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OBJECTIVES The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts. DESIGN Pragmatic cluster randomized trial. SETTING A total of 86 primary care practices within 10 US healthcare systems. PARTICIPANTS A total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries. MEASUREMENTS Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months. RESULTS Over a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months. CONCLUSION Completion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.

BACKGROUND. Endobronchial ultrasound (EBUS) transbronchial needle aspiration (TBNA) has a high diagnostic yield when evaluating mediastinal and hilar lymphadenopathy (LAD). Having previously demonstrated the safety of EBUS-guided cautery-assisted transbronchial nodal forceps biopsy (ca-TBFB), we report disease-specific improvements in diagnostic yield and tissue acquisition when supplementing the EBUS-TBNA–based standard ofcare (SOC) with ca-TBFB. METHODS. We retrospectively reviewed 213 patients who sequentially underwent SOC and ca-TBFB during the same procedure. We determined 3 clinical scenarios of interest based on preprocedural imaging: isolated mediastinal/hilar LAD, LAD associated with a nodule or mass suspicious for malignancy, and LAD associated with parenchymal findings suggestive of sarcoidosis. Using validated methods, we assessed diagnostic yield on a per-patient basis and specimen quality on a per-node basis on the 136 patients meeting diagnostic criteria. RESULTS. Administration of disease-specific SOC with ca-TBFB yielded gains that varied by diagnosis. Diagnostic yields of SOC and its supplementation with ca-TBFB were 91.8% and 93.4% (P = .50) of the 61 patients diagnosed with solid-organ malignancy, 62.7% and 94.9% (P < .001) of the 59 patients diagnosed with sarcoidosis, and 62.5% and 93.8% (P = .042) of the 16 patients diagnosed with lymphoma, the. For each disease process, specimens obtained with ca-TBFB exhibited statistically higher quality. CONCLUSIONS. We suggest that relative to SOC, ca-TBFB improves diagnostic yield for sarcoidosis and lymphoma while providing uniformly better tissue quality and cellularity. We propose a protocol for use of this innovative technique.

Author(s): Jennings, Lee A; Araujo, Katy LB; Meng, Can; Peduzzi, Peter; Charpentier, Peter; Reuben, David B | Abstract: BackgroundBecause of the COVID-19 pandemic, the ongoing D-CARE pragmatic trial of two models of dementia care management needed to transition to all data collection by telephone.MethodsFor the first 1069 D-CARE participants, we determined the feasibility of administering a short 3-item version of the Montreal Cognitive Assessment (MoCA) to persons with dementia by telephone and examined the correlation with the full 12-item version.ResultsThe 3-item version could be administered by telephone in approximately 6nmin and was highly correlated with the full MoCA (rn=n0.78, p l 0.0001).ConclusionsThis brief version of the MoCA was feasible to collect by telephone and could be used as an alternative to the full MoCA, particularly if the purpose of cognitive assessment is characterization of study participants.

Background Patients undergoing thoracentesis often have comorbid conditions or take medications that potentially put them at higher bleeding risk. Direct oral anticoagulant (DOAC) use has also increased significantly. There are no published guidelines or consensus on when to perform thoracentesis in patients on anticoagulants. Recent studies support the safety of a more liberal approach for thoracentesis among patients with coagulopathy. Methods We conducted a survey to ascertain the practices of physicians regarding thoracentesis in patients with increased bleeding risk. The survey was administered to the email distribution lists of the American Association of Bronchology and Interventional Pulmonology and of the American Thoracic Society. Results The survey was completed by 256 attending physicians. Most of them were general pulmonologists practicing at academic medical centers. Most of them would perform a thoracentesis in patients receiving acetylsalicylic acid or prophylactic doses of unfractionated heparin or low molecular weight heparin (96%, 89%, and 88%, respectively). Half of the respondents would perform a thoracentesis in patients on antiplatelet medications (clopidogrel and ticagrelor, 51%; ticlopidine, 53%). A minority would perform thoracentesis in patients on direct oral anticoagulants or infused thrombin inhibitors (19% and 12%, respectively). The only subgroup that had a higher proclivity for performing thoracentesis without holding medications were attending physicians practicing for under 10 years. Relative to noninterventional pulmonologists, there were no significant differences in the responses of interventional pulmonologists. Conclusion There was variation in the practice patterns of attending physicians in performing thoracentesis in patients with elevated bleeding risk. Further data and guidelines regarding the safety of thoracentesis in these patients are needed.

Background:Pleural effusions may be aspirated manually or via vacuum during thoracentesis. This study compares the safety, pain level, and time involved in these techniques.Methods:We randomized 100 patients receiving ultrasound-guided unilateral thoracentesis in an academic medical center from Dece

Author(s): Gill, Thomas M; Bhasin, Shalender; Reuben, David B; Latham, Nancy K; Araujo, Katy; Ganz, David A; Boult, Chad; Wu, Albert W; Magaziner, Jay; Alexander, Neil; Wallace, Robert B; Miller, Michael E; Travison, Thomas G; Greenspan, Susan L; Gurwitz, Jerry H; Rich, Jeremy; Volpi, Elena; Waring, Stephen C; Manini, Todd M; Min, Lillian C; Teresi, Jeanne; Dykes, Patricia C; McMahon, Siobhan; McGloin, Joanne M; Skokos, Eleni A; Charpentier, Peter; Basaria, Shehzad; Duncan, Pamela W; Storer, Thomas W; Gazarian, Priscilla; Allore, Heather G; Dziura, James; Esserman, Denise; Carnie, Martha B; Hanson, Catherine; Ko, Fred; Resnick, Neil M; Wiggins, Jocelyn; Lu, Charles; Meng, Can; Goehring, Lori; Fagan, Maureen; Correa-de-Araujo, Rosaly; Casteel, Carri; Peduzzi, Peter; Greene, Erich J | Abstract: Background/objectivesIn the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.DesignPragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.SettingA total of 86 primary care practices within 10 U.S. healthcare systems.ParticipantsA random subsample of 743 persons aged 75 and older.MeasurementsThe well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.ResultsParticipants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.ConclusionsSTRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

Author(s): Reuben, David B; Gill, Thomas M; Stevens, Alan; Williamson, Jeff; Volpi, Elena; Lichtenstein, Maya; Jennings, Lee A; Tan, Zaldy; Evertson, Leslie; Bass, David; Weitzman, Lisa; Carnie, Martie; Wilson, Nancy; Araujo, Katy; Charpentier, Peter; Meng, Can; Greene, Erich J; Dziura, James; Liu, Jodi; Unger, Erin; Yang, Mia; Currie, Katherine; Lenoir, Kristin M; Green, Aval-NaʼRee S; Abraham, Sitara; Vernon, Ashley; Samper-Ternent, Rafael; Raji, Mukaila; Hirst, Roxana M; Galloway, Rebecca; Finney, Glen R; Ladd, Ilene; Rahm, Alanna Kulchak; Borek, Pamela; Peduzzi, Peter | Abstract: Background/objectivesAlthough several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown.DesignPragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.SettingFour clinical trial sites (CTSs) based in academic and clinical health systems.ParticipantsA total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers.InterventionsEighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline.MeasurementsPrimary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.Secondary outcomesNPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims.ResultsThe results will be reported in the spring of 2024.ConclusionD-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.

BackgroundInjuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.MethodsWe conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.ResultsThe demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.ConclusionsA multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

In response to the epidemic of falls and serious falls-related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co-managing fall risk in partnership with patients and their primary care providers (PCPs). The components include a standardized assessment of eight modifiable risk factors (medications; postural hypotension; feet and footwear; vision; vitamin D; osteoporosis; home safety; strength, gait, and balance impairment) and the use of protocols and algorithms to generate recommended management of risk factors; explanation of assessment results to the patient (and caregiver when appropriate) using basic motivational interviewing techniques to elicit patient priorities, preferences, and readiness to participate in treatments; co-creation of individualized falls care plans that patients' PCPs review, modify, and approve; implementation of the falls care plan; and ongoing monitoring of response, regularly scheduled re-assessments of fall risk, and revisions of the falls care plan. Custom-designed falls care management software facilitates risk factor assessment, the identification of recommended interventions, clinic note generation, and longitudinal care management. The trial testing the effectiveness of the STRIDE intervention is in progress, with results expected in late 2019.

Author(s): Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter | Abstract: Background:Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Methods:Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Results:Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing. Conclusions:The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.

Background This paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an “as-needed” basis. Methods STRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant’s underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant’s primary care provider. STRIDE’s primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be “serious” (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant’s self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed. Discussion Adjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources. Trial registration ClinicalTrials.gov (NCT02475850). Electronic supplementary material The online version of this article (10.1186/s40621-019-0190-2) contains supplementary material, which is available to authorized users.

PurposeDisturbances, such as in-room activity and sound, are significant sources of sleep disruption among critically ill patients. These factors are potentially modifiable. We tested the impact of an intensive care unit (ICU) sleep promotion protocol on overnight in-room disturbance.MethodsOur protocol restricted non-urgent bedside care from 00:00 to 03:59. Patients were assigned to usual care (n=30) or the sleep protocol (n=26). The primary outcomes were measures of in-room activity, sound and light. These three types of disturbance were compared between arms during a baseline time block (20:00–23:59) and a rest time block (00:00–03:59). We assessed the sleep protocol effect with generalised linear models.ResultsUsual care and sleep protocol patients had equivalent levels of in-room activity, sound and light during the baseline time block (20:00–23:59). In contrast, during the rest time block (00:00–03:59), the sleep protocol arm had 32% fewer room entries (rate ratio (RR) 0.68, p=0.001) and 9.1 fewer minutes of in-room activity (p=0.0002). Also, the length of time between room entrances increased from 26.4 to 45.8 min (p=0.0004). The sleep protocol arm also had lower sound during the rest time block. Mean A-weighted sound was 2.5 decibels lower (p=0.02), and there were 36% fewer peaks (RR 0.64, p=0.02). Light levels were highly variable and not changed by the sleep protocol.ConclusionsSleep promotion protocols can improve in-room activity and sound. This provides a better sleep opportunity and may, therefore, improve ICU sleep.Trial registration number1112009428

Longitudinal research on older persons in the medical intensive care unit (MICU) is often complicated by the time-dependent confounding of concurrently administered interventions such as medications and intubation. Such temporal confounding can bias the respective longitudinal associations between concurrently administered treatments and a longitudinal outcome such as delirium. Although marginal structural models address time-dependent confounding, their application is non-trivial and preferably justified by empirical evidence. Using data from a longitudinal study of older persons in the MICU, we constructed a plausibility score from 0 - 10 where higher values indicate higher plausibility of time-dependent confounding of the association between a time-varying explanatory variable and an outcome. Based on longitudinal plots, measures of correlation, and longitudinal regression, the plausibility scores were compared to the differences in estimates obtained with non-weighted and marginal structural models of next day delirium. The plausibility scores of the three possible pairings of daily doses of fentanyl, haloperidol, and intubation indicated the following: low plausibility for haloperidol and intubation, moderate plausibility for fentanyl and haloperidol, and high plausibility for fentanyl and intubation. Comparing multivariable models of next day delirium with and without adjustment for time-dependent confounding, only intubation's association changed substantively. In our observational study of older persons in the MICU, the plausibility scores were generally reflective of the observed differences between coefficients estimated from non-weighted and marginal structural models.

Exposure-crossover design offers a non-experimental option to control for stable baseline confounding through self-matching while examining causal effect of an exposure on an acute outcome. This study extends this approach to longitudinal data with repeated measures of exposure and outcome using data from a cohort of 340 older medical patients in an intensive care unit (ICU). The analytic sample included 92 patients who received ≥1 dose of haloperidol, an antipsychotic medication often used for patients with delirium. Exposure-crossover design was implemented by sampling the 3-day time segments prior (Induction) and posterior (Subsequent) to each treatment episode of receiving haloperidol. In the full cohort, there was a trend of increasing delirium severity scores (Mean±SD: 4.4±1.7) over the course of the ICU stay. After exposure-crossover sampling, the delirium severity score decreased from the Induction (4.9) to the Subsequent (4.1) intervals, with the treatment episode falling in-between (4.5). Based on a GEE Poisson model accounting for self-matching and within-subject correlation, the unadjusted mean delirium severity scores was −0.55 (95% CI: −1.10, −0.01) points lower for the Subsequent than the Induction intervals. The association diminished by 32% (−0.38, 95%CI: −0.99, 0.24) after adjusting only for ICU confounding, while being slightly increased by 7% (−0.60, 95%CI: −1.15, −0.04) when adjusting only for baseline characteristics. These results suggest that longitudinal exposure-crossover design is feasible and capable of partially removing stable baseline confounding through self-matching. Loss of power due to eliminating treatment-irrelevant person-time and uncertainty around allocating person-time to comparison intervals remain methodological challenges.

