Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%-69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants' concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.

Perceptions of alcohol misuse among Alaska native health care system stakeholders: A qualitative exploration.

Although alcohol misuse is a priority for health care systems serving Alaska Native and American Indian (ANAI) people, stakeholders' perceptions of misuse are understudied. Patients (n = 34), providers (n = 20), and leaders (n = 16) at a Tribally owned and operated health care system reported that alcohol misuse results from the interaction of factors, including colonization, structural factors, social alienation, social norms about overdrinking introduced at the time of colonizing contact, coping with emotions, and beliefs about ANAI people and alcohol. Childhood exposure to alcohol misuse leads some ANAI people to avoid alcohol altogether, shedding light on the high levels of abstinence observed in ANAI communities.

Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline.

BACKGROUND: The CHOICE care management intervention did not improve drinking relative to usual care (UC) for patients with frequent heavy drinking at high risk of alcohol use disorders. Patients with alcohol dependence were hypothesized to benefit most. We conducted preplanned secondary analyses to test whether the CHOICE intervention improved drinking relative to UC among patients with and without baseline DSM-IV alcohol dependence. METHODS: A total of 304 patients reporting frequent heavy drinking from 3 VA primary care clinics were randomized (stratified by DSM-IV alcohol dependence, sex, and site) to UC or the patient-centered, nurse-delivered, 12-month CHOICE care management intervention. Primary outcomes included percent heavy drinking days (%HDD) using 28-day timeline follow-back and a "good drinking outcome" (GDO)-abstaining or drinking below recommended limits and no alcohol-related symptoms on the Short Inventory of Problems at 12 months. Generalized estimating equation binomial regression models (clustered on provider) with interaction terms between dependence and intervention group were fit. RESULTS: At baseline, 59% of intervention and UC patients had DSM-IV alcohol dependence. Mean drinking outcomes improved for all subgroups. For participants with dependence, 12-month outcomes did not differ for intervention versus UC patients (%HDD 37% versus 38%, p = 0.76 and GDO 16% versus 16%, p = 0.77). For participants without dependence, %HDD did not differ between intervention (41%) and UC (31%) patients (p = 0.12), but the proportion with GDO was significantly higher among UC participants (26% versus 13%, p = 0.046). Neither outcome was significantly modified by dependence (interaction p values 0.19 for %HDD and 0.10 for GDO). CONCLUSIONS: Among participants with frequent heavy drinking, care management had no benefit relative to UC for patients with dependence, but UC may have had benefits for those without dependence. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400581.

If You Listen, I Will Talk: the Experience of Being Asked About Suicidality During Routine Primary Care.

BACKGROUND: Routine population-based screening for depression is an essential part of evolving health care models integrating care for mental health in primary care. Depression instruments often include questions about suicidal thoughts, but how patients experience these questions in primary care is not known and may have implications for accurate identification of patients at risk. OBJECTIVES: To explore the patient experience of routine population-based depression screening/assessment followed, for some, by suicide risk assessment and discussions with providers. DESIGN: Qualitative, interview-based study. PARTICIPANTS: Thirty-seven patients from Kaiser Permanente Washington who had recently screened positive for depression on the 2-item Patient Health Questionnaire [PHQ] and completed the full PHQ-9. APPROACH: Criterion sampling identified patients who had recently completed the PHQ-9 ninth question which asks about the frequency of thoughts about self-harm. Patients completed semi-structured interviews by phone, which were recorded and transcribed. Directive and conventional content analyses were used to apply knowledge from prior research and elucidate new information from interviews; thematic analysis was used to organize key content overall and across groups based on endorsement of suicide ideation. KEY RESULTS: Four main organizing themes emerged from analyses: (1) Participants believed being asked about suicidality was contextually appropriate and valuable, (2) some participants described a mismatch between their lived experience and the PHQ-9 ninth question, (3) suicidality disclosures involved weighing hope for help against fears of negative consequences, and (4) provider relationships and acts of listening and caring facilitated discussions about suicidality. CONCLUSIONS: All participants believed being asked questions about suicidal thoughts was appropriate, though some who disclosed suicidal thoughts described experiencing stigma and sometimes distanced themselves from suicidality. Direct communication with trusted providers, who listened and expressed empathy, bolstered comfort with disclosure. Future research should consider strategies for reducing stigma and encouraging fearless disclosure among primary care patients experiencing suicidality.

