Correction: Key Variables for Effective eHealth Designs for Individuals With and Without Mental Health Disorders: 212-4 Fractional Factorial Experiment.

[This corrects the article DOI: 10.2196/23137.].

Key Variables for Effective eHealth Designs for Individuals With and Without Mental Health Disorders: 212-4 Fractional Factorial Experiment.

BACKGROUND: eHealth applications not only offer the potential to increase service convenience and responsiveness but also expand the ability to tailor services to improve relevance, engagement, and use. To achieve these goals, it is critical that the designs are intuitive. Limited research exists on designs that work for those with a severe mental illness (SMI), many of whom have difficulty traveling for treatments, reject or infrequently seek treatment, and tend to discontinue treatments for significant periods. OBJECTIVE: This study aims to evaluate the influence of 12 design variables (eg, navigational depth, reading level, and use of navigational lists) on the usability of eHealth application websites for those with and without SMI. METHODS: A 212-4 fractional factorial experiment was used to specify the designs of 256 eHealth websites. This approach systematically varied the 12 design variables. The final destination contents of all websites were identical, and only the designs of the navigational pages varied. The 12 design elements were manipulated systematically to allow the assessment of combinations of design elements rather than only one element at a time. Of the 256 websites, participants (n=222) sought the same information on 8 randomly selected websites. Mixed effect regressions, which accounted for the dependency of the 8 observations within participants, were used to test for main effects and interactions on the ability and time to find information. Classification and regression tree analyses were used to identify effects among the 12 variables on participants' abilities to locate information, for the sample overall and each of the 3 diagnostic groups of participants (schizophrenia spectrum disorder [SSD], other mental illnesses, and no mental illness). RESULTS: The best and worst designs were identified for each of these 4 groups. The depth of a website's navigation, that is, the number of screens users needed to navigate to find the desired content, had the greatest influence on usability (ability to find information) and efficiency (time to find information). The worst performing designs for those with SSD had a 9% success rate, and the best had a 51% success rate: the navigational designs made a 42% difference in usability. For the group with other mental illnesses, the design made a 50% difference, and for those with no mental illness, a 55% difference was observed. The designs with the highest usability had several key design similarities, as did those with the poorest usability. CONCLUSIONS: It is possible to identify evidence-based strategies for designing eHealth applications that result in significantly better performance. These improvements in design benefit all users. For those with SSD or other SMIs, there are designs that are highly effective. Both the best and worst designs have key similarities but vary in some characteristics.

Identifying the Demographic and Mental Health Factors That Influence Insomnia Treatment Recommendations Within a Veteran Population.

Objective/Background: Insomnia is a pervasive and costly disorder that is particularly prevalent within the U.S. Veteran population. Although Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment for insomnia, high rates of sedative-hypnotic prescribing continue. There is little research investigating the rates and factors impacting insomnia treatment recommendations, both behavioral and pharmacological. Participants: A cohort of 5,254 Veterans referred for either CBT-I or prescribed a sedative-hypnotic medication at a single VA Medical Center composed the group of participants. Methods: The current study evaluated the rates of insomnia treatment recommendations and the extent to which demographic variables, psychiatric disorders, and sleep disorders contributed to referrals for CBT-I or prescriptions for sedative-hypnotic medications within a large administrative data set. Results: Military service-related disability, insomnia diagnosis, and having one or more psychiatric diagnoses were associated with a greater likelihood of receiving a CBT-I referral (alone or in addition to a sedative-hypnotic medication) rather than a sedative-hypnotic prescription alone. A diagnosis of posttraumatic stress disorder was associated with a greater likelihood of receiving a sedative-hypnotic medication alone versus a CBT-I referral. Conclusions: Overall, the findings suggest that sedative-hypnotic medications were overwhelmingly the primary treatment recommendation despite evidence to support CBT-I as the recommended first-line treatment. However, key factors were identified that increased the likelihood of Veterans being referred for CBT-I. Suggestions for better identifying and understanding key factors that impact treatment recommendations are discussed.

