The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics.

BACKGROUND: While electronic health records (EHRs) play a key role in increasing colorectal cancer (CRC) screening by identifying individuals who are overdue, important shortfalls remain. OBJECTIVES: As part of the Strategies and Opportunities to STOP Colon Cancer (STOP CRC) study, we assessed the accuracy of EHR codes in identifying patients eligible for CRC screening. METHODS: We selected a stratified random sample of 800 study participants from 26 participating clinics, in the Pacific Northwest region of the USA. We compared data obtained through codes in the EHR to conduct a manual chart audit. A trained chart abstractor completed the abstraction of eligible and ineligible patients. RESULTS: Of 520 individuals in need of CRC screening, identified via the EHR, 459 were confirmed through chart review (positive predictive value = 88%). Of 280 individuals flagged as up-to-date in their screening per EHR data, 269 were confirmed through chart review (negative predictive value = 96%). Among the 61 patients incorrectly classified as eligible, 83.6% of disagreements were due to evidence of a prior colonoscopy or referral that was not captured in recognizable fields in the EHR. CONCLUSIONS: Our findings highlight importance of better capture of past screening events in the EHR. While the need for better population-based data is not unique to CRC screening, it provides an important example of the use of population-based data not only for tracking care, but also for delivering interventions.

Safety of Gastrointestinal Endoscopy With Conscious Sedation in Patients With and Without Obstructive Sleep Apnea.

BACKGROUND AND STUDY AIMS: Patients with obstructive sleep apnea (OSA) undergoing endoscopy with sedation are considered by practitioners to be at a higher risk for cardiopulmonary complications. The aim of the present study was to evaluate the safety of conscious sedation in patients with OSA undergoing gastrointestinal endoscopy. PATIENTS AND METHODS: This is an IRB-approved prospective cohort study performed at the James A. Haley VA. A total of 248 patients with confirmed moderate or severe OSA by polysomnography and 252 patients without OSA were enrolled. Cardiopulmonary variables such as heart rate, blood pressure, and level of blood oxygen saturation were recorded at 3-minute intervals throughout the endoscopic procedure. RESULTS: In total, 302 colonoscopies, 119 esophagogastroduodenoscopies, 6 flexible sigmoidoscopies, and 60 esophagogastroduodenoscopy/colonoscopies were performed. None of the patients in the study required endotracheal intubation, pharmacologic reversal, or experienced an adverse outcome as a result of changes in blood pressure, heart rate, or blood oxygen saturation. There were no significant differences in the rate of tachycardia (P=0.749), bradycardia (P=0.438), hypotension (systolic/diastolic, P=0.460; mean arterial pressure, P=0.571), or hypoxia (P=0.787) between groups. The average length of time spent in each procedure and the average dose of sedation administered also did not differ significantly between the groups. CONCLUSIONS: Despite the presumed increased risk of cardiopulmonary complications, patients with OSA who undergo endoscopy with conscious sedation have clinically insignificant variations in cardiopulmonary parameters that do not differ from those without OSA. Costly preventative measures in patients with OSA are not warranted.

Intraoperative digital specimen mammography: rapid, accurate results expedite surgery.

INTRODUCTION: Specimen mammography during image guided breast surgery is a daily occurrence. The process of specimen travel, imaging and reporting may take 20-30 minutes. An intraoperative method to obtain digital specimen mammograms may expedite the process. We compared intraoperative digital specimen mammography (IDSM) as well as standard specimen mammography (SSM) on 121 consecutive image guided lumpectomies. METHODS: Each lumpectomy specimen had IDSM obtained followed by travel to radiology for SSM. Surgical decisions were based on all imaging obtained. Data included 1) the ability of each imaging method to identify the target lesion, 2) degree of concordance of surgical interpretation of IDSM compared to radiologist interpretation of SSM, 3) the time required from lumpectomy to surgical review of images from each method, and 4) potential operative time savings. RESULTS: Intraoperative digital specimen mammography (IDSM) was equally as accurate as standard x-ray film specimen mammography. There was no significant difference between 1) the frequency of identification of the target lesion by surgeon or radiologist, 2) lack of identification of any lesion, or 3) frequency of involved margins using imaging criteria. However, there was a marked difference in 1) the time needed to obtain images ready to read, 2) the ability to re-excise tissue promptly, and 3) the overall operating room time with an average decrease of 19 minutes. CONCLUSIONS: Intraoperative digital specimen mammography (IDSM) was equally accurate as SSM obtained in this study. Use of this new technology allows surgeons to quickly view specimen images which translate into shorter more efficient operations.

Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record.

BACKGROUND: Documentation of the clinical breast examination (CBE) has consisted of simple hand-drawings and stick figures without a common lexicon. There is a need for a device that can accurately depict the CBE in digital format while being objective, reproducible over time, and useable in the electronic medical record. This new device is called palpation imaging (PI). METHODS: We examined 110 patients with a complaint of a breast mass using PI. This laptop-sized device creates a real-time digital display of the palpable area in both video and still formats. The size, hardness, shape, homogeneity, and mass location may be extracted from the image. RESULTS: Of those with a true mass, PI identified the mass in 94% while physical examination identified 86%. The positive predictive value (PPV) for breast cancer using PI was 94% and 78% for physical examination. A survey of primary care physicians revealed the inclusion of the PI record in a consultation note implied competence, experience, and skill by the surgeon. CONCLUSIONS: PI documented the CBE in a timely, efficient, and accurate manner. A reproducible record allows objective review by multiple examiners at varied times. Continued work will optimize examination methods.

Intraoperative digital specimen mammography: prompt image review speeds surgery.

Specimen mammograms are often a time-consuming event for image-guided surgery. The use of an intraoperative imaging device may improve the speed of surgery, but comparison must be made to ensure accuracy is maintained. One hundred fifty consecutive image localized patients underwent both intraoperative digital specimen mammogram (in the operating room) and standard specimen mammogram (in radiology). Intraoperative mammograms as read by breast surgeons were as accurate as standard films while saving an average of 19 minutes per operative procedure. Intraoperative digital specimen mammograms can accurately identify target lesions while saving operating room time.

Office-based cryoablation of breast fibroadenomas with long-term follow-up.

Approximately 10% of women will experience a breast fibroadenoma in their lifetime. Cryoablation is a new treatment that combines the better attributes of the current standards: surveillance and surgery. It is a minimally invasive office-based procedure that is administered without the use of general anesthesia, involving minimal patient discomfort and little to no scarring. This work aimed to establish the long-term (2-3 years) efficacy, safety, and satisfaction of the procedure, as well as the impact of cryoablation on mammogram and ultrasound images. Thirty-seven treated fibroadenomas were available for assessment with an average follow-up period of 2.6 years. Of the original 84% that were palpable prior to treatment, only 16% remained palpable to the patient as of this writing. Of those fibroadenomas that were initially < or = 2.0 cm in size, only 6% remained palpable. A median volume reduction of 99% was observed with ultrasound. Ninety-seven percent of patients and 100% of physicians were satisfied with the long-term treatment results. Mammograms and ultrasounds showed cryoablation produced no artifact that would adversely affect interpretation. Cryoablation for breast fibroadenomas has previously been reported as safe and effective both acutely and at the 1-year follow-up mark, and thus has been implemented as a treatment option. At long-term follow-up, cryoablation as a primary therapy for breast fibroadenomas demonstrates progressive resolution of the treated area, durable safety, and excellent patient and physician satisfaction. The treatment is performed in an office setting rather than an operating room, resulting in a cost-effective and patient-friendly procedure. Cryoablation should be considered a preferred option for those patients desiring definitive therapy for their fibroadenomas without surgical intervention.

Cryoablation treatment of benign breast lesions with 12-month follow-up.

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.

Intraoperative ultrasonography guidance is accurate and efficient according to results in 100 breast cancer patients.

BACKGROUND: The frequency of nonpalpable breast cancer has doubled in the last 10 years. Surgical use of high quality portable ultrasound units has made it possible to evaluate the time-saving method of intraoperative ultrasonography localization. METHODS: Ultrasonography localization in the operating room immediately prior to definitive surgery was performed by the surgeon. All tissue underwent specimen mammography and ink orientation. The presence of negative margins, the closest margins, the need for reexcision, and the cosmetic result were examined for each patient. RESULTS: Ultrasonography correctly localized all breast cancers at surgery (100% sensitivity). Negative margins for invasive carcinoma were found in 90% of patients. Negative margins were at least 10 mm in 27%, at least 5 mm in 62%, and at least 1 mm in 90%. Positive margins were due to the presence of noncalcified ductal carcinoma in-situ (4 of 10) or multifocal invasive disease (6 of 10) noted at final histology. Reexcisions were performed in 9% of patients. CONCLUSIONS: Surgical use of intraoperative ultrasonography for localization of breast cancer is accurate and efficient. Ultrasonography localization is easier on the patient, is time and cost efficient, and convenient to schedule. Surgeons should embrace this new skill and utilize this tool whenever a nonpalpable breast cancer can be seen with ultrasonography.

