Alexandra Webb

Chlorhexidine–Alcohol versus Povidone–Iodine for Surgical-Site Antisepsis

BACKGROUND Since the patients skin is a major source of pathogens that cause surgical-site infection, optimization of preoperative skin antisepsis may decrease postoperative infections. We hypothesized that preoperative skin cleansing with chlorhexidine-alcohol is more protective against infection than is povidone-iodine. METHODS We randomly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine-alcohol scrub or povidone-iodine scrub and paint. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections. RESULTS A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs. 16.1%; P=0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections (4.2% vs. 8.6%, P=0.008) and deep incisional infections (1% vs. 3%, P=0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups. CONCLUSIONS Preoperative cleansing of the patients skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean-contaminated surgery. (ClinicalTrials.gov number, NCT00290290.)

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 VAs 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. RBs 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.

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 Backs (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 VAs 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 &khgr;2 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).

Duty-hour restrictions and the work of surgical faculty: results of a multi-institutional study.

Purpose To examine whether duty-hour restrictions have been consequential for various aspects of the work of surgical faculty and if those consequences differ for faculty in academic and nonacademic general surgery residency programs. Method Questionnaires were distributed in 2004 to 233 faculty members in five academic and four nonacademic U.S. residency programs in general surgery. Participation was restricted to those who had been faculty for at least one year. Ten items on the questionnaire probed faculty work experiences. Results include means, percentages, and t-tests on mean differences. Of the 146 faculty members (63%) who completed the questionnaire, 101 volunteered to be interviewed. Of these, 28 were randomly chosen for follow-up interviews that probed experiences and rationales underlying items on the questionnaire. Interview transcripts (187 single-spaced pages) were analyzed for main themes. Results Questionnaire respondents and interviewees associated duty-hour restrictions with lowered faculty expectations and standards for residents, little change in the supervision of residents, a loss of time for teaching, increased work and stress, and less satisfaction. No significant differences in these perceptions (p ≪ .05) were found for faculty in academic and nonacademic programs. Main themes from the interviews included a shift of routine work from residents to faculty, a transfer of responsibility to faculty, more frequent skill gaps at night, a loss of time for research, and the challenges of controlling residents’ hours. Conclusions Duty-hour restrictions have been consequential for the work of surgical faculty. Faculty should not be overlooked in future studies of duty-hour restrictions.

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 &KHgr;2 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

Perioperative Complications After Noncardiac Surgery in Patients With Insertion of Second-Generation Drug-Eluting Stents

The perioperative outcomes of noncardiac surgery in patients who have received second-generation drug-eluting stents (DESs) have received limited study. We reviewed the medical records of 1,748 consecutive patients who received DES at our institution (1,789 procedures) from January 1, 2009, to July 1, 2012, to determine the outcomes of subsequent noncardiac surgery. During a median follow-up of 43 months, 221 patients underwent 345 noncardiac surgeries (138 low risk, 130 intermediate risk, and 77 high risk), of which 278 were in patients with previous second-generation DES implantation. The incidence of noncardiac surgery in patients with previous second-generation DES implantation was 4.5% at 1 year, 11.6% at 2 years, and 15.2% at 3 years. The mean time from stent implantation to surgery was 21±12.9 months. Mean age was 66±8 years, 99% were men, and 11% had a perioperative complication, including 5.8% major bleeding, 2.5% acute kidney injury, 2.2% major adverse cardiac event, and 1.4% stroke. Perioperative stent thrombosis occurred in 2 patients (0.7%, 95% confidence interval 0.2% to 2.6%): 1 patient had received a DES 14 months before surgery and had stent thrombosis on the day of surgery and the other had a DES implanted 21 months before surgery and developed stent thrombosis the day after surgery. In conclusion, the incidence of perioperative complications with noncardiac surgery after second-generation DES implantation was 11% and consisted mainly of bleeding (5.8%). The incidence of definite stent thrombosis was 0.7%.