Robert Welsh

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.

Outcomes After Stereotactic Lung Radiotherapy or Wedge Resection for Stage I Non–Small-Cell Lung Cancer

PURPOSE To compare outcomes between lung stereotactic radiotherapy (SBRT) and wedge resection for stage I non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS One hundred twenty-four patients with T1-2N0 NSCLC underwent wedge resection (n = 69) or image-guided lung SBRT (n = 58) from February 2003 through August 2008. All were ineligible for anatomic lobectomy; of those receiving SBRT, 95% were medically inoperable, with 5% refusing surgery. Mean forced expiratory volume in 1 second and diffusing capacity of lung for carbon monoxide were 1.39 L and 12.0 mL/min/mmHg for wedge versus 1.31 L and 10.14 mL/min/mmHg for SBRT (P = not significant). Mean Charlson comorbidity index and median age were 3 and 74 years for wedge versus 4 and 78 years for SBRT (P < .01, P = .04). SBRT was volumetrically prescribed as 48 (T1) or 60 (T2) Gy in four to five fractions. Results Median potential follow-up is 2.5 years. At 30 months, no significant differences were identified in regional recurrence (RR), locoregional recurrence (LRR), distant metastasis (DM), or freedom from any failure (FFF) between the two groups (P > .16). SBRT reduced the risk of local recurrence (LR), 4% versus 20% for wedge (P = .07). Overall survival (OS) was higher with wedge but cause-specific survival (CSS) was identical. Results excluding synchronous primaries, nonbiopsied tumors, or pathologic T4 disease (wedge satellite lesion) showed reduced LR (5% v 24%, P = .05), RR (0% v 18%, P = .07), and LRR (5% v 29%, P = .03) with SBRT. There were no differences in DM, FFF, or CSS, but OS was higher with wedge. CONCLUSION Both lung SBRT and wedge resection are reasonable treatment options for stage I NSCLC patients ineligible for anatomic lobectomy. SBRT reduced LR, RR, and LRR. In this nonrandomized population of patients selected for surgery versus SBRT (medically inoperable) at physician discretion, OS was higher in surgical patients. SBRT and surgery, however, had identical CSS.

Improving patient safety in intensive care units in Michigan.

PURPOSE The aim of this study was to describe the design and lessons learned from implementing a large-scale patient safety collaborative and the impact of an intervention on teamwork climate in intensive care units (ICUs) across the state of Michigan. MATERIALS AND METHODS This study used a collaborative model for improvement involving researchers from the Johns Hopkins University and Michigan Health and Hospital Association. A quality improvement team in each ICU collected and submitted baseline data and implemented quality improvement interventions. Primary outcome measures were improvements in safety culture scores using the Teamwork Climate Scale of the Safety Attitudes Questionnaire (SAQ); 99 ICUs provided baseline SAQ data. Baseline performance for adherence to evidence-based interventions for ventilated patients is also reported. The intervention to improve safety culture was the comprehensive unit-based safety program. The rwg statistic measures the extent to which there is a group consensus. RESULTS Overall response rate for the baseline SAQ was 72%. Statistical tests confirmed that teamwork climate scores provided a valid measure of teamwork climate consensus among caregivers in an ICU, mean rwg was 0.840 (SD = 0.07). Teamwork climate varied significantly among ICUs at baseline (F98, 5325 = 5.90, P < .001), ranging from 16% to 92% of caregivers in an ICU reporting good teamwork climate. A subset of 72 ICUs repeated the culture assessment in 2005, and a 2-tailed paired samples t test showed that teamwork climate improved from 2004 to 2005, t(71) = -2.921, P < .005. Adherence to using evidence-based interventions ranged from a mean of 25% for maintaining glucose at 110 mg/dL or less to 89% for stress ulcer prophylaxis. CONCLUSION This study describes the first statewide effort to improve patient safety in ICUs. The use of the comprehensive unit-based safety program was associated with significant improvements in safety culture. This collaborative may serve as a model to implement feasible and methodologically rigorous methods to improve and sustain patient safety on a larger scale.