Encircling guidewire facilitates complete excision of image-localized breast lesions.

BACKGROUND: An innovative encircling guidewire defines three sides of a target lesion with a single puncture to achieve negative margins. METHODS: Twenty-five patients requiring image-guided surgery were localized with an encircling guidewire. Although the deployed wire is circular, it is straight when placed, using a straight outer needle. After image-guided placement of the wire around the lesion, all patients underwent standard surgical excision. Each patient was categorized by proper localization of the target lesion, presence of negative margins, closest margin, and need for reexcision. RESULTS: The circlewire wire identified the target lesion in all cases. There were no complications relative to either version of the leading tip on the guidewire. Negative margins were achieved in all pure invasive ductal carcinomas. Positive margins were found in all 3 patients with extensive noncalcified in-situ disease and 1 patient with multifocal invasive lobular carcinoma. CONCLUSIONS: An innovative encircling localizing guidewire device gives the surgeon a new option to completely remove a nonpalpable breast lesion.

Intraoperative ultrasound facilitates surgery for early breast cancer.

BACKGROUND: Mammogram-directed wire localization for nonpalpable cancer requires surgeon's time and coordination and some patient discomfort. Up to half of these nonpalpable lesions can be visualized by ultrasound. Use of intraoperative ultrasound streamlines the process of image-guided surgery. METHODS: We prospectively visualized 69 nonpalpable breast cancers between January 1998 and July 2001. Ultrasound localization was performed in the operating room immediately before definitive surgery. Breast cancers were localized using either blue dye or a guide wire. RESULTS: Ultrasound correctly localized all lesions at surgery. Negative margins for invasive carcinoma were found in 97% (67 of 69) of patients. Re-excisions were performed in only 6% (4 of 69) of patients. Overall negative margins were found in 90% (62 of 69) of patients. Most positive margins (71%) were due to the presence of noncalcified ductal carcinoma in situ. Mastectomy was necessary in 4% of patients, usually due to multifocal invasive carcinoma. CONCLUSIONS: Increased familiarity with ultrasound has allowed the surgeon to localize breast cancer in the operating room, improving the process of image-guided surgery. Ultrasound localization is accurate, time efficient, technically feasible, and easier for the patient. The re-excision rate is very low and is similar to that for mammographic localization. Intraoperative ultrasound localization should be considered whenever a breast cancer needs image-guided excision.

Office-based ultrasound-guided cryoablation of breast fibroadenomas.

BACKGROUND: Fibroadenomas commonly found by palpation and routine mammography account for approximately 20% of open surgical breast biopsies. Alternatives to open surgery include tumor removal using an automated coring device and tumor ablation using heating or cooling elements. We report our initial experience with cryoablation of biopsy-proven benign fibroadenomas. METHODS: A table-top cryoablation system employing a 2.4-mm cryoprobe was used to treat biopsy-proven benign fibroadenomas up to 4 cm in maximum diameter in a prospective nonrandomized fashion. The cryoprobe was placed under ultrasound guidance. Using a treatment algorithm based on fibroadenoma size, all tumors were subjected to two freeze cycles with an interposing thaw. Skin appearance and temperature, probe temperature, iceball size, and patient comfort were closely monitored during the procedure. Follow-up examinations including ultrasonography and photographs were scheduled for up to 12 months postablation. RESULTS: Fifty patients with 57 core biopsy-proven benign fibroadenomas were treated. Seven early cases were treated in an ambulatory surgery center setting. The remaining procedures were completely office-based using only local anesthetic. Tumor diameter varied from 7 mm to 42 mm (mean 21 mm). The iceball engulfed the target lesion in each case. Transient postoperative side effects were local swelling and ecchymosis. Postoperative discomfort rarely required medication beyond acetaminophen or ibuprofen. Lesions showed progressive shrinkage and disappearance over 3 to 12 months. No skin injury was noted and appearance remained excellent. Patient satisfaction was excellent. CONCLUSIONS: With office-based use of ultrasound-guided cryoablation for fibroadenomas there was little or no pain, target lesions were reduced in size or eliminated, scarring was minimal, cosmesis outstanding, and patient satisfaction was excellent. Cryoablation offers a useful office-based alternative to surgical excision of benign fibroadenomas.