Gary B Deutsch1, Jeremiah L Deneve2, Mazin F Al-Kasspooles3, Valentine N Nfonsam4, Camille C Gunderson5, Angeles Alvarez Secord6, Phillip Rodgers7, Samantha Hendren8, Eric J Silberfein9, Marcia Grant10, Jeff Sloan11, Virginia Sun10, Kathryn B Arnold12, Garnet L Anderson12, Robert S Krouse13,14,15. 1. Department of Surgery, Northwell Health, Lake Success, NY, USA. 2. Department of Surgery, University of Tennessee Health Science Center, Memphis, TN, USA. 3. Department of Surgery, University of Kansas, Kansas City, KS, USA. 4. Department of Surgery, University of Arizona, Tucson, AZ, USA. 5. Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, OK, USA. 6. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke Cancer Institute, Durham, NC, USA. 7. Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. 8. Department of Surgery, University of Michigan, Ann Arbor, MI, USA. 9. Department of Surgery, Baylor College of Medicine, Houston, TX, USA. 10. Division of Nursing Research and Education, City of Hope National Medical Center, Duarte, CA, USA. 11. Mayo Clinic Rochester, Rochester, MN, USA. 12. SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. 13. Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA. 14. Department of Surgery, University of Pennsylvania, Philadelphia, PA, USA. 15. Leonard Davis Institute of Health Policy, Philadelphia, PA, USA.
Abstract
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.
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.
Entities:
Keywords:
S1316; equipoise; malignant bowel obstruction; palliative; randomization; surgery
Authors: Lauris C Kaldjian; Ann E Curtis; Laura A Shinkunas; Katrina T Cannon Journal: Am J Hosp Palliat Care Date: 2008 Dec-2009 Jan Impact factor: 2.500
Authors: Daisy Elliott; Freddie C Hamdy; Tom A Leslie; Derek Rosario; Tim Dudderidge; Richard Hindley; Mark Emberton; Simon Brewster; Prasanna Sooriakumaran; James W F Catto; Amr Emara; Hashim Ahmed; Paul Whybrow; Steffi le Conte; Jenny L Donovan Journal: BJU Int Date: 2018-08-15 Impact factor: 5.588