Evidence map›Paper›PMID 36063792›Full record

Trial reportCerebrovascular diseases (Basel, Switzerland)2023

Statistical Analysis Plan for the INTEnsive Care Bundle with Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial: A Stepped-Wedge Cluster Randomized Controlled Trial.

Laurent Billot, Lili Song, Xin Hu, Lu Ma, Menglu Ouyang, Xiaoying Chen, Chao You, Craig S Anderson, INTERACT3 Investigators

Open access · hybridAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cerebrovascular diseases (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

9 authors at 3 institutions in 2 countries.

Laurent BillotThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Lili SongThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Xin HuDepartment of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
Lu MaDepartment of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
Menglu OuyangThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Xiaoying ChenThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Chao YouDepartment of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
Craig S AndersonThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
INTERACT3 Investigators
Peking University · CNSichuan University · CNUNSW Sydney · AU

Funding

Medical Research Council MR/T005009/1
6 · The paper itself

Abstract

The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) is an international, multicenter, stepped-wedge (4 phases/3 steps) cluster randomized trial involving 110 hospitals in mainly low- and middle-income countries during 2017-2022. The aim is to determine the effectiveness of a goal-directed care bundle of intensive blood pressure (BP) lowering, glycemic control, antipyrexia, and anticoagulation reversal treatment versus usual standard of care, in patients with acute intracerebral hemorrhage (ICH). After a "usual care" period, hospitals were randomly allocated to implementing care-bundle protocols for control targets (systolic BP <140 mm Hg; glucose 6.1-7.8/7.8-10.0 mmol/L according to diabetes mellitus status; temperature ≤37.5°C; normalization of anticoagulation). A sample size of 8,360 patients (mean 19 per phase per site) provides 90% power (α = 0.05) for a 5.6% absolute improvement in the primary outcome of scores on the modified Rankin scale at 6 months, analyzed by ordinal logistic regression. A detailed statistical analysis plan (SAP) was developed to prespecify the method of analysis for all outcomes and key variables collected in the trial. The primary analysis will use ordinal logistic regression adjusted for the stepped-wedge design. The SAP also includes planned sensitivity analyses, including covariate adjustments, missing data imputations, and subgroup analysis. This SAP allows transparent, verifiable, and prespecified analyses in consideration of the challenges in conducting the study during the COVID pandemic. It also avoids analysis bias arising from prior knowledge of the findings in determining the benefits and harms of a care bundle in acute ICH.

Indexed as

COVID-19Patient Care BundlesAntihypertensive AgentsBlood PressureCerebral HemorrhageCritical CareHumansTreatment OutcomeAntihypertensive AgentsClinical trialClusterHypertensionIntracerebral hemorrhageStatistical analysis planStroke

Identifiers

PMID36063792
PMCPMC10906468
OpenAlexW4294653813

What OpenQuestion holds

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LicenceCC BY-NC
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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.