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1.  Implementation of a Parental Tobacco Control Intervention in Pediatric Practice 
Pediatrics  2013;132(1):109-117.
To test whether routine pediatric outpatient practice can be transformed to assist parents in quitting smoking.
Cluster RCT of 20 pediatric practices in 16 states that received either CEASE intervention or usual care. The intervention gave practices training and materials to change their care delivery systems to provide evidence-based assistance to parents who smoke. This assistance included motivational messaging; proactive referral to quitlines; and pharmacologic treatment of tobacco dependence. The primary outcome, assessed at an exit interview after an office visit, was provision of meaningful tobacco control assistance, defined as counseling beyond simple advice (discussing various strategies to quit smoking), prescription of medication, or referral to the state quitline, at that office visit.
Among 18 607 parents screened after their child’s office visit between June 2009 and March 2011, 3228 were eligible smokers and 1980 enrolled (999 in 10 intervention practices and 981 in 10 control practices). Practices’ mean rate of delivering meaningful assistance for parental cigarette smoking was 42.5% (range 34%–66%) in the intervention group and 3.5% (range 0%–8%) in the control group (P < .0001). Rates of enrollment in the quitline (10% vs 0%); provision of smoking cessation medication (12% vs 0%); and counseling for smoking cessation (24% vs 2%) were all higher in the intervention group compared with the control group (P < .0001 for each).
A system-level intervention implemented in 20 outpatient pediatric practices led to 12-fold higher rates of delivering tobacco control assistance to parents in the context of the pediatric office visit.
PMCID: PMC3691536  PMID: 23796741
Smoking cessation; tobacco smoke exposure; parental smoking; pediatrics; secondhand smoke
2.  The use of furosemide in critically ill trauma patients: A retrospective review 
Excessive fluid administration in critically ill post-traumatic patients is common and is associated with poorer outcomes. Once resuscitation is complete; however, assisted diuresis with furosemide is not an option commonly exercised. We hypothesize that diuresis with furosemide in hemodynamically stable, critically ill trauma patients is safe and effective in promoting diuresis.
Materials and Methods:
In this retrospective chart review, all injured patients admitted to the trauma ICU between March 2007 and June 2009 were identified. Data collection included demographic data, traumatic mechanism, physiologic data, laboratory data, medications, complications, ventilator days, ICU and hospital length of stay. Statistical analyses using two-sample t tests, Wilcoxon rank sum tests, chi-square tests, paired t-tests, and one-sample signed rank tests were performed.
Of 162 screened patients, 85 were identified as eligible. Twenty-seven patients (31.8%) received furosemide within the first 14 ICU days, and there were no significant differences in age, ISS, gender, blunt mechanism, co-morbid conditions, overall complications, or mortality when compared to patients who did not receive diuresis. Furosemide administration resulted in a median of 45% increased 24 h urine output and a median of 82% less 24 h net fluid gain without any significant change in HR, MAP, CVP, Hct, creatinine, or potassium.
Administration of furosemide in stable, significantly fluid positive critically ill trauma patients results in significantly increased urine output and significantly less net fluid gain with no detrimental effect on hemodynamic parameters or laboratory values.
PMCID: PMC4013742  PMID: 24812452
Diuresis; furosemide; trauma
3.  Healthcare System Effects of Pay-for-performance for Smoking Status Documentation 
To evaluate the impact on smoking status documentation of a payer-sponsored P4P incentive that targeted a minority of an integrated healthcare delivery system’s patients.
Three commercial insurers simultaneously adopted P4P incentives to document smoking status of their members with three chronic diseases. The healthcare system responded by adding a smoking status reminder to all patients’ EHR. We measured change in smoking status documentation before (2008–09) and after (2010–11) P4P implementation by P4P-eligibility.
P4P-eligible patients were compared primarily to a subset of non-P4P-eligible patients who resembled P4P-eligible patients and also to all non-P4P-eligible patients. Multivariate models adjusted for patient and provider characteristics and accounted for provider-level clustering and pre-implementation trends.
Documentation increased from 48% of 207,471 patients before P4P to 71% of 227,574 patients after P4P. Improvement occurred both among P4P-eligible patients, 56% to 83% (AOR, 3.6; 95% CI, 2.9 to 4.5) and the comparable subset of non-P4P-eligible patients, 56% to 80% (AOR, 3.0; 95% CI, 2.3 to 3.9). The difference in improvement between groups was significant (AOR, 1.3; 95% CI, 1.1 to 1.4, p=0.009).
A P4P incentive targeting a minority of a healthcare system’s patients stimulated adoption of a system-wide EHR reminder and improved smoking status documentation overall. Combining a P4P incentive with an EHR reminder might help health care systems improve treatment delivery for smokers and meet Meaningful Use standards for EHRs.
PMCID: PMC3874815  PMID: 23919419
4.  Free air on plain film: Do we need a computed tomography too? 
Standard teaching is that patients with pneumoperitoneum on plain X-ray and clinical signs of abdominal pathology should undergo urgent surgery. It is unknown if abdominal computed tomography (CT) provides additional useful information in this scenario.
The aim of this study is to determine whether or not CT scanning after identification of pneumoperitoneum on plain X-ray changes clinical management or outcomes.
