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.

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.

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).

Arteriovenous fistula construction using femoral vein in the thigh and upper extremity: single-center experience.

The objective of this study was to determine the outcome of femoral vein (FV) access as either a FV thigh transposition or upper extremity FV translocation. This is a retrospective review of all end-stage renal disease (ESRD) patients who underwent FV access at the University of Colorado Health Sciences Center from December 2004 to May 2007. Demographics, number of prior access procedures, FV dialysis access procedure, periprocedural complications, mean follow-up, secondary access-related procedures, and access function were recorded. Complications were subdivided into FV harvest site- and ischemia-related. Nineteen patients underwent FV access during the study period: 10 underwent FV thigh transpositions and nine underwent upper extremity FV translocations. The median number of prior access procedures was two. The median hospital stay was 3 days, and there were no perioperative deaths. Eight patients had FV harvest site complications: six lymphoceles, one AVF infection requiring ligation, and one compartment syndrome requiring fasciotomy. Three (16%) patients had ischemic complications: one required ligation of the AVF and two required distal revascularization interval ligation. Seventy-nine percent of patients had a functioning access at a mean follow-up of 6 months (range 23 days to 3 years). Four FV arteriovenous accesses required one or more endovascular procedures to maintain function at 12 months. The use of FV access in ESRD is durable at intermediate follow-up but has significant morbidity. FV access should be reserved for good-risk patients who have exhausted other autogenous options.

Endovascular therapy of superior gluteal artery aneurysms: case report and review of literature.

We report two cases of superior gluteal artery aneurysms successfully treated with coil embolization and review treatment options for these lesions. Our experience in the treatment of three total aneurysms, two likely post-traumatic in etiology and one mycotic, suggests that endovascular therapy is an effective alternative to open surgery when treating superior gluteal artery aneurysms.

Functional outcome in a contemporary series of major lower extremity amputations.

PURPOSE: We undertook this study to document the functional natural history of patients undergoing major amputation in an academic vascular surgery and rehabilitation medicine practice. METHODS: A retrospective review was conducted of consecutive patients undergoing major lower extremity amputation and rehabilitation in a university and Department of Veterans Affairs hospital. Main outcome variables included operative mortality, follow-up, survival, median time to incision healing, secondary operative procedures for wound management, and conversion from below-knee amputation (BKA) to above-knee amputation (AKA). For surviving patients, quality of life was determined by degree of ambulation, eg, outdoors, indoors only, or no ambulation; use of a prosthesis; and independence, eg, community housing or nursing facility. RESULTS: From August 1997 through March 2002, 154 patients (130 men; median age, 62 years) underwent 172 major amputations, 78 AKA and 94 BKA, because of either critical limb ischemia (87%) or diabetic neuropathy (13%). Thirty-day operative mortality was 10%. Mean follow-up was 14 months. Healing at 100 and 200 days, as determined with the Kaplan-Meier method, was 55% and 83%, respectively, for BKA, and 76% and 85%, respectively, for AKA. Twenty-three BKA and 16 AKA required additional operative revision, and 18 BKA ultimately were converted to AKA. Survival was 78% at 1 year and 55% at 3 years. Function in surviving patients at 10 and 17 months, respectively, was as follows: 21% and 29% of patients ambulated outdoors, 28% and 25% ambulated indoors only, and 51% and 46% of patients were nonambulatory; 32% and 42% of patients used prosthetic limbs; and 17% and 8% of patients who lived in the community before amputation required care in a nursing facility. CONCLUSIONS: We were surprised to find that vascular patients in a contemporary setting who require major lower extremity amputation and rehabilitation often remain independent despite infrequent prosthesis use and outdoor ambulation. Although any hope for postoperative ambulation in this population requires salvaging the knee joint, because of the morbidity incurred in both wound healing and rehabilitation efforts, aggressive effort should be reserved for selected patients at good risk. Ability to predict ambulation after BKA in the vascular population is poor.

Outcome of catheter-directed thrombolysis for lower extremity arterial bypass occlusion.