Author(s): Gill, Thomas M; McGloin, Joanne M; Latham, Nancy K; Charpentier, Peter A; Araujo, Katy L; Skokos, Eleni A; Lu, Charles; Shelton, Amy; Bhasin, Shalender; Bianco, Luanne M; Carnie, Martha B; Covinsky, Kenneth E; Dykes, Patricia; Esserman, Denise A; Ganz, David A; Gurwitz, Jerry H; Hanson, Catherine; Nyquist, Linda V; Reuben, David B; Wallace, Robert B; Greene, Erich J | Abstract: BackgroundWe describe the recruitment of participants for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large pragmatic cluster randomized trial that is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Eligible persons were 70 years or older, community-living, and at increased risk for serious fall injuries. The modified goal was to recruit 5,322 participants over 20 months from 86 primary care practices within 10 diverse health care systems across the United States.MethodsThe at-risk population was identified using two distinct but complementary screening strategies that included three questions administered centrally via the mail (nine sites) or in the clinic (one site), while recruitment was completed centrally by staff at Yale.ResultsFor central screening, 226,603 letters mailed to 135,118 patients yielded 28,719 positive screens (12.7% of those mailed and 46.5% of the 61,729 returned). In the clinic, 22,537 screens were completed, leading to 5,732 positive screens (25.4%). Of the 34,451 patients who screened positive for high risk of serious fall injuries, 31,872 were sent a recruitment packet and, of these, 5,451 (17.1%) were enrolled over 20 months (mean age: 80 years; 62% female). The participation rate was 34.0% among eligible patients. The enrollment yields were 3.6% (vs 5% projected) for each patient screened centrally, despite multiple screens, and 10.5% (vs 33.9% projected) for each positive clinic screen.ConclusionsDespite lower-than-expected yields, the STRIDE Study exceeded its modified recruitment goal. If the STRIDE intervention is found to be effective, the two distinct strategies for identifying a high-risk population of older persons could be implemented by most health care systems.

Objectives To evaluate age-related differences in sleep–wake symptoms. Design Cross-sectional. Setting Technologist-attended, laboratory-based polysomnography (PSG). Participants Community-dwelling adults aged 20 to 89 (N = 201): 52 aged 18 to 39, 72 aged 40 to 59, and 77 aged 60 and older. Measurements Medical burden (Charlson Comorbidity Index, medications, health status), PSG-defined sleep disorders (sleep-disordered breathing (SDB), sleep-associated hypoxemia, periodic limb movements in sleep (PLMS)), sleep–wake symptoms (Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), fatigue (Facit-F Scale)). Results Medical burden increased significantly with age (Charlson Comorbidity Index and number of medications, P

Of the 1.5 million people diagnosed with pleural effusion in the USA annually, ∼178 000 undergo thoracentesis. While it is known that malignant pleural effusion portends a poor prognosis, mortality of patients with nonmalignant effusions has not been well studied.This prospective cohort study evaluated 308 patients undergoing thoracentesis. Chart review was performed to obtain baseline characteristics. The aetiology of the effusions was determined using standardised criteria. Mortality was determined at 30 days and 1 year.247 unilateral and 61 bilateral thoracenteses were performed. Malignant effusion had the highest 30-day (37%) and 1-year (77%) mortality. There was substantial patient 30-day and 1-year mortality with effusions due to multiple benign aetiologies (29% and 55%), congestive heart failure (22% and 53%), and renal failure (14% and 57%, respectively). Patients with bilateral, relative to unilateral, pleural effusion were associated with higher risk of death at 30 days and 1 year (17% versus 47% (hazard ratio (HR) 2.58, 95% CI 1.44–4.63) and 36% versus 69% (HR 2.32, 95% CI 1.55–3.48), respectively).Patients undergoing thoracentesis for pleural effusion have high short- and long-term mortality. Patients with malignant effusion had the highest mortality followed by multiple benign aetiologies, congestive heart failure and renal failure. Bilateral pleural effusion is distinctly associated with high mortality.

The efficacy of haloperidol treatment on delirium among critically ill older patients has relied on limited randomized trials. Using causal methods, we estimate average treatment effect (ATE) of haloperidol from 304 older patients hospitalized in a medical intensive care unit (ICU) with daily assessment of delirium symptoms using the Confusion Assessment Methods for ICU (CAM-ICU). Haloperidol exposure was tracked daily to define the treatment versus comparison groups. A propensity score (PS) of receiving haloperidol in the ICU was estimated for each patient and used in three approaches: covariate adjustment, matching and inverse-probability-of-treatment-weighting (IPTW). PS matching (N=172 or 56.6%) achieved balance (Standardized Difference

Although bronchoscopy has conventionally been performed using conscious sedation, advanced diagnostic techniques like endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), peripheral EBUS, and electromagnetic navigational bronchoscopy add to procedural complexity. The adaptation of these techniques by bronchoscopists of varied backgrounds is expanding. It is not clear how patients will tolerate these advanced procedures when they are performed using traditional conscious sedation. We prospectively studied patients that underwent diagnostic bronchoscopic procedures using conscious sedation over a 1-year period. The primary outcome was patient tolerability measured with four questions soliciting subjective responses. Secondary outcomes included required dosage of medications, thoroughness of the procedure, diagnostic yield, and occurrence of complications. A total of 181 patients were enrolled. Compared to patients in whom conventional bronchoscopy with transbronchial biopsies were performed, there was no difference in patient tolerability using the advanced techniques. Although some of the advanced procedures added to the procedure time, the required amount of medication was within commonly accepted dosages. When EBUS-TBNA was performed, a mean of 2.8 lymph node stations per patient were sampled. A specific diagnosis was obtained in 55.9 % of patients who solely underwent EBUS-TBNA. The diagnostic yield increased to 75.7 % when a parenchymal abnormality prompted additional biopsies. One patient required sedation reversal. Complications were minimal. This study suggests that advanced diagnostic bronchoscopic procedures are well tolerated using conscious sedation with no compromise of thoroughness, diagnostic yield, or safety. This may be useful for bronchoscopists using these techniques who do not have ready access to general anesthesia.

Background Anecdotal observation suggests that older patients in medical intensive care units receive higher doses of psychoactive medications during evening shifts than day and night shifts. Objectives To determine the dosing patterns and total doses of fentanyl, lorazepam, and haloperidol according to nursing shift in a cohort of older patients in a medical intensive care unit. Methods The sample consisted of 309 patients 60 years and older admitted to the medical intensive care unit at Yale-New Haven Hospital, New Haven, Connecticut. Data on time, dosage, and route of administration of the drugs were collected. Data were analyzed by using a Bayesian random effects Poisson model adjusted for individual heterogeneity, excess zero doses, and important clinical covariates. Results Mean age of the patients was 75 years; 58% received fentanyl, 55% received lorazepam, and 32% received haloperidol. Although dosing with fentanyl did not differ according to shift, doses of both lorazepam and haloperidol were higher during the evening shifts (4 pm to midnight) than during the day or night shifts. Compared with women, men received higher doses of both haloperidol and lorazepam and variability between shifts was greater. Conclusions In this longitudinal, observational sample of older patients, data indicated a positive association between dose levels of lorazepam and haloperidol during the evening nursing shifts relative to other shifts. Further investigation is needed to determine potential causes and to evaluate the impact on outcomes of sleep deprivation and delirium.

