Changes in alcohol consumption reported on routine healthcare screenings are associated with changes in depression symptoms.

BACKGROUND: The Alcohol Use Disorders Identification Test-Consumption version (AUDIT-C) has been robustly validated as a point-in-time screen for unhealthy alcohol use, but less is known about the significance of changes in AUDIT-C scores from routine screenings over time. Unhealthy alcohol use and depression commonly co-occur, and changes in drinking often co-occur with changes in depression symptoms. We assess the associations between changes in AUDIT-C scores and changes in depression symptoms reported on brief screens completed in routine care. METHODS: The study sample included 198,335 primary care patients who completed two AUDIT-C screens 11 to 24 months apart and the Patient Health Questionnaire-2 (PHQ-2) depression screen on the same day as each AUDIT-C. Both screening measures were completed as part of routine care within a large health system in Washington state. AUDIT-C scores were categorized to reflect five drinking levels at both time points, resulting in 25 subgroups with different change patterns. For each of the 25 subgroups, within-group changes in the prevalence of positive PHQ-2 depression screens were characterized using risk ratios (RRs) and McNemar's tests. RESULTS: Patient subgroups with increases in AUDIT-C risk categories generally experienced increases in the prevalence of positive depression screens (RRs ranging from 0.95 to 2.00). Patient subgroups with decreases in AUDIT-C risk categories generally experienced decreases in the prevalence of positive depression screens (RRs ranging from 0.52 to 1.01). Patient subgroups that did not have changes in AUDIT-C risk categories experienced little or no change in the prevalence of positive depression screens (RRs ranging from 0.98 to 1.15). CONCLUSIONS: As hypothesized, changes in alcohol consumption reported on AUDIT-C screens completed in routine care were associated with changes in depression screening results. Results support the validity and clinical utility of monitoring changes in AUDIT-C scores over time as a meaningful measure of changes in drinking.

Association between clinical measures of unhealthy alcohol use and subsequent year hospital admissions in a primary care population.

BACKGROUND: Screening for unhealthy alcohol use in primary care may help identify patients at risk for negative health outcomes. AIMS: This study examined the associations between 1) screening with the AUDIT-C (alcohol consumption) and 2) an Alcohol Symptom Checklist (symptoms of alcohol use disorder) and subsequent-year hospitalizations. METHODS: This retrospective cohort study was conducted in 29 primary care clinics in Washington State. Patients were screened in routine care (10/1/2016-2/1/2019) with the AUDIT-C (0-12) and administered the Alcohol Symptom Checklist (0-11) if they had AUDIT-C score ≥ 7. All-cause hospitalizations were measured within 1 year of the AUDIT-C and Alcohol Symptom Checklist. AUDIT-C and Alcohol Symptom Checklist scores were categorized based on previously used cut-points. FINDINGS: Of 305,376 patients with AUDIT-Cs, 5.3% of patients were hospitalized in the following year. AUDIT-C scores had a J-shaped relationship with hospitalizations, with risk for all-cause hospitalizations higher for patients with the AUDIT-C scores 9-12 (12.1%; 95% CI: 10.6-13.7%, relative to a comparison group of those with AUDIT-C scores 1-2 (female)/1-3 (male) (3.7%; 95% CI: 3.6-3.8%), adjusted for socio-demographics. Patients with AUDIT-C ≥ 7 and Alcohol Symptom Checklist scores reflecting severe AUD were at increased risk of hospitalization (14.6%, 95% CI: 11.9-17.9%) relative to those with lower scores. CONCLUSIONS: Higher AUDIT-C scores were associated with higher incidence of hospitalizations except among people with low-level drinking. Among patients with AUDIT-C ≥ 7, the Alcohol Symptom Checklist identified patients at increased risk of hospitalization. This study helps demonstrate the potential clinical utility of the AUDIT-C and Alcohol Symptom Checklist.

Primary Care Provider Experience With Proactive E-Consults to Improve COPD Outcomes and Access to Specialty Care.