Collaborative Cohort Study of an Intervention to Reduce Ventilator-Associated Pneumonia in the Intensive Care Unit

OBJECTIVE To evaluate the impact of a multifaceted intervention on compliance with evidence-based therapies and ventilator-associated pneumonia (VAP) rates. DESIGN Collaborative cohort before-after study. SETTING Intensive care units (ICUs) predominantly in Michigan. INTERVENTIONS We implemented a multifaceted intervention to improve compliance with 5 evidence-based recommendations for mechanically ventilated patients and to prevent VAP. A standardized CDC definition of VAP was used and maintained at each site, and data on the number of VAPs and ventilator-days were obtained from the hospitals infection preventionists. Baseline data were reported and postimplementation data were reported for 30 months. VAP rates (in cases per 1,000 ventilator-days) were calculated as the proportion of ventilator-days per quarter in which patients received all 5 therapies in the ventilator care bundle. Two interventions to improve safety culture and communication were implemented first. RESULTS One hundred twelve ICUs reporting 3,228 ICU-months and 550,800 ventilator-days were included. The overall median VAP rate decreased from 5.5 cases (mean, 6.9 cases) per 1,000 ventilator-days at baseline to 0 cases (mean, 3.4 cases) at 16-18 months after implementation (P < .001) and 0 cases (mean, 2.4 cases) at 28-30 months after implementation (P < .001). Compared to baseline, VAP rates decreased during all observation periods, with incidence rate ratios of 0.51 (95% confidence interval, 0.41-0.64) at 16-18 months after implementation and 0.29 (95% confidence interval, 0.24-0.34) at 28-30 months after implementation. Compliance with evidence-based therapies increased from 32% at baseline to 75% at 16-18 months after implementation (P < .001) and 84% at 28-30 months after implementation (P < .001). CONCLUSIONS A multifaceted intervention was associated with an increased use of evidence-based therapies and a substantial (up to 71%) and sustained (up to 2.5 years) decrease in VAP rates.

Implementing Standardized Operating Room Briefings and Debriefings at a Large Regional Medical Center

BACKGROUND Effective communication and teamwork are critical in many health care settings, particularly the operating room (OR). Several studies have implicated failures of communication and teamwork as the root cause in a high proportion of sentinel events in the OR. METHODS In a prospective cohort study at a high-volume teaching, research, and tertiary care referral hospital, a standardized one-page briefing and debriefing tool was developed and implemented in October 2006 to improve interdisciplinary communication and teamwork in the OR. The briefing portion of the tool was completed by the surgical team after the patients final positioning and before incision; the debriefing portion was initiated and completed by the circulating nurse after the first counts were conducted. Compliance was calculated as the number of cases where the briefing and debriefing tool was completed divided by the total number of eligible cases. Surveys (n=40) were conducted to elicit caregiver perceptions of interdisciplinary communication and teamwork in the OR and the burden and average time taken to complete the briefing and debriefing tool. RESULTS Between October 2006 and March 2008, 37,133 briefings and debriefings were conducted. Average compliance varied over time since implementation, with overall compliance ranging from 76% to 95%. The majority of caregivers perceived that the briefing and debriefing tool improved interdisciplinary communication and teamwork. On average, it took 2.9 minutes (range, 1-5 minutes) to complete the briefing portion of the tool and 2.5 minutes (range, 1-5 minutes) to complete the debriefing portion. DISCUSSION Implementation of a standardized briefing and debriefing tool in a large regional medical center was a, practical and feasible strategy to improve perceptions of interdisciplinary communication and teamwork in the OR.

Wedge resection margin distances and residual adenocarcinoma in lobectomy specimens.

