Michael C. Leo

Tooth-surface-specific Effects of Xylitol: Randomized Trial Results

The Xylitol for Adult Caries Trial was a three-year, double-blind, multi-center, randomized clinical trial that evaluated the effectiveness of xylitol vs. placebo lozenges in the prevention of dental caries in caries-active adults. The purpose of this secondary analysis was to investigate whether xylitol lozenges had a differential effect on cumulative caries increments on different tooth surfaces. Participants (ages 21-80 yrs) with at least one follow-up visit (n = 620) were examined at baseline, 12, 24, and 33 months. Negative binomial and zero-inflated negative binomial regression models were used to estimate incidence rate ratios (IRR) for xylitol’s differential effect on cumulative caries increments on root and coronal surfaces and, among coronal surfaces, on smooth (buccal and lingual), occlusal, and proximal surfaces. Participants in the xylitol arm developed 40% fewer root caries lesions (0.23 D2FS/year) than those in the placebo arm (0.38 D2FS/year; IRR = 0.60; 95% CI [0.44, 0.81]; p < .001). There was no statistically significant difference between xylitol and control participants in the incidence of smooth-surface caries (p = .100), occlusal-surface caries (p = .408), or proximal-surface caries (p = .159). Among these caries-active adults, xylitol appears to have a caries-preventive effect on root surfaces (ClinicalTrials.gov NCT00393055).

Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial

BACKGROUND AND OBJECTIVE: Health care providers have few alternatives for youth depression other than antidepressants. We examined whether brief cognitive behavioral therapy (CBT) is a viable alternative in primary care. METHODS: A total of 212 adolescents aged 12 to 18 with major depression who had recently declined or quickly discontinued new antidepressant treatment were randomized to self-selected treatment as usual (TAU) control condition or TAU plus brief individual CBT. Blinded evaluators followed youth for 2 years. The primary outcome was time to major depression diagnostic recovery. RESULTS: CBT was superior to the control condition on the primary outcome of time to diagnostic recovery from major depression, with number needed to treat from 4 to 10 across follow-up. A similar CBT advantage was found for time to depression diagnosis response, with number needed to treat of 5 to 50 across time points. We observed a significant advantage for CBT on many secondary outcomes over the first year of follow-up but not the second year. Cohen’s d effect sizes for significant continuous measures ranged from 0.28 to 0.44, in the small to medium effect range. Most TAU health care services did not differ across conditions, except for psychiatric hospitalizations, which occurred at a significantly higher rate in the control condition through the first year of follow-up. CONCLUSIONS: Observed results were consistent with recent meta-analyses of CBT for youth depression. The initial year of CBT superiority imparted an important clinical benefit and may reduce the risk of future recurrent depression episodes.

The NextGen Study: patient motivation for participation in genome sequencing for carrier status

While translational genomic sequencing research is increasing, few studies have been limited to healthy individuals; most have focused on patients with a disease or a strong family history of a disorder. The limited studies that have included healthy individuals have focused on the disclosure of medically actionable secondary results, rather than carrier status, to assess reproductive risks. To address this important gap, we conducted the NextGen study, which focuses on carrier status and medically actionable secondary findings in a population of women planning a pregnancy.

Medication-assisted treatment for substance use disorders within a national community health center research network

ABSTRACT Background: The Affordable Care Act increases access to treatment services for people who suffer from substance use disorders (SUDs), including alcohol use disorders (AUDs) and opioid use disorders (OUDs). This increased access to treatment has broad implications for delivering health services and creates a dramatic need for transformation in clinical care, service lines, and collaborative care models. Medication-assisted treatments (MAT) are effective for helping SUD patients reach better outcomes. This article uses electronic health record (EHR) data to examine the prevalence of EHR-documented SUDs, patient characteristics, and patterns of MAT prescribing and screening for patients within the Community Health Applied Research Network (CHARN), a national network of 17 community health centers that facilitates patient-centered outcomes research among underserved populations. Methods: Hierarchical generalized linear models examined patient characteristics, SUD occurrence rates, MAT prescription, and human immunodeficiency virus (HIV) and hepatitis virus C screening for patients with AUDs or OUDs. Results: Among 572,582 CHARN adult patients, 16,947 (3.0%) had a documented AUD diagnosis and 6,080 (1.1%) an OUD diagnosis. Alcohol MAT prescriptions were documented for 547 AUD patients (3.2%) and opioid MAT for 1,764 OUD patients (29.0%). Among OUD patients, opioid MAT was significantly associated with HIV screening (odds ratio [OR] = 1.31, P < .001) in OUD patients, as was alcohol MAT among AUD patients (OR = 1.30, P = .013). Conclusions: These findings suggest that effective opioid and alcohol MAT may be substantially underprescribed among safety-net patients identified as having OUDs or AUDs.

Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults

OBJECTIVES To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. METHODS As part of the Xylitol for Adult Caries Trial (X-ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. RESULTS The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. CONCLUSIONS There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. TRIAL REGISTRATION ClinicalTrials.Gov NCT00393055.

Referring Hospitalized Smokers to Outpatient Quit Services

INTRODUCTION Linking outpatient cessation services to bedside counseling for hospitalized smokers can improve long-run quit rates. Adding an assisted referral (AR) offer to a tobacco treatment specialist consult service fits the team approach to care in U.S. hospitals. DESIGN A two-arm patient-randomized trial tested the effectiveness of adding an AR offer to outpatient smoking-cessation services and interactive voice recognition (AR+IVR) follow-up to a usual care (UC) tobacco-cessation consult for hospitalized smokers. SETTING/PARTICIPANTS Over 24 months (November 2011-November 2013), 898 hospitalized adult smokers interested in quitting smoking were recruited from three large hospitals in the Portland, Oregon, area: an integrated group model HMO (n=622), a community hospital (n=195), and an academic health center (n=81). INTERVENTION Tobacco treatment specialists identified smokers and provided an intensive bedside tobacco use assessment and cessation consultation (UC). AR+IVR recipients also received proactive ARs to available outpatient counseling programs and medications, and linked patients to a tailored IVR telephone follow-up system. MAIN OUTCOME MEASURES The primary outcome was self-reported 30-day abstinence at 6-month follow-up. Secondary outcomes included self-reported and continuous abstinence and biochemically confirmed 7-day abstinence at 6 months. Follow-up was completed in September 2014; data were analyzed in 2015. RESULTS A total of 597 and 301 hospitalized smokers were randomized to AR+IVR and UC, respectively. AR+IVR and UC recipients received 19.3 and 17.0 minutes of bedside counseling (p=0.372), respectively. Most (58%) AR+IVR patients accepted referrals for counseling, 43% accepted medications, and 28% accepted both. Self-reported 30-day abstinence for AR+IVR (17.9%) and UC (17.3%) were not statistically significant (p=0.569). Differences in 7-day, continuous, and biochemically confirmed abstinence by treatment group also were insignificant, overall and adjusting for site. CONCLUSIONS Adding an AR to outpatient counseling and medications did not increase cigarette abstinence at 6 months compared to UC alone.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial

Background Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. Methods/design This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. Discussion This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592

Participatory Research to Advance Colon Cancer Prevention (PROMPT): Study protocol for a pragmatic trial

BACKGROUND Colon cancer is the second leading cause of cancer deaths in the United States. The Participatory Research to Advance Colon Cancer Prevention (PROMPT) study is a collaboration between two research institutions and a federally qualified health center (FQHC). The study seeks to raise colon cancer screening rates using a direct-mail fecal immunochemical testing (FIT) and reminder program in an FQHC serving a predominantly Latino population in California. METHODS PROMPT is a pragmatic trial enrolling 16 clinics. The study will test automated and live prompts (i.e., alerts, reminders) to a direct-mail FIT program in two phases. In Phase I, we tailored and defined intervention components for the pilot using a community-based participatory research approach called boot camp translation. We then plan to conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts, 2) live prompts, and 3) a combination of automated plus live prompts to alert and remind patients to complete screening. In Phase II, the adapted best practice intervention will be spread to additional clinics within the FQHC (estimated population 27,000) and assessed for effectiveness. Patient and staff interviews will be conducted to explore receptivity to the program and identify barriers to implementation. DISCUSSION This pragmatic trial applies innovative approaches to engage diverse stakeholders and will test the effectiveness and spread of a direct-mail plus reminder program. If successful, the program will provide a model for a cost-effective method to raise colon cancer screening rates among Latino patients receiving care in FQHCs. TRIAL REGISTRATION National Clinical Trial (NCT) Identifier NCT03167125.

