Systematic Review of Preoperative Risk Discussion in Practice.

Background: Informed consent is an ethical imperative of surgical practice. This requires effective communication of procedural risks to patients and is learned during residency. No systematic review has yet examined current risk disclosure.

A First-in-Human Phase 1 Study of LY3023414, an Oral PI3K/mTOR Dual Inhibitor, in Patients with Advanced Cancer.

The PI3K/mTOR pathway is frequently aberrated in cancer. LY3023414 is a potent and selective ATP-competitive inhibitor of class I PI3K isoforms, mTOR, and DNA-PK. Here we report the dose-escalation results of the first-in-human phase I study of LY3023414.

Phase 1 and pharmacokinetic study of LY3007113, a p38 MAPK inhibitor, in patients with advanced cancer.

Background The signaling protein p38 mitogen-activated protein kinase (MAPK) regulates the tumor cell microenvironment, modulating cell survival, migration, and invasion. This phase 1 study evaluated the safety of p38 MAPK inhibitor LY3007113 in patients with advanced cancer to establish a recommended phase 2 dose. Methods In part A (dose escalation), LY3007113 was administered orally every 12 h (Q12H) at doses ranging from 20 mg to 200 mg daily on a 28-day cycle until the maximum tolerated dose (MTD) was reached.

Does adding clinical data to administrative data improve agreement among hospital quality measures?

Background: Hospital performance measures based on patient mortality and readmission have indicated modest rates of agreement. We examined if combining clinical data on laboratory tests and vital signs with administrative data leads to improved agreement with each other, and with other measures of hospital performance in the nation's largest integrated health care system.

Methods: We used patient-level administrative and clinical data, and hospital-level data on quality indicators, for 2007-2010 from the Veterans Health Administration (VA).

How pooling fragmented healthcare encounter data affects hospital profiling.

Objectives: People receiving healthcare from multiple payers (eg, Medicare and the Veterans Health Administration [VA]) have fragmented health records. How the use of more complete data affects hospital profiling has not been examined.

Study Design: Retrospective cohort study.

Patient perceptions of surgical informed consent: is repeat back helpful or harmful?

Background: Informed consent (IC)comprehension is suboptimal. Repeat back (RB)-asking the patient to repeat in their own words key elements of the consent-is believed to improve the consent process.

Objective: This study aims to assess the impact of RB on patient perceptions of surgical informed consent.

Enhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trial.

Objective: In this randomized, controlled, unblinded trial, we sought to test Repeat Back's (RB) effect on comprehension following informed consent discussions.

Summary Background Data: RB has been suggested as a method to improve patient comprehension when obtaining informed consent. In this technique, patients are asked to recount what they have been told in the informed consent discussion.

Predictors of comprehension during surgical informed consent.

Background: Patient comprehension during surgical informed consent remains problematic. Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding.

Study Design: Patients scheduled for 1 of 4 elective operations (total hip arthroplasty [n = 137], carotid endarterectomy [n = 178], laparoscopic cholecystectomy [n = 179], or radical prostatectomy [n = 81]) at 7 Department of Veterans Affairs (VA) medical centers were enrolled.

Adjusted or unadjusted outcomes.

Background: Surgeons have long maintained an interest in assessing the outcomes of their therapeutic efforts. Previously, such goals were supported by mortality and morbidity conferences or surgical audits. The latter typically focus on unadjusted rates of adverse events.

Inguinoscrotal bladder hernias: report of a series and review of the literature.

Bladder involvement occurs in 1%-4% of cases of inguinal hernias. Among obese men aged 50 to 70, the incidence may reach 10%.1,2 The diagnosis of bladder involvement is often difficult to delineate at the time of presentation and may only become apparent at the time of herniorrhaphy.

Successful implementation of the Department of Veterans Affairs' National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study.

Background: The Veterans Affairs' (VA) National Surgical Quality Improvement Program (NSQIP) has been associated with significant reductions in postoperative morbidity and mortality. We sought to determine if NSQIP methods and risk models were applicable to private sector (PS) hospitals and if implementation of the NSQIP in the PS would be associated with reductions in adverse postoperative outcomes.

Methods: Data from patients (n = 184,843) undergoing major general or vascular surgery between October 1, 2001, and September 30, 2004, in 128 VA hospitals and 14 academic PS hospitals were used to develop prediction models based on VA patients only, PS patients only, and VA plus PS patients using logistic regression modeling, with measures of patient-related risk as the independent variables and 30-day postoperative morbidity or mortality as the dependent variable.

Assessing the quality of surgical care.

