Publication Highlights

Published
2/2/2016
Study
Supplemental Data
Published
2/2/2016
Perspective
Viewpoint

Overview

The FIRST Trial was a national, cluster-randomized, pragmatic noninferiority trial to test whether surgical-patient outcomes under flexible, less-restrictive duty-hour policies would be no worse than outcomes under standard ACGME policies. Secondary outcomes also studied included resident satisfaction, resident perceptions of patient care, resident education, and resident well-being. Of the 136 eligible general surgery residency programs, 117 (87%) programs and 151 affiliated hospitals participated. Programs and their affiliate hospitals were randomized to the control group (standard-policy group) or the intervention group (flexible-policy group). Outcomes were measured using ACS NSQIP data and the American Board of Surgery In-Training Examination (ABSITE) survey.

Summarized Results

Patient Outcomes

Patient outcome analyses were performed on 138,691 general surgery patients. The rate of death or serious complication did not significantly differ between study groups (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92). In regards to other secondary patient outcomes, the flexible-policy group was found to be noninferior to the standard-policy group for serious complications, any complication, unplanned reoperation, sepsis, surgical-site infection, and urinary tract infection.

Resident Outcomes

Resident outcomes were analyzed for 4,330 general surgery residents. There was no significant difference in resident satisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or resident satisfaction with overall resident well-being (14.9% vs 12.0%, respectively; P=0.10). Residents in the flexible-policy group compared to the standard-policy group were less likely to be dissatisfied with continuity of care (odds ratio 0.44; 95% CI, 0.32 to 0.60; P < 0.001) and quality and ease of handoffs and transitions in care (odds ratio 0.69; 95% CI, 0.52 to 0.92; P=0.01), and less likely to perceive a negative effect of institutional duty-hour policies on patient safety, continuity of care, clinical-skills acquisition, operative-skills style="line-height: 1.4em;" acquisition, autonomy, operative volume, availability for elective and urgent cases, conference attendance, time for teaching medical students, the relationship between interns and residents, and professionalism (all odds ratios>1.00, P < 0.001 for all comparisons except P=0.003 for professionalism). There were no differences in ABSITE or board examination scores between study arms.

In contrast, the flexible-policy group was more likely to be dissatisfied with time for rest (odds ratio 1.41; 95% CI, 1.06 to 1.89; P=0.02) and perceive negative effects of duty hour policies on resident outcomes that depend on time away from the hospital (odds ratios >1.00, P < 0.001). However, most of these concerns decreased as residents progressed through their residency. In fact, compared to interns, overall well-being was significantly better in the flexible-policy group for PGY2-3s, and even more so for PGY4-5s.

When residents were asked what proportion would choose a standard-arm policy program vs a flexible-arm program if they could go back in time, only 14% preferred standard policy.

Finally, it could be that cumulative years under flexible duty hour policies would result in worse patient outcomes and worse resident wellness. In examining the long-term results of the FIRST trial, we found that there was no significant change over time in resident well-being or patient outcomes. Flexibility continued to have a positive impacts on continuity of care.

ACGME Policy Changes

Accordingly, after a period of detailed review, the ACGME revised duty hour requirements in accordance with the flexible duty hour requirements utilized in the FIRST Trial beginning July 1, 2017.

