Association of cumulative dose of haloperidol with next-day delirium in older medical ICU patients.

OBJECTIVES: 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. DESIGN: Prospective, observational study. SETTING: Medical ICU at an urban, academic medical center. PATIENTS: 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. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.

Functional status after critical illness: agreement between patient and proxy assessments.

BACKGROUND: assessment of baseline functional status of older patients during and after intensive care unit (ICU) admission is often hampered by challenges related to the critical illness such as cognitive dysfunction, neuropsychological morbidity and pain. To explore the reliability of assessments by carefully chosen proxies, we designed a discriminating selection of proxies and evaluated agreement between patient and proxy responses by assessing activities of daily living (ADLs) at 1 month post-ICU discharge. METHODS: patients ≥60 years old admitted to the medical ICU were enrolled in a prospective parent cohort studying delirium. Proxies were carefully screened at ICU admission to choose the best available respondent. Follow-up interviews, including instruments for ADLs, were conducted 1 month after ICU discharge. We examined 179 paired patient-proxy follow-up interviews. Kappa statistics assessed inter-observer agreement, and McNemar's exact test assessed response differences. RESULTS: patients averaged 73.3 ± 8.1 years old with 29% having evidence of cognitive impairment. Proxies were most commonly spouses (38%) or children (39%). Overall, there was substantial (κ ≥ 0.6) to excellent agreement (κ ≥ 0.8) between patients and proxies on assessment of all but one basic and one instrumental ADL. CONCLUSION: proxies carefully chosen at ICU admission show high levels of inter-observer agreement with older patients when assessing current functional status at 1 month post-ICU discharge. This motivates further study of proxy assessments that could be used earlier in critical illness to assess premorbid functional status.

Advanced diagnostic bronchoscopy using conscious sedation and the laryngeal nerve block: tolerability, thoroughness, and diagnostic yield.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Medication reconciliation accuracy and patient understanding of intended medication changes on hospital discharge.

BACKGROUND: Adverse drug events after hospital discharge are common and often serious. These events may result from provider errors or patient misunderstanding. OBJECTIVE: To determine the prevalence of medication reconciliation errors and patient misunderstanding of discharge medications. DESIGN: Prospective cohort study SUBJECTS: Patients over 64 years of age admitted with heart failure, acute coronary syndrome or pneumonia and discharged to home. MAIN MEASURES: We assessed medication reconciliation accuracy by comparing admission to discharge medication lists and reviewing charts to resolve discrepancies. Medication reconciliation changes that did not appear intentional were classified as suspected provider errors. We assessed patient understanding of intended medication changes through post-discharge interviews. Understanding was scored as full, partial or absent. We tested the association of relevance of the medication to the primary diagnosis with medication accuracy and with patient understanding, accounting for patient demographics, medical team and primary diagnosis. KEY RESULTS: A total of 377 patients were enrolled in the study. A total of 565/2534 (22.3 %) of admission medications were redosed or stopped at discharge. Of these, 137 (24.2 %) were classified as suspected provider errors. Excluding suspected errors, patients had no understanding of 142/205 (69.3 %) of redosed medications, 182/223 (81.6 %) of stopped medications, and 493 (62.0 %) of new medications. Altogether, 307 patients (81.4 %) either experienced a provider error, or had no understanding of at least one intended medication change. Providers were significantly more likely to make an error on a medication unrelated to the primary diagnosis than on a medication related to the primary diagnosis (odds ratio (OR) 4.56, 95 % confidence interval (CI) 2.65, 7.85, p<0.001). Patients were also significantly more likely to misunderstand medication changes unrelated to the primary diagnosis (OR 2.45, 95 % CI 1.68, 3.55), p<0.001). CONCLUSIONS: Medication reconciliation and patient understanding are inadequate in older patients post-discharge. Errors and misunderstandings are particularly common in medications unrelated to the primary diagnosis. Efforts to improve medication reconciliation and patient understanding should not be disease-specific, but should be focused on the whole patient.

Bayesian time-series analysis of a repeated-measures poisson outcome with excess zeroes.

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.

Disability in activities of daily living, depression, and quality of life among older medical ICU survivors: a prospective cohort study.

BACKGROUND: Accurate measurement of quality of life in older ICU survivors is difficult but critical for understanding the long-term impact of our treatments. Activities of daily living (ADLs) are important components of functional status and more easily measured than quality of life (QOL). We sought to determine the cross-sectional associations between disability in ADLs and QOL as measured by version one of the Short Form 12-item Health Survey (SF-12) at both one month and one year post-ICU discharge. METHODS: Data was prospectively collected on 309 patients over age 60 admitted to the Yale-New Haven Hospital Medical ICU between 2002 and 2004. Among survivors an assessment of ADL's and QOL was performed at one month and one-year post-ICU discharge. The SF-12 was scored using the version one norm based scoring with 1990 population norms. Multivariable regression was used to adjust the association between ADLs and QOL for important covariates. RESULTS: Our analysis of SF-12 data from 110 patients at one month post-ICU discharge showed that depression and ADL disability were associated with decreased QOL. Our model accounted for 17% of variability in SF12 physical scores (PCS) and 20% of variability in SF12 mental scores (MCS). The mean PCS of 37 was significantly lower than the population mean whereas the mean MCS score of 51 was similar to the population mean. At one year mean PCS scores improved and ADL disability was no longer significantly associated with QOL. Mortality was 17% (53 patients) at ICU discharge, 26% (79 patients) at hospital discharge, 33% (105 patients) at one month post ICU admission, and was 45% (138 patients) at one year post ICU discharge. CONCLUSIONS: In our population of older ICU survivors, disability in ADLs was associated with reduced QOL as measured by the SF-12 at one month but not at one year. Although better markers of QOL in ICU survivors are needed, ADLs are a readily observable outcome. In the meantime, clinicians must try to offer realistic estimates of prognosis based on available data and resources are needed to assist ICU survivors with impaired ADLs who wish to maintain their independence. More aggressive diagnosis and treatment of depression in this population should also be explored as an intervention to improve quality of life.

