Intellectual Equipoise and Challenges: Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316)

American Journal of Hospice and Palliative Medicine - Tập 37 Số 1 - Trang 12-18 - 2020
Gary B. Deutsch1, Jeremiah L. Deneve2, Mazin F Al-Kasspooles3, Valentine Nfonsam4, Camille C. Gunderson5, Angeles Alvarez Secord6, Phillip Rodgers7, Samantha Hendren8, Eric J. Silberfein9, Marcia Grant10, Jeff A. Sloan11, Virginia Sun10, Kathryn B. Arnold12, Garnet L. Anderson12, Robert S. Krouse13,14,15
1Department of Surgery, Northwell Health, Lake Success, NY, USA
2Department of Surgery, University of Tennessee Health Science Center, Memphis, TN, USA
3Department of Surgery, University of Kansas, Kansas City, KS, USA
4Department of Surgery, University of Arizona, Tucson, AZ, USA
5Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, OK, USA
6Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke Cancer Institute, Durham, NC, USA
7Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA
8Department of Surgery, University of Michigan, Ann Arbor, MI, USA
9Department of Surgery, Baylor College of Medicine, Houston, TX, USA.
10Division of Nursing Research and Education, City of Hope National Medical Center, Duarte, CA, USA
11Mayo Clinic Rochester, Rochester, MN, USA
12SWOG Statistics and Data Management Center/Fred Hutchinson Cancer Research Center, Seattle, WA, USA
13Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA
14Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA
15Leonard Davis Institute of Health Policy, Philadelphia, PA, USA

Tóm tắt

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.

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