Impact of including quantitative information in a decision aid for colorectal cancer screening: A randomized controlled trial

Objective: Guidelines recommend that decision aids provide quantitative information about risks and benefits of available options. Impact of providing this information is unknown.Methods: Randomized trial comparing two decision aids about colorectal cancer (CRC) screening with colonoscopy or fecal immunochemical test (FIT). 688 primary care patients due for CRC screening viewed a decision aid that uses words only (Verbal arm) vs. one that provides quantitative information (Quantitative arm). Main outcomes included perceived CRC risk, intent to be screened, and test preference, measured before and after viewing decision aid, and screening uptake at six months. Analyses were performed with ANCOVA and logistic regression.Results: Compared to the Verbal arm, those in the Quantitative arm had a larger increase in intent to undergo FIT (p?=?0.011) and were more likely to switch their preferred test from non-FIT to FIT (28% vs. 19%, p?=?.010). There were decreases in perceived risk in the Verbal Arm but not the Quantitative Arm (p?=?0.004). There was no difference in screening uptake. Numeracy did not moderate any effects.Conclusions: Quantitative information had relatively minor impact and no clearly negative effects, such as reducing uptake.Practice implications: Quantitative information may be useful but not essential for patients viewing decision aids.     

Development and preliminary evaluation of a bowel cancer screening decision aid for adults with lower literacy

Objective

Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, information is needed to suit adults ranging in literacy level. Decision aids are effective in providing balanced information and have been applied in screening. However, few have been designed for populations with lower education and literacy. This article describes the development and preliminary evaluation of a bowel cancer screening decision aid for this group.

Method

We conducted face-to-face interviews with adults of varying literacy ability, to develop the decision aid (Stage 1). We applied principles of plain language, created visual illustrations to support key textual messages, and used colour coding to direct the reader through the booklet. We then explored its acceptability and comprehension among consumers with higher and lower education (Stage 2). Participants were recruited from a community sample with lower education and a university alumni network.

Results

A total of 75 participants were interviewed, 43 with lower educational attainment and 32 with university education. The decision aid was positively reviewed by both education groups. Results highlighted the need to clarify the purpose of the decision aid and the availability of choice in the context of screening, especially to those with lower education.

Conclusion

The 2 stage iterative development process identified important factors to consider in the development of decision tools for this target group, and is recommended.

Practice implications

Our findings have implications for how to support people with lower education and literacy make informed screening decisions.     

Development and pilot-testing of a colorectal cancer screening decision aid for individuals with varying health literacy levels

ObjectiveMaking an informed decision about colorectal cancer screening requires health literacy. Our aim was to develop and pilot-test a computer-based decision aid to support informed decision making about whether or not to participate in colorectal cancer screening for individuals with varying health literacy levels in the Netherlands.MethodsFirst, we designed and adapted the decision aid prototype among 25 individuals with low (n = 15) and adequate (n = 10) health literacy. Second, we used a before/after study to assess changes in knowledge, attitude, intention, decisional conflict, deliberation, anxiety and risk perception in an online survey among 81 individuals eligible for colorectal cancer screening with low (n = 35) and adequate (n = 46) health literacy.ResultsThe decision aid was acceptable, comprehensible, reduced decisional conflict, increased deliberation and improved knowledge about colorectal cancer screening, but not about colorectal cancer, among individuals with adequate and low health literacy. Usability was slightly higher for participants with adequate health literacy compared to those with low health literacy.ConclusionThe decision aid is promising in supporting informed decision making about colorectal cancer screening, also among individuals with lower health literacy.Practice implicationsFurther refinement of interactive features, such as videos, animations and the values clarification exercise, is needed to increase the usability of the decision aid.     