Background: Often patients with chronic obstructive pulmonary disease (COPD) receive poor quality care with limited access to pulmonologists. We tested a novel intervention, INtegrating Care After Exacerbation of COPD (InCasE), that improved patient outcomes after hospitalization for COPD. InCasE used population-based identification of patients for proactive e-consultation by pulmonologists, and tailored recommendations with pre-populated orders timed to follow-up with primary care providers (PCPs). Although adoption by PCPs was high, we do not know how PCPs experienced the intervention. Objective: Our objective was to assess PCPs' experience with proactive pulmonary e-consults after hospitalization for COPD. Methods: We conducted a convergent mixed methods study among study PCPs at 2 medical centers and 10 outpatient clinics. PCPs underwent semi-structured interviews and surveys. We performed descriptive analyses on quantitative data and inductive and deductive coding based on prespecified themes of acceptability, appropriateness, and feasibility for qualitative data. Key Results: We conducted 10 interviews and 37 PCPs completed surveys. PCPs perceived InCasE to be acceptable and feasible. Facilitators included the proactive consult approach to patient identification and order entry. PCPs also noted the intervention was respectful and collegial. PCPs had concerns regarding appropriateness related to an unclear role in communicating recommendations to patients. PCPs also noted a potential decrease in autonomy if overused. Conclusion: This evaluation indicates that a proactive e-consult intervention can be deployed to collaboratively manage the health of populations with COPD in a way that is acceptable, appropriate, and feasible for primary care. Lessons learned from this study suggest the intervention may be transferable to other settings and specialties.

Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.

Rationale: Patients discharged from the hospital for chronic obstructive pulmonary disease (COPD) exacerbation have impaired quality of life and frequent readmission and death. Clinical trials to reduce readmission demonstrate inconsistent results, including some demonstrating potential harms. Objectives: We tested whether a pragmatic proactive interdisciplinary and virtual review of patients discharged after hospitalization for COPD exacerbation would improve quality of life, using the Clinical COPD Questionnaire, and reduce all-cause 180-day readmission and/or mortality. Methods: We performed a stepped-wedge clinical trial. We enrolled primary care providers and their patients after hospital discharge for COPD at two Department of Veterans Affairs medical centers and 10 outpatient clinics. A multidisciplinary team reviewed health records and developed treatment recommendations delivered to primary care providers via E-consult. We facilitated uptake by entering recommendations as unsigned orders that could be accepted, modified, or canceled. Providers and patients made all final treatment decisions. Measurements and Main Results: We enrolled 365 primary care providers. Over a 30-month period, 352 patients met eligibility criteria, with 191 (54.3%) patients participating in the control and 161 (45.7%) in the intervention. The intervention led to clinically significant better Clinical COPD Questionnaire scores (-0.47; 95% confidence interval [CI], -0.85 to -0.09; 52.6% missing) but did not reduce 180-day readmission and/or mortality (adjusted odds ratio, 0.83; 95% CI, 0.49 to 1.38), in part because of wide CIs. Among the 161 patients in the intervention group, we entered 519 recommendations as unsigned orders, of which 401 (77.3%) were endorsed. Conclusions: A pragmatic health system-level intervention that delivered proactive specialty supported care improved quality of life but did not reduce 180-day readmission or death. Clinical trial registered with www.clinicaltrials.gov (NCT02021955).

Primary Care and Mental Health Prescribers, Key Clinical Leaders, and Clinical Pharmacist Specialists' Perspectives on Opioids and Benzodiazepines.

OBJECTIVE: Due to increased risks of overdose fatalities and injuries associated with coprescription of opioids and benzodiazepines, healthcare systems have prioritized deprescribing this combination. Although prior work has examined providers' perspectives on deprescribing each medication separately, perspectives on deprescribing patients with combined use is unclear. We examined providers' perspectives on coprescribed opioids and benzodiazepines and identified barriers and facilitators to deprescribing. DESIGN: Qualitative study using semistructured interviews. SETTING: One multisite Veterans Affairs (VA) healthcare system in the United States of America. SUBJECTS: Primary care and mental health prescribers, key clinical leaders, clinical pharmacist specialists (N = 39). METHODS: Interviews were audio-recorded, transcribed, and analyzed using thematic analysis. Themes were identified iteratively, through a multidisciplinary team-based process. RESULTS: Analyses identified four themes related to barriers and facilitators to deprescribing: inertia, prescriber self-efficacy, feasibility of deprescribing/tapering, and promoting deprescribing, as well as a fifth theme, consequences of deprescribing. Results highlighted the complexity of deprescribing when multiple prescribers are involved, a need for additional support and time, and concerns about patients' reluctance to discontinue these medications. Facilitators included agreement with the goal of deprescribing and fear of negative consequences if medications are continued. Providers spoke to how deprescribing efforts impaired patient-provider relationships and informed their decisions not to start patients on these medications. CONCLUSIONS: Although providers agree with the goal, prescribers' belief in a limited deprescribing role, challenges with coordination among prescribers, concerns about insufficient time and patients' resistance to discontinuing these medications need to be addressed for efforts to be successful.

