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1.  Comparative effectiveness of post-discharge strategies for hospitalized smokers: study protocol for the Helping HAND 2 randomized controlled trial 
BMC Public Health  2015;15:109.
Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study.
A 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6-month follow-up. Other outcome measures include self-reported tobacco abstinence measures, use of medication and counseling after discharge, hospital readmissions, and program cost-effectiveness.
We adapted a proven intervention for hospitalized smokers to enhance its potential for dissemination and are testing it in a multi-site trial. Study enrollment data suggests that the trial achieved the goal of recruiting a broader sample of hospitalized smokers.
Trial registration
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (Helping HAND2) NCT01714323. Registered October 22, 2012.
PMCID: PMC4328622
Smoking cessation; Hospitalization; Pharmacotherapy; Counseling; Interactive voice response; Randomized controlled trial
2.  Predicting Hematoma Expansion After Primary Intracerebral Hemorrhage 
JAMA neurology  2014;71(2):158-164.
Many clinical trials focus on restricting hematoma expansion following acute intracerebral hemorrhage (ICH), but selecting those patients at highest risk of hematoma expansion is challenging.
To develop a prediction score for hematoma expansion in patients with primary ICH.
Prospective cohort study at 2 urban academic medical centers among patients having primary ICH with available baseline and follow-up computed tomography for volumetric analysis (817 patients in the development cohort and 195 patients in the independent validation cohort).
Hematoma expansion was assessed using semiautomated software and was defined as more than 6 mL or 33% growth. Covariates were tested for association with hematoma expansion using univariate and multivariable logistic regression. A 9-point prediction score was derived based on the regression estimates and was subsequently tested in the independent validation cohort.
Hematoma expansion occurred in 156 patients (19.1%). In multivariable analysis, predictors of expansion were as follows: warfarin sodium use, the computed tomography angiography spot sign, and shorter time to computed tomography (≤ 6 vs >6 hours) (P <.001 for all), as well as baseline ICH volume (<30 [reference], 30–60 [P =.03], and >60 [P =.005] mL). The incidence of hematoma expansion steadily increased with higher scores. In the independent validation cohort (n = 195), our prediction score performed well and showed strong association with hematoma expansion (odds ratio, 4.59; P <.001 for a high vs low score). The C statistics for the score were 0.72 for the development cohort and 0.77 for the independent validation cohort.
A 9-point prediction score for hematoma expansion was developed and independently validated. The results open a path for individualized treatment and trial design in ICH aimed at patients at highest risk of hematoma expansion with maximum potential for therapeutic benefit.
PMCID: PMC4131760  PMID: 24366060
3.  Risk of Thromboembolism Following Acute Intracerebral Hemorrhage 
Neurocritical care  2008;10(1):28-34.
Intracerebral hemorrhage (ICH) is the most feared complication of oral anticoagulant therapy (OAT). While anticoagulated patients have increased severity of bleeding following ICH, they may also be at increased risk for thromboembolic events (TEs) given that they had been prescribed OAT prior to their ICH. We hypothesized that TEs are relatively common following ICH, and that anticoagulated patients are at higher risk for these complications.
Consecutive patients with primary ICH presenting to a tertiary care hospital from 1994 to 2006 were prospectively characterized and followed. Hospital records were retrospectively reviewed for clinically relevant inhospital TEs and patients were prospectively followed for 90 day mortality.
For 988 patients of whom 218 (22%) were on OAT at presentation, median hospital length of stay was 7 (IQR 4–13) days and 90-day mortality was 36%. TEs were diagnosed in 71 patients (7.2%) including pulmonary embolism (1.8%), deep venous thrombosis (1.1%), myocardial ischemia (1.6%), and cerebrovascular ischemia (3.0%). Mean time to event was 8.4 ± 7.0 days. Rates of TE were 5% among those with OAT-related ICH and 8% among those with non-OAT ICH (P = 0.2). After multivariable Cox regression, the only independent risk factor for developing a TE was external ventricular drain placement (HR 2.1, 95% CI 1.1–4.1, P = 0.03). TEs had no effect on 90-day mortality (HR 0.7, 95% CI 0.5–1.1, P = 0.1).
The incidence of TEs in an unselected ICH population was 7.2%. Patients with OAT-related ICH were not at increased risk of TEs.
