Clinical trial · Observational
Admission, Triage, and Discharge Criteria for Oncological Patients in the Intensive Care Unit
International Consensus Statement on the Admission, Triage, and Discharge Criteria for Oncological Patients in the Intensive Care Unit: Protocol for a Modified Delphi Consensus Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
This study will create one agreed set of rules to help doctors decide which people with cancer should be treated in an intensive care unit (ICU), and when they are well enough to leave it. An ICU is a hospital ward for people who are very sick and need close watching and life support. Why the researchers are doing this study Hospitals do not agree on when a person with cancer should go to the ICU. Because of this, some people who could recover are turned away. Others get treatments that cannot help them and may add to their suffering. These choices are harder than for people without cancer. Doctors must weigh the sudden illness, the type of cancer, how well the cancer is responding to treatment, how strong the person is day to day, and what matters most to the person. Cancer care has improved a lot, and many people with cancer now recover well after ICU care. Current rules do not reflect this. How the study will work No new medicine or treatment will be tested, and no patients will take part. Instead, cancer and critical care experts will vote to agree on the rules. This is called a Delphi process. A steering group of 12 to 14 experts will plan the project. They will read the published research and write draft statements about ICU care for people with cancer. The researchers will then invite 30 to 40 experts from around the world to vote on these statements. Participants will be doctors with long experience in cancer care, critical care, or emergency care. Taking part is voluntary. Participants will not know who the other voters are, so no one person can sway the group. Participants will vote in online surveys. They will rate each statement from 1 (strongly disagree) to 7 (strongly agree) and answer some multiple-choice questions. There will be at least three rounds of voting. After each round, participants will see how the group voted as a whole. The steering group will reword statements that did not reach agreement, and participants will vote again. The researchers will count a statement as agreed when about 3 out of 4 participants (75%) vote the same way. For multiple-choice questions, 8 out of 10 participants (80%) must pick the same answer. Statements with very high agreement will use firm wording, such as "should". Statements with lower agreement will use softer wording, such as "may". If participants stay split after repeated rounds, the researchers will report that no recommendation can be made. What the criteria will cover Which people with cancer are likely to benefit from ICU care Who should be treated first when ICU beds are scarce Time-limited trials: when the outcome is unclear, doctors give full ICU care for an agreed short period, then review whether it is helping When and how a person should leave the ICU, whether to a normal ward, to a palliative care unit, or to a hospice Palliative care and hospice care focus on comfort, dignity, and support rather than on curing the cancer. Who is running the study The Onco Critical Care Society is running this project. No company or outside body is paying for it. All experts involved must declare anything that could affect their judgement, such as payments from drug companies. A methods expert will run the surveys and handle the votes so that the results stay fair and private. What happens with the results The researchers expect the work to take about nine months. They will publish the final criteria in a medical journal and share a one-page chart that doctors can use at the bedside. They will also list the questions that research has not yet answered. The rules will be reviewed at least every five years, or sooner if cancer or ICU care changes a great deal. The aim is simple: to help people with cancer get ICU care when it can truly help them, and to spare them care that cannot.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Critical Care | Malignant Neoplasm | ALIAS | 0.85 |
| Cancer Critically Ill | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention: Observational Cohort | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- A cohort of 40 delphi panelist
- interventionNames
- Other: No Intervention: Observational Cohort
Primary outcomes (2)
- measure
- Number of candidate consensus statements achieving consensus, defined a priori as a median score ≥5 with ≥80% of panellist votes in the 5-7 range on a 7-point Likert scale
- timeFrame
- From closure of Delphi Round 2 to closure of the final Delphi round, an assessment period of up to 3 months (study months 8-10)
- description
- The unit of measurement is the candidate statement, not the participant. Each candidate statement is voted on by the expert panel using a 7-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = somewhat disagree, 4 = neither agree nor disagree, 5 = somewhat agree, 6 = agree, 7 = strongly agree). Agreement is defined as a score of 5-7 and disagreement as a score of 1-3; a score of 4 is retained in the denominator. Abstentions are excluded from the denominator and reported separately. For each statement and each round, the number and percentage of votes in each response category and the median score are calculated. A statement is classified as having achieved consensus when the median is ≥5 with ≥80% of votes in the 5-7 range (positive consensus), or the median is ≤3 with ≥80% of votes in the 1-3 range (negative consensus). Statements meeting neither criterion are classified as "no consensus." The outcome will be reported as the number of statements achieving consensus out of t
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Aged 18 years or older Clinician, methodologist will be invited to serve as a voting panelist For clinicians: recognized specialist qualification in intensive care medicine, medical oncology, haematology (including haematopoietic cell transplantation or cellular therapy), palliative medicine, emergency medicine. For clinicians: at least five years of post-qualification practice involving critically ill adults with cancer Current professional base in one of the six WHO regions Able to complete online questionnaires in English Willing to participate in all planned Delphi rounds and to complete a conflict-of-interest declaration Provides informed consent Exclusion Criteria: Member of the Steering Committee or the study methodologist (non-voting roles) Unable to commit to the full sequence of Delphi rounds Declared conflict of interest that the Steering Committee judges incompatible with voting Second or subsequent nominee from a country already represented, where the one-panellist-per-co
References
Publications (16)
- BACKGROUNDvan Zuuren EJ, Logullo P, Price A, Fedorowicz Z, Hughes EL, Gattrell WT. Existing guidance on reporting of consensus methodology: a systematic review to inform ACCORD guideline development. BMJ Open. 2022 Sep 8;12(9):e065154. doi: 10.1136/bmjopen-2022-065154. PMID 36201247
- BACKGROUNDNasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20. PMID 34322364
- BACKGROUNDDiamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014 Apr;67(4):401-9. doi: 10.1016/j.jclinepi.2013.12.002. PMID 24581294
- BACKGROUNDChang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000. PMID 33843946
- BACKGROUNDQuill TE, Holloway R. Time-limited trials near the end of life. JAMA. 2011 Oct 5;306(13):1483-4. doi: 10.1001/jama.2011.1413. No abstract available. PMID 21972312
- BACKGROUNDThiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13. doi: 10.1200/JCO.2005.01.487. PMID 15994150
- BACKGROUNDSoares M, Carvalho MS, Salluh JI, Ferreira CG, Luiz RR, Rocco JR, Spector N. Effect of age on survival of critically ill patients with cancer. Crit Care Med. 2006 Mar;34(3):715-21. doi: 10.1097/01.ccm.0000201883.05900.3f.