BACKGROUND Increasing frequency of shift-to-shift handoffs coupled with regulatory requirements to evaluate handoff quality make a handoff evaluation tool necessary. OBJECTIVE To develop a handoff evaluation tool. DESIGN Tool development. SETTING Two academic medical centers. SUBJECTS Nurse practitioners, medicine housestaff, and hospitalist attendings. INTERVENTION Concurrent peer and external evaluations of shift-to-shift handoffs. MEASUREMENTS The Handoff CEX (clinical evaluation exercise) consists of 6 subdomains and 1 overall assessment, each scored from 1 to 9, where 1 to 3 is unsatisfactory and 7 to 9 is superior. We assessed range of scores, performance among subgroups, internal consistency, and agreement among types of raters. RESULTS We conducted 675 evaluations of 97 unique individuals during 149 handoff sessions. Scores ranged from unsatisfactory to superior in each domain. The highest rated domain for handoff providers was professionalism (median: 8; interquartile range [IQR]: 7–9); the lowest was content (median: 7; IQR: 6–8). Scores at the 2 institutions were similar, and scores did not differ significantly by training level. Spearman correlation coefficients among the CEX subdomains for provider scores ranged from 0.71 to 0.86, except for setting (0.39–0.40). Third-party external evaluators consistently gave lower marks for the same handoff than peer evaluators did. Weighted kappa scores for provider evaluations comparing external evaluators to peers ranged from 0.28 (95% confidence interval [CI]: 0.01, 0.56) for setting to 0.59 (95% CI: 0.38, 0.80) for organization. CONCLUSIONS This handoff evaluation tool was easily used by trainees and attendings, had high internal consistency, and performed similarly across institutions. Because peers consistently provided higher scores than external evaluators, this tool may be most appropriate for external evaluation. Journal of Hospital Medicine 2013;8:191–200. © 2013 Society of Hospital Medicine

Background Diffuse parenchymal lung diseases (DPLDs) are common. An accurate diagnosis is essential due to differences in etiology, clinicopathologic features, therapeutic options, and prognosis. Transbronchial lung biopsies (TBLBs) are often limited by small specimen size, crush artifact, and other factors. Transbronchial lung cryobiopsies (TBLCs) are under investigation to overcome these limitations. Methods We conducted a retrospective study of 56 patients in a single, tertiary-care academic center to compare the yield of both techniques when performed in the same patient. Patients underwent flexible bronchoscopy using moderate sedation with TBLB followed by TBLC in the most radiographically abnormal areas. Clinical data and postprocedural outcomes were reviewed, with a final diagnosis made utilizing a multidisciplinary approach. Results The mean age of patients was 60 years and 54% were male. Comorbidities included COPD (14%) and prior malignancy (48%). The number of TBLB specimens ranged from 1 to 10 per patient (mean 4) and size varied from 0.1 to 0.8 cm. The number of TBLC specimens ranged from 1 to 4 per patient (mean 2) and size ranged from 0.4 to 2.6 cm. Both techniques provided the same diagnosis in 26 patients (46%). An additional 11 (20%) patients had a diagnosis established by adding TBLC to TBLB. Compared with TBLB, TBLC had a higher diagnostic yield in patients with hypersensitivity pneumonitis and interstitial lung disease. Only 2 patients required video-assisted thoracoscopic surgery to establish a diagnosis. Complications included pneumothorax (20%) and massive hemoptysis (2%). Conclusion TBLC used with TBLB can improve the diagnostic yield of flexible bronchoscopy in patients with DPLD.

Background. Sepsis is a major cause of morbidity and mortality among older adults. The main goals of this study were to assess the association of sepsis at intensive care unit (ICU) admission with mortality and to identify predictors associated with increased mortality in older adults. Methods. We conducted a prospective cohort study of 309 participants ≥60 years admitted to an ICU. Sepsis was defined as 2 of 4 systemic inflammatory response syndrome criteria plus a documented infection within 2 calendar days before or after admission. The main outcome measure was time to death within 1 year of ICU admission. Sepsis was evaluated as a predictor for mortality in a Cox proportional hazards model. Results. Of 309 participants, 196 (63%) met the definition of sepsis. Among those admitted with and without sepsis, 75 (38%) vs 20 (18%) died within 1 month of ICU admission (P < .001) and 117 (60%) vs 48 (42%) died within 1 year (P < .001). When adjusting for baseline characteristics, sepsis had a significant impact on mortality (hazard ratio [HR] = 1.80; 95% confidence interval [CI], 1.28–2.52; P < .001); however, after adjusting for baseline characteristics and process covariates (antimicrobials and vasopressor use within 48 hours of admission), the impact of sepsis on mortality became nonsignificant (HR = 1.26; 95% CI, .87–1.84; P = .22). Conclusions. The diagnosis of sepsis in older adults upon ICU admission was associated with an increase in mortality compared with those admitted without sepsis. After controlling for early use of antimicrobials and vasopressors for treatment, the association of sepsis with mortality was reduced.

In this article, the authors demonstrate a time-series analysis based on a hierarchical Bayesian model of a Poisson outcome with an excessive number of zeroes. The motivating example for this analysis comes from the intensive care unit (ICU) of an urban university teaching hospital (New Haven, Connecticut, 2002–2004). Studies of medication use among older patients in the ICU are complicated by statistical factors such as an excessive number of zero doses, periodicity, and within-person autocorrelation. Whereas time-series techniques adjust for autocorrelation and periodicity in outcome measurements, Bayesian analysis provides greater precision for small samples and the flexibility to conduct posterior predictive simulations. By applying elements of time-series analysis within both frequentist and Bayesian frameworks, the authors evaluate differences in shift-based dosing of medication in a medical ICU. From a small sample and with adjustment for excess zeroes, linear trend, autocorrelation, and clinical covariates, both frequentist and Bayesian models provide evidence of a significant association between a specific nursing shift and dosing level of a sedative medication. Furthermore, the posterior distributions from a Bayesian random-effects Poisson model permit posterior predictive simulations of related results that are potentially difficult to model.

OBJECTIVES: To evaluate the association between sleep disturbances and adverse driving events in active older drivers. DESIGN: Longitudinal. SETTING: Clinic and community sites in greater New Haven, Connecticut. PARTICIPANTS: Four hundred thirty older persons (mean age 78.5, 84.9% male) who drove at least once a week. MEASUREMENTS: Baseline measures included self-reported driving patterns and sleep questionnaires (Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Sleep Apnea Clinical Score (SACS)). The primary outcome was an adverse driving event based on self-report and driving records and categorized as a crash or traffic infraction (composite I) or as a crash, traffic infraction, near crash, or getting lost (composite II). RESULTS: Participants reported driving a median of 17.0 miles per day, with 96.7% (416/430) driving daily or every other day. Although 26.0% (112/430) had insomnia (ISI≥8), 19.3% (83/430) had daytime drowsiness (ESS≥10), and 19.9% (84/422) had high sleep apnea risk (SACS>15), the median scores for the ISI, ESS, and SACS were normal at 3.0, 6.0, and 8.0, respectively, and only 5.1% reported drowsy driving. Over a period of up to 2 years, 24.9% (104/418) and 51.4% (215/418) of participants had a composite I and II driving event, respectively. In unadjusted and adjusted multivariable models, insomnia, daytime drowsiness, and high sleep apnea risk were not associated with a composite I or II driving event. CONCLUSION: In a predominantly male cohort of active older drivers, sleep disturbances were mild and not associated with adverse driving events. Accordingly, and because older persons are known to self-regulate driving practices, future studies should evaluate whether sleep disturbances are more important as a mechanism that underlies driving cessation rather than compromising driving safety.