PMCID: PMC4307935  PMID: 18810667
Cerebral hemorrhage; Warfarin; Venous thrombosis; Pulmonary embolism; Brain ischemia; Myocardial ischemia
5.  Strict Smoke-free Home Policies Among Smoking Parents in Pediatric Settings 
Academic pediatrics  2013;13(6):517-523.
To examine strict smoke-free home policies among smoking parents assessed in pediatric offices.
We analyzed baseline parental survey data from 10 control practices in a national trial of pediatric office-based tobacco control interventions (Clinical Effort Against Second-hand Smoke Exposure, CEASE). We used logistic regression models with generalized estimating equations to examine factors associated with strict smoke-free home policies.
Subjects were 952 parents who were current smokers. Just over half (54.3%) reported strict smoke-free home policies. Few reported being asked (19.9%) or advised (17.1%) regarding policies by pediatricians. Factors associated with higher odds of policies were child 5 years or younger (adjusted odds ratio [aOR] 2.43, 95% confidence interval [CI] 1.53, 3.86), nonblack race/ethnicity (aORs 2.17–2.60, 95% CIs 1.25–5.00), non-Medicaid (HMO/private (aOR 1.84, 95% CI 1.31, 2.58); self-pay/other aOR 1.76, 95% CI 1.12, 2.78); well-child versus sick child visit (aOR 1.61, 95% CI 1.11, 2.34), fewer than 10 cigarettes per day (aOR 1.80, 95% CI 1.31, 2.47), no other home smokers (aOR 1.68, 95% CI 1.26, 2.25), only father smoking (aOR 1.73, 95% CI 1.06, 2.83), and strict smoke-free car policy (aOR 3.51, 95% CI 2.19, 5.64).
Nearly half of smoking parents did not have strict smoke-free home policies. Parents were less likely to report policies if they were heavier smokers, black, living with other smokers, or attending a sick child visit; if they did not have a young child or smoke-free car policy; if they had a child on Medicaid; and if anyone other than only the father smoked. Few pediatricians addressed or recommended strict smoke-free home policies in an office visit. The pediatric office encounter represents a currently missed opportunity to intervene regarding smoke-free homes, particularly for high-risk groups.
PMCID: PMC4046861  PMID: 24238677
environmental tobacco smoke; parental smoking; secondhand smoke; smoking
6.  Using Lean-Based Systems Engineering to Increase Capacity in the Emergency Department 
While emergency department (ED) crowding has myriad causes and negative downstream effects, applying systems engineering science and targeting throughput remains a potential solution to increase functional capacity. However, the most effective techniques for broad application in the ED remain unclear. We examined the hypothesis that Lean-based reorganization of Fast Track process flow would improve length of stay (LOS), percent of patients discharged within one hour, and room use, without added expense.
This study was a prospective, controlled, before-and-after analysis of Fast Track process improvements in a Level 1 tertiary care academic medical center with >95,000 annual patient visits. We included all adult patients seen during the study periods of 6/2010–10/2010 and 6/2011–10/2011, and data were collected from an electronic tracking system. We used concurrent patients seen in another care area used as a control group. The intervention consisted of a simple reorganization of patient flow through existing rooms, based in systems engineering science and modeling, including queuing theory, demand-capacity matching, and Lean methodologies. No modifications to staffing or physical space were made. Primary outcomes included LOS of discharged patients, percent of patients discharged within one hour, and time in exam room. We compared LOS and exam room time using Wilcoxon rank sum tests, and chi-square tests for percent of patients discharged within one hour.
Following the intervention, median LOS among discharged patients was reduced by 15 minutes (158 to 143 min, 95%CI 12 to 19 min, p<0.0001). The number of patients discharged in <1 hr increased by 2.8% (from 6.9% to 9.7%, 95%CI 2.1% to 3.5%, p<0.0001), and median exam room time decreased by 34 minutes (90 to 56 min, 95%CI 31 to 38 min, p<0.0001). In comparison, the control group had no change in LOS (265 to 267 min) or proportion of patients discharged in <1 hr (2.9% to 2.9%), and an increase in exam room time (28 to 36 min, p<0.0001).
