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1.  The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU 
Critical care medicine  2013;41(3):800-809.
To determine if a quality improvement (QI) intervention improves sleep and delirium/cognition.
Observational, pre-post design.
A tertiary academic hospital in the US.
300 medical ICU (MICU) patients.
This MICU-wide project involved a “usual care” baseline stage, followed by a QI stage incorporating multi-faceted sleep-promoting interventions implemented with the aid of daily reminder checklists for ICU staff.
Measurements and Main Results
Primary ICU outcomes were perceived sleep quality and noise ratings (measured on a 0-100 scale using the valid and reliable Richards-Campbell Sleep Questionnaire [RCSQ]) and delirium/coma-free days. Secondary outcomes included ICU and hospital length of stay and mortality. Post-ICU measures of cognition and perceived sleep quality were evaluated in an ICU patient subset.
During the baseline and sleep QI stages there were 122 and 178 patients, respectively, with >1 night in the ICU, accounting for 634 and 826 patient-days. Within the groups, 78 (63.9%) and 83 (46.6%) patients received mechanical ventilation. Over the 826 patient-day QI period, checklist item completion rates ranged from 86-94%. In multivariable regression analysis of the QI vs. baseline stages, improvements in overall RCSQ sleep quality ratings did not reach statistical significance, but there were significant improvements in daily noise ratings (mean ± standard deviation: 65.9 ± 26.6 vs. 60.5 ± 26.3, P=0.001), incidence of delirium/coma (odds ratio: 0.46; 95% confidence interval, 0.23-0.89; P=0.02), and daily delirium/coma-free status (odds ratio: 1.64; 95% confidence interval, 1.04-2.58; P=0.03). Improvements in secondary ICU outcomes and post-ICU outcomes did not reach statistical significance.
An ICU-wide QI intervention to improve sleep and delirium is feasible and associated with significant improvements in perceived nighttime noise, incidence of delirium/coma, and daily delirium/coma-free status. Improvement in perceived sleep quality did not reach statistical significance.
PMCID: PMC3579000  PMID: 23314584
Sleep; Intensive Care Unit; Quality Improvement; Richards-Campbell Sleep Questionnaire; Delirium; Cognition; Outcome Assessment
2.  Baseline Quality of Life before Intensive Care: A Comparison of Patient versus Proxy Responses 
Critical care medicine  2010;38(3):855-860.
To compare acute lung injury (ALI) patients’ self-reported, retrospective baseline quality of life (QOL) before their intensive care hospitalization with population norms and retrospective proxy estimates.
Prospective cohort study using the Short Form 36 (SF-36) QOL survey.
13 intensive care units at 4 teaching hospitals in Baltimore, MD, USA.
136 ALI survivors and their designated proxies.
Both patients and proxies were asked to estimate patient baseline QOL before hospital admission using the SF-36 survey.
Measurements and Main Results
Compared to population norms, QOL scores were lower in ALI patients across all 8 domains, but the difference was significantly greater than the minimum clinically important difference in only 2 of 8 domains (Physical Role and General Health). The mean paired difference between patient versus proxy responses revealed no clinically important difference. However, kappa statistics demonstrated only fair to moderate agreement for all domains. Bland-Altman analysis revealed that for all domains, proxies tended to overestimate QOL when patient scores were low and underestimate QOL when patient scores were high.
Retrospective assessment of QOL prior to hospitalization revealed that ALI patients were consistently lower than population norms, but the magnitude of this difference may not be clinically important. Proxy assessments had only fair to moderate agreement with patient assessments. Across all 8 SF-36 QOL domains, proxy responses represented an attenuation of patient QOL estimates.
PMCID: PMC3932297  PMID: 20068465
Critical care; Quality of life; Acute lung injury; Proxy; Respiratory distress syndrome; adult; Health status
3.  Quality of Life Before Intensive Care Using EQ-5D: Patient versus Proxy Responses 
Critical care medicine  2013;41(1):9-14.
To compare patient’s retrospectively reported baseline quality of life before intensive care hospitalization with population norms and proxy reports.
Prospective cohort study.
13 intensive care units at 4 teaching hospitals in Baltimore, MD, USA.
140 acute lung injury survivors and their designated proxies.
Around the time of hospital discharge, both patients and proxies were asked to retrospectively estimate patients' baseline quality of life before hospital admission using the EQ-5D quality of life instrument.
Measurements and Main Results
Mean patient-rated EQ-5D visual analog scale scores and utility scores were significantly lower than population norms, but were significantly higher than proxy ratings. However, the magnitude of difference in average utility scores between patients and either population norms or proxies were not clinically important. For the 5 individual EQ-5D domains, kappa statistics revealed slight to fair agreement between patients and proxies. Bland-Altman plots demonstrated that for both the visual analog scale and utility scores, proxies underestimated scores when patients reported high ratings and overestimated scores for low patient ratings.
