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.

Evaluating the Acceptability and Feasibility of a Sexual Health-Focused Contraceptive Decision Aid for Diverse Young Adults: User-Centered Usability Study.

BACKGROUND: Young adults with low sexual health literacy levels may find it difficult to make informed decisions about contraceptive methods. We developed and pilot-tested a web-based decision aid-Healthy Sex Choices-designed to support diverse young adults with their contraceptive decision-making. OBJECTIVE: This pilot study aimed to evaluate whether the Healthy Sex Choices decision aid is acceptable and feasible to patients and clinicians. METHODS: We used the Ottawa Decision Support Framework and the International Patient Decision Aid Standards to develop and pilot the decision tool. We first conducted a needs assessment with our advisory panel (5 clinicians and 2 patients) that informed decision aid development. All panelists participated in semistructured interviews about their experience with contraceptive counseling. Clinicians also completed a focus group session centered around the development of sex education content for the tool. Before commencing the pilot study, 5 participants from ResearchMatch (Vanderbilt University Medical Center) assessed the tool and suggested improvements. RESULTS: Participants were satisfied with the tool, rating the acceptability as "good." Interviewees revealed that the tool made contraceptive decision-making easier and would recommend the tool to a family member or friend. Participants had a nonsignificant change in knowledge scores (53% before vs 45% after; P=.99). Overall, decisional conflict scores significantly decreased (16.1 before vs 2.8 after; P<.001) with the informed subscale (patients feeling more informed) having the greatest decline (23.1 vs 4.7; mean difference 19.0, SD 27.1). Subanalyses of contraceptive knowledge and decisional conflict illustrated that participants of color had lower knowledge scores (48% vs 55%) and higher decisional conflict (20.0 vs 14.5) at baseline than their white counterparts. CONCLUSIONS: Participants found Healthy Sex Choices to be acceptable and reported reduced decisional conflict after using the tool. The development and pilot phases of this study provided a foundation for creating reproductive health decision aids that acknowledge and provide guidance for diverse patient populations.

Improving access to vision rehabilitation care: implementation of the South East Ontario Vision Rehabilitation Service.

OBJECTIVE: To investigate the effect of the South East Ontario Vision Rehabilitation Service (SOVRS), a centrally administered, regionally delivered vision rehabilitation service, on access to vision rehabilitation care. DESIGN: Pre-implementation (n = 1196) and post-implementation (n = 414) observational study. PARTICIPANTS: Patients referred for low-vision assessment at the hospital-based Kingston Health Sciences Centre Vision Rehabilitation Clinic and community-based Southeastern Vision Loss Rehabilitation Ontario clinics from 2014 to 2019. METHODS: Markers for access to care (e.g., patient rurality, diversity of referral source, distance and time travelled, and wait times) were compared before and after SOVRS implementation. RESULTS: After SOVRS implementation, there was a significant increase (p < 0.001) in the number of rural patients seen in the community. After SOVRS implementation, the hospital-based Vision Rehabilitation Clinic site experienced a significant increase in referrals from outside of Kingston (p < 0.001) and non-eye-care clinicians (p < 0.001), a significant reduction in patient time and distance travelled (p < 0.001), a 6% decrease in median wait time for low-vision assessments, and a significant reduction in wait time between referral and first available appointment (p = 0.011). CONCLUSION: SOVRS, a novel service-delivery model for vision rehabilitation care, improved the delivery of and access to vision rehabilitation care in southeast Ontario through the integration of regional resources and services.

Clinicians' Perspectives and Proposed Solutions to Improve Contraceptive Counseling in the United States: Qualitative Semistructured Interview Study With Clinicians From the Society of Family Planning.

