Admission, Triage, and Discharge Criteria for Oncological Patients in the Intensive Care Unit

Condition(s) studied

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort: no interventions

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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 — 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)
  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
• Number of consensus statements meeting the pre-specified stability criterion on chi-square testing of collapsed 7-point Likert response distributions between two consecutive Delphi rounds — 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)
  The unit of measurement is the candidate statement. Stability is assessed from Round 2 onwards by comparing the distribution of Likert responses for each statement between two consecutive rounds. To avoid sparse cells at a panel size of 30-40, responses are collapsed into three ordered categories (1-3, 4, 5-7) before non-parametric chi-square testing; Fisher's exact test is substituted where expected cell counts fall below five. A p value \<0.05 indicates instability. A statement is retired from further voting only when it has met the consensus definition in two consecutive rounds. A statement 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 outcome will be reported as the number of statements meeting both the consensus and the stability criteria (these constitute the final consensus statements), the number that are stable but without consensus, and

Trial sites (1)

More Onco Critical Care Society trials in India