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. This systematic review aims to use existing published information to assess preoperative provision of risk information by surgeons. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses as a guide, a standardized search in Ovid MEDLINE, Embase, CINHAL, and PubMed was performed. Three reviewers performed the study screening, with 2-reviewer consensus required at each stage. Studies containing objective information concerning preoperative risk provision in adult surgical patients were selected for inclusion. Studies exclusively addressing interventions for pediatric patients or trauma were excluded, as were studies addressing risks of anesthesia. RESULTS: The initial search returned 12,988 papers after deduplication, 33 of which met inclusion criteria. These studies primarily evaluated consent through surveys of providers, record reviews and consent recordings. The most ubiquitous finding of all study types was high levels of intra-surgeon variation in what risk information is provided to patients preoperatively. Studies recording consents found the lowest rates of risk disclosure. Studies using multiple forms of investigation corroborated this, finding disparity between verbally provided information vs chart documentation. CONCLUSIONS: The wide variance in what information is provided to patients preoperatively inhibits the realization of the ethical and practical components of informed consent. The findings of this review indicate that significant opportunities exist for practice improvement. Future development of surgical communication tools and techniques should emphasize standardizing what risks are shared with patients.

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). For patients admitted for acute myocardial infarction (AMI), heart failure (HF) and pneumonia we examined changes in hospital performance on 30-d mortality and 30-d readmission rates as a result of adding clinical data to administrative data. We evaluated whether this enhancement yielded improved measures of hospital quality, based on concordance with other hospital quality indicators. RESULTS: For 30-d mortality, data enhancement improved model performance, and significantly changed hospital performance profiles; for 30-d readmission, the impact was modest. Concordance between enhanced measures of both outcomes, and with other hospital quality measures - including Joint Commission process measures, VA Surgical Quality Improvement Program (VASQIP) mortality and morbidity, and case volume - remained poor. CONCLUSIONS: Adding laboratory tests and vital signs to measure hospital performance on mortality and readmission did not improve the poor rates of agreement across hospital quality indicators in the VA. INTERPRETATION: Efforts to improve risk adjustment models should continue; however, evidence of validation should precede their use as reliable measures of quality.

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. METHODS: We examined 30-day mortality following acute myocardial infarction at 104 VA hospitals for veterans 66 years and older from 2006 through 2010 who were also Medicare beneficiaries. Using VA-only data versus combined VA/Medicare data, we calculated 2 risk-standardized mortality rates (RSMRs): 1 based on observed mortality (O/E) and the other from CMS' Hospital Compare program, based on model-predicted mortality (P/E). We also categorized hospital outlier status based on RSMR relative to overall VA mortality: average, better than average, and worse than average. We tested whether hospitals whose patients received more of their care through Medicare would look relatively better when including those data in risk adjustment, rather than including VA data alone. RESULTS: Thirty-day mortality was 14.8%. Adding Medicare data caused both RSMR measures to significantly increase in about half the hospitals and decrease in the other half. O/E RSMR increased in 53 hospitals, on average, by 2.2%, and decreased in 51 hospitals by -2.6%. P/E RSMR increased, on average, by 1.2% in 56 hospitals, and decreased in the others by -1.3%. Outlier designation changed for 4 hospitals using O/E measure, but for no hospitals using P/E measure. CONCLUSIONS: VA hospitals vary in their patients' use of Medicare-covered care and completeness of health records based on VA data alone. Using combined VA/Medicare data provides modestly different hospital profiles compared with those using VA-alone data.