Rationale: Delirium is a frequent occurrence in older intensive care unit (ICU) patients, but the importance of the duration of delirium in contributing to adverse long-term outcomes is unclear. Objectives: To examine the association of the number of days of ICU delirium with mortality in an older patient population. Methods: We performed a prospective cohort study in a 14-bed ICU in an urban acute care hospital. The patient population comprised 304 consecutive admissions 60 years of age and older. Measurements and Main Results: The main outcome was 1-year mortality after ICU admission. Patients were assessed daily for delirium with the Confusion Assessment Method for the ICU and a validated chart review method. The median duration of ICU delirium was 3 days (range, 1–46 d). During the follow-up period, 153 (50%) patients died. After adjusting for relevant covariates, including age, severity of illness, comorbid conditions, psychoactive medication use, and baseline cognitive and functional status, the number of days of ICU delirium was significantly associated with time to death within 1 year post-ICU admission (hazard ratio, 1.10; 95% confidence interval, 1.02–1.18). Conclusions: Number of days of ICU delirium was associated with higher 1-year mortality after adjustment for relevant covariates in an older ICU population. Investigations should be undertaken to reduce the number of days of ICU delirium and to study the impact of this reduction on important health outcomes, including mortality and functional and cognitive status.

There is a high prevalence of delirium in older medical intensive care unit (ICU) patients and delirium is associated with adverse outcomes. We need to identify modifiable risk factors for delirium, such as medication use, in the ICU. The objective of this study was to examine the impact of benzodiazepine or opioid use on the duration of ICU delirium in an older medical population.Prospective cohort study.Fourteen-bed medical intensive care unit in an urban university teaching hospital.304 consecutive admissions age 60 and older.None.The main outcome measure was duration of ICU delirium, specifically the first episode of ICU delirium. Patients were assessed daily for delirium with the Confusion Assessment Method for the ICU and a validated chart review method. Our main predictor was receiving benzodiazepines or opioids during ICU stay. A multivariable model was developed using Poisson rate regression.Delirium occurred in 239 of 304 patients (79%). The median duration of ICU delirium was 3 days with a range of 1-33 days. In a multivariable regression model, receipt of a benzodiazepine or opioid (rate ratio [RR] 1.64, 95% confidence interval [CI] 1.27-2.10) was associated with increased delirium duration. Other variables associated with delirium duration in this analysis include preexisting dementia (RR 1.19, 95% CI 1.07-1.33), receipt of haloperidol (RR 1.35, 95% CI 1.21-1.50), and severity of illness (RR 1.01, 95% CI 1.00-1.02).The use of benzodiazepines or opioids in the ICU is associated with longer duration of a first episode of delirium. Receipt of these medications may represent modifiable risk factors for delirium. Clinicians caring for ICU patients should carefully evaluate the need for benzodiazepines, opioids, and haloperidol.

BACKGROUND: Lower levels of driving capacity in older persons are typically attributed to cognitive, visual, and/or physical impairments, with sleep disturbances rarely considered. This is in contrast to the general adult population for whom sleep disturbances are established risk factors for crashes. We thus set out to determine the prevalence of sleep disturbances in the form of insomnia symptoms, daytime drowsiness, and sleep apnea risk in a cohort of older drivers and to assess how these relate to self-reported driving capacity. METHODS: Participants included 430 active drivers aged > or =70 years. Questionnaires measured self-reported insomnia symptoms (Insomnia Severity Index [ISI]), drowsiness (Epworth Sleepiness Scale [ESS]), apnea risk (Sleep Apnea Clinical Score [SACS]), driving mileage, driver self-ratings (overall and nighttime), and prior adverse driving events. RESULTS: Mean age was 78.5 years, with 85% being male. Overall, 64% were dissatisfied with sleep patterns and 26% had an abnormal ISI (> or =8). A large proportion (60%) reported a moderate-to-high chance of dozing in the afternoon, and 19% had an abnormal ESS (> or =10). Habitual snoring was noted by 43%, with 20% at risk for sleep apnea (SACS > 15). Regarding driving, the most consistent finding was for lower levels of nighttime driver self-ratings in participants with insomnia symptoms or drowsiness. Lower levels of driving mileage were also noted but only with difficulty falling asleep. Otherwise, sleep disturbances were not associated with prior adverse driving events. CONCLUSION: In our cohort of older drivers, insomnia symptoms and daytime drowsiness were prevalent and associated with lower levels of nighttime driver self-ratings. Although sleep apnea risk was also prevalent, it was not associated with self-reported driving capacity. These preliminary findings suggest that insomnia symptoms and drowsiness merit continued consideration as risk factors for lower levels of driving capacity in older persons, particularly given that effective interventions are available. Language: en

Objective Properly handling missing data is a challenge, especially when working with older populations that have high levels of morbidity and mortality. We illustrate methods for understanding whether missing values are ignorable and describe implications of their use in regression modeling. Study Design and Setting The use of missingness screens such as Little's missing completely at random “MCAR test” (1988) and the “Index of Sensitivity to Nonignorability (ISNI)” by Troxel and colleagues (2004)introduces complications for regression modeling, and, particularly, for risk factor selection. In a case study of older patients with simulated missing values for a delirium outcome set in a 14-bed medical intensive care unit, we outline a model fitting process that incorporates the use of missingness screens, controls for collinearity, and selects variables based on model fit. Results The proposed model fitting process identifies more actual risk factors for ICU delirium than does a complete case analysis. Conclusion Use of imputation and other methods for handling missing data assist in the identification of risk factors. They do so accurately only when correct assumptions are made about the nature of missing data. Missingness screens enable researchers to investigate these assumptions.

This study was designed to determine whether an education program consisting of classroom and on-road training could enhance driving performance.This randomized controlled trial with blinded endpoint assessment enrolled 126 community-living drivers 70 years old or older who were recruited from clinic and community sources. Treatment assignment was concealed until eligibility was established. Participants randomized to intervention underwent two 4-hour classroom and two 1-hour on-road sessions focused on common problem areas of older drivers. Controls received modules directed at vehicle, home, and environmental safety. A knowledge test and driving performance were assessed at baseline and 8 weeks. On-road driving performance was assessed by an experienced evaluator in a dual-brake-equipped vehicle in urban, residential, and highway traffic. Driving performance was rated on a 36-item scale with potential scores from 0 to 72 (higher score better). The knowledge test included 20 road knowledge and eight road sign questions, scored from 0 to 28 correct.The least squares mean change in road test score relative to baseline was 2.87 points higher in the intervention than in the control group (p =.001). The least squares mean change in knowledge test scores relative to baseline was 3.45 points higher in the intervention than in the control group (p.001).An education program consisting of classroom and on-road training targeted to common errors of older drivers enhanced performance on knowledge and on-road tests. Such interventions offer older drivers the potential to continue driving safely longer and to maintain their out-of-home mobility.