Impact of initiatives to reduce prescription opioid risks on medically attended injuries in people using chronic opioid therapy.

PURPOSE: The purpose of the study is to determine whether initiatives to improve the safety of opioid prescribing decreased injuries in people using chronic opioid therapy (COT). METHODS: We conducted an interrupted time series analysis using data from Group Health (GH), an integrated health care delivery system in the United States. In 2007, GH implemented initiatives which substantially reduced daily opioid dose and increased patient monitoring. Among GH members age 18 or older receiving COT between 2006 and 2014, we compared injury rates for patients in GH's integrated group practice (IGP; exposed to the initiatives) vs patients cared for by contracted providers (not exposed). Injuries were identified using a validated algorithm. We calculated injury incidence during the baseline (preintervention) period from 2006 to 2007; the dose reduction period, 2008 to 2010; and the risk stratification and monitoring period, 2010 to 2014. Using modified Poisson regression, we estimated adjusted relative risks (RRs) representing the relative change per year in injury rates. RESULTS: Among 21 853 people receiving COT in the IGP and 8260 in contracted care, there were 2679 injuries during follow-up. The baseline injury rate was 1.0% per calendar quarter in the IGP and 0.9% in contracted care. Risk reduction initiatives did not decrease injury rates: Within the IGP, the RR in the dose reduction period was 1.01 (95% CI, 0.95-1.07) and in the risk stratification and monitoring period, 0.99 (95% CI, 0.95-1.04). Injury trends did not differ between the two care settings. CONCLUSIONS: Risk reduction initiatives did not decrease injuries in people using COT.

Barriers to and Facilitators of Alcohol Use Disorder Pharmacotherapy in Primary Care: A Qualitative Study in Five VA Clinics.

BACKGROUND: Three medications are FDA-approved and recommended for treating alcohol use disorders (AUD) but they are not offered to most patients with AUD. Primary care (PC) may be an optimal setting in which to offer and prescribe AUD medications, but multiple barriers are likely. OBJECTIVE: This qualitative study used social marketing theory, a behavior change approach that employs business marketing techniques including "segmenting the market," to describe (1) barriers and facilitators to prescribing AUD medications in PC, and (2) beliefs of PC providers after they were segmented into groups more and less willing to prescribe AUD medications. DESIGN: Qualitative, interview-based study. PARTICIPANTS: Twenty-four providers from five VA PC clinics. APPROACH: Providers completed in-person semi-structured interviews, which were recorded, transcribed, and analyzed using social marketing theory and thematic analysis. Providers were divided into two groups based on consensus review. KEY RESULTS: Barriers included lack of knowledge and experience, beliefs that medications cannot replace specialty addiction treatment, and alcohol-related stigma. Facilitators included training, support for prescribing, and behavioral staff to support follow-up. Providers more willing to prescribe viewed prescribing for AUD as part of their role as a PC provider, framed medications as a potentially effective "tool" or "foot in the door" for treating AUD, and believed that providing AUD medications in PC might catalyze change while reducing stigma and addressing other barriers to specialty treatment. Those less willing believed that medications could not effectively treat AUD, and that treating AUD was the role of specialty addiction treatment providers, not PC providers, and would require time and expertise they do not have. CONCLUSIONS: We identified barriers to and facilitators of prescribing AUD medications in PC, which, if addressed and/or capitalized on, may increase provision of AUD medications. Providers more willing to prescribe may be the optimal target of a customized implementation intervention to promote changes in prescribing.

Understanding What Is Most Important to Individuals with Multiple Chronic Conditions: A Qualitative Study of Patients' Perspectives.

BACKGROUND: To improve care for individuals living with multiple chronic conditions, patients and providers must align care planning with what is most important to patients in their daily lives. We have a limited understanding of how to effectively encourage communication about patients' personal values during clinical care. OBJECTIVE: To identify what patients with multiple chronic conditions describe as most important to their well-being and health. DESIGN: We interviewed individuals with multiple chronic conditions in their homes and analyzed results qualitatively, guided by grounded theory. PARTICIPANTS: A total of 31 patients (mean age 68.7 years) participated in the study, 19 of which included the participation of family members. Participants were from Kaiser Permanente Washington, an integrated health care system in Washington state. APPROACH: Qualitative analysis of home visits, which consisted of semi-structured interviews aided by photo elicitation. KEY RESULTS: Analysis revealed six domains of what patients described as most important for their well-being and health: principles, relationships, emotions, activities, abilities, and possessions. Personal values were interrelated and rarely expressed as individual values in isolation. CONCLUSIONS: The domains describe the range and types of personal values multimorbid older adults deem important to well-being and health. Understanding patients' personal values across these domains may be useful for providers when developing, sharing, and following up on care plans.