Settings and Design:
Retrospective study carried out over 4 years at a tertiary care academic medical center. All patients in our acute care surgery database with pneumoperitoneum on plain X-ray were included. Patients who underwent subsequent CT scanning (CT group) were compared with patients who did not (non-CT group).
Statistical Analysis Used:
The Wilcoxon rank-sum test, t-test and Fisher's exact test were used as appropriate to compare the groups.
There were 25 patients in the non-CT group and 18 patients in the CT group. There were no differences between the groups at presentation. All patients in the non-CT group underwent surgery, compared with 83% (n = 15) of patients in the CT group (P = 0.066). 16 patients in the non-CT and 11 patients in the CT group presented with peritonitis and all underwent surgery regardless of group. For patients undergoing surgery, there were no differences in outcomes between the groups. After X-ray, patients undergoing CT required 328.0 min to arrive in the operating room compared with 136.0 min in the non-CT group (P = 0.007).
In patients with pneumoperitoneum on X-ray and peritonitis on physical exam, CT delays surgery without providing any measurable benefit.
PMCID: PMC3912647  PMID: 24550622
Acute abdomen; computed tomography scan; gastrointestinal perforation; peritonitis; plain film; pneumoperitoneum
5.  Prolonged Emergency Department Length of Stay is not Associated with Worse Outcomes in Patients with Intracerebral Hemorrhage 
Neurocritical care  2012;17(3):334-342.
Prolonged emergency department length of stay (EDLOS) has been associated with worse patient outcomes, longer inpatient stays, and failure to meet quality measures in several acute medical conditions, but these findings have not been consistently reproduced. We performed this study to explore the hypothesis that longer EDLOS would be associated with worse outcomes in a large cohort of patients presenting with spontaneous intracerebral hemorrhage (ICH).
We performed a secondary analysis of a prospective cohort of consecutive patients with spontaneous ICH who presented to a single academic referral center from February 2005 to October 2009. The primary exposure variable was EDLOS, and our primary outcome was neurologic status at hospital discharge, measured with a modified Rankin scale (mRS). Secondary outcomes were ICU length of stay, total hospital length of stay, and total hospital costs.
Our cohort included 616 visits of which 42 were excluded, leaving 574 patient encounters for analysis. Median age was 75 years (IQR 63–82), median EDLOS 5.1 h (IQR 3.7–7.1) and median discharge mRS 4 (IQR 3–6). Thirty percent of the subjects died in-hospital. Multivariable proportional odds logistic regression, controlling for age, initial Glasgow Coma Scale, initial hematoma volume, ED occupancy at registration, and the need for intubation or surgical intervention, demonstrated no association between EDLOS and outcome. Furthermore, multivariable analysis revealed no association of increased EDLOS with ICU or hospital length of stay or hospital costs.
We found no effect of EDLOS on neurologic outcome or resource utilization for patients presenting with spontaneous ICH.
PMCID: PMC3684176  PMID: 21912953
Emergency medicine; Emergency department crowding; Emergency department length of stay; Intracerebral hemorrhage
6.  Augmenting Communication and Decision Making in the Intensive Care Unit with a Cardiopulmonary Resuscitation Video Decision Support Tool: A Temporal Intervention Study 
Journal of Palliative Medicine  2012;15(12):1382-1387.
Effective communication between intensive care unit (ICU) providers and families is crucial given the complexity of decisions made regarding goals of therapy. Using video images to supplement medical discussions is an innovative process to standardize and improve communication. In this six-month, quasi-experimental, pre-post intervention study we investigated the impact of a cardiopulmonary resuscitation (CPR) video decision support tool upon knowledge about CPR among surrogate decision makers for critically ill adults.
We interviewed surrogate decision makers for patients aged 50 and over, using a structured questionnaire that included a four-question CPR knowledge assessment similar to those used in previous studies. Surrogates in the post-intervention arm viewed a three-minute video decision support tool about CPR before completing the knowledge assessment and completed questions about perceived value of the video.
We recruited 23 surrogates during the first three months (pre-intervention arm) and 27 surrogates during the latter three months of the study (post-intervention arm). Surrogates viewing the video had more knowledge about CPR (p=0.008); average scores were 2.0 (SD 1.1) and 2.9 (SD 1.2) (out of a total of 4) in pre-intervention and post-intervention arms. Surrogates who viewed the video were comfortable with its content (81% very) and 81% would recommend the video. CPR preferences for patients at the time of ICU discharge/death were distributed as follows: pre-intervention: full code 78%, DNR 22%; post-intervention: full code 59%, DNR 41% (p=0.23).
PMCID: PMC3713444  PMID: 23098632
7.  Successful Outcomes of a Clinical Decision Support System in an HIV Practice: A Randomized Controlled Trial 
Annals of internal medicine  2012;157(11):10.7326/0003-4819-157-11-201212040-00003.
Data to support improved patient outcomes from clinical decision support systems (CDSS) are lacking in HIV care.
To conduct a randomized controlled trial testing the efficacy of a CDSS to improve HIV outcomes in an outpatient clinic.
We conducted a randomized controlled trial where half of each provider’s patients were randomized to interactive or static computer alerts ( #NCT00678600).
The study was conducted at the Massachusetts General Hospital HIV Clinic.
Participants were HIV providers and their HIV-infected patients.