Utility of a short, telephone-administered version of the Montreal Cognitive Assessment.

BACKGROUND: Because 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. METHODS: For 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. RESULTS: The 3-item version could be administered by telephone in approximately 6 min and was highly correlated with the full MoCA (r = 0.78, p < 0.0001). CONCLUSIONS: This 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.

Days of delirium are associated with 1-year mortality in an older intensive care unit population.

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.

Physician Practice Patterns for Performing Thoracentesis in Patients Taking Anticoagulant Medications.

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.

Improved Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Forceps Biopsies: A Retrospective Analysis.

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 of care (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.

Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study.

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.

Benzodiazepine and opioid use and the duration of intensive care unit delirium in an older population.

OBJECTIVE: 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. DESIGN: Prospective cohort study. SETTING: Fourteen-bed medical intensive care unit in an urban university teaching hospital. PATIENTS: 304 consecutive admissions age 60 and older. INTERVENTIONS: None. MAIN OUTCOME MEASUREMENTS: 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. RESULTS: 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). CONCLUSIONS: 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.

Safety and Tolerability of Vacuum Versus Manual Drainage During Thoracentesis: A Randomized Trial.

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 December 2015 through September 2017 to either vacuum or manual drainage. Without using pleural manometry, the effusion was drained completely or until the development of refractory symptoms. Measurements included self-reported pain before and during the procedure (from 0 to 10), time for completion of drainage, and volume removed. Primary outcomes were rates of all-cause complications and of early termination of the procedure with secondary outcomes of change in pain score, drainage time, volume removed, and inverse rate of removal. RESULTS: Patient characteristics in the manual (n=49) and vacuum (n=51) groups were similar. Rate of all-cause complications was higher in the vacuum group (5 vs. 0; P=0.03): pneumothorax (n=3), surgically treated hemothorax with subsequent death (n=1) and reexpansion pulmonary edema causing respiratory failure (n=1), as was rate of early termination (8 vs. 1; P=0.018). The vacuum group exhibited greater pain during drainage (P<0.05), shorter drainage time (P<0.01), no association with volume removed (P>0.05), and lower inverse rate of removal (P≤0.01). CONCLUSION: Despite requiring less time, vacuum aspiration during thoracentesis was associated with higher rates of complication and of early termination of the procedure and greater pain. Although larger studies are needed, this pilot study suggests that manual aspiration provides greater safety and patient comfort.

Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study.

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).

Prevalence of sleep disturbances in a cohort of older drivers.

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.

Characteristics associated with delirium in older patients in a medical intensive care unit.

BACKGROUND: Delirium is a highly prevalent disorder among older patients in the intensive care unit. METHODS: We performed a prospective cohort study of 304 patients 60 years or older admitted from September 5, 2002, through September 30, 2004, to a 14-bed ICU in an urban university teaching hospital. The main outcome measure was ICU delirium that developed within 48 hours of ICU admission. Patients were assessed for delirium with the Confusion Assessment Method for the ICU and medical record review. Risk factors for delirium were assessed on ICU admission by interview with proxies and medical record review. A model was developed using multivariate logistic regression and internally validated with bootstrapping methods. RESULTS: Delirium occurred in 214 study participants (70.4%) within the first 48 hours of ICU admission. In a multivariate regression model, 4 admission risk factors for delirium were identified. These risk factors included dementia (odds ratio [OR], 6.3; 95% confidence interval [CI], 2.9-13.8), receipt of benzodiazepines before ICU admission (OR, 3.4; 95% CI, 1.6-7.0), elevated creatinine level (OR, 2.1; 95% CI, 1.1-4.0), and low arterial pH (OR, 2.1; 95% CI, 1.1-3.9). The C statistic was 0.78. CONCLUSIONS: Delirium is frequent among older ICU patients. Admission characteristics can be important markers for delirium in these patients. Knowledge of these admission risk factors can prompt early correction of metabolic abnormalities and may subsequently reduce delirium duration.

Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study.

Background: We 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. Methods: The 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. Results: For 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. Conclusions: Despite 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.

The use of missingness screens in clinical epidemiologic research has implications for regression modeling.

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.

A randomized trial of a physical conditioning program to enhance the driving performance of older persons.

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 > or = 70 years with physical, but without substantial visual (acuity 20/40 or better) or cognitive (Mini Mental State Examination score > or =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.