Patients retrospectively reported worse baseline health status before acute lung injury than population norms and better status than proxy reports; however, the magnitude of these differences in health status may not be clinically important. Proxies had only slight to fair agreement with patients in all 5 EQ-5D domains, attenuating patients’ more extreme ratings towards moderate scores. Caution is required when interpreting proxy retrospective reports of baseline health status for survivors of acute lung injury.
PMCID: PMC3531666  PMID: 23232287
Critical care; Quality of life; Acute lung injury; Proxy; Respiratory distress syndrome, adult; Health status
4.  Increasing the dose of acute rehabilitation: is there a benefit? 
BMC Medicine  2013;11:199.
Rehabilitation interventions, including physiotherapy and occupational therapy, can improve patient outcomes; however, the optimal duration and frequency of inpatient rehabilitation interventions is uncertain. In a recent randomized controlled trial published in BMC Medicine, 996 patients in two publicly-funded Australian metropolitan rehabilitation facilities were assigned to physiotherapy and occupational therapy delivered Monday through Friday (five days/week control group) versus Monday through Saturday (six days/week intervention group). This increased dose of rehabilitation in the intervention group resulted in greater functional independence and quality of life at discharge, with a trend towards significant improvement at six-month follow-up. Moreover, the length of stay for the intervention group was shorter by two days (95% CI 0 to 4, P = 0.10). Hence, in the acute inpatient rehabilitation setting, a larger dose of physiotherapy and occupational therapy, via six versus five days/week treatment, improves patient outcomes and potentially reduces overall length of stay and costs.
Please see related research:
PMCID: PMC3844507  PMID: 24228867
Occupational therapy; Physical therapy modalities; Rehabilitation; Quality of life; Activities of daily living; Mobility limitation; Length of stay
5.  ICU Exposures for Long-Term Outcomes Research: Development and Description of Exposures for 150 ALI Patients 
Journal of critical care  2007;22(4):275-284.
Long-term follow-up studies in critical care have described survivors’ outcomes, but provided less insight into the patient/disease characteristics and intensive care therapies (“exposures”) associated with these outcomes. Such insights are essential for improving patients’ long-term outcomes. This report describes the development of a strategy for comprehensively measuring relevant exposures for long-term outcomes research, and presents empirical results from its implementation.
Materials and Methods
A multi-step, iterative process was used to develop the exposures strategy. First, a comprehensive list of potential exposures was generated and subsequently reduced based on feasibility, redundancy, and relevance criteria. Next, data abstraction methods were designed and tested. Finally, the strategy was implemented in 150 acute lung injury patients with iterative refinement.
The strategy resulted in development of >60 unique exposures requiring <45 minutes per patient-day for data collection. The vast majority of exposures had minimal missing data and adequate reliability. These data revealed that evidence-based practices including lower tidal volume ventilation, spontaneous breathing trials, sedation interruption, adequate nutrition, and blood glucose <6.1 mmol/L (110 mg/dl) occurred in only 23%-50% of assessments.
Using a multi-step, iterative process, a comprehensive and feasible exposure measurement strategy for long-term outcomes research was successfully developed and implemented.
PMCID: PMC3678945  PMID: 18086397
6.  Patient-Nurse Interrater Reliability and Agreement of the Richards-Campbell Sleep Questionnaire 
The Richards-Campbell Sleep Questionnaire (RCSQ) is a simple, validated survey instrument for measuring sleep quality in intensive care patients. Although both patients and nurses can complete the RCSQ, interrater reliability and agreement have not been fully evaluated.
To evaluate patient-nurse interrater reliability and agreement of the RCSQ in a medical intensive care unit.
The instrument included 5 RCSQ items plus a rating of nighttime noise, each scored by using a 100-mm visual analogue scale. The mean of the 5 RCSQ items comprised a total score. For 24 days, the night-shift nurses in the medical intensive care unit completed the RCSQ regarding their patients’ overnight sleep quality. Upon awakening, all conscious, nondelirious patients completed the RCSQ. Neither nurses nor patients knew the others’ ratings. Patient-nurse agreement was evaluated by using mean differences and Bland-Altman plots. Reliability was evaluated by using intraclass correlation coefficients.