Computer alerts were generated for virologic failure (HIV RNA >400 c/mL after HIV RNA ≤400 c/mL), evidence of suboptimal follow-up, and 11 abnormal laboratory tests. Providers received interactive computer alerts, facilitating appointment rescheduling and repeat laboratory testing, for half of their patients and static alerts for the other half.
The primary endpoint was change in CD4 count. Other endpoints included time-to-clinical event, 6-month suboptimal follow-up, and severe laboratory toxicity.
Thirty-three HIV providers followed 1,011 HIV-infected patients. For the intervention arm, the mean CD4 count increase was greater (5.3 versus 3.2 cells/mm3/month; difference = 2.0 cells/mm3/month 95% CI [0.1, 4.0], p=0.040) and the rate of 6-month suboptimal follow-up was lower (20.6 versus 30.1 events per 100 patient-years, p=0.022). Median time-to-next scheduled appointment was shorter in the intervention arm after a suboptimal follow-up alert (1.71 versus 3.48 months; p<0.001) and after a toxicity alert (2.79 versus >6 months for control); p=0.072). Ninety-six percent of providers supported adopting the CDSS as part of standard care.
This was a one-year informatics study conducted at a single hospital sub-specialty clinic.
A CDSS using interactive provider alerts improved CD4 counts and clinic follow-up for HIV-infected patients. Wider implementation of such systems can provide important clinical benefits.
PMCID: PMC3829692  PMID: 23208165
Clinical Outcomes; Disease Management; Clinical Decision Support Systems; Electronic Medical Record; Alerts; HIV
8.  Pediatrician Interventions and Thirdhand Smoke Beliefs of Parents 
Thirdhand smoke is residual tobacco smoke contamination that remains after a cigarette is extinguished. A national study indicates that adults’ belief that thirdhand smoke (THS) harms children is associated with strict household no-smoking policies. The question of whether pediatricians can influence THS beliefs has not been assessed.
To identify prevalence of THS beliefs and associated factors among smoking parents, and the association of pediatrician intervention on parent belief that THS is harmful to their children.
Exit interview data were collected from 1980 parents following a pediatric office visit. Parents' level of agreement or disagreement that THS can harm the health of babies and children was assessed. A multivariate logistic regression model was constructed to identify whether pediatricians’ actions were independently associated with parental belief that THS can harm the health of babies and children. Data were collected from 2009 to 2011, and analyses were conducted in 2012.
Ninety-one percent of parents believed that THS can harm the health of babies and children. Fathers (AOR 0.59 [95% CI=0.42, 0.84]) and parents who smoked >10 cigarettes per day (AOR 0.63 [95% CI=0.45, 0.88]) were less likely to agree with this statement. In contrast, parents who received advice (AOR 1.60 [95% CI=1.04, 2.45]) to have a smokefree home or car or to quit smoking and parents who were referred (AOR 3.42 [95% CI=1.18, 9.94]) to a “quitline” or other cessation program were more likely to agree that THS can be harmful.
Fathers and heavier smokers were less likely to believe that THS is harmful. However, pediatricians’ actions to encourage smoking parents to quit or adopt smokefree home or car policies were associated with parental beliefs that THS harms children.
PMCID: PMC3486922  PMID: 23079177
9.  Population-based breast cancer screening in a primary care network 
To assess up to 3-year follow-up of a health information technology system that facilitated population-based breast cancer screening.
Study Design
Cohort study with 2-year follow-up after completing a 1-year cluster randomized trial.
Women 42-69 years old receiving care within a 12-practice primary care network. The trial tested an integrated, non-visit-based population management informatics system that: 1) identified women overdue for mammograms, 2) connected them to primary care providers using a Web-based tool, 3) created automatically-generated outreach letters for patients specified by providers, 4) monitored for subsequent mammography scheduling and completion, and 5) provided practice delegates a list of women remaining unscreened for reminder phone calls. All practices also provided visit-based cancer screening reminders. Eligible women overdue for a mammogram during a one-year study period included those overdue at study start (prevalent cohort) or becoming overdue during follow-up (incident cohort). The main outcome measure was mammography completion rates over three years.
Among 32,688 eligible women, 9,795 (30%) were overdue for screening including 4,487 in intervention and 5,308 in control practices. Intervention patients were somewhat younger, more likely to be non-Hispanic white, and have health insurance compared to control patients. Among patients in the prevalent cohort (n=6,697), adjusted completion rates were significantly higher among intervention compared to control patients after 3 years (51.7% vs. 45.8%, p=0.002). For patients in the incident cohort (n=3,098), adjusted completion rates after 2 years were 53.8% vs. 48.7%, p=0.052, respectively.
Population-based informatics systems can enable sustained increases in mammography screening rates beyond that seen with office-based visit reminders.
PMCID: PMC3766952  PMID: 23286611
population management; cancer screening; health information technology; primary care
10.  Augmenting Advance Care Planning in Poor Prognosis Cancer with a Video Decision Aid: A Pre-Post Study 
Cancer  2012;118(17):4331-4338.
We tested whether an educational video on the goals of care in advanced cancer (life-prolonging, basic or comfort care) can help patients understand these goals and impact preferences for resuscitation.
