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
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
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.
Background and Justification The admission of a critically ill patient with cancer to the intensive care unit (ICU) is a complex decision at the intersection of evolving oncology therapeutics, expanding critical care capability, and medical ethics. While historical perceptions of poor outcomes persist, contemporary data demonstrate improved survival, particularly among patients with reversible acute illness and treatment-responsive underlying malignancy. This progress has, however, generated a different set of problems in regards to appropriate patient selection, equitable allocation of a scarce resource, and avoidance of non-beneficial or disproportionately burdensome care.
Substantial variability exists in ICU admission and discharge practice for patients with cancer across institutions and regions. This variability can lead to both under-utilisation of the ICU for patients with a high likelihood of benefit and over-utilisation for patients in the terminal phase of refractory disease.
A standardised framework is therefore required - one that moves beyond the outdated dichotomy of "cancer versus no cancer" and instead integrates the key prognostic determinants namely, reversibility of the acute illness, performance status and frailty, tumour biology and treatment trajectory, and the patient's own values and goals.
How admission and discharge decisions differ from those in non-oncological patients Several features distinguish this population and prevent direct adaptation of general ICU triage guidance, such as the Society of Critical Care Medicine framework for ICU admission, discharge, and triage, which does not address oncology-specific determinants in detail.
In non-cancer patients, ICU admission decisions rely principally on acute physiological derangement and its reversibility. In patients with cancer, a dual prognostic assessment is required: acute illness severity and organ failure are assessed with the usual severity assessment tools, while underlying cancer biology (histology, stage, molecular markers), treatment responsiveness, and performance status (ECOG or Karnofsky) must be assessed in parallel. Acute illness severity predicts short-term ICU mortality, whereas longer-term survival is determined predominantly by cancer-specific factors such as disease status and response to therapy.
In general ICU practice, reversibility refers to recovery of organ function. In oncology critical care, reversibility may additionally depend on delivering cancer-directed therapy while organ support is provided. Acute respiratory failure due to pulmonary lymphomatous infiltration may require mechanical ventilation while chemotherapy is administered; the reversible component is the tumour's response to treatment as well as the organ dysfunction itself.
Where ICU admission for a non-cancer patient with uncertain prognosis is often open-ended, a pre-defined time-limited trial with an agreed reassessment point is frequently the appropriate structure for a patient with cancer and an intermediate prognosis. Haematopoietic stem cell transplant recipients, recipients of CAR-T cell therapy, and patients with haematological malignancy and neutropenic sepsis may warrant priority for ICU admission rather than deferral.
Considerations without a general-ICU equivalent include whether cancer-directed therapy is curative or palliative in intent, whether the patient is receiving induction or late-line therapy, and whether this is a first or a repeated admission for progressive disease. Tumour lysis syndrome, superior vena cava syndrome with airway compromise, hyperleukocytosis with leukostasis, and malignant spinal cord compression with neurological deficit demand specific triage pathways.
For patients with cancer, discharge planning must additionally integrate the oncology treatment schedule and supportive care needs. For patients with limited prognosis despite ICU care, transition to palliative care is a defined destination requiring early palliative team involvement, patient and family acceptance of a change in goals, and structured handover. This pathway is used more frequently in oncology than in other ICU populations.
Why a consensus exercise, and why the Delphi method The evidence relevant to admission, triage, and discharge decisions in this population consists predominantly of observational cohorts, single-centre series, and indirect data. Randomised evidence bearing directly on who should be admitted, when a time-limited trial should be concluded, or when discharge is safe does not exist and is unlikely to be generated. Where evidence is limited or absent but decisions must nonetheless be made daily, formal consensus methods are the appropriate means of collating and structuring expert judgement, and are more reliable than the unstructured opinion of individuals or of an unstructured meeting. The method is described as "modified" because candidate statements are generated by the Steering Committee from a structured literature review rather than by open idea-generation among panellists in Round one; panellists may nonetheless propose additional statements during Round one.
Aim, intended audience, and scope of application The aim is to generate an international expert consensus statement on the criteria and procedures for ICU admission, triage, and discharge of adult patients with cancer. The intended audience comprises intensivists, medical and surgical oncologists, haematologists, palliative medicine and emergency physicians, critical care nurses and hospital administrators, and health policymakers. The intended geographical scope is global: for application in both high-resource and resource-limited health systems.