Utility of routine alcohol screening for monitoring changes in alcohol consumption.

BACKGROUND: Routine alcohol screening scores are increasingly available in electronic health records (EHRs). Changes in such scores could be useful for monitoring response to brief intervention or treatment of alcohol use disorder. However, it is unclear whether changes in clinically-documented AUDIT-C alcohol screening scores reflect true changes in drinking. This study evaluated associations between changes in EHR AUDIT-C scores and changes in high density lipoprotein cholesterol (HDL), a laboratory test that reflects average alcohol consumption. METHODS: National U.S. Veterans Affairs EHR data (2004-2007) were used to identify patients screened with the AUDIT-C (0-12 points), on two occasions at least a year apart, who had HDL measured in the year after each screen. First differencing linear regression estimated associations between changes in AUDIT-C score (-12 to 12 points; modeled categorically to allow for non-linear associations) and subsequent changes in HDL (mg/dL), adjusting for baseline HDL. Additional analyses evaluated whether associations between changes in AUDIT-C and changes in HDL were modified by baseline AUDIT-C. RESULTS: Among 316,712 patients, increases-but not decreases-in AUDIT-C scores were associated with commensurate changes in HDL. However, a significant interaction was observed with baseline AUDIT-C score (p < 0.00001), which revealed that decreases in AUDIT-C scores were also associated with commensurate decreases in HDL (p-values<0.05) except among the 1.5% of patients with the highest baseline AUDIT-C scores (10-12). CONCLUSIONS: Findings suggest that changes in EHR AUDIT-C scores reflect changes in drinking. These results support the use of clinically-documented alcohol screening scores for monitoring patients' alcohol use over time.

Electronic Medical Record Alert Associated With Reduced Opioid and Benzodiazepine Coprescribing in High-risk Veteran Patients.

BACKGROUND: Over the past decade, overdoses involving opioids and benzodiazepines have risen at alarming rates, making reductions in coprescribing of these medications a priority, particularly among patients who may be susceptible to adverse events due to high-risk conditions. OBJECTIVES: This quality improvement project evaluated the effectiveness of a medication alert designed to reduce opioid and benzodiazepine coprescribing among Veterans with known high-risk conditions (substance use, sleep apnea, suicide-risk, age 65 and above) at 1 Veterans Affairs (VA) health care system. METHODS: Prescribers were exposed to the point-of-prescribing alert for 12 months. For each high-risk cohort we used interrupted time series design to examine population trends in coprescribing 12 months after alert launch adjusting for coprescribing 12 months before launch, demographics and clinical covariates. Trends at the alert site were compared with those of a similar VA health care system without the alert. Secondary analyses examined population trends in opioid and benzodiazepine prescribing separately. RESULTS: Over 12 months, the alert activated for 1332 patients. Proportions of patients with concurrent prescriptions decreased significantly postalert launch among substance use [adjusted odds ratio (AOR)=0.97; 95% confidence interval (CI)=0.96-0.99; 12-month decrease=25.0%], sleep apnea (AOR=0.97, 95% CI=0.95-0.98, 12-month decrease=38.5%), and suicide-risk (AOR=0.94, 95% CI=0.91-0.98, 12-month decrease=61.5%) cohorts at the alert site. Decreases in coprescribing were significantly different from the comparison site among suicide-risk (AOR=0.92, 95% CI=0.86-0.97) and sleep apnea (AOR=0.98, 95% CI=0.96-1.00) cohorts. Significant decreases in benzodiazepine prescribing trends were observed at the alert site only. CONCLUSIONS: Medication alerts hold promise as a means of reducing opioid and benzodiazepine coprescribing among certain high-risk groups.