Background As the number of older drivers increases, concern has been raised about the potential safety implications. Flexibility, coordination, and speed of movement have been associated with older drivers’ on road performance. Objective To determine whether a multicomponent physical conditioning program targeted to axial and extremity flexibility, coordination, and speed of movement could improve driving performance among older drivers. Design Randomized controlled trial with blinded assignment and end point assessment. Participants randomized to intervention underwent graduated exercises; controls received home, environment safety modules. Participants Drivers, 178, age ≥ 70 years with physical, but without substantial visual (acuity 20/40 or better) or cognitive (Mini Mental State Examination score ≥24) impairments were recruited from clinics and community sources. Measurements On-road driving performance assessed by experienced evaluators in dual-brake equipped vehicle in urban, residential, and highway traffic. Performance rated three ways: (1) 36-item scale evaluating driving maneuvers and traffic situations; (2) evaluator’s overall rating; and (3) critical errors committed. Driving performance reassessed at 3 months by evaluator blinded to treatment group. Results Least squares mean change in road test scores at 3 months compared to baseline was 2.43 points higher in intervention than control participants (P = .03). Intervention drivers committed 37% fewer critical errors (P = .08); there were no significant differences in evaluator’s overall ratings (P = .29). No injuries were reported, and complaints of pain were rare. Conclusions This safe, well-tolerated intervention maintained driving performance, while controls declined during the study period. Having interventions that can maintain or enhance driving performance may allow clinician–patient discussions about driving to adopt a more positive tone, rather than focusing on driving limitation or cessation.

Objective To evaluate the mechanisms of action in two successful geriatric clinical trials that tested multicomponent physical conditioning programs and to determine whether the pathways for overall benefit were through improvement in physical ability and/or self-confidence. Study Design and Setting PREHAB and DRIVER were conducted by the Yale Pepper Center. PREHAB participants received an individualized program that focused on the impairments present (standardly tailored design); DRIVER participants received the entire intervention (global design). PREHAB enrolled 188 community-living persons, aged 75 years or older, who were physically frail but ambulatory; DRIVER enrolled 178 drivers aged 70 years or older with physical impairments associated with poor driving performance. The primary outcome for PREHAB was a disability score and for DRIVER it was a driving score; potential mediators were measures of physical ability and self-confidence. Results In PREHAB, pathways for the intervention were established through improvement in physical ability and self-confidence. In DRIVER, there was some evidence for a pathway through improved driving self-confidence but not through physical ability; however, the intervention effect was largely unexplained. Conclusion Multicomponent physical interventions may operate through psychological mechanisms, and these mechanisms should be anticipated in trial designs so that the component effects can be suitably evaluated.

Background: Pleural effusions impact over 1.5 million people annually in the United States and cause significant morbidity. Although therapeutic thoracentesis is associated with improvement in respiratory parameters, unanswered questions remain regarding its impact. Objective: The purpose of this study was to investigate patient-centered outcomes, the need for additional pleural interventions, and mortality in the 30 days following thoracentesis. Methods: This prospective observational cohort study was performed in a tertiary care academic medical center between December 2010 and December 2011. Adult patients referred for thoracentesis were offered enrollment. The following characteristics were evaluated both before and at 30 days postprocedure: dyspnea using modified BORG (mBORG), physical and mental quality of life (QoL) using the short form 12, and basic activities of daily living (BADLs). The primary outcomes included changes in these parameters 30 days after thoracentesis. Secondary outcomes included the need for additional pleural procedures and mortality within 30 days of the thoracentesis. Multivariable logistic regression was used for analysis. Results: Of the 284 patients who underwent thoracentesis, 80 (28.2%) died within 30 days of the procedure. Of the 163 patients comprising the analytical cohort, 35 (21.5%) patients required an additional pleural intervention within 30 days of the index procedure. Patients who survived more than 30 days following thoracentesis had a sustained improvement in dyspnea and mental QoL, but a minority had improvement in physical QoL or BADLs. Surviving patients demonstrated no significant associations between bilateral and unilateral thoracentesis, volume of fluid removed, or the etiology of the effusion (malignant vs nonmalignant) and improvement in QoL, dyspnea, and BADLs. Relative to nonmalignant etiology, the presence of a malignant effusion was strongly associated with the need for an additional intervention, yielding an odds ratio (95% confidence interval [95% CI]) of 16.92 (5.47-52.37). Patients with hepatic hydrothorax and infectious etiologies of their effusion were also likely to require additional pleural interventions. Conclusion: The majority of patients in this cohort demonstrated sustained improvement in dyspnea and the mental aspect of QoL 30 days following thoracentesis, independent of the etiology and regardless of the volume of pleural fluid removed. A minority experienced sustained improvements in the physical aspect of QoL and BADLs. Although 28.2% of patients died within 30 days, nearly 1 in 5 survivors required an additional pleural intervention. These results emphasize the significant clinical impact, morbidity, and mortality experienced by patients who undergo thoracentesis for pleural effusions.

Objectives To evaluate the association between performance on a single chair stand and moderate to severe exertional dyspnea. Design Cross-sectional. Setting Cardiovascular Health Study. Participants Community-dwelling individuals aged 65 and older (N = 4,413; mean age 72.6; female, n = 2,518 (57.1%); nonwhite, n = 199 (4.5%); obese, n = 788 (17.9%); history of smoking, n = 2,410 (54.6%)). Measurements Performance on single chair stand (poor (unable to rise without arm use) vs normal (able to rise without arm use)), moderate to severe exertional dyspnea (American Thoracic Society grade ≥2), age, sex, ethnicity, obesity, smoking, frailty status (Fried-defined nonfrail, prefrail, frail), high cardiopulmonary risk (composite of cardiopulmonary diseases and diabetes mellitus), spirometric impairment, arthritis, depression, stroke, and kidney disease. Results Poor performance on the single chair stand was established in 369 (8.4%) and moderate to severe exertional dyspnea in 773 (17.5%). Prefrail status was established in 2,210 (50.1%), frail status in 360 (8.2%), arthritis in 2,241 (51.4%), high cardiopulmonary risk in 2,469 (55.9%), spirometric impairment in 1,076 (24.4%), kidney disease in 111 (2.5%), depression in 107 (2.4%), and stroke in 93 (2.1%). In multivariable regression models, poor performance on the single chair stand was associated with moderate to severe exertional dyspnea (unadjusted odds ratio (OR) = 3.48, 95% confidence interval (CI) = 2.78–4.36; adjusted OR = 1.85, 95% CI = 1.41–2.41). Conclusion Poor performance on a single chair stand was associated with an adjusted 85% greater likelihood of moderate to severe exertional dyspnea than normal performance. These results suggest that reduced proximal muscle function of the lower extremities is associated with moderate to severe exertional dyspnea, even after adjusting for multiple confounders.