A decision aid to facilitate informed choices among cataract patients: A randomized controlled trial

ObjectiveTo assess the effect of a patient decision aid on the quality of decision-making for patients with age-related cataracts.Methods773 patients with cataracts aged 50–80 years were randomly assigned to receive either the intervention decision aid (including standard information, quantitative information on the possible outcomes of cataract surgery and a value clarification exercise) or the control booklet (including standard information). The primary outcome was informed choice (defined as adequate knowledge and congruency between attitudes and surgical intentions), which was assessed at 2 weeks after intervention via a telephone interview.ResultsThe decision aid increased the proportion of participants making an informed choice, from 5.68 % in the control group to 27.7 % in the intervention group (P < 0.001). Compared with controls, more participants in the intervention group had adequate overall knowledge about cataract surgery (36.8 % vs. 8.79 % in controls; P < 0.001), and fewer participants intended to undergo surgery (22.5 % vs. 34.1 % in controls; P < 0.001).ConclusionUse of the patient decision aid may increase the proportion of patients making informed choices. Importantly, it might also reduce the acceptance of operations.Practice implications: Patient decision aids represent a simple and low-cost tool to facilitate informed choice among patients with cataracts.     

Evaluation of a mammography decision aid for women 75 and older at risk for lower health literacy in a pretest-posttest trial

ObjectiveThe evaluation of the effect of a mammography decision aid (DA) designed for older women at risk for lower health literacy (LHL) on their knowledge of mammography’s benefits and harms and decisional conflict.MethodsUsing a pretest-posttest design, women > 75 years at risk for LHL reviewing a mammography DA before and after their [B] primary care provider visit. Women were recruited from an academic medical center and community health centers and clinics.ResultsOf 147 eligible women approached, 43 participated. Receipt of the DA significantly affected knowledge of mammography’s benefits and harms [B] (pre-test (M = 3.75, SD = 1.05) to post-test (M = 4.42, SD = 1.19), p = .03). Receipt of the DA did not significantly affect decisional conflict (pre-test (M = 3.10, SD = .97) to post-test (M = 3.23, SD = 1.02), p = .71, higher scores = lower decisional conflict). The majority of the women (97%) indicated that the DA was helpful.ConclusionsWomen found a mammography screening DA helpful and its use was associated with these women having increased knowledge of mammography’s benefits and harms.Practice ImplicationsWith the shift toward shared decision-making for women > 75 years, there is a need to engage women of all literacy levels to participate in these decisions and have tools such as the one tested in this study.     

The impact of a patient decision aid on intention to undergo surgery for subacromial pain syndrome: An online randomised controlled trial

ObjectiveTo evaluate the effects of a patient decision aid for people considering shoulder surgery.MethodsParticipants with shoulder pain considering shoulder surgery (n = 425) were recruited online and randomised to (i) a decision aid outlining the benefits and harms of shoulder surgery and non-surgical options (then randomised to a side-by-side vs. top-and-bottom display of options); and (ii) general information about shoulder pain from the NHS. Outcomes included treatment intention (primary), knowledge, attitudes, informed choice, and decisional conflict. Linear and logistic regression models were used to evaluate between-groups differences in outcomes.Results409 participants (96%) had post-intervention data. Mean age was 41.3 years, 44.2% were female. There was no between-group difference in post-intervention treatment intention (MD ?0.2, 95% CI: ?3.3 to 2.8) and likelihood of intending to have shoulder surgery (OR 0.7, 95% CI: 0.3–1.5). The decision aid slightly improved knowledge (MD 4.4, 95% CI: 0.2–8.6), but not any other secondary outcomes. The display of options did not influence any outcome.ConclusionsIn this online trial, a co-designed patient decision aid had no effect on treatment intention, attitudes, informed choice, and decisional conflict, but a small effect on improving knowledge.Practice implicationsResearch is needed to understand reasons for the lack of anticipated effects.Trial registrationAustralia New Zealand Clinical Trials Registry (ACTRN12621000992808).     

Helping men make an informed decision about prostate cancer screening: A pilot study of telephone counseling

Objective

Evaluate a computer-assisted telephone counseling (CATC) decision aid for men considering a prostate specific antigen (PSA) test.

Methods

Eligible men were invited by their primary care providers (PCPs) to participate. Those consenting received an educational booklet followed by CATC. The counselor assessed stage of readiness, reviewed booklet information, corrected knowledge deficits and helped with a values clarification exercise. The materials presented advantages and disadvantages of being screened and did not advocate for testing or for not testing. Outcome measures included changes in stage, decisional conflict, decisional satisfaction, perceived vulnerability and congruence of a PSA testing decision with a pros/cons score. Baseline and final surveys were administered by telephone.