Thirty-three patients had a total of 92 paired patient-nurse assessments. For all RCSQ items, nurses’ scores were higher (indicating “better” sleep) than patients’ scores, with significantly higher ratings for sleep depth (mean [SD], 67 [21] vs 48 [35], P = .001), awakenings (68 [21] vs 60 [33], P = .03), and total score (68 [19] vs 57 [28], P = .01). The Bland-Altman plots also showed that nurses’ ratings were generally higher than patients’ ratings. Intraclass correlation coefficients of patient-nurse pairs ranged from 0.13 to 0.49 across the survey questions.
Patient-nurse interrater reliability on the RCSQ was “slight” to “moderate,” with nurses tending to overestimate patients’ perceived sleep quality.
PMCID: PMC3667655  PMID: 22751369
7.  Occupational Therapy for Patients With Acute Lung Injury: Factors Associated With Time to First Intervention in the Intensive Care Unit 
Very early occupational therapy intervention in the intensive care unit improved the physical recovery of 514 consecutive patients with acute lung injury.
OBJECTIVE. Very early occupational therapy intervention in the intensive care unit (ICU) improves patients’ physical recovery. We evaluated the association of patient, ICU, and hospital factors with time to first occupational therapy intervention in ICU patients with acute lung injury (ALI).
METHOD. We conducted a prospective cohort study of 514 consecutive patients with ALI from 11 ICUs in three hospitals in Baltimore, MD.
RESULTS. Only 30% of patients ever received occupational therapy during their ICU stay. Worse organ failure, continuous hemodialysis, and uninterrupted continuous infusion of sedation were independently associated with delayed occupational therapy initiation, and hospital study site and admission to a trauma ICU were independently associated with earlier occupational therapy.
CONCLUSION. Severity of illness and ICU practices for sedation administration were associated with delayed occupational therapy. Both hospital study site and type of ICU were independently associated with timing of occupational therapy, indicating modifiable environmental factors for promoting early occupational therapy in the ICU.
PMCID: PMC3722660  PMID: 23597694
acute lung injury; critical care; health services research; occupational therapy; rehabilitation; time factors
8.  Depressive Symptoms and Impaired Physical Function after Acute Lung Injury 
Rationale: Survivors of acute lung injury (ALI) frequently have substantial depressive symptoms and physical impairment, but the longitudinal epidemiology of these conditions remains unclear.
Objectives: To evaluate the 2-year incidence and duration of depressive symptoms and physical impairment after ALI, as well as risk factors for these conditions.
Methods: This prospective, longitudinal cohort study recruited patients from 13 intensive care units (ICUs) in four hospitals, with follow-up 3, 6, 12, and 24 months after ALI. The outcomes were Hospital Anxiety and Depression Scale depression score greater than or equal to 8 (“depressive symptoms”) in patients without a history of depression before ALI, and two or more dependencies in instrumental activities of daily living (“impaired physical function”) in patients without baseline impairment.
Measurements and Main Results: During 2-year follow-up of 186 ALI survivors, the cumulative incidences of depressive symptoms and impaired physical function were 40 and 66%, respectively, with greatest incidence by 3-month follow-up; modal durations were greater than 21 months for each outcome. Risk factors for incident depressive symptoms were education 12 years or less, baseline disability or unemployment, higher baseline medical comorbidity, and lower blood glucose in the ICU. Risk factors for incident impaired physical function were longer ICU stay and prior depressive symptoms.
Conclusions: Incident depressive symptoms and impaired physical function are common and long-lasting during the first 2 years after ALI. Interventions targeting potentially modifiable risk factors (e.g., substantial depressive symptoms in early recovery) should be evaluated to improve ALI survivors’ long-term outcomes.
PMCID: PMC3297105  PMID: 22161158
depression; recovery of function; critical illness; critical care; acute lung injury
9.  Does ICU Severity of Illness Influence Recall of Baseline Physical Function? 
Journal of critical care  2011;26(6):634.e1-634.e7.
To evaluate if severity of illness in the intensive care unit influences patients' retrospective recall of their baseline physical function from prior to hospital admission.
Materials and Methods
A prospective cohort study of 193 acute lung injury (ALI) survivors who, prior to hospital discharge, retrospectively reported their pre-hospitalization physical function using the SF-36 quality of life survey.
Four measures were used to evaluate ICU severity of illness: (1) Acute Physiology and Chronic Health Evaluation II Acute Physiologic Score at ICU admission, (2) Lung Injury Score at ALI diagnosis, (3) Sequential Organ Failure Assessment (SOFA) score at study enrollment, and (4) maximum daily SOFA score during the entire ICU stay. In multivariable linear regression analysis, no measure of severity of illness was associated with prehospitalization Physical Function. Education level significantly modified the relationship between ICU severity of illness and baseline Physical Function with lower educational attainment having a stronger association with baseline physical function.