In this single center trial, a focused Lean-based reorganization of patient flow improved Fast Track ED performance measures and capacity, without added expense. Broad multi-centered application of systems engineering science might further improve ED throughput and capacity.
PMCID: PMC4251218  PMID: 25493117
7.  A Randomized Trial of Temazepam versus Acetazolamide in High Altitude Sleep Disturbance 
High Altitude Medicine & Biology  2013;14(3):234-239.
Tanner, John B., Sarah M.E. Tanner, Ghan Bahadur Thapa, Yuchiao Chang, Kirsty L.M. Watson, Eamon Staunton, Claire Howarth, Buddha Basnyat, and N. Stuart Harris. A randomized trial of temazepam versus acetazolamide in high-altitude sleep disturbance. High Alt Med Biol 14, 234–239, 2013.—This study is the first comparative trial of sleep medications at high altitude. We performed a randomized, double-blind trial of temazepam and acetazolamide at an altitude of 3540 meters. 34 healthy trekkers with self-reports of high-altitude sleep disturbance were randomized to temazepam 7.5 mg or acetazolamide 125 mg taken at bedtime for one night. The primary outcome was sleep quality on a 100 mm visual analog scale. Additional measurements were obtained with actigraphy; pulse oximetry; and questionnaire evaluation of sleep, daytime drowsiness, daytime sleepiness, and acute mountain sickness. Sixteen subjects were randomized to temazepam and 18 to acetazolamide. Sleep quality on the 100 mm visual analog scale was higher for temazepam (59.6, SD 20.1) than acetazolamide (46.2, SD 20.2; p=0.048). Temazepam also demonstrated higher subjective sleep quality on the Groningen Sleep Quality Scale (3.5 vs. 6.8, p=0.009) and sleep depth visual analog scale (60.3 vs. 41.4, p=0.028). The acetazolamide group reported significantly more awakenings to urinate (1.8 vs. 0.5, p=0.007). No difference was found with regards to mean nocturnal oxygen saturation (84.1 vs. 84.4, p=0.57), proportion of the night spent in periodic breathing, relative desaturations, sleep onset latency, awakenings, wake after sleep onset, sleep efficiency, Stanford Sleepiness Scale scores, daytime drowsiness, or change in self-reported Lake Louise Acute Mountain Sickness scores. We conclude that, at current recommended dosing, treatment of high-altitude sleep disturbance with temazepam is associated with increased subjective sleep quality compared to acetazolamide.
PMCID: PMC3785216  PMID: 24028643
acetazolamide; altitude; hypoxia; sleep disorders; temazepam
8.  Measuring decision quality: psychometric evaluation of a new instrument for breast cancer chemotherapy 
Women diagnosed with early stage (I or II) breast cancer face a highly challenging decision – whether or not to undergo adjuvant chemotherapy. We developed a decision quality instrument for chemotherapy for early stage breast cancer and sought to evaluate its performance.
Cross-sectional, mailed survey of recent breast cancer survivors, providers, and healthy controls and a retest survey of survivors. The decision quality instrument includes questions on knowledge and personal goals. It results in a knowledge score and concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, validity, and reliability of the survey instrument were examined.
Responses were received from 352 patients, 89 providers and 35 healthy controls. The decision quality instrument was feasible to implement with few missing data. The knowledge scores had good retest reliability (intraclass correlation coefficient (ICC) =0.75). Knowledge scores discriminated between providers and patients (mean difference 31.1%, 95% CI 26.9, 35.3) and between patients and healthy controls (mean difference 11.2, 95% CI 5.4, 17.1). Most providers reported that the knowledge items covered essential content. Two of the five goal items had a ceiling effect, and one goal had low content validity. The goal items had moderate retest reliability (ICC’s 0.57 to 0.78). In the multivariable model of treatment, none of the patient goals was associated with receipt of chemotherapy. Age and hormone receptor status were the only variables independently associated with chemotherapy. Most patients (77.6%) had treatment concordant with that predicted by the model. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.
The Decision Quality Instrument is a reliable and valid measure of patient knowledge about chemotherapy, but its ability to measure concordance with patient goals is limited. In this sample, patient goals were not associated with treatment, and most patients reported they were not asked their preference, suggesting that goals were not adequately considered in decision making.