Increased Rates of Documented Alcohol Counseling in Primary Care: More Counseling or Just More Documentation?

BACKGROUND: Clinical performance measures often require documentation of patient counseling by healthcare providers. Little is known about whether such measures encourage delivery of counseling or merely its documentation. OBJECTIVE: To assess changes in provider documentation of alcohol counseling and patient report of receiving alcohol counseling in the Veterans Administration (VA) from 2009 to 2012. DESIGN: Retrospective time-series analysis. PARTICIPANTS: A total of 5413 men who screened positive for unhealthy alcohol use at an outpatient visit and responded to a confidential mailed survey regarding alcohol counseling from a VA provider in the prior year. MAIN MEASURES: Rates of provider documentation of alcohol counseling in the electronic health record and patient report of such counseling on the survey were assessed over 4 fiscal years. Annual rates were calculated overall and with patients categorized into four mutually exclusive groups based on their own reports of alcohol counseling (yes/no) and whether alcohol counseling was documented by a provider (yes/no). KEY RESULTS: Provider documentation of alcohol counseling increased 23.6% (95% CI: 17.0, 30.2), from 59.4% to 83.0%, while patient report of alcohol counseling showed no significant change (4.0%, 95% CI: -2.3, 10.3), increasing from 66.1% to 70.1%. An 18.7% (95% CI: 11.7, 25.7) increase in the proportion of patients who reported counseling that was documented by a provider largely reflected a 14.7% decline (95% CI: 8.5, 20.8) in the proportion of patients who reported alcohol counseling that was not documented by a provider. The proportion of patients who did not report counseling but whose providers documented it did not show a significant change (4.9%, 95%CI: 0.0, 9.9). CONCLUSIONS: If patient report is accurate, increased rates of documented alcohol counseling in the VA from 2009 to 2012 predominantly reflected improved documentation of previously undocumented counseling rather than delivery of additional counseling or increased documentation of counseling that did not meaningfully occur.

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.

Influence of a targeted performance measure for brief intervention on gender differences in receipt of brief intervention among patients with unhealthy alcohol use in the Veterans Health Administration.

AIMS: Women are less likely than men to receive brief intervention (BI) for unhealthy alcohol use. In 2007, the U.S. Veterans Health Administration (VA) used a national performance measure to implement BI. Although AUDIT-C scores ≥3 for women and ≥4 for men optimize sensitivity and specificity for identifying unhealthy alcohol use, VA's performance measure required BI only among a targeted subgroup defined by a non-gender-specific score threshold (AUDIT-C ≥5). This may have influenced gender differences in receipt of BI among those optimally eligible for BI. Therefore, we evaluate differences in proportions of women and men offered BI before and after BI implementation. METHODS: National secondary chart review data (7/06-6/10) identified all outpatients with unhealthy alcohol use for whom BI would be indicated (AUDIT-C ≥3 women, ≥4 men). Logistic regression, including a time-by-gender interaction, estimated the prevalence and 95% confidence interval (CI) of BI for women and men pre- and post-implementation. FINDINGS: Among patients optimally eligible for BI (n=51,272, 8206 women and 43,066 men), the prevalence of BI increased more steeply for men than women after implementation (interaction p-value <0.0001). Pre-implementation rates of BI were 21% (95% CI, 18-24) for women and 26% (95% CI, 24-29) for men, and post-implementation rates were 32% (95% CI, 30-34) for women and 47% (95% CI, 45-49) for men. CONCLUSIONS: Healthcare systems implementing BI with performance measures may wish to consider that specifying a single alcohol screening threshold for men and women may increase gender differences in receipt of BI among patients likely to benefit.

Comparison of DSM-IV and DSM-5 criteria for alcohol use disorders in VA primary care patients with frequent heavy drinking enrolled in a trial.