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. DESIGN: Secondary analysis of a randomized trial. SUBJECTS: Elective surgical patients were consented using iMedConsent, the VA's computer-based IC platform. Patients were randomized to RB (IC could not be signed until the patient satisfactorily expressed key elements) or standard iMedConsent (no RB). MEASURES: A questionnaire was given immediately after IC assessing time for decision, satisfaction with and ease of understanding consent, and the amount of information provided about the proposed surgery (e.g., indications, benefits, risks, and alternatives). Groups were compared with Χ tests. RESULTS: We enrolled 575 subjects (276 RB and 299 no RB); 92% were men with a mean age of 61.6 years and high school level reading ability. The groups were comparable in their perceptions regarding time to make a decision (RB 88% Strongly Agree (SA), no RB 88% SA; P = 0.61), satisfaction with consent (RB 90% SA, no RB 87% SA; P = 0.27), ease of understanding (RB 69% SA, no RB 67% SA; P = 0.73) receipt of the right amount of information regarding the indications (RB 85% SA, no RB 87%; P = 0.61), the benefits (RB 87% SA, no RB 86% SA; P = 0.29), and the risks (RB 87% SA, no RB 84% SA; P = 0.19) of surgery. More of the RB group felt they received the right amount of information about alternatives to surgery (RB 80% SA) than did the no RB group (69% SA); P = 0.01. CONCLUSIONS: Patients were highly satisfied with RB during surgical IC RB is not detrimental to the consent process and may improve informed consent for surgery. TRIAL REGISTRATION: Clinical Trials Identifier NCT00288899 http://www.clinicaltrials.gov.

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. Despite preliminary data, this practice has not been evaluated in any large scale study. METHODS: This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent, the VA's computer based platform. Patients scheduled for elective surgeries were randomized to RB (a module added to the iMedConsent package) or standard iMedConsent (no RB). Comprehension was tested after the informed consent using procedure-specific questionnaires. Time stamps in the iMedConsent program estimated the time spent completing the informed consent process. Provider and patient satisfaction were measured using 5-point Likert scales. Statistical comparisons of groups were performed using t-tests and chi tests. RESULTS: A total of 575 patients were enrolled. In the RB group, providers spent 2.6 minutes longer (P < 0.0001) obtaining informed consent. The mean comprehension score was significantly higher in the RB group (71.4%) versus the no RB group (68.2%, P = 0.03); the effect was greatest in carotid endarterectomy patients (RB = 73.4% vs. no RB = 67.7%, P = 0.02). Quality of decision making was rated similarly. Providers were neutral to slightly favorable regarding RB. CONCLUSIONS: RB implemented within an electronic informed consent system improved patient comprehension. The additional time required was acceptable to providers. RB should be considered as an enhancement to surgical informed consent.This clinical trial was registered at http://www.clinicaltrials.gov (Identifier NCT00288899).

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. All informed consent discussions were performed using iMedConsent (Dialog Medical), the VA's computerized informed consent platform. Using a unique module within iMedConsent, we randomized patients to repeat back (RB), requiring correct reiteration of procedure-specific facts, or standard (STD) iMedConsent. Patient comprehension was tested after the informed consent discussion using procedure-specific questionnaires. Time spent completing the informed consent process was measured using time stamps within iMedConsent. Multiple linear regression identified factors independently associated with improved comprehension. RESULTS: We enrolled 575 patients (276 RB, 299 standard); 93% were male, 74% were Caucasian, and 89% had at least a high school education. Independent factors associated with improved comprehension included race (p < 0.01), ethnicity (p < 0.05), age (p < 0.02), operation type (p < 0.01), group assignment (+/- RB; p < 0.05), and total consent time (p < 0.0001). Patient comprehension was maximized when informed consent took between 15 and 30 minutes. RB's positive impact on patient comprehension was weaker in the analysis including consent time. CONCLUSIONS: Comprehension during informed consent discussions may be limited in individuals with potential language difficulty due to ethnicity or education. Total consent time was the strongest predictor of patient comprehension. Affording adequate time for informed consent discussions and using informed consent adjuncts such as RB may enhance comprehension in such individuals.