BACKGROUND: Contraceptive care is a key element of reproductive health, yet only 12%-30% of women report being able to access and receive the information they need to make these complex, personal health care decisions. Current guidelines recommend implementing shared decision-making approaches; and tools such as patient decision aid (PtDA) applications have been proposed to improve patients' access to information, contraceptive knowledge, decisional conflict, and engagement in decision-making and contraception use. To inform the design of meaningful, effective, elegant, and feasible PtDA applications, studies are needed of all users' current experiences, needs, and barriers. While multiple studies have explored patients' experiences, needs, and barriers, little is known about clinicians' experiences, perspectives, and barriers to delivering contraceptive counseling. OBJECTIVE: This study focused on assessing clinicians' experiences, including their perspectives of patients' needs and barriers. It also explored clinicians' suggestions for improving contraceptive counseling and the feasibility of a contraceptive PtDA. METHODS: Following the decisional needs assessment approach, we conducted semistructured interviews with clinicians recruited from the Society of Family Planning. The Ottawa Decision Support Framework informed the interview guide and initial codebook, with a specific focus on decision support and decisional needs as key elements that should be assessed from the clinicians' perspective. An inductive content approach was used to analyze data and identify primary themes and suggestions for improvement. RESULTS: Fifteen clinicians (12 medical doctors and 3 nurse practitioners) participated, with an average of 19 years of experience in multiple regions of the United States. Analyses identified 3 primary barriers to the provision of quality contraceptive counseling: gaps in patients' underlying sexual health knowledge, biases that impede decision-making, and time constraints. All clinicians supported the development of contraceptive PtDAs as a feasible solution to these main barriers. Multiple suggestions for improvement were provided, including clinician- and system-level training, tools, and changes that could support successful implementation. CONCLUSIONS: Clinicians and developers interested in improving contraceptive counseling and decision-making may wish to incorporate approaches that assess and address upstream factors, such as sexual health knowledge and existing heuristics and biases. Clinical leaders and administrators may also wish to prioritize solutions that improve equity and accessibility, including PtDAs designed to provide education and support in advance of the time-constrained consultations, and strategic training opportunities that support cultural awareness and shared decision-making skills. Future studies can then explore whether well-designed, user-centered shared decision-making programs lead to successful and sustainable uptake and improve patients' reproductive health contraceptive decision-making.

Concerned friends of intimate partner violence survivors: results from the myPlan randomized controlled trial on college campuses.

BACKGROUND: Nearly half of intimate partner violence (IPV) survivors experience their first abusive relationship at college age (18-24 years). Most often they disclose the violence to friends. Existing college campus "bystander" interventions training peers to safely intervene have been effective in sexual assault prevention; similar interventions have rarely been tested for IPV. Therefore, we evaluated the effectiveness of an interactive, personalized safety decision and planning tool, myPlan app, on decisional conflict, decisional preparedness, confidence in intervening, supportive safety behaviors, and IPV attitudes with concerned friends of abused college women. METHODS: We recruited college students (age 18-24, N = 293) of any gender who had a female-identified friend who had recently experienced IPV ("concerned friends") from 41 Oregon and Maryland colleges/universities. Participants were randomized to myPlan (n = 147) or control (usual web-based resources; n = 146). Outcomes included decisional conflict, decisional preparedness, confidence to intervene, safety/support behaviors, and IPV attitudes. RESULTS: At baseline, concerned friends described the abused person as a close/best friend (79.1%); 93.7% had tried at least one strategy to help. Most (89.2%) reported concerns their friend would be seriously hurt by the abuser; 22.7% reported extreme concern. Intervention participants had greater improvements in decisional conflict (specifically, understanding of their own values around the decision to intervene and help a friend) and decisional preparedness immediately after their first use of myPlan, and a significantly greater increase in confidence to talk with someone about their own relationship concerns at 12 months. At 12-month follow-up, both intervention and control groups reported increased confidence to intervene, and did not differ significantly in terms of percentage of safety/support strategies used, whether strategies were helpful, or IPV attitudes. CONCLUSIONS: A technology-based intervention, myPlan, was effective in reducing one aspect of decisional conflict (improving clarity of values to intervene) and increasing decisional preparedness to support a friend in an unsafe relationship. Information on IPV and related safety strategies delivered through the myPlan app or usual web-based resources both increased confidence to intervene with a friend. College students in the myPlan group were more likely to talk with someone about concerns about their own relationship, demonstrating potential for IPV prevention or early intervention. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02236663, registration date 10/09/2014.