BACKGROUND: Criteria for alcohol use disorders (AUD) in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) were intended to result in a similar prevalence of AUD as DSM-IV. We evaluated the prevalence of AUD using DSM-5 and DSM-IV criteria, and compared characteristics of patients who met criteria for: neither DSM-5 nor DSM-IV AUD, DSM-5 alone, DSM-IV alone, or both, among Veterans Administration (VA) outpatients in the Considering Healthier drinking Options In primary CarE (CHOICE) trial. METHODS: VA primary care patients who reported frequent heavy drinking and enrolled in the CHOICE trial were interviewed at baseline using the DSM-IV Mini International Neuropsychiatric Interview for AUD, as well as questions about socio-demographics, mental health, alcohol craving, and substance use. We compared characteristics across 4 mutually exclusive groups based on DSM-5 and DSM-IV criteria. RESULTS: Of 304 participants, 13.8% met criteria for neither DSM-5 nor DSM-IV AUD; 12.8% met criteria for DSM-5 alone, and 73.0% met criteria for both DSM-IV and DSM-5. Only 1 patient (0.3%) met criteria for DSM-IV AUD alone. Patients meeting both DSM-5 and DSM-IV criteria had more negative drinking consequences, mental health symptoms and self-reported readiness to change compared with those meeting DSM-5 criteria alone or neither DSM-5 nor DSM-IV criteria. CONCLUSIONS: In this sample of primary care patients with frequent heavy drinking, DSM-5 identified 13% more patients with AUD than DSM-IV. This group had a lower mental health symptom burden and less self-reported readiness to change compared to those meeting criteria for both DSM-IV and DSM-5 AUD. Trial Registration ClinicalTrials.gov NCT01400581. 2011 February 17.

Survey of Primary Care and Mental Health Prescribers' Perspectives on Reducing Opioid and Benzodiazepine Co-Prescribing Among Veterans.

Background: Due to the involvement of opioids and benzodiazepines in rising pharmaceutical overdoses, a reduction in coprescribing of these medications is a national priority, particularly among patients with substance use disorders and other high-risk conditions. However, little is known about primary care (PC) and mental health (MH) prescribers' perspectives on these medications and efforts being implemented to reduce coprescribing. Design: An anonymous survey. Setting: One multisite VA health care system. Subjects: Participants were 55 PC and 31 MH prescribers. Methods: Survey development was guided by the Promoting Action on Research Implementation in Health Services (PARIHS) conceptual framework. PC and MH prescribers of opioids or benzodiazepines were invited to complete an anonymous electronic survey. Responses were collapsed to highlight agreement, disagreement, and neutrality and summarized with means and percentages. Results: Over 80% of both prescriber groups reported concern about concurrent use and > 75% strongly agreed with clinical practice guidelines (CPG) that recommend caution in coprescribing among patients with high-risk conditions. More than 40% of both prescriber groups indicated that coprescribing continues because of beliefs that patients appear stable without adverse events and tapering/discontinuation is too difficult. Over 70% of prescribers rated strategies for addressing patients who refuse to discontinue, more time with patients, and identification of high-risk patients as helpful in reducing coprescribing. Conclusion: Despite strong agreement with CPGs, prescribers reported several barriers that contribute to coprescribing of opioids and benzodiazepines and challenge their ability to taper these medications. Multiple interventions are likely needed to reduce opioid and benzodiazepine coprescribing.

Predictive validity of clinical AUDIT-C alcohol screening scores and changes in scores for three objective alcohol-related outcomes in a Veterans Affairs population.