Impact of an opioid risk reduction initiative on motor vehicle crash risk among chronic opioid therapy patients.

PURPOSE: Although prescription opioids have been associated with higher motor vehicle crash (MVC) risk, it is unknown whether health system initiatives to better manage chronic opioid therapy (COT) can reduce MVC risk at the population level. METHODS: We conducted an interrupted time series population-level cohort study at Group Health (GH), between January 2006 and September 2014, comparing MVC risk among COT patients who were GH members receiving care in either group practice or contracted care settings. Group practice COT risk reduction initiatives were implemented in two phases: (1) altered prescribing expectations and (2) multifaceted initiatives. These initiatives did not exist in the contracted care network. We compared the adjusted quarterly rate of MVC between group practice and contracted care patients over time using a modified Poisson regression model for a binary outcome. RESULTS: A total of 32 691 COT patients (27.4% from contracted care) met eligibility criteria and experienced a total of 1956 MVCs during study follow-up (mean, 8.1 quarters per person), of which 810 were serious injury crashes. Crash rates were not significantly different between the patient groups within any of the time periods. Analyses stratified by concurrent prescription of a sedative hypnotic or benzodiazepine found no significant difference between the group practice and contracted care patients. There was a modest elevation of MVC risk for high-dose patients relative to former COT patients who stopped receiving opioids. CONCLUSIONS: The risk of MVC was not mitigated in a large cohort of COT patients exposed to a health plan policy initiative that substantially lowered mean opioid dose. Copyright © 2016 John Wiley & Sons, Ltd.

The Relations of Cognitive, Behavioral, and Physical Activity Variables to Depression Severity in Traumatic Brain Injury: Reanalysis of Data From a Randomized Controlled Trial.

OBJECTIVE: To explore the relations of cognitive, behavioral, and physical activity variables to depression severity among people with traumatic brain injury (TBI) undergoing a depression treatment trial. SETTING: Community. PARTICIPANTS: Adults (N = 88) who sustained complicated mild to severe TBI within the past 10 years, met criteria for major depressive disorder, and completed study measures. DESIGN: Randomized controlled trial. METHODS: Participants were randomized to cognitive-behavioral therapy (n = 58) or usual care (n = 42). Outcomes were measured at baseline and 16 weeks. We combined the groups and used regressions to explore the relations among theoretical variables and depression outcomes. MAIN MEASURES: Depression severity was measured with the Hamilton Depression Rating Scale and Symptom Checklist-20. Theory-based measures were the Dysfunctional Attitudes Scale (DAS), Automatic Thoughts Questionnaire (ATQ), Environmental Rewards Observation Scale (EROS), and the International Physical Activity Questionnaire (IPAQ). RESULTS: Compared with non-TBI norms, baseline DAS and ATQ scores were high and EROS and IPAQ scores were low. All outcomes improved from baseline to 16 weeks except the DAS. The ATQ was an independent predictor of baseline depression. An increase in EROS scores was correlated with decreased depression. CONCLUSIONS: Increasing participation in meaningful roles and pleasant activities may be a promising approach to treating depression after TBI.

Conducting a large, multi-site survey about patients' views on broad consent: challenges and solutions.

BACKGROUND: As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS: A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS: Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS: Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

Factors Underlying Quality Problems with Alcohol Screening Prompted by a Clinical Reminder in Primary Care: A Multi-site Qualitative Study.