Associations of Unintended Pregnancy With Maternal and Infant Health Outcomes: A Systematic Review and Meta-analysis.

Importance: Unintended pregnancy is common in the US and is associated with adverse maternal and infant health outcomes; however, estimates of these associations specific to current US populations are lacking. Objective: To evaluate associations of unintended pregnancy with maternal and infant health outcomes during pregnancy and post partum with studies relevant to current clinical practice and public health in the US. Data Sources: Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, PsycINFO, SocINDEX, and MEDLINE databases (January 1, 2000, to June 15, 2022) and manual review of reference lists. Study Selection: Epidemiologic studies relevant to US populations that compared key maternal and infant health outcomes for unintended vs intended pregnancies and met prespecified eligibility criteria were included after investigators' independent dual review of abstracts and full-text articles. Data Extraction and Synthesis: Investigators abstracted data from publications on study methods, participant characteristics, settings, pregnancy intention, comparators, confounders, and outcomes; data were validated by a second investigator. Risk of bias was independently dual rated by investigators using criteria developed by the US Preventive Services Task Force. Results of studies controlling for confounders were combined by using a profile likelihood random-effects model. Main Outcomes and Measures: Prenatal depression, postpartum depression, maternal experience of interpersonal violence, preterm birth, and infant low birth weight. Results: Thirty-six studies (N = 524 522 participants) were included (14 cohort studies rated good or fair quality; 22 cross-sectional studies); 12 studies used large population-based data sources. Compared with intended pregnancy, unintended pregnancy was significantly associated with higher odds of depression during pregnancy (23.3% vs 13.9%; adjusted odds ratio [aOR], 1.59 [95% CI, 1.35-1.92]; I2 = 85.0%; 15 studies [n = 41 054]) and post partum (15.7% vs 9.6%; aOR, 1.51 [95% CI, 1.40-1.70]; I2 = 7.1%; 10 studies [n = 82 673]), interpersonal violence (14.6% vs 5.5%; aOR, 2.22 [95% CI, 1.41-2.91]; I2 = 64.1%; 5 studies [n = 42 306]), preterm birth (9.4% vs 7.7%; aOR, 1.21 [95% CI, 1.12-1.31]; I2 = 1.7%; 10 studies [n = 94 351]), and infant low birth weight (7.3% vs 5.2%; aOR, 1.09 [95% CI, 1.02-1.21]; I2 = 0.0%; 8 studies [n = 87 547]). Results were similar in sensitivity analyses based on controlling for history of depression for prenatal and postpartum depression and on study design and definition of unintended pregnancy for relevant outcomes. Studies provided limited sociodemographic data and measurement of confounders and outcomes varied. Conclusions and Relevance: In this systematic review and meta-analysis of epidemiologic observational studies relevant to US populations, unintended pregnancy, compared with intended pregnancy, was significantly associated with adverse maternal and infant outcomes. Trial Registration: PROSPERO Identifier: CRD42020192981.