ICU severity of illness was not associated with patients' retrospectively recalled baseline physical function. Patients with a lower level of education maybe more influenced by ICU severity of illness, but the magnitude of this effect may not be clinically meaningful.
PMCID: PMC3191318  PMID: 21737233
Critical care; Quality of life; Respiratory distress syndrome, adult; Health status; Mental recall; Bias, epidemiologic
10.  Repeated Attempts using Different Strategies are Important for Timely Contact with Study Participants 
Journal of clinical epidemiology  2010;64(10):1144-1151.
To study the effect of different mail- and phone-based strategies, along with patient- and research-related factors, on the time to contact with research participants.
Study Design and Setting
A prospective evaluation of a 12-week standardized protocol (embedded with two randomized trials of mail- and phone-based strategies) for contacting existing research participants for recruitment into a related study.
Of 146 participants, 87 were eligible for contact via the standardized protocol and 63 (72%) of these were successfully contacted within 12 weeks after multiple mail- and phone-based efforts. Using Cox proportional hazards regression analysis, the different mail and phone strategies showed no significant difference in the time to contact with participants. Of 34 patient- and research-related factors evaluated, only 2 were independently associated with time to contact among all 146 participants: (1) participants having their last visit conducted outside of the research clinic due to patient illness/condition had a longer time to contact; and (2) those with a self-reported chronic fatigue history had a shorter time to contact.
Few patient characteristics and research-related factors accurately predict time to contact. Repeated attempts using different strategies are important to successful and timely contact with study participants.
PMCID: PMC3116960  PMID: 21109398
patient selection; risk factors; cohort studies; patient participation; respiratory distress syndrome, adult
11.  The functional comorbidity index had high inter-rater reliability in patients with acute lung injury 
BMC Anesthesiology  2012;12:21.
The Functional Comorbidity Index (FCI) was recently developed to predict physical function in acute lung injury patients using comorbidity data. Our objectives were to determine: (1) the inter-rater reliability of the FCI collected using in-patient discharge summaries (primary objective); and (2) the accuracy and predictive validity of the FCI collected using hospital discharge summaries and admission records versus complete chart review (secondary objectives).
For reliability, we evaluated the FCI’s intraclass correlation coefficient (ICC) among trained research staff performing data collection for 421 acute lung injury patients enrolled in a prospective cohort study. For validity and accuracy, we compared the detection of FCI comorbidities across three types of inpatient medical records, and the association of the respective FCI scores obtained with patients’ SF-36 physical function subscale (PFS) scores at 1-year follow-up.
Inter-rater reliability was near-perfect (ICC 0.91; 95% CI 0.89-0.94). Hospital admission records and discharge summaries (vs. complete chart review) significantly underestimated the total FCI score. However, using multivariable linear regression, FCI scores collected using each of the three types of inpatient medical records had similar associations with PFS, suggesting similar predictive value.
Data collection using in-patient discharge summaries represents a reliable and valid method for collecting FCI comorbidity information.
PMCID: PMC3517372  PMID: 22974239
Comorbidity; Intensive care unit; Reproducibility of results; Respiratory distress syndrome, Adult
12.  Short-Term Mortality Prediction for Acute Lung Injury Patients: External Validation of the ARDSNet Prediction Model 
Critical care medicine  2011;39(5):1023-1028.
An independent cohort of acute lung injury (ALI) patients was used to evaluate the external validity of a simple prediction model for short-term mortality previously developed using data from ARDS Network (ARDSNet) trials.
Design, Setting, and Patients
Data for external validation were obtained from a prospective cohort study of ALI patients from 13 ICUs at four teaching hospitals in Baltimore, Maryland.
Measurements and Main Results
Of the 508 non-trauma, ALI patients eligible for this analysis, 234 (46%) died in-hospital. Discrimination of the ARDSNet prediction model for inhospital mortality, evaluated by the area under the receiver operator characteristics curves (AUC), was 0.67 for our external validation dataset versus 0.70 and 0.68 using APACHE II and the ARDSNet validation dataset, respectively. In evaluating calibration of the model, predicted versus observed in-hospital mortality for the external validation dataset was similar for both low risk (ARDSNet model score = 0) and high risk (score = 3 or 4+) patient strata. However, for intermediate risk (score = 1 or 2) patients, observed in-hospital mortality was substantially higher than predicted mortality (25.3% vs. 16.5% and 40.6% vs. 31.0% for score = 1 and 2, respectively). Sensitivity analyses limiting our external validation data set to only those patients meeting the ARDSNet trial eligibility criteria and to those who received mechanical ventilation in compliance with the ARDSNet ventilation protocol, did not substantially change the model’s discrimination or improve its calibration.
