Predictors of efficacy and health resource utilization in treatment of complicated intra-abdominal infections: evidence for pooled clinical studies comparing tigecycline with imipenem-cilastatin.

BACKGROUND: Duration of intravenous (IV) treatment, surgical/radiologic interventions for infection control, and hospital length of stay (LOS) are important cost considerations in complicated intra-abdominal infections (cIAIs). METHODS: Data were pooled from two multinational, double-blind studies conducted in hospitalized adults with cIAIs who were randomized (1:1) to receive tigecycline (100 mg IV initial dose then 50 mg IV every 12 h) or imipenem-cilastatin (500 mg IV every 6 h) for 5 to 14 days in order to assess tigecycline safety and efficacy. This report focuses on developing predictors of cure and health care resource utilization, including the need for repeat surgical/radiologic interventions, duration of IV antibiotic therapy, and hospital LOS. Multiple regression models were applied for each of the above outcomes, incorporating both baseline and on-treatment potential covariates. Logistic modeling was used for categorical outcomes (cure; repeat surgical/radiologic interventions) and least squares modeling for continuous outcomes (duration of IV antibiotic therapy; LOS). Stepwise selection was used to retain only those predictors found to be significant (p < 0.05) independent risk factors. RESULTS: The most common causative pathogen was Escherichia coli (63.0%), with 63.3% of the patients exhibiting polymicrobial infections. The most common cIAI diagnosis was complicated appendicitis (51.9%). Lack of clinical cure (+ 6.1 days; p < 0.0001), perforation of the intestine (+3.7 days; p < 0.0001), an Acute Physiology and Chronic Health Evaluation (APACHE) score >15 (+3.1 days; p=0.039), abnormal plasma sodium concentration (+3.7 days; p=0.026), and repeat surgical/radiologic intervention (+2.2 days; p=0.0097) were identified as key risk factors for longer LOS. Inadequate source control was associated with reduced odds of cure, longer IV treatment duration (+1.5 days; p=0.007), and longer LOS. The treatment groups did not differ in terms of LOS, IV treatment duration, or clinical cure. CONCLUSION: Tigecycline was similar to imipenem-cilastatin in terms of both efficacy and health resource utilization. Risk factors identified in this study for both outcome measures are offered as support for guiding clinical practice.

Creation of clinical research databases in the 21st century: a practical algorithm for HIPAA Compliance.

BACKGROUND: Enforcement of the Health Insurance Portability and Accountability Act (HIPAA) began in April, 2003. Designed as a law mandating health insurance availability when coverage was lost, HIPAA imposed sweeping and broad-reaching protections of patient privacy. These changes dramatically altered clinical research by placing sizeable regulatory burdens upon investigators with threat of severe and costly federal and civil penalties. This report describes development of an algorithmic approach to clinical research database design based upon a central key-shared data (CK-SD) model allowing researchers to easily analyze, distribute, and publish clinical research without disclosure of HIPAA Protected Health Information (PHI). METHODS: Three clinical database formats (small clinical trial, operating room performance, and genetic microchip array datasets) were modeled using standard structured query language (SQL)-compliant databases. The CK database was created to contain PHI data, whereas a shareable SD database was generated in real-time containing relevant clinical outcome information while protecting PHI items. Small (< 100 records), medium (< 50,000 records), and large (> 10(8) records) model databases were created, and the resultant data models were evaluated in consultation with an HIPAA compliance officer. RESULTS: The SD database models complied fully with HIPAA regulations, and resulting "shared" data could be distributed freely. Unique patient identifiers were not required for treatment or outcome analysis. Age data were resolved to single-integer years, grouping patients aged > 89 years. Admission, discharge, treatment, and follow-up dates were replaced with enrollment year, and follow-up/outcome intervals calculated eliminating original data. Two additional data fields identified as PHI (treating physician and facility) were replaced with integer values, and the original data corresponding to these values were stored in the CK database. Use of the algorithm at the time of database design did not increase cost or design effort. CONCLUSIONS: The CK-SD model for clinical database design provides an algorithm for investigators to create, maintain, and share clinical research data compliant with HIPAA regulations. This model is applicable to new projects and large institutional datasets, and should decrease regulatory efforts required for conduct of clinical research. Application of the design algorithm early in the clinical research enterprise does not increase cost or the effort of data collection.

Web-based minimally invasive surgery training: competency assessment in PGY 1-2 surgical residents.