We studied 31 T1 N0 M0 peripheral adenocarcinomas diagnosed by wedge resection and treated by lobectomy. Factors recorded were pleural surface-based, gross cut-surface, and microscopic margin distances; morphologic features of the adenocarcinomas; microscopic extension distance of beyond gross perimeter of neoplasm; and presence of residual adenocarcinoma in the lobectomy specimen. All staple-line margins in the wedge and lobectomy specimens underwent complete histologic examination. The mean pleural surface-based, gross cut-surface, and microscopic margin distances in wedge resections were 13.1, 4.1, and 2.3 mm, respectively. The mean microscopic wedge resection margin distance was 11 mm smaller than the pleural surface-based measured margin. The mean microscopic lepidic growth beyond the gross perimeter of the neoplasm was 7.4 mm. Fourteen lobectomy specimens (45%) included adenocarcinoma. The mean microscopic wedge resection specimen margin distances in cases with and without residual adenocarcinoma in the lobectomy specimens were 0.7 and 2.4 mm, respectively (P < .001). Incomplete excision may contribute to higher locoregional recurrence rates following limited resection surgery. Two processes affected wedge resection margin distances: stapling-induced parenchymal stretching, resulting in overestimation of pleural surface-based distances, and microscopic extension of adenocarcinoma beyond the gross perimeter of the neoplasm.

Age, tumor size, type of surgery, and gender predict survival in early stage (stage I and II) non-small cell lung cancer after surgical resection

BACKGROUND Even after presumably curative resection the 5-year survival rates are only 60-80% in stage I and 40-50% in stage II NSCLC. Purpose of the present study was the identification of independent clinico-pathological predictors of their survival. METHODS A retrospective review of 519 consecutive subjects who had undergone attempted curative resection for stage I or II NSCLC was performed. Patients who had received any adjuvant or neo-adjuvant chemo- or radiation therapy were excluded. Primary outcome measure was the duration of overall survival. RESULTS Median survival was 7.25 years for stage IA, 5.71 years for stage IB and 3.85 years for stage IIB. In univariate analysis, six variables were significantly associated (p-value<0.05) with poorer survival: older age, larger size of the tumor, male gender, surgery other than lobectomy, squamous histology and later stages (stage IB and IIB). In multivariate analysis, age (Hazard ratio=1.06 per year increase in age; p<0.0001), larger tumor size (Hazard ratio=1.54 per doubling of tumor size; p<0.0001), type of surgery (Hazard ratio=1.50 for surgery other than lobectomy; p=0.036), and gender (Hazard ratio=1.45 for male gender; p=0.039) were the predictors of overall survival. CONCLUSIONS In surgically treated early stage (I and II) NSCLC patients, age, tumor size, type of surgery, and gender are the important predictors of survival.

RAPID DISEASE PROGRESSION WITH DELAY IN TREATMENT OF NON-SMALL-CELL LUNG CANCER

PURPOSE To assess rate of disease progression from diagnosis to initiation of treatment for Stage I-IIIB non-small-cell lung cancer (NSCLC). METHODS AND MATERIALS Forty patients with NSCLC underwent at least two sets of computed tomography (CT) and 18-fluorodeoxyglucose positron emission tomography (PET) scans at various time intervals before treatment. Progression was defined as development of any new lymph node involvement, site of disease, or stage change. RESULTS Median time interval between first and second CT scans was 13.4 weeks, and between first and second PET scans was 9.0 weeks. Median initial primary maximum tumor dimension (MTD) was 3.5 cm (0.6-8.5 cm) with a median standardized uptake value (SUV) of 13.0 (1.7-38.5). The median MTD increased by a median of 1.0 cm (mean, 1.6 cm) between scans for a median relative MTD increase of 35% (mean, 59%). Nineteen patients (48%) progressed between scans. Rate of any progression was 13%, 31%, and 46% at 4, 8, and 16 weeks, respectively. Upstaging occurred in 3%, 13%, and 21% at these intervals. Distant metastasis became evident in 3%, 13%, and 13% after 4, 8, and 16 weeks, respectively. T and N stage were associated with progression, whereas histology, grade, sex, age, and maximum SUV were not. At 3 years, overall survival for Stage III patients with vs. without progression was 18% vs. 67%, p = 0.05. CONCLUSIONS With NSCLC, treatment delay can lead to disease progression. Diagnosis, staging, and treatment initiation should be expedited. After 4-8 weeks of delay, complete restaging should be strongly considered.