Evaluation of the ARDSNet prediction model using an external ALI cohort demonstrated similar discrimination of the model as was observed with the ARDSNet validation dataset. However, there were substantial differences in observed versus predicted mortality among intermediate risk ALI patients. The ARDSNet model provided reasonable, but imprecise, estimates of predicted mortality when applied to our external validation cohort of ALI patients.
PMCID: PMC3129473  PMID: 21761595
respiratory distress syndrome; adult; statistical model; mortality determinants; prognosis; health status indicators; intensive care units
13.  Estimating the Causal Effect of Low Tidal Volume Ventilation on Survival in Patients with Acute Lung Injury† 
Acute lung injury (ALI) is a condition characterized by acute onset of severe hypoxemia and bilateral pulmonary infiltrates. ALI patients typically require mechanical ventilation in an intensive care unit. Low tidal volume ventilation (LTVV), a time-varying dynamic treatment regime, has been recommended as an effective ventilation strategy. This recommendation was based on the results of the ARMA study, a randomized clinical trial designed to compare low vs. high tidal volume strategies (The Acute Respiratory Distress Syndrome Network, 2000) . After publication of the trial, some critics focused on the high non-adherence rates in the LTVV arm suggesting that non-adherence occurred because treating physicians felt that deviating from the prescribed regime would improve patient outcomes. In this paper, we seek to address this controversy by estimating the survival distribution in the counterfactual setting where all patients assigned to LTVV followed the regime. Inference is based on a fully Bayesian implementation of Robins’ (1986) G-computation formula. In addition to re-analyzing data from the ARMA trial, we also apply our methodology to data from a subsequent trial (ALVEOLI), which implemented the LTVV regime in both of its study arms and also suffered from non-adherence.
PMCID: PMC3197806  PMID: 22025809
Bayesian inference; Causal inference; Dynamic treatment regime; G-computation formula
14.  Early Physical Rehabilitation in the ICU: A Review for the Neurohospitalist 
The Neurohospitalist  2012;2(3):96-105.
Advances in critical care have resulted in improved intensive care unit (ICU) mortality. However, improved ICU survival has resulted in a growing number of ICU survivors living with long-term sequelae of critical illness, such as impaired physical function and quality of life (QOL). In addition to critical illness, prolonged bed rest and immobility may lead to severe physical deconditioning and loss of muscle mass and muscle weakness. ICU-acquired weakness is associated with increased duration of mechanical ventilation and weaning, longer ICU and hospital stay, and increased mortality. These physical impairments may last for years after ICU discharge. Early Physical Medicine and Rehabilitation (PM&R) interventions in the ICU may attenuate or prevent the weakness and physical impairments occurring during critical illness. This article reviews the evidence regarding safety, feasibility, barriers, and benefits of early PM&R interventions in ICU patients and discusses the limited existing data on early PM&R in the neurological ICU and future directions for early PM&R in the ICU.
PMCID: PMC3726090  PMID: 23983871
bed rest; deconditioning; early ICU rehabilitation; early Neuro-ICU rehabilitation; feasibility; immobility; muscle weakness; outcomes; safety
15.  Early mobilisation of intensive care unit patient: the challenges of morbid obesity and multiorgan failure 
BMJ Case Reports  2010;2010:bcr09.2009.2257.
A 44-year-old morbidly obese (body mass index 69 kg/m2) woman presented to our medical intensive care unit (ICU) with septic shock and multiorgan failure requiring mechanical ventilation, a vasopressor infusion, and haemodialysis. Before this admission, the patient reported being able to ambulate approximately 3 m with a walker. Intensive physical therapy was started on ICU day 2, and the patient was successfully mobilised throughout her ICU stay despite the extreme challenges posed by her morbid obesity and critical illness. After only a 9 day stay, the patient was discharged directly home from the medical ICU, walking a total distance of 37 m in a single physical therapy session.
PMCID: PMC3027523  PMID: 22461852
16.  Sleep Deprivation in Critical Illness: Its Role in Physical and Psychological Recovery 
Critically ill patients frequently experience poor sleep, characterized by frequent disruptions, loss of circadian rhythms, and a paucity of time spent in restorative sleep stages. Factors that are associated with sleep disruption in the intensive care unit (ICU) include patient-ventilator dysynchrony, medications, patient care interactions, and environmental noise and light. As the field of critical care increasingly focuses on patients' physical and psychological outcomes following critical illness, understanding the potential contribution of ICU-related sleep disruption on patient recovery is an important area of investigation. This review article summarizes the literature regarding sleep architecture and measurement in the critically ill, causes of ICU sleep fragmentation, and potential implications of ICU-related sleep disruption on patients' recovery from critical illness. With this background information, strategies to optimize sleep in the ICU are also discussed.