Survey of 80 advanced cancer patients before and after viewing the video. Outcomes included changes in goals-of-care preference and knowledge, and consistency of preferences with code status.
Before viewing the video, 10 patients (13%) preferred life-prolonging care; 24 (30%) basic care; and 29 (36%) comfort care; 17 (21%) were unsure. Preferences did not change after the video: 9 (11%) chose life-prolonging care; 28 (35%) basic care; 29 (36%) comfort care; and, 14 (18%) were unsure (p=0.28). Compared to baseline, after the video presentation more patients did not want CPR (71 vs 61%, p=0.03) or ventilation (79 vs 67%, p=0.008). Knowledge about goals of care and likelihood of resuscitation increased post-video (p<.001). Of the patients who did not want CPR or ventilation after the video augmentation, only 4 (5%) had a documented DNR order in the medical record (kappa statistic −0.01; 95% CI −0.06 – 0.04). Acceptability of the video was high.
Patients with advanced cancer did not change care preferences after viewing the video, but fewer wanted CPR or ventilation. Documented code status was inconsistent with patient preferences. Patients were more knowledgeable after the video, found the video acceptable, and would recommend it to others. Video may enable visualization of “goals of care,” enriching patient understanding of worsening health states and better informing decision-making.
PMCID: PMC3359413  PMID: 22252775
Decision-Making; video decision aids; end-of-life decision-making; advanced cancer; advance care planning; code status; resuscitation; preferences
11.  Photoimmunotherapy and irradiance modulation reduce chemotherapy cycles and toxicity in a murine model for ovarian carcinomatosis: perspective and results 
Israel journal of chemistry  2012;52(8-9):776-787.
Significant toxicities from multiple cycles of chemotherapy often cause delays or early termination of treatment, leading to poor outcomes in ovarian cancer patients. Complementary modalities that potentiate the efficacy of traditional agents with fewer cycles and less toxicity are needed. Photodynamic therapy is a mechanistically-distinct modality that synergizes with chemo and biologic agents. A combination regimen with a clinically relevant chemotherapy cocktail (cisplatin + paclitaxel) and anti-EGFR targeted photoimmunotherapy (PIT) is evaluated in a murine model for ovarian carcinomatosis. Mice received either 1 or 2 chemotherapy cycles followed by PIT with a chlorine6-Erbitux photoimmunoconjugate and 25 J/cm2 light. PIT + 1 cycle of chemotherapy significantly reduced tumor burden, comparable to multiple chemotherapy cycles. Relative to 1 cycle of chemotherapy, the addition of PIT did not cause significant mouse weight loss, whereas 2 cycles of chemotherapy led to a significant reduction in weight. Irradiance-dependence on PIT efficacy was a function of the conjugation chemistry, providing an additional variable for optimization of PIT outcome.
PMCID: PMC3634612  PMID: 23626376
12.  Limited English Proficient Patients and Time Spent in Therapeutic Range in a Warfarin Anticoagulation Clinic 
While anticoagulation clinics have been shown to deliver tailored, high‐quality care to patients receiving warfarin therapy, communication barriers with limited English proficient (LEP) patients may lead to disparities in anticoagulation outcomes.
Methods and Results
We analyzed data on 3770 patients receiving care from the Massachusetts General Hospital Anticoagulation Management Service (AMS) from 2009 to 2010. This included data on international normalized ratio (INR) tests and patient characteristics, including language and whether AMS used a surrogate for primary communication. We calculated percent time in therapeutic range (TTR for INR between 2.0 and 3.0) and time in danger range (TDR for INR <1.8 or >3.5) using the standard Rosendaal interpolation method. There were 241 LEP patients; LEP patients, compared with non‐LEP patients, had a higher number of comorbidities (3.2 versus 2.9 comorbidities, P=0.004), were more frequently uninsured (17.0% versus 4.3%, P<0.001), and less educated (47.7% versus 6.0% ≤high school education, P<0.001). LEP patients compared with non‐LEP patients spent less TTR (71.6% versus 74.0%, P=0.007) and more TDR (12.9% versus 11.3%, P=0.018). In adjusted analyses, LEP patients had lower TTR as compared with non‐LEP patients (OR 1.5, 95% CI [1.1, 2.2]). LEP patients who used a communication surrogate spent less TTR and more TDR.
Even within a large anticoagulation clinic with a high average TTR, a small but significant decrease in TTR was observed for LEP patients compared with English speakers. Future studies are warranted to explore how the use of professional interpreters impact TTR for LEP patients.
PMCID: PMC3828815  PMID: 23832325
adverse drug events; limited English proficiency; outcomes research; quality of care; warfarin
13.  Diabetes Differentially Affects Depression and Self-Rated Health by Age in the U.S. 
Diabetes Care  2012;35(7):1575-1577.
To determine whether the relationship between age and physical and mental health varies by diabetes status in older U.S. adults.
Using data from the National Social Life, Health, and Aging Project, a national sample of 3,005 adults aged 57–85 years, we tested the significance of the interaction between age and diabetes in association with health states.
Respondents with diabetes in the youngest age cohort had more medical conditions than those without diabetes, a difference that narrowed with age (P for interaction <0.01). The youngest cohort with diabetes had a higher rate of depression compared to those without diabetes (14 vs. 8%). Depression declined with age and did not differ by diabetes status in the oldest respondents (P = 0.01 for age-diabetes interaction).