BACKGROUND: Population-based alcohol screening is recommended in primary care, and increasingly incentivized by policies, yet is challenging to implement. The U.S. Veterans Health Administration (VA) achieved high rates of screening using a national performance measure and associated electronic clinical reminder to prompt and facilitate screening and document results. However, the sensitivity of alcohol screening for identifying unhealthy alcohol use is low in VA clinics. OBJECTIVE: We aimed to understand factors that might contribute to low sensitivity of alcohol screening. DESIGN: This was an observational, qualitative study. PARTICIPANTS: Participants included clinical staff responsible for conducting alcohol screening and nine independently managed primary care clinics of a single VA medical center in the Northwestern U.S. APPROACH: Four researchers observed clinical staff as they conducted alcohol screening. Observers took handwritten notes, which were transcribed and coded iteratively. Template analysis identified a priori and emergent themes. KEY RESULTS: We observed 72 instances of alcohol screening conducted by 31 participating staff. Observations confirmed known challenges to implementation of care using clinical reminders, including workflow and flexibility limitations. Three themes specific to alcohol screening emerged. First, most observed screening was conducted verbally, guided by the clinical reminder, although some variability in approaches to screening (e.g., paper-based or laminate-based screening) was observed. Second, specific verbal screening practices that might contribute to low sensitivity of clinical screening were identified, including conducting non-verbatim screening and making inferences, assumptions, and/or suggestions to input responses. Third, staff introduced and adapted screening questions to enhance patient comfort. CONCLUSIONS: This qualitative study in nine clinics found that implementation of alcohol screening facilitated by a clinical reminder resulted primarily in verbal screening in which questions were not asked vertbatim and were otherwise adapted. Non-verbal approaches to screening, or patient self-administration, may enhance validity and standardization of screening while simultaneously addressing limitations of the clinical reminder and issues related to perceived discomfort.

Community dissemination and genetic research: moving beyond results reporting.

The community-based participatory research (CBPR) literature notes that researchers should share study results with communities. In the case of human genetic research, results may be scientifically interesting but lack clinical relevance. The goals of this study were to learn what kinds of information community members want to receive about genetic research and how such information should be conveyed. We conducted eight focus group discussions with Yup'ik Alaska Native people in southwest Alaska (N = 60) and 6 (N = 61) with members of a large health maintenance organization in Seattle, Washington. Participants wanted to receive genetic information they "could do something about" and wanted clinically actionable information to be shared with their healthcare providers; they also wanted researchers to share knowledge about other topics of importance to the community. Although Alaska Native participants were generally less familiar with western scientific terms and less interested in web-based information sources, the main findings were the same in Alaska and Seattle: participants wished for ongoing dialogue, including opportunities for informal, small-group conversations, and receiving information that had local relevance. Effective community dissemination is more than a matter of presenting study results in lay language. Community members should be involved in both defining culturally appropriate communication strategies and in determining which information should be shared. Reframing dissemination as a two-way dialogue, rather than a one-way broadcast, supports the twin aims of advancing scientific knowledge and achieving community benefit.

Collaborative care for patients with depression and chronic illnesses.

BACKGROUND: Patients with depression and poorly controlled diabetes, coronary heart disease, or both have an increased risk of adverse outcomes and high health care costs. We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients. METHODS: We conducted a single-blind, randomized, controlled trial in 14 primary care clinics in an integrated health care system in Washington State, involving 214 participants with poorly controlled diabetes, coronary heart disease, or both and coexisting depression. Patients were randomly assigned to the usual-care group or to the intervention group, in which a medically supervised nurse, working with each patient's primary care physician, provided guideline-based, collaborative care management, with the goal of controlling risk factors associated with multiple diseases. The primary outcome was based on simultaneous modeling of glycated hemoglobin, low-density lipoprotein (LDL) cholesterol, and systolic blood-pressure levels and Symptom Checklist-20 (SCL-20) depression outcomes at 12 months; this modeling allowed estimation of a single overall treatment effect. RESULTS: As compared with controls, patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels (difference, 0.58%), LDL cholesterol levels (difference, 6.9 mg per deciliter [0.2 mmol per liter]), systolic blood pressure (difference, 5.1 mm Hg), and SCL-20 depression scores (difference, 0.40 points) (P<0.001). Patients in the intervention group also were more likely to have one or more adjustments of insulin (P=0.006), antihypertensive medications (P<0.001), and antidepressant medications (P<0.001), and they had better quality of life (P<0.001) and greater satisfaction with care for diabetes, coronary heart disease, or both (P<0.001) and with care for depression (P<0.001). CONCLUSIONS: As compared with usual care, an intervention involving nurses who provided guideline-based, patient-centered management of depression and chronic disease significantly improved control of medical disease and depression. (Funded by the National Institute of Mental Health; ClinicalTrials.gov number, NCT00468676.).