Randomized Clinical Trial of Standard- Versus High-Calorie Formula for Methadone-Exposed Infants: A Feasibility Study.

BACKGROUND: Newborns who are prenatally exposed to methadone are at risk for neonatal abstinence syndrome and the associated excess weight loss and poor weight gain. This pilot feasibility study aimed to evaluate early caloric enhancement on weight patterns among infants born to women receiving methadone maintenance therapy while pregnant. METHODS: In this double-blind pilot feasibility study, we randomly assigned infants with fetal methadone exposure to 24 or 20 kcal/oz formula from days 3 to 21. Randomization was stratified by any breastfeeding, sex of the infant, and gestational age. Eligible infants were ≥35 weeks' gestation and weighed ≥2200 g. Outcomes were days to weight nadir, maximum percent weight loss, days to birth weight, percentage weight change per day, and feasibility. RESULTS: A total of 49 infants were randomly assigned (22 to standard- and 27 to high-calorie formula); groups had comparable demographic characteristics. Main outcomes comparing standard- to high-calorie formula groups were not significant (days to weight nadir, 5.0 vs 4.4 days; P = .20; maximum percent weight loss, -9.4% vs -8.6%; P = .15; days to birth weight, 14.7 vs 13.6 days; P = .07); however, in longitudinal analyses (days 4 to 21), the high-calorie group had a higher percent weight gained per day compared with the standard-calorie group (P <.001). There were high levels of protocol adherence, and no adverse effects were observed. CONCLUSIONS: Study findings suggest that early initiation of high-calorie formula for infants with prenatal methadone exposure may be beneficial for weight gain; evaluation in a larger study is warranted.

Corrected QT Interval and Methadone Dose and Concentrations in Pregnant and Postpartum Women.

BACKGROUND: Methadone is a standard treatment for opioid dependence in pregnancy; however, its impact on maternal corrected QT interval (QTc) has not been evaluated. We studied the association between methadone dose and enantiomer-specific plasma concentrations and QTc among pregnant and postpartum women and newborns. We assessed the relevance of QTc screening guidelines for pregnant women and infants. METHODS: From 2006 to 2008, plasma methadone concentrations were measured during pregnancy, postpartum, and in cord blood in women treated for opioid dependence at a single treatment program. Electrocardiograms (ECGs) were obtained at peak methadone concentrations in mothers and within 48 hours of birth for infants. Pearson correlations were performed at each time point for QTc and R-methadone, S-methadone, and total methadone concentrations and ratio of R-methadone/S-methadone concentrations. RESULTS: Mean (SD) daily methadone dose for the 25 women was 94.2 (39.1) mg during pregnancy and 112.5 (46.6) mg postpartum. During the third trimester, higher methadone dose and R-methadone concentration correlated with longer QTc (Pearson r = 0.67, P < .001 and Pearson r = 0.49, P = .02, respectively), while S-methadone concentration, R-methadone/S-methadone concentration ratio, and total methadone concentration did not. Postpartum, QTc did not significantly correlate with dose or enantiomer concentrations. Infant QTc did not correlate with maternal dose at delivery or enantiomer-specific cord methadone concentrations. In pregnant and postpartum women, 13% and 17%, respectively, had QTc ≥ 450 ms, as did 19% of infants. CONCLUSIONS: QTc correlated with dose and R-methadone concentration during the third trimester. However, longer QTc was common among women during and after pregnancy. Given the relatively high rate of QTc > 450 ms, an ECG before and after methadone initiation is advisable for pregnant and postpartum women.

Designing eHealth Applications to Reduce Cognitive Effort for Persons With Severe Mental Illness: Page Complexity, Navigation Simplicity, and Comprehensibility.

