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BackgroundPatients with diabetes lack information on which commercially available applications (apps) improve diabetes-related outcomes. We conducted a rapid evidence review to examine features, clinical efficacy, and usability of apps for self-management of type 1 and type 2 diabetes in adults.MethodsOvid/Medline and the Cochrane Database of Systematic Reviews were searched for systematic reviews and technology assessments. Reference lists of relevant systematic reviews were examined for primary studies. Additional searches for primary studies were conducted online, through Ovid/Medline, Embase, CINAHL, and ClinicalTrials.gov. Studies were evaluated for eligibility based on predetermined criteria, data were extracted, study quality was assessed using a risk of bias tool, information on app features was collected, and app usability was assessed. Results are summarized qualitatively.ResultsFifteen articles evaluating 11 apps were identified: six apps for type 1 and five apps for type 2 diabetes. Common features of apps included setting reminders and tracking blood glucose and hemoglobin A1c (HbA1c), medication use, physical activity, and weight. Compared with controls, use of eight apps, when paired with support from a healthcare provider or study staff, improved at least one outcome, most often HbA1c. Patients did not experience improvements in quality of life, blood pressure, or weight, regardless of app used or type of diabetes. Study quality was variable. Of the eight apps available for usability testing, two were scored “acceptable,” three were “marginal,” and three were “not acceptable.”DiscussionLimited evidence suggests that use of some commercially available apps, when combined with additional support from a healthcare provider or study staff, may improve some short-term diabetes-related outcomes. The impact of these apps on longer-term outcomes is unclear. More rigorous and longer-term studies of apps are needed.RegistrationThis review was funded by the Agency for Healthcare Research and Quality (AHRQ). The protocol is available at: http://www.effectivehealthcare.ahrq.gov/topics/diabetes-mobile-devices/research-protocol.

BackgroundIncreases in patient needs can strain hospital resources, which may worsen care quality and outcomes. This systematic literature review sought to understand whether hospital capacity strain is associated with worse health outcomes for hospitalized patients and to evaluate benefits and harms of health system interventions to improve care quality during times of hospital capacity strain.MethodsParallel searches were conducted in MEDLINE, CINAHL, the Cochrane Library, and reference lists from 1999-2015. Two reviewers assessed study eligibility. We included English-language studies describing the association between capacity strain (high census, acuity, turnover, or an indirect measure of strain such as delayed admission) and health outcomes or intermediate outcomes for children and adults hospitalized in highly developed countries. We also included studies of health system interventions to improve care during times of capacity strain. Two reviewers extracted data and assessed risk of bias using the Newcastle-Ottawa Score for observational studies and the Cochrane Collaboration Risk of Bias Assessment Tool for experimental studies.ResultsOf 5,702 potentially relevant studies, we included 44 observational and 8 experimental studies. There was marked heterogeneity in the metrics used to define capacity strain, hospital settings, and overall study quality. Mortality increased during times of capacity strain in 18 of 30 studies and in 9 of 12 studies in intensive care unit settings. No experimental studies were randomized, and none demonstrated an improvement in health outcomes after implementing the intervention. The pediatric literature is very limited; only six observational studies included children. There was insufficient study homogeneity to perform meta-analyses.DiscussionIn highly developed countries, hospital capacity strain is associated with increased mortality and worsened health outcomes. Evidence-based solutions to improve outcomes during times of capacity strain are needed.

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.

Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Māori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Māori and 0.76 (95% CI -5.57 to 7.09) for non-Māori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Māori and 1.36 (-3.16 to 5.88) for non-Māori. No study-related adverse events were reported. The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Māori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).

BackgroundAs 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.MethodsWe 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.ResultsWe 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.ConclusionsThe 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.RegistrationThe protocol of this review is registered in the PROSPERO database, #CRD42016036695.

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. This pilot study aimed to evaluate whether the Healthy Sex Choices decision aid is acceptable and feasible to patients and clinicians. 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. 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. 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.

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.

To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Scale development study, involving construct, item and scale development, validation and reliability testing. There has been increasing use of decision support technologies--adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Scale development study, involving construct, item and scale development, validation and reliability testing. Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Patient participation in medical decision-making is widely advocated, but outcomes are inconsistent. We examined the associations between medical decision-making roles, and patients' perceptions of their care and knowledge while undergoing pulmonary nodule surveillance. 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. 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. 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.

Background Coaching and guidance are structured approaches that can be used within or alongside patient decision aids (PtDAs) to facilitate the process of decision making. Coaching is provided by an individual, and guidance is embedded within the decision support materials. The purpose of this paper is to: a) present updated definitions of the concepts “coaching” and “guidance”; b) present an updated summary of current theoretical and empirical insights into the roles played by coaching/guidance in the context of PtDAs; and c) highlight emerging issues and research opportunities in this aspect of PtDA design. Methods We identified literature published since 2003 on shared decision making theoretical frameworks inclusive of coaching or guidance. We also conducted a sub-analysis of randomized controlled trials included in the 2011 Cochrane Collaboration Review of PtDAs with search results updated to December 2010. The sub-analysis was conducted on the characteristics of coaching and/or guidance included in any trial of PtDAs and trials that allowed the impact of coaching and/or guidance with PtDA to be compared to another intervention or usual care. Results Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients in the process of thinking about a decision and in communicating their values/preferences with others. In 98 randomized controlled trials of PtDAs, 11 trials (11.2%) included coaching and 63 trials (64.3%) provided guidance. Compared to usual care, coaching provided alongside a PtDA improved knowledge and decreased mean costs. The impact on some other outcomes (e.g., participation in decision making, satisfaction, option chosen) was more variable, with some trials showing positive effects and other trials reporting no differences. For values-choice agreement, decisional conflict, adherence, and anxiety there were no differences between groups. None of these outcomes were worse when patients were exposed to decision coaching alongside a PtDA. No trials evaluated the effect of guidance provided within PtDAs. Conclusions Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients to participate in decision making. However, there are few randomized controlled trials that have compared the effectiveness of coaching used alongside PtDAs to PtDAs without coaching, and no trials have compared the PtDAs with guidance to those without guidance.