To evaluate the association between cumulative dose of haloperidol and next-day diagnosis of delirium in a cohort of older medical ICU patients, with adjustment for its time-dependent confounding with fentanyl and intubation.Prospective, observational study.Medical ICU at an urban, academic medical center.Age 60 years and older admitted to the medical ICU who received at least one dose of haloperidol (n = 93). Of these, 72 patients were intubated at some point in their medical ICU stay, whereas 21 were never intubated.None.Detailed data were collected concerning time, dosage, route of administration of all medications, as well as for important clinical covariates, and daily status of intubation and delirium using the confusion assessment method for the ICU and a chart-based algorithm. Among nonintubated patients, and after adjustment for time-dependent confounding and important covariates, each additional cumulative milligram of haloperidol was associated with 5% higher odds of next-day delirium with odds ratio of 1.05 (credible interval [CI], 1.02-1.09). After adjustment for time-dependent confounding and covariates, intubation was associated with a five-fold increase in odds of next-day delirium with odds ratio of 5.66 (CI, 2.70-12.02). Cumulative dose of haloperidol among intubated patients did not change their already high likelihood of next-day delirium. After adjustment for time-dependent confounding, the positive associations between indicators of intubation and of cognitive impairment and next-day delirium became stronger.These results emphasize the need for more studies regarding the efficacy of haloperidol for treatment of delirium among older medical ICU patients and demonstrate the value of assessing nonintubated patients.

Background Endobronchial ultrasound (EBUS)–guided transbronchial needle aspiration (TBNA) is important in the evaluation of thoracic lymphadenopathy. Reliably providing excellent diagnostic yield for malignancy, its diagnosis of sarcoidosis is inconsistent. Furthermore, TBNA may not suffice when larger "core biopsy" samples of malignant tissue are required. The primary objective of this study was to determine if the sequential use of TBNA and a novel technique called cautery-assisted transbronchial forceps biopsy (ca-TBFB) was safe. Secondary outcomes included sensitivity and successful acquisition of tissue. Methods The study prospectively enrolled 50 unselected patients undergoing convex-probe EBUS. All lymph nodes exceeding 1 cm were sequentially biopsied under EBUS guidance using TBNA and ca-TBFB. Safety and sensitivity were assessed at the nodal level for 111 nodes. Results of each technique were also reported for each patient. Results There were no significant adverse events. In nodes determined to be malignant, TBNA provided higher sensitivity (100%) than ca-TBFB (78%). However, among nodes with granulomatous inflammation, ca-TBFB exhibited higher sensitivity (90%) than TBNA (33%). On the one hand, for analysis based on patients rather than nodes, 6 of the 31 patients with malignancy would have been missed or understaged if the diagnosis were based on samples obtained by ca-TBFB. On the other hand, 3 of 8 patients with sarcoidosis would have been missed if analysis were based only on TBNA samples. In some patients, only ca-TBFB acquired sufficient tissue for the core samples needed in clinical trials of malignancy. Conclusions The sequential use of TBNA and ca-TBFB appears to be safe. The larger samples obtained from ca-TBFB increased its sensitivity to detect granulomatous disease and provided adequate specimens for clinical trials of malignancy when specimens from needle biopsies were insufficient. For thoracic surgeons and advanced bronchoscopists, we advocate ca-TBFB as an alternative to TBNA in select clinical scenarios.

Our purpose was to determine the extent to which a predetermined set of modifiable impairments predicted progression of disability. Method: We conducted a 3-year follow-up of two community-based cohorts of older adults. The impairment areas included lower extremity, upper extremity, hearing, vision, and affect. Home management and social or productive activities were the domains of function investigated. Results: All five impairments were of at least borderline significance in predicting decline in both functional domains in both cohorts with the exception of hearing for home management activities. The five impairments together explained from 17% to 23% of the decline seen in the functional outcomes (partial R2s 0.17 to 0.23). Discussion: Five prevalent and potentially modifiable impairments explained much of the progressive disability experienced. Given the priority that older patients place on function as a health outcome, these impairments should be routinely assessed and modified.

Objective: Many important physiologic and clinical predictors are continuous. Clinical investigators and epidemiologists’ interest in these predictors lies, in part, in the risk they pose for adverse outcomes, which may be continuous as well. The relationship between continuous predictors and a continuous outcome may be complex and difficult to interpret. Therefore, methods to detect levels of a predictor variable that predict the outcome and determine the threshold for clinical intervention would provide a beneficial tool for clinical investigators and epidemiologists. Study Design and Setting: We present a case study using regression tree methodology to predict Social and Productive Activities score at 3 years using five modifiable impairments. The predictive ability of regression tree methodology was compared with multiple linear regression using two independent data sets, one for development and one for validation. Results: The regression tree approach and the multiple linear regression model provided similar fit (model deviances) on the development cohort. In the validation cohort, the deviance of the multiple linear regression model was 31% greater than the regression tree approach. Conclusion: Regression tree analysis developed a better model of impairments predicting Social and Productive Activities score that may be more easily applied in research settings than multiple linear regression alone. 2005 Elsevier Inc. All rights reserved.

Summary objective We evaluated menopausal symptoms, menstrual cycle bleeding characteristics and reproductive hormones for their associations with thyroid stimulating hormone (TSH) concentrations in women at the mid-life from five ethnic groups. methods This report is from the baseline evaluation of the Study of Women's Health Across the Nation (SWAN), a community-based multiethnic study of the natural history of the menopausal transition. Enrollees were 42–52 years old (pre- and early perimenopausal) African American, Caucasian, Chinese, Hispanic and Japanese women (n = 3242). Enrollees were interviewed about self-reported diagnosed hypo- and hyperthyroidism or thyroid treatment, menopausal symptoms and menstrual cycle bleeding characteristics. Serum was assayed for TSH, oestradiol, testosterone, FSH and SHBG. results There were 6·2% of women with TSH > 5·0 mIU/ml and 3·2% with TSH 5·0 mIU/ml (P

Age-eligible patients are recruited if they answer yes to: (1) have you fallen and hurt yourself in the past year? (2) have you fallen more than 2 times in the past year? and/or (3) are you afraid that you might fall because of balance or walking problems? Patients are screened via postal questionnaire at 9 of the 10 sites and in the clinic at the 10th site. Screen-positive patients are mailed a recruitment packet, and those who do not opt-out are called by study staff (blinded to practice intervention assignment) to confirm eligibility, obtain verbal consent, and complete the baseline assessment. Recruitment yield [(enrolled/screens attempted)*100] ranges from 2.9% to 8.8% across sites for central screening and is 2.9% for clinic screening. Strategies to increase the yield include sending out 2nd and 3rd postal questionnaires to non-responders, rescreening patients who were initially screen negative, and raising study visibility at the 86 participating practices.