BACKGROUND: eHealth technologies offer great potential for improving the use and effectiveness of treatments for those with severe mental illness (SMI), including schizophrenia and schizoaffective disorder. This potential can be muted by poor design. There is limited research on designing eHealth technologies for those with SMI, others with cognitive impairments, and those who are not technology savvy. We previously tested a design model, the Flat Explicit Design Model (FEDM), to create eHealth interventions for individuals with SMI. Subsequently, we developed the design concept page complexity, defined via the design variables we created of distinct topic areas, distinct navigation areas, and number of columns used to organize contents and the variables of text reading level, text reading ease (a newly added variable to the FEDM), and the number of hyperlinks and number of words on a page. OBJECTIVE: The objective of our study was to report the influence that the 19 variables of the FEDM have on the ability of individuals with SMI to use a website, ratings of a website's ease of use, and performance on a novel usability task we created termed as content disclosure (a measure of the influence of a homepage's design on the understanding user's gain of a website). Finally, we assessed the performance of 3 groups or dimensions we developed that organize the 19 variables of the FEDM, termed as page complexity, navigational simplicity, and comprehensibility. METHODS: We measured 4 website usability outcomes: ability to find information, time to find information, ease of use, and a user's ability to accurately judge a website's contents. A total of 38 persons with SMI (chart diagnosis of schizophrenia or schizoaffective disorder) and 5 mental health websites were used to evaluate the importance of the new design concepts, as well as the other variables in the FEDM. RESULTS: We found that 11 of the FEDM's 19 variables were significantly associated with all 4 usability outcomes. Most other variables were significantly related to 2 or 3 of these usability outcomes. With the 5 tested websites, 7 of the 19 variables of the FEDM overlapped with other variables, resulting in 12 distinct variable groups. The 3 design dimensions had acceptable coefficient alphas. Both navigational simplicity and comprehensibility were significantly related to correctly identifying whether information was available on a website. Page complexity and navigational simplicity were significantly associated with the ability and time to find information and ease-of-use ratings. CONCLUSIONS: The 19 variables and 3 dimensions (page complexity, navigational simplicity, and comprehensibility) of the FEDM offer evidence-based design guidance intended to reduce the cognitive effort required to effectively use eHealth applications, particularly for persons with SMI, and potentially others, including those with cognitive impairments and limited skills or experience with technology. The new variables we examined (topic areas, navigational areas, columns) offer additional and very simple ways to improve simplicity.

Mood Disorders in Middle-Aged and Older Veterans With Multimorbidity.

OBJECTIVE: This study identified the prevalence of and relationship between mood disorders and multimorbidity in middle-aged and older veterans. METHOD: Cross-sectional data were obtained from veterans who received primary care services at VA Pittsburgh Healthcare System from January 2007 to December 2011 ( n = 34,786). RESULTS: Most veterans had three or more organ systems with chronic disease (95.3%), of which 4.1% had a depressive disorder, 2.5% had an anxiety disorder, and 0.7% had co-occurring depression and anxiety. The odds of having a mood disorder increased with each additional organ system with chronic disease, with odds being the greatest in those with 10 to 13 organ systems with chronic disease. Younger age, female gender, non-married marital status, and having a service connected disability were also significant predictors of having a mood disorder. DISCUSSION: These findings suggest a need to integrate mental health assessment and treatment in chronic health care management for veterans.

Clinical Characterization of Insomnia among Veterans with PTSD: Identifying Risk Factors for Diagnosis and Treatment with Sedative-Hypnotics.

Insomnia is prevalent among Veterans with post-traumatic stress disorder (PTSD), it exacerbates PTSD symptoms, and it contributes to impaired functioning and quality of life. To improve treatment outcomes, it is important to identify risk factors for insomnia and sedative-hypnotic use. Classification and regression trees and logistic regression models were used to identify variables associated with insomnia or sedative-hypnotic use. Key findings include low insomnia diagnosis rates (3.5-5.6%) and high rates of sedative-hypnotics (44.2-49.0%). Younger Veterans and those without a breathing-related sleep disorder (BRSD) were more likely to receive an insomnia diagnosis. Veterans with greater service connection and those with an alcohol/substance use disorder were more likely to be prescribed sedative-hypnotics. Interaction terms may have identified potential groups at risk of being under-diagnosed with insomnia (i.e. non-black Veterans with psychiatric co-morbidity, black Veterans without psychiatric co-morbidity) as well as groups at risk for sedative-hypnotic use (i.e. younger Veterans without BRSD). In sum, Veterans with PTSD have high rates of sedative-hypnotic use despite minimal evidence they are effective. This is counter to recommendations indicating behavioral interventions are the first-line treatment. Policy changes are needed to reduce use of sedative-hypnotics and increase access to behavioral insomnia interventions.

Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.

BACKGROUND: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. METHODS: 680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. RESULTS: 390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. CONCLUSIONS: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.

Using the IRB Researcher Assessment Tool to Guide Quality Improvement.

Institutional Review Boards (IRBs) are intended to protect those who participate in research. However, because there is no established measure of IRB quality, it is unclear whether these committees achieve their goal. The IRB Researcher Assessment Tool is a previously validated, internally normed, proxy measure of IRB quality that assesses 45 distinct IRB activities and functions. We administered this instrument to a sample of investigators and IRB members at a large urban VA Medical Center. We describe a systematic approach to analyze and interpret survey responses that can identify the IRB activities and functions most in need of quality improvement. The proposed approach to empirical data analysis and presentation could inform local initiatives to improve the quality of IRB review.

Racial Differences in Veterans' Satisfaction With Addiction Treatment Services.

OBJECTIVES: Racial minorities experience lower rates of alcohol treatment completion than whites. Treatment satisfaction is an important factor in alcohol treatment retention, yet few studies have explored the satisfaction of racial minorities while in treatment. This study examined racial differences in addiction treatment satisfaction and explored factors that might mediate or moderate racial differences in satisfaction. METHODS: We surveyed non-Hispanic black and non-Hispanic white veterans with an alcohol-related diagnosis about addiction treatment services at a large Veterans Affairs medical center. Treatment satisfaction was measured using the 8-item Client Satisfaction Questionnaire, dichotomized as low versus non-low satisfaction in analyses. The χ and logistic regression methods were used to test for associations of race and sociodemographic characteristics with treatment satisfaction. RESULTS: Among 271 black and 304 white veterans with an alcohol-related diagnosis, race was not statistically associated with treatment satisfaction in bivariate analyses (P > 0.05). However, we identified significant interactions of race with mental health diagnoses in predicting treatment satisfaction in multivariable analyses (adj odds ratio = 0.55; 95% confidence interval [CI] = 0.39-0.78). In post hoc comparisons among veterans with zero mental health diagnoses, black veterans had a greater probability of reporting low satisfaction than whites (marginal difference = 0.13; 95% CI = 0.04-0.22). In veterans with 4 or more diagnoses, whites had a greater probability than blacks of reporting low satisfaction (marginal difference = 0.28, 95% CI = 0.10-0.46). Regardless of race, past homelessness was associated with low satisfaction (adj odds ratio = 2.09; 95% CI = 1.19-3.67). CONCLUSIONS: Racial minorities, veterans with unstable housing, and white veterans with co-occurring mental health disorders may be at risk of experiencing low treatment satisfaction.

Alcohol brief intervention for hospitalized veterans with hazardous drinking: protocol for a 3-arm randomized controlled efficacy trial.

BACKGROUND: Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trials conducted with hospital inpatients vary widely in methodological quality. While the majority of these studies indicate limited to no effects of BI in this population, none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null: assessment reactivity (AR). METHODS/DESIGN: This is a three-arm, single-site, randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder. Participants are randomized to one of three study conditions. Study Arm 1 receives a three-part alcohol BI. Study Arm 2 receives attention control. To account for potential AR, Study Arm 3 receives AC with limited assessment. Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge. Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use. To assess differences in primary outcomes across the three arms, we will use mixed-effects regression models that account for a patient's repeated measures over the timepoints and clustering within medical units. Intervention implementation will be assessed by: a) review of intervention audio recordings to characterize barriers to intervention fidelity; and b) feasibility of participant recruitment, enrollment, and follow-up. DISCUSSION: The results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures. TRIAL REGISTRATION: NCT01602172.

Do surgeons and patients discuss what they document on consent forms?

BACKGROUND: Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. METHODS: We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. RESULTS: Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. CONCLUSIONS: The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need.

