Eric L. Grogan

Relationship between patient complaints and surgical complications

Background: Patient complaints are associated with increased malpractice risk but it is unclear if complaints might be associated with medical complications. The purpose of this study was to determine whether an association exists between patient complaints and surgical complications. Methods: A retrospective analysis of 16 713 surgical admissions was conducted over a 54 month period at a single academic medical center. Surgical complications were identified using administrative data. The primary outcome measure was unsolicited patient complaints. Results: During the study period 0.9% of surgical admissions were associated with a patient complaint. 19% of admissions associated with a patient complaint included a postoperative complication compared with 12.5% of admissions without a patient complaint (p = 0.01). After adjusting for surgical specialty, co-morbid illnesses and length of stay, admissions with complications had an odds ratio of 1.74 (95% confidence interval 1.01 to 2.98) of being associated with a complaint compared with admissions without complications. Conclusions: Admissions with surgical complications are more likely to be associated with a complaint than surgical admissions without complications. Further research is necessary to determine if patient complaints might serve as markers for poor clinical outcomes.

Reduced heart rate volatility: An early predictor of death in trauma patients

Objective:To determine if using dense data capture to measure heart rate volatility (standard deviation) measured in 5-minute intervals predicts death. Background:Fundamental approaches to assessing vital signs in the critically ill have changed little since the early 1900s. Our prior work in this area has demonstrated the utility of densely sampled data and, in particular, heart rate volatility over the entire patient stay, for predicting death and prolonged ventilation. Methods:Approximately 120 million heart rate data points were prospectively collected and archived from 1316 trauma ICU patients over 30 months. Data were sampled every 1 to 4 seconds, stored in a relational database, linked to outcome data, and de-identified. HR standard deviation was continuously computed over 5-minute intervals (CVRD, cardiac volatility–related dysfunction). Logistic regression models incorporating age and injury severity score were developed on a test set of patients (N = 923), and prospectively analyzed in a distinct validation set (N = 393) for the first 24 hours of ICU data. Results:Distribution of CVRD varied by survival in the test set. Prospective evaluation of the model in the validation set gave an area in the receiver operating curve of 0.81 with a sensitivity and specificity of 70.1 and 80.0, respectively. CVRD predict death as early as 24 hours in the validation set. Conclusions:CVRD identifies a subgroup of patients with a high probability of dying. Death is predicted within first 24 hours of stay. We hypothesize CVRD is a surrogate for autonomic nervous system dysfunction.

VATS Lobectomy is Better than Open Thoracotomy: What is the Evidence for Short-Term Outcomes?

VATS lobectomy is an acceptable alternative to open lobectomy for treating early-stage NSCLC. Although no large randomized control trial has compared these procedures, recent large series and case-control studies provide strong evidence that patients undergoing VATS lobectomy have less pain, fewer perioperative complications, shorter chest-tube duration, and decreased length of stay. Increasing evidence supports improved quality of life up to 1 year, less inflammation, and greater safety profile in high-risk patients. More data are needed to better show an improvement in the economic efficacy, ability to more effectively administer adjuvant therapies, and benefit of robotic assistance in VATS lobectomy.

Volatility: a new vital sign identified using a novel bedside monitoring strategy.

BACKGROUND SIMON (Signal Interpretation and Monitoring) monitors and archives continuous physiologic data in the ICU (HR, BP, CPP, ICP, CI, EDVI, SVO2, SPO2, SVRI, PAP, and CVP). We hypothesized: heart rate (HR) volatility predicts outcome better than measures of central tendency (mean and median). METHODS More than 600 million physiologic data points were archived from 923 patients over 2 years in a level one trauma center. Data were collected every 1 to 4 seconds, stored in a MS-SQL 7.0 relational database, linked to TRACS, and de-identified. Age, gender, race, Injury Severity Score (ISS), and HR statistics were analyzed with respect to outcome (death and ventilator days) using logistic and Poisson regression. RESULTS We analyzed 85 million HR data points, which represent more than 71,000 hours of continuous data capture. Mean HR varied by age, gender and ISS, but did not correlate with death or ventilator days. Measures of volatility (SD, % HR >120) correlated with death and prolonged ventilation. CONCLUSIONS 1) Volatility predicts death better than measures of central tendency. 2) Volatility is a new vital sign that we will apply to other physiologic parameters, and that can only be fully explored using techniques of dense data capture like SIMON. 3) Densely sampled aggregated physiologic data may identify sub-groups of patients requiring new treatment strategies.

