ReliabilityNCT06410183
Inter-rater Reliability of Preoperative Mortality Risk Calculators
An observational study of Reliability, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The goal of this study is to investigate the inter-rater variability of mortality risk calculations for high-risk non-cardiac surgical patients. For this purpose patient information from health care files were used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reliability
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2019to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: HIgh-risk non-cardiac surgical patients discussed in an MDT meeting.
Who may be able to join
- Patients discussed in a preoperative multidisciplinary team (MDT) meeting.
Who cannot join
- No complete patient file to calculate the mortality risks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inter-rater Reliability of Preoperative Mortality Risk Calculators Used for High-risk Noncardiac Surgical Patients
The goal of this study is to investigate the inter-rater variability of mortality risk calculations for high-risk non-cardiac surgical patients. For this purpose patient information from health care files were used. Five anesthesiologists calculated the mortality risks with three calculators for 34 high-risk non-cardiac surgical patients. The patients were discussed in a preoperative multidisciplinary discussion in a large teaching hospital in The Netherlands.
Read the detailed description
Identifying high-risk patients for perioperative treatment and decision-making remains a challenge due to difficulty in reliably estimating morbidity and mortality risks. Assessing surgical risk helps allocating resources, obtaining informed consent, and making shared decisions with a multidisciplinary team (MDT). Multimorbidity is increasing globally in an ageing population with a growing burden of chronic diseases. It has been shown that high-risk non-cardiac surgical patients suffer disproportionally from perioperative complications. Preoperative mortality risk calculators are available and may help to identify high-risk non-cardiac surgical patients already before surgery, triggering efforts to lower the burden of possible complications, e.g., by extended monitoring or specified treatments. A systematic review suggested a significant risk of bias in developing current preoperative risk calculators due to lack of external validation, highlighting the need for enhanced performance and reliability to ensure their effectiveness in clinical practice. Low reliability and performance may, despite their general availability, be why that preoperative risk calculators are not yet consistently used in clinical practice. For daily clinical use, good predictive performance, low inter rater variability and user friendliness are essential. Discrepancies in predictor measurements can cause miscalibration, changes in discriminatory ability, and overall accuracy, leading to clinically relevant variability in risk calculator results. Previous studies have shown that physicians must trust a mortality risk calculator before utilization. High-risk patients suffer especially from complications, and it has been shown that the complications often result in death perioperatively. Therefore, adequate preoperative calculation of mortality risks and early recognition of high-risk non-cardiac surgical patients could benefit from reliable preoperative risk calculation. These high-risk patients can then be discussed in a preoperative multidisciplinary discussion to lower complications and perioperative deaths.
The current study evaluated the inter-rater reliability of calculating preoperative mortality risk scores for high-risk non-cardiac surgical patients in clinical practice among five anesthesiologists. The hypothesis was that the available risk calculators would show moderate to good reliability. For this purpose, five anesthesiologists used the following three risk calculators: the preoperative score to predict postoperative morbidity [POSPOM, the American College of Surgeons surgical risk calculator, and the surgical outcome risk tool [SORT].
- Conditions
- Reliability
- Being tested
- no intervention
- Keywords
- preoperative, high-risk patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-rater reliability of three risk calculators: POSPOM, SRC and SORT
Five anesthesiologists calculated mortality risks retrospectively for 34 patients. The intra-class correlation coefficient (ICC) was calculated per risk calculator
Measured: After calculation of the mortality risks (1 month)
Secondary outcomes (1)
mortality risk calculations or 34 patients
the Preoperative scale of postoperative outcome: (POSPOM), the surgical risk calculator: (SRC) and the surgical outcome risk tool: (SORT) mortality risk calculators were used for (retrospective) 30-day mortality risk calculation of 34 patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Feb 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReliabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Responsible party
- Sponsor
- Investigators
- Jacqueline E. Vernooij, MD, MA, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410183
- Sponsor's protocol ID
- 2022-2161
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-rater Reliability of Preoperative Mortality Risk Calculators Used for High-risk Noncardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT06410183
- Acronym / sponsor ID
- 2022-2161
- Conditions
- Reliability
- Keywords
- preoperative, high-risk patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Utrecht University, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate the inter-rater variability of mortality risk calculations for high-risk non-cardiac surgical patients. For this purpose patient information from health care files were used. Five anesthesiologists calculated the mortality risks with three calculators for 34 high-risk non-cardiac surgical patients. The patients were discussed in a preoperative multidisciplinary discussion in a large teaching hospital in The Netherlands.
Detailed description
Identifying high-risk patients for perioperative treatment and decision-making remains a challenge due to difficulty in reliably estimating morbidity and mortality risks. Assessing surgical risk helps allocating resources, obtaining informed consent, and making shared decisions with a multidisciplinary team (MDT). Multimorbidity is increasing globally in an ageing population with a growing burden of chronic diseases. It has been shown that high-risk non-cardiac surgical patients suffer disproportionally from perioperative complications. Preoperative mortality risk calculators are available and may help to identify high-risk non-cardiac surgical patients already before surgery, triggering efforts to lower the burden of possible complications, e.g., by extended monitoring or specified treatments. A systematic review suggested a significant risk of bias in developing current preoperative risk calculators due to lack of external validation, highlighting the need for enhanced performance and reliability to ensure their effectiveness in clinical practice. Low reliability and performance may, despite their general availability, be why that preoperative risk calculators are not yet consistently used in clinical practice. For daily clinical use, good predictive performance, low inter rater variability and user friendliness are essential. Discrepancies in predictor measurements can cause miscalibration, changes in discriminatory ability, and overall accuracy, leading to clinically relevant variability in risk calculator results. Previous studies have shown that physicians must trust a mortality risk calculator before utilization. High-risk patients suffer especially from complications, and it has been shown that the complications often result in death perioperatively. Therefore, adequate preoperative calculation of mortality risks and early recognition of high-risk non-cardiac surgical patients could benefit from reliable preoperative risk calculation. These high-risk patients can then be discussed in a preoperative multidisciplinary discussion to lower complications and perioperative deaths.
The current study evaluated the inter-rater reliability of calculating preoperative mortality risk scores for high-risk non-cardiac surgical patients in clinical practice among five anesthesiologists. The hypothesis was that the available risk calculators would show moderate to good reliability. For this purpose, five anesthesiologists used the following three risk calculators: the preoperative score to predict postoperative morbidity [POSPOM, the American College of Surgeons surgical risk calculator, and the surgical outcome risk tool [SORT].
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- HIgh-risk non-cardiac surgical patients discussed in an MDT meeting.
Key inclusion criteria (1 listed)
- Patients discussed in a preoperative multidisciplinary team (MDT) meeting.
Key exclusion criteria (1 listed)
- No complete patient file to calculate the mortality risks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
inter-rater reliability of three risk calculators: POSPOM, SRC and SORT
Time frame: After calculation of the mortality risks (1 month)
Five anesthesiologists calculated mortality risks retrospectively for 34 patients. The intra-class correlation coefficient (ICC) was calculated per risk calculator
1 secondary outcome
mortality risk calculations or 34 patients
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline E. Vernooij, MD, MA principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reliability, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-rater reliability of three risk calculators: POSPOM, SRC and SORT (time frame: After calculation of the mortality risks (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.