Results

There was an increase in PSA knowledge (p < 0.001), and in decisional satisfaction (p < 0.001), a decrease in decisional conflict (p < 0.001), and a general consistency of those decisions with the man's values. Among those initially who had not made a decision, 83.1% made a decision by final survey with decisions equally for or against screening.

Conclusions

The intervention provides realistic, unbiased and effective decision support for men facing a difficult and confusing decision.

Practice implications

Our intervention could potentially replace a discussion of PSA testing with the PCP for most men.     

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.     

Effect of culturally competent educational films about prenatal screening on informed decision making of pregnant women in the Netherlands

ObjectiveTo evaluate the effect of a culturally competent educational film (CCEF) on informed decision making (IDM) regarding prenatal screening (PS) in a study population consisting of multicultural pregnant women.MethodsA cross-sectional study with 262 women in the control group and 117 in the intervention group. All counselled participants received a self-report questionnaire to obtain data on IDM and only the intervention group received the CCEF. Twenty two percent of the study population had an ethnic minority background and 52% had a low or medium educational level.ResultsAfter exposure to the CCEF, knowledge about the Fetal Anomaly Scan (FAS) was significantly increased in ethnic minority women and in ‘medium’ and ‘highly’ educated women. Among women in the intervention group who had the intention to participate in FAS, there was an increase of 11% in IDM and a decrease of 12% in uninformed decision making.ConclusionCCEF leads to a significant increase in the level of knowledge in medium and highly educated groups as well as non-western ethnic minority groups. The increase in IDM among intentional participants in the FAS is promising as well. CCEF’s are a valuable complement to counseling about PS.     

ORCA,a values-based decision aid for selecting additional findings from genomic sequencing in adults: Efficacy results from a randomized trial

PurposeIndividuals having genomic sequencing can choose to be notified about pathogenic variants in genes unrelated to the testing indication. A decision aid can facilitate weighing one’s values before making a choice about these additional results.MethodsWe conducted a randomized trial (N = 231) comparing informed values-choice congruence among adults at risk for a hereditary cancer syndrome who viewed either the Optional Results Choice Aid (ORCA) or web-based additional findings information alone. ORCA is values-focused with a low-literacy design.ResultsIndividuals in both arms had informed values-choice congruence (75% and 73% in the decision aid and web-based groups, respectively; odds ratio [OR] = 1.10, 95% CI = 0.58-2.08). Most participants had adequate knowledge (79% and 76% in the decision aid and web-based groups, respectively; OR = 1.20, 95% CI = 0.61-2.34), with no significant difference between groups. Most had information-seeking values (97% and 98% in the decision aid and web-based groups, respectively; OR = 0.59, 95% CI = 0.10-3.61) and chose to receive additional findings.ConclusionThe ORCA decision aid did not significantly improve informed values-choice congruence over web-based information in this cohort of adults deciding about genomic results. Both web-based approaches may be effective for adults to decide about receiving medically actionable additional results.     

A decision aid for additional findings in genomic sequencing: Development and pilot testing

ObjectiveTo describe the development of a web-based, patient-facing decision aid to support patients and research participants to make an informed, values-based decision about whether to receive additional results from genomic sequencing.MethodsWe developed the decision aid following the multi-step process described in the International Patient Decision Aids Standards. This utilized literature review, focus groups, and alpha testing with research participants undergoing clinical genomic sequencing.ResultsThe decision aid, the Optional Results Choice Aid (ORCA), includes a seven-question “values clarification exercise,” illustrative patient quotes, and summative guidance for the user. The decision aid was found to be highly readable, acceptable and relevant in alpha testing.ConclusionWe developed a decision aid to support informed, values-based decision making for patients and research participants considering whether to receive additional results from genomic sequencing. ORCA is being implemented in the NHGRI-funded Cancer Health Assessment Reaching Many (CHARM) study, where we are measuring informed values-choice congruence.Practice implicationsORCA was designed to support patients and research participants to make an informed, values-based decision about whether to receive additional results from genomic sequencing.     