Identification of Small Lung Nodules: Technique of Radiotracer-Guided Thoracoscopic Biopsy

BACKGROUND This study describes a thoracoscopic technique to reliably locate and excise lung nodules that were not thought to be thoracoscopically visible or instrumentally palpable. METHODS Initial laboratory studies succeeded in selecting a technetium 99m gamma-emitting solution, technetium 99m macro-aggregated albumin, that remained localized in lung parenchyma after percutaneous placement. Subsequently, 84 patients with solitary small nodules underwent computed tomography (CT)-guided percutaneous placement of this technetium solution in or near the nodule. Thoracoscopic localization with a radioprobe and excisional biopsy followed. RESULTS In 3 patients, the previous lesion was not present on the CT scan done on the day of surgery. The 81 remaining patients underwent radiotracer placement and operation. No tracer activity was present in the lung in 4 patients, and open thoracotomy was necessary to locate the lesion. The lesion was successfully localized and excised in 77 patients (95.1%), and 71 underwent thoracoscopic excisional biopsy. Four underwent intentional thoracotomy for deep small nodules in which the tracer was used to guide the open biopsy. Two required conversion from thoracoscopy to thoracotomy because the anatomic location of the lesion prevented a thoracoscopic staple excision. Fifty percent of the lesions were benign, 39% were primary lung cancers, and additional 11% were either solitary metastatic lesions or lymphoma. No patients died, and morbidity rate was 16% (arrhythmias or pneumothoraces). CONCLUSIONS Radiotracer-guided thoracoscopic biopsy was 95% reliable for subsequent surgical successful localization and excision of small nodules. This technique can be expanded to localize deep lesions for open thoracotomy and be used to prevent thoracotomy in 50% of patients with benign disease.

Laparoscopic adrenalectomy: 100 resections with clinical long-term follow-up

BackgroundThe operative results of 100 laparoscopic adrenal resections in 94 patients and the subsequent impact on postoperative antihypertensive therapy are presented.MethodsClinical and follow-up data for resections performed between 1995 and 2003 were obtained from medical records, patient questionnaires, and telephone interviews.ResultsThe diseases included Conn’s syndrome (27 patients), Cushing’s syndrome (30 patients), pheochromocytoma (11 patients), and Other tumors (26 patients). Antihypertensive therapy was eliminated or reduced for Conn’s syndrome (75%), Cushing’s syndrome (27%), pheochromocytoma (88%) and patients with Other tumors (54%). Clinical improvement was observed by 12 months for pheochromocytoma patients as compared with 35 to 45 months for the other groups (p < 0.05). Multivariate analysis showed that pheochromocytoma patients were more likely to experience improvement or cure than the Other tumor group (hazard ratio, 4.87; 95% confidence interval, 1.61-14.7).ConclusionsLaparoscopic adrenalectomy continues to be safe and efficacious for benign adrenal diseases. Although patients with functional tumors can expect improvement or cure, the time until improvement may be longer than previously recognized.

A Three-Part Intervention To Change the Use of Hormone Replacement Therapy in Response to New Evidence

