse–standardized patient encounters using DSAT-10 and providing feedback to nurses was feasible. Although DSAT-10 items had adequate inter-rater reliability and discriminated between trained/untrained nurses, some items were problematic.

Practice implications

Providing feedback on nurse encounters with standardized patients experiencing uncertainty has the potential to enhance nurses’ decision support skills.     

Effectiveness of a discharge education program in reducing the severity of postpartum depression: A randomized controlled evaluation study

Objective

The effectiveness of a hospital discharge education program including information on postnatal depression was evaluated to reduce psychological morbidity after childbirth.

Methods

A randomized controlled trial (RCT) was conducted in a regional hospital in Taipei. Two hundred first-time mothers agreed to take part and were randomly allocated to an intervention group (n = 100) or control group (n = 100). The intervention group received discharge education on postnatal depression provided by postpartum ward nurses. The control group received general postpartum education. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) administered by postal questionnaire at six weeks and three months after delivery.

Results

Women who received discharge education intervention on postnatal depression were less likely to have high depression scores when compared to the control group at three months postpartum.

Conclusion

A discharge educational intervention including postnatal depression information given to women during the postpartum stay benefits psychological well-being.

Practice implications

A postpartum discharge education program including information on postnatal depression should be integrated into postpartum discharge care in general practice.     

Efficacy and tolerability of calcium, vitamin D and a plant-based omega-3 oil for osteopenia: a pilot RCT

Objectives

Our pilot study tested the efficacy, acceptability and tolerability of DHA supplementation in addition to calcium and vitamin D in individuals with osteopenia.

Study design

40 participants were randomised to either algal oil containing 400 mg docosahexanoic acid (DHA) daily or placebo. All participants received 1200 mg calcium carbonate with vitamin D₃ 1000 IU daily.

Main outcome measures

Bone mineral density (BMD) was measured at baseline and 12 months. Bone turnover was assessed with serum c-terminal telopeptides (CTx) at baseline and 12 months. Tolerability and acceptability were assessed using a validated questionnaire.

Results

Mean CTx was suppressed after 12 months for all participants (p = 0.04) with no difference in effect size between DHA and control groups (p = 0.53). Changes in CTx at 12 months were significantly correlated with changes in BMD at the lumbar spine (p = 0.01) and total proximal femur (TPF) (p = 0.03). There was a non-significant trend towards rising BMD at 12 months. Participants rated the supplements as tolerable and acceptable, with few adverse events.

Conclusions

The combination of oral calcium, vitamin D₃ and DHA was safe, tolerable and acceptable when used for 12 months by osteopenic individuals in this pilot study. The combination had a positive effect on bone health as indicated by serum CTx, with no effect demonstrated from the addition of DHA 400 mg. Changes in BMD at the lumbar spine and TPF were significantly correlated with changes in CTx, which may be useful in monitoring bone health and response to treatment.     

Patient and observer ratings of physician shared decision making behaviors in breast cancer consultations

Objective

Explore the validity of using patient reports to measure shared decision making (SDM).

Methods

178 patients diagnosed with breast cancer obtained SDM assistance in a university-based clinic. Trained observers rated physician SDM behaviors and surveyed patients. We calculated the frequency with which patients and observers reported maximum SDM behaviors for each survey item. We also calculated agreement frequency between patients and observers.

Results

Over 90% of patients rated doctors as reflecting SDM competencies. Patients reported doctors making recommendations more than soliciting their preferred choice (90% vs. 69%, p < 0.001). Patients heard benefits discussed “a lot” more often than they heard risks and side effects discussed “a lot” (81% vs. 58%, p < 0.001). Agreement between patients and observers was 75%. In cases of disagreement, patients more frequently perceived SDM behaviors than did observers (15% vs. 9%, p = 0.002), suggesting a possible agreement bias.

Conclusions

High agreement supports further investigation into using patients as efficient and effective raters of SDM. Patient ratings may be inflated by agreement bias.

Practice implications

Doctors presentations may be biased toward discussing benefits more than risks. Policy makers can solicit patient ratings of SDM as long as they are aware of possibly inflated ratings due to agreement bias.