Oral docetaxel plus encequidar - a phase 1 clinical trial.

PURPOSE: To determine the bioavailability, safety, and tolerability of a single dose of oral docetaxel plus encequidar (oDox + E) and compare its pharmacokinetic exposure with current standard of care IV docetaxel. INTRODUCTION: Docetaxel is a taxane widely used as an anti-neoplastic agent. Due to low oral bioavailability secondary to gut P-glycoprotein (P-gp) efflux, its current use is limited to intravenous administration. Oral docetaxel may provide a less resource intensive, more convenient, and tolerable alternative. Encequidar is a first in class, minimally absorbed, oral gut-specific P-gp inhibitor. We tested whether oDox + E can achieve comparable pharmacokinetic exposure to IV docetaxel. METHODS: A multicentre, phase I open-label, pharmacokinetic trial was undertaken to determine the bioavailability, safety, and tolerability of a single dose of oDox + E (at 75 mg/m2 + 15 mg, 150 mg/m2 + 15 mg, and 300 mg/m2 + 15 mg) in metastatic prostate cancer (mPC) patients compared to standard of care IV docetaxel as prescribed by their oncologists. The 15 mg of Encequidar at each dose level was given one hour prior to oral docetaxel. RESULTS: 11 patients were enrolled; 9 patients completed the study. Oral docetaxel exposure increased with dose, achieving the highest at 300 mg/m2 oDox + E (with AUC0 - infinity of 1343.3 ± 443.0 ng.h/mL compared to the IV docetaxel AUC0 - infinity of 2000 ± 325 ng.h/mL) and became non-linear at 300 mg/m2. The mean absolute bioavailability of oDox + E across all 3 dose levels was 16.14% (range: 8.19-25.09%). No patient deaths, dose limiting toxicity, treatment-related serious adverse event or grade 4 toxicity were observed. Maximal tolerated dose was not reached. CONCLUSION: oDox + E has a safe and tolerable adverse event profile in patients with metastatic prostate cancer. The increase in oral bioavailability of oDox + E suggests a multi-dose oDox + E regimen could theoretically achieve exposures comparable with standard of care IV docetaxel. Further development to examine the optimal multiple dose regimen of oDox + E is warranted. TRIAL REGISTRATION NUMBER: U1111-1173-5473.

Show me the roads and give me a road map: Development of a patient conversation tool to improve lung cancer treatment decision-making.

Objective: Evidence-based decision support resources do not exist for persons with lung cancer. We sought to develop and refine a treatment decision support, or conversation tool, to improve shared decision-making (SDM). Methods: We conducted a multi-site study among patients with stage I-IV non-small cell lung cancer (NSCLC) who completed or had ongoing lung cancer treatment using semi-structured, cognitive qualitative interviews to assess participant understanding of content. We used an integrated approach of deductive and inductive thematic analysis. Results: Twenty-seven patients with NSCLC participated. Participants with prior cancer experiences or those with family members with prior cancer experiences reported better preparedness for cancer treatment decision-making. All participants agreed the conversation tool would be helpful to clarify their thinking about values, comparisons, and goals of treatment, and to help patients communicate more effectively with their clinicians. Conclusion: Participants reported that the tool may empower them with confidence and agency to actively participate in cancer treatment SDM. The conversation tool was acceptable, comprehensible, and usable. Next steps will test effectiveness on patient-centered and decisional outcomes. Innovation: A personalized conversation tool using consequence tables and core SDM components is novel in that it can encourage a tailored, conversational dynamic and includes patient-centered values along with traditional decisional outcomes.

Use of an Online Breast Cancer Risk Assessment and Patient Decision Aid in Primary Care Practices.