Diabetes differentially affects self-rated overall health and depression by age, with convergence in the oldest age-group with and without diabetes.
PMCID: PMC3379579  PMID: 22611066
14.  30-day Mortality after Ischemic Stroke and Intracranial Hemorrhage in Patients with Atrial Fibrillation On and Off Anticoagulants 
Prescribing warfarin for atrial fibrillation depends in large part on the expected reduction in ischemic stroke risk versus the expected increased risk of intracranial hemorrhage (ICH). However, the anticoagulation decision also depends on the relative severity of such events. We assessed the impact of anticoagulation on 30-day mortality from ischemic stroke vs. ICH in a large community-based cohort of patients with atrial fibrillation.
We followed 13,559 patients with atrial fibrillation enrolled in an integrated healthcare delivery system for a median 6 years. Incident ischemic strokes and ICHs were identified from computerized databases and validated through medical record review. The association of warfarin and international normalized ratio (INR) at presentation with 30-day mortality was modeled using multivariable logistic regression, adjusting for clinical factors.
We identified 1025 incident ischemic strokes and 299 ICHs during follow-up. Compared with no antithrombotic therapy, warfarin was associated with reduced Rankin score and lower 30-day mortality from ischemic stroke (adjusted odds ratio and 95% confidence interval [OR] = 0.64 [0.45, 0.91]), but a higher mortality from ICH (OR = 1.62 [0.88, 2.98]). Therapeutic INRs (2-3) were associated with an especially low ischemic stroke mortality (OR = 0.38 [0.20, 0.70]) while INRs > 3 increased the odds of dying of ICH by 2.66 fold (95% confidence interval: 1.21, 5.86).
Warfarin reduces 30-day mortality from ischemic stroke, but increases ICH-related mortality. Both effects on event severity as well as on event rates need to be incorporated into rational decision-making about anticoagulants for atrial fibrillation.
PMCID: PMC3383879  PMID: 22539546
Acute stroke; Intracranial hemorrhage; Anticoagulants; Warfarin; Atrial fibrillation
15.  A Randomized Controlled Trial of a Goals-of-Care Video for Elderly Patients Admitted to Skilled Nursing Facilities 
Journal of Palliative Medicine  2012;15(7):805-811.
To determine the impact of a video on preferences for the primary goal of care.
Design, subjects, and intervention
Consecutive subjects 65 years of age or older (n=101) admitted to two skilled nursing facilities (SNFs) were randomized to a verbal narrative (control) or a video (intervention) describing goals-of-care options. Options included: life-prolonging (i.e., cardiopulmonary resuscitation), limited (i.e., hospitalization but no cardiopulmonary resuscitation), or comfort care (i.e., symptom relief).
Main measures
Primary outcome was patients' preferences for comfort versus other options. Concordance of preferences with documentation in the medical record was also examined.
Fifty-one subjects were randomized to the verbal arm and 50 to the video arm. In the verbal arm, preferences were: comfort, n=29 (57%); limited, n=4 (8%); life-prolonging, n=17 (33%); and uncertain, n=1 (2%). In the video arm, preferences were: comfort, n=40 (80%); limited, n=4 (8%); and life-prolonging, n=6 (12%). Randomization to the video was associated with greater likelihood of opting for comfort (unadjusted rate ratio, 1.4; 95% confidence interval [CI], 1.1–1.9, p=0.02). Among subjects in the verbal arm who chose comfort, 29% had a do-not-resuscitate (DNR) order (κ statistic 0.18; 95% CI–0.02 to 0.37); 33% of subjects in the video arm choosing comfort had a DNR order (κ statistic 0.06; 95% CI–0.09 to 0.22).
Subjects admitted to SNFs who viewed a video were more likely than those exposed to a verbal narrative to opt for comfort. Concordance between a preference for comfort and a DNR order was low. These findings suggest a need to improve ascertainment of patients' preferences.
Trial Registration: Identifier: NCT01233973.
PMCID: PMC3387760  PMID: 22559905
16.  A New Risk Scheme to Predict Ischemic Stroke and Other Thromboembolism in Atrial Fibrillation: The ATRIA Study Stroke Risk Score 
More accurate and reliable stroke risk prediction tools are needed to optimize anticoagulation decision making in patients with atrial fibrillation (AF). We developed a new AF stroke prediction model using the original Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) AF cohort and externally validated the score in a separate, contemporary, community‐based inception AF cohort, ATRIA–Cardiovascular Research Network (CVRN) cohort.
Methods and Results
The derivation ATRIA cohort consisted of 10 927 patients with nonvalvular AF contributing 32 609 person‐years off warfarin and 685 thromboembolic events (TEs). The external validation ATRIA‐CVRN cohort included 25 306 AF patients contributing 26 263 person‐years off warfarin and 496 TEs. Cox models identified 8 variables, age, prior stroke, female sex, diabetes mellitus, heart failure, hypertension, proteinuria, and eGFR<45 mL/min per 1.73 m2 or end‐stage renal disease, plus an age×prior stroke interaction term for the final model. Point scores were assigned proportional to model coefficients. The c‐index in the ATRIA cohort was 0.73 (95% CI, 0.71 to 0.75), increasing to 0.76 (95% CI, 0.74 to 0.79) when only severe events were considered. In the ATRIA‐CVRN, c‐indexes were 0.70 (95% CI, 0.67 to 0.72) and 0.75 (95% CI, 0.72 to 0.78) for all events and severe events, respectively. The C‐index was greater and net reclassification improvement positive comparing the ATRIA score with the CHADS2 or CHA2DS2‐VASc scores.