Effects of technology-based contraceptive decision aids: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to conduct a systematic review and meta-analysis of the effects of technology-based decision aids on contraceptive use, continuation, and patient-reported and decision-making outcomes. DATA SOURCES: A systematic search was conducted in OVID MEDLINE, Cochrane Database of Systematic Reviews, CENTRAL, CINAHL, Embase, PsycINFO, and SocINDEX databases from January 2005 to April 2022. Eligible references from a concurrent systematic review evaluating contraceptive care were also included for review. STUDY ELIGIBILITY CRITERIA: Studies were included if a contraceptive decision aid was technology-based (ie, mobile/tablet application, web, or computer-based) and assessed contraceptive use and/or continuation or patient-reported outcomes (knowledge, self-efficacy, feasibility/acceptability/usability, decisional conflict). The protocol was registered under the International Prospective Register of Systematic Reviews (CRD42021240755). METHODS: Three reviewers independently performed data abstraction and quality appraisal. Dichotomous outcomes (use and continuation) were evaluated with an odds ratio, whereas continuous outcomes (knowledge and self-efficacy) were evaluated with the mean difference. Subgroup analyses were performed for the mode of delivery (mobile and tablet applications vs web and computer-based) and follow-up time (immediate vs >1 month). RESULTS: This review included 18 studies evaluating 21 decision aids. Overall, there were higher odds of contraceptive use and/or continuation among decision aid users compared with controls (odds ratio, 1.27; 95% confidence interval, [1.05-1.55]). Use of computer and web-based decision aids was associated with higher odds of contraceptive use and/or continuation (odds ratio, 1.36; 95% confidence interval, [1.08-1.72]) than mobile and tablet decision aids (odds ratio, 1.27; 95% confidence interval, [0.83-1.94]). Decision aid users also had statistically significant higher self-efficacy scores (mean difference, 0.09; 95% confidence interval, [0.05-0.13]), and knowledge scores (mean difference, 0.04; 95% confidence interval, [0.01-0.07]), with immediate measurement of knowledge having higher retention than measurement after 1 month. Other outcomes were evaluated descriptively (eg, feasibility, applicability, decisional conflict) but had little evidence to support a definite conclusion. Overall, the review provided moderate-level evidence for contraceptive use and continuation, knowledge, and self-efficacy. CONCLUSION: The use of technology-based contraceptive decision aids to support contraceptive decision-making has positive effects on contraceptive use and continuation, knowledge, and self-efficacy. There was insufficient evidence to support a conclusion about effects on other decision-making outcomes.

Effectiveness and Harms of Contraceptive Counseling and Provision Interventions for Women : A Systematic Review and Meta-analysis.

BACKGROUND: The effectiveness and harms of contraceptive counseling and provision interventions are unclear. PURPOSE: To evaluate evidence of the effectiveness of contraceptive counseling and provision interventions for women to increase use of contraceptives and reduce unintended pregnancy, as well as evidence of their potential harms. DATA SOURCES: English-language searches of Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, SocINDEX, and MEDLINE (1 January 2000 to 3 February 2022) and reference lists of key studies and systematic reviews. STUDY SELECTION: Randomized controlled trials of interventions providing enhanced contraceptive counseling, contraceptives, or both versus usual care or an active control. DATA EXTRACTION: Dual extraction and quality assessment of studies; results combined using a profile likelihood random-effects model. DATA SYNTHESIS: A total of 38 trials (43 articles [25 472 participants]) met inclusion criteria. Contraceptive use was higher with various counseling interventions (risk ratio [RR], 1.39 [95% CI, 1.16 to 1.72]; I 2 = 85.3%; 10 trials), provision of emergency contraception in advance of use (RR, 2.12 [CI, 1.79 to 2.36]; I 2 = 0.0%; 8 trials), and counseling or provision postpartum (RR, 1.15 [CI, 1.01 to 1.52]; I 2 = 6.6%; 5 trials) or at the time of abortion (RR, 1.19 [CI, 1.09 to 1.32]; I 2 = 0.0%; 5 trials) than with usual care or active controls in multiple clinical settings. Pregnancy rates were generally lower with interventions, although most trials were underpowered and did not distinguish pregnancy intention. Interventions did not increase risk for sexually transmitted infections (STIs) (RR, 1.05 [CI, 0.87 to 1.25]; I 2 = 0.0%; 5 trials) or reduce condom use (RR, 1.03 [CI, 0.94 to 1.13]; I 2 = 0.0%; 6 trials). LIMITATION: Interventions varied; few trials were adequately designed to determine unintended pregnancy outcomes. CONCLUSION: Contraceptive counseling and provision interventions that provide services beyond usual care increase contraceptive use without increasing STIs or reducing condom use. Contraceptive care in clinical practice could be improved by implementing enhanced contraceptive counseling, provision, and follow-up; providing emergency contraception in advance; and delivering contraceptive services immediately postpartum or at the time of abortion. PRIMARY FUNDING SOURCE: Resources Legacy Fund. (PROSPERO: CRD42020192981).