Relationship to existing documents This is a new consensus statement and not an update or adaptation of any existing document. Where a consensus statement of this panel diverges from that framework or from other published guidance, the divergence and its rationale will be identified explicitly in the resulting manuscript.
Objectives Primary objective To develop an international consensus statement providing explicit criteria and a procedural framework for the admission, triage, and discharge of adult critically ill patients with cancer in the ICU.
Secondary objectives
Methods Scope and population The statement applies to adults (≥18 years) with active haematological malignancy or solid tumour who present with, or develop, a critical illness requiring consideration of ICU admission, or who are admitted to the ICU and being considered for discharge. Both emergency and planned admissions are included.
Registration, protocol availability, and amendments This protocol will be posted at www.oncoccs.com before the first invitation to vote is issued. The protocol is version-controlled. Any amendment made after registration will be recorded.
Steering Committee: composition, selection, and role The Steering Committee (SC) comprises 12 to 14 members: intensivists with oncology critical care practice, medical oncologists, palliative medicine physicians, and an independent Delphi methodology expert. Members were identified by the Principal Investigator and the OCCS on the basis of clinical and scholarly standing in oncology and critical care. All SC members will be named in the manuscript, with their discipline, country, and role.
The SC is responsible for scope definition, the structured literature review, drafting and revision of candidate statements, adjudication of the consensus process, and preparation of the manuscript.
SC members will not vote in any Delphi round and will not be members of the expert panel. Where the SC exercises judgement that affects the content of the final statement - revising the wording of a statement between rounds, merging or splitting items, or retaining an item that failed to reach consensus. The SC will not reinstate any statement rejected by the panel without unanimous SC agreement and explicit reporting of that fact.
The independent Delphi methodology expert administers the surveys, holds the participant key, performs the anonymised analysis, and prepares the between-round feedback. The methodology expert does not draft or revise statements and does not vote.
Expert panel: eligibility criteria and panel size Eligibility requires all of the following: (i) a substantial clinical practice in the care of critically ill patients with cancer, in intensive care, oncology, haematology, palliative medicine, or emergency medicine; (ii) at least five years of post-training practice; and (iii) demonstrated scholarly contribution to the field - peer-reviewed publication, invited lecturing, or a leadership role in a relevant professional society or guideline body. Panellists will be selected by the Steering Committee against these criteria.
The target panel size is 30-40 voting members to preserve an adequate number of respondents after attrition across three rounds and disciplinary and regional representation. A minimum of 24 completed responses will be required for any round to be analysed.
Composition will be reported against the following requirements:
Recruitment of the panel Candidate panellists will be identified from the author lists of publications retrieved in the structured literature review and from the membership and faculty lists of relevant professional societies. Invitations will be issued by e-mail from a single project address under the centralised oversight of the Steering Committee. Up to two reminders will be sent to non-responders.
Invitees will not be asked to nominate additional panellists, except that an invitee who declines may propose a colleague of equivalent standing as a replacement; any such substitution requires SC approval against the eligibility criteria and will be recorded. The number of invitations issued, the number accepted, the number declining, and the number not responding will be reported. Participation is voluntary; consent is implied by completion of a survey questionnaire, and the information pack sent to each panellist will state this explicitly.
Preparatory research and evidence summaries Candidate statements will be generated from a structured review of the literature. The search will cover PubMed/MEDLINE, Cochrane Central Register of Controlled Trials from inception to the date of the search, using a combination of MeSH terms and free-text keywords; the full search strings, the dates on which each search was run, and the yield at each stage will be reported in the supplementary material.
Development of candidate statements
The steering group will convert the evidence summaries and identified gaps into candidate statements grouped into pre-specified clinical domains, subject to the following rules:
The complete Round 1 instrument, the domain structure, will be published as supplementary material.
Structure and objectives of the consensus rounds
A minimum of three rounds will be conducted. Each round has a distinct, pre-specified objective:
Step Objective Items presented Round 1 Obtain first-pass agreement across the full statement set; elicit proposed rewording and additional statements All candidate statements Round 2 Confirm the stability of statements that reached consensus in Round 1; re-vote on revised statements; vote on statements newly proposed by panellists in Round 1 Statements reaching consensus in Round 1 (for confirmation), revised statements, and new statements Round 3 Resolve statements that remain without consensus or that showed unstable agreement across Rounds 1 and 2 Unresolved and unstable statements only Round 4 (conditional) Conducted only if instability persists on more than 10% of items after Round 3; otherwise not conducted Unstable statements only
Statements are retired from further voting once they have met the consensus definition in two consecutive rounds. A statement reaching consensus in a single round is not retired. Statements failing to reach consensus after the final round are recorded as "no consensus" and are not carried forward.