PMCID: PMC3299928  PMID: 21220271
sleep; sleep deprivation; intensive care unit; mental health; outcomes
17.  Inter-rater reliability of manual muscle strength testing in ICU survivors and simulated patients 
Intensive care medicine  2010;36(6):1038-1043.
The goal of the paper is to determine inter-rater reliability of trained examiners performing standardized strength assessments using manual muscle testing (MMT).
Design, subjects, and setting
The authors report on 19 trainees undergoing quality assurance within a multi-site prospective cohort study.
Inter-rater reliability for specially trained evaluators (“trainees”) and a reference rater, performing MMT using both simulated and actual patients recovering from critical illness was evaluated.
Measurements and results
Across 26 muscle groups tested by 19 trainee-reference rater pairs, the median (interquartile range) percent agreement and intraclass correlation coefficient (ICC; 95% CI) were: 96% (91, 98%) and 0.98 (0.95, 1.00), respectively. Across all 19 pairs, the ICC (95% CI) for the overall composite MMT score was 0.99 (0.98–1.00). When limited to actual patients, the ICC was 1.00 (95% CI 0.99–1.00). The agreement (kappa; 95% CI) in detecting clinically significant weakness was 0.88 (0.44–1.00).
MMT has excellent inter-rater reliability in trained examiners and is a reliable method of comprehensively assessing muscle strength.
PMCID: PMC2891143  PMID: 20213068
Diagnostic techniques and procedures; Epidemiologic research design; Muscle strength; Muscle weakness; Physical examination; Reproducibility of results
18.  Beyond Mortality 
Mortality in National Heart, Lung and Blood Institute–sponsored clinical trials of treatments for acute lung injury (ALI) has decreased dramatically during the past two decades. As a consequence, design of such trials based on a mortality outcome requires ever-increasing numbers of patients. Recognizing that advances in clinical trial design might be applicable to these trials and might allow trials with fewer patients, the National Heart, Lung and Blood Institute convened a workshop of extramural experts from several disciplines. The workshop assessed the current state of clinical research addressing ALI, identified research needs, and recommended: (1) continued performance of trials evaluating treatments of patients with ALI; (2) development of strategies to perform ALI prevention trials; (3) observational studies of patients without ALI undergoing prolonged mechanical ventilation; and (4) development of a standardized format for reporting methods, endpoints, and results of ALI trials.
PMCID: PMC2874454  PMID: 20224063
clinical trials; acute respiratory distress syndrome; pulmonary diseases; edema; inflammation
19.  Impact of a statewide intensive care unit quality improvement initiative on hospital mortality and length of stay: retrospective comparative analysis 
Objective To evaluate whether implementation of the Michigan Keystone ICU project, a comprehensive statewide quality improvement initiative focused on reduction of infections, was associated with reductions in hospital mortality and length of stay for adults aged 65 or more admitted to intensive care units.
Design Retrospective comparative study, using data from Medicare claims.
Setting Michigan and Midwest region, United States.
Population The study period (October 2001 to December 2006) spanned two years before the project was initiated to 22 months after its implementation. The study sample included hospital admissions for patients treated in 95 study hospitals in Michigan (238 937 total admissions) compared with 364 hospitals in the surrounding Midwest region (1 091 547 total admissions).
Main outcome measures Hospital mortality and length of hospital stay.
Results The overall trajectory of mortality outcomes differed significantly between the two groups upon implementation of the project (Wald test χ2=8.73, P=0.033). Reductions in mortality were significantly greater for the study group than for the comparison group 1-12 months (odds ratio 0.83, 95% confidence interval 0.79 to 0.87 v 0.88, 0.85 to 0.90, P=0.041) and 13-22 months (0.76, 0.72 to 0.81 v 0.84, 0.81 to 0.86, P=0.007) after implementation of the project. The overall trajectory of length of stay did not differ significantly between the groups upon implementation of the project (Wald test χ2=2.05, P=0.560). Group differences in adjusted length of stay compared with baseline did not reach significance during implementation of the project (−0.45 days, 95% confidence interval −0.62 to −0.28 v −0.35, −0.52 to −0.19) or during post-implementation months 1-12 (−0.59, −0.80 to −0.37 v −0.42, −0.59 to −0.25) and 13-22 (−0.67, −0.91 to −0.43 v −0.54, −0.72 to −0.37).
