Making Informed Choices On Incorporating Chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial.

INTRODUCTION: Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. METHODS/DESIGN: We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. RESULTS/DISCUSSION: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. TRIAL REGISTRATION: NCT04496739.

Intra-abdominal abscess after laparoscopic appendectomy for perforated appendicitis.

HYPOTHESIS: The incidence of postoperative intra-abdominal abscess is higher after laparoscopic compared with open appendectomy for perforated appendicitis. METHODS: A historical cohort study of pediatric patients operated on for suspected appendicitis by open appendectomy or laparoscopic appendectomy compares the incidence of postoperative intra-abdominal abscess for each procedure. SETTING: A tertiary care center. PATIENTS: Five hundred thirty-eight pediatric patients were operated on for suspected appendicitis at our institution between 1974 and 1999. Of these, 453 were included in the study. Of the excluded patients, 9 had incomplete medical records, 69 had normal or interval appendectomies, and 7 had appendixes removed by methods other than laparoscopy or right lower quadrant incision. INTERVENTIONS: Open appendectomy performed through a right lower quadrant incision or laparoscopic appendectomy performed through a 3-trocar approach by 1 of 3 pediatric surgeons at our institution. MAIN OUTCOME MEASURE: The incidence of postoperative intra-abdominal abscess after laparoscopic vs open appendectomy. RESULTS: In perforated appendicitis (170 patients), the incidence of postoperative abscess after laparoscopic appendectomy was 24% vs 4.2% after open appendectomy. The relative risk ratio of developing a postoperative abscess after perforated appendicitis was 5.6 (confidence interval, 2.1-16.0) after laparoscopic vs open appendectomy. The results remained significant when controlled for age, sex, intraoperative irrigation, and preoperative antibiotics. Postoperative abscess in all acute, gangrenous, and perforated appendicitis after laparoscopic appendectomy was 6.4% vs 3.0% after open appendectomy. This was not statistically significant. CONCLUSION: There is a significant increase in the incidence of postoperative intra-abdominal abscess with perforated appendicitis after laparoscopic compared with open appendectomy in pediatric patients.