OBJECTIVES: Little published literature describes accurate evaluation and assessment of surgical residents' technical competencies. Work-hour limitations and the proposed changes in training duration challenge our ability to provide core technical competencies, particularly during PGY-1-2. We identified minimally invasive surgery as a particularly challenging competency training area, requiring significant allocation of resident and faculty time and resources, with inconsistent training results. This project evaluated a standardized competency training curriculum in minimally invasive surgery in comparison to existing training. METHODS: The Laparoscopy 101-a Resource for Resident Education minimally invasive surgery competency training curriculum consists of CD-ROM-based self-paced didactic self-instruction modules, skills laboratories, and web-based testing, evaluation, and reporting. Five didactic self-study modules and their corresponding web-based examinations were selected for this study. PGY 1-2 residents (11/group) were enrolled. PGY-1 residents received no formal minimally invasive surgery training in our program before participating, whereas PGY-2 residents were exposed to the minimally invasive surgery training program in place in our department. PGY-1 residents completed the training modules and web-based testing over 4 days. PGY-2 residents underwent testing before (pre-test) and after (post-test) completing identical training modules and testing over an identical time period. Test results were examined and compared in both groups. A user-satisfaction survey assessed resident opinions about the quality of the curriculum, use of the CD-ROM/web-based system, and trainee perceptions about performance. RESULTS: PGY-2 Pre-test scores were equivalent to PGY-1 scores after training (mean overall performance, 52.4% vs 65.5% p = ns). PGY-2 Post-test scores were significantly higher when compared with pre-test scores (mean overall performance; pre: 52.4% vs post: 85.3% p <== 0.001). Interestingly, post-training scores were significantly higher for PGY-2 than PGY-1 (mean overall performance PGY-1: 52.4% vs PGY-2: 65.5% p = ns). Competencies achieved persisted 6 months after initial training in both PGY 1-2 groups without additional training using this curriculum. Overall user satisfaction was positive in each category evaluated. CONCLUSIONS: The Laparoscopy 101 minimally invasive surgery curriculum (1) p;rovides a structured self-paced curriculum for minimally invasive didactic training that is well accepted by trainees; (2) yields PGY-1 competencies equivalent to PGY-2 who receive training in our department's existing program; and (3) yields significant improvement in PGY-2 minimally invasive surgery competencies. Training effects persist to 6 months without reinforcement. Our observations of PGY-2 performance and competency suggest that this training would best be instituted during PGY-2.

Clinical outcomes and fiscal consequences of bilateral neck exploration for primary idiopathic hyperparathyroidism without preoperative radionuclide imaging or minimally invasive techniques.

BACKGROUND: Radionuclide imaging-directed, minimally invasive parathyroid operation is promoted in the surgical literature and public domain as the fastest, most successful, and cheapest means of treating primary idiopathic hyperparathyroidism. The validity of these claims is unproven. This study reviews the treatment outcome results of a large series of patients treated with standard parathyroid operation without preoperative localization studies. Cost comparisons are made between this series and previous reports of selected patients in whom preoperative radionuclide imaging preceded minimally invasive parathyroid operation. METHODS: Diagnosis, treatment, and outcome data for 688 consecutive patients undergoing first neck exploration for primary idiopathic hyperparathyroidism were prospectively collected. All patients in our series underwent standard bilateral neck exploration without preoperative localization studies. Intraoperative methylene blue was used to aid identification of all parathyroid glands. Surgical findings, pathological diagnosis, operative time, length-of-stay, and treatment success data were collected. Cost data were calculated for our series using the identical calculations used in previous reports. Our outcome and calculated cost data were compared with previous reports by centers advocating scan-directed, minimally invasive parathyroid operation. RESULTS: Of 2,752 predicted total glands, 2,520 (91.6%) were identified using standard neck exploration without radionuclide localization studies. Single adenoma, with at least 1 normal gland, was found in 542 patients (78.8%), with 8 in a fifth gland. Multiple-gland hyperplasia was identified in 98 patients (14.2%) and of these 22 (3.2%) were double adenomas. Ten patients had parathyroid carcinoma (1.5%), and all received definitive surgical treatment during the primary operation. Cure rates were assessed by measurement of normal serum calcium and parathyroid hormone levels at 3 and 12 months after operation, and were 97.7% in our series. Mean operating time for the entire series was 65 minutes, decreased to 35 minutes in patients with single adenomas, and mean recovery room time was 30 minutes. Mean total costs for patients undergoing standard exploration for single adenoma was US dollars 1,107, and increased to US dollars 1,243 when patients with multigland disease, hyperplasia, or malignancy were included. CONCLUSIONS: Our series demonstrates operative times and treatment outcomes with costs that are approximately one-third less than those for scan-directed, minimally invasive operation for primary idiopathic hyperparathyroidism. Thus, claims that scan-directed parathyroid operation is the cheapest, fastest, and most successful means of treatment are not supported by these data.