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.

Validation of the visual acuity iPad app Eye Chart Pro compared to the standard Early Treatment Diabetic Retinopathy Study chart in a low-vision population.

INTRODUCTION: A low-vision assessment (LVA) is central to developing a vision rehabilitation plan. However, access to LVAs is often limited by the quantity and geographic distribution of low-vision providers, as well as patient-centred transportation challenges. A tablet-based LVA tool kit, delivered virtually, has the potential to overcome many of these barriers. The purpose of this research was to validate a key component of the tablet-based tool kit - a commercially available iPad visual acuity (VA) test (Eye Chart Pro) iPad app - in a low-vision population. METHODS: Participants with low vision (n = 26) and those who were normally sighted (n = 25) underwent VA testing with both the iPad VA test application and the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The VA data were compared using a t-test, linear regression and Bland-Altman analysis. RESULTS: There was no significant difference in the mean absolute difference in VA (log of minimum angle of resolution (logMAR)=0.11; p = 0.82). Eye Chart Pro and Standard ETDRS Chart measures were also not significantly different (p = 0.98). However, there were significant differences between test methods in the low-vision group and the normally sighted group (p > 0.0001 and p = 0.007, respectively). The Bland-Altman analysis showed a mean bias (difference) of -0.0005 logMAR between methods, and 95% limits of agreement of 0.298 and -0.299 logMAR. DISCUSSION: The ETDRS chart function on the Eye Chart Pro application can reliably measure VA across a range, from normally sighted patients to those with low vision.

Validation of a portable, remotely delivered refraction approach compared to standard in-clinic refraction in a low-vision population.

INTRODUCTION: A low-vision assessment (LVA) is critical in developing a vision rehabilitation plan. A remotely delivered LVA that replicates a standard in-clinic assessment may bridge the gap for patients not accessing care due to the limited quantity and distribution of low-vision providers. Within an LVA, an accurate and consistent assessment of refraction error is an essential component. No system has currently been validated for the purposes of a remote LVA. The purpose of this study was to validate a commercially available portable refraction approach in a low-vision population. METHODS: Low-vision patients (n = 26) or normally sighted patients (n = 25) underwent a refraction assessment using the Adaptica® 2WIN autorefractor, adaptor scope (Kaleidos) and VisionFit phoropter portable refraction devices, as well as a standard autorefractor (Huvitz) and phoropter (Haag-Streit). Refraction data between systems and populations were compared using intraclass correlations. Bland-Altman plots were used to assess the differences between devices. RESULTS: Spherical equivalent values were found to be reproducible between standard and experimental autorefraction devices (intraclass correlation coefficient (ICC) > 0.8) in both low-vision and normally sighted groups. Similarly, manifest refraction was highly consistent (ICC > 0.8) between devices in all groups. The Bland-Altman plots showed clinically acceptable mean differences of 0.701 between autorefraction methods and -0.116 between manifest refraction methods. DISCUSSION: The 2WIN/VisionFit system can reliably generate refraction values across a spectrum of errors in normally sighted and visually impaired people, and would be feasible to deliver remotely.

Longitudinal Impact of the myPlan App on Health and Safety Among College Women Experiencing Partner Violence.

The objective of this study was to examine differences in change over time in health and safety outcomes among female college students randomized to myPlan, a tailored safety planning app, or usual web-based safety planning resources. Three hundred forty-six women (175 intervention, 171 control) from 41 colleges/universities in Oregon and Maryland completed surveys at baseline, 6- and 12-months from July 2015 to October 2017. Generalized estimating equations were used to test group differences across time. Both groups improved on four measure of intimate partner violence (IPV; Composite Abuse Scale [CAS], TBI-related IPV, digital abuse, reproductive coercion [RC]) and depression. Reduction in RC and improvement in suicide risk were significantly greater in the myPlan group relative to controls (p = .019 and p = .46, respectively). Increases in the percent of safety behaviors tried that were helpful significantly reduced CAS scores, indicating a reduction in IPV over time in the myPlan group compared to controls (p = .006). Findings support the feasibility and importance of technology-based IPV safety planning for college women. myPlan achieved a number of its objectives related to safety planning and decision-making, the use of helpful safety behaviors, mental health, and reductions in some forms of IPV.