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. While comparisons of these outcome metrics between individuals or institutions are held to portray quality of surgical care, such comparisons are compromised by the divergent risk profiles associated with the patient population in question, underscoring the import of adequate and validated risk adjustment measures. Numerous risk adjustment strategies have been developed, based either on more readily available, and thus less expensive, administrative claims data or on more reliable and robust, but more expensive, clinical data. The National Surgical Quality Improvement Program (NSQIP), which is requires abstraction of clinical data, stands as the "gold standard" for assessment of surgical quality. DATA SOURCES: While risk adjustment seems essential to truly assess surgical quality, alternatives to use of clinical data continue to be explored. Some alternatives from previous works published by the author and others are briefly reviewed in this presentation. CONCLUSIONS: When assessing the quality of surgical outcomes, risk adjustment seems superior. Ongoing research is needed to help achieve balance between the benefit of clinically based models and less expensive alternatives based on administrative data.

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. Surgical management pertaining to the approach, repair and potential need for bladder resection may challenge the surgeon. We report a series of 4 cases of large inguinoscrotal bladder hernias and provide a literature review. Our goal is to highlight the clinical presentation and the decisive issues surrounding the diagnosis and management of this condition.

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. RESULTS: Nine of the top 10 predictors of postoperative mortality and 7 of the top 10 for postoperative morbidity were the same in the VA and PS models. The ratios of observed to expected mortality and morbidity in the PS hospitals based on a model using PS data only versus VA + PS data were nearly identical (correlation coefficient = 0.98). Outlier status of PS hospitals was concordant in 26 of 28 comparisons. Implementation of the NSQIP in PS hospitals was associated with statistically significant reductions in overall postoperative morbidity (8.7%, P = 0.002), surgical site infections (9.1%, P = 0.02), and renal complications (23.7%, P = 0.004). CONCLUSIONS: The VA NSQIP methods and risk models in general and vascular surgery were fully applicable to PS hospitals. Thirty-day postoperative morbidity in PS hospitals was reduced with the implementation of the NSQIP.

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. Therefore, health care policy makers, health service researchers, and others are aggressively developing and implementing quality indicators for surgical practice. Given the complex interplay of structure, process, and outcomes, assessment of surgical quality presents a daunting task. We must firmly establish the links between these elements to validate current and future metrics, while engendering "buy-in'' on the part of surgeons.

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. An Internet-based data collection system was used to input data from the different private medical centers. Semiannual feedback of observed to expected mortality and morbidity ratios was provided to the participating medical centers. RESULTS: During the 3-year study, total accrual in general surgery was 145,618 patients, including 68.5% from the VA and 31.5% from the private sector. Accrual in vascular surgery totaled 39,225 patients, including 77.8% from the VA and 22.2% from the private sector. VA patients were older and included a larger proportion of male patients and African Americans and Hispanics. The VA population included more inguinal, umbilical, and ventral hernia repairs, although the private-sector population included more thyroid and parathyroid, appendectomy, and operations for breast cancer. Preoperative comorbidities were similar in the two populations, but the rates of comorbidities were higher in the VA. American Society of Anesthesiologists classification tended to be higher in the VA. CONCLUSIONS: The National Surgical Quality Improvement Program methodology was successfully implemented in the 14 university medical centers. The data from the study provided the basis for the articles in this issue of the Journal of the American College of Surgeons.