Voting instrument, response options, and administration Surveys will be administered electronically on a secure survey platform. Responses will be collected individually and asynchronously; at no point will responses be collected in a group setting. Each statement will be presented with its evidence summary, a seven-point Likert response (1 = strongly disagree; 4 = neither agree nor disagree; 7 = strongly agree), and a free-text field.
Free-text comment is optional for every item and required for any vote of 1-3 on a statement, so that disagreement is accompanied by its reasoning and can be acted upon between rounds. In Round 1 only, panellists may propose additional statements for inclusion in subsequent rounds. Panellists may abstain from any item on grounds of insufficient expertise; abstentions are excluded from the denominator and reported separately.
Statements will be presented grouped by clinical domain in a fixed order rather than randomised, because the domains follow the clinical sequence of admission, triage, and discharge and random presentation would impair comprehension.
Surveys will be conducted in English. A plain-language summary will accompany the information pack, each round will remain open for a minimum of three weeks with two reminders, and panellists in any time zone or with limited connectivity may request an extension or a document-based version of the ballot. Any adaptation granted will be recorded.
Definition of consensus and its rationale For Likert-scale items, agreement is defined as a score of 5-7 and disagreement as a score of 1-3; 4 denotes neither agreement nor disagreement and is included in the denominator. All thresholds are specified a priori.
Category Likert-scale items Strong consensus (opinion unlikely to change with time) Median 6-7 with ≥90% of votes in the 5-7 range, or median 1-2 with ≥90% of votes in the 1-3 range Consensus Median ≥5 with ≥80% of votes in the 5-7 range, or median ≤3 with ≥80% of votes in the 1-3 range No consensus All items not meeting the above criteria
The rationale for these thresholds is as follows. Percentage agreement is the most commonly used operationalisation of consensus in health Delphi studies, with a median threshold of 75% across published studies; an 80% threshold is therefore at the stricter end of accepted practice and was chosen because the statements will bear on decisions to admit or not to admit patients to intensive care, where a bare majority view should not be presented as consensus. The additional median criterion prevents an item from qualifying on percentage agreement alone when the distribution is concentrated at the weakest point of the agreement range. The 90% threshold for strong consensus follows the convention that a near-unanimous position is unlikely to shift on further iteration. Thresholds will not be altered after Round 1 opens; if any threshold is altered, the alteration and its timing will be reported as a protocol deviation.
Feedback of rounds After closing of each round, and along with the subsequent round, every panellist will receive: the anonymised distribution of votes for each statement, expressed as the number and percentage in each response category; the median and interquartile range; so that individual position can be compared with the group; an anonymised thematic synthesis of the free-text comments; and, for every statement whose wording has changed, a side-by-side display of the previous and revised text with the change highlighted.
Anonymity Anonymity is planned by design and applies among panellists and between panellists and the Steering Committee. Panellists will not know the identity of other panellists until the study is complete, at which point those consenting will be named in the collaborative group. The Steering Committee receives aggregate and free-text data with identifiers removed and at no point has access to identifiable individual responses.
Processing and analysis of responses Quantitative responses will be summarised as counts and percentages in each response category, with median and interquartile range for Likert items and percentage selection for multiple-choice items. Free-text responses will be analysed by two members of the Steering Committee. Steering group will decide whether an item is revised, split, merged, or retained unchanged for the next round.
Stability of responses will be assessed by comparing the distribution of responses for each statement between two consecutive rounds. To avoid sparse cells at a panel size of 30-40, responses will be collapsed into three ordered categories (1-3, 4, 5-7) before non-parametric chi-square (χ²) testing; where expected cell counts fall below five, Fisher's exact test will be substituted. A p value <0.05 indicates instability. An item achieving agreement in one round and falling into disagreement in the next is classified as unstable and is revised and re-presented rather than counted as having reached consensus.
The stopping rule requires demonstration of stability across two consecutive rounds, irrespective of whether consensus or divided opinion is observed. Statements with persistent but stable division will be reported as: "No consensus statement can be made owing to divided expert opinion." Attrition bias will be assessed by comparing response distributions between rounds and, where feasible, between completers and non-completers of the subsequent round.