Association of depression with increased risk of severe hypoglycemic episodes in patients with diabetes.

PURPOSE: Although psychosocial and clinical factors have been found to be associated with hypoglycemic episodes in patients with diabetes, few studies have examined the association of depression with severe hypoglycemic episodes. This study examined the prospective association of depression with risk of hypoglycemic episodes requiring either an emergency department visit or hospitalization. METHODS: In a longitudinal cohort study, a sample of 4,117 patients with diabetes enrolled between 2000 and 2002 were observed from 2005 to 2007. Meeting major depression criteria on the Patient Health Questionnaire-9 was the exposure of interest, and the outcome of interest was an International Classification of Disease, Ninth Revision code for a hypoglycemic episode requiring an emergency department visit or hospitalization. Proportional hazard models were used to analyze the association of baseline depression and risk of one or more severe hypoglycemic episodes. Poisson regression was used to determine whether depression status was associated with the number of hypoglycemic episodes. RESULTS: After adjusting for sociodemographic, clinical measures of diabetes severity, non-diabetes-related medical comorbidity, prior hypoglycemic episodes, and health risk behaviors, depressed compared with nondepressed patients who had diabetes had a significantly higher risk of a severe hypoglycemic episode (hazard ratio = 1.42, 95% CI, 1.03-1.96) and a greater number of hypoglycemic episodes (odds ratio = 1.34, 95% CI, 1.03-1.74). CONCLUSION: Depression was significantly associated with time to first severe hypoglycemic episode and number of hypoglycemic episodes. Research assessing whether recognition and effective treatment of depression among persons with diabetes prevents severe hypoglycemic episodes is needed.

Improving confidence for self care in patients with depression and chronic illnesses.

The aim of this study was to examine whether patients who received a multicondition collaborative care intervention for chronic illnesses and depression had greater improvement in self-care knowledge and efficacy, and whether greater knowledge and self-efficacy was positively associated with improved target outcomes. A randomized controlled trial with 214 patients with comorbid depression and poorly controlled diabetes and/or coronary heart disease tested a 12-month team-based intervention that combined self-management support and collaborative care management. At 6 and 12 month outcomes the intervention group showed significant improvements over the usual care group in confidence in ability to follow through with medical regimens important to managing their conditions and to maintain lifestyle changes even during times of stress. Improvements in self care-efficacy were significantly related to improvements in depression, and early improvements in confidence to maintain lifestyle changes even during times of stress explained part of the observed subsequent improvements in depression.

Measuring Attitudes About Alcohol Misuse and Dependence Among Alaska Native People Within a Tribal Health Care System.

OBJECTIVES: Attitudes about alcohol misuse and dependence influence alcohol use and help-seeking behavior. Alaska Native and American Indian (AN/AI) people have higher rates of alcohol-related morbidity and mortality but engage in treatment at lower rates than the general population. No validated instruments exist to assess attitudes of AN/AI people about alcohol misuse and dependence to inform treatment and prevention efforts. This study aimed to develop an instrument to assess public attitudes among AN/AI people of alcohol misuse and dependence. METHODS: This multiphase, mixed-methods study was conducted at Southcentral Foundation, a tribally owned health system serving 65,000 AN/AI people in Alaska. We conducted focus groups and interviews with health system users, providers, and leaders to adapt the Public Attitudes About Addiction Survey. The adapted instrument was piloted with 200 people. Cognitive interviews and exploratory and confirmatory factor analyses were used to refine the instrument, which were then administered to 777 AN/AI people. RESULTS: Initial exploratory factor analysis identified 5 factors, including 3 from the original Public Attitudes About Addiction Survey (moral, disease, nature), a combined psychology and sociology factor (psychosocial), and a new factor (environment). A final 4-factor model (psychosocial, moral, disease, nature) with 14 items had good fit with root mean square error of approximation (0.035; comparative fit index = 0.977; Tucker-Lewis index = 0.970; standardized root mean residual = 0.040) and loadings ranging from 0.41 to 0.80. CONCLUSIONS: This study developed the first instrument to assess AN/AI attitudes about alcohol misuse and dependence. This instrument has potential to inform alcohol-related treatment in AN/AI communities. Future research is warranted to adequately measure place-based contributors salient to AN/AI people.

A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes.