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. Multiple logistic regression analysis was used to identify preoperative predictors of postoperative mortality and morbidity. An indicator variable for VA versus private-sector medical center was added to the model to determine if risk-adjusted outcomes were significantly different in the two systems. RESULTS: The unadjusted 30-day mortality rate was higher in the VA compared with the private sector (2.62% versus 2.03%, p = 0.0002); unadjusted morbidity rate was lower in the VA compared with the private sector (12.24% versus 13.99%, p < 0.0001). After risk adjustment, odds ratio for mortality for the VA versus private sector was 1.23 (95% CI, 1.08-1.41). For morbidity after risk adjustment, the indicator variable for health-care system just missed statistical significance (p = 0.0585). Thirty-day postoperative mortality was comparable in the VA and private sector for very common operations but was higher in the VA for less common, more complex operations. CONCLUSIONS: In general surgery operations in men, the VA appeared to have a higher risk-adjusted mortality rate compared with the private sector, but differences in mortality ascertainment in the two sectors might account for some of this effect. The higher mortality in the VA could be the result of higher mortality in the less common, more complex operations. There is a trend toward lower risk-adjusted morbidity in the VA compared with the 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. STUDY DESIGN: Preoperative patient characteristics and laboratory variables, operative variables, and unadjusted postoperative outcomes were compared between VA and the private sector populations. In addition, stepwise logistic regression models were developed for 30-day postoperative mortality and morbidity. Finally, the effect of being treated in a VA or private sector hospital was assessed by adding an indicator variable to the models and testing it for statistical significance. RESULTS: Data from 5,157 female general surgical VA patients who underwent eligible procedures were compared with those from 27,467 patients in the private sector. Unadjusted 30-day mortality was virtually identical in the two groups (1.3%). The unadjusted morbidity rate was slightly, but notably, higher in the private sector (10.9%) as compared with that observed in the VA (8.5%, p < 0.0001). Predictive models were generated for mortality and morbidity combining both groups; top variables in these models were similar to those described previously in the National Surgical Quality Improvement Program. The indicator variable for system of care (VA versus private sector) was not statistically significant in the mortality model, but substantially favored the VA in the morbidity model (odds ratio=0.80, 95% CI=0.71, 0.90). CONCLUSIONS: The data demonstrate that in female general surgical patients, risk-adjusted mortality rates are comparable in the VA and the private sector, but risk-adjusted morbidity is higher in the private sector. Rates of urinary tract infections in the two populations may account for much of the latter difference.

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. STUDY DESIGN: A cross-sectional survey was mailed to 123 Department of Veteran Affairs (VA) and 14 private sector sites participating in the Agency for Healthcare Research and Quality (AHRQ)-funded Patient Safety in Surgery (PSS) Study. The survey included questions about organizational structures and processes of preoperative, intraoperative, and postoperative general surgical care services. For this study, we included only data from 90 VA sites that returned a survey (73% response rate). We used descriptive statistics and examined the bivariate association of structures and processes items or scales with risk-adjusted observed-to-expected (O/E) ratios of surgical morbidity and mortality. RESULTS: Examination of frequency or means and standard deviations of items and scales revealed substantial variation in the structures and processes of surgical care services in participating VA sites, with correlation analyses demonstrating that, of 35 process and structure variables, there was a statistically significant relationship with the hospital's observed-to-expected ratio for 14 variables for morbidity, but only 4 variables for mortality. CONCLUSIONS: This descriptive analysis provides support for the potential importance of measuring organizational structures and processes of care in addition to risk-adjusted morbidity and mortality.

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). Qualitative interviews were transcribed and analyzed to identify common structures and processes mentioned by interviewees to include on a quantitative survey and to develop a rich description of salient themes on indicators of effective surgical care services and surgical care teams. RESULTS: Qualitative analyses of transcripts resulted in detailed descriptions of structures and processes of surgical care services that affected surgical care team performance--and how particular structures led to effective and ineffective processes that impacted quality and outcomes of surgical care. Communication and care coordination were most frequently mentioned as essential to effective surgical care services and teams. Informants also described other influences on surgical quality and outcomes, such as staffing, the role of residents, and team composition and continuity. CONCLUSIONS: Surgical care team members reinforced the importance of understanding surgical care processes and structures to improve both quality and outcomes of surgical care. The analysis of interviews helped the study team identify potential measures of structures and processes to include in our quantitative survey.

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. Responsibility for antibiotic administration was shifted from preoperative nursing staff to the anesthetist. Electronic quick orders were developed to encourage appropriate antibiotic selection and simplify order creation. RESULTS: Timely administration of preoperative antibiotics improved from 51% to 98% from February 2005 to February 2006. Appropriate antibiotic administered improved from 78% to 94%. The clean wound infection rate decreased from 2.7% to 1.4% over the same time period. CONCLUSION: A multidisciplinary approach to prophylactic antibiotic use, including computer-guided decision support, facilitates appropriate preoperative antibiotic use, resulting in a significant decrease in surgical wound infections.