A patient decision aid for prescribing pain medication: Results from a pilot test in two emergency departments.

OBJECTIVE: This study piloted a patient education and decision aid tool about prescription pain relievers to determine potential impact on: comfort receiving an opioid prescription; knowledge about opioids; decisional conflict about whether to take an opioid; and shared decision making with the prescribing physician. METHODS: Patients with acute pain were recruited from two emergency departments (ED), and randomized to complete the tool (N = 65) or a time-matched control (N = 59) on a tablet. Data collection involved: a baseline survey; a post-test immediately following the assigned program; a discharge survey after seeing the physician; and a 6-week follow-up survey. RESULTS: Knowledge increased and comfort receiving an opioid decreased as hypothesized, but did not reach statistical significance. Despite the lack of knowledge differences, the tool had significant positive impact on patients feeling more informed and experiencing less decisional conflict. Shared decision making with the prescribing physician was not impacted. CONCLUSION: A patient decision aid can help ED patients feel more informed and less conflicted about prescription pain relievers but did not impact shared decision-making. PRACTICE IMPLICATIONS: Patient education programs implemented in the ED should consider engaging physicians in the program to help to promote patient-centered approaches in the treatment of acute pain.

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.

Training patients to review scientific reports for the Patient-Centered Outcomes Research Institute: an observational study.

OBJECTIVE: The peer review of completed Patient-Centered Outcomes Research Institute (PCORI) funded research includes reviews from patient reviewers (patients, caregivers, and patient advocates). Very little is known about how best to support these reviewers in writing helpful comments from a patient-centred perspective. This study aimed to evaluate the effect of a new training in peer review for patient reviewers. DESIGN: Observational study. SETTING: Online. PARTICIPANTS: Adults registered in the PCORI Reviewer Database as a patient stakeholder. INTERVENTION: A new online training in peer review. MAIN OUTCOME MEASURES: Changes in reviewers' knowledge and skills; change in self-efficacy and attitudes, satisfaction with the training and perceived benefits and relevance of the training. RESULTS: Before-after training survey data were analysed for 37 (29.4% of 126) patient reviewers invited to participate in an online training as part of a quality improvement effort or as part of a PCORI peer review. The reviewers improved their answers to the knowledge questions (p<0.001, median number of answers improved 4 (95% CI 3 to 5), large effect size (ES) Cohen's w=0.94) after the training, particularly in the questions targeting the specifics of PCORI peer review. Reviewers improved their skills in recognising helpful review comments, but those without peer-review background improved proportionally more (p=0.008, median number of answers improved 2 (95% CI 1 to 3), medium ES w=0.60). The use of training modestly increased reviewers' confidence in completing a high-quality peer review (p=0.005, mean increase in 5-point Likert rating 0.51 (95% CI 0.17 to 0.86), small-to-medium ES Cliff's delta=0.32) and their excitement about providing a review slightly increased (p=0.019, mean increase in 5-point Likert rating 0.35 (95% CI 0.03 to 0.68), small ES delta=0.19). All reviewers were satisfied with the training and would recommend it to other reviewers. CONCLUSIONS: Training improved knowledge, skills and self-efficacy and slightly increased enthusiasm for completing a PCORI peer review.

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.

Decisional Conflict Scale Findings among Patients and Surrogates Making Health Decisions: Part II of an Anniversary Review.