Radiographic and metabolic response rates following image-guided stereotactic radiotherapy for lung tumors

PURPOSE To evaluate radiographic and metabolic response after stereotactic body radiotherapy (SBRT) for early lung tumors. MATERIALS AND METHODS Thirty-nine tumors were treated prospectively with SBRT (dose=48-60 Gy, 4-5 Fx). Thirty-six cases were primary NSCLC (T1N0=67%; T2N0=25%); three cases were solitary metastases. Patients were followed using CT and PET at 6, 16, and 52 weeks post-SBRT, with CT follow-up thereafter. RECIST and EORTC criteria were used to evaluate CT and PET responses. RESULTS At median follow-up of 9 months (0.4-26), RECIST complete response (CR), partial response (PR), and stable disease (SD) rates were 3%, 43%, 54% at 6 weeks; 15%, 38%, 46% at 16 weeks; 27%, 64%, 9% at 52 weeks. Mean baseline tumor volume was reduced by 46%, 70%, 87%, and 96%, respectively at 6, 16, 52, and 72 weeks. Mean baseline maximum standardized uptake value (SUV) was 8.3 (1.1-20.3) and reduced to 3.4, 3.0, and 3.7 at 6, 16, and 52 weeks after SBRT. EORTC metabolic CR/PR, SD, and progressive disease rates were 67%, 22%, 11% at 6 weeks; 86%, 10%, 3% at 16 weeks; 95%, 5%, 0% at 52 weeks. CONCLUSIONS SBRT yields excellent RECIST and EORTC based response. Metabolic response is rapid however radiographic response occurs even after 1-year post treatment.

The Safe Transition from Open to Thoracoscopic Lobectomy: A 5-Year Experience

BACKGROUND We hypothesized that established thoracic surgeons without formal minimally invasive training can learn thoracoscopic lobectomy without compromising patient safety or outcome. METHODS Data were retrospectively collected on patients who underwent pulmonary lobectomy at a single health system between August 1, 2003, and April 1, 2008. Age, sex, pulmonary function tests, preoperative and postoperative stages, pathologic diagnosis, anatomic resection, extent of lymph node sampling, surgical technique and duration, complications, blood loss, transfusion requirement, chest tube duration, length of hospital stay, 30-day readmission, and mortality rate were examined. The percentage of patients who underwent thoracoscopic lobectomy and their outcomes were then compared among three chronologic cohorts. RESULTS Three hundred sixty-four patients underwent pulmonary lobectomy (239 open; 99 thoracoscopic; 26 thoracoscopic converted to open). Baseline characteristics, staging, pathologic diagnosis, and anatomic resections were similar in the early, middle, and late cohorts. The percentage of thoracoscopic lobectomies increased from 16% to 49%, whereas open lobectomy decreased from 81% to 42% (p < 0.0001). The complication rate remained constant with the exception of air leaks lasting more than 7 days (9% versus 10% versus 2%; p = 0.02). Hospital length of stay (6 versus 5 versus 4 days; p < 0.0001) and chest tube duration (4 versus 3 versus 3 days; p < 0.0001) decreased and operative duration increased as more thoracoscopic lobectomies were performed. Blood loss, transfusion requirement, 30-day readmission, and 1-year survival were not significantly different among chronologic cohorts. CONCLUSIONS Established thoracic surgeons can safely incorporate thoracoscopic lobectomy with no increase in morbidity or mortality.