OBJECTIVE: The purpose of this study was to determine the clinical outcome of patients undergoing catheter-directed thrombolysis (CDT) for lower extremity arterial bypass (LEAB) occlusion. METHODS: A retrospective review was performed of two university-based practices from 1988 to 2001. All patients with LEAB occlusion (<14 days by history) undergoing CDT as initial treatment were included. Technical success, complications, secondary patency, and limb salvage were examined. Additional analysis examined secondary procedures performed for residual lesions or failed CDT and the number of LEABs that were replaced or that became infected. RESULTS: One hundred four patients (77% male; mean age, 65 years) had 109 LEAB occlusions. CDT restored patency in 77%. Of the 25 LEABs that failed initial CDT, 15 underwent surgical thrombectomy/revision, four were replaced, and six underwent no further interventions. Of the 84 LEABs successfully lysed, 51 had residual lesions that underwent revision with interventional (n = 30) or surgical (n = 15) techniques or both (n = 6). Median hospital stay was 8 days with three periprocedural deaths. One quarter of CDT procedures had bleeding or thrombotic complications or both. The mean follow-up period was 45 months. Secondary patency rates on an intention-to-treat basis (attempted thrombolysis) were 32% and 19% at 1 and 5 years, respectively. After successful CDT, the 1-year secondary patency rate was comparable in LEABs with or without residual lesions (42% versus 45%). Overall, the limb salvage rates were 73% and 55% at 1 and 5 years, respectively. The survival rate was 56% at 5 years. Ten of the 54 LEABs (19%) that eventually failed after successful CDT had three or more reocclusive episodes. Seven LEABs (8.3%) salvaged with CDT eventually became infected from recurrent interventions; six of these necessitated major amputation. Twenty LEABs initially salvaged with CDT were replaced (four immediately and 16 after episodes of recurrent ischemia). Two patients died during hospitalization for treatment of recurrent ischemia. CONCLUSION: Despite relatively high initial technical success for LEAB thrombolysis, eventual failure is the rule rather than the exception. Recurrent LEAB occlusions lead to significant morbidity, including recurrent interventions, eventual graft infection/replacement, and limb loss. However, LEAB replacement has substantial problems associated with limited conduit, reoperative anatomy, and subsequent wound complications. We therefore advocate an initial attempt at CDT with liberal use of graft replacement for early and late failures or as an initial strategy in those with favorable remaining conduit.

Preoperative cardiac risk management.

Numerous strategies exist for preoperative cardiac testing before patients undergo vascular operations. Potential adverse effects of evaluation and cardiac intervention should be considered before undertaking screening studies. We recently analyzed the adverse outcomes of preoperative cardiac evaluation and intervention before vascular operations in patients treated at the Denver Department of Veterans Affairs Medical Center. During the 12 month study period, 161 patients were scheduled to undergo major vascular operations; 153 patients came to operation. The decision to pursue a cardiac evaluation was made without a defined protocol. Forty two men, aged 68+/-9 years underwent comprehensive preoperative cardiac evaluations Sixteen (38%) patients had untoward events related to cardiac evaluation, including eight patients (19%) who refused vascular surgery after cardiac screening and/or intervention. Other complications included prosthetic graft infection, pseudoaneurysms (2), sternal wound infections (2) amputations (2), renal failure and brain anoxia. Extensive cardiac evaluation prior to vascular operations can result in morbidity, delays, and refusal to undergo vascular surgery. The underlying indication for vascular operations and the local iatrogenic cardiac complication rates must be considered before ordering special studies.

Smoking cessation counseling: a missed opportunity for general surgery trainees.

PURPOSE: The purpose of this study was to evaluate and compare the attitudes, practices, technique utilizations, and barrier perceptions of smoking cessation counseling (SCC) in general surgery (GS) and primary care (PC) residents. METHODS: One hundred house staff officers (45 GC and 55 PC residents, consisting of internal medicine and family medicine disciplines) were randomly surveyed. chi(2) and t tests were used for comparative analysis where appropriate. The National Cancer Institute's recommendation that physicians follow the "four A's" for SCC (Ask, Advise, Assist, and Arrange follow-up) was examined with respect to compliance by surgical and medical residents. RESULTS: Fewer GS than PC residents thought physicians were responsible for SCC (64% versus 85%; P <.02), and fewer felt well prepared to counsel their patients (38% versus 58%; P <.05). Nevertheless, about 85% of both groups reported a higher inclination to provide SCC to patients who expressed an interest for cessation. Although many GC residents Ask (89% GS versus 100% PC residents; P <.03) and Advise (64% versus 89%; P <.003) new patients about smoking, they did so less frequently than PC residents. GC residents used fewer SCC techniques than did PC residents (3.96 versus 6.00; P <.001) and Arranged fewer follow-up visits for SCC (7% versus 44%; P <.001). Postgraduate year did not correlate with SCC in either GS or PC residents. Residents from both groups perceived time constraints, lack of patient desire, and poor patient compliance to be the main barriers in SCC. CONCLUSION: In this study, many GC residents agreed that physicians were responsible for SCC, but few followed through by arranging SCC follow-up visits compared with their PC resident counterparts. Behavior does not appear to change as residents mature, despite greater exposure to smoking-related diseases. In every dimension of SCC studied, GS residents played a less assertive role when compared with PC residents. GC residents should be more proactive in SCC because the diseases they treat are often related to cigarette smoking.