The ATRIA stroke risk score performed better than existing risk scores, was validated successfully, and showed improvement in predicting severe events, which is of greatest concern. The ATRIA score should improve the antithrombotic decision for patients with AF and should provide a secure foundation for the addition of biomarkers in future prognostic models.
PMCID: PMC3698792  PMID: 23782923
anticoagulants; atrial fibrillation; risk score; stroke
17.  Parent smoker role conflict and planning to quit smoking: a cross-sectional study 
BMC Public Health  2013;13:164.
Role conflict can motivate behavior change. No prior studies have explored the association between parent/smoker role conflict and readiness to quit. The objective of the study is to assess the association of a measure of parent/smoker role conflict with other parent and child characteristics and to test the hypothesis that parent/smoker role conflict is associated with a parent’s intention to quit smoking in the next 30 days. As part of a cluster randomized controlled trial to address parental smoking (Clinical Effort Against Secondhand Smoke Exposure—CEASE), research assistants completed exit interviews with 1980 parents whose children had been seen in 20 Pediatric Research in Office Settings (PROS) practices and asked a novel identity-conflict question about “how strongly you agree or disagree” with the statement, “My being a smoker gets in the way of my being a parent.” Response choices were dichotomized as “Strongly Agree” or “Agree” versus “Disagree” or “Strongly Disagree” for the analysis. Parents were also asked whether they were “seriously planning to quit smoking in 30 days.” Chi-square and logistic regression were performed to assess the association between role conflict and other parent/children characteristics. A similar strategy was used to determine whether role conflict was independently associated with intention to quit in the next 30 days.
As part of a RTC in 20 pediatric practices, exit interviews were held with smoking parents after their child’s exam. Parents who smoked were asked questions about smoking behavior, smoke-free home and car rules, and role conflict. Role conflict was assessed with the question, “Please tell me how strongly you agree or disagree with the statement: ‘My being a smoker gets in the way of my being a parent.’ (Answer choices were: “Strongly agree, Agree, Disagree, Strongly Disagree.”)
Of 1980 eligible smokers identified, 1935 (97%) responded to the role-conflict question, and of those, 563 (29%) reported experiencing conflict. Factors that were significantly associated with parent/smoker role conflict in the multivariable model included: being non-Hispanic white, allowing home smoking, the child being seen that day for a sick visit, parents receiving any assistance for their smoking, and planning to quit in the next 30 days. In a separate multivariable logistic regression model, parent/smoker role conflict was independently associated with intention to quit in the next 30 days [AOR 2.25 (95% CI 1.80-2.18)].
This study demonstrated an association between parent/smoker role conflict and readiness to quit. Interventions that increase parent/smoker role conflict might act to increase readiness to quit among parents who smoke.
Trial registration
Clinical trial registration number: NCT00664261.
PMCID: PMC3600049  PMID: 23433098
Parent smoker identity; Parent smoker role conflict; Tobacco smoke exposure; Readiness to quit; Stages of change; Tobacco control; Pediatrics; Smoking cessation; Parent child dyad
18.  Age and the Risk of Warfarin-Associated Hemorrhage: The Anticoagulation and Risk Factors In Atrial Fibrillation Study 
To assess whether older age is independently associated with hemorrhage risk in patients with atrial fibrillation, whether or not they are taking warfarin therapy.
Cohort study.
Integrated healthcare delivery system.
Thirteen thousand five hundred fifty-nine adults with nonvalvular atrial fibrillation.
Patient data were collected from automated clinical and administrative databases using previously validated search algorithms. Medical charts were reviewed from patients hospitalized were for major hemorrhage (intracranial, fatal, requiring ≥2 units of transfused blood, or involving a critical anatomic site). Age was categorized into four categories (<60, 60–69, 70–79, and ≥80), and multivariable Poisson regression was used to assess whether major hemorrhage rates increased with age, stratified by warfarin use and adjusted for other clinical risk factors for hemorrhage.
A total of 170 major hemorrhages were identified during 15,300 person-years of warfarin therapy and 162 major hemorrhages during 15,530 person-years off warfarin therapy. Hemorrhage rates rose with older age, with an average increase in hemorrhage rate of 1.2 (95% confidence interval (CI) 1.0–1.4) per older age category in patients taking warfarin and 1.5 (95% CI=1.3–1.8) in those not taking warfarin. Intracranial hemorrhage rates were significantly higher in those aged 80 and older (adjusted rate ratio=1.8, 95% CI=1.1–3.1 for those taking warfarin, adjusted rate ratio=4.7, 95% CI=2.4–9.2 for those not taking warfarin) than in those younger than 80.
Older age increases the risk of major hemorrhage, particularly intracranial hemorrhage, in patients with atrial fibrillation, whether or not they are taking warfarin. Hemorrhage rates were generally comparable with those reported in previous randomized trials, indicating that carefully monitored warfarin therapy can be used with reasonable safety in older patients.