Analyses will be performed using Microsoft Office 365 Excel (Microsoft Corp., Redmond, WA, USA) and IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). No inferential comparison between subgroups of panellists is planned; any such analysis, if undertaken, will be reported as exploratory and unplanned.
Incentives No payment, honorarium, reimbursement, or other incentive will be offered to Steering Committee members or panellists. The only acknowledgement of participation is authorship or collaborator status as set out under Manuscript Preparation and Authorship, and the criteria for this are stated in the invitation.
Data management During the study, anonymised data will be stored securely by the methodology expert. On completion, anonymised datasets will be retained by the first and corresponding authors and made available on reasonable request, subject to institutional approval. The participant key will be destroyed once the collaborative group byline has been finalised.
Ethical considerations The study involves healthcare professionals and collects no patient-identifiable clinical data. Institutional ethics committee approval will not be obtained. Participation is voluntary, panellists may withdraw at any round without giving a reason, and consent is implied by completion of a survey questionnaire.
Formulation of the Final Consensus Statements
Final consensus statements will be derived from items achieving consensus and stability. Wording will be calibrated to the degree of agreement obtained:
Every published statement will carry an explicit label identifying it as expert consensus and will state the percentage agreement and median on which it rests.
Planned Reporting The manuscript will be prepared in accordance with the ACCORD checklist, and a completed checklist will accompany the submission.
Results to be reported
Other information to be reported
Manuscript Preparation and Authorship The Steering Committee will synthesise the evidence summaries and the statements achieving consensus into a cohesive manuscript. Authorship will follow ICMJE criteria: a named writing committee comprising members who meet all four criteria, together with a collaborative group byline listing all panellists who completed the required voting rounds, indexed as collaborators. Individual contributions will be described using the CRediT taxonomy. The criteria for inclusion in the collaborative byline - completion of a specified minimum number of rounds - will be stated in the invitation, so that panellists know at the outset what participation entails. The manuscript will be circulated to the full panel for review and approval before submission.
Declaration of the Use of Artificial Intelligence Artificial intelligence (AI)-assisted technology was used in the preparation of this protocol and language edition. This section records that use prospectively so that the declaration required at submission is drawn from a contemporaneous record rather than reconstructed. The declaration follows the ICMJE Recommendations, which require disclosure at submission of any use of AI-assisted technologies, description of that use in the cover letter and in the appropriate section of the manuscript, and retention of full human accountability for the content; the position statements of COPE and WAME are consistent with this.
Tools used, and the purpose of each use Tool and developer Version and period of use Purpose and verification Claude (Anthropic PBC, San Francisco, CA, USA) Claude Opus 5; date of use 01.08.2026 Drafting and editing of the protocol text; document formatting. All output reviewed, corrected, and approved by the Principal Investigator and the Steering Committee; all references independently verified against PubMed
Reporting of AI use in the manuscript The manuscript will carry the declaration in line with ICMJE guidance: a statement at submission in the cover letter; a description in the Methods of any AI use bearing on the generation of study materials, including the drafting of candidate statements and evidence summaries; and a statement in the Acknowledgements of AI use for writing and language editing. The wording will name the tool, its developer, the model version, the period of use, and the purpose, and will state that no AI tool contributed to panel selection, voting, analysis, or interpretation, and that the authors take responsibility for the final content. If the target journal specifies a different declaration format, that format will be followed and the substance retained. Any additional AI use arising later in the project will be added to the table of tools and purposes above at the time it occurs.
Planned Timeline Period Activity Output Months 1-2 Steering Committee formation; scope and clinical questions finalised; protocol registered Registered protocol Months 3-5 Structured literature review; evidence summaries; drafting of candidate statements Evidence summaries; candidate statements Months 5-6 Panel constitution; conflict-of-interest declarations; recruitment of patient representatives; piloting of the Round 1 instrument Final panel roster; piloted Round 1 instrument Month 7 Delphi Round 1 Round 1 results; feedback report Month 8 Analysis, statement revision, Delphi Round 2 Round 2 results; feedback report Month 9 Analysis, statement revision, Delphi Round 3 Final consensus statements Month 10 Drafting of the full consensus statement document Complete draft Month 11 Panel review, final revisions, ACCORD checklist completion, submission Submitted manuscript
Dissemination and Implementation
Review and Update The Steering Committee will undertake a formal review and update every five years, or sooner in response to major shifts in cancer therapeutics or critical care evidence. Any update will state why it was needed and will cite this statement as the document being updated.
Anticipated Limitations
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