AIMS: To evaluate the association between Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) alcohol screening scores, collected as part of routine clinical care, and three outcomes in the following year (Aim 1), and the association between changes in AUDIT-C risk group at 1-year follow-up and the same outcomes in the subsequent year (Aim 2). DESIGN: Cohort study. SETTING: Twenty-four US Veterans Affairs (VA) healthcare systems (2004-07), before systematic implementation of brief intervention. PARTICIPANTS: A total of 486 115 out-patients with AUDIT-Cs documented in their electronic health records (EHRs) on two occasions ≥ 12 months apart ('baseline' and 'follow-up'). MEASUREMENTS: Independent measures were baseline AUDIT-C scores and change in standard AUDIT-C risk groups (no use, low-risk use and mild, moderate, severe misuse) from baseline to follow-up. Outcome measures were (1) high-density lipoprotein cholesterol (HDL), (2) alcohol-related gastrointestinal hospitalizations ('GI hospitalizations') and (3) physical trauma, each in the years after baseline and follow-up. FINDINGS: Baseline AUDIT-C scores had a positive association with outcomes in the following year. Across AUDIT-C scores 0-12, mean HDL ranged from 41.4 [95% confidence interval (CI) = 41.3-41.5] to 53.5 (95% CI = 51.4-55.6) mg/l, and probabilities of GI hospitalizations from 0.49% (95% CI = 0.48-0.51%) to 1.8% (95% CI = 1.3-2.3%) and trauma from 3.0% (95% CI = 2.95-3.06%) to 6.0% (95% CI = 5.2-6.8%). At follow-up, patients who increased to moderate or severe alcohol misuse had consistently higher mean HDL and probabilities of subsequent GI hospitalizations or trauma compared with those who did not (P-values all < 0.05). For example, among those with baseline low-risk use, in those with persistent low-risk use versus severe misuse at follow-up, the probabilities of subsequent trauma were 2.65% (95% CI = 2.54-2.75%) versus 5.15% (95% CI = 3.86-6.45%), respectively. However, for patients who decreased to lower AUDIT-C risk groups at follow-up, findings were inconsistent across outcomes, with only mean HDL decreasing in most groups that decreased use (P-values all < 0.05). CONCLUSIONS: When AUDIT-C screening is conducted in clinical settings, baseline AUDIT-C scores and score increases to moderate-severe alcohol misuse at follow-up screening appear to have predictive validity for HDL cholesterol, alcohol-related gastrointestinal hospitalizations and physical trauma. Decreasing AUDIT-C scores collected in clinical settings appear to have predictive validity for only HDL.

Local Implementation of Alcohol Screening and Brief Intervention at Five Veterans Health Administration Primary Care Clinics: Perspectives of Clinical and Administrative Staff.

BACKGROUND AND OBJECTIVE: Population-based alcohol screening, followed by brief intervention for patients who screen positive for unhealthy alcohol use, is widely recommended for primary care settings and considered a top prevention priority, but is challenging to implement. However, new policy initiatives in the U.S., including the Affordable Care Act, may help launch widespread implementation. While the nationwide Veterans Health Administration (VA) has achieved high rates of documented alcohol screening and brief intervention, research has identified quality problems with both. We conducted a qualitative key informant study to describe local implementation of alcohol screening and brief intervention from the perspectives of frontline adopters in VA primary care in order to understand the process of implementation and factors underlying quality problems. METHODS: A purposive snowball sampling method was used to identify and recruit key informants from 5 VA primary care clinics in the northwestern U.S. Key informants completed 20-30 minute semi-structured interviews, which were recorded, transcribed, and qualitatively analyzed using template analysis. RESULTS: Key informants (N=32) included: clinical staff (n=14), providers (n=14), and administrative informants (n=4) with varying participation in implementation of and responsibility for alcohol screening and brief intervention at the medical center. Ten inter-related themes (5 a priori and 5 emergent) were identified and grouped into 3 applicable domains of Greenhalgh's conceptual framework for dissemination of innovations, including values of adopters (theme 1), processes of implementation (themes 2 and 3), and post-implementation consequences in care processes (themes 4-10). While key informants believed alcohol use was relevant to health and important to address, the process of implementation (in which no training was provided and electronic clinical reminders "just showed up") did not address critical training and infrastructure needs. Key informants lacked understanding of the goals of screening and brief intervention, believed referral to specialty addictions treatment (as opposed to offering brief intervention) was the only option for following up on a positive screen, reported concern regarding limited availability of treatment resources, and lacked optimism regarding patients' interest in seeking help. CONCLUSIONS: Findings suggest that the local process of implementing alcohol screening and brief intervention may have inadequately addressed important adopter needs and thus may have ultimately undermined, instead of capitalized on, staff and providers' belief in the importance of addressing alcohol use as part of primary care. Additional implementation strategies, such as training or academic detailing, may address some unmet needs and help improve the quality of both screening and brief intervention. However, these strategies may be resource-intensive and insufficient for comprehensively addressing implementation barriers.