PMCID: PMC3534958  PMID: 16913990
aging; anticoagulation; hemorrhage; atrial fibrillation
19.  Comparison of Risk Stratification Schemes to Predict Thromboembolism in People With Nonvalvular Atrial Fibrillation 
We assessed 5 risk stratification schemes for their ability to predict atrial fibrillation (AF)–related thromboembolism in a large community-based cohort.
Risk schemes can help target anticoagulant therapy for patients at highest risk for AF–related thromboembolism. We tested the predictive ability of 5 risk schemes: the Atrial Fibrillation Investigators, Stroke Prevention in Atrial Fibrillation, CHADS2 (Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, and prior Stroke or transient ischemic attack) index, Framingham score, and the 7th American College of Chest Physicians Guidelines.
We followed a cohort of 13,559 adults with AF for a median of 6.0 years. Among non-warfarin users, we identified incident thromboembolism (ischemic stroke or peripheral embolism) and risk factors from clinical databases. Each scheme was divided into low, intermediate, and high predicted risk categories and applied to the cohort. Annualized thromboembolism rates and c-statistics (to assess discrimination) were calculated for each risk scheme.
We identified 685 validated thromboembolic events that occurred during 32,721 person-years off warfarin therapy. The risk schemes had only fair discriminating ability, with c-statistics ranging from 0.56 to 0.62. The proportion of patients assigned to individual risk categories varied widely across the schemes. The proportion categorized as low risk ranged from 11.7% to 37.1% across schemes, and the proportion considered high risk ranged from 16.4% to 80.4%.
Current risk schemes have comparable, but only limited, overall ability to predict thromboembolism in persons with AF. Recommendations for antithrombotic therapy may vary widely depending on which scheme is applied for individual patients. Better risk stratification is crucially needed to improve selection of AF patients for anticoagulant therapy.
PMCID: PMC3534960  PMID: 18294564
20.  Death and Disability from Warfarin-Associated Intracranial and Extracranial Hemorrhages 
The American journal of medicine  2007;120(8):700-705.
Little is known about the outcomes of patients who have hemorrhagic complications while receiving warfarin therapy. We examined the rates of death and disability resulting from warfarin-associated intracranial and extracranial hemorrhages in a large cohort of patients with atrial fibrillation.
We assembled a cohort of 13,559 adults with nonvalvular atrial fibrillation and identified patients hospitalized for warfarin-associated intracranial and major extracranial hemorrhage. Data on functional disability at discharge and 30-day mortality were obtained from a review of medical charts and state death certificates. The relative odds of 30-day mortality by hemorrhage type were calculated using multivariable logistic regression.
We identified 72 intracranial and 98 major extracranial hemorrhages occurring in more than 15,300 person-years of warfarin exposure. At hospital discharge, 76% of patients with intracranial hemorrhage had severe disability or died, compared with only 3% of those with major extracranial hemorrhage. Of the 40 deaths from warfarin-associated hemorrhage that occurred within 30 days, 35 (88%) were from intracranial hemorrhage. Compared with extracranial hemorrhages, intracranial events were strongly associated with 30-day mortality (odds ratio 20.8 [95% confidence interval, 6.0–72]) even after adjusting for age, sex, anticoagulation intensity on admission, and other coexisting illnesses.
Among anticoagulated patients with atrial fibrillation, intracranial hemorrhages caused approximately 90% of the deaths from warfarin-associated hemorrhage and the majority of disability among survivors. When considering anticoagulation, patients and clinicians need to weigh the risk of intracranial hemorrhage far more than the risk of all major hemorrhages.
PMCID: PMC3534961  PMID: 17679129
Atrial fibrillation; Death; Disability; Hemorrhage; Intracranial hemorrhage; warfarin
21.  Decision Making about Surgery for Early Stage Breast Cancer 
Practice variation in breast cancer surgery has raised concerns about the quality of treatment decisions. We sought to evaluate the quality of decisions about surgery for early stage breast cancer by measuring patient knowledge, concordance between goals and treatments, and involvement in decisions.
Study Design
A mailed survey of Stage I/II breast cancer survivors was conducted at four sites. The Decision Quality Instrument measured knowledge, goals, and involvement in decisions. A multivariable logistic regression model of treatment was developed. The model-predicted probability of mastectomy was compared to treatment received for each patient. Concordance was defined as having mastectomy and predicted probability >=0.5 or partial mastectomy and predicted probability <0.5. Frequency of discussion about partial mastectomy was compared to discussion about mastectomy using chi-squared tests.
440 patients participated (59% response rate). Mean overall knowledge was 52.7%. 45.9% knew that local recurrence risk is higher after breast conservation. 55.7% knew that survival is equivalent for the two options. Most participants (89.0%) had treatment concordant with their goals. Participants preferring mastectomy had lower concordance (80.5%) than those preferring partial mastectomy (92.6%, p=0.001). Participants reported more frequent discussion of partial mastectomy and its advantages than of mastectomy. 48.6% reported being asked their preference.
Breast cancer survivors had major knowledge deficits, and those preferring mastectomy were less likely to have treatment concordant with goals. Patients perceived that discussions focused on partial mastectomy, and many were not asked their preference. Improvements in the quality of decisions about breast cancer surgery are needed.