Time required for institutional review board review at one Veterans Affairs medical center.

IMPORTANCE: Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. OBJECTIVE: To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS: After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. MAIN OUTCOMES AND MEASURES: Calendar days from initial submission to final approval of research protocols. RESULTS: Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. CONCLUSIONS AND RELEVANCE: Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels. The method described here could be applied to other IRBs to begin identifying and improving inefficiencies.

Critical design elements of e-health applications for users with severe mental illness: singular focus, simple architecture, prominent contents, explicit navigation, and inclusive hyperlinks.

OBJECTIVE: E-health applications are becoming integral components of general medical care delivery models and emerging for mental health care. Few exist for treatment of those with severe mental illness (SMI). In part, this is due to a lack of models to design such technologies for persons with cognitive impairments and lower technology experience. This study evaluated the effectiveness of an e-health design model for persons with SMI termed the Flat Explicit Design Model (FEDM). METHODS: Persons with schizophrenia (n = 38) performed tasks to evaluate the effectiveness of 5 Web site designs: 4 were prominent public Web sites, and 1 was designed according to the FEDM. Linear mixed-effects regression models were used to examine differences in usability between the Web sites. Omnibus tests of between-site differences were conducted, followed by post hoc pairwise comparisons of means to examine specific Web site differences when omnibus tests reached statistical significance. RESULTS: The Web site designed using the FEDM required less time to find information, had a higher success rate, and was rated easier to use and less frustrating than the other Web sites. The home page design of one of the other Web sites provided the best indication to users about a Web site's contents. The results are consistent with and were used to expand the FEDM. CONCLUSIONS: The FEDM provides evidence-based guidelines to design e-health applications for person with SMI, including: minimize an application's layers or hierarchy, use explicit text, employ navigational memory aids, group hyperlinks in 1 area, and minimize the number of disparate subjects an application addresses.

A cluster randomized trial of adding peer specialists to intensive case management teams in the Veterans Health Administration.

Use of peer specialists (PSs)--individuals with serious mental illness who use their experiences to help others with serious mental illness--is increasing. However, their impact on patient outcomes has not been demonstrated definitively. This cluster randomized, controlled trial within the Veterans Health Administration compared patients served by three intensive case management teams that each deployed two PSs for 1 year, to the patients of three similar teams without PSs (Usual Care). All patients (PS group = 149, Usual Care = 133) had substantial psychiatric inpatient histories and a primary Axis 1 psychiatric disorder. Before and after the year PSs worked, patients were surveyed on their recovery, quality of life, activation (health self-management efficacy), interpersonal relations, and symptoms. Patients in the PS group improved significantly more (z = 2.00, df = 1, p = 0.05) than those receiving Usual Care on activation. There were no other significant differences. PSs helped patients become more active in treatment, which can promote recovery.

Impact of prenatal exposure to serotonin reuptake inhibitors or maternal major depressive disorder on infant developmental outcomes.

OBJECTIVE: To examine the impact of prenatal exposure to both serotonin reuptake inhibitors (SRIs; during any trimester) and maternal major depressive disorder (MDD; by DSM-IV criteria) on infant functioning. We hypothesized that infants with prenatal exposure to SRIs or MDD would have lower psychomotor, mental, and behavioral scores compared with nonexposed infants. METHOD: This longitudinal study included 166 mother-infant dyads: 68 with prenatal MDD/SRI (n = 41) or MDD/no SRI exposure (n = 27) and 98 nonexposed controls. Maternal depression and SRI exposure assessments were completed at or as near to 20, 30, and 36 prenatal weeks and 12, 26, 52, and 78 weeks postpartum as feasible. Infants were evaluated with the Bayley Scales of Infant Development, Second Edition, including the psychomotor (Psychomotor Development Index; PDI), cognitive (Mental Development Index; MDI), and behavioral (Behavioral Rating Scale; BRS) components. Study assessments occurred between 2003 and 2009. RESULTS: Neither prenatal exposure to MDD/SRI nor MDD/no SRI significantly impacted overall PDI, MDI, or BRS scores. However, we observed a significant SRI exposure by time interaction for the PDI (P = .038). MDD/SRI exposure was associated with lower PDI scores at 26 (mean = 97.0) and 52 weeks (mean = 92.9) compared with nonexposed infants (mean = 101.4 and 100.5). This difference was no longer significant at the 78-week assessment. CONCLUSIONS: Consistent with previous studies, we found no impact of prenatal MDD/SRI exposure on MDI scores. Less favorable PDI scores were observed in the first year; notably, these scores remained well within the normative range. The effects of prenatal MDD/SRI exposure on motor functioning may be transitory. A longitudinal pattern of poor developmental outcomes has not been established. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00279370.

