Facilitating the implementation of the American College of Surgeons/Association of Program Directors in Surgery phase III skills curriculum: training faculty in the assessment of team skills

2015 ◽  
Vol 210 (5) ◽  
pp. 933-941.e2 ◽  
Author(s):  
Louise Hull ◽  
Sonal Arora ◽  
Dimitrios Stefanidis ◽  
Nick Sevdalis
Keyword(s):  
Program Directors ◽  
Phase Iii ◽  
American College Of Surgeons ◽  
Training Faculty

scholarly journals Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Clinical Trials ◽  
Study Drug ◽  
Phase Iii ◽  
Oncology Group ◽  
North Central ◽  
American College Of Surgeons ◽  
Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

Institution-specific utilization of the American College of Surgeons/Association of Program Directors operative skills curriculum: From needs assessment to implementation

Surgery ◽  
2020 ◽  
Vol 168 (5) ◽  
pp. 888-897
Author(s):  
Karen J. Dickinson ◽  
Stephanie Zajac ◽  
Sara G. McNeil ◽  
Benjamin Benavides ◽  
Barbara L. Bass
Keyword(s):  
Needs Assessment ◽  
Program Directors ◽  
American College Of Surgeons

Barriers to adoption of the surgical resident skills curriculum of the American College of Surgeons/Association of Program Directors in Surgery

Surgery ◽  
2013 ◽  
Vol 154 (1) ◽  
pp. 23-28 ◽  
Author(s):  
Patricia A. Pentiak ◽  
Diane Schuch-Miller ◽  
Ronald T. Streetman ◽  
Kimberly Marik ◽  
Rose E. Callahan ◽  
...  
Keyword(s):  
Program Directors ◽  
Barriers To Adoption ◽  
Surgical Resident ◽  
American College Of Surgeons

Factors influencing accrual to ACOSOG Z0011, a randomized phase III trial of axillary dissection vs. observation for sentinel node positive breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 601-601 ◽  
Author(s):  
A. M. Leitch ◽  
L. McCall ◽  
P. Beitsch ◽  
P. Whitworth ◽  
D. Reintgen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sentinel Node ◽  
Frozen Section ◽  
Geographic Region ◽  
Axillary Node ◽  
Phase Iii ◽  
The South ◽  
American College Of Surgeons ◽  
Type Of Institution ◽  
Clinical Bias

601 Background: The American College of Surgeons Oncology Group opened a phase III randomized trial to assess the value of axillary node dissection (ALND) after positive sentinel node biopsy (SNB). After 5.5 years, the trial closed due to poor accrual with only 891 patients of the planned 1900 accrued. The purpose of the current analysis is to assess factors impacting accrual to Z0011. Methods: Women having SNB for T1 or T2 breast cancer were eligible for participation in the Z0010 trial to assess the significance of micrometastases identified by immunohistochemistry. If the SN was positive for metastasis by H&E, the patient was eligible for randomization on Z0011 trial. Intraoperative (IOR) and postoperative randomization were allowed. Patients having SNB outside of the Z0010 trial were eligible. Results: 1003 patients from the Z0010 trial were eligible for randomization on Z0011. Of these, only 37% were entered in Z0011. Z0010 participants accounted for 42% of patients in Z0011. 16% of patients not randomized refused ALND. 69% of those not randomized had ALND. 67% of these had no additional positive nodes. Only 14% had ≥ 4 positive nodes. Enrollment of eligible Z0010 patients varied by type of institution: 25% at academic sites, 42% at teaching affiliated and 53% at community (p < 0.0001). By geographic region, sites in the South entered 42% of eligible patients compared with 24–36% in other geographic regions (p=0.0027). Only 32% of patients were consented for IOR based on frozen section of the SN. Sites in the South and West were less likely to use IOR (25% and 28%) compared to Northeast and Midwest (45% and 46%) (p < 0.0001). 110 sites participated in Z0011, yet 48% of patients were enrolled by 10% of sites. Conclusions: Failure of this important trial to accrue as planned is likely related to the clinical bias of physicians and patients to standard ALND. Yet, 2/3 of patients had no additional positive nodes and extensive nodal disease was infrequent. While it was thought that IOR might improve accrual to Z0011, the most successful sites were less likely to use this approach. Community surgeons were most successful in randomizing patients. [Table: see text]

scholarly journals American College of Surgeons Oncology Group (ACOSOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 45-53
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Sentinel Node ◽  
Axillary Node ◽  
Phase Iii ◽  
List Type ◽  
Oncology Group ◽  
Current Contact ◽  
American College Of Surgeons ◽  
Estrogen Receptor Positive

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by American College of Surgeons Oncology Group (ACOSOG). Clinical trials include: ACOSOG Z1031: A randomized phase III trial comparing 16–18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1mg) in postmenopausal women with clinical stages II and III estrogen receptor positive breast cancer.ACOSOG Z0010: A prognostic study of sentinel node and bone marrow micrometastases in women with clinical T1 or T2 N0 M0 breast cancer.ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1–2 N0 M0 breast cancer who have a positive sentinel node.

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