Background: U.S. Preventive Services Task Force (USPSTF) recommendations for mammography screening, genetic counseling and testing for pathogenic BRCA1/2 mutations, and use of risk-reducing medications require assessment of breast cancer risk for clinical decision-making, but efficient methods for risk assessment in clinical practice are lacking. Materials and Methods: A cross-sectional study evaluating a web-based breast cancer risk assessment and decision aid (MammoScreen) was conducted in an academic general internal medicine clinic. All eligible women, 40-74 years of age without previous diagnosis of breast or ovarian cancer and who were enrolled in the Epic MyChart patient portal were invited. MammoScreen uptake and completion rates and consistency between breast cancer risk determined by MammoScreen and existing risk information in the Epic record were measured. Patient and physician experiences were summarized from interviews. Results: Of 448 invited participants, 339 (75.7%) read their MyChart invitation and 125 (36.9%) who read invitations enrolled in the study; 118 (94.4% of enrolled) completed MammoScreen. Twenty-one women were categorized as above-average risk from either MammoScreen data or the chart review and 7 (33.3%) were identified by both sources. Physicians and patients believed MammoScreen was easy to use and was helpful in identifying risks and facilitating shared decision-making. Conclusions: Breast cancer risk assessment and mammography screening decision support were efficiently implemented through a web-based tool for patients sent through an electronic patient portal. Integration of patient decision aids with risk algorithms in clinical practice may help support the implementation of USPSTF recommendations that include risk assessment and shared decision-making.

Decisional Conflict Scale Use over 20 Years: The Anniversary Review.

Background. The Decisional Conflict Scale (DCS) measures 5 dimensions of decision making (feeling: uncertain, uninformed, unclear about values, unsupported; ineffective decision making). We examined the use of the DCS over its initial 20 years (1995 to 2015). Methods. We conducted a scoping review with backward citation search in Google Analytics/Web of Science/PubMed, followed by keyword searches in Cochrane Library, PubMed, Ovid MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, PRO-Quest, and Web of Science. Eligible studies were published between 1995 and March 2015, used an original experimental/observational research design, concerned a health-related decision, and provided DCS data (total/subscales). Author dyads independently screened titles, abstracts, full texts, and extracted data. We performed narrative data synthesis. Results. We included 394 articles. DCS use appeared to increase over time. Three hundred nine studies (76%) used the original DCS, and 29 (7%) used subscales only. Most studies used the DCS to evaluate the impact of decision support interventions (n = 238, 59%). The DCS was translated into 13 languages. Most decisions were made by people for themselves (n = 353, 87%), about treatment (n = 225, 55%), or testing (n = 91, 23%). The most common decision contexts were oncology (n = 113, 28%) and primary care (n = 82, 20%). Conclusions. This is the first study to descriptively synthesize characteristics of DCS data. Use of the DCS as an outcome measure for health decision interventions has increased over its 20-year existence, demonstrating its relevance as a decision-making evaluation measure. Most studies failed to report when decisional conflict was measured during the decision-making process, making scores difficult to interpret. Findings from this study will be used to update the DCS user manual.

Understanding patients' values and preferences regarding early stage lung cancer treatment decision making.

INTRODUCTION: With advances in treatments among patients with lung cancer, it is increasingly important to understand patients' values and preferences to facilitate shared decision making. METHODS: Prospective, multicenter study of patients with treated stage I lung cancer. At the time of study participation, participants were 4-6 months posttreatment. Value clarification and discrete choice methods were used to elicit participants' values and treatment preferences regarding stereotactic body radiation therapy (SBRT) and surgical resection using only treatment attributes. RESULTS: Among 114 participants, mean age was 70 years (Standard Deviation = 7.9), 65% were male, 68 (60%) received SBRT and 46 (40%) received surgery. More participants valued independence and quality of life (QOL) as "most important" compared to survival or cancer recurrence. Most participants (83%) were willing to accept lung cancer treatment with a 2% chance of periprocedural death for only one additional year of life. Participants also valued independence more than additional years of life as most (86%) were unwilling to accept either permanent placement in a nursing home or being limited to a bed/chair for four additional years of life. Surprisingly, treatment discordance was common as 49% of participants preferred the alternative lung cancer treatment than what they received. CONCLUSIONS: Among participants with early stage lung cancer, maintaining independence and QOL were more highly valued than survival or cancer recurrence. Participants were willing to accept high periprocedural mortality, but not severe deficits affecting QOL when considering treatment. Treatment discordance was common among participants who received SBRT or surgery. Understanding patients' values and preferences regarding treatment decisions is essential to foster shared decision making and ensure treatment plans are consistent with patients' goals. Clinicians need more resources to engage in high quality communication during lung cancer treatment discussions.