Context Evidence documents that months to years often elapse before physicians adopt clinical practices supported by randomized, controlled trials. These researchers studied interventions to decrease this lag time after publication of the Womens Health Initiative, a trial that concluded that the overall risks of combination hormone replacement therapy exceeded its benefits. Contribution A multicomponent intervention (patient notification, provider education, electronic alert in patient chart) seemed to increase the discontinuation rate of hormone replacement therapy use after release of study results from the Womens Health Initiative in July 2002. Caution The study did not include a true control group. The Editors The Womens Health Initiative (WHI), a large National Institutes of Healthsponsored primary prevention trial of combination hormone replacement therapy (HRT), was stopped early because the overall risk outweighed the benefits (1). The risks included nonfatal myocardial infarction and coronary deaths, which combined were the studys primary end point. The results of other recent randomized, placebo-controlled trials have also called into question the benefits of HRT (1-8). On the basis of this evidence, several organizations have now changed their recommendations on the use of combination HRT (9-13). For example, in November 2002, the U.S. Preventive Health Services Task Force recommended against prescribing combination HRT to prevent disease (14, 15). Changes in the recommendations for HRT use represent a small fraction of an escalating amount of information that providers must process and put into practice. New clinical knowledge, such as revised recommendations for HRT use, requires providers to change their behavior (16, 17). Consensus guidelines, continuing medical education, and reminders are common, albeit marginally effective, strategies used to influence behavior (18-27). Additional strategies, such as formulary changes, can be perceived as institutional control mechanisms and, therefore, may be resisted by providers (28, 29). Strategies for change often fail because they do not consider patient or provider preferences, provider time burden, delays introduced by waiting until the patients next office visit, and perceptions that the change may stifle the patientprovider relationship (30-36). We sought to address some of the gaps in the current array of interventions for integrating new clinical knowledge into daily practice by developing an approach that is timely, patient-centered, and effective (30, 37, 38). Our goal was to inform both patients and providers about the risks and benefits of HRT and to facilitate an interaction by which that information could be applied without interfering in the providerpatient relationship. Methods Setting The Veterans Health Administration nationwide is composed of 23 Veterans Integrated Service Networks. Each network comprises hospitals, ambulatory facilities, and community-based outpatient centers. In Veterans Integrated Service Network 9, located in the mid-south and including the states of Kentucky and Tennessee, there are more than 1 million veterans, including approximately 65 000 women. Almost half of these female veterans are older than 45 years of age (Alvarez V. Personal communication). Of the 6 health care systems in the Veterans Integrated Service Network 9, the Veterans Affairs Tennessee Valley Healthcare System (VA-TVHS), a convenience sample, was selected to be the intervention group. The VA-TVHS comprises 2 teaching hospitals and 8 community-based outpatient centers. The VA-TVHS offers outpatient primary, secondary, and tertiary care to more than 150 000 veterans who are predominantly in middle Tennessee. Ambulatory care, including womens health care, is provided at all of the sites. In 2002, 2576 female veterans older than 45 years of age enrolled for care within the VA-TVHS (Alvarez V. Personal communication). Study Design This quality improvement project used a prospective, quasi-experimental intervention design. All female veterans using combination HRT and their providers were notified of the WHI study results in a staggered fashion. The study intervention was implemented at 3 sites; start times were separated by 2 weeks (Figure 1). Figure 1. Study timeline. Given the media coverage surrounding the WHI study, this design was chosen to account for the secular trends that may have affected rates of HRT discontinuation (39). The WHI study results appeared in the 17 July 2002 issue of the Journal of the American Medical Association but were released to the press 1 week earlier. The WHI study results also appeared in the 10 July 2002 edition of The New York Times and other national and local papers. The Nashville Veterans Affairs Medical Center was the first site for intervention, which began on 1 September 2002. At that point, the other 2 sites, which were exposed only to the media information on HRT, continued current care. The study intervention was replicated for all patients and providers at the community-based outpatient centers on 16 September 2002 and at the Alvin C. York Veterans Affairs Medical Center on 30 September and 1 October 2002. This staggered design was implemented to allow for concurrent comparison with usual care until the final group of the cohort underwent the intervention. Patient Identification We identified female veterans with a prescription filled for combination HRT by using the VA-TVHS pharmacy database. The pharmacy collects prescribing information in a relational database. This information is downloaded each month from the Veterans Affairs mainframe computer by a pharmacy supervisor. Search terms were Prempro (Wyeth-Ayerst, Philadelphia, Pennsylvania), Premphase (Wyeth-Ayerst), and medroxyprogesterone linked to any strength conjugated estrogens (0.3 mg, 0.625 mg, 0.9 mg, 1.25 mg, or 2.5 mg). We initially identified 131 veterans with this strategy. Using the WHI inclusion criteria, we limited our sample to female veterans age 50 to 79 years. To establish a clear baseline, we limited the sample to patients who had a prescription filled between 1 January 2002 and 1 July 2002. The final cohort consisted of 91 female veterans. Intervention Before implementing the intervention, leadership within the quality improvement, pharmacy, and primary care departments discussed and agreed on the design of the intervention. The intervention had 3 components: Two focused on education (targeting patient and provider) and 1 integrated new information with patient care. The provider education component ensured that all of the prescribing providers received information about the WHI study (Appendix Figure 1). This involved sending an e-mail message from the chief of pharmacy services and the medical director of the Pharmacy and Therapeutics Committee to all clinical chiefs explaining the planned intervention. Each clinical chief disseminated the e-mail to practitioners within their division. The e-mail also included an electronic link to the WHI study (jama.ama-assn.org/cgi/reprint/288/3/321.pdf) (1). The patient education component of the intervention involved sending a personalized letter from the TVHS pharmacy to current users of combination HRT. This letter was signed by the medical director of the Pharmacy and Therapeutics Committee (Appendix Figure 2). The letter reported that WHI study participants taking combination HRT had higher risks for disease, including a slight increase in the chance of developing breast cancer, a trend toward more heart attacks and strokes, and more likely to have blood clots in their veins. The letter acknowledged benefits of combination HRT for relief of menopausal symptoms in many women and emphasized that, We recommend that patients and providers review the risks and benefits of HRT therapy on a personal basis. A pharmacy alert was placed in the electronic chart of each patient identified to be using combination HRT in order to facilitate a timely conversation between the patient and the provider. This component served to overcome a common barrier to action: the need for the provider to identify all of the patients affected by new information. The pharmacy alert was an electronic notification that was sent, by the pharmacy, to the prescribing provider via each patients electronic medical record. It contained a summary of the WHI study results and provided an electronic link to the WHI study as a reinforcement of the educational component. The Veterans Affairs network uses a computerized patient record system that allows for real-time processing of information. Each time that providers would sign on to a computer, any medical record that contained an electronic alert would be brought to their attention. The pharmacy alert asked the provider to reevaluate the need for combination HRT and generate an addendum to this alert. The addendum gave the provider several options for action, including continuation or discontinuation of combination HRT at the current time or at some point in the future (Appendix Figure 3). Measurement The primary outcome measure was the percentage of female veterans using combination HRT at the beginning of the study who discontinued this therapy. The measure of discontinuation was assessed through 2 steps. First, if the primary provider, in response to the chart alert, recorded the discontinuation order, then the date that the order was entered could be ascertained by reviewing the addendum to the pharmacy alert. When an addendum to the original note is generated, the results of that addendum automatically return to the original author of the pharmacy alert, allowing for collection of responses. Second, we reviewed charts at study completion to confirm whether combination HRT was discontinued. We also confirmed the date the discontinuation order was placed in the patients electronic medical record. Upon completion of the study, we repeated the initial search strategy

