Evidence map›Paper›PMID 33342434›Full record

Trial reportBMC medicine2020

Does paracetamol improve quality of life, discomfort, pain and neuropsychiatric symptoms in persons with advanced dementia living in long-term care facilities? A randomised double-blind placebo-controlled crossover (Q-PID) trial.

Paulien H van Dam, Wilco P Achterberg, Bettina S Husebo, Monique A A Caljouw

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2020. 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
0.8field-weighted citation impact, top 28% 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, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  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

4 authors at 2 institutions in 2 countries.

Paulien H van DamDepartment of Public Health and Primary Care, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands. P.H.van_Dam@lumc.nl.ORCID 0000-0003-1066-2457
Wilco P AchterbergDepartment of Public Health and Primary Care, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands.
Bettina S HuseboDepartment of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, University of Bergen, Bergen, Norway.
Monique A A CaljouwDepartment of Public Health and Primary Care, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands.
Leiden University · NLBergen Kommune · NO

Funding

ZonMw 83912-0006
6 · The paper itself

Abstract

backgroundThe objectives of this study are to determine the effects of regularly scheduled administration of paracetamol (acetaminophen) on quality of life (QoL), discomfort, pain and neuropsychiatric symptoms of persons with dementia living in long-term care facilities (LTCFs).

methodsA multicentre randomised double-blind placebo-controlled crossover trial for 13 weeks (January 2018 to June 2019) in 17 LTCFs across the west of the Netherlands. Inclusion criteria were age ≥ 65 years, (advanced) dementia and a moderate to low QoL, independent of the presence of pain (QUALIDEM ≤ 70). Exclusion criteria were the use of regular pain treatment, allergies to the study medication, severe liver disease, use of > 4 units of alcohol/day, weight < 50 kg and/or concomitant use of flucloxacillin. Participants received study medication (paracetamol/placebo) in two periods of 6 weeks each (1 week in between as a wash-out period). Randomisation decided in which order participants received paracetamol and placebo. Primary outcomes included QoL (QUALIDEM) and discomfort (DS-DAT), secondary outcomes included pain (MOBID-2) and neuropsychiatric symptoms (NPI-NH).

resultsNinety-five LTCF residents (mean age 83.9 years [SD 7.6], 57.9% females) were included. Repeated linear mixed models showed no difference in mean differences of QUALIDEM (paracetamol +1.3 [95% CI -1.0-3.5], placebo +1.5 [95% CI -0.7-3.8]), DS-DAT (paracetamol -0.1 [95% CI -1.4-1.2], placebo 0.6 [95 CI -0.7-1.8]), MOBID-2 (paracetamol 0.0 [95% CI -0.5-0.5], placebo -0.2 [95% CI -0.7-0.3]) and NPI-NH (paracetamol +1.5 [95% CI -2.3-5.4], placebo -2.1 [95% CI -6.0-1.7]) in favour of either paracetamol or placebo.

conclusionsCompared to placebo, paracetamol showed no positive effect on QoL, discomfort, pain and neuropsychiatric symptoms in persons with advanced dementia with low QoL. It is important to find out more specifically which individual persons with advanced dementia could benefit from pain treatment with paracetamol, and for clinicians to acknowledge that a good assessment, monitoring and multidomain approach is vital for improving QoL in this vulnerable group.

trial registrationNetherlands Trial Register NTR6766 . Trial registration date: 20 October 2017.

Indexed as

Patient ComfortQuality of LifeAcetaminophenAgedAged, 80 and overCross-Over StudiesDementiaDisease ProgressionDouble-Blind MethodFemaleGeriatric AssessmentHumansLong-Term CareMaleNetherlandsNursing HomesAcetaminophenPlacebosDementiaLong-term care facilityParacetamolQUALIDEMQuality of life

Identifiers

PMID33342434
PMCPMC7751102
OpenAlexW3115577186

What OpenQuestion holds

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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.