Published Studies

Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.
N Engl J Med. 2016;374(8):713-727.
Asch DA, Bilimoria KY, Desai SV. Resident Duty Hours and Medical Education Policy - Raising the Evidence Bar.
N Engl J Med. 2017;376(18):1704-1706.
Ban KA, Chung JW, Matulewicz RS, et al. Gender-Based Differences in Surgical Residents' Perceptions of Patient Safety, Continuity of Care, and Well-Being: An Analysis from the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial.
J Am Coll Surg. 2017;224(2):126-136 e122.
Bilimoria KY, Chung JW, Hedges LV. External validity is also an ethical consideration in cluster-randomised trials of policy changes. BMJ Qual Saf. 2019;28(2):167.
Bilimoria KY, Chung JW, Hedges LV, et al. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies. JAMA Surg. 2016;151(3):273-281.
Bilimoria KY, Hoyt DB, Lewis F. Making the Case for Investigating Flexibility in Duty Hour Limits for Surgical Residents.
JAMA Surg. 2015;150(6):503-504.
Bilimoria KY, Hoyt DB, Lewis F. Perspective of the FIRST Trial Investigators on Accreditation Council for Graduate Medical Education Changes in Resident Work Environment and Duty Hours. JAMA Surg. 2017;152(10):903-904.
Bilimoria KY, Hoyt DB, Lewis FR. Surgical Resident Duty Hours. N Engl J Med. 2016;374(24):2402-2403.
Bilimoria KY, Quinn CM, Dahlke AR, et al. Use and Underlying Reasons for Duty Hour Flexibility in the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. J Am Coll Surg. 2017;224(2):118-125.
Blay E, Jr., Engelhardt KE, Hewitt DB, Dahlke AR, Yang AD, Bilimoria KY. Evaluation of Reasons Why Surgical Residents Exceeded 2011 Duty Hour Requirements When Offered Flexibility: A FIRST Trial Analysis. JAMA Surg. 2018;153(9):860-862. PMC6233647
Blay E, Jr., Hewitt DB, Chung JW, et al. Association Between Flexible Duty Hour Policies and General Surgery Resident Examination Performance: A Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Analysis. J Am Coll Surg. 2017;224(2):137-142. PMC5851285
Chung JW, Bilimoria KY, Stulberg JJ, Quinn CM, Hedges LV. Estimation of Population Average Treatment Effects in the FIRST Trial: Application of a Propensity Score-Based Stratification Approach. Health Serv Res. 2018;53(4):2567-2590. PMC6051989
Dahlke AR, Johnson JK, Greenberg CC, et al. Gender Differences in Utilization of Duty-hour Regulations, Aspects of Burnout, and Psychological Well-being Among General Surgery Residents in the United States. Ann Surg. 2018;268(2):204-211.
Dahlke AR, Quinn CM, Chung JW, Bilimoria KY. Surgical Residents' Work Hours and Well-Being in Year 2 of the FIRST Trial. N Engl J Med. 2017;377(2):192-194.
Desai SV, Asch DA, Bellini LM, et al. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2018;378(16):1494-1508. PMC6101652
Ellis RJ, Hewitt DB, Hu YY, et al. Can the Culture of Surgical Residency be Measured? An Empirical National Assessment of the Learning Environment. 2019.
Ellis RJ, Hewitt DB, Hu YY, et al. Modifiable Risk Factors Associated with Burnout, Thoughts of Attrition, and Suicidal Ideation in Surgical Residents. 2019.
Ellis RJ, Hewitt DB, Hu YY, et al. A Comprehensive National Survey on Thoughts of Attrition, Alternative Career Paths, and Reasons for Staying in General Surgery Residency. 2019.
Hu YY, Ellis RJ, Hewitt DB, et al. National Evaluation of Gender Discrimination and Sexual Harassment in U.S. Surgical Residency Programs. 2019.
Kreutzer L, Dahlke AR, Love R, et al. Exploring Qualitative Perspectives on Surgical Resident Training, Well-Being, and Patient Care. J Am Coll Surg. 2017;224(2):149-159.
Odell DD, Quinn CM, Matulewicz RS, et al. Association between Hospital Safety Culture and Surgical Outcomes in a Statewide Surgical Quality Improvement Collaborative. J Am Coll Surg. 2019.
Rajaram R, Chung JW, Cohen ME, et al. Association of the 2011 ACGME Resident Duty Hour Reform with Postoperative Patient Outcomes in Surgical Specialties. J Am Coll Surg. 2015;221(3):748-757.
Rajaram R, Chung JW, Jones AT, et al. Association of the 2011 ACGME resident duty hour reform with general surgery patient outcomes and with resident examination performance. JAMA. 2014;312(22):2374-2384.
Rajaram R, Saadat L, Chung J, et al. Impact of the 2011 ACGME resident duty hour reform on hospital patient experience and processes-of-care. BMJ Qual Saf. 2016;25(12):962-970.
Saadat LV, Dahlke AR, Rajaram R, et al. Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements. J Am Coll Surg. 2016;222(6):1098-1105.
Stulberg JJ, Pavey ES, Cohen ME, Ko CY, Hoyt DB, Bilimoria KY. Effect of Flexible Duty Hour Policies on Length of Stay for Complex Intra-Abdominal Operations: A Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Analysis. J Am Coll Surg. 2017;224(2):143-148 e141.

Media Attention

Additional Content

For questions or comments about the FIRST Trial, please contact SENTteam@iu.edu

Extension of the FIRST Trial

The Surgical Education Culture Optimization through targeted interventions based on National comparative Data (SECOND) Trial

With the success of the FIRST Trial, the SECOND Trial was developed. The SECOND Trial will begin with a national mixed-methods analysis to examine programs with respect to resident wellness. Lessons learned from these programs will be incorporated into a multidimensional improvement toolkit. The SECOND Trial will be a prospective, pragmatic cluster-randomized trial examining whether giving programs access to their performance data and the toolkit can improve residency program culture and resident wellness. For more information, please visit the SECOND Trial website at ­­­ https://thesecondtrial.org/.

Second Trial logo