Prostate Cancer Screening Patient Decision Aids: A Systematic Review and Meta-analysis.

CONTEXT: Although screening recommendations for prostate cancer using prostate-specific antigen testing often include shared decision making, the effect of patient decision aids on patients' intention and uptake is unclear. This study aimed to review the effect of decision aids on men's screening intention, screening utilization, and the congruence between intentions and uptake. EVIDENCE ACQUISITION: Data sources were searched through April 6, 2018, and included MEDLINE, Scopus, CENTRAL, CT.gov, Cochrane report, PsycARTICLES, PsycINFO, and reference lists. This study included RCTs and observational studies of decision aids that measured prostate screening intention or behavior. The analysis was completed in April 2018. EVIDENCE SYNTHESIS: Eighteen studies (13 RCTs, four before-after studies, and one non-RCT) reported data on screening intention for ≅8,400 men and screening uptake for 2,385 men. Compared with usual care, the use of decision aids in any format results in fewer men (aged ≥40 years) planning to undergo prostate-specific antigen testing (risk ratio=0.88, 95% CI=0.81, 0.95, p=0.006, I2=66%, p<0.001, n=8). Many men did not follow their screening intentions during the first year after using a decision aid; however, most men who were planning to undergo screening did so (probability that men who wanted to be screened would receive screening was 95%). CONCLUSIONS: Integration of decision aids in clinical practice may result in a decrease in the number of men who elect prostate-specific antigen testing, which may in turn reduce screening uptake. To ensure high congruence between intention and screening utilization, providers should not delay the shared decision-making discussion after patients use a decision aid.

Association of Decision-making with Patients' Perceptions of Care and Knowledge during Longitudinal Pulmonary Nodule Surveillance.

RATIONALE: Patient participation in medical decision-making is widely advocated, but outcomes are inconsistent. OBJECTIVES: We examined the associations between medical decision-making roles, and patients' perceptions of their care and knowledge while undergoing pulmonary nodule surveillance. METHODS: The study setting was an academically affiliated Veterans Affairs hospital network in which 121 participants had 319 decision-making encounters. The Control Preferences Scale was used to assess patients' decision-making roles. Associations between decision-making, including role concordance (i.e., agreement between patients' preferred and actual roles), shared decision-making (SDM), and perceptions of care and knowledge, were assessed using logistic regression and generalized estimating equations. RESULTS: Participants had a preferred role in 98% of encounters, and most desired an active role (shared or patient controlled). For some encounters (36%), patients did not report their actual decision-making role, because they did not know what their role was. Role concordance and SDM occurred in 56% and 26% of encounters, respectively. Role concordance was associated with greater satisfaction with medical care (adjusted odds ratio [Adj-OR], 5.39; 95% confidence interval [CI], 1.68-17.26), higher quality of patient-reported care (Adj-OR, 2.86; 95% CI, 1.31-6.27), and more disagreement that care could be better (Adj-OR, 2.16; 95% CI, 1.12-4.16). Role concordance was not associated with improved pulmonary nodule knowledge with respect to lung cancer risk (Adj-OR, 1.12; 95% CI, 0.63-2.00) or nodule information received (Adj-OR, 1.13; 95% CI, 0.31-4.13). SDM was not associated with perceptions of care or knowledge. CONCLUSIONS: Among patients undergoing longitudinal nodule surveillance, a majority had a preference for having active roles in decision-making. Interestingly, during some encounters, patients did not know what their role was or that a decision was being made. Role concordance was associated with greater patient-reported satisfaction and quality of medical care, but not with improved knowledge. Patient participation in decision-making may influence perceptions of care; however, clinicians may need to focus on other communication strategies or domains to improve patient knowledge and health outcomes.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values. OBJECTIVES: To assess the effects of decision aids in people facing treatment or screening decisions. SEARCH METHODS: Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008. SELECTION CRITERIA: We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence. MAIN RESULTS: We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup. AUTHORS' CONCLUSIONS: Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.