Conclusions Implementation of the Keystone ICU project was associated with a significant decrease in hospital mortality in Michigan compared with the surrounding area. The project was not, however, sufficiently powered to show a significant difference in length of stay.
PMCID: PMC3031651  PMID: 21282262
20.  A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial 
Advances in resuscitation science have dramatically improved survival rates following cardiac arrest. However, about 60% of adults that regain spontaneous circulation die before leaving the hospital. Recently it has been shown that inducing hypothermia in cardiac arrest survivors immediately following their arrival in hospital can dramatically improve both overall survival and neurological outcomes. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that therapeutic hypothermia is delivered inconsistently, incompletely, and often with delay.
Methods and design
This study will evaluate a multi-faceted knowledge translation strategy designed to increase the utilization rate of induced hypothermia in survivors of cardiac arrest across a network of 37 hospitals in Southwestern Ontario, Canada. The study is designed as a stepped wedge randomized trial lasting two years. Individual hospitals will be randomly assigned to four different wedges that will receive the active knowledge translation strategy according to a sequential rollout over a number of time periods. By the end of the study, all hospitals will have received the intervention. The primary aim is to measure the effectiveness of a multifaceted knowledge translation plan involving education, reminders, and audit-feedback for improving the use of induced hypothermia in survivors of cardiac arrest presenting to the emergency department. The primary outcome is the proportion of eligible OHCA patients that are cooled to a body temperature of 32 to 34°C within six hours of arrival in the hospital. Secondary outcomes will include process of care measures and clinical outcomes.
Inducing hypothermia in cardiac arrest survivors immediately following their arrival to hospital has been shown to dramatically improve both overall survival and neurological outcomes. However, this lifesaving treatment is frequently not applied in practice. If this trial is positive, our results will have broad implications by showing that a knowledge translation strategy shared across a collaborative network of hospitals can increase the number of patients that receive this lifesaving intervention in a timely manner.
Trial Registration Trial Identifier: NCT00683683
PMCID: PMC3031244  PMID: 21235799
21.  Deciding who to admit to a critical care unit 
BMJ : British Medical Journal  2007;335(7630):1103-1104.
Scarce resources may cause doctors to be pessimistic about prognosis and refuse critical care admissions
PMCID: PMC2099542  PMID: 17975253
22.  Are Intensive Care Factors Associated with Depressive Symptoms Six Months after Acute Lung Injury? 
Critical care medicine  2009;37(5):1702-1707.
To evaluate intensive care-related factors as predictors of depressive symptoms 6 months after acute lung injury (ALI)
Prospective cohort study
Thirteen intensive care units (ICUs) in 4 hospitals in Baltimore, MD
Consecutive ALI survivors (n = 160; 71% from medical ICUs) screened for depressive symptoms at six months post-ALI
Measurements and Main Results
We prospectively measured 12 features of critical illness and ICU care and used multivariable regression to evaluate associations with depressive symptoms as measured by the Hospital Anxiety and Depression (HAD) depression score. The prevalence of a positive screening for depression (score ≥8) at 6 months post-ALI was 26%. Depressive symptoms were significantly associated with surgical (versus medical or trauma) ICU admission (relative risk [RR] 2.2, 95% confidence interval [CI] 1.1 – 4.2), maximum daily Sequential Organ Failure Assessment score of >10 (RR 2.1, 95% CI 1.1 – 3.5), and mean daily ICU benzodiazepine dose of ≥75mg of midazolam-equivalent (RR 2.1, 95% CI 1.1 – 3.5).
Depressive symptoms at 6 months post-ALI are common and potentially associated with ICU-related factors. Mechanisms by which critical illness and intensive care management associate with depressive symptoms merit further investigation.
PMCID: PMC2769249  PMID: 19357507
depression; intensive care units; respiratory distress syndrome; adult; critical care; outcome assessment (health care)
23.  Pulmonary vs Nonpulmonary Sepsis and Mortality in Acute Lung Injury 
Chest  2008;134(3):534-538.
Acute lung injury (ALI) is a frequent complication of sepsis. It is unclear if a pulmonary vs nonpulmonary source of sepsis affects mortality in patients with sepsis-induced ALI.
Two hundred eighty-eight consecutive patients with sepsis-induced ALI from 14 ICUs at four hospitals in Baltimore,MDwere prospectively classified as having a pulmonary vs nonpulmonary source of sepsis. Multiple logistic regression was conducted to evaluate the independent association of a pulmonary vs nonpulmonary source of sepsis with inpatient mortality.