Objectives To evaluate the feasibility of using unattended, portable polysomnography (PSG) to measure sleep among patients in the medical intensive care unit (MICU). Background Accurate measurement of sleep is critical to studies of MICU sleep deprivation. Although PSG is the gold standard, there is limited data regarding the feasibility of utilizing unattended, portable PSG modalities in the MICU. Methods MICU based observational pilot study. We conducted unattended, 24-h PSG studies in 29 patients. Indicators of feasibility included attainment of electroencephalography data sufficient to determine sleep stage, sleep efficiency, and arousal indices. Results Electroencephalography data were not affected by electrical interference and were of interpretable quality in 27/29 (93%) of patients. Overnight sleep efficiency was 48% reflecting a mean overnight sleep duration of 3.7 h. Conclusions Unattended, portable PSG produces high quality sleep data in the MICU and can facilitate investigation of sleep deprivation among critically ill patients. Patient sleep was short and highly fragmented.

Background: Each year in the United States an estimated 1.5 million people develop pleural effusions and approximately 178,000 thoracenteses (12%) are performed. While it has been established that malignant effusions are associated with increased mortality, the association between mortality and all-cause pleural effusions in a medical population has not been previously evaluated. Our objective was to evaluate associations between 30-day and 12-month all-cause mortality among patients with a pleural effusion. Methods: All patients admitted to the medical service at Yale-New Haven Hospital during March 2011 were screened for pleural effusion. Pleural effusions were documented by the attending radiologist and the medical record was reviewed for admitting diagnosis, severity of illness and whether a thoracenteses was performed. The outcomes were 30-day and 12-month mortality after identification of the pleural effusion. Results: One-hundred and four patients admitted to the medical service had pleural effusions documented by the attending radiologist. At 30-days, 15% of these patients had died and by 12-months mortality had increased to 32%. Eleven (10.6%) of the 104 patients underwent a thoracenteses. Severity of illness and malignancy were associated with 30-day mortality. For 12-month mortality, associations were found with age, severity of illness, malignancy, and diagnosis of pulmonary disease. Although sample size precluded statistical significance with mortality, the hazard ratio for thoracenteses and 30-day mortality was protective, suggesting a possible short term survival benefit. Conclusions: In hospitalized medical patients with a pleural effusion, age, severity of illness and malignancy or pulmonary disease were associated with higher 12-month mortality. Thoracenteses may provide a protective effect in the first 30 days, but larger studies are needed to detect a short-term survival benefit. The presence of a pleural effusion indicates a high risk of death, with 15% of patients dying within 30 days and 32% dead within one-year of hospital admission.

Objectives: To evaluate the associations between sleep disturbances and driving practices, including driving cessation and trajectories of daily driving mileage (change over time), in older drivers. Design: Longitudinal. Setting: New Haven, Connecticut. Participants: Four hundred thirty older drivers, mean age 78.5, recruited from clinic and community sites. Measurements: Baseline measures included medical history, daily driving mileage, Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Sleep Apnea Clinical Score (SACS). Longitudinal outcomes included at least one episode of driving cessation and trajectories of miles driven per day, as recorded every 6 months over 2 years. Results: At baseline, participants drove an average of 22.2 miles per day; 26.0% (112/430) had insomnia (ISI ? 8), 19.3% (83/430) had daytime drowsiness (ESS ? 10), and 19.9% (84/422) had high sleep apnea risk (SACS > 15). The sleep-based predictors of insomnia (risk ratio (RR) = 1.20, 95% confidence interval (CI) = 0.65�2.20), daytime drowsiness (RR = 0.94, 95% CI = 0.46�1.95), and high sleep apnea risk (RR = 0.62, 95% CI = 0.27�1.42) did not confer a significantly greater risk of driving cessation. Insomnia was the only sleep-based predictor that conferred a significant change in driving mileage, yielding an average decrease of 4.5 miles per day over 2 years (P = .01). In the insomnia model, covariates that were associated with less driving mileage were polypharmacy (?4 medications) and each year of additional age, yielding an average decrease of 8.3 (P = .01) and 0.4 miles per day (P = .02), respectively, over 2 years. Conclusion: In a cohort of older drivers, insomnia and the covariates of polypharmacy and advancing age were longitudinally associated with less daily driving mileage. Because reductions in driving mileage in older persons often occur in response to reductions in driving capacity, these results support a clinical approach that considers insomnia-based cognitive-behavioral therapy and reduced polypharmacy as strategies for improving driving capacity in older persons.

Thoracentesis is commonly performed to evaluate pleural effusions. Many medications (warfarin, heparin, clopidogrel) or physiological factors (elevated International Normalized Ratio [INR], thrombocytopenia, uremia) increase the risk for bleeding. Frequently these medications are withheld or transfusions are performed to normalize physiological parameters before a procedure. The safety of performing thoracentesis without correction of these bleeding risks has not been prospectively evaluated.This prospective observational cohort study enrolled 312 patients who underwent thoracentesis. All patients were evaluated for the presence of risk factors for bleeding. Hematocrit levels were obtained pre- and postprocedure, and the occurrence of postprocedural hemothorax was evaluated.Thoracenteses were performed in 312 patients, 42% of whom had a risk for bleeding. Elevated INR, secondary to liver disease or warfarin, and renal disease were the two most common etiologies for bleeding risk, although many patients had multiple potential bleeding risks. There was no significant difference in pre- and postprocedural hematocrit levels in patients with a bleeding risk when compared with patients with no bleeding risk. No patient developed a hemothorax as a result of the thoracentesis.This single-center, observational study suggests that thoracentesis may be safely performed without prior correction of coagulopathy, thrombocytopenia, or medication-induced bleeding risk. This may reduce the morbidity associated with transfusions or withholding of medications.

BACKGROUND Discharge summaries are essential for safe transitions from hospital to home. OBJECTIVE To conduct a comprehensive quality assessment of discharge summaries. DESIGN Prospective cohort study. SUBJECTS Three hundred seventy-seven patients discharged home after hospitalization for acute coronary syndrome, heart failure, or pneumonia. MEASURES Discharge summaries were assessed for timeliness of dictation, transmission of the summary to appropriate outpatient clinicians, and presence of key content including elements required by The Joint Commission and elements endorsed by 6 medical societies in the Transitions of Care Consensus Conference (TOCCC). RESULTS A total of 376 of 377 patients had completed discharge summaries. A total of 174 (46.3%) summaries were dictated on the day of discharge; 93 (24.7%) were completed more than a week after discharge. A total of 144 (38.3%) discharge summaries were not sent to any outpatient physician. On average, summaries included 5.6 of 6 The Joint Commission elements and 4.0 of 7 TOCCC elements. Summaries dictated by hospitalists were more likely to be timely and to include key content than summaries dictated by housestaff or advanced practice nurses. Summaries dictated on the day of discharge were more likely to be sent to outside physicians and to include key content. No summary met all 3 quality criteria of timeliness, transmission, and content. CONCLUSIONS Discharge summary quality is inadequate in many domains. This may explain why individual aspects of summary quality such as timeliness or content have not been associated with improved patient outcomes. However, improving discharge summary timeliness may also improve content and transmission. Journal of Hospital Medicine 2013;8:436–443. © 2013 Society of Hospital Medicine