Use of patient decision aids increased younger women's reluctance to begin screening mammography: a systematic review and meta-analysis.

BACKGROUND: As breast cancer screening guidelines have changed recently, additional investigation is needed to understand changes in women's behavior after using breast cancer screening patient decision aids (BCS-PtDAs) and the potential effect on mammography utilization. This systematic review and meta-analysis sought to evaluate the effect of BCS-PtDAs on changes in women's intentions to undergo screening mammography and whether women deciding to begin or discontinue screening mammography displayed similar changes in screening intentions after using a BCS-PtDA. METHODS: We searched Medline, Scopus, PsycINFO, CENTRAL, Health and Psychosocial Instruments, Health Technology Assessment Database, PsycARTICLES, and cited references in eligible papers for randomized controlled trials (RCTs) and observational studies, published through August 24, 2016. The proportions of women who did and not intend to undergo screening and who were uncertain about undergoing screening mammography were pooled, using risk ratios (RR) and random effects. According to the protocol, RCTs or observational studies and any language were considered eligible for systematic review if they included data about women for which shared decision making is recommended. RESULTS: We ultimately included six studies with screening intention data for 2040 women. Compared to usual care, the use of BCS-PtDAs in three RCTs resulted in significantly more women deciding not to undergo screening mammography (RR 1.48 [95% CI 1.04-2.13]; P = 0.03), particularly for younger (38-50 years) women (1.77 [1.34-2.34]; P < 0.001). The use of BCS-PtDAs had a non-significant effect on the intentions of older women (69-89 years) to discontinue screening. CONCLUSIONS: The use of BCS-PtDAs increased younger women's reluctance to undergo screening for breast cancer. The implementation of such BCS-PtDAs in clinical practice would be expected to result in a 77% increase in the number of younger women (aged 38-50) who do not intend to be screened, and as a consequence, may reduce utilization of screening mammography. REGISTRATION: The protocol of this review is registered in the PROSPERO database, #CRD42016036695.

Evaluation of risk communication in a mammography patient decision aid.

OBJECTIVES: We characterized patients' comprehension, memory, and impressions of risk communication messages in a patient decision aid (PtDA), Mammopad, and clarified perceived importance of numeric risk information in medical decision making. METHODS: Participants were 75 women in their forties with average risk factors for breast cancer. We used mixed methods, comprising a risk estimation problem administered within a pretest-posttest design, and semi-structured qualitative interviews with a subsample of 21 women. RESULTS: Participants' positive predictive value estimates of screening mammography improved after using Mammopad. Although risk information was only briefly memorable, through content analysis, we identified themes describing why participants value quantitative risk information, and obstacles to understanding. We describe ways the most complicated graphic was incompletely comprehended. CONCLUSIONS: Comprehension of risk information following Mammopad use could be improved. Patients valued receiving numeric statistical information, particularly in pictograph format. Obstacles to understanding risk information, including potential for confusion between statistics, should be identified and mitigated in PtDA design. PRACTICE IMPLICATIONS: Using simple pictographs accompanied by text, PtDAs may enhance a shared decision-making discussion. PtDA designers and providers should be aware of benefits and limitations of graphical risk presentations. Incorporating comprehension checks could help identify and correct misapprehensions of graphically presented statistics.