Primary Care Management of Alcohol Misuse.

More than one in four American adults consume alcohol in quantities exceeding recommended limits. One in 12 have an alcohol use disorder marked by harmful consequences. Both types of alcohol misuse contribute to acute injury and chronic disease, making alcohol the third largest cause of preventable death in the United States. Alcohol misuse alters the management of common conditions from insomnia to anemia. Primary care providers should screen adult patients to identify the full spectrum of alcohol misuse. A range of effective treatments are available - from brief counselling interventions and mutual help groups to medications and behavioral therapies.

Comparison of provider-documented and patient-reported brief intervention for unhealthy alcohol use in VA outpatients.

BACKGROUND: Performance measures for brief alcohol interventions (BIs) are currently based on provider documentation of BI. However, provider documentation may not be a reliable measure of whether or not patients are offered clinically meaningful BIs. In particular, BI documented with clinical decision support in an electronic medical record (EMR) could appear identical irrespective of the quality of BI provided. We hypothesized that differences in how BI was implemented across health systems could lead to differences in the proportion of documented BI recalled and reported by patients across health systems. METHODS: Male outpatients with unhealthy alcohol use identified by confidential satisfaction surveys (2009-2012) were assessed for whether they reported receiving BI in the past year (patient-reported BI) and whether they had BI documented in the EMR during the same period (documented BI). We evaluated and compared the prevalence of documented BI to patient-reported BI across 21 VA networks to determine whether documented BI had a variable association with patient-reported BI across the networks. RESULTS: Of 9896 eligible male outpatients with unhealthy alcohol use, 59.0% (95% CI 57.4-60.5%) reported BI (50.4-64.9% across networks) and 37.4% (95% CI 36.0-38.9%) had BI documented in the EMR (28.0-44.2% across networks). Overall, 72.9% (95% CI 70.8-75.5%) of patients with documented BI also reported BI. The association between documented BI and patient-reported BI did not vary across VA networks in adjusted logistic regression models. CONCLUSIONS: Performance measures of BI that rely on provider documentation in EMRs appear comparable to patient report for comparing care across VA networks.

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.

Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder.

While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, "partially-controlled clinical data" because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

Double blinding requirement for validity claims in cognitive-behavioral therapy intervention trials for major depressive disorder. Analysis of Hollon S, et al., Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial.

This paper will focus on problems in the inability to double-blind cognitive-behavioral therapy (CBT) studies for major depressive disorder (MDD), and provides an analysis of a recently published study to show how this problem can lead to faulty conclusions. A study by Hollon et al. published in JAMA Psychiatry that compared an antidepressant medication-only arm with a combined CBT/antidepressant arm concluded that the cognitive therapy/antidepressant combination enhanced the recovery rates compared with antidepressant alone, and that the magnitude of this increment nearly doubled for patients with more severe depression. We propose that for subjects with greater severity, there could have been both antidepressant efficacy as well as more hope and expectation in the group who knew they had received combined cognitive therapy/medication, leading to an erroneous conclusion of greater efficacy for the combined group. The large subject number in this study could easily lead to an erroneous finding on statistical testing as a small amount of bias in the subjects adds-up. We opine that the conclusions of unblind CBT outcome research in conditions with subjective endpoints such as MDD need to be given with great caution. The validity of CBT (and its derivatives such as dialectical behavioral therapy) for indications other than MDD is also part of a larger problem in  the inability to blind outcome studies for these interventions.

Leg discomfort: beyond the joints.

Although simple characterization of discomfort as cramps, heaviness, shooting pains, and so forth can be misleading, history and examination are key to accurate diagnosis. Absence of both dorsalis pedis and posterior tibial pulses strongly suggests peripheral arterial disease (PAD), and the presence of either pulse makes PAD less likely. Hydroxymethylglutaryl coenzyme A reductase inhibitors (statins) are a common cause of lower extremity myalgias. Restless legs syndrome causes nocturnal discomfort but must be distinguished from confounding"mimics." Neurologic causes of leg symptoms include lumbar spinal stenosis, radiculopathy, distal symmetric polyneuropathy, and entrapment neuropathy. Many common causes of leg discomfort can be managed conservatively.