Evidence map›Paper›PMID 31122027›Full record

Trial reportThe American journal of hospice & palliative care2020

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 and 5 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The American journal of hospice & palliative care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Use and Outcomes of Dexamethasone in the Management of Malignant Small Bowel Obstruction.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2024
    Article
  5. Article
  6. Trajectories of Patient-Reported Outcomes After Palliative Gastrointestinal Surgery in Advanced Cancer: Is Good Quality of Life Sustainable?Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2022
    Article
  7. Robotic surgery: getting the evidence right.The Medical journal of Australia · 2022
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Gary B DeutschDepartment of Surgery, Northwell Health, Lake Success, NY, USA.
Jeremiah L DeneveDepartment of Surgery, University of Tennessee Health Science Center, Memphis, TN, USA.
Mazin F Al-KasspoolesDepartment of Surgery, University of Kansas, Kansas City, KS, USA.
Valentine N NfonsamDepartment of Surgery, University of Arizona, Tucson, AZ, USA.
Camille C GundersonDepartment of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, OK, USA.
Angeles Alvarez SecordDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke Cancer Institute, Durham, NC, USA.
Phillip RodgersDepartment of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
Samantha HendrenDepartment of Surgery, University of Michigan, Ann Arbor, MI, USA.
Eric J SilberfeinDepartment of Surgery, Baylor College of Medicine, Houston, TX, USA.
Marcia GrantDivision of Nursing Research and Education, City of Hope National Medical Center, Duarte, CA, USA.
Jeff SloanMayo Clinic Rochester, Rochester, MN, USA.
Virginia SunDivision of Nursing Research and Education, City of Hope National Medical Center, Duarte, CA, USA.
Kathryn B ArnoldSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Garnet L AndersonSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Robert S KrouseCorporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.

Funding

SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan · 2019 to 2026
$13.7M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
UM LAPs- U10 GrantU10CA180801 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ZALUPSKI, MARK M · 2014 to 2018
$3.7M
Prospective Comparative Effectiveness Trial for Malignant Bowel ObstructionR01HS021491 · AHRQ · UNIVERSITY OF PENNSYLVANIA · PI KROUSE, ROBERT SCOTT · 2013 to 2017
$1.1M
AHRQ HHS R01 HS021491NCI NIH HHS U10 CA180801NCI NIH HHS UG1 CA189974NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233193
6 · The paper itself

Abstract

backgroundProspective, 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.

methodsPatients 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.

resultsAccrual 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.

conclusionsExperience 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.

Indexed as

Research DesignAlgorithmsHumansIntestinal ObstructionNeoplasmsPalliative CarePatient SelectionProspective Studiesequipoisemalignant bowel obstructionpalliativerandomizationS1316surgery

Identifiers

PMID31122027
PMCPMC6868288

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.