Impact of a decision aid on reducing uncertainty: pilot study of women in their 40s and screening mammography.

BACKGROUND: In 2009 the United States Preventive Services Task Force updated its breast cancer screening guidelines to recommend that average-risk women obtain a screening mammogram every two years starting at age 50 instead of annually starting at age 40. Inconsistencies in data regarding the benefit versus risk of routine screening for women less than 50-years-of-age led to a second recommendation - that women in their forties engage in a shared decision making process with their provider to make an individualized choice about screening mammography that was right for them. In response, a web-based interactive mammography screening decision aid was developed and evaluated. METHODS: The decision aid was developed using an agile, iterative process. It was further honed based on feedback from clinical and technical subject matter experts. A convenience sample of 51 age- and risk-appropriate women was recruited to pilot the aid. Pre-post decisional conflict and screening choice was assessed. RESULTS: Women reported a significant reduction in overall decisional conflict after using the decision aid (Z = -5.3, p < 0.001). These participants also reported statistically significant reductions in each of the decisional conflict subscales: feeling uncertain (Z = -4.7, p < 0.001), feeling uninformed (Z = -5.2, p < 0.001), feeling unclear about values (Z = -5.0, p < 0.001), and feeling unsupported (Z = -4.0, p < 0.001). However, a woman's intention to obtain a screening mammogram in the next 1-2 years was not significantly changed (Wilcoxon signed-rank Z = -1.508, p = 0.132). CONCLUSION: This mammography screening decision aid brings value to patient care not by impacting what a woman chooses but by lending clarity to why or how she chooses it.

Mammography Decision Aid Reduces Decisional Conflict for Women in Their Forties Considering Screening.