Background. We explored decisional conflict as measured with the 16-item Decisional Conflict Scale (DCS) and how it varies across clinical situations, decision types, and exposure to decision support interventions (DESIs). Methods. An exhaustive scoping review was conducted using backward citation searches and keyword searches. 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. Dyads independently screened titles/abstracts and full texts, and extracted data. We performed narrative syntheses and calculated average or median DCS scores. Results. We included 246 articles reporting on 253 studies. DCS scores ranged from 2.4 to 89.6 out of 100. Highest baseline DCS scores were for care planning (30.5 ± 12.8, median = 30.9) and treatment decisions (30.5 ± 14.6, median = 28.0), in contexts of primary care (33.8 ± 19.8), obstetrics/gynecology (28.8 ± 10.4), and geriatrics (32.6 ± 10.7). Baseline scores were high among decision makers who were ill (29.5 ± 13.8, median = 27.2) or making decisions for themselves (29.7 ± 14.8, median = 26.9). Total DCS scores <25 out of 100 were associated with implementing decisions. Without DESIs, DCS scores tended to increase shortly after decision making (>37.4). After DESI use, DCS scores decreased short-term but increased or remained the same long-term (>6 months). Conclusions. DCS scores were highest at baseline and decreased after decision making. DESIs decreased decisional conflict immediately after decision making. The largest improvements after DESIs were in decision makers who were ill, male, or made decisions for themselves. Meta-analyses focusing on decision types, contexts, and interventions could inform hypotheses about the expected effects of DESIs, the best timing for measurement, and interpretation of DCS scores.

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.

Using m-health tools to reduce the misuse of opioid pain relievers.

BACKGROUND: Emergency department (ED) patients are among the many groups at risk for prescription drug overdose. There is limited research on how best to communicate with ED patients about options for pain management and the risks of opioids. The aim of this study is to pilot test a web-based, patient-centred educational programme that encourages the patient to have an informed discussion about pain medication options with their ED provider. METHODS: This multisite, randomised trial will evaluate an m-health programme designed to aid the patient in making an informed decision about their pain treatment. Patients reporting to the ED with an injury-related or pain- related chief complaint who agree to participate are randomised to receive the intervention programme, My Healthy Choices, or an attention-matched control. My Healthy Choices pairs tailored education with a patient decision aid to describe what opioid and non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse effects, and produce a tailored report that patients are encouraged to share with their doctor. Data are collected through surveys at three time points during the ED encounter (baseline, immediately after the intervention and just before discharge), and at a 6-week follow-up survey. The primary outcomes are whether the patient prefers an opioid pain reliever (OPR) and whether the patient takes an OPR. DISCUSSION: We hope this programme will facilitate patient-provider communication, as well as reduce the number of prescriptions written for OPRs and thus the number of patients exposed to prescription opioids and the associated risks of addiction and overdose. TRIAL REGISTRATION NUMBER: NCT03012087; Pre-results.

Contraceptive knowledge and use among women with intellectual, physical, or sensory disabilities: A systematic review.

BACKGROUND: Women spend most of their reproductive years avoiding pregnancy. However, we know little about contraceptive knowledge and use among women with disabilities, or about strategies to improve contraceptive knowledge and decision-making in this population. OBJECTIVE: To systematically review published literature on women with disabilities and: 1) contraceptive knowledge; 2) attitudes and preferences regarding contraception; 3) contraceptive use; 4) barriers and facilitators to informed contraceptive use; and 5) effectiveness of interventions to improve informed contraceptive decision-making and use. METHODS: We searched MEDLINE, PsychINFO, the Cochrane Library, CINAHL, and ERIC databases from inception through December 2017. Two reviewers independently reviewed studies for eligibility, abstracted study data, and assessed risk of bias following PRISMA guidance. RESULTS: We reviewed 11,659 citations to identify 62 publications of 54 unique studies (total n of women with disabilities = 21,246). No standard definition of disability existed across studies. The majority of studies focused on women with intellectual disabilities (ID). Women with ID and those who were deaf or hard-of-hearing had lower knowledge of contraceptive methods than women without disabilities. Estimates of contraceptive use varied widely, with some evidence that women with disabilities may use a narrower range of methods. Five of six studies evaluating educational interventions to increase contraceptive knowledge or use reported post-intervention improvements. CONCLUSIONS: Women with disabilities may use a more narrow mix of contraceptive methods and are often less knowledgeable about contraceptives than women without disabilities. Interventions to improve knowledge show some promise. A lack of data exists on contraceptive preferences among women with disabilities.