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial

Objective

To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund.

Methods

Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence.

Results

Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001).

Conclusion

PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account.

Practice implications

This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.     

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.     

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention

ObjectiveWe conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD).MethodsWe recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms.ResultsTwo out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm.ConclusionsThis pilot trial provides important guidance for developing a larger scale trial of a modified intervention.Practice implicationsOverall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.     

Development and pilot testing of an online screening decision aid for men with a family history of prostate cancer

Objective

This study aimed to develop and pilot test an online screening decision aid (DA) for men with a family history of prostate cancer.

Methods

Eligible men (with no previous prostate cancer diagnosis) were recruited through relatives attending a urology outpatient clinic. Men evaluated the DA in two stages. First, they appraised a paper-based version using a questionnaire (n = 22). Second, the same men were asked to reflect on an interactive web-based version via a semi-structured telephone interview (n = 20).

Results

Men evaluated both forms of the DA positively. Of the paper-based version, the majority of participants found the DA useful (91%), and that it contained enough information to make a screening decision (73%). All participants reported that the online DA was easy to use and navigate. Most participants reported that a website was their preferred mode of receiving prostate cancer screening information (70%).

Conclusion

The developed DA may represent the first online decision-making tool designed specifically for men with a family history prostate cancer that presents age and risk specific information to the user.

Practice implications

Comprehensive evaluations of the efficacy and impact of educational interventions such as this are crucial to improve services for individuals making informed screening decisions.     

A community-based intervention to promote informed decision making for prostate cancer screening among Hispanic American men changed knowledge and role preferences: a cluster RCT

Objective

We assessed the short-term effects of a community-based intervention for Hispanic men to encourage informed decision making (IDM) about prostate cancer screening with prostate specific antigen (PSA).

Methods

All senior social and housing centers in El Paso, TX were randomized to intervention, a group-based Spanish language educational program facilitated by promotores (12 centers; 161 men) [I's], or to control, promotores-facilitated diabetes video and discussion (13 centers; 160 men) [C's].

Results

Participants had low levels of schooling and baseline knowledge; 44% reported previous PSA testing. At post-test, the I's made large knowledge gains, increased their understanding that experts disagree about testing, shifted toward more active decision making roles, were more likely to believe that it is important to weigh the advantages and disadvantages of screening and to anticipate potential screening outcomes in making a decision, and were less likely to consider the screening decision easy. The I's did not change in their screening intention or the belief that choosing not to be screened could be a responsible choice.

Conclusions

A community-based intervention to support IDM for prostate cancer screening can increase knowledge and may promote more active involvement in decision making about prostate cancer screening. Such an approach can increase knowledge and may promote more active involvement in decision making about prostate cancer screening.

Practice implications

It is feasible to develop and implement a community-based intervention program to promote IDM for prostate cancer screening.     

Effectiveness of an online group course for depression in adolescents and young adults: a randomized trial

Background

Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course.

Objective

To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group.

Methods

We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed.

Results

The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t ₁₈₇ = 6.62, P < .001), with a large between-group effect size of d = 0.94 (95% confidence interval [CI] 0.64–1.23). The MYM group also showed greater improvement in anxiety (t ₁₈₇ = 3.80, P < .001, d = 0.49, 95% CI 0.24–0.75) and mastery (t ₁₈₇ = 3.36, P = .001, d = 0.44, 95% CI 0.19–0.70). At 12 weeks, 56% (68/121) of the participants in the MYM group and 20% (24/123) in the control group showed reliable and clinically significant change. This between-group difference was significant (χ² ₁ = 35.0, P < .001) and yielded a number needed to treat of 2.7. Improvements in the MYM group were maintained at 6 months. A limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months.

Conclusions

The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months.

Trial Registration

Nederlands Trial Register: NTR1694; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1694 (Archived by WebCite at http://www.webcitation.org/683SBoeGV)     

Evaluation of a widely available patient decision aid for the treatment of prostate cancer

Background

The effectiveness of patient decision aids (PtDA) is rarely evaluated in the “real world” where patients vary in their preferences related to decision support.