BACKGROUND: Clinical guidelines recommend a personalized approach to mammography screening for women in their forties; however, methods to do so are lacking. An evidence-based mammography screening decision aid was developed as an electronic mobile application and evaluated in a before-after study. METHODS: The decision aid (Mammopad) included modules on breast cancer, mammography, risk assessment, and priority setting about screening. Women aged 40-49 years who were patients of rural primary care clinics, had no major risk factors for breast cancer, and no mammography during the previous year were invited to use the decision aid. Twenty women participated in pretesting of the decision aid and 75 additional women completed the before-after study. The primary outcome was decisional conflict measured before and after using Mammopad. Secondary outcomes included decision self-efficacy and intention to begin or continue mammography screening. Differences comparing measures before versus after use were determined using Wilcoxon signed rank tests. RESULTS: After using Mammopad, women reported reduced decisional conflict based on mean Decisional Conflict Scale scores overall (46.33 versus 8.33; Z = -7.225; p < 0.001) and on all subscales (p < 0.001). Women also reported increased mean Decision Self-Efficacy Scale scores (79.67 versus 95.73; Z = 6.816, p < 0.001). Although 19% of women changed their screening intentions, this was not statistically significant. CONCLUSIONS: Women reported less conflict about their decisions for mammography screening, and felt more confident to make decisions after using Mammopad. This approach may help guide women through the decision making process to determine personalized screening choices that are appropriate for them.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. OBJECTIVES: To assess the effects of decision aids for people facing treatment or screening decisions. SEARCH METHODS: For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). SELECTION CRITERIA: We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes.Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. MAIN RESULTS: This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids prepare people to participate in decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES: To evaluate the effectiveness of decision aids for people facing treatment or screening decisions. SEARCH STRATEGY: For this update, we searched from January 2006 to December 2009 in MEDLINE (Ovid); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, issue 4 2009); CINAHL (Ovid) (to September 2008 only); EMBASE (Ovid); PsycINFO (Ovid); and grey literature. Cumulatively, we have searched each database since its start date. SELECTION CRITERIA: We included published randomised controlled trials (RCTs) of decision aids, which are interventions designed to support patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies in which participants were not making an active treatment or screening decision. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts for inclusion, extracted data, and assessed potential risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards, were:A) decision attributes;B) decision making process attributes.Secondary outcomes were behavioral, health, and health system effects. We pooled results of RCTs using mean differences (MD) and relative risks (RR), applying a random effects model. MAIN RESULTS: Of 34,316 unique citations, 86 studies involving 20,209 participants met the eligibility criteria and were included. Thirty-one of these studies are new in this update. Twenty-nine trials are ongoing. There was variability in potential risk of bias across studies. The two criteria that were most problematic were lack of blinding and the potential for selective outcome reporting, given that most of the earlier trials were not registered.Of 86 included studies, 63 (73%) used at least one measure that mapped onto an IPDAS effectiveness criterion: A) criteria involving decision attributes: knowledge scores (51 studies); accurate risk perceptions (16 studies); and informed value-based choice (12 studies); and B) criteria involving decision process attributes: feeling informed (30 studies) and feeling clear about values (18 studies).A) Criteria involving decision attributes:Decision aids performed better than usual care interventions by increasing knowledge (MD 13.77 out of 100; 95% confidence interval (CI) 11.40 to 16.15; n = 26). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 4.97 out of 100; 95% CI 3.22 to 6.72; n = 15). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.74; 95% CI 1.46 to 2.08; n = 14). The effect was stronger when probabilities were expressed in numbers (RR 1.93; 95% CI 1.58 to 2.37; n = 11) rather than words (RR 1.27; 95% CI 1.09 to 1.48; n = 3). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.25; 95% CI 1.03 to 1.52; n = 8).B) Criteria involving decision process attributes:Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -6.43 of 100; 95% CI -9.16 to -3.70; n = 17); b) lower decisional conflict related to feeling unclear about personal values (MD -4.81; 95% CI -7.23 to -2.40; n = 14); c) reduced the proportions of people who were passive in decision making (RR 0.61; 95% CI 0.49 to 0.77; n = 11); and d) reduced proportions of people who remained undecided post-intervention (RR 0.57; 95% CI 0.44 to 0.74; n = 9). Decision aids appear to have a positive effect on patient-practitioner communication in the four studies that measured this outcome. For satisfaction with the decision (n = 12) and/or the decision making process (n = 12), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There were no studies evaluating the decision process attributes relating to helping patients to recognize that a decision needs to be made or understand that values affect the choice.C) Secondary outcomesExposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favour of conservative options (RR 0.80; 95% CI 0.64 to 1.00; n = 11). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.85; 95% CI 0.74 to 0.98; n = 7). When detailed compared to simple decision aids were used, there was reduced choice of menopausal hormones (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from -8 minutes to +23 minutes (median 2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 20), and general health outcomes (n = 7), and condition specific health outcomes (n = 9). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. AUTHORS' CONCLUSIONS: New for this updated review is evidence that: decision aids with explicit values clarification exercises improve informed values-based choices; decision aids appear to have a positive effect on patient-practitioner communication; and decision aids have a variable effect on length of consultation.Consistent with findings from the previous review, which had included studies up to 2006: decision aids increase people's involvement, and improve knowledge and realistic perception of outcomes; however, the size of the effect varies across studies. Decision aids have a variable effect on choices. They reduce the choice of discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, patient-practitioner communication, cost-effectiveness, and use with developing and/or lower literacy populations need further evaluation. Little is known about the degree of detail that decision aids need in order to have positive effects on attributes of the decision or decision-making process.

Decision aids for people facing health treatment or screening decisions.

