Evidence map›Paper›PMID 37612654›Full record

ArticleBMC palliative care2023

Dry mouth in patients with a life-limiting condition or frailty: a study protocol for two intervention studies and a nested qualitative sub-study (the Dry mOuth Project, DROP).

Annelot I van der Meulen, Evelien P J G Neis, Ellen J M de Nijs, Bénédicte J E G Coenegracht, Arianne Stoppelenburg, Marieke H J van den Beuken-van Everdingen, Yvette M van der Linden

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC palliative care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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.

NCT05506137 phase3unknown statusnot on this map

Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial

TypeinterventionalSponsorMaastricht University Medical CenterRan2023 to 2025Enrolled120ConditionsXerostomia, Dry MouthArmsPilocarpine, Placebo
NCT05964959 nacompletednot on this map

Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program

TypeinterventionalSponsorLeiden University Medical CenterRan2023 to 2026Enrolled70ConditionsXerostomia, End of Life, Frailty, Dry MouthArmsMouth Educational Program, Care as Usual
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  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

7 authors at 4 institutions in 1 country.

Annelot I van der MeulenCenter of Expertise in Palliative Care, Leiden University Medical Center, Leiden, Netherlands. aivandermeulen@lumc.nl.
Evelien P J G NeisCenter of Expertise in Palliative Care, Maastricht University Medical Center, Maastricht, Netherlands.
Ellen J M de NijsCenter of Expertise in Palliative Care, Leiden University Medical Center, Leiden, Netherlands.
Bénédicte J E G CoenegrachtIntegrative Supportive and Palliative Care Team, Zuyderland Medical Center, Heerlen, Netherlands.
Arianne StoppelenburgCenter of Expertise in Palliative Care, Leiden University Medical Center, Leiden, Netherlands.
Marieke H J van den Beuken-van EverdingenCenter of Expertise in Palliative Care, Maastricht University Medical Center, Maastricht, Netherlands.
Yvette M van der LindenCenter of Expertise in Palliative Care, Leiden University Medical Center, Leiden, Netherlands.
Leiden University Medical Center · NLMaastricht University · NLNetherlands Comprehensive Cancer Organisation · NLZuyderland Medisch Centrum · NL

Funding

ZonMw NL08440012010001
6 · The paper itself

Abstract

backgroundDespite its prevalent and impactful nature, dry mouth remains an underexposed and undertreated symptom in patients with a life-limiting condition or frailty. The main contributing factors are a lack of awareness and knowledge amongst both healthcare professionals and patients, and a scarcity of effective, evidence-based interventions. In the DRy mOuth Project (DROP), we address these factors by investigating both a non-pharmacological and a pharmacological intervention: a nurse-led patient education program and locally applied pilocarpine.

methodsThis intervention-based research project consists of two parallel studies. The non-pharmacological study is a cluster non-randomized controlled trial in 228 palliative nursing home and hospital patients, investigating the effect of structured use of guidelines and of patient education on dry mouth symptoms. This intervention, a nurse-led patient education program (the Mouth Education Program, MEP), will be compared to care as usual, the control. The pharmacological study is a double-blind placebo-controlled randomized trial that examines the effect of locally applied pilocarpine drops in 120 patients with dry mouth symptoms. Both studies use the same mixed-methods study design, in which the primary outcome is the clinical response to the intervention at 4 weeks, as measured by a dry mouth severity score (numeric rating scale from 0 to 10). Other outcomes, as measured by questionnaires over a 12-week follow-up period, include durability of the effect, impact on quality of life and, adherence and acceptability of the intervention. In addition, the feasibility and cost-effectiveness are evaluated by means of questionnaires and focus groups with healthcare professionals, and interviews with patients. DISCUSSION: This study investigates the effectiveness and feasibility of two interventions for dry mouth symptoms in patients with life-limiting conditions or frailty. Due to the large-scale and mixed-method nature of the study, this study will also improve our understanding of dry mouth and its relating factors and of the patients' and healthcare professionals' experiences with symptoms, care and guidelines of dry mouth, including any perceived barriers and facilitators.

trial registrationNCT05964959 & NCT05506137.

Indexed as

FrailtyXerostomiaHumansInpatientsNon-Randomized Controlled Trials as TopicPilocarpineQuality of LifeRandomized Controlled Trials as TopicPilocarpineDry MouthEducationEnd-of-Life-CarePalliative CarePilocarpinePlaceboRandomized Controlled TrialXerostomia

Identifiers

PMID37612654
PMCPMC10463805
OpenAlexW4386095325

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.