PMCID: PMC3256735  PMID: 22056355
22.  Gender Differences in the Risk of Ischemic Stroke and Peripheral Embolism in Atrial Fibrillation 
Circulation  2005;112(12):1687-1691.
Previous studies provide conflicting results about whether women are at higher risk than men for thromboembolism in the setting of atrial fibrillation (AF). We examined data from a large contemporary cohort of AF patients to address this question.
Methods and Results
We prospectively studied 13 559 adults with AF and recorded data on patients’ clinical characteristics and the occurrence of incident hospitalizations for ischemic stroke, peripheral embolism, and major hemorrhagic events through searching validated computerized databases and medical record review. We compared event rates by patient sex using multivariable log-linear regression, adjusting for clinical risk factors for stroke, and stratifying by warfarin use. We identified 394 ischemic stroke and peripheral embolic events during 15 494 person-years of follow-up off warfarin. After multivariable analysis, women had higher annual rates of thromboembolism off warfarin than did men (3.5% versus 1.8%; adjusted rate ratio [RR], 1.6; 95% CI, 1.3 to 1.9). There was no significant difference by sex in 30-day mortality after thromboembolism (23% for both). Warfarin use was associated with significantly lower adjusted thromboembolism rates for both women and men (RR, 0.4; 95% CI, 0.3 to 0.5; and RR, 0.6; 95% CI, 0.5 to 0.8, respectively), with similar annual rates of major hemorrhage (1.0% and 1.1%, respectively).
Women are at higher risk than men for AF-related thromboembolism off warfarin. Warfarin therapy appears be as effective in women, if not more so, than in men, with similar rates of major hemorrhage. Female sex is an independent risk factor for thromboembolism and should influence the decision to use anticoagulant therapy in persons with AF.
PMCID: PMC3522521  PMID: 16157766
anticoagulants; atrial fibrillation; risk factors; stroke; women
23.  Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial 
Trials  2012;13:124.
A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care.
A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit.
This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs.
Trial registration
United States Clinical Trials Registry NCT01177176.
PMCID: PMC3487923  PMID: 22852832
Smoking cessation; Hospitalization; Pharmacotherapy; Counseling; Randomized clinical trial; Interactive voice response
24.  A New Risk Scheme to Predict Warfarin-Associated Hemorrhage: The AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study 
To develop a risk stratification score to predict warfarin-associated hemorrhage
Optimal decision-making regarding warfarin use for atrial fibrillation requires estimation of hemorrhage risk.
We followed 9,186 patients with atrial fibrillation contributing 32,888 person-years of follow-up on warfarin, obtaining data from clinical databases and validating hemorrhage events using medical record review. We used Cox regression models to develop a hemorrhage risk stratification score, selecting candidate variables using bootstrapping approaches. The final model was internally validated via split-sample testing and compared to six published hemorrhage risk schemes.
We observed 461 first major hemorrhages during follow-up (1.4% annually). Five independent variables were included in the final model and weighted by regression coefficients: anemia (3 points), severe renal disease (e.g., glomerular filtration rate < 30 ml/min or dialysis-dependent, 3 points), age ≥ 75 years (2 points), prior bleeding (1 point), and hypertension (1 point). Major hemorrhage rates ranged from 0.4% (0 points) to 17.3% per year (10 points). Collapsed into a 3-category risk score, major hemorrhage rates were 0.8% in the low risk group (0-3 points), 2.6% in intermediate risk (4 points), and 5.8% in high risk (5-10 points). The c-index for the continuous risk score was 0.74 and 0.69 for the 3-category score, higher than in the other risk schemes. There was net reclassification improvement versus all six comparators (from 27% to 56%).
A simple 5-variable risk score was effective in quantifying the risk of warfarin-associated hemorrhage in a large community-based cohort of patients with atrial fibrillation.
PMCID: PMC3175766  PMID: 21757117
anticoagulants; atrial fibrillation; hemorrhage; risk prediction; warfarin
25.  Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery 
The purpose of this paper is to examine the acceptability, feasibility, reliability and validity of a new decision quality instrument that assesses the extent to which patients are informed and receive treatments that match their goals.
Cross-sectional mail survey of recent breast cancer survivors, providers and healthy controls and a retest survey of survivors. The decision quality instrument includes knowledge questions and a set of goals, and results in two scores: a breast cancer surgery knowledge score and a concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, discriminant validity, content validity, predictive validity and retest reliability of the survey instrument were examined.
We had responses from 440 eligible patients, 88 providers and 35 healthy controls. The decision quality instrument was feasible to implement in this study, with low missing data. The knowledge score had good retest reliability (intraclass correlation coefficient = 0.70) and discriminated between providers and patients (mean difference 35%, p < 0.001). The majority of providers felt that the knowledge items covered content that was essential for the decision. Five of the 6 treatment goals met targets for content validity. The five goals had moderate to strong retest reliability (0.64 to 0.87). The concordance score was 89%, indicating that a majority had treatments concordant with that predicted by their goals. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.
The decision quality instrument met the criteria of feasibility, reliability, discriminant and content validity in this sample. Additional research to examine performance of the instrument in prospective studies and more diverse populations is needed.
PMCID: PMC3411423  PMID: 22681763

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