Brief motivational enhancement intervention to prevent or reduce postpartum alcohol use: a single-blinded, randomized controlled effectiveness trial.

AIMS: The aim of this study is to assess the effect of brief motivational enhancement intervention postpartum alcohol use. DESIGN: This study is a single-blinded, randomized controlled effectiveness trial in which pregnant women were assigned to receive usual care or up to 5 face-to-face brief motivational enhancement sessions lasting 10-30 minutes each and occurring at study enrollment, 4 and 8 weeks after enrollment, 32 weeks of gestation, and 6 weeks postpartum. SETTING: The setting is in a large, urban, obstetrics clinic. PARTICIPANTS: Participants were women who were ≥ 18 years old, <20 weeks of gestation, and consumed alcohol during pregnancy. Of 3438 women screened, 330 eligible women were assigned to usual care (n = 165) or intervention (n=165). Due to missing data, we analyzed 125 in the intervention group and 126 in the usual care group. MEASUREMENTS: The measurements were the proportion of women with any alcohol use and the number of drinks per day, reported via follow-up telephone interviews at 4 and 8 weeks after enrollment, 32 weeks of gestation, and 6 weeks, 6 months, and 12 months postpartum. FINDINGS: In random effects models adjusted for confounders, the intervention group was less likely to use any alcohol (odds ratio 0.50; 95% confidence interval [CI], 0.23-1.09; P=0.08) and consumed fewer drinks per day (coefficient -0.11; 95% CI -0.23-0.01; P=0.07) than, the usual care group in the postpartum period but these differences were non-significant. Missing data during the prenatal period prevented us from modeling prenatal alcohol use. CONCLUSIONS: Brief motivational enhancement intervention delivered in an obstetrical outpatient setting did not conclusively decrease alcohol use during the postpartum period.

Willingness and access to joint replacement among African American patients with knee osteoarthritis: a randomized, controlled intervention.

OBJECTIVE: African American patients are significantly less likely to undergo knee replacement for the management of knee osteoarthritis (OA). Racial difference in preference (willingness) has emerged as a key factor. This study was undertaken to examine the efficacy of a patient-centered educational intervention on patient willingness and the likelihood of receiving a referral to an orthopedic clinic. METHODS: A total of 639 African American patients with moderate-to-severe knee OA from 3 Veterans Affairs primary care clinics were enrolled in a randomized, controlled trial with a 2 × 2 factorial design. Patients were shown a knee OA decision-aid video with or without brief counseling. The main outcome measures were change in patient willingness and receipt of a referral to an orthopedic clinic. Also assessed were whether patients discussed knee pain with their primary care provider or saw an orthopedic surgeon within 12 months of the intervention. RESULTS: At baseline, 67% of the participants were definitely/probably willing to consider knee replacement, with no difference among the groups. The intervention increased patient willingness (75%) in all groups at 1 month. For those who received the decision aid intervention alone, the gains were sustained for up to 3 months. By 12 months postintervention, patients who received any intervention were more likely to report engaging their provider in a discussion about knee pain (92% versus 85%), to receive a referral to an orthopedic surgeon (18% versus 13%), and for those with a referral, to attend an orthopedic consult (61% versus 50%). CONCLUSION: An educational intervention significantly increased the willingness of African American patients to consider knee replacement. It also improved the likelihood of patient-provider discussion about knee pain and access to surgical evaluation.