PMCID: PMC4150558  PMID: 25142035
Decision; Regret; Breast cancer; Shared decision making; Quality of care; Decision quality; Chemotherapy; Adjuvant therapy
9.  Acute Respiratory Distress Syndrome After Spontaneous Intracerebral Hemorrhage 
Critical care medicine  2013;41(8):1992-2001.
Acute respiratory distress syndrome develops commonly in critically ill patients in response to an injurious stimulus. The prevalence and risk factors for development of acute respiratory distress syndrome after spontaneous intracerebral hemorrhage have not been reported. We sought to determine the prevalence of acute respiratory distress syndrome after intracerebral hemorrhage, characterize risk factors for its development, and assess its impact on patient outcomes.
Retrospective cohort study at two academic centers.
We included consecutive patients presenting from June 1, 2000, to November 1, 2010, with intracerebral hemorrhage requiring mechanical ventilation. We excluded patients with age less than 18 years, intracerebral hemorrhage secondary to trauma, tumor, ischemic stroke, or structural lesion; if they required intubation only during surgery; if they were admitted for comfort measures; or for a history of immunodefciency.
Measurements and Main Results
Data were collected both prospectively as part of an ongoing cohort study and by retrospective chart review. Of 1,665 patients identified by database query, 697 met inclusion criteria. The prevalence of acute respiratory distress syndrome was 27%. In unadjusted analysis, high tidal volume ventilation was associated with an increased risk of acute respiratory distress syndrome (hazard ratio, 1.79 [95% CI, 1.13–2.83]), as were male sex, RBC and plasma transfusion, higher fluid balance, obesity, hypoxemia, acidosis, tobacco use, emergent hematoma evacuation, and vasopressor dependence. In multivariable modeling, high tidal volume ventilation was the strongest risk factor for acute respiratory distress syndrome development (hazard ratio, 1.74 [95% CI, 1.08–2.81]) and for inhospital mortality (hazard ratio, 2.52 [95% CI, 1.46–4.34]).
Development of acute respiratory distress syndrome is common after intubation for intracerebral hemorrhage. Modifiable risk factors, including high tidal volume ventilation, are associated with its development and in-patient mortality.
PMCID: PMC3752686  PMID: 23760151
acute lung injury; hemorrhagic stroke; mechanical ventilation; tidal volume; ventilator-induced lung injury
10.  Are patients making high-quality decisions about breast reconstruction after mastectomy? 
Variation in rates of breast reconstruction after mastectomy has raised concerns about the quality of decisions about reconstruction. We sought to evaluate patient decision making about reconstruction, using a validated measure of knowledge and preferences related to reconstruction.
A cross-sectional survey of early-stage breast cancer survivors from four university medical centers was conducted. The survey included measures of knowledge about specific reconstruction facts, personal goals and concerns, and involvement in decision making. A multivariable linear regression model of characteristics associated with knowledge and a logistic regression model of factors associated with having reconstruction were developed.
84 patients participated (59% response rate). Participants answered 37.9% of knowledge questions correctly. Higher education (beta 15%, p=0.003) and having reconstruction (beta 21%, p<0.0001) were associated with higher knowledge. The goals “use your own tissue to make a breast” (OR 1.53, 95% CI 1.15, 2.05) and “wake up after mastectomy with reconstruction underway” (OR 1.66, 95% CI 1.30, 2.12) were associated with reconstruction. The goal “avoid putting foreign material in your body” was associated with no reconstruction (OR 0.64, 95% CI 0.48, 0.86). Most patients reported they mainly made the decision or made the decision with the doctor equally (93%, 95%CI 85-97%), and that their degree of involvement was about right (85%, 95%CI 75-91%).
Women treated with mastectomy in this study were not well-informed about breast reconstruction. Treatments were associated with patients' goals and concerns, however, and patients were highly involved in their decisions. Knowledge deficits suggest that breast cancer patients would benefit from interventions to support their decision making.
PMCID: PMC4100583  PMID: 21200195
11.  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
12.  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
13.  Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer 
Journal of Clinical Oncology  2012;31(3):380-386.
Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer.
Patients and Methods
We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video.
The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video.
Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative.
PMCID: PMC4090424  PMID: 23233708
14.  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
15.  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
16.  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
17.  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
18.  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
19.  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
20.  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
21.  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
22.  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
23.  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
24.  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
25.  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

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