In an unadjusted analysis, in-hospital mortality was lower for pulmonary vs nonpulmonary source of sepsis (42% vs 66%, p < 0.0001). Patients with pulmonary sepsis had lower acute physiology and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores, shorter ICU stays prior to the development of ALI, and higher lung injury scores. In the adjusted analysis, several factors were predictive of mortality: age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01 to 1.06), Charlson comorbidity index (OR, 1.15; 95% CI, 1.02 to 1.30), ICU length of stay prior to ALI diagnosis (OR, 1.19; 95% CI, 1.01 to 1.39), APACHE II score (OR, 1.07; 95% CI, 1.03 to 1.12), lung injury score (OR, 1.64; 95% CI, 1.11 to 2.43), SOFA score (OR, 1.15; 95% CI, 1.06 to 1.26), and cumulative fluid balance in the first 7 days after ALI diagnosis (OR, 1.06; 95% CI, 1.03 to 1.10). A pulmonary vs nonpulmonary source of sepsis was not independently associated with mortality (OR, 0.72; 95% CI, 0.38 to 1.35).
Although lower mortality was observed for ALI patients with a pulmonary vs nonpulmonary source of sepsis, this finding is likely due to a lower severity of illness in those with pulmonary sepsis. Pulmonary vs nonpulmonary source of sepsis was not independently predictive of mortality for patients with ALI.
PMCID: PMC2849158  PMID: 18641112
ARDS; critical illness; mortality; sepsis
24.  Improving data quality control in quality improvement projects 
The results of many quality improvement (QI) projects are gaining wide-spread attention. Policy-makers, hospital leaders and clinicians make important decisions based on the assumption that QI project results are accurate. However, compared with clinical research, QI projects are typically conducted with substantially fewer resources, potentially impacting data quality. Our objective was to provide a primer on basic data quality control methods appropriate for QI efforts.
Data quality control methods should be applied throughout all phases of a QI project. In the design phase, project aims should guide data collection decisions, emphasizing quality (rather than quantity) of data and considering resource limitations. In the data collection phase, standardized data collection forms, comprehensive staff training and a well-designed database can help maximize the quality of the data. Clearly defined data elements, quality assurance reviews of both collection and entry and system-based controls reduce the likelihood of error. In the data management phase, missing data should be quickly identified and corrected with system-based controls to minimize the missing data. Finally, in the data analysis phase, appropriate statistical methods and sensitivity analysis aid in managing and understanding the effects of missing data and outliers, in addressing potential confounders and in conveying the precision of results.
Data quality control is essential to ensure the integrity of results from QI projects. Feasible methods are available and important to help ensure that stakeholder's decisions are based on accurate data.
PMCID: PMC2734082  PMID: 19218334
data quality; research design; data reporting; quality controls
25.  Sustaining reductions in catheter related bloodstream infections in Michigan intensive care units: observational study 
Objectives To evaluate the extent to which intensive care units participating in the initial Keystone ICU project sustained reductions in rates of catheter related bloodstream infections.
Design Collaborative cohort study to implement and evaluate interventions to improve patients’ safety.
Setting Intensive care units predominantly in Michigan, USA.
Intervention Conceptual model aimed at improving clinicians’ use of five evidence based recommendations to reduce rates of catheter related bloodstream infections rates, with measurement and feedback of infection rates. During the sustainability period, intensive care unit teams were instructed to integrate this intervention into staff orientation, collect monthly data from hospital infection control staff, and report infection rates to appropriate stakeholders.
Main outcome measures Quarterly rate of catheter related bloodstream infections per 1000 catheter days during the sustainability period (19-36 months after implementation of the intervention).
Results Ninety (87%) of the original 103 intensive care units participated, reporting 1532 intensive care unit months of data and 300 310 catheter days during the sustainability period. The mean and median rates of catheter related bloodstream infection decreased from 7.7 and 2.7 (interquartile range 0.6-4.8) at baseline to 1.3 and 0 (0-2.4) at 16-18 months and to 1.1 and 0 (0.0-1.2) at 34-36 months post-implementation. Multilevel regression analysis showed that incidence rate ratios decreased from 0.68 (95% confidence interval 0.53 to 0.88) at 0-3 months to 0.38 (0.26 to 0.56) at 16-18 months and 0.34 (0.24-0.48) at 34-36 months post-implementation. During the sustainability period, the mean bloodstream infection rate did not significantly change from the initial 18 month post-implementation period (−1%, 95% confidence interval −9% to 7%).
Conclusions The reduced rates of catheter related bloodstream infection achieved in the initial 18 month post-implementation period were sustained for an additional 18 months as participating intensive care units integrated the intervention into practice. Broad use of this intervention with achievement of similar results could substantially reduce the morbidity and costs associated with catheter related bloodstream infections.
PMCID: PMC2816728  PMID: 20133365

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