Implications of American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Guidelines on Statin Underutilization for Prevention of Cardiovascular Disease in Diabetes Mellitus Among Several US Networks of Community Health Centers

Background Little is known about statin underutilization among diabetes mellitus patients cared for in community health centers, which tend to serve socioeconomically disadvantaged populations. Implications of the American College of Cardiology/American Heart Association (ACC/AHA) guidelines on preexisting gaps in statin treatment in this population are unclear. Methods and Results We included 32 440 adults (45% male, 63% nonwhite, 29% uninsured/Medicaid) aged 40 to 75 years with diabetes mellitus who received care within 16 community health center groups in 11 states in the Community Health Applied Research Network during 2013. Statin prescribing was analyzed as a function of concordance with the National Cholesterol Education Program Adult Treatment Panel 2001 and ACC/AHA 2013 guidelines. More patients’ treatments were concordant with the ACC/AHA (52.8%) versus the National Cholesterol Education Program Adult Treatment Panel (36.2%) guideline. Female sex was associated with lower concordance for both (odds ratio [OR] 0.90, CI 0.85‐0.94; and OR 0.84, CI 0.80‐0.88, respectively). Being insured, an Asian/Pacific Islander, or primarily Spanish speaking were associated with greater concordance for both guidelines: 35.5% (11 526/32 440) were concordant with neither guideline, the majority (79.7%) having no statin prescribed; 28.2% (9168/32 440) were concordant with ACC/AHA but not the National Cholesterol Education Program Adult Treatment Panel. 8.7% of these patients had a low‐density lipoprotein cholesterol >160 mg/dL despite having a moderate‐ or high‐intensity statin prescribed. And 11.6% (3772/32 440) were concordant with the National Cholesterol Education Program Adult Treatment Panel but not with ACC/AHA. Most of these patients had a low‐density lipoprotein cholesterol between 70 and 99 mg/dL with no or a low‐intensity statin prescribed. Conclusions Opportunities exist to improve cholesterol management in diabetes mellitus patients in community health centers. Addressing care gaps could improve cardiovascular disease prevention in this high‐risk population.

Recovery challenges faced by bladder cancer survivors after recent cystectomy and urinary diversion.

90 Background: Bladder cancer patients who are treated with cystectomy (bladder removal) and urinary diversion (bladder replacement) experience high rates of complications and hospital readmissions, and have substantial supportive care needs. Patient-reported priorities for improving early-phase survivorship care are lacking. METHODS On the basis of focus groups and in-depth interviews with 32 bladder cancer survivors about post-operative challenges, we developed a structured question listing 16 early survivorship challenges. We asked respondents to indicate which challenges had been difficult to manage at home. The item was part of a survey mailed to members of three Kaiser Permanente regions who had undergone cystectomy and urinary diversion for bladder cancer approximately 6 months previously (N = 197). Eligible patients were identified through health plan databases and chart review. RESULTS The response rate to the survey was 65%. Respondents reported an average of 3 challenges. The most commonly reported challenges pertained to coordination of medical care (69%), such as confusion about follow-up care, problems obtaining medical and ostomy supplies, knowing what complications to look for and who to notify if they occur, receiving home health care, or obtaining prompt medical advice. Other problems were caring for the urinary diversion (53%); dealing with urine leaks and incontinence (49%); problems with balance, vision, and dexterity (32%); difficulty managing emotions (23%); and management of lymphedema (11%) or incisional or parastomal hernias (7%). CONCLUSIONS More than two thirds of bladder cancer survivors who had recently undergone cystectomy and urinary diversion struggled with medical care coordination. Managing self-care, complications, and emotional well-being after this major surgery can be difficult for patients, who must also navigate a variety of supportive services, such as medical follow-up with multiple departments and providers, home health services, and wound or ostomy care. A more formal approach to discharge and better communication among patients and providers will help improve early survivorship care for this group.