Radiotracer-Guided Thoracoscopic Resection is a Cost-Effective Technique for the Evaluation of Subcentimeter Pulmonary Nodules

BACKGROUND Excisional biopsy of small subcentimeter pulmonary nodules can be difficult using standard thoracoscopic techniques and may require thoracotomy. Radiotracer-guided thoracoscopic resection (RGTR) was developed to facilitate resection of intraparenchymal subcentimeter pulmonary nodules. Decision analysis, used to model cost and effectiveness, is useful to compare treatment options. We hypothesize that RGTR strategy is more cost-effective compared with thoracotomy for subcentimeter pulmonary nodules. METHODS The cost-effectiveness of RGTR versus thoracotomy for evaluating highly suspicious subcentimeter pulmonary nodules was examined with a decision analysis model (Fig 1). A 40-patient institutional cohort who underwent RGTR was used to estimate probabilities and costs of the two treatment options within the model. Effectiveness was estimated using 5-year, stage-specific cancer survival and population survival curves. The Society of Thoracic Surgeons General Thoracic Database was queried obtaining mortality estimates for thoracotomy and thoracoscopic wedge resections. These were used to adjust the 5-year survival estimates of patients with benign disease. Sensitivity analyses determined model robustness and the thresholds at which the most cost-effective strategy changed. RESULTS Radiotracer-guided thoracoscopic resection was 95% successful with no mortality. The average cost-to-effectiveness ratio of RGTR strategy was

Diagnostic Characteristics of a Serum Biomarker in Patients With Positron Emission Tomography Scans

27,887 versus

Transplant pneumonectomy in a patient with an acutely thrombosed allograft.

32,271 for thoracotomy. Sensitivity analyses demonstrated that the thoracotomy strategy was more cost-effective if the estimated cost of RGTR increased by 33% or the estimated cost-effectiveness of thoracotomy decreased by 14% or more. Radiotracer-guided thoracoscopic resection was more cost-effective as long as the probability of success was greater than 44%. CONCLUSIONS Decision analysis is a useful tool to evaluate treatment options for thoracic surgeons, and RGTR is a more cost-effective strategy than thoracotomy for subcentimeter pulmonary nodules.