BACKGROUND: To reduce technical variation in cancer surgery, the Commission on Cancer (CoC) recently implemented 6 operative standards as part of its national cancer center accreditation process. CoC sites are evaluated for compliance with these standards through scheduled visits conducted by trained site reviewers. We characterized site reviewers’ perspectives on the implementation of the operative standards. STUDY DESIGN: Twenty interviews were conducted with CoC site reviewers using a semistructured interview guide based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Themes were identified using thematic analysis mapped to the updated Consolidated Framework for Implementation Research. RESULTS: Site reviewers viewed the operative standards as an effective starting point for improving technical quality and were optimistic the standards would lead to positive change. Compliance was associated with supportive site leadership, effective interdisciplinary communication, and the availability of adequate personnel and institutional resources. In contrast, resistance from surgeons was identified as a key barrier. CoC site reviewers interpret their role as extending beyond assessing compliance, viewing themselves as advocates, educators, and partners to the sites. CONCLUSIONS: Overall, CoC site reviewers perceive the operative standards favorably. To enhance implementation of the operative standards, efforts should focus on modifiable institutional and individual-level factors, such as leadership support and surgeon engagement. Additionally, the multifaceted role of the site reviewers presents a valuable opportunity to improve compliance by formalizing the supportive relationship between reviewers and sites.
Intellectual Equipoise and Challenges: Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316)
Background: Prospective, randomized trials are needed to determine optimal treatment approaches for palliative care problems such as malignant bowel obstruction (MBO). Randomization poses unique issues for such studies, especially with divergent treatment approaches and varying levels of equipoise. We report our experience accruing randomized patients to the Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (SWOG S1316) study, comparing surgical and nonsurgical management of MBO. Methods: Patients with MBO who were surgical candidates and had treatment equipoise were accrued and offered randomization to surgical or nonsurgical management. Patients choosing nonrandomization were offered prospective observation. Trial details are listed on www.clinicaltrials.gov (NCT #02270450). An accrual algorithm was developed to enhance enrollment. Results: Accrual is ongoing with 176 patients enrolled. Most (89%) patients chose nonrandomization, opting for nonsurgical management. Of 25 sites that have accrued to this study, 6 enrolled patients on the randomization arm. Approximately 59% (20/34) of the randomization accrual goal has been achieved. Patient-related factors and clinician bias have been the most prevalent reasons for lack of randomization. An algorithm was developed from clinician experience to aid randomization. Using principles in this tool, repeated physician conversations discussing treatment options and goals of care, and a supportive team–approach has helped increase accrual. Conclusions: Experience gained from the S1316 study can aid future palliative care trials. Although difficult, it is possible to randomize patients to palliative studies by giving clinicians clear recommendations utilizing an algorithm of conversation, allotment of necessary time to discuss the trial, and encouragement to overcome internal bias.
The impact of health insurance on cancer care in disadvantaged communities