Evidence map›Paper›PMID 36750953›Full record

Trial reportTrials2023

Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial.

Rebecca K Metcalfe, Mark Harrison, Joel Singer, Mary Lewisch, Terry Lee, Peter von Dadelszen, Laura A Magee, Nick Bansback, CHIPS Study Group

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01192412 (The CHIPS Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT01192412 nacompletednot on this map

The CHIPS Trial (Control of Hypertension In Pregnancy Study)

TypeinterventionalSponsorUniversity of British ColumbiaRan2009 to 2014Enrolled987ConditionsGestational HypertensionArmsIntervention is blood pressure management approach, Intervention is blood pressure management approach.
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Rebecca K MetcalfeCentre for Health Evaluation & Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada.
Mark HarrisonCentre for Health Evaluation & Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada.
Joel SingerCentre for Health Evaluation & Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada.
Mary LewischPatient Partner, BC Support Unit, 420-1367 West Broadway, Vancouver, British Columbia, V6H 4A7, Canada.
Terry LeeCentre for Health Evaluation & Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada.
Peter von DadelszenDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine, King's College London, Becket House, 1 Lambeth Palace Road, Room BH.05.11, London, SE1 7EU, UK.
Laura A MageeDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine, King's College London, Becket House, 1 Lambeth Palace Road, Room BH.05.11, London, SE1 7EU, UK.
Nick BansbackCentre for Health Evaluation & Outcome Sciences, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia, V6Z 1Y6, Canada. nick.bansback@ubc.ca.ORCID http://orcid.org/0000-0002-1510-3462
CHIPS Study Group

Funding

BC SUPPORT Unit RWCT-001CIHR MCT 87522
6 · The paper itself

Abstract

backgroundClinical trials commonly use multiple endpoints to measure the impact of an intervention. While this improves the comprehensiveness of outcomes, it can make trial results difficult to interpret. We examined the impact of integrating patient weights into a composite endpoint on the interpretation of Control of Hypertension in Pregnancy Study (CHIPS) Trial results.

methodsOutcome weights were extracted from a previous patient preferences study in pregnancy hypertension (N = 183 women) which identified (i) seven outcomes most important to women (taking medication, severe hypertension, pre-eclampsia, blood transfusion, Caesarean, delivery < 34 weeks, and baby born smaller-than-expected) and (ii) three preference subgroups: (1) 'equal prioritizers', 62%; (2) 'early delivery avoiders', 23%; and (3) 'medication minimizers', 14%. Outcome weights from the preference subgroups were integrated with CHIPS data for the seven outcomes identified in the preference study. A weighted composite score was derived for each participant by multiplying the preference weight for each outcome by the binary outcome if it occurred. Analyses considered equal weights and those from the preference subgroups. The mean composite scores were compared between trial arms (t-tests).

resultsComposite scores were similar between trial arms with the use of equal weights or those of subgroup (1) (95% confidence intervals [CIs]: - 0.03, 0.02; p > 0.50 for each). 'Tight' control was superior when using subgroup (2) weights (95% CIs: 0.002, 0.07; p = 0.03), and 'less-tight' control was superior when using subgroup (3) weights (95% CIs: - 0.11, - 0.04; p < 0.01).

conclusionsEvidence-based recommendations for 'tight' control are consistent with most women's preferences, but for a sixth of women, 'less-tight' control is more preference consistent. Depending on patient preferences, a single trial may support different interventions. Future trials should specify component weights to improve interpretation.

trial registrationClinicalTrials.gov NCT01192412.

Indexed as

Hypertension, Pregnancy-InducedPre-EclampsiaAntihypertensive AgentsFemaleHumansPregnancyAntihypertensive AgentsComposite endpointsPatient-centredPerinatalPregnancy hypertensionRandomized controlled trial

Identifiers

PMID36750953
PMCPMC9906819

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Registered trials

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.