BACKGROUND: Decision aids prepare people to participate in 'close call' decisions that involve weighing benefits, harms, and scientific uncertainty. OBJECTIVES: To conduct a systematic review of randomised controlled trials (RCTs) evaluating the efficacy of decision aids for people facing difficult treatment or screening decisions. SEARCH STRATEGY: We searched MEDLINE (Ovid) (1966 to July 2006); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library; 2006, Issue 2); CINAHL (Ovid) (1982 to July 2006); EMBASE (Ovid) (1980 to July 2006); and PsycINFO (Ovid) (1806 to July 2006). We contacted researchers active in the field up to December 2006. There were no language restrictions. SELECTION CRITERIA: We included published RCTs of interventions designed to aid patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to no intervention, usual care, and alternate interventions. We excluded studies in which participants were not making an active treatment or screening decision, or if the study's intervention was not available to determine that it met the minimum criteria to qualify as a patient decision aid. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts for inclusion, and extracted data from included studies using standardized forms. The primary outcomes focused on the effectiveness criteria of the International Patient Decision Aid Standards (IPDAS) Collaboration: attributes of the decision and attributes of the decision process. We considered other behavioural, health, and health system effects as secondary outcomes. We pooled results of RCTs using mean differences (MD) and relative risks (RR) using a random effects model. MAIN RESULTS: This update added 25 new RCTs, bringing the total to 55. Thirty-eight (69%) used at least one measure that mapped onto an IPDAS effectiveness criterion: decision attributes: knowledge scores (27 trials); accurate risk perceptions (11 trials); and value congruence with chosen option (4 trials); and decision process attributes: feeling informed (15 trials) and feeling clear about values (13 trials).This review confirmed the following findings from the previous (2003) review. Decision aids performed better than usual care interventions in terms of: a) greater knowledge (MD 15.2 out of 100; 95% CI 11.7 to 18.7); b) lower decisional conflict related to feeling uninformed (MD -8.3 of 100; 95% CI -11.9 to -4.8); c) lower decisional conflict related to feeling unclear about personal values (MD -6.4; 95% CI -10.0 to -2.7); d) reduced the proportion of people who were passive in decision making (RR 0.6; 95% CI 0.5 to 0.8); and e) reduced proportion of people who remained undecided post-intervention (RR 0.5; 95% CI 0.3 to 0.8). When simpler decision aids were compared to more detailed decision aids, the relative improvement was significant in knowledge (MD 4.6 out of 100; 95% CI 3.0 to 6.2) and there was some evidence of greater agreement between values and choice.In this review, we were able to explore the use of probabilities in decision aids. Exposure to a decision aid with probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.6; 95% CI 1.4 to 1.9). The effect was stronger when probabilities were measured quantitatively (RR 1.8; 95% CI 1.4 to 2.3) versus qualitatively (RR 1.3; 95% CI 1.1 to 1.5).As in the previous review, exposure to decision aids continued to demonstrate reduced rates of: elective invasive surgery in favour of conservative options, decision aid versus usual care (RR 0.8; 95% CI 0.6 to 0.9); and use of menopausal hormones, detailed versus simple aid (RR 0.7; 95% CI 0.6 to 1.0). There is now evidence that exposure to decision aids results in reduced PSA screening, decision aid versus usual care (RR 0.8; 95% CI 0.7 to 1.0) . For other decisions, the effect on decisions remains variable.As in the previous review, decision aids are no better than comparisons in affecting satisfaction with decision making, anxiety, and health outcomes. The effects of decision aids on other outcomes (patient-practitioner communication, consultation length, continuance, resource use) were inconclusive.There were no trials evaluating the IPDAS decision process criteria relating to helping patients to recognize a decision needs to be made, understand that values affect the decision, or discuss values with the practitioner. AUTHORS' CONCLUSIONS: Patient decision aids increase people's involvement and are more likely to lead to informed values-based decisions; however, the size of the effect varies across studies. Decision aids have a variable effect on decisions. They reduce the use of discretionary surgery without apparent adverse effects on health outcomes or satisfaction. The degree of detail patient decision aids require for positive effects on decision quality should be explored. The effects on continuance with chosen option, patient-practitioner communication, consultation length, and cost-effectiveness need further evaluation.