Evidence map›Paper›PMID 30287610›Full record

ArticleBMJ open2018

OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial.

James P Sheppard, Jenni Burt, Mark Lown, Eleanor Temple, John Benson, Gary A Ford, Carl Heneghan, F D Richard Hobbs, Sue Jowett, Paul Little and 8 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

10 citing papers in PubMed, 24 citations in OpenAlex.

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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

18 authors at 5 institutions in 1 country.

James P SheppardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-4461-8756
Jenni BurtThe Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, UK.ORCID 0000-0002-0037-274X
Mark LownPrimary Care Research Group, University of Southampton, Southampton, UK.
Eleanor TempleNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
John BensonPrimary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Gary A FordNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Carl HeneghanNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0002-1009-1992
F D Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Sue JowettInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Paul LittlePrimary Care Research Group, University of Southampton, Southampton, UK.
Jonathan MantPrimary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Jill MollisonNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Alecia NicklessNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Emma OgburnNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Rupert PayneCentre for Academic Primary Care, University of Bristol, Bristol, UK.
Marney WilliamsPatient and Public Involvement Representative, London, UK.
Ly-Mee YuNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0003-0331-7364
Richard J McManusNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0003-3638-028X
University of Oxford · GBUniversity of Cambridge · GBUniversity of Southampton · GBUniversity of Birmingham · GBUniversity of Bristol · GB

Funding

Department of Health IS-SPC-0514-10043Department of Health NIHR-RP-02-12-015
6 · The paper itself

Abstract

introductionRecent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without significant changes in blood pressure control at follow-up. METHODS AND ANALYSIS: This trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life. ETHICS AND DISSEMINATION: The protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central-Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001-0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: EudraCT 2016-004236-38; ISRCTN97503221; Pre-results.

Indexed as

DeprescriptionsHypertensionQuality of LifeAgedBlood Pressure DeterminationEquivalence Trials as TopicFemaleHumansMaleMultimorbidityOutcome and Process Assessment, Health CarePatient Care ManagementPolypharmacyPrimary Health CareRandomized Controlled Trials as TopicSeverity of Illness Indexantihypertensivecardiovascular diseasede-prescribingfrailtymulti-morbidity

Identifiers

PMID30287610
PMCPMC6173263
OpenAlexW2889950511

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.