TY - JOUR
T1 - Intellectual Equipoise and Challenges
T2 - Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316)
AU - Deutsch, Gary B.
AU - Deneve, Jeremiah L.
AU - Al-kasspooles, Mazin F.
AU - Nfonsam, Valentine N.
AU - Gunderson, Camille C.
AU - Secord, Angeles Alvarez
AU - Rodgers, Phillip
AU - Hendren, Samantha
AU - Silberfein, Eric J.
AU - Grant, Marcia
AU - Sloan, Jeff
AU - Sun, Virginia
AU - Arnold, Kathryn B.
AU - Anderson, Garnet L.
AU - Krouse, Robert S.
N1 - Publisher Copyright: © The Author(s) 2019.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - S1316
KW - equipoise
KW - malignant bowel obstruction
KW - palliative
KW - randomization
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85066831813&partnerID=8YFLogxK
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U2 - 10.1177/1049909119851471
DO - 10.1177/1049909119851471
M3 - Article
C2 - 31122027
SN - 1049-9091
VL - 37
SP - 12
EP - 18
JO - American Journal of Hospice and Palliative Medicine
JF - American Journal of Hospice and Palliative Medicine
IS - 1
ER -