Intellectual Equipoise and Challenges

Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316)

Gary B. Deutsch, Jeremiah L. Deneve, Mazin F. Al-kasspooles, Valentine N. Nfonsam, Camille C. Gunderson, Angeles Alvarez Secord, Phillip Rodgers, Samantha Hendren, Eric J. Silberfein, Marcia Grant, Jeff A Sloan, Virginia Sun, Kathryn B. Arnold, Garnet L. Anderson, Robert S. Krouse

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalAmerican Journal of Hospice and Palliative Medicine
DOIs
StatePublished - Jan 1 2019

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Random Allocation
Neoplasms
Palliative Care
Patient Care Planning
boldenone undecylenate
Therapeutics
Observation
Physicians

Keywords

  • equipoise
  • malignant bowel obstruction
  • palliative
  • randomization
  • S1316
  • surgery

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Intellectual Equipoise and Challenges : Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316). / Deutsch, Gary B.; Deneve, Jeremiah L.; Al-kasspooles, Mazin F.; Nfonsam, Valentine N.; Gunderson, Camille C.; Secord, Angeles Alvarez; Rodgers, Phillip; Hendren, Samantha; Silberfein, Eric J.; Grant, Marcia; Sloan, Jeff A; Sun, Virginia; Arnold, Kathryn B.; Anderson, Garnet L.; Krouse, Robert S.

In: American Journal of Hospice and Palliative Medicine, 01.01.2019.

Research output: Contribution to journalArticle

Deutsch, GB, Deneve, JL, Al-kasspooles, MF, Nfonsam, VN, Gunderson, CC, Secord, AA, Rodgers, P, Hendren, S, Silberfein, EJ, Grant, M, Sloan, JA, Sun, V, Arnold, KB, Anderson, GL & Krouse, RS 2019, '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. https://doi.org/10.1177/1049909119851471
Deutsch, Gary B. ; Deneve, Jeremiah L. ; Al-kasspooles, Mazin F. ; Nfonsam, Valentine N. ; Gunderson, Camille C. ; Secord, Angeles Alvarez ; Rodgers, Phillip ; Hendren, Samantha ; Silberfein, Eric J. ; Grant, Marcia ; Sloan, Jeff A ; Sun, Virginia ; Arnold, Kathryn B. ; Anderson, Garnet L. ; Krouse, Robert S. / Intellectual Equipoise and Challenges : Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316). In: American Journal of Hospice and Palliative Medicine. 2019.
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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.",
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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 A

AU - Sun, Virginia

AU - Arnold, Kathryn B.

AU - Anderson, Garnet L.

AU - Krouse, Robert S.

PY - 2019/1/1

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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.

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