Because of better educated patients, more demanding payers, and regulatory agencies, safety and quality have become prominent criteria for evaluating surgical care. Providers are increasingly asked to document these areas, and patients are using this documentation to select surgeons and hospitals. Payers are using the data to direct patients to providers, and potentially to adjust reimbursement rates.

Relationship of processes and structures of care in general surgery to postoperative outcomes: a descriptive analysis.

Background: The systematic collection of quantitative data on structures and processes from surgical services participating in the National Surgical Quality Improvement Program (NSQIP) has not been a focus to date. Efficient collection of useful measures of structures and processes may improve understanding of surgical outcomes and strategies for improving the quality of surgical care, as NSQIP continues to expand. The purpose of this article was to describe results of a quantitative survey designed to measure surgical care structures and processes within NSQIP sites.

Relationship of processes and structures of care in general surgery to postoperative outcomes: a qualitative analysis.

Background: With increased focus on improving surgical care quality, understanding structures and processes that influence surgical care is timely and important, as is more precise specification of these through improved measurement.

Study Design: We conducted a qualitative study to help design a quantitative survey of structures and processes of surgical care. We audiotaped 44 face-to-face interviews with surgical care leaders and other diverse members of the surgical care team from 6 hospitals (two Veterans Affairs, four private sector).

Comparison of risk-adjusted 30-day postoperative mortality and morbidity in Department of Veterans Affairs hospitals and selected university medical centers: general surgical operations in women.

Background: In 1985, Congress mandated that the Department of Veterans Affairs (VA) compare its risk-adjusted surgical results with those in the private sector. The National Surgical Quality Improvement Program was developed as a result, in the VA system, and subsequently trialed in 14 university medical centers in the private sector. This report examines the results of the comparison between patient characteristics and outcomes of female general surgical patients in the two health care environments.

Comparison of risk-adjusted 30-day postoperative mortality and morbidity in Department of Veterans Affairs hospitals and selected university medical centers: general surgical operations in men.

Background: We used data from the Patient Safety in Surgery Study to compare patient populations, operative characteristics, and unadjusted and risk-adjusted 30-day postoperative mortality and morbidity between the Veterans Affairs (VA) (n = 94,098) and private (n = 18,399) sectors for general surgery operations in men.

Study Design: This is a prospective cohort study. Trained nurses collected preoperative risk factors, operative variables, and 30-day postoperative mortality and morbidity outcomes in male patients undergoing major general surgery operations at 128 VA medical centers and 14 university medical centers from October 1, 2001, to September 30, 2004.

The patient safety in surgery study: background, study design, and patient populations.

Background: The purpose of this article is to describe the background, design, and patient populations of the Patient Safety in Surgery Study, as a preliminary to the articles in this journal that will report the results of the Study.

Study Design: The Patient Safety in Surgery Study was a prospective cohort study. Trained nurses collected preoperative risk factors, operative variables, and 30-day postoperative mortality and morbidity outcomes in patients undergoing major general and vascular operations at 128 Veterans Affairs (VA) medical centers and 14 selected university medical centers between October 1, 2001 and September 30, 2004.

Reducing surgical site infections through a multidisciplinary computerized process for preoperative prophylactic antibiotic administration.

Background: Surgical site infections (SSIs) result in significant postoperative morbidity and mortality. Although many of these infections can be prevented by timely administration of preoperative antibiotics, data suggest that many patients do not receive such therapy.

Methods: A multidisciplinary team was convened that reviewed published guidelines, made antibiotic recommendations, and addressed administration issues.

Informed versus uninformed consent for prostate surgery: the value of electronic consents.

Purpose: We evaluated the documentation of informed consent for 2 common prostate operations using current, conventional, paper based consent forms. Based on the results of the review the conventional paper based consent system was replaced with a new, standardized electronic consent system.

Materials And Methods: We retrospectively reviewed the consent forms obtained for transurethral resection of the prostate and radical prostatectomy procedures during the 6-year period 1995 to 2000 at Atlanta Veterans Affairs Medical Center.

The role of the Veterans Affairs Medical Centers in patient care, surgical education, research and faculty development.

Veterans Administration (VA) medical centers have had a long history of providing medical care to those who have served their country. Over time, the VA has evolved into a facility that has had a major role in graduate medical education. In surgery, this had provided experience in the medical and surgical management of complex surgical disease involving the head and neck, chest, and gastrointestinal tract, and in the fields of surgical oncology, peripheral vascular disease, and the subspecialties of urology, orthopedics, and neurosurgery.