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.

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).

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.

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.

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.

Rapid Evidence Review of Mobile Applications for Self-management of Diabetes.

BACKGROUND: Patients 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. METHODS: Ovid/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. RESULTS: Fifteen 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." DISCUSSION: Limited 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. REGISTRATION: This 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 .

Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.

BACKGROUND: 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. OBJECTIVE: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS: 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. RESULTS: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Maori (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 Maori and 0.76 (95% CI -5.57 to 7.09) for non-Maori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Maori and 1.36 (-3.16 to 5.88) for non-Maori. No study-related adverse events were reported. CONCLUSIONS: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Maori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION: 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).

Texting 4 Sexual Health: Improving Attitudes, Intention, and Behavior Among American Indian and Alaska Native Youth.

PURPOSE: To design and test the effectiveness of a text messaging intervention to promote condom use and STI/HIV testing among American Indian and Alaska Native youth. METHOD: A total of 408 study participants, 15 to 24 years old, were recruited, consented, surveyed, were sent intervention messages, and were incentivized via text message over a 9-month period. Complete pre- and postsurvey data were collected from 192 participants using SMS short codes. A mixed-effects logistic regression model was used to analyze before-after change in responses assessing sexual health knowledge, attitude, self-efficacy, intention, and behavior. RESULTS: Participants' condom use attitude, condom use behavior, and STI/HIV testing intention improved after the intervention ( p < .05). Frequent condom use increased from 30% to 42% and was retained by participants at least 3 months postintervention, and the intervention improved participants' intention to get tested for STI/HIV after changing sexual partners, increasing from 46% to 58% postintervention. CONCLUSIONS: Given the widespread use of cell phones by youth, text-based interventions may offer a feasible and effective tool to promote condom use and STI/HIV testing.

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.

The Association Between Hospital Capacity Strain and Inpatient Outcomes in Highly Developed Countries: A Systematic Review.

BACKGROUND: Increases 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. METHODS: Parallel 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. RESULTS: Of 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. DISCUSSION: In 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.

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.

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

BACKGROUND: Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent. METHODS/DESIGN: In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship. DISCUSSION: This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures. TRIAL REGISTRATION: Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .

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.

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.

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.

Coaching and guidance with patient decision aids: A review of theoretical and empirical evidence.

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.

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.

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.

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.