INTRODUCTION: Evidence about the effectiveness and safety of dog visits in pediatric oncology is limited. METHOD: We conducted a randomized controlled trial (n=26) of dog visits versus usual care among pediatric oncology inpatients. Psychological functioning and microbial load from hand wash samples were evaluated. Parental anxiety was a secondary outcome. RESULTS: We did not observe a difference in the adjusted mean present functioning score (-3.0; 95% confidence interval [CI], -12.4 to 6.4). The difference in microbial load on intervention versus control hands was -0.04 (95% CI, -0.60 to 0.52) log10 CFU/mL, with an upper 95% CI limit below the prespecified noninferiority margin. Anxiety was lower in parents of intervention versus control patients. DISCUSSION: We did not detect an effect of dog visits on functioning; however, our study was underpowered by low recruitment. Visits improved parental anxiety. With hand sanitization, visits did not increase hand microbial levels. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT03471221.

Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial.

PURPOSE: Medication nonadherence, inconsistent patient self-monitoring, and inadequate treatment adjustment exacerbate poor disease control. In a collaborative, team-based, care management program for complex patients (TEAMcare), we assessed patient and physician behaviors (medication adherence, self-monitoring, and treatment adjustment) in achieving better outcomes for diabetes, coronary heart disease, and depression. METHODS: A randomized controlled trial was conducted (2007-2009) in 14 primary care clinics among 214 patients with poorly controlled diabetes (glycated hemoglobin [HbA(1c)] ≥8.5%) or coronary heart disease (blood pressure >140/90 mm Hg or low-density lipoprotein cholesterol >130 mg/dL) with coexisting depression (Patient Health Questionnaire-9 score ≥10). In the TEAMcare program, a nurse care manager collaborated closely with primary care physicians, patients, and consultants to deliver a treat-to-target approach across multiple conditions. Measures included medication initiation, adjustment, adherence, and disease self-monitoring. RESULTS: Pharmacotherapy initiation and adjustment rates were sixfold higher for antidepressants (relative rate [RR] = 6.20; P <.001), threefold higher for insulin (RR = 2.97; P <.001), and nearly twofold higher for antihypertensive medications (RR = 1.86, P <.001) among TEAMcare relative to usual care patients. Medication adherence did not differ between the 2 groups in any of the 5 therapeutic classes examined at 12 months. TEAMcare patients monitored blood pressure (RR = 3.20; P <.001) and glucose more frequently (RR = 1.28; P = .006). CONCLUSIONS: Frequent and timely treatment adjustment by primary care physicians, along with increased patient self-monitoring, improved control of diabetes, depression, and heart disease, with no change in medication adherence rates. High baseline adherence rates may have exerted a ceiling effect on potential improvements in medication adherence.

Obesity, depression, and health services costs among middle-aged women.

BACKGROUND: Both obesity and depression have been associated with significant increases in health care costs. Previous research has not examined whether cost increases associated with obesity could be explained by confounding effects of depression. OBJECTIVE: Examine whether the association between obesity and health care costs is explained by co-occurring depression. DESIGN: Cross-sectional study including telephone survey and linkage to health plan records. PARTICIPANTS: 4462 women aged 40 to 65 enrolled in prepaid health plan in the Pacific Northwest. MAIN MEASURES: The telephone survey included self-report of height and weight and measurement of depression by the Patient Health Questionnaire (PHQ9). Survey data were linked to health plan cost accounting records. KEY RESULTS: Compared to women with BMI less than 25, proportional increases in health care costs were 65% (95% CI 41% to 93%) for women with BMI 30 to 35 and 157% (95% CI 91% to 246%) for women with BMI of 35 or more. Adjustment for co-occurring symptoms of depression reduced these proportional differences to 40% (95% CI 18% to 66%) and 87% (95% CI 42% to 147%), respectively. Cost increases associated with obesity were spread across all major categories of health services (primary care visits, outpatient prescriptions, inpatient medical services, and specialty mental health care). CONCLUSIONS: Among middle-aged women, both obesity and depression are independently associated with substantially higher health care costs. These cost increases are spread across the full range of outpatient and inpatient health services. Given the high prevalence of obesity, cost increases of this magnitude have major policy and public health importance.

A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

BACKGROUND: Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. PURPOSE: This study examined treatment outcomes among women with comorbid obesity and depression. METHODS